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National ProfileChemicals Management in Germany

S. FellerU. Kowalski

U. Schlottmann

National Profile

Chemicals Managementin Germany

Dortmund/Berlin/Dresden 2005

Editorial staff: Silke Feller, Ulrike KowalskiDivision 5 „Chemicals, Notification and Authorisation“ of theFederal Institute for Occupational Safety and HealthTelephone: +49 231 - 90 71 - 23 19 / 25 16Telefax: +49 231 - 90 71 - 26 79E-Mail: [email protected]

Prof. Dr. Ulrich SchlottmannFederal Ministry for the Environment, Nature Conservationand Nuclear SafetyTelephone: +49 18 88 - 3 05 - 27 40Telefax: +49 18 88 - 3 05 - 35 24E-Mail: [email protected]

Publisher: Federal Institute for Occupational Safety and HealthFriedrich-Henkel-Weg 1-25, D-44149 Dortmund, GermanyTelephone: +49 231 - 90 71 - 0Telefax: +49 231 - 90 71 - 24 54E-Mail: [email protected]: www.baua.de

Berlin:Nöldnerstr. 40-42, D-10317 Berlin, GermanyTelephone: +49 30 - 5 15 48 - 0Telefax: +49 30 - 5 15 48 - 41 70

Dresden:Proschhübelstr. 8, D-01099 Dresden, GermanyTelephone: +49 351 - 56 39 - 50Telefax: +49 351 - 56 39 - 52 10

All rights reserved, including photomechanical reproductionand the reprinting of extracts.

http://www.baua.de

3

OVERVIEW OF CONTENTS

Introduction 9

Chapter 1 Background information 11

Chapter 2 Production, export/import and use of chemical substances 17

Chapter 3 Special environmental problems with chemical substances 22

Chapter 4 Statutory regulations and voluntary agreements 29

Chapter 5 Procedures, participating ministries and authorities 57

Chapter 6 Non-governmental organizations 81

Chapter 7 Cooperation between the federal and regional authorities as well as with further participating institutions 86

Chapter 8 Data stocks and databases 96

Chapter 9 Technical infrastructure 103

Chapter 10 International relations 105

Annexes 107

4

5

LIST OF CONTENTS

Introduction 9

Chapter 1 Background information 111.1 Basic geographical and demographic conditions 11

1.2 Politico-geographical structure 13

1.3 Industry and agriculture 15

Chapter 2 Production, export/import and use of chemical substances 17

2.1 Turnover, numbers of employees, export/import 17

2.2 Use of chemicals according to classes of substances 19

2.3 Chemical wastes and environmental pollution 20Chemical wastes 20Environmental pollution 21

Chapter 3 Special environmental problems with chemical substances 22

Example: drinking water 23Example: soil protection 24

Chapter 4 Statutory regulations and voluntary agreements 294.1 Basic administrative framework 29

4.2 Statutory regulations 294.2.1 Chemicals management in the narrower sense 30

4.2.1.1 General legislation on hazardous substances 30EC Regulations, directives and guidelines 30National laws and guidelines 33National ordinances 34National administrative provisions 35Technical Rules for Hazardous Substances (TRGS) 35

4.2.1.2 Special legislation on hazardous substances 35Biocides 36Plant protection products and fertilizers 37Pharmaceuticals 40

4.2.2 Chemicals management in the wider sense 41Laundry and cleaning products 41Foodstuffs and commodities 42Waste law 43Immission control 45Protection of aquatic environments 48Protection of the soil 49Animal welfare 49Chemical weapons 49Transport of dangerous goods 50Narcotic drugs and psychotropic substances 50

4.2.3 Additional regulations specific to individual Länder 52

6

4.3 Voluntary agreements with the chemical industry 54Self-imposed obligations on the part of the associations of the chemical industry at national level 54Self-imposed obligations on the part of the associations of the chemical industry at Länder level 56

Hamburg 56Lower Saxony 56North Rhine-Westphalia 56

Chapter 5 Procedures, participating ministries and authorities 575.1 General legislation on hazardous substances 57

5.1.1 Procedure for new chemical substances 57General information on the duty to notify chemical substances 57Tonnage-related procedure 58Prior inquiry duty / utilization of existing test reports 58Good laboratory practice (GLP) 58Submission of the notification documents 59

5.1.2 European procedure for existing chemical substances 605.1.3 International activities concerning existing chemical substances 61

5.1.3.1 OECD High Production Volume (HPV) Chemicals – Programme / Screening Information Data Sets (SIDS) 635.1.3.2. ICCA High Production Volume (HPV) Chemicals Initiative 63

5.1.4 Marketing, production and use of chemicals 64Classification 65Labelling, safety data sheet 65Prohibitions and restrictions 65Occupational safety rules 66Notification duty in the case of new knowledge about carcinogenic, mutagenic or reproductivetoxic properties of chemical substances 65

5.1.5 Export/Import of dangerous substances, PIC procedure 67Notification procedure for the export from the EU of certain dangerous chemicals 67Prior Informed Consent (PIC) procedure 67Labelling rules 67General export ban 67The European Commission's database "EDEXIM" 68Import notifications by non-EU countries 68

5.1.6 CFC regulations 70

5.2 Special dangerous substances legislation 715.2.1 Biocides 72

5.2.1.1 Procedure for active biocidal substances 725.2.1.2 Procedure for biocidal products 735.2.1.3 Further procedures 745.2.1.4 Biocide procedures at other authorities 75

5.2.2 Pharmaceuticals 765.2.3 Plant Protection Products 77

5.3 Dangerous substances legislation in the wider sense 775.3.1 Laundry and cleaning products 775.3.2 Transport of dangerous goods 785.3.3 Chemical weapons 80

Chapter 6 Non-governmental organizations 816.1 Industry associations 81

6.1.1 The Chemicals Industry Association (VCI) 816.1.2 The Agricultural Industry Association (IVA) 826.1.3 The Chemical Trading Association (VCH) 82

6.2 German Statutory Accident Insurance Institutions and trade unions 826.2.1 The Federation of German Statutory Accident Insurance Institutions for the Industrial Sector (HVBG) 82

7

6.2.2 The Industrial Trade Union for the Mining, Chemicals and Energy Industries (IG BCE) 83

6.3 Environmental and consumer protection organizations 836.3.1 Exemplified by Greenpeace 846.3.2 Exemplified by the non-profit Federation of German Consumer Organizations (vzbv) 84

6.4 Scientific organizations 85Exemplified by the Society of German Chemists (GDCh) 85

Chapter 7 Cooperation between the federal and regional authorities as well as with further participating institutions 86

7.1 Interministerial commissions and general coordination mechanisms 86Federal/regional Committee on the Safety of Chemicals (BLAC) 86Federal/regional Working Group on Environmental Information Systems (BLAK-UIS) 86Federal/regional Expert Committee "Transport of Dangerous Goods" (BLFA-GG) 86Commission for the Identification and Treatment of Symptoms of Poisoning (Poison InformationCentres, GIZ) 86Regional Committee on Protection against Immissions (LAI) 87Regional Working Group on Water (LAWA) 87Regional Working Group on Waste (LAGA) 87Regional Committee on Soil Protection (LABO) 87Regional Committee on Occupational Safety and Safety Technology (LASI) 87Committees for the Harmonization of Procedures for the Notification of New and Existing ChemicalSubstances 87Committee for Harmonization Within the Biocide Procedure 87Committee on Hazardous Substances (AGS) 88MAK Commission 88Advisory Committee on Existing Chemicals of Environmental Relevance (BUA) 88

7.2 Enforcement at regional level 887.2.1 Hamburg 88

Enforcement of the Chemicals Act 88Enforcement of the rules on the transport of dangerous goods 91Enforcement of the Foodstuffs and Commodities Act 92

7.2.2 Saxony 93Enforcement of the rules and regulations on chemicals 93Enforcement of the rules and regulations on plant protection 94Enforcement of the rules and regulations on waste and soil protection 95Enforcement of the rules and regulations on water 94

Chapter 8 Data stocks and databases 968.1 Databases available to the Federal Institute for Occupational Safety and Health, Division 5 (own and external) 96

• Admin (administration relating to the Chemicals Act) 96• NST database for new chemical substances 96• EINECS (European Inventory of Existing Chemical Substances) 97• IUCLID database for existing chemical substances 97• BUA substance reports 98• EDEXIM and the national database EPA notification 98

8.2 Joint substance-data pool shared by the Federal Government and the Länder (GSBL) 99

8.3 Joint Länder Database on Hazardous Substances (GDL) 100

8.4 Central substance-data pool 100

8.5 Further databases 101

8

Chapter 9 Technical infrastructure 1039.1 GLP Procedure 103

9.2 Good professional practice 104

Chapter 10 International relations 10510.1 Participation in international organizations and bodies 105

10.2 Technical assistance projects 105

Annexes 107Annex 1: List of abbreviations 107

Annex 2: Address List 111Federal Authorities 111Regional Authorities 112International Institutions 113Non-governmental Organizations 114

9

Introduction

In 1992 Rio de Janeiro was the setting for a United Nations Conference on Environment andDevelopment (UNCED). Known by the general public as the Rio Conference, it succeeded inturning "sustainable development" into a key international goal. The more than 170 participat-ing countries passed Agenda 21, a programme of action for the 21st century. Implementationof the aims described in Agenda 21 is monitored by the Commission on Sustainable Develop-ment (CSD).

Chapter 19 of Agenda 21 contains objectives for environmentally compatible handling of toxicchemicals, including measures for the prevention of the illegal international trade in toxic anddangerous products. An essential part of chapter 19 concerns the coordination of internationaland regional activities as well as the intensification of international cooperation.

For the purpose of controlling compliance with Chapter 19 and its harmonized implementation,in April 1994 the United Nations Environment Programme (UNEP), the International LabourOrganization (ILO) and the World Health Organization (WHO) held the Chemical Safety Con-ference in Stockholm. It was at this conference, which was attended by participants from 130countries, that the Intergovernmental Forum on Chemical Safety (IFCS) was established. TheIFCS elaborates recommendations for governments as well as for international and transna-tional organizations.

As an important element in improving global cooperation in the field of chemicals safety, theIFCS recommends that, as a matter of urgency, the individual states take stock of the nationalstructures for chemicals management in the form of a so-called "National Profile" (NP). Theaim of the National Profile is to provide relevant information on the areas of responsibility andprocedures associated with chemical substances as well as to make statements on the effec-tiveness of the specific rules and regulations. In addition, the National Profiles from the indus-trialized nations can serve as a model for developing countries and countries undergoing eco-nomic change. Together with the IFCS secretariat, the United Nations Institute for Training andResearch (UNITAR) has published a guidance document which, by laying down a structureand providing useful advice on how to proceed, assists in the production of a NP and helpsensure international comparability. So far, almost 50 countries have published a NP, e.g.:Australia, France, Ghana, Indonesia, Canada, Mexico, Nicaragua, Switzerland, Slovenia,Hungary, and the USA.

At the beginning of 1997 the Federal Environment Ministry asked the Federal Institute forOccupational Safety and Health (BAuA) � Division 5 � chemicals, notification and authoriza-tion - in Dortmund to produce a NP for Germany. This task is to be seen against the back-ground of the fact that the Federal Institute for Occupational Safety and Health � Division 5 isthe central coordinator for the notification procedure according to the Chemicals Act as well asthe competent authority for the enforcement of the following European regulations and agree-ments: the export-import regulation, the Rotterdam Convention on protection against the im-port of dangerous chemicals, the existing substances regulation, the regulation on CFCs andthe Montreal Protocol. Since June 2002 Division 5 of the Federal Institute for OccupationalSafety and Health is additionally the authorization unit for biocidal products.

The positive expectations associated with the publication of a NP for Germany such as

• increased effectiveness of the work performed by the government/authorities through theprovision of clear information on chemicals management;

10

• initiation or simplification of the information-exchange and dialogue procedures betweenauthorities on the one hand and between authorities and non-governmental organizationson the other;

• the provision of more comprehensive information to the general public and to industry bymeans of readily comprehensible descriptions of areas of responsibility;

• critical analysis of the procedural channels in order to avoid duplication of work,

have largely been met by the first edition in 2000. The first edition of the NP has made an im-portant contribution towards enabling participating groups and any interested party to acquirean overview of chemicals management in Germany.

New and amended rules and regulations as well as a reorganization of authority structureshave made a new edition an urgent necessity. It was only possible to undertake revision of theexisting content of the first edition. Continuation of the work on the NP in the form of closinggaps in content was not possible.

The National Profile is also available in the English language.

The editorial team wishes to thank all who have supported the production of the NP.

Further advice, corrections and additions will be gratefully received.

Dortmund, December 2004

The editorial team

11

Chapter 1 Background information

1.1 Basic geographical and demographic conditions

From the North Sea and the Baltic to the Alps in the south, the Federal Republic of Germany isdivided geographically into the North German Plain, the Central German Upland Range, theSouthwest German Central Upland Scarps, the South German Alpine Foreland and the BavarianAlps. The total area amounts to 357 022 km².

At 53.5% of the total area, agriculture accounts for the greatest share of land utilization. Forestareas make up 29.5 %. Traffic infrastructures and settlements constitute approx. 12.3 %. Theremainder is divided up between aquatic environments, marshlands and land left in a natural state.

The climate in Germany is temperate and the weather very changeable. The average monthlytemperatures are between -6° C in January and + 20° C in July, the average annual tempera-ture amounting to +9° C. Prevalent west winds as well as precipitation throughout the year,with annual amounts of between 500 and 700 mm in the lowland plain region of northern Ger-many and up to more than 2,000 mm in the Alps, are typical. The climate zones are dividedinto a maritime climate in the north and a continental climate in central Germany and thesouth.

The official national language is German. The capital city is Berlin, the seat of governmenthaving transferred from Bonn to Berlin in 1999.With 82 million inhabitants (230 inhabitants per km2), German is densely populated. Thegreatest population density is to be found in the Ruhr area, along the Rhine, in the areaaround Halle and Leipzig as well as in a few city conurbations in the south of the country.

12

The most densely populated cities are Berlin (3.4 million), Hamburg (1.7 million) and Munich(1.2 million).

Population according to sex and nationality in the year 2003Male: 40 359 000 German: 75 183 400Female: 42 172 600 other: 7 348 300

Birth rate: 1.35 children per woman

Level of education (persons over 15 years old)

45,3%

20,1%

19,2%

7,5%

4,6%0,9%2,4%

still in education no qualifications secondary modern school unified comprehensive schoolsecondary school leaving certificate or similarcollege/university entrance qualificationno data

13

No. of employed persons: 38.2 mio.of whom 47.1% women

Unemployment rate: 10.5%

Percentage of persons employed in particular sectors of the economy

agricultural industry

2,4%

service industries

44,3%

commerce, catering

and transport

25,5%

manufactur-ing industry

(with buildung industry)

27,8%

Percentage of employed persons according to professional status

civil servants6,4%

workers30,2%

employees51,8%

self-employed10,3%

assisting members of the family

1,3%

(Source: Federal Statistics Office: 2002)

1.2 Politico-geographical structure

The Federal Republic of Germany is a federal constitutional state comprising the 16 Länder:

Land Population Area | Land Population Area

Baden-Württemberg 10.6 mio. 35 751 km²| Bavaria 12.3 mio. 70 554 km²Berlin* 3.4 mio. 891 km²| Brandenburg 2.5 mio. 29 476 km²Bremen* 0.6 mio. 404 km²| Hamburg* 1.7 mio. 755 km²Hesse 6 mio. 21 114 km²| Mecklenburg-W-Pomerania 1.8 mio. 23 173 km²Lower Saxony 7.9 mio. 47 617 km²| North Rhine-Westphalia 18 mio. 34 082 km²Rhineland-Palatinate 4 mio. 19 849 km²| Saarland 1 mio. 2 570 km²Saxony 4.3 mio. 18 413 km²| Sachsen-Anhalt 2.5 mio. 20 444 km²Schleswig-Holstein 2.8 mio. 15 762 km²| Thuringia 2.4 mio. 16 172 km²

(* city states)

The Lower House of the German Parliament is the body which represents the will of thepeople. It currently consists of 601 members of parliament who are elected for a period offour years according to an electoral system combining elements from majority voting andproportional representation. Via the Upper House the Länder participate in legislation andthe administration of the Federal Government. The Upper House consists of the minister-presidents and other representatives of the regional governments.

The Head of State is the Federal President, a role which is largely representative. As a rule,a politician from the largest political group in the Lower House of Parliament assumes theoffice of Federal Chancellor. It is the Chancellor's task to lay out policy guidelines.

14

By means of the separation of powers, the state's responsibilities � legislative power, execu-tive power and the administration of justice - are divided between the state organs - parlia-ment, governments, including administrations - and the courts. Executive power and the ad-ministration of justice are bound by the law. Legislative power is in turn bound by the consti-tutional order (the German Constitution).

State responsibilities are divided up between the Federal Government and the 16 Länder.The Constitution of the Federal Republic of Germany guarantees the separation of legislativepowers between the Federal Government and the Länder as well as the execution of Federallaws.

The Federal Government has solelegislative power, inter alia, in theareas relating to foreign policy,defence, currency, customs duties,air transport and the postal serv-ice.

The 16 Länder possess the qualityof states. They have their ownpower of jurisdiction � albeit onelimited to specific areas � whichthey exercise through their ownlegislative acts, enforcement andadministration of justice.

The task of administrative en-forcement of federal laws and,therefore, of exercising the powersvested in the State mainly falls tothe Länder. Federal Authoritiesassume responsibility for matterswhich require uniform enforcementthroughout the country but not alocal presence of the competentauthority.

15

1.3 Industry and agriculture

In 2003 the gross domestic product amounted to 2,129.20 thousand million euros.

The contribution of the individual economic sectors to the gross domestic product can be meas-ured according to the gross value which they add. The gross value added is the sum of thegoods and services produced by domestic economic units or economic sectors minus the mate-rials and services (e.g. raw materials, primary products, merchandise, repair services) pur-chased from other economic units or other economic sectors.

Gross value added according to economicsectors in %

3 0 , 51 , 1 4 , 2

2 1 , 7

2 4 , 5

1 8

a g r ic u l t u r e , f o r e s t r y ,f is h in g in d u s t r y

m a n u f a c t u r in gin d u s t r y ( w i t h o u tb u i ld in g in d u s t r y )

c o m m e r c e ,t r a n s p o r t , c a t e r in g

p u b l ic a n d p r iv a t es e r v ic e p r o v id e r s

f in a n c in g , le t t in g ,c o r p o r a t e s e r v ic ep r o v id e r s

b u i ld in g in d u s t r y

Germany has only an insufficient supply of non-renewable natural resources. Significant mineralresources include, inter alia, brown coal and hard coal, iron ore, some petroleum and naturalgas as well as mineral salts.

Both with regard to imports and exports Germany takes second place in world trade behind theUnited States and ahead of Japan. In 2002 goods to the value of 651.3 thousand million euroswere exported and goods amounting to 518.5 thousand million euros imported. Since approxi-mately 72 % of German exports and imports remain in Europe or come from Europe, Germany�smost important sales and employment markets are based in Europe. In the form of the UnitedStates, Japan and China, only three of the ten most important trade partners were located out-side Europe.

16

Germany’s largest trade partners 2002 in thousand million euros

69 68

5447

4034 31 29 27

16

01020304050607080

France UnitedStates

UnitedKingdom

Italy Netherlands Austria Belgium Spain Switzerland Poland

data in thousand million euros

Export

4841 40

33 3325

21 21 20 19

0

10

20

30

40

50

60

France Netherlands UnitedStates

Italy UnitedKingdom

Belgium China Austria Japan Switzerland

data inthousandmillioneuros

Import

(Source: Federal Statistics Office)

17

Chapter 2 Production, export/import and use ofchemical substances

2.1 Turnover, numbers of employees, export/import

The chemical industry accounts for a significant share of the German economy. It is impossibleto imagine many areas of life without chemical products. They make a wide-ranging contributionto increased prosperity.

2 0 8 , 6

5 4 , 3

1 2 , 7

4 4 4

8 3 7

4 9 9

2 5 8

1 0 4

1 0 8 , 7

1 4 4 , 3

1 5 1 , 7

1 1 3 , 3

9 5 4

7 7 3

0 2 0 0 4 0 0 6 0 0 8 0 0 1 0 0 0 1 2 0 0

m o t o r v e h i c l e s a n dv e h i c l e p a r t s

c h e m i s t r y

m e c h a n i c a le n g i n e e r i n g

o f f i c e e q u i p m e n t , D Pe q u i p m e n t

f o o d i n d u s t r y

m e t a l p r o d u c t i o n a n dw o r k i n g

t e x t i l e t r a d e

n u m b e r o f e m p l o y e d p e r s o n s i n 2 0 0 3 i n t h o u s a n d st u r n o v e r i n 2 0 0 3 i n t h o u s a n d s o f m i l l i o n s o f e u r o s

(source: VCI)

In 2003 the turnover per employee amounted to 293,830 euros. By comparison, a turnover of221,400 was achieved per employee in manufacturing industry.

The world turnover for chemicals amounted to over 1,600 thousand million euros in 2003. Be-hind the USA and Japan but ahead of France, China and Italy, Germany is the third largest pro-ducer of chemicals in the world. The position of the German chemical industry within Europe isexceptional: in 2003 it had a share of over 25 % of the turnovers for chemical products in theEuropean Union and provided more than one in four jobs in the chemical industry within the EU.

In 2003 chemical products to the value of 87.4 thousand million euros were exported from Ger-many. Germany is therefore the �world champion� in terms of exports.

However, with regard to these data it is necessary to take account of the fact that, as a result ofglobalization, international comparison of turnover figures is becoming increasingly difficult. Anever-greater percentage of the turnover is namely being generated by German subsidiariesabroad, something which these statistics fail to record. The importance of the foreign branchesis meanwhile almost as great as that of the companies at home: in 2002 401,000 employees inthe foreign branches generated a turnover of 124.5 thousand million euros.

18

51% of the turnover in the chemical industry was achieved in Germany, 49% abroad. With apercentage share of worldwide chemical exports of 15.5%, Germany was the world's leadingexporter of chemicals in 1996, ahead of the United States, France and Japan.

E xp ort o f ch e m ica l p ro d u cts in 2 00 3 in th o us an d s o f m illion s o f eu ro s

44 .6 91

6.34 88 .5 29 9 .16 9

18 24 ,1

4 88 6,2

2 54 6,112 08 ,1 71 1,3

0

5 .00 0

10 .00 0

15 .00 0

20 .00 0

25 .00 0

30 .00 0

35 .00 0

40 .00 0

45 .00 0

50 .00 0

E U c ou n tries

o th er w es t E u ro pe an co u ntries

C E E (in c lu d in g C IS )

N A FT A

L a tin A m e ric a

E as t As ia w ith o u t J ap an

oth er As ia n c o un trie s

Afric a

Au stra lia /O ce an ia

Import of chemical products in 2003 in thousands of millions of euros

38.283

4.1302.214

6.473

301,5 1696,2 779,1 249,6 105,40

5.000

10.000

15.000

20.000

25.000

30.000

35.000

40.000

45.000

EU countriesother west European countriesCEE (including CIS)NAFTALatin AmericaEast Asia without Japanother Asian countriesAfricaAustralia/Oceania

EU countries: Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg,Netherlands, Austria, Portugal, Spain, Sweden, United Kingdom

Other west-europ. countries: Iceland, Liechtenstein, Norway, Switzerland, TurkeyCEE (incl. CIS): Croatia, Poland, Romania, Russian Federation, Slovakia, Slovenia, Czech Republic, Ukraine, Hun-

garyNAFTA countries: Canada, Mexico, United StatesLatin America: Argentina, Brazil, Chile, ColumbiaEast Asia without Japan: The People’s Republic of China, Hong Kong, Indonesia, Republic of Korea, Malaysia, Philippines,

Singapore, Taiwan,Thailand,(source: VCI)

19

2.2 Use of chemicals according to classes of substances

The chemical industry has an extremely wide range of products, extending from intermediatesfor manufacturing processes in other branches of industry to finished products in areas relatingto the environment, health and nutrition.

4 8 ,4 7

2 2 ,4 4

7 ,7 3

7 ,8 4

3 ,1 7

0 ,9 3

9 ,4 2

0 1 0 2 0 3 0 4 0 5 0 6 0

P ro d u c t io n in d e x fo r 2 0 0 2 in %

b a s ic c h e m ic a l s u b s ta n c e s

p h a rm a c e u t ic a l p ro d u c ts

s o a p s , la u n d ry a n d c le a n in gp ro d u c ts , b o d y -c a re p ro d u c ts

p a in ts , p r in t in g in k s a n d f i lle rs

s y n th e t ic f ib re s

p e s t ic id e s a n d p la n t p r o te c t io np ro d u c ts

o th e r c h e m ic a l p ro d u c ts

The sales structure of chemical products has hardly changed over recent years. The largest partremains within the chemical industry itself, followed by the areas relating to the health service,the automobile industry, private consumption and the building industry.

21,7

9,9

13,8

10,4

6,5

5,9

1,9

2,3

3,1

4,3

11

0 5 10 15 20 25

sales structure for 2002 in %

chemical industry

private consumption

health service

motor vehicle industry

building industry

agriculture

textile industry

paper industry

electronics industry

packaging industry

others

(source: VCI)

20

2.3 Chemical wastes and environmental pollution

Chemical wastes

As a result of changes made to processes and the increased utilization of waste in the chemi-cals industry, it is generally possible to observe a clear reduction in the quantities of waste re-quiring disposal.

Year Wastes requiring disposal(in millions of tonnes)

1995 3.971996 2.371997 2.5519981999

2.132.00

Waste requiring spe-cial monitoring

Waste not requiringspecial monitoring

200020012002

0.910.991.10

1.491.201.10

(As from the year 2000 the wastes intended for disposal were for the first time recorded separately according to�wastes requiring special monitoring� and �wastes not requiring special monitoring�. This represented adaptation toreporting in the EU).

(Source: VCI)

To the greatest possible extent, the cross-border shipment of wastes is regulated by provisionscontained in European legislation. In Germany, rules relating to this area are to be found in theEC Regulation on the supervision and control of shipments of waste within, into and out of theEuropean Community and the law on the supervision and control of cross-border shipments ofwastes. Both the European and German regulations transpose the "Basle Convention of22.03.1989 on the Control of Transboundary Shipment of Dangerous Wastes and their Dis-posal".

According to the EC regulation on the supervision and control of shipments of waste, the export,import and transit of wastes are only permitted after all relevant countries have been notifiedand have given prior informed consent. With few exceptions, the shipment of notifiable wastesto states not belonging to the OECD or EU is prohibited. The exporter and, in a supporting ca-pacity, the country of origin are responsible for compliance with the demands of the EC regula-tion on the supervision and control of shipments of waste. The duty to return the waste exists inthe case of failed or illegal shipments.

21

Export of notifiable wastes in 2003

(Source: Federal Environmental Office)

Export in total: 907 000 t- for utilization 843 000 t- for disposal 64 000 t- hazardous wastes 186 000 t

Import of notifiable wastes in 2003

(Source: Federal Environmental Agency)

Import in total 4 854 000 t- for utilization 4 223 000 t- for disposal 631 000 t- hazardous wastes 1 244 000 t

Environmental pollution

In the past the improper use of chemical substances and the environmentally incompatible dis-posal of wastes has resulted in extensive soil contamination. Above all, soil contamination dueto heavy metals, active substances and mineral-oil products must be mentioned in this connec-tion. Old production sites such as those found in brown-coal excavation and uranium mining inthe new federal states as well as the former military training areas there represent a particularproblem. In the old and new federal states about 362,689 areas are suspected of being hazard-ous waste sites (as at 2000).

The restoration of hazardous waste sites and the proper disposal of unavoidable wastes are anessential contribution to environmental protection. Which disposal procedure is used in a par-ticular case depends on the type and quantity of the waste, in particular on the risk potential.Account must be taken of the fact that during air cleaning measures, waste-water treatment orwaste disposal new hazardous wastes may also occur which, in turn, have to be disposed of inan environmentally compatible way. As far as possible, the wastes occurring in the chemicalindustry during secondary reactions and cleaning stages should be used as raw materials ordisposed of in the works itself.

In the years 1995-2001 the German chemical industry spent almost 20 thousand million euroson end-of-pipe environmental protection. During this period it invested almost 2.8 thousand mil-lion euros in end-of-pipe environmental equipment, so-called additive environmental protection.Measures for the protection of aquatic environments and air pollution control accounted for mostof the investment. Thus far the statistics do not record measures by means of which emissionsor water pollution are avoided at the outset, for example, through changes in production tech-nology. These measures are assuming increasing importance.

22

Chapter 3 Special environmental problems with chemicalsubstances

The following problem areas have been identified:

Problem Scale ofproblem

Level ofconcern

Ability tocontrolproblem

Availability ofstatistical data

Specific chemi-cals causingconcern

Priority ranking

(1=high - 5=low)

Marine pollu-tion

Local,regional,national,global

Dependenton thesubstance

Dependenton thesubstance

Insufficient 1998: OSPAR &HELCOM conven-tion

Reduction measuresfor mercury, orga-notin compounds,musk xylols

Priority measures arebeing elaborated ona priority basis for afurther 24 sub-stances (e.g. lindane,PCBs, cadmium).

1

Pollution ofaquatic envi-ronments

National

interna-tional

High Medium Insufficient Pesticides (pro-tected asset:drinking watersupply)

Agriculture:

Diuron, isoproturon,terbutylazine, di-chlorprop, mecoprop,atrazine, chloridazon,chlorotoluron, lin-dane

Production:

River Rhine: Chlorid-azon, diuron, meta-benzthiazuron,melamitron, thi-azaphos

RiversElbe/Saale/Mulde:

Ametryn, dimethoate,parathionmethyl,prometryn, propa-zine, lindane, atra-zine, simazine

Industrial chemi-cals:

Dichloromethane,hexachlorobenzene,trichloromethane,nitrobenzene, 1,4-dichlorobenzene

2

23

Problem Scale ofproblem

Level ofconcern

Ability tocontrolproblem

Availability ofstatistical data

Specific chemi-cals causingconcern

Priority ranking

(1=high - 5=low)

Ground waterpollution

Local,regional

Medium,high

Low Insufficient

Data source:

Nitrates:

Nitrate report pro-duced by LAWA

Pesticides:

PSM report producedby LAWA (in print)

N-containing fertiliz-ers

Pesticides, wide-spread critical pesti-cides are listed indetail (PSM reportproduced by LAWA,annex 9)

N-containing fertilizers:

1

Pesticides:

1-2

Drinking wa-ter contami-nation

Local Low High Sufficient Nitrates

Pesticides (atrazine)

Contamination ofareas after the de-parture of the militaryand industrial pro-duction sites

3

Hazardouswaste

Disposal /removal

National High High

(for thepurpose ofoccupa-tionalsafety andhealth =medium)

Sufficient

(for the purpose ofoccupational safetyand health = insuffi-cient)

PCB, CFCs 2

Storage /disposal ofobsoletechemicals

National High Medium Insufficient PCP

PCDD/PCDF

2

PersistentOrganicPollutants(POP)a)

Global/national

SomePOPs suchas PCB orPCDD/Fcause localproblems(contami-nated sites)

Low

(for pesti-cide POPs)

Medium(for otherPOPs,mostlyoccurringas by-products)

High Databases/ monitor-ing of individualPOPs (e.g. PCB,PCDD):

Information systembelonging to theenvironmental sam-ple bank

Dioxin database(inter alia, all of thereports from theLänder are enteredhere)

PCB

PCDD/PCDF

4

a) The data refer to the substances currently identified by UNEP as priority POPs

Example: drinking water

The management of water resources, including ensuring an adequate supply of water in termsof both quantity and quality, has always been one of the tasks a community has had to perform.It represents the oldest environmental protection task of all. Consequently, the protection ofaquatic environments includes protecting the environmental medium water against pollution andagainst too many demands being made upon it.

Only a few problems exist with regard to drinking water, e.g. lead in old drinking-water pipes. Ingeneral, the monitoring and control of the quality of drinking water as well as the quality of thesources and resources comply with European guidelines. Problems which do exist result fromthe fact that, in part, one and the same region is used for both the extraction of ground andsurface water for the purpose of providing drinking water as well as for the cultivation of agri-cultural products (e.g. wine and asparagus).

24

Water pollution arising from the abandonment of military bases and industrial production sitesalso has a problematical impact on the protection of sources and resources.

Legislation on water protection and legislation on hazardous substances overlap. Their sub-stance-related and medium-related regulatory approaches are also interlinked. This applies tothe rules for restricting the use of agricultural chemicals in the interest of water and soil protec-tion as well as to protection against chemical accidents.

The act of spreading fertilizers on areas of land used for agricultural purposes does not consti-tute a case of water utilization even if the fertilizers which are washed out may enter surfacewaters. As a rule, fertilizers are used to improve the fertility of the soil. The Federal Govern-ment's concept for soil protection which, inter alia, has had an influence on the Federal SoilProtection Act, provides for a reduction in the release of harmful substances such as cadmium,heavy metals, nitrate and persistent organic compounds resulting from the use of plant protec-tion products, fertilizers and sewage sludge.

Example: soil protection

Soil protection and hazardous waste sites number among the current topics in the area of envi-ronmental protection.

The soil is a sink for contaminants. As a rule, the contaminants which are released into the soilremain there for long periods. They may then slowly seep into the ground water and enter theplants growing there or they may be dispersed or released as gas.

Hazardous waste sites are themselves sources of contaminants for the surrounding soil, theground water and the air. Consequently, when their emissions pose a risk, hazardous wastesites must be dealt with actively and restored.

The Federal Soil Protection Act (BBodSchG), which came fully into force on the 01.03.1999,was enacted in order to safeguard or restore sustainably the functions of the soil. As a subordi-nate body of regulations the Federal Soil Protection and Hazardous Site Ordinance came intoforce on 17.07.1999. It regulates the requirements for the investigation and assessment of soilcontamination as well as restoration and restriction measures and lays down soil values. Thislegislation therefore improves the prevention of adverse changes to the soil and creates legaland investment-related certainty by placing uniform demands on hazard prevention throughoutthe Federal Republic of Germany.

Restoration technologies are continuously being further developed or refined, inter alia, in orderto increase the effectiveness of the acts of restoration while keeping costs at an acceptablelevel.

The Federal Soil Protection Act differentiates between hazardous waste-disposal sites and haz-ardous waste sites. Hazardous waste-disposal sites include waste removal plant which hasbeen shut down and other sites on which waste has been treated, stored or disposed of. Haz-ardous waste sites include plant which has been shut down and other industrially utilized siteson which environmentally dangerous substances have been handled. However, contaminationcaused by agricultural or horticultural uses as well as contamination resulting from warfareagents or nuclear fuels is excluded here. Areas suspected of being hazardous waste sites arehazardous waste-disposal sites or hazardous waste sites about which there is concern that theymay adversely affect the public good.

25

The general restoration aim of the Federal Soil Protection Act is therefore to permanently avertdangers. Decontamination and safeguarding measures may be employed to avert dangers aslong as they ensure that dangers are permanently averted. In order to ensure this, monitoringand the subsequent restorability of the safeguarding effect are required in the case of safe-guarding measures and, in particular, with regard to other protection and restriction measures.An additional rule for so-called "new cases" states that in instances where soil contamination orhazardous waste sites occur after the Act has come into force, removal of the contaminants(decontamination) shall always have priority over other restoration measures, account beingtaken here of the extent of the prior contamination.

Sequence of the work on hazardous waste sites

The first stage of work on hazardous waste sites involves the systematic and comprehensiverecording and geographical localization of areas suspected of being hazardous waste-disposalsites or hazardous waste sites as well as the gathering or additional ascertainment of all of theinformation which is available on them. During the information-gathering phase, particular im-portance attaches to questions concerning possible effects of relevance to contamination andthe possible contaminant inventory.

The data-recording phase is followed by a decision on whether, and how intensively, work onareas suspected of being hazardous waste-disposal sites or hazardous waste sites should con-tinue, i.e. on whether they have to be examined and, if necessary, restored. Thorough researchof all available data creates the requisite basis for further rational planning of a programme ofinvestigation into an area suspected of being a hazardous waste-disposal site or a hazardouswaste site.

Responsibility

According to the German Constitution, the Länder have the responsibility of recording hazard-ous waste sites, estimating the risk posed by them, and restoring them. On the basis of wastelaw and general police-law and water-law clauses contained in legislation pertaining to theLänder, the relevant competent authorities are authorized to record areas suspected of beinghazardous waste-disposal sites or hazardous waste sites.

The current state of the recording process

The hazardous waste site registers in the Länder were developed and structured even beforethe federal soil protection rules came into force. The differences in the data recording and dataadministration caused by this prevent direct comparability of the statistics.The data which the Länder have made available to the Federal Environmental Agency can befound in the following table. It reflects the state of the recording of areas suspected of beinghazardous waste sites in the individual Länder.

At the initiative of the hazardous waste site committee of the Länder, work is on harmonizationof the data is now in progress.

26

National overview of the recording of hazardous waste sites

Table showing the number of areas suspected of being hazardous waste-disposal sites or hazardous waste sites inthe Federal Republic of Germany on the basis of the data conveyed by the Länder.

(Data compiled by the Federal Environmental Agency on the basis of information provided by the Länder as at De-cember 2000)

LänderNumber of recorded

hazardous waste-disposal sites

hazardous wastesites

total areas

Baden-Württemberg 6,229 11,567 17,796Bavaria 10,034 3,295 13,329Berlin 763 6,220 6,983Brandenburg 8,189 14,447 25,313*Bremen 173 18,154 18,327Hamburg 491 1,638 2,129Hesse 6,630 63,539 70,169Mecklenburg-WestPomerania

4,078 7.264 11,342

Lower Saxony 8,957 50,000 58,957North Rhine-Westphalia 18,116 17,147 35,263Rhineland-Palatinate 10,578 No data 10,578Saarland 1,686 3,530 5,216Saxony 8,590 19,115 27,705Saxony-Anhalt 6,296 14,692 20,988Schleswig-Holstein 3,181 16,451 19,632Thuringia 6,138 12,824 18,962

Total for the Federal Re-public of Germany

100,129 259,883 362,689

* The difference in the total number of areas in Brandenburg results from individual areas there which cannot beassigned to hazardous waste-disposal sites or hazardous waste sites.

27

National overview of the status of the assessment of areas suspected of beinghazardous waste sites

(Source: Data compiled by the Federal Environmental Agency on the basis of information provided by the Länder asat December 2000)

Status of the investigations/estimations of risk

Landinitiated concluded

totalhazardouswaste-disposalsites

hazardouswaste sites

hazardouswaste-disposalsites

hazardouswaste sites

Baden-Württemberg 5,339 2,660 409 149 8,557Bavaria 670 280 1,085 450 2,575Berlin 1092 6102 1812 4722 1,3722

Brandenburg 5911 1,4951 2,208Bremen 771 1,0901 1,167Hamburg 57 1044 222 4204 803Hesse 900 866 1,7663

Mecklenburg-West Pom-erania

no data no data 519 1,148 1,6673

Lower Saxony 170 no data 650 no data 820North Rhine-Westphalia 844 343 3,733 2,832 7,752Rhineland-Palatinate no data no data no data no dataSaarland no data no data no data no dataSaxony 5,612 10,685 357 826 17,480Saxony-Anhalt 552 2,384 309 650 3,895Schleswig-Holstein 162 341 847 756 2,106Thuringia together 3,0071

Total for the FederalRepublic of Germany

approx.55,175

1. Initiated and concluded2. Investigation and restoration3. Only concluded cases4. Without petrol stations and dry cleaners

In Rhineland-Palatinate new data will not be ascertained until 2001. They will then be inserted into thisoverview.

28

National survey of the status of the restoration of hazardous waste sites

(Source: Data collated by the Federal Environmental Agency on the basis of information provided by the Länder as atDecember 2000)

state of restoration type of restora-tion

LandTemporary protectionand restriction ormonitoring measures

initiated concluded safe-guardingmeasures

decon-taminationmeasures

HWDS HWS HWDS HWSBaden-Württemberg no data no

datano

dataapprox. 500 no data no data

Bavaria 75 130 165 215 115 160Berlin 1091 6101 1811 4721

Brandenburg no data nodata

nodata

547 442 388 151

Bremen 4 4 64 15 274 49 72Hamburg 35 504 67 1104 213 1453

Hesse no data 35 136 37 273 75 395Mecklenburg-WestPomerania

no data 339 169 1,350 666 no data no data

Lower Saxony nodata

nodata

nodata

nodata

no data no data

North Rhine-Westphalia

4402 1,4662 537 1,7853

Rhineland-PalatinateSaarland no data no

datano

datano

datanodata

no data no data

Saxony 186 188 808 251 1,302 no data no dataSaxony-Anhalt k. A. 29 32 272 126 no data no dataSchleswig-Holstein 3204 16 68 40 370 no data no dataThuringia 280 7142

Bundesrepublikgesamt

1 Investigation and restoration2 Initiated and concluded3 Only concluded cases4 Without petrol stations and dry cleaners

In Rhineland-Palatinate new data will not be ascertained until 2001. They will then be inserted into thisoverview.

Legend: HWDS = hazardous waste-disposal sites HWS = hazardous waste sites

29

Chapter 4 Statutory regulations and voluntary agreements

4.1 Basic administrative framework

The concept of environmental protection is standardized in Article 20a of the German Constitu-tion. However, environmental legislation is integrated into the widest variety of statutory areas.Although a uniform "Environmental Code" is in preparation it has not been realized yet.

The competences of the various legislative organs in the federal system which exists in theFederal Republic of Germany are regulated by the German Constitution. Draft bills can be intro-duced by the German government, the Lower House of Parliament or the Upper House of Par-liament. A decision on them is then taken in the Lower House. Implementation of the statutoryregulations is generally the responsibility of the Länder.

The Federal Republic of Germany is a member of the European Union (EU) and is thereforesubject to the "Treaty for the Foundation of the European Community (EC)". Areas such as thehealth service, consumer and environmental protection in the European single market areregulated in a uniform manner by means of Community legislation such as EC Directives -which must be transposed into national law by national regulations - and EC Regulations whichenter into force directly.

4.2 Statutory regulations

The following table (as at August 2004) provides an overview of the essential areas of hazard-ous substances legislation. It is not final.

Hazardous substances legislation in the narrower sense protects the environment as suchagainst environmental chemicals and aims, above all, at preventive product control whereashazardous substances legislation in the wider sense in each case records the environmentalchemicals as a source of risk for a particular environmental medium and mainly regulates thedisposal of the hazardous substance.

Within hazardous substances legislation in the narrower sense it is necessary to distinguishbetween the special rules and regulations relating to hazardous substances on the one handand the general hazardous substance rules on the other hand.

The texts of the laws are in part available on the Internet (see Annex 2 for the Internet ad-dresses).

30

4.2.1 Chemicals management in the narrower sense

4.2.1.1 General legislation on hazardous substances

EC Regulations, directives and guidelines

Regulation CompetentAuthority

Where to find theregulation/date

Content Availabletranslations

Directive 67/548/EEC of27.06.1997 on the approxi-mation of the laws, regula-tions and administrativeprovisions relating to theclassification, packagingand labelling of dangeroussubstances (fundamentalchemicals directive)

BMU Official Journal of theEC L 196 p. 1 of16. 8.1967; lastamended on29.04.2004 (OfficialJournal of the ECL 152 p. 1)

Notification of substancesand assessment of the dan-gers they pose to man andthe environment

Official EC lan-guages

Council Directive 76/769/EEC of 27.07.1976 relating torestrictions on the marketingand use of certain danger-ous substances and prepa-rations (chemicals prohibi-tion directive)

BMU Official Journal of theEC L 262 p. 201 of27.09.1976; lastamended on16.06.2004 (OfficialJournal of the ECL 162 p. 3)

Restrictions on the marketingand use of the dangerouschemicals listed in the annex


Directive 1999/45/EC of31.05.1999 concerning theapproximation of the laws,regulations and administra-tive provisions of the Mem-ber States relating to theclassification, packagingand labelling of dangerouspreparations (new prepara-tions directive)

BMWA Official Journal of theEC L 200 p. 1 of30.07.1999; lastamended on22.08.2001 (OfficialJournal of the ECL 226 p. 5)

Rules on the classification,packaging and labelling ofpreparations


Directive 91/155/EEC of05.03.1991 defining and lay-ing down the detailed ar-rangements for the systemof specific information re-lating to dangerous prepara-tions (safety data sheet di-rective)

BMWA Official Journal of theEC L 76 p. 35 of22.03.1991, lastamended on07.08.2001 (OfficialJournal of the ECL 212 p. 24)

Information required in thesafety data sheet


Council Regulation (EEC) No793/93 of 23.03.1993 on theevaluation and control of therisks of existing substances(existing substances regula-tion)

BMU Official Journal of theEC L 84 p.1 of 05.04.1993, last amendedon 03.09.1993 (Offi-cial Journal of theEC, L 224 p.34)

Announcement duties andthe assessment of existingsubstances


Commission Regulation (EC)No 1179/94 of 25.05.1994concerning the first list ofpriority substances as fore-seen under Council Regula-tion (EEC) No 793/93

BMU Official Journal of theEC L 131 p.3 of26.05.1994

1st Priority list Official EC lan-guages

31




Commission Regulation (EC)No 1488/94 of 28.06.1994laying down the principlesfor the assessment of risksto man and the environmentof existing substances inaccordance with CouncilRegulation (EEC) No 793/93


Principles for the assessmentof existing substances


Commission Regulation (EC)No 2268/95 of 27.09.1995concerning the second listof priority substances asforeseen under CouncilRegulation (EEC) No 793/93

BMU Official Journal of theEC L 231 p. 18 of28.09.1995

2nd priority list Official EC lan-guages

Commission Regulation (EC)No 142/97 of 27.01.1997 con-cerning the delivery of in-formation about certain ex-isting substances as fore-seen under Council Regula-tion (EEC) No 793/93


Parallel list of existing sub-stances


Commission Regulation (EC)No 143/97 of 27.0.1997 con-cerning the third list of pri-ority substances as foreseenunder Council Regulation(EEC) No 793/93


3rd priority list Official EC lan-guages

Commission Regulation (EC)No 2364/2000 of 25 October2000 concerning the fourthlist of priority substances asforeseen under CouncilRegulation (EEC) No 793/93


4th priority list Official EC lan-guages

Commission Regulation (EC)No 2592/2001 of 28 Decem-ber 2001 imposing furtherinformation and testing re-quirements on the manufac-turers or importers of certainpriority substances in ac-cordance with CouncilRegulation (EEC) No 793/93on the evaluation and con-trol of the risk of existingsubstances



Commission Regulation (EC)No 1217/2002 of 5 July 2002requiring importers or manu-facturers of certain EINECSsubstances to supply certaininformation and performcertain tests pursuant toCouncil Regulation (EEC) No793/93



32



Content Available tran-lations

Regulation (EC) No304/2003 of the EuropeanParliament and of the Coun-cil of 28 January 2003 con-cerning the export and im-port of dangerous chemi-cals

BMU Official Journal ofthe EC L 63 p. 1 of06.03.2003, lastamended on27.04.2004 (OfficialJournal of the ECL 123 p. 27)

Links exports to prior informa-tion duties, implementation ofthe PIC procedure / Rotter-dam Convention


Regulation (EC) No2037/2000 of the EuropeanParliament and of theCouncil of 29 June 2000 onsubstances that deplete theozone layer

BMU Official Journal ofthe EC L 244 p. 1 of29.09.2000, lastamended on 16.10.2003 (Official Jour-nal of the EC L 265p. 1)

Prohibitions and restrictionson CFCs, halons and othersubstances harmful to theozone layer


Regulation (EC) No850/2004 of the EuropeanParliament and of theCouncil of 29 April 2004 onpersistent organic pollut-ants and amending Direc-tive 79/117/EEC

BMU Official Journal ofthe EC L 158 p. 7 of30.04.2004, cor-rected on29.06.2004 OfficialJournal of the ECL 229 p. 5

Protection of human healthand of the environmentagainst persistent organicpollutants; implementation ofthe Stockholm Convention


Council Directive 88/320/EEC on the inspection andverification of good labora-tory practice (GLP directive)

BMU Official Journal ofthe EC L 145 p. 35of 11.06.1988, lastamended on 08.03.1999 (Official Jour-nal of the EC L 77,p. 2)

GLP determinations Official EC lan-guages

Directive 2004/9/EC of theEuropean Parliament and ofthe Council of 11 February2004 on the inspection andverification of good labora-tory practice (GLP) (codifiedversion)

BMU Official Journal ofthe EC L 50 p. 28 of20.02.2004

GLP determinations Official EC lan-guages

Council Directive89/391/EEC of 12 June 1989on the introduction ofmeasures to encourageimprovements in the safetyand health of workers atwork

BMWA Official Journal ofthe EC L 183 p. 1 of19.06.1989

Occupational safety andhealth outline directive forhandling chemicals


Council Directive 98/24/ECof 7 April 1998 on the pro-tection of the health andsafety of workers from therisks related to chemicalagents at work (chemicalagents directive)

BMWA Official Journal ofthe EC L 131 p. 11of 05.05.1998

Measures for handling chemi-cal agents


33




Directive 2004/37/EC of theEuropean Parliament and ofthe Council of 29 April 2004on the protection of work-ers from the risks related toexposure to carcinogens ormutagens at work (newcancer directive)

BMWA Official Journal ofthe EC L 158 p. 50of 30.04.2004

Special protection measuresfor handling carcinogenicsubstances


Directive 92/85/EEC of19.10.1992 on the introduc-tion of measures to encour-age improvements in theprotection of the safety andhealth at work of pregnantworkers, workers who haverecently given birth andworkers who are breast-feeding (Directive on nurs-ing and expectant mothers)

BMFSFJ Official Journal ofthe EC L 348 p. 1 of28.11.92

Measures for improving safetyand health


Technical Guidance Docu-ments on Risk Assessmentin support of CommissionDirective 93/67/EEC on RiskAssessment for new noti-fied substances, Commis-sion Regulation (EC) No1488/94 on Risk Assess-ment for existing sub-stances, Directive 98/8/ECof the European Parliamentand of the Council con-cerning the placing of bio-cidal products on the mar-ket

EC/BMU/

NotificationUnit withinthe Chemi-cals Act

Assessmentunits

Office for OfficialPublications of theEuropean Commu-nities, 2003

Technical guidance documentof the authorities for the riskassessment of new and ex-isting substances

English

Guide to Regulation (EC) ofthe European Parliamentand of the Council No304/2003

EC/JRC-ECB

European Commis-sion, DG XI, 2004

Guidance document for ex-porters

English

National laws and guidelines




Act on the protectionagainst dangerous sub-stances (Chemicals Act -ChemG)

BMU In the version of20.06.2002 (FederalLaw Gazette Ip. 2090), last amen-ded on 13.5.2004(Federal Law Ga-zette I p. 934)

Basic notification, classifica-tion, labelling and packagingduties as well as powers ofdecree (inter alia, in connec-tion with the performance ofrisk assessments, the prohi-bition of substances etc.)

-

Guidance document fornotifications of new sub-stances pursuant to theChemicals Act

NotificationUnit withinthe Chemi-cals Act

Notification Unit ac-cording to theChemicals Act,

5th edition 2003

Information to producers orimporters concerning thenotification procedure

-

34

National ordinances

Regulation Competentauthority



Ordinance on bans andrestrictions on the placingon the market of dangeroussubstances, preparationsand products pursuant tothe Chemicals Act (Chem-VerbotsV)

BMU In the version of13.06.2003 (FederalLaw Gazette Ip. 867), lastamended on25.02.2004 (FederalLaw Gazette I p. 328)

Marketing bans and restric-tions for certain substances,preparations and products

-

Ordinance on protectionagainst hazardous sub-stances(Hazardous SubstancesOrdinance - GefStoffV)

BMWA In the version of23.12.2004 (FederalLaw Gazette Ip 3758)

Classification, labelling andpackaging duties, in particularalso in connection with prepa-rations (flexible referencing toEC Directives). Bans andrestrictions on production anduse; special rules for han-dling.

-

Ordinance on test reportsand other notification andinformation documentsunder the Chemicals Act(ChemPrüfV)

BMU Of 01.08.1994 (Fed-eral Law Gazette Ip. 1877), amendedon 18.07.2002 (Fed-eral Law Gazette Ip.2666)

Notification documents andtest reports

-

Ordinance on obligations,pursuant to article 16e ofthe Chemicals Act, to pro-vide notification: prevent-ing poisoning and provid-ing information in cases ofpoisoning (Poisoning in-formation ordinance -ChemGiftInfoV)

BMU In the version of31.07.1996 (FederalLaw Gazette Ip. 1198, last amen-ded on 06.08.2002(Federal Law Ga-zette I p. 3082)

Obligations to provide infor-mation in cases of poisoning

-

Ordinance on the costs ofofficial acts of the FederalAuthorities under theChemicals Act (ChemicalsCosts Ordinance - Chem-KostV)

BMU Of 01.07.2002 (Fed-eral Law Gazette Ip. 4421), amendedon 14.11.2003 (Fed-eral Law Gazette I p.2283)

Costs of the notification andmini-notification proceduresand official acts relating toGLP

-

Ordinance for the enforce-ment of Community lawregulations relating to sub-stances and preparations(ChemStrOWiV)

BMU Of 25.04.1996 (Fed-eral Law Gazette Ip. 662), amended on18.10.1999 (FederalLaw Gazette I p.2059)

Assignment of violations ofEU regulations (e.g. theregulation on existing sub-stances and the regulation onthe export and import of cer-tain dangerous chemicals) tothe rules in chemicals lawrelating to criminal acts andfines

English

Ordinance on the prohibi-tion of certain ozone-depleting halogenated hy-drocarbons (FCKW-Halon-Verbots-Verordnung)

BMU Of 06.05.1991 (Fed-eral Law Gazette Ip. 1090), last amen-ded on 29.10.2001(Federal Law Ga-zette I p. 2758)

Prohibition of certain ozone-depleting substances for par-ticular applications

-

35

National administrative provisions




General administrativeprovision for the perform-ance of the assessmentaccording to § 12 Section 2Clause 1 of the ChemicalsAct (ChemVwV-Bewertung)

BMU Of 11.09.1997(General informationbulletin of06.10.1997)

Cooperation between theauthorities in connection withthe notification of new sub-stances

-

General administrative pro-vision for the imple-mentation of CouncilRegulation No 793/93 of23.03.1993 on the assess-ment and control of theenvironmental risks of ex-isting substances .

(ChemVwV-Altstoffe)

BMU Of 11.09.1997(General informationbulletin of06.10.1997), lastamended on13.12.2001 (Generalinformation bulletin2002 p.263)

Cooperation between theauthorities in connection withthe assessment of existingsubstances

-

General administrative pro-vision relating to the pro-cedure of official monitor-ing of adherence to theprinciples of Good Labora-tory Practice (ChemVwVGLP)

BMU New version of15.05.1997(General informationbulletin p. 257)

Inspections for the control ofcompliance with the principlesof GLP

-

Technical Rules for Hazardous Substances (TRGS)




TRGS 900 BMWA Federal Labour Ga-zette 10/96,last amendedFederal Labour Ga-zette 5/2004

Limit values for the workplaceatmosphere � occupationalexposure limit

-


Biological tolerance values forworking substances in theworkplace � BAT values

-


List of carcinogenic, muta-genic or reproductive toxicsubstances

-


List of sensitizing substances -

36




TRGS 200 BMWA Federal Labour Ga-zette 3/99,last amendedFederal Labour Ga-zette 3/2002Corrected 1/2003

Classification and labelling ofsubstances, preparations andproducts

-

TRGS 220 BMWA Federal Labour Ga-zette 9/93,last amended7-8/2002corrected 1/2003

Safety data sheet for hazard-ous substances and prepara-tions

English

TRGS 500 BMWA Federal Labour Ga-zette 3/98

Protection measures: mini-mum standards

English

4.2.1.2 Special legislation on hazardous substances

Biocides




Directive 98/8/EC of16.02.1998 concerning theplacing of biocidal productson the market

BMU Official Journal of theEC L 123 p. 1 of24.04.1998,correctedOfficial Journal of theEC L 123 p. 63

Rules for the authorization,the placing on the market,the application and the con-trol of biocidal products


Commission Regulation (EC)No 1896/2000 of 7 Septem-ber 2000 on the first phaseof the programme referredto in Article 16(2) of Direc-tive 98/8/EC of the EuropeanParliament and of the Coun-cil on biocidal products (so-called 1st review regulation)


Work programme to examineexisting active biocidal sub-stances, request for notifica-tion and identification


Commission Regulation (EC)No 1687/2002 of 25 Septem-ber 2002 on an additionalperiod for notification ofcertain active substancesalready on the market forbiocidal use as establishedin Article 4(1) of Regulation(EC) No 1896/2000 (so-calledextension regulation)


Extension of the deadline forthe notification of active sub-stances


37




Regulation (EC) No2032/2003 of 4 November2003 on the second phase ofthe 10-year work programmereferred to in Article 16(2) ofDirective 98/8/EC of theEuropean Parliament and ofthe Council concerning theplacing of biocidal productson the market, and amend-ing Regulation (EC) No1896/2000 (so-called 2ndreview regulation)


Rules for the systematic ex-amination of notified activesubstances, lists of the noti-fied and identified active sub-stances


Ordinance on the authoriza-tion of biocidal products andother procedures in chemi-cals law relating to biocidalproducts and active biocidalsubstances (biocideauthorization ordinance -ChemBiozidZulV)

BMU Of the 04.07.2002(Federal Law Ga-zette I p. 2514)

Form / content of authoriza-tion applications

-

Plant protection products and fertilizers




Directive 91/414 of 15.07.1991concerning the placing of plantprotection products on themarket

BMVEL Official Journal of theEC L 230 p. 1 of19.08.1991, lastamended on 12.09.2003 (Official Journal ofthe EC L 228 p.11)

Rules on the licensing, market-ing, use and control of plantprotection products


Commission Regulation (EEC)No. 3600/92 of 11.12.1992 layingdown the detailed rules for theimplementation of the firststage of the work programmereferred to in Article 8(2) ofCouncil Directive 91/414/EECconcerning the placing of plantprotection products on themarket

BMVEL Official Journal of theEC L 366 p. 10 of15.12.1992, lastamended on13.10.2000 (OfficialJournal of the EC L259 p. 27)

Work programme for the mar-keting of plant protection prod-ucts, request for notification


Commission Regulation (EC)No 933/94 of 27 April 1994 lay-ing down the active substancesof plant protection productsand designating the rapporteurMember States for the imple-mentation of CommissionRegulation (EEC) No 3600/92


Designation of the rapporteurs,laying down the deadline for thesubmission of the dossiers, listof notifiers


38




Commission Regulation (EC)No 451/2000 of 28 February2000 laying down the detailedrules for the implementation ofthe second and third stages ofthe work programme referred toin Article 8(2) of Council Direc-tive 91/414/EEC


Laying down the active sub-stances in the second stage oftesting, request for the notifica-tion of all the remaining activesubstances, laying down theprocedural sequences, introduc-tion of a rule on fees


Commission Regulation (EC)No 703/2001 of 6 April 2001laying down the active sub-stances of plant protectionproducts to be assessed in thesecond stage of the work pro-gramme referred to in Article8(2) of Council Directive91/414/EEC and revising the listof Member States designated asrapporteurs for these sub-stances

BMVEL Official Journal of theEC L 98 p.6 of07.04.2001

Naming of the rapporteur Mem-ber States for the examination ofthe active substances in thesecond stage of the testing ofexisting active substances, list ofnotifiers, laying down the dead-line for the submission of thedossiers


Commission Regulation (EC)No 1112/2002 of 20 June 2002laying down the detailed rulesfor the implementation of thefourth stage of the programmeof work referred to in Article8(2) of Council Directive91/414/EEC

BMVEL Official Journal of theEC L 168 p. 14 of27.06.2002

Request for the notification of all�existing active substances�which were not included in thefirst three stages, the layingdown of the procedural se-quences and the rule on fees


Commission Regulation (EC)No 1490/2002 of 14 August2002 laying down furtherdetailed rules for the imple-mentation of the third stageof the programme of workreferred to in Article 8(2) ofCouncil Directive 91/414/EEC and amending Regula-tion (EC) No 451/2000

BMVEL Official Journal of theEC L 224 p. 23 of21.08.2002, lastamended on19.06.2003 (OfficialJournal of the ECL 151 p. 32)

Naming of the rapporteurMember States for the ex-amination of the active sub-stances in the third stage, listof notifiers, the laying downof deadlines for the submis-sion of the dossiers, the pro-duction of the monographs,rules relating to the test se-quence, rule on fees


Commission Regulation (EC)No 2076/2002 of 20 Novem-ber 2002 extending the timeperiod referred to in Article8(2) of Council Directive91/414/ EEC and concerningthe non-inclusion of certainactive substances in Annex Ito that Directive and thewithdrawal of authorizationsfor plant protection productscontaining these substances

BMVEL Offical Journal of theEC L 319 p. 3 of23.11.2002, lastamended on29.04.2004 (OfficalJournal of the ECL 127 p. 43)

Extension of the deadlinesfor the examination of theactive substances in the 1st,2nd and 3rd stages of the ex-amination of existing sub-stances, non-inclusion inAnnex I of certain active sub-stances, list of �essentialuses� for certain active sub-stances with time-limitedtransitional rules


39




Commission Regulation (EC)No 771/2004 of 23 April 2004laying down transitionalmeasures with regard tocontinued use of plant pro-tection products containingcertain active substancesfollowing the accession ofnew Member States to theEuropean Union

BMVEL Official Journal of theEC L 123 p. 7 of27.04.2004

Special transitional rules for 5active substances in Hungaryuntil the end of 2005 or 2006,transitional rules for furtherexisting substances until30.04.2007


Regulation (EC) No2003/2003 of the EuropeanParliamentand of the Council relatingto fertilizers

BMVEL Official Journal of theEC L 304 p.1 of21.11.2003, lastamended on26.04.2004 (OfficialJournal L 168 p.1)

Authorization, composition,labelling and packaging ofEC fertilizers


Directive 91/676/EEC of12.12.1991 on the protectionof waters against pollutioncaused by nitrates from ag-ricultural sources

BMU,BMVEL

Official Journal of theEC L 375 p. 1 of31.12.1991, lastamended on31.10.2003 (OfficialJournal of the ECL 284 p. 1)

Reduction in the releases ofnitrogen into the waters. Interalia, areas at risk are to beidentified and programmes ofaction undertaken in theseareas. Within the frameworkof the programmes of action,the Member States establishrules for good professionalpractice in the application offertilizers which must be ob-served by farmers


Law on the protection ofcultivated plants(Plant Protection Act -PflSchG)

BMVEL In the version of14.05.1998 (FederalLaw Gazette I,p. 971), last amen-ded on 25.11.2003(Federal Law GazetteI, p. 2304)

Protection of plants and culti-vated plants against harmfulorganisms; averting dangersby means of plant protectionproducts

-

Ordinance on evidence ofspecialist knowledge aboutplant protection(PflSchSachkV)

BMVEL Of 28.07.1987 (Fed-eral Law Gazette I p.1752), last amendedon 07.05.2001 (Fed-eral Law Gazette I p.885)

Specialist knowledge aboutplant protection

-

Ordinance on plant protec-tion products and plant pro-tection equipment(PflanzenschutzMGV)

BMVEL In the version of17.08.1998, (FederalLaw Gazette Ip. 2161), lastamended on26.11.2003 (FederalLaw Gazette Ip. 2438)

Regulates the licensing ofplant protection products andplant protection equipment

-

40




Ordinance on prohibitions ofuse of plant protectionproducts(PflschAnwV)

BMVEL Of 10.11.1992 (Fed-eral Law Gazette Ip. 1887), last amen-ded on 23.07.2003(Federal Law GazetteI p. 1533)

Prohibitions and restrictionsof use of plant protectionproducts

-

Announcement of the prin-ciples of good professionalpractice in the area of plantprotection

BMVEL Federal Gazette No.220a of 21.11.1998

Principles for the realizationof good professional practicein the area relating to plantprotection

-

Fertilizer Act(DüngMG)

BMVEL Of 15.11.1977 (Fed-eral Law Gazette Ip. 2134), last amen-ded on 29.10.2001(Federal Law GazetteI p. 2785)

Licensing of types of fertilizer,labelling and packaging, theprinciples of good profes-sional practice during theapplication of fertilizers

-

Ordinance on the placing onthe market of fertilizers, soilsupplements, culture sub-strates and plant supple-ments (fertilizer ordinance -DüMV)

BMVEL In the version of11.08.1999 (FederalLaw Gazette I p.1758), last amendedon 04.12.2003 (Fed-eral Law Gazette I p.2373)

Licensing of types of fertiliz-ers, listing and description ofthe licensed types of fertiliz-ers, rules on labelling andpackaging

-

Ordinance on the principlesof good professional prac-tice during the application offertilizers (DüngeV)


More precise determinationof the principles of goodprofessional practice, re-quirements for the applicationof fertilizers

-

Ordinance on the costs ofthe Federal Office of Con-sumer Protection and FoodSafety and the Federal Bio-logical Research Centre forAgriculture and Forestry inplant protection (plant pro-tection fee ordinance -PfSchMGebV)


Fees and expenses incurredin the licensing procedure forplant protection products andactive substances

-

Pharmaceuticals




Law on the distribution ofmedicines(German Drugs Act - AMG)

BMGS In the version of11.12.1998 (FederalLaw Gazette Ip. 3586), last amen-ded on 09.12.2004(Federal Law Ga-zette I p. 3214)

Basic licensing and registra-tion duties for drugs, homeo-pathic drugs and veterinarypharmaceuticals

-

41




General administrative pro-vision for application of theguidelines for the testing ofdrugs

BMGS Of 14.12.1989, lastamended on11.10.2004

-

Council Regulation (EEC) No2309/93 of 22 July 1993 lay-ing down Community proce-dures for the authorizationand supervision of medici-nal products for human andveterinary use and estab-lishing a European Agencyfor the Evaluation of Medici-nal Products

BMGS Of 22. 07.1993 (Offi-cial Journal L 214 of24.08.1993 p. 1), lastamended on18.06.2003 (OfficialJournal L 245 of29.09.2003, p. 19)

Fundamental licensing dutyfor certain pharmaceuticals inthe European Union


Regulation (EC) No 726/2004of the European Parliamentand of the Council of 31March 2004 laying downCommunity procedures forthe authorisation and super-vision of medicinal productsfor human and veterinaryuse and establishing aEuropean Medicines Agency

BMGS Of 31.03.2004 (Offi-cial Journal L 136 of30.04.2004, p. 1)

Fundamental licensing dutyfor certain pharmaceuticals inthe European Union (re-places Regulation 2309/93)


4.2.2 Chemicals management in the wider sense

Laundry and cleaning products




Regulation (EC) No648/2004 of the EuropeanParliament and of theCouncil of 31 March 2004on detergents


Placing detergents and ten-sides on the market


Law on the environmentalimpact of laundry andcleaning products(WRMG)

BMU In the version of05.03.1987 (FederalLaw Gazette Ip.875), last amendedon 27.06.1994 (Fed-eral Law Gazette Ip. 1440)

Rule on the environmentallycompatible employment(marketing, consumption anduse) of laundry and cleaningproducts

-

42

Foodstuffs and commodities




Foodstuffs and Commodi-ties Act(LMBG)

BMVEL In the version of09.09.1997 (FederalLaw Gazette Ip. 2296), lastamended on13.05.2004 (FederalLaw Gazette I p. 934)

Prohibition of the use of for-eign substances in foods,tobacco products, cosmeticsand other consumer goods

-

Commodities Ordinance

(BedGgstV)

BMVEL In the version of23.12.1997 (FederalLaw Gazette I p. 5),last amended on07.01.2004 (FederalLaw Gazette I p. 31)

-

Ordinance on the MaximumQuantities of HazardousSubstances in Foods(SHmV)

BMU In the version of19.12.2003, (FederalLaw Gazette Ip. 2755)

-

Ordinance on maximumquantities of residues ofplant protection productsand pesticides, fertilizersand other products in or onfoodstuffs and tobaccoproducts (RHmV)

BMVEL In the version of21.10.1999 (FederalLaw Gazette Ip. 2082), last amen-ded on 19.12.2003(Federal Law Ga-zette I p. 2755)

-

Ordinance on Drinking Wa-ter and on Water for FoodProcessing Companies(TrinkwV)

BMVEL In the version of05.12.1990 (FederalLaw Gazette Ip. 2612) lastamended on25.11.2003 (FederalLaw Gazette Ip. 2304)

Regulates the quality andmonitoring of drinking water

-

43

Waste law




Directive 2002/95/EC of theEuropean Parliament andof the Council of 27 Janu-ary 2003 on the restrictionof the use of certain haz-ardous substances in elec-trical and electronicequipment


Restriction on hazardoussubstances in electrical andelectronic equipment


Council Regulation (EEC)No 259/93of 1 February 1993on the supervision andcontrol of shipments ofwaste within, into and outof the EuropeanCommunity


Restriction on/prohibition oftransborder shipments ofwastes


Waste Avoidance, Recy-cling and Disposal Act - alaw to promote recyclingand ensure environmen-tally compatible removal ofwastes (KrW/AbfG)


Principles relating to theavoidance or handling ofwastes. Rules on waste dis-posal plants

English

Ordinance on the avoid-ance and utilization ofpackaging wastes (pack-aging ordinance - Ver-packV)


English

Ordinance on the utilizationof biological wastes onsoils used for agriculture,forestry and horticulture(biological wastes ordi-nance - BioAbfV)


-

Ordinance on the Disposalof Waste Halogenated Sol-vents(HKWAbfV)

BMU Of 23.10.1989 (Fed-eral Law Gazette Ip. 1918)

Demands on solvents whichare to be utilized as waste ordisposed of

-

Ordinance on Used Oil(AltölV)

BMU New version of16.04.2002 (FederalLaw Gazette Ip. 1368)

Demands on processing anddisposal as well as sale to theend-user

-

Sewage Sludge Ordinance(AbfKlärV)


Demands relating to the ap-plication of sewage sludge toagricultural areas

-

44




Ordinance on the environ-mentally compatible dis-posal of residential wastes(disposal ordinance - Ab-fAblV)


-

Law on the monitoring andcontrol of the transbordershipment of wastes (wasteshipment law - AbfVerbrG)


-

Ordinance on the require-ments relating to the dis-charge of waste water intoaquatic environments(AbwV)


-

Ordinance on the shipmentof radioactive wastes intoor out of the territory of theFederal Republic of Ger-many


-

Ordinance on the disposalof polychlorinated bi-phenyls, polychlorinatedterphenyls and halogen-ated monomethyldiphenyl-methanes (PCB waste ordi-nance - PCBAbfallV)


-

Waste wood ordinance BMU Of 15.08.2002 (Fed-eral Law Gazette Ip. 3302)

Ensuring the pollutant-freematerial utilization of wastewood

English

45

Immission control




Directive 2003/87/EC of theEuropean Parliament and ofthe Council of 13 October 2003establishing a scheme forgreenhouse gas emission al-lowance trading within theCommunity and amendingCouncil Directive 96/61/EC



Law implementing Directive2003/87/EC which estab-lishes a scheme for green-house gas emission allow-ance trading within theCommunity (greenhousegas emission trading law –TEHG)


Federal Immission ControlAct, law protecting againstharmful environmental in-fluences due to air pollut-ants, noise, vibrations andsimilar processes(BlmSchG)


Demands on plant, nature offuels, monitoring of air quality

-

First general administrativeprovision relating to theFederal Immission ControlAct (Technical Instructionson Air Quality Control - TA-Luft)

BMU Of 24.07.2002(General informationbulletin p. 511)

Limit values for immissionsand emissions of certain sub-stances; demands in connec-tion with the operation of plant

-

First ordinance imple-menting the Federal Immis-sion Control Act (Ordi-nance on Small Furnaces -1.BImSchV)


Emission demands on smallfurnaces not requiring li-cences

-

Second ordinance imple-menting the Federal Immis-sion Control Act (Ordi-nance on the restriction ofemissions of highly volatilehalogenated hydrocarbons- 2.BImSchV)

BMU Of 10.12.1990 (Fed-eral Law Gazette Ip. 2694), amendedon 21.08.2001 (Fed-eral Law Gazette Ip. 2180)

Requirements in the case ofthe use of highly volatilehalogenated hydrocarbons incertain plants

-

Third ordinance imple-menting the Federal Immis-sion Control Act (Ordi-nance on the sulphur con-tent of certain liquid motoror heating fuels3.BImSchV)

BMU Of 15.01.1975 (Fed-eral Law Gazette Ip. 264) last amendedon 24.06.2002 (Fed-eral Law Gazette Ip. 2243)

Sulphur content of heating oiland diesel

-

46




Fourth ordinance implement-ing the Federal ImmissionControl Act (Ordinance onplants requiring licences -4.BImSchV)

BMU In the version of14.03.1997 (FederalLaw Gazette I p.504),last amended on06.01.2004 (FederalLaw Gazette I p. 2)

Names types of plant whichrequire licences and licensingprocedures

-

Seventh ordinance imple-menting the Federal ImmissionControl Act (Ordinance on thelimitation of the emission ofwood dust – 7. BImSchV)

BMU Of 18.12.1975 (FederalLaw Gazette I p. 3133)

-

Tenth ordinance implementingthe Federal Immission ControlAct (Ordinance on the consti-tution of fuels and the label-ling of fuel qualities -10.BImSchV)

BMU Of 24.06.2004 (FederalLaw Gazette I p. 1342),

Constitution of fuels -

Twelfth ordinance implement-ing the Federal ImmissionControl Act (Hazardous Inci-dent Ordinance - 12.BImSchV)

BMU In the version of26.04.2000 (FederalLaw Gazette I p. 603)

Measures to prevent hazardousincidents and limit the effects ofhazardous incidents

-

Thirteenth ordinance imple-menting the Federal ImmissionControl Act (Ordinance onlarge furnaces and turbineplant - 13.BImSchV)

BMU Of 22.07.2004 (FederalLaw Gazette I p. 1717),

Erection, operation and con-struction of furnaces >50 MW

-

Seventeenth ordinance im-plementing the Federal Immis-sion Control Act (Ordinanceon incineration plants forwastes and similar combusti-ble substances - 17.BImSchV)

BMU Of 23.11.1990 (FederalLaw Gazette I p. 2545),revised on 14.08.2003(Federal Law Gazette Ip. 1633)

Erection, operation and con-struction of waste-incinerationplants for solid and liquid wastes

-

Nineteenth ordinance imple-menting the Federal ImmissionControl Act (Ordinance onchlorine and bromine com-pounds used as fuel additives- 19.BImSchV)

BMU Of 17.01.1992 (FederalLaw Gazette I p. 75),last amended on21.12.2000 (FederalLaw Gazette I p. 1956)

Prohibition of chlorine and bro-mine compounds in fuels

-

Twenty-first ordinance imple-menting the Federal ImmissionControl Act (Ordinance onlimiting hydrocarbon emis-sions during the fuelling ofmotor vehicles - 21. BImSchV)

BMU Of 07.10.1992 (FederalLaw Gazette I p. 1730),amended on06.05.2002 (FederalLaw Gazette I p. 1566)

Protection again hydrocarbonemissions during the fuelling ofmotor vehicles

-

Twenty-second ordinanceimplementing the FederalImmission Control Act (Ordi-nance on emission limit valuesfor air pollutants -22.BImSchV)

BMU In the version of11.09.2002 (FederalLaw Gazette I p. 3626),last amended on13.07.2004 (FederalLaw Gazette I p. 1612)

Air-quality standards for particu-lar substances

-

47




Twenty-third ordinanceimplementing the FederalImmission Control Act (Or-dinance on the determina-tion of concentration val-ues – 23. BImSchV)


Concentration values for air-polluting substances

-

Twenty-fifth ordinance im-plementing the FederalImmission Control Act (Or-dinance on the limitation ofemissions from the tita-nium oxide industry – 25.BImSchV)


Measures to reduce and putan end to pollution caused bywastes from the titanium ox-ide industry

-

Twenty-seventh ordinanceimplementing the FederalImmission Control Act (Or-dinance on plants used forcremation – 27. BImSchV)

BMU Of 19.03.1997 (Fed-eral Law Gazette I p.545), last amendedon 03.05.2000 (Fed-eral Law Gazette Ip. 632)

-

Twenty-eighth ordinanceimplementing the FederalImmission Control Act (Or-dinance on emission limitsfor combustion engines –28. BImSchV)


Measures to combat gaseouspollutants and air-pollutingparticles from combustionengines for mobile machinesand equipment

-

Thirty-first ordinance im-plementing the FederalImmission Control Act (Or-dinance on the limitation ofthe emissions of volatileorganic compounds duringthe use of organic solventsin particular plants - 31.BImSchV)


Law on the reduction in airpollutants as a result oflead compounds in fuelsfor motor vehicle engines(BzBIG)

BMU Of 05.08.1971 (Fed-eral Law Gazette Ip. 1234) lastamended on25.11.2003 (FederalLaw Gazette Ip. 2304)

Restriction of lead com-pounds and other metal com-pounds in motor fuels

-

First ordinance imple-menting the law on the leadcontent of motor fuel(BzBIGDV)


Lays down the permissiblelead content in motor fuel

-

48

Protection of aquatic environments




Water Resources Manage-ment Act (WHG)

BMU In the version of19.08.2002 (FederalLaw Gazette Ip. 3245) last amen-ded on 06.01.2004(Federal Law Ga-zette I p. 2)

Principles concerning the useof waters and how to dealwith water, in particular de-mands on the discharge ofwaste water and the protec-tion of the ground water

-

Waste Water Levy ActLaw on levies for dis-charging waste water intoaquatic environments(AbwAG)

BMU In the version of03.11.1994 (FederalLaw Gazette Ip. 3370), lastamended on09.09.2001 (FederalLaw Gazette Ip. 2331)

Levies for the discharge ofwaste water into aquatic envi-ronments

-

Ordinance relating to waterpollutants conveyedthrough pipelines (Wass-gefStBefV)

BMU Of 19.12.1973 (Fed-eral Law Gazette Ip. 1946) amended on05.04.1976 (FederalLaw Gazette I p. 915)

Provisions relating to waterpollutants which are con-veyed through pipelines

-

Ordinance for the imple-mentation of Council Direc-tive 80/68/EEC of 17 De-cember 1979 on the protec-tion of the ground wateragainst pollution by certaindangerous substances(ground water ordinance -GrWV)

BMU Of 18th March 1997(Federal Law Ga-zette I p. 542)

Conditions for the dischargeof certain substances into theground water

-

Ordinance on the demandson the discharge of wastewater into aquatic envi-ronments (waste water or-dinance - AbwV)

BMU In the version of15.10.2002 (FederalLaw Gazette Ip. 4047)

Demands on waste water thatis discharged into aquaticenvironments

-

General administrative pro-vision relating to the WaterResources ManagementAct concerning the classi-fication of water pollutantsaccording to water-hazardclasses (VwVwS)

BMU Of 17th May 1999(Federal Gazette No.98a of 29.05.1999)

Classification rules -

49

Protection of the soil




Law on protection againstharmful changes to the soiland restoration of hazard-ous waste sites (Federalsoil protection law -BBodSchG)

BMU Of 17.05.1998 (Fed-eral Law Gazette Ip. 502), last amen-ded on 09.09.2001(Federal Law Ga-zette I p. 2331, cor-rected Federal LawGazette 2002 Ip. 615)

Ensuring or restoring thesustainable functions of thesoil

-

German ordinance on soilprotection and hazardouswaste sites (BBodSchV)

BMU In the version of12.07.1999 (FederalLaw Gazette Ip. 1554)

Monitoring and assessment ofhazardous waste sites; de-mands on acts of restoration;prevention values

-

Animal welfare




Animal Welfare Act(TierSchG)

BMVEL In the version of25.05.1999 (FederalLaw Gazette Ip. 1105), last amen-ded on 25.11.2003(Federal Law Ga-zette I p. 2304)

The regulation of animal ex-periments, the protection ofthe life and well-being ofanimals

-

Chemical weapons




Implementing statute re-lating to the Agreement onChemical Weapons(CWÜAG)

BMVg Of 02.08.1994 (Fed-eral Law Gazette I p.1954), last amendedon 25.11.2003 (Fed-eral Law Gazette I p.2304)

Restrictions on chemicalwarfare agents, key chemi-cals, intermediates and or-ganic chemicals

-

Implementing ordinancerelating to the Agreementon Chemical Weapons(CWÜVO)

BMVg Of 20.11.1996(Federal Law Ga-zette I p. 1794)

Implementing provisions re-lating to the Agreement onChemical Weapons

-

Implementing statute re-lating to Article 26 Para-graph 2 of the Constitutionof the Federal Republic ofGermany (military weaponscontrol law - KrWaffKontrG)

BMVg Of 20.04.1961 (Fed-eral Law Gazette I p.444), last amendedon 25.11.2003 (Fed-eral Law Gazette Ip. 2304)

Licensing, production, trans-portation, acquisition of mili-tary weapons

-

50

Transport of dangerous goods




Directive 2002/59/EC of theEuropean Parliament andof the Council of 27 June2002 establishing a Com-munity vessel traffic moni-toring and information sys-tem and repealing CouncilDirective 93/75/EEC

BMVBW Official Journal of theEC L 208 p.10 of05.08.2002

Safety of sea transport, infor-mation on the movement ofships transporting dangerousor environmentally harmfulsubstances


Council Directive 94/55/ECof 21.11.1994 on the ap-proximation of the laws ofthe Member States withregard to the transport ofdangerous goods by road

BMVBW Official Journal of theEC L 319 p. 7 of12.12.1994, lastamended on08.04.2003 (OfficialJournal of the ECL 90 p. 45)


Council Directive 95/50/ECof 06.10.1995 on standard-ized procedures for thecontrol of the transport ofdangerous goods by road

BMVBW Official Journal of theEC L 249 p. 35 of17.10.1995, lastamended on23.06.2001 (OfficialJournal of the ECL 168 p. 23)


Directive 96/35/EC of03.06.1996 on the appoint-ment and vocational quali-fication of safety advisersfor the transport of danger-ous goods by road, rail oron inland waterways

BMVBW Official Journal of theEC L 145 p. 10 of19.06.1996


Council Directive 96/49/ECof 23.07.1996 on the ap-proximation of the statu-tory provisions of theMember States with regardto the transport of danger-ous goods by rail

BMVBW Official Journal of theEC L 235 p. 25 of17.09.1996, lastamended on08.04.2003 (OfficialJournal of the EC L90 p. 47)


Directive 98/91/EC of theEuropean Parliament andof the Council of 14 De-cember 1998 relating tomotor vehicles and theirtrailers intended for thetransport of dangerousgoods by road andamending Directive70/156/EEC relating to thetype approval of motor ve-hicles and their trailers

BMVBW Official Journal of theEC L 11 p. 25 of16.01.1999


51




Law on the transport ofdangerous goods(GGBefG)

BMVBW In the version of29.09.1998 (FederalLaw Gazette Ip. 3114), last amen-ded on 06.08.2002(Federal Law Ga-zette I p. 3082)

Transport of dangerous goodsby rail, magnetic levitation,road, water and air

-

Air-transport Act (LuftVG) BMVBW In the version of27.03.1999 (FederalLaw Gazette I p.550), last amendedon 29.12.2003 (Fed-eral Law Gazette Ip. 3093)

Licensing / permission ofaircraft, aeronauts and air-ports etc.

-

Ordinance on the intra- andinterstate transport of dan-gerous goods by road andrail (dangerous goods or-dinance for road and rail -GGVSE)

BMVBW In the version of10.09.2003 (FederalLaw Gazette Ip. 1913), last amen-ded on 04.11.2003(Federal Law Ga-zette I p. 2286)

-

Ordinance on the transportof dangerous goods oninland waterways(GGVBinSch)

BMVBW In the version of31.01.2004 (FederalLaw Gazette I p. 136)

-

Ordinance on the transportof dangerous goods by seavessels (GGVSee)

BMVBW In the version of04.11.2003 (FederalLaw Gazette I p.2286)

-

Ordinance on exemptionsto the regulations on thetransport of dangerousgoods (dangerous goodsexemptions ordinance –GGAV 2000)

BMVBW Of 06.11.2002 (Fed-eral Law Gazette Ip. 4350), last amen-ded on 28.04.2003(Federal Law Ga-zette I p. 595)

Narcotic drugs and psychotropic substances




Council Regulation (EEC)No 3677/90of 13 December 1990laying down measures tobe taken to discourage thediversion of certain sub-stances to the illicitmanufacture of narcoticdrugs and psychotropicsubstances

BMGS Official Journal of theEC L 357 p. 1 of20.12.1990, lastamended on10.07.2002 (OfficialJournal of the ECL 180 p. 5)

Implementation of the ViennaConvention of the United Na-tions of 19.12.1988 againstthe illicit trafficking of narcoticdrugs and psychotrophic sub-stances


52




Regulation (EC) No273/2004 of the EuropeanParliament and of theCouncil of 11 February2004 on drug precursors

BMGS Official Journal of theEC L 47 p.1 of18.02.2004

Uniform measures for thecontrol and monitoring withinthe Community of certainsubstances that are fre-quently used in the illicit pro-duction of narcotic drugs andpsychotropic substances


Law on the monitoring oftrafficking with basic sub-stances which may be mis-used for the illegal produc-tion of narcotic agents (ba-sic substances monitoringlaw – GÜG)

BMGS In the version of26.06.2002 (FederalLaw Gazette I.p. 2261), last amen-ded on 25.11.2003(Federal Law GazetteI p. 2304)

Prevention of the diversion ofbasic substances for the ille-gal production of narcoticagents

-

Ordinance naming thecriminal and administrativefine acts according to § 29Section 1 No. 3 and § 30Section 1 No. 9 of the basicsubstances monitoring law(GÜG-VV)

BMGS In the version of24.07.2002 (FederalLaw Gazette Ip. 2915)

-

4.2.3 Additional regulations specific to individual Länder

Within the framework of their responsibility at regional level, some Länder have further regula-tions which either go beyond the national regulations or supplement them. A few regulationsfrom the State of Baden-Württemberg relating to the areas of chemical safety and plant protec-tion product law are provided here as an example. Analogous regulations exist for the otherareas of law cited in the previous chapter.

Baden-Württemberg (BW): As at: 01.12.2001

Regulation Author-ity


Content

Ordinance on competences accord-ing to the Chemicals Act and the or-dinances passed in accordance withthis Act (ChemGZuVO)

UVM,WMMLRSM

Of 23.01.1995(Joint Official Journalp. 133), amended on25.01.2001 (Joint Offi-cial Journal p. 127)

Regulation of the com-petences in the state forthe enforcement of therules and regulationsrelating to chemicals law

Guidelines for the assessment andrestoration of weakly bound asbestosproducts in buildings (asbestosguidelines, January 1996)

WM Announcement of04.02.1997Joint Official Journalp. 207/226

Demands relating to theassessment and resto-ration of asbestos inbuildings

53

Regulation Behörde Where to find theregulation/date

Content

Guideline for the assessment andrestoration of PCP-contaminatedbuilding materials and structural ele-ments in buildings (PCP guideline)

WM Announcement of04.02.1997Joint Official Journal p.207/233corrected p. 468

Rules for the assess-ment of PCP-contaminated buildingmaterials and structuralelements

Guideline for the assessment of PCB-contaminated building materials andstructural elements in buildings(PCB guideline)

WM Announcement of09.03.1995Joint Official Journal p.220

Advice on the assess-ment and restoration ofPCB-contaminatedbuilding materials

Report by the regional governmenton indoor-air quality

SMUVMWM

Appeared as a brochure(July 1999)

Description of the re-gional government'sprevious and plannedmeasures for improvingindoor-air quality

Ordinance for the implementation ofthe Plant Protection Act

MLR 14.05.1987Law Gazettte p. 235,last amended bythe amendment ordi-nance of 07.01.1991Law Gazette p.15

Ordinance laying downareas of competence

Ordinance on the examination relat-ing to the provision of evidence ofexpert knowledge in the area of theuse and sale of plant protectionproducts (PrOPflSch)

MLR 23.12.1988Law Gazette 1989, p. 7

Ordinance on the ex-amination relating to theprovision of evidence ofexpert knowledge in thearea of plant protection

Administrative provision relating tothe ordinance for testing expertknowledge in the area of plant protec-tion products (VwVPrOPfSch)

MLR 12.08.1997Joint Official Journalp. 501

Explanations relating tothe ordinance for testingexpert knowledge

Administrative provision of the Minis-try for Rural Spaces concerning therecognition of qualifications as evi-dence of expert knowledge in thearea of the use and sale of plant pro-tection products


Certain vocational quali-fications are recognizedas evidence of expertknowledge

Law on the restriction of use of plantprotection products

MLR 17.12.1990Law Gazette p. 426

Further restriction of theuse of plant protectionproducts in the privatesphere

Ordinance on the admission of ex-emptions from the prohibition of useof plant protection products in theopen air (plant protection productexemption ordinance)


Exemption of certainagents from the prohibi-tion of the use of plantprotection products inthe open air

Ordinance of the Ministry for RuralSpaces concerning the recognition ofinspection sites and the testing ofplant protection equipment used inextensive cultivation (plant protectionequipment ordinance)

MLR 29.06.1993Law Gazette p. 501corrected p. 671

Prerequisites for theperformance of inspec-tions of plant protectionequipment

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4.3 Voluntary agreements with the chemical industry

A number of voluntary, self-imposed obligations exist for the chemical industry in the FederalRepublic of Germany. Some of them are listed here as examples. However, these agreementscan only supplement state control in the area of chemicals management, and not replace it.These self-imposed obligations do not apply to companies which are not affiliated to the par-ticular industry association.

Self-imposed obligations on the part of the associations of the chemical industryat national level(Source: VCI; as at: 2003)

• Provision of additional warnings in the case of washing-up liquids (1980/89)

• Decision of the wood protection product industry to dispense with the manufacture of prod-ucts containing PCPs (1984)

• Self-imposed obligation to reduce the parts of solvents and heavy metal compounds in lac-quers and paints (1984)

• Agreement on household cleaners containing hypochloride (1985)

• Provision of childproof caps in the case of highly irritant or corrosive products (1985)

• Decision to dispense with the use of polybrominated diphenyl ether (PBDE) as a flame-proofing agent for plastics (1986)

• Agreement to reduce polluting agents in underwater paints intended for use in paintingboats (1986)

• Commitment to dispense with alkyl phenol ethoxylates (APEO) in laundry and cleaningproducts (1986)

• Announcement of the basic recipes and other details relating to the environmental compati-bility of laundry and cleaning products according to § 9 of the law on laundry products(1986)

• Programme for reduction of the discharge of ammonium in the waste water of the chemicalindustry (1986)

• Code of conduct for the export of dangerous chemicals (1986)

• Statement on the reduction in the use of fully halogenated chlorofluorcarbons (CFCs) insprays (1987)

• Agreement on the production and placing on the market of finger paints (1987)

• Decision to dispense with highly volatile chlorinated hydrocarbons in laundry and cleaningproducts (1987)

• Declaration of the constituents according to the American CTFA system (1988)

• Decision to dispense with animal tests for finished cosmetic products as well as to publish aguideline on alternative methods (1989/92)

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• Substitution of the softener constituent distearyl dimethyl ammonium chloride (DSDMAC) bysubstances that degrade more rapidly and better (1990)

• Self-imposed obligation on the part of the chemical industry to gradually cease production offully halogenated CFCs (1991)

• Agreement between the Rotterdam community and the Association of the Chemical Industry(1991/1995/2000)

• Self-imposed obligation on the part of the chemical industry to take back and reutilize CFCsand used oils from refrigeration and air-conditioning devices (1990)

• Declaration on the reduction of the pollution of aquatic environments by EDTA (1991/2000)

• Voluntary announcement of the basic recipes of laundry and cleaning products to the Fed-eral Health Office and the information and treatment centres for poisoning (1993)

• Recommendations on the use of musk xylol in cosmetic products as well as laundry andcleaning products (1993)

• Decision to dispense with large packing drums for peracetic acid (1994/96)

• Code of Practice to ensure consumer safety in the case of gable box packaging for laundryand cleaning products (1995)

• Self-imposed obligation on the part of the manufacturers of XPS to convert to the productionof insulating boards free of halogenated CFCs (1996)

• Self-imposed obligation on the part of the chemical industry to reduce the energy-relatedCO2 emissions (1996)

• Self-imposed obligation to provide consumer or environmental organizations with detailedinformation on enzymes produced by gene technology (1996)

• Self-imposed obligation on the part of the chemical industry to record and assess sub-stances (in particular intermediates) in order to improve the meaningfulness of the informa-tion (1997)

• Self-imposed obligation relating to products for the protection of wood against wood-destroying and wood discolouring organisms (1997)

• Self-imposed obligation on the part of the manufacturers of laundry products to provide theFederal Environmental Agency with information on the enzymes used in laundry and clean-ing products (1997)

• Self-imposed obligation on the part of the manufacturers of laundry products to label therange of all laundry products (1997)

• Self-imposed obligation to classify textile auxiliaries according to their relevance to aquaticenvironments (1997)

• Notification of basic cosmetic recipes to the central office of the German Cosmetic, Toiletry,Perfumery and Detergent Association (IKW), cases of poisoning to be notified to the FederalInstitute for Risk Assessment (BfR) (1997)

56

• Self-imposed obligation for the reduction of hardly degradable complexing agents in thephotographic industry (1998)

• Self-imposed obligation to dispense with the use of alkyl phenol ethoxylates (APEO) in poly-acrylamide emulsion polymers for the purpose of treating waste water and sewage sludge(1998)

• Branch rule �low-chromate cements and products� (1998/2002)

• Raw substance exclusion list for printing inks and associated products (1999/2001)

• Further developed self-obligation declaration of the chemical industry within the frameworkof the climate protection agreement of the German economy of November 2000 (2000)

Self-imposed obligations on the part of the associations of the chemical industryat Länder level(examples)

Hamburg• �Increased solvent emissions (per) in the neighbourhood of dry cleaners�

since February 1988

Lower Saxony• "Agreement on reducing the use of low-boiling cleaning agents in offset printing" since the 18th of April 1987

North Rhine-Westphalia

• "Plan for the reduction of emissions from waste-incineration plants" February 1990 - 1st of December 1995

• "Self-imposed obligation to limit hydrocarbon emissions during the fuelling of motor vehicles" since the 1st of January 1993

• "Agreement on the voluntary self-monitoring of dry cleaners by external experts" since the 1st of January 1994

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Chapter 5 Procedures, participating ministries and authorities

5.1 General legislation on hazardous substances

5.1.1 Procedure for new chemical substances

Against the background of the Community-wide trade in dangerous substances which, for trade-policy reasons, necessitated a harmonization of the chemicals legislation in the EuropeanCommunity, directives for the harmonization of national law in this area were promulgated at anearly stage. The Council Directive 67/548/EEC on the approximation of laws, regulations andadministrative provisions relating to the classification, packaging and labelling of dangeroussubstances is to be regarded as the fundamental directive. It obliged the Member States to takethe necessary measures to ensure that dangerous substances can only be placed on the mar-ket after prior classification, packaging and labelling according to the provisions of the Directive.This fundamental directive has been amended several times. For example, the chemical policyof the EC was fundamentally restructured by the so-called 6th Amendment of Directive67/548/EEC. It introduced a uniform notification and test procedure throughout the Community.In the Federal Republic of Germany the law for protection from dangerous substances (Chemi-cals Act � ChemG) was enacted in order to transpose this 6th Amendment. In 1992 Directive92/32/EEC of 30 April 1992, amending for the seventh time Directive 67/548/EEC on the ap-proximation of the laws, regulations and administrative provisions relating to the classification,packaging and labelling of dangerous substances, was passed. It obliged the Member States totranspose into national law the regulations which it laid down. In the Federal Republic of Ger-many, the 7th Amendment was transposed by means of the 2nd Amendment of the ChemicalsAct.

General information on the duty to notify chemical substances

The Chemicals Act regulates the duties to notify, test and, if necessary, label new substances.New substances are all substances not listed in EINECS, the European Inventory of ExistingCommercial Chemical Substances. Substances, preparations or products which are regulatedby special laws are exempted or only subject to the scope of the law to a limited extent.

The notifier who produces, obtains or brings the substance or a preparation into the area of ap-plicability of the Chemicals Act must reside or have his business premises in the Federal Re-public of Germany. After a notification has been undertaken, producers or importers may freelymarket the substance throughout the entire EU area as well as in states within the EuropeanEconomic Area which have transposed the 7th Amendment into national law.

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Tonnage-related procedure

The Chemicals Act provides for the tonnage-related notification of each new substance placedon the market in quantities of ≥ 10 kg per year. Once the next tonnage threshold has beenreached, further documents must be submitted. The decisive factor with regard to import notifi-cations is the total quantity of the substance which is imported into the EU and the EEA statesper producer.

Quantity placed on themarket per year

Total quantity placed onthe market

Type of notification

10 kg - < 100 kg - reduced notification100 kg - < 1 t > 500 kg reduced notification> 1 t > 5 t base set> 10 t > 50 t early level I> 100 t > 500 t level I> 1,000 t > 5,000 t level II

Prior inquiry duty / utilization of existing test reports

Each notifier has a duty to make a prior inquiry before performing animal tests for the purpose ofpreparing a notification or a mini-notification. Within the framework of this procedure the poten-tial notifier or mini-notifier must inquire about the need to perform animal tests. If the NotificationUnit already possesses sufficient knowledge about the relevant substance from a third party'stest reports, a procedure for the utilization of the third party's test reports is initiated whereby thethird party and the subsequent notifier have the opportunity to reach an agreement about jointutilization of the test reports. If no agreement is reached, so-called compulsory referencing isundertaken. According to this procedure, the third party whose test reports are utilized has theright to seek compensation from the subsequent notifier at a level of 50% of the saved expen-diture. For his part, the subsequent notifier has a right to be provided with a copy of the utilizedtest report.

Good laboratory practice (GLP)

Non-clinical experimental tests whose results are to be submitted within the framework of thenotification procedure must be performed in accordance with the principles of good laboratorypractice (GLP). Proof that the test results satisfy these demands must be furnished in the formof

• a certificate from the competent authority (GLP certificate) that the test institute and the testsit performs comply with the principles of good laboratory practice and

• a written declaration from the test institute that the particular test has been performed ac-cording to the principles of good laboratory practice.

Test results are regarded as not having been submitted if one of the above-mentioned reportshas not been provided.

Further explanations concerning GLP are provided in chapter 9.1.

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Submission of the notification documents

The notification procedure requires the completion of a form in the German language. Use ofthe SNIF format (Structured Notification Interchange Format) on disk is the preferred optionhere. The notification documents must be submitted to the Federal Institute for OccupationalSafety and Health (BAuA) as the Notification Unit within the Chemicals Act (Division 5 �Chemicals, Notification and Authorization). The submitted documents are here checked forcompleteness and forwarded to the assessment units BAuA (Division 4 � Safety and Healthconcerning Chemical and Biological Working Substances), the Federal Institute for Risk As-sessment (BfR) and the Federal Environmental Agency (UBA) for expert assessment. Incertain cases the Federal Biological Research Centre for Agriculture and Forestry (BBA)and the Federal Institute for Materials Research and Testing (BAM) are included in the pro-cess.

The assessment units and the Notification Unit examine, within their area of competence, theplausibility and validity of the notification documents. In total a period of

- 30 days for reduced notifications and- 60 days for a complete notification at base-set level

is available for this procedure.

If the documents are in order the Notification Unit confirms this fact by issuing a notice of ac-ceptance.

If the submitted notification documents and test reports do not permit adequate assessment ofwhether the notified substance has adverse effects on man or the environment and if this inabil-ity to perform an assessment is due to incomplete or incorrect notification documents, the Notifi-cation Unit asks the notifier to supplement or correct his documents within the 30/60-day period.For the notifier this means that the notified substance cannot be placed on the market until 30 or60 days respectively after receipt of all the required corrections or supplementary data. If ade-quate assessment is not possible even after the subsequent submission of further documents,the complaint procedure is repeated. On conclusion of the procedure the notifier is sent a noticeof the relevant costs.

The Notification Unit can make further demands due to incomplete or incorrect test reports evenafter expiry of the notification period if, for example, test reports are required due to an EU legalinstrument or if new aspects have come to light after expiry of the specified period.

In addition, in cases where an assessment of the notified substance would not otherwise bepossible, supplementary information can also be demanded in the case of complete and correctdocuments, too. Furthermore, the Notification Unit can demand the early submission of test re-ports if there are grounds for suspecting a particular substance of being dangerous. Suchgrounds may, for example, result from structure-activity-relationships and exposure to the sub-stance or exist in cases where the test reports are required for performance of the risk assess-ment. In addition, the Notification Unit can order that certain substances may only be placed onthe market if conditions are fulfilled or after a future event has occurred. If documents are notsubmitted within the specified period or if obligations or conditions are not met, the NotificationUnit can prohibit the marketing of the substance concerned.

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5.1.2 European procedure for existing chemical substances

Council Regulation No. 793/93 of 23 March 1993 on the Evaluation and Control of the Risks ofExisting Substances came into force on the 04.06.1993. It takes direct effect in the MemberStates and does not require special transposition into national law.

About 100,000 substances, which in principle can be freely traded and used, are listed in theEuropean Inventory of Existing Commercial Chemical Substances (EINECS). It was thereforenecessary for existing substances to be regulated on their own - in analogy to the procedure fornew substances - in order to be able to perform, at EU level, systematic assessments of therisks posed by chemicals from which - if necessary - specific protection measures for workers,consumers and the environment can be derived.

16Federal States

BfR*Assessment Unit

UBAAssessment Unit

BMU

BAuA

AMSt ChemG*

Participating authorityBBA

BMVEL

BAuAAssessment Unit

BMWA

EC/EEAstates

EC CommissionECB-Ispra

Notifier

Participating authority

BAM

BMWA

Chemicals management

* Specialist supervision provided by the Federal Envionment Ministry (BMU)

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Work on existing substances takes place in four phases:

1) The collation of available information, at first for substances produced or imported inquantities > 1,000 t/year, at a later date for substances in quantities between 10 and1,000 t/year.

This phase has been concluded. The European Chemicals Bureau in Ispra/Italytherefore possesses an extensive pool of data on substances produced in large vol-umes. In particular, data on producers, quantities and intended uses are available.

2) The drawing up of priority lists and the division of the priority substances among the

Member States.

Substances in quantities > 1,000 t/year for which, as a result of gaps in the data, there isa need for testing or for which there is a need for regulation due to problems relating tohandling are included in a priority list after joint discussion between the European Com-mission and the Member States. Four priority lists, containing a total of 140 substances,currently exist. A Member State was assigned to each substance as rapporteur. TheFederal Republic of Germany was designated the rapporteur for 37 of the 140 sub-stances.

3) The supply of test protocols, data relating to use, exposure data and other available

knowledge concerning the priority substances by the manufacturing or importing compa-nies. Examination of usability and, if necessary, demands for further investigations. Theminimum amount of data required in connection with the properties of the substance de-pends on the extent of testing at base-set level within the framework of the procedure fornew substances.

4) Assessment of the risks to workers, consumers and the environment which are posed bythe substance. A proposal for protective measures and, if necessary, the indication ofsubstitute substances and their risks and availability.

Using the documents conveyed to them and available knowledge, the Member Statesproduce comprehensive risk assessments. In Germany, the responsibility for performingthis work is regulated by the Administrative Provision for Existing Commercial ChemicalSubstances (ChemVwV-Altstoffe) of the 11.09.1997. Accordingly, the national rapporteuris the Notification Unit within the Chemicals Act and the assessment units are theFederal Environmental Agency (UBA), the Federal Institute for Risk Assessment(BfR) and the Federal Institute for Occupational Safety and Health (BAuA), eachhaving responsibility for the specific areas targeted by them for protection. The AdvisoryCommittee on Existing Chemicals of Environmental Relevance (BUA), which com-prises experts from the scientific field, industry and the authorities, can be called upon ifthe above-mentioned state bodies consider external support with selected risk assess-ments to be appropriate.

The draft risk assessments produced by the individual Member States are distributed to theEuropean Commission and all the other Member States. In several different phases of work,the risk assessments are discussed and, if necessary, altered before being accepted by all ofthose participating in the procedure. The results which are obtained are subsequently publishedin the Official Journal of the European Communities.

Necessary measures such as, inter alia, classification, labelling, the establishment of limit val-ues for the workplace, restrictions, and prohibitions must then be derived from the generallyaccepted risk assessments and pushed through politically.

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5.1.3 International activities concerning existing chemical substances

An important player in international efforts to ensure the safety of chemicals is the OECD. Ap-proximately 78 % of worldwide production of chemicals takes place in the 29 OECD MemberStates. In the last 20 years the OECD has shown considerable commitment in the field ofchemical safety while at the same time giving due consideration to the safeguarding of eco-

16Federal States

BUA

UBAAssessment Unit

BMU

BAuA

AMSt ChemG*

BgVV*Assessment Unit

BAuAAssessment Unit

BMA

EC/EEA states

EC CommissionECB-Ispra

notifying companies

Participating authority

BAM

BMWi

Chemicals management Procedure for existing chemical substances

* Specialist supervision by the Federal Environment Ministry (BMU)

63

nomic growth and environmental-protection issues. Examples of the activities of the OECD inthe area of chemical safety are as follows:

Main foci of work:

International harmonization of measures for the identification and prevention of dangers result-ing from chemicals:

• Mutual recognition of data- Test methods for chemicals and plant protection products- Good Laboratory Practice (GLP) for pharmaceuticals, chemicals and plant

protection products

• Work relating to existing chemical substances- Assessment of substances in the Member States according to the

work-sharing principle.- Proposals of measures in connection with selected substances

• Risk identification and minimization• Accidents involving chemicals• Biotechnology

Working groups, inter alia: - test methods for chemicals- GLP- existing chemical substances- risk assessment- plant protection products- harmonization of classification

Organization of the work: - Plenum (joint meeting) every 9 months- Combined session with the group responsible for

plant protection products- Steering body (bureaux)

5.1.3.1 OECD High Production Volume (HPV) Chemicals – Programme / Screening Information Data Sets (SIDS)

Since 1990 there has been intensive cooperation between the Member States and industry toproduce so-called Screening Information Data Sets (SIDS) for existing chemical substances.These data sets include data on substances, on the dangers posed by them and, in part, onexposure to them. Consideration is given to substances which are produced either in quantitiesabove 10,000 t in one Member State or above 1,000 t in at least two Member States. The workis coordinated with the activities of the EC and the International Programme on Chemical Safety(IPCS). Between 1992 and 1996 approx. 100 chemicals were considered. Work is currentlycontinuing on about 200 further chemicals.

The SIDS Initial Assessment Reports (SIAR) produced on the basis of the SIDS are not ascomprehensive as the substance reports produced by the IPCS (EHC reports: EnvironmentalHealth Criteria) or the EC substance reports which are in the process of being written. The SIARare primarily intended to show whether there is sufficient data on a particular substance andwhether, on the basis of the currently available data, there are grounds for considering the sub-stance further, e.g. within the framework of a risk assessment.

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The SIDS contact point for Germany is the Notification Unit within the Chemicals Act. TheFederal Institute for Risk Assessment, the Federal Environmental Agency and � within theframework of the EC procedure for existing chemical substances � the assessment unit of theFederal Institute for Occupational Safety and Health � are all involved in the production ofthe SIARs, each with responsibility for the area they target for protection.

5.1.3.2. ICCA* High Production Volume (HPV) Chemicals Initiative (*ICCA = International Council of Chemical Associates)

This worldwide, voluntary initiative by the chemical industry intends to perform an initial hazardassessment of 1,000 HPV chemicals by the end of 2004.

The information gathered on the individual substances is integrated into the OECD�s HPVChemicals Programme in the form of a Screening Data Set Dossier (SIDS dossier) and a SIDSInitial Assessment Report (SIAR).

The reasons for the ICCA HPV Chemicals Initiative are as follows:

• Acceleration of the existing regional and/or global programmes by specifying a clear targetdate

• Globally standardized and internationally accepted data sets and risk assessments withinthe framework of the OECD HPC Chemicals Programme.

• Avoidance of the duplication of work.

A company or a group of several companies produces the initial assessment (SIDS dossier;SIAR) for a selected HPV substance. The SIAR is forwarded to a sponsor country for expertassessment. If it agrees with the initial hazard assessment the sponsor country integrates theinitial hazard assessment into the OECD HPV chemicals procedure. The Advisory Committeeon Existing Chemicals of Environmental Relevance is the competent contact point for the Fed-eral Republic of Germany as a sponsor country for the ICCA substances.

5.1.4 Marketing, production and use of chemicals

The outline directives listed in chapter 4.2.1.1, i.e. 67/548/EEC (classification, packaging andlabelling of dangerous substances), 1999/45/EC (classification, packaging and labelling of dan-gerous preparations) and 76/769/EEC (restrictions on marketing and use) apply with regard toplacing chemicals on the market in the EU.

These outline directives, including the relevant adaptation directives or independent directives,have been mainly transposed into German law in the Chemicals Act, the Hazardous Sub-stances Ordinance and the Prohibition of Chemicals Ordinance. By means of flexible referenc-ing to the relevant EU directives in the Hazardous Substances Ordinance the need for trans-posing EU law into national law in the area of the classification, packaging and labelling of dan-gerous substances is dispensed with, thus allowing a rapid application of new rules.

Directive 98/24/EC includes the minimum European requirements for handling chemicals in theworkplace. It supersedes the previous outline directive 80/1107/EEC on the protection of work-ers from risks related to chemical, physical and biological working substances. In addition, thereare further chemicals-related regulations, e.g. Directive 90/394/EEC (in the version of theamendment 1999/38/EC) on the protection of workers from risks related to carcinogens or Di-

65

rective 92/85/EEC on the improvement of the health protection of pregnant workers, workerswho have recently given birth and workers who are breastfeeding.

Directive 98/24/EC was transposed into German law within the framework of a revised Hazard-ous Substances Ordinance at the beginning of 2005. According to § 21 Section 5 of the Healthand Safety at Work Act (ArbSchG), responsibility for the monitoring performed in the companiesand administrations belonging to the Federal Government lies - apart from exceptional cases inthe federal area - with the Central Office for Occupational Safety and Health at the FederalMinistry of the Interior as the competent authority according to whose instructions the federalaccident and insurance fund always acts.The requirements of Directive 90/394/EEC are found again in the Hazardous Substances Ordi-nance. In 1997 Directive 92/85/EEC was transposed into German law as an independent Pro-tection of Nursing and Expectant Mothers Ordinance.

Classification

Classification is the substance-related assignment of danger categories (e.g. flammable, toxic,carcinogenic, dangerous for the environment) on the basis of statutorily defined criteria. It trig-gers duties on the part of the person placing chemical substances and preparations on the mar-ket to label them and provide relevant information. In accordance with Article 95 of the Euro-pean Treaty, the EU is striving for harmonization of classification within the single market. Theregularly updated Annex I of Directive 67/548/EEC contains a list of the dangerous substancesfor which an EU-harmonized, binding classification already exists ("legal classification"). The"definition principle" applies to all other substances and preparations, i.e. the person placingthem on the market is solely responsible for the decisions he takes on the basis of the prede-termined criteria contained in Annex V to Directive 67/548/EEC or Directive 1999/45/EC.

Labelling, safety data sheet

A labelling duty for the substance and for preparations containing the substance in amountsabove certain concentration limits ensues from the classification. The Directives 67/548/EECand 1999/45/EC contain an EU-harmonized, detailed system of labelling rules which brings to-gether the insights gained in the course of the classification process in order to provide initialinformation for the customer which is oriented towards the principal risks posed by the sub-stance or preparation. As a result of this concentrated form of information, which applies in par-ticular to the labelling of preparations, there is, however, the need for further information in con-nection with particular areas targeted for protection. This is above all the case with regard tooccupational safety and health since the users of chemical products may be exposed to verydifferent risks dependent on the type and frequency of handling. Consequently, Directive88/379/EEC provided for the establishment of the safety data sheet as an additional instrument.Directive 91/155/EEC then ensured that the safety data sheet successfully established itself inEurope.

Labelling and the safety data sheet represent the first and basic items of information for the userof chemical products without which he is unable to fulfil his statutory obligations to protect work-ers from dangerous substances.

Prohibitions and restrictions

Directive 76/769/EEC contains harmonized rules for the removal of trade restrictions within theEU that result from restrictions on dangerous substances, preparations and associated finishedproducts imposed by individual Member States. In addition, it includes requirements relating toareas in which there is agreement between the Member States about the need for restrictions inorder to protect human health, the environment and the interests of consumers. As a rule, therestrictions relate to particular use categories. Complete prohibitions of the marketing of sub-stances and preparations are rare (e.g. occurring in the case of PCBs and asbestos).

66

The European prohibitions and restrictions are transposed into German law in the HazardousSubstances Ordinance and the Prohibition of Chemicals Ordinance.

Occupational safety rules

In accordance with Article 138 of the European Treaty, Directive 98/24/EC and the other EUsafety directives relating to the handling of chemicals (production and use) contain minimumrequirements for the particular provisions in individual Member States. Consequently, the re-quirements of national statutory rules can exceed those laid down in European legislation. Thesafety data sheet should draw attention to particular national rules and the safety measuresensuing from them.

The occupational safety provisions for the handling of hazardous substances which apply inGermany are mainly to be found in the Hazardous Substances Ordinance. The scope of themeasures that are to be taken are oriented towards the classification of the utilized hazardoussubstances. Therefore, in the case of a carcinogenic substance, for example, any exposuremust be prevented according to the current state of technology. By contrast, in the case of anirritant substance, adherence to a predetermined occupational exposure limit may suffice.

The duty to examine substitutes and alternative processes with a lower risk takes priority in in-dustrial management of hazardous substances. If this is either not possible or cannot be ex-pected of the company, combating risks at source always takes priority over personal protectivemeasures. Work processes must therefore be designed in such a way that hazardous sub-stances are either not released or harmful contact with the skin cannot occur. Taking into con-sideration the appropriateness of the means, the use of closed processes, local exhaust venti-lation or technical ventilation measures is therefore required. By contrast, respiratory protectionand full protective suits are not acceptable as long-term protective measures.

Industrial management of hazardous substances also includes the design of the working prem-ises and the organization of the sequence of operations, the provision of both oral and writteninformation to workers and, in a some cases, medical surveillance. The utilized hazardous sub-stances, the result of examining substitute solutions, the adherence to occupational exposurelimits and the instruction of the workers must be documented in such a way that they can serveas proof vis-à-vis the monitoring authorities.

Important assistance in the application of the Hazardous Substances Ordinance is provided bythe Technical Rules for Hazardous Substances (TRGS). They are elaborated by the Committeeon Hazardous Substances (AGS), involve active participation on the part of the social part-ners, are passed according to the principle of consensus and announced in the Federal LabourGazette by the Federal Ministry of Economics and Labour (BMWA). The Technical Rulesdescribe in concrete terms the current state of technology with regard to the demands of theHazardous Substances Ordinance, e.g. for particular substances or activities. However, only theHazardous Substances Ordinance is directly binding in law. It is therefore permitted to deviatefrom the stipulations of the Technical Rule if the area targeted for protection can be safe-guarded through the application of measures of similar value (however not through the use ofrespiratory protection or chemical protection suits on a permanent basis).

Notification duty in the case of new knowledge about carcinogenic, mutagenic orreproductive toxic properties of chemical substances

If the producer or importer classifies as carcinogenic, mutagenic or reproductive toxic a sub-stance which is not yet included in Annex I to Directive 67/548/EEC as a "legally" classified sub-stance he must immediately announce the data forming the basis for his decision to the Notifi-

67

cation Unit within the Chemicals Act. The same applies in cases where the substance is al-ready named in Annex I due to other dangerous properties. The conveyed data should include abibliography of all the important literature references as well as all relevant unpublished data.

5.1.5 Export/Import of dangerous substances, PIC procedure

Council Regulation (EC) No 304/2003 of 28 January 2003 concerning the export and import ofcertain dangerous chemicals (Export/Import Regulation) was announced in the Official Journalof the EU on the 6th of March 2003 and came into force the following day.

Notification procedure for the export from the EU of certain dangerous chemicals

The exporter of a substance listed in Annex I Part I of the Regulation, or of a preparation con-taining the substance at a percentage of relevance to labelling, must make an announcementaccording to Annex III to the competent national authority at least 30 days prior to the first ex-port to the particular outside country. In Germany, the Federal Institute for OccupationalSafety and Health, Division 5, - Chemicals, Notification and Authorization has been cho-sen as the Designated National Authority (DNA). It examines the documents and forwards themto the European Commission, in this case to the joint research centre of the European Chemi-cals Bureau (ECB) in Ispra/Italy.

Per calendar year the ECB sends an export notification to the importing country in connectionwith the first export of a substance contained in Annex I. It is only necessary for the exporter torenew the announcement if the statutory EU regulations for placing on the market or for using orlabelling the substance concerned have significantly altered or if the composition of the relevantpreparation has changed to such an extent that its labelling has also changed.

Prior Informed Consent (PIC) procedure

The European Union participates in the PIC procedure within the environmental programme ofthe United Nations (UNEP) and the Food and Agricultural Organization (FAO). At an interna-tional conference (the Rotterdam Convention) held in September 1998, this procedure was laiddown as binding in international law. The Rotterdam Convention entered into force on the24.02.2004, 90 days after the 50th document of the ratification was deposited. The GermanFederal Government has designated the Federal Office of Consumer Protection and FoodSafety as the competent national authority vis-à-vis the FAO in connection with plant protectionproducts and the Federal Institute for Occupational Safety and Health (BAuA), Division 5 –Chemicals, Notification and Authorization as the competent national authority vis-à-visUNEP with regard to all other chemicals.

The export of a chemical subject to the PIC procedure (Annex I, Part 3 of the Regulation) or ofan EU PIC candidate (Annex I, Part 2 of the Regulation) can only take place after express con-sent in writing by the recipient country. If the export of one of these chemicals is intended, it isfirst necessary to examine whether a PIC decision by the relevant importing country is con-tained in the current PIC circular. If this is the case, the existing decision must be observed. Inall other cases the Member State of the EU which receives the first notification in the calendaryear must ask the recipient country for express consent. If this has generally been granted itapplies to the entire EU. Any conditions that may be contained there must be adhered to.

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Labelling rules

The packaging and labelling rules which are in force in the EU in connection with dangeroussubstances and preparations must be applied to all dangerous chemicals intended for export.Consequently, it is not only the substances and preparations listed in Annex I of the Regulationwhich have to be labelled in accordance with the relevant EC directives as though they are be-ing placed on the EU market. Instead, this duty applies to all dangerous substances and prepa-rations. Any special provisions in force in the importing non-EU countries are unaffected by thisobligation.

General export ban

Annex V of the Regulation includes those substances or articles which are subject to an abso-lute export ban in the EU. Mercury soaps and the persistent organic pollutants (POPs) are cur-rently affected.

The European Commission's database "EDEXIM"

In connection with the Regulation the ECB in Ispra/Italy has produced the European databaseon the export and import of certain dangerous chemicals "EDEXIM" to support the Commissionand the Member States with the implementation of Council Regulation (EC) No 304/2003. Be-sides the annexes of the Regulation, EDEXIM also contains, for example, the addresses of allthe DNAs, the PIC decisions taken by the FAO and UNEP, identity data such as CAS, EINECSnumbers as well as, in particular, the guidance document relating to the Regulation. In addition,the Commission has created a non-confidential online version of "EDEXIM" which can beviewed via the Internet. The address is: http://ecb.jrc.it/edex .

Import notifications by non-EU countries

The EU Member States also receive notifications from non-EU countries. In Germany's case(BAuA, Division 5 � Chemicals, Notification and Authorization), these are mainly notificationsfrom the United States. The notifications that are based on prohibitions or important restrictionsimposed by the exporting countries are reported to the ECB which, in turn, forwards them to allthe other Member States.

http://ecb.jrc.it/edex

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1 6F e d e r a l S ta te s

B V LP a rt ic ip a t in g

a u th o r ity

B M V E L

U B AA s s e s s m e n t U n it

B M U

B A u A

F B 5*(D N A )

B fR *A s s e s s m e n t U n it

E C /E E As ta te s

E C C o m m is s io nE C B -Is p ra

B A u AA s s e s s m e n t U n it

B M W A

U N E PE x p o rte r

n o n -E U c o u n tr ie s

C h e m ic a ls m a n a g e m e n t E x - / im p o rt , P IC p ro c e d u re

* S p e c ia lis t s u p e rv is io n b y th e B M U

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5.1.6 CFC regulations

Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000on substances that deplete the ozone layer regulates the production, import, export, the placingon the market, the use, the recovery, the recycling and the reprocessing and destruction of sub-stances that harm the ozone layer. The Federal Institute for Occupational Safety and Health,Division 5 � Chemicals, Notification and Authorization � is the competent authority according tothe meaning of this Regulation.

The following deadlines for the step-by-step cessation of the production of ozone-depleting sub-stances apply in the EU:

1. CFC R 11, R 12, R 113, R114, R 115: 100% 19952. Other fully halogenated CFCs: 100% 19953. Halons: 100% 19944. Carbon tetrachloride 100% 19955. 1.1.1-trichloroethane 100% 19966. Partially halogenated halons 100% 19967. Methyl bromide (1991 basis) freezing from 1995

25% 199960% 200175% 2003100% 2005

8. Partially halogenated CFCs (1997 basis) freezing from 200065% 200880% 201485% 2020100% 2026

In addition, it is regulated that:- the placing on the market and the use of the substances listed in the above under 1. to 6. is

prohibited. Exempted from this are the destruction within the Community, the covering of thelicensed need as well as, in the case of special applications, the use as starting and proc-essing auxiliaries. The use of halons is still permitted in a very few exceptional cases thatare specifically named in Annex VII of the Regulation. A temporary exemption can beauthorized for implants (pharmaceuticals) and military purposes;

- the quantity of methyl bromide and partially halogenated CFCs that is to be placed on themarket by the manufacturer or importer is continuously reduced and

- products and equipment containing the substances listed in the above under 1. to 6. maynot be placed on the market if they were produced after the Regulation came into force.

Basically the following restrictions apply to partially halogenated CFCs:- Since the 1st of January 2004 use as a refrigerant in all new equipment / refrigeration and

air-conditioning plant, including combined air-conditioning and heat-pump systems is pro-hibited.

- As from the 1st of January 2010 the use of unprocessed partially halogenated CFCs for themaintenance and operation of existing refrigeration and air-conditioning plant is prohibited.As from the 1st of January 2015 the use of partially halogenated CFCs as refrigerants is ab-solutely prohibited.

- Since the 1st of January 2004 no plastic foams may be produced using partially halogenatedCFCs. All of the previous exemptions no longer apply.

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- Products and equipment containing partially halogenated CFCs may no longer be placed onthe market. Exempted here are products and equipment produced before the prohibition onuse came into force.

In each case quotas are required for the production and use of regulated substances. They aregranted by the Commission.

It is necessary to apply to the Commission for licences permitting the import and export ofregulated substances. The Federal Institute for Occupational Safety and Health, Division 5 andthe Federal Environment Ministry are informed about licences by copy.

B A u AF B 5 *

B M U

E C /E E AS ta te s

E C C o m m is s io nP ro d u c e r, u s e r ,

im p o rte r , e x p o rte r

C h e m ic a ls m a n a g e m e n t C F C p ro c e d u re

*S p e c ia lis t s u p e rv is io n b y th e B M U

Going beyond the European Regulation, the national CFC-halon Prohibition Ordinance regu-lates the production, the placing on the market and the use of 12 ozone-layer depleting sub-stances in pressurized gas packages, refrigerants, extinguishing agents, plastic foams, cleaningproducts and solvents.

5.2 Special dangerous substances legislation

The areas listed in this chapter provide, by way of example, an overview of the other substance-related rules and regulations.

See chapter 7.1 for the inclusion of the Länder in the enforcement of the federal laws.

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5.2.1 Biocides

The German Biocide Act came into force on the 28th of June 2002. It essentially integrated intothe Chemicals Act (ChemG, in particular section II a) the rules required for transposition of Di-rective 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerningthe placing of biocidal products on the market. The authorization procedure for biocidal productswhich came into force as a result states that biocidal products may only be marketed and usedafter prior authorization.

The authorization authority is the Federal Institute for Occupational Safety and Health(BAuA), Division 5, Chemicals, Notification and Authorization.

The national expert authorities included in the procedure as authorities whose consent is sought

are:

- Division 4 of the Federal Institute for Occupational Safety and Health (responsible for theprotection of workers)

- The Federal Environmental Agency (UBA) (responsible for protection of the environment)- The Federal Institute for Risk Assessment (BfR) (responsible for the protection of consum-

ers)

The Federal Institute for Materials Research and Testing (BAM), the Federal Office of Con-sumer Protection and Food Safety (BVL) and the Robert-Koch Institute (RKI) participate in theauthorization procedure for certain types of products as consultation authorities.

5.2.1.1 Procedure for active biocidal substances

The active substances procedure represents an essential core process of the statutory rules forbiocides. Within the framework of this European procedure it is decided whether an active bio-cidal substance is included in one of the Annexes I, IA or IB of Directive 98/8/EC. The inclusionof the active biocidal substance in one of the aforementioned Annexes is a precondition for theauthorization of biocidal products.

Within one year after acknowledgement of the documents the participating authorities undertakean assessment and make a recommendation about the inclusion or non-inclusion of the activebiocidal substance in the particular annex. If further information is required from the applicant,the one-year deadline is suspended until the documents have been submitted. The recommen-dation (the report by the competent authority) is passed on to the Commission, the other Mem-ber States and the applicant.At the latest 12 months after receipt of the documents the Commission decides, with the assis-tance of a Standing Committee, whether or not the active biocidal substance is included in oneof the Annexes I, IA or IB of the Directive.

Programme for existing active substances

Existing active substances are active biocidal substances that were already used in biocidalproducts in an EU Member State prior to the 14th of May 2000. Consequently, in considerationof the already existing statutory rules, they can continue to be marketed for biocidal purposesduring the programme for existing active substances as long as they have either been notifiedor identified.

The notified active biocidal substances which are subjected to examination within the frameworkof the existing active substances programme are listed in Annex II of Regulation (EC) No2032/2003. If after examination one of these active substances is not included in one of the An-nexes I, IA or IB of Directive 98/8/EC, all of the biocidal products that include this active sub-stance as well as the active substance itself must be withdrawn from the market. If the active

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biocidal substance is included in one of the above-mentioned annexes, the corresponding bio-cidal products require authorization.Within the framework of the above-mentioned Regulation, inter alia, the first two of a total of fourpriority lists have also been laid down.The documents relating to the active substances for wood preservatives (product type 8) androdenticides (product type 14) were received at the end of March 2004 and processing hasstarted.The documents for the second priority list must be submitted within the period from 01.11.2005to 30.06.2006.Identified active substances and biocidal products containing them may continue to be placedon the market up to 01.09.2006.

New active substances

New active substances are active biocidal substances which have not been placed on the mar-ket in an EU Member State until after the 14th May 2000. In contrast to the existing active sub-stances programme, the new active substances may only be marketed in biocidal products afterinclusion in one of the annexes of Directive 98/8/EC.

Basic substances

A basic substance is a substance which is listed in Annex I B, whose major use is non-pesticidalbut which has some minor use as a biocide either directly or in a product consisting of the sub-stance and a simple diluent which itself is not a substance of concern and which is not directlymarketed for this biocidal use.

5.2.1.2 Procedure for biocidal products

Authorization of a biocidal product

Alongside the active substances procedure, the authorization of biocidal products represents afurther main process in the biocide procedure.The product authorization itself is subject to the rules cited in Article 5 of Directive 98/8/EC. As arule, the authorization unit decides on fulfilment or otherwise of the preconditions for authoriza-tion within one year of receipt of the application. The procedure for the authorization of biocidalproducts is similar in structure to the active substances procedure.

A precondition for a successful authorization of a biocidal product is that the active biocidal sub-stances contained within it are included in Annex I or IA of Directive 98/8/EC. The authorizationprocedure therefore builds upon the active substances procedure.

Registration of a biocidal product with low risk potential

The aim of the procedure �registration of biocidal products� is to record products with a low riskpotential.

The risk potential of a biocidal product is essentially determined by the active biocidal sub-stances contained within it. A registration of the product can only be applied for if all of the ac-tive biocidal substances included in the biocidal product are found in Annex IA of Directive98/8/EC.

The authorization unit always decides on the registration application within 60 days of receipt ofthe documents.From the procedural point of view, the registration of biocidal products represents a shortenedauthorization procedure.

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Frame formulationDuring the authorization or registration of biocidal products there is the possibility of laying downa frame formulation. Such a formulation describes a group of biocidal products for the same useand user category which contain the same active biocidal substances of the same specificationand which only reveal such deviations from the authorized biocidal product as do not affect thelevel of risk associated with them or impair their efficacy.

A frame formulation is laid down as a result of the submission of an application or officially bythe authorization unit

Reference product

A reference product is present when a biocidal product is imported from another EU MemberState or state party to the Convention on the European Economic Area, has been authorized orregistered there in an equivalent procedure and coincides with a biocidal product (referenceproduct) that has been authorized or registered in Germany.

Mutual recognition of an authorization or registration

Initially, authorizations and registrations of biocidal products are only valid in the particularMember State. In the mutual recognition procedure a biocidal product that has already beenauthorized or registered in another Member State is authorized or registered in Germany. Thedecision is taken within 120 or 60 days respectively after receipt of the application by theauthorization unit.

Provisional authorization of a biocidal product

A provisional authorization of a biocidal product can be granted prior to the decision about theinclusion or non-inclusion of an active biocidal substance in one of the annexes of Directive98/8/EC if it is to be expected that the substances contained within it and the product itself fulfilthe statutory preconditions for this and if no Member State raises objections. However, this pro-visional authorization is granted for a maximum of 3 years and may be extended by one year atmost.

5.2.1.3 Further procedures

Research and developmentBiocidal products and active biocidal substances intended exclusively for use in biocidal prod-ucts which are placed on the market for purposes of scientific and process-related research aresubject to the statutory rules for research and development.

In the case of scientific research and development documents are only submitted after theyhave been requested by the authorization unit.In the case of process-related research and development an announcement duty vis-à-vis theauthorization unit exists.The authorization unit can prohibit the performance of the tests or order that the tests only beperformed in observance of certain conditions.

Prior enquiry duty/ utilization of available test reportsBefore performing tests on vertebrates the person intending to submit the test report has a priorenquiry duty. The procedure is comparable with the prior enquiry duty in the European newsubstances procedure.

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5.2.1.4 Biocide procedures at other authorities

A biocidal product which does not meet the authorization requirements or for whose authoriza-tion the necessary documents are not fully available may be authorized to combat an unfore-seen risk which cannot be contained by other means. This authorization is valid for a maximumof 120 days, a new authorization may be granted. The authorization unit is

BfR* Consenting

Unit

BMU

16Federal States

UBAConsenting

Unit

BMU

BAuAConsenting

Unit

BMWA

BAuA

FB 5 ChemG*

BVL*Consultation

Unit

BMU

BAMConsultation

Unit

BMWA

EC/EEAStates

EC Comm.C C iECB Ispra

Applicant

RKI*

ConsultationUnit

BMU

Chemicals management biocide procedure

* Specialist supervision by the BMU

76

- the Robert Koch Institute (RKI)

in the case of biocidal products which must be used for disinfection measures accordingto § 18 of the Infection Protection Act,

- the Federal Office of Consumer Protection and Food Safety (BVL)

(a) in the case of biocidal products which, in accordance with § 18 of the Infection Pro-tection Act, must be used in disinfestation measures and in measures to control ver-tebrate animals by means of which pathogens may be spread as well as

(b) in the case of biocidal products which, on the basis of § 17 f of the Animal InfectiousDisease Act, may be used in disinfections and disinfestations as provided for in ani-mal infectious disease legislation.

5.2.2 Pharmaceuticals

Pharmaceuticals and homeopathic pharmaceuticals must be licensed or registered by the rele-vant competent authority before they may be placed on the market. A distinction is made be-tween three licensing procedures:

• centralized licensing procedures• decentralized licensing procedures• national licensing procedures

The centralized licensing procedure is regulated in Regulation (EC) No 726/2004. It is manda-tory for pharmaceuticals that are produced biotechnologically or which are technically highlyinnovative in character. The submissions office is the European Agency for the Evaluation ofMedicinal Products (EMEA � London, GB). The Member States participate in the examinationof the documents. The licence granted by the European Commission is valid throughout the EU.

In addition to the centralized licensing procedure there is the national licensing procedure whichall other finished pharmaceutical products must undergo prior to marketing in the Federal Re-public of Germany. The national licensing procedure is harmonized throughout Europe andregulated in the German Drugs Act (AMG). The Federal Institute for Pharmaceuticals andMedical Products (BfArM) in Bonn is the licensing and registration authority for human andhomeopathic pharmaceuticals. The licence is only valid in the Federal Republic of Germany. Ifthe pharmaceutical is also to be placed on the market of another EU Member State, an applica-tion for mutual recognition (decentralized procedure) must be submitted there. A decision mustbe taken within 90 days.

In addition, the Paul Ehrlich Institute (Federal Office for Sera and Vaccines, PEI) in Langen isthe licensing office for sera, vaccines, blood preparations, test allergens, test sera and test anti-gens. Veterinary pharmaceuticals are licensed by the Federal Office of Consumer Protectionand Food Safety (BVL) in Braunschweig.

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5.2.3 Plant Protection Products

Directive 91/414/EC on placing plant protection products on the market regulates the licensingprocedure within the European Union in a uniform manner and is transposed into German lawby the law on the protection of cultivated plants (Plant Protection Act - PflSchG). This law is tar-geted at protecting in equal measure the health of man and animal on the one hand and theground water and the environment on the other.

A distinction is made between the procedure for active substances and the procedure for theactual plant protection products.

• Active substances in plant protection products are tested at EU level. In conjunction with theMember States, the EU Commission decides on the acceptance of an active substance andits inclusion in Annex I of the Directive. Inclusion in this positive list is a prerequisite for the li-censing of plant protection products containing the tested active substance.

The licensing of the plant protection products is the responsibility of the Member States. InGermany, the Federal Office of Consumer Protection and Food Safety (BVL) inBraunschweig grants a licence to the applicant for the plant protection product if the licenceapplication for the plant protection product meets the demands and testing shows that

1. the plant protection product is sufficiently effective,

2. there is no conflict with the demands relating to the protection of man and animals during the handling of dangerous substances,

3. during proper use as intended, the plant protection product

a) does not have any adverse effects, in particular with regard to human andanimal health and the ground water and

b) does not have any other effects, in particular on the balance of nature, which,according to the current state of scientific knowledge, are not acceptable.

The Federal Office of Consumer Protection and Food Safety (BVL) decides on the exis-tence of the preconditions on a consensual basis with the Federal Environmental Agency(UBA) and in consultation with the Federal Biological Research Centre for Agriculture andForestry (BBA) and the Federal Institute for Risk Assessment (BfR).

5.3 Dangerous substances legislation in the wider sense

5.3.1 Laundry and cleaning products

In Germany the production and the marketing of laundry and cleaning products is regulated bythe Laundry and Cleaning Products Act (WRMG). The WRMG obliges the producers and im-porters of such products or persons responsible for marketing them to inform the Federal Envi-ronmental Agency (UBA) about the basic recipes and to provide the agency with environ-mental compatibility data prior to placing the product on the market for the first time. The Fed-eral Environmental Agency then evaluates the environmental compatibility data with regard toadverse effects on the nature of aquatic environments and informs the regional control authori-ties.

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The aim of the Act is to ensure that laundry and cleaning products are only placed on the mar-ket in such a way that their use does not result in any avoidable impairment of the nature ofaquatic environments, particularly with regard to the balance of nature and the drinking watersupply.

According to the meaning of this Act, laundry and cleaning products are products (mixtures ofsubstances) which serve in cleaning or support cleaning and can subsequently enter aquaticenvironments. Included here are also products containing surface-active substances (tensides)or organic solvents if they are used for the purpose of cleaning and can enter aquatic environ-ments after use.

In implementation of the statutory demands, legislation prohibiting certain substances with anadverse effect on the environment has been passed (Tenside Ordinance, Ordinance on Maxi-mum Quantities of Phosphate). This aim is supported by voluntary renunciation declarations inwhich the industry unilaterally agrees, for example, to dispense with the use of alkyl phenol eth-oxylates and to minimize the use of EDTA and NTA. An important rule for the consumer im-poses the obligation on the producer of laundry products to indicate on the packaging recom-mended amounts for use as well as the most important constituents (consumer protection). As aresult, consumer and environmental organizations are better able to provide recommendationsabout the purchase of more environmentally compatible laundry products.

In addition, the European Community has concerned itself with laundry and cleaning productssince the 1970s. For example, with its policy in the laundry products sector the Community isattempting to remove the problems caused by tenside foams in aquatic environments. To thisend, a total of five Directives, all of which aim to reduce environmental problems such as theformation of foam in rivers, have so far been enacted. The examination of biodegradability iscrucially important here.The new Detergent Regulation - Regulation (EC) No 648/2004 � was passed on the 31st ofMarch 2004. It replaces the five existing directives on the biodegradability of surface-active sub-stances in detergents. The detergent regulation will come into force on the 8th of October 2005.By then the Laundry and Cleaning Products Act will have been amended accordingly andadapted to the Detergent Regulation.

5.3.2 Transport of dangerous goods

The law on the transport of dangerous goods in Germany is characterized by a series of inter-national frameworks. Due to the importance of foreign trade, transport legislation in particular isregulated by international treaties. Worthy of special note in this connection are the recommen-dations on the transport of dangerous substances made by the Economic and Social Council ofthe United Nations (ECOSOC) and the international agreements RID (Règlement conçernant letransport international ferroviaire des marchandises dangereuses), ADR (Accord européen re-latif au transport des marchandises dangereuses par route) and ADNR (Accord européen con-çernant le transport international des marchandises dangereuses par navigation du Rhin). Dueto this regulation density EU law is of less importance in this connection than international law.

Nationally these rules and regulations acquire validity via the law on the transport of dangerousgoods (GBefGG) of 1975 in the new version of 1998 (see 4.2.2). It creates a uniform legal basisfor the Federal Republic of Germany and includes the basic rules for the areas road, rail, seavessel, inland waterway vessel and aircraft. In addition, the GbefGG includes in particular thebases of authorization for the individual rules which are standardized by ordinances.

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The transport-carrier-related, in part very extensive and technically detailed individual rules arecontained in special ordinances since they have to be altered continuously and developed fur-ther in revisions that occur at relatively short notice. The following ordinances currently exist:

- Dangerous Goods Ordinance � road and rail (GGVSE)- Dangerous Goods Ordinance � inland waterway vessel (GGVBinSch)- Dangerous Goods Ordinance � sea (GGVSee)

There is still no ordinance for the area relating to air transport. The Air Transport Act is applieddirectly here.

According to the power of the dangerous goods law the individual provisions of the ordinancesrelate in particular to the following points:1. the licensing of the goods that are to be transported,2. the requirements relating to packaging, packing together, loading together, separating,3. the labelling of pieces intended for dispatch and vehicles,4. the construction, nature, the equipment and the testing of means of transport,5. the transport permits, accompanying documents,6. duties to provide information, records and reports,7. manning, accompanying the vehicles,8. the training, further training, examination, proof of ability of persons participating in the trans-

port,9. conduct and protection and aid measures after accidents

This always applies in so far as it is required for protection against the risks posed by the trans-port of dangerous goods and considerable nuisances. The ordinance must take account of thestate of technology. The ordinances may also regulate that additional liability insurances mustbe concluded.

Ordinances and general administrative provisions may also be enacted to implement or trans-pose legal instruments of the European Union. Relevant EU directives or regulations on thetransport of dangerous goods by road and rail, the training of lorry drivers, the control of thetransport of dangerous goods by road, the introduction of safety advisers into companies whichtransport dangerous goods by road, rail or on inland waterways as well as minimum require-ments for ships bound for or leaving Community ports and carrying dangerous goods have al-ready been passed and transposed into national law.

An essential aim of future law-making procedures is to achieve harmonization, i.e. conformity ofthe international recommendations and agreements with the national and European regulations,in order to avoid parallel, but different, regulation of comparable procedures. Harmonizationefforts in the international bodies of the ILO, the UN and the IMO are directed towards dealingwith the problem of the uniform classification and labelling of dangerous substances from boththe point of view of occupational safety and consumer protection as well as transport safety andenvironmental protection.

Fulfilment of the tasks in the area relating to the federal railway, air transport as well as travel bysea and on federal waterways, including federally-owned ports, is the responsibility of the Fed-eral Government, one discharged via the federal administrative system. This means that theLänder are left with the task of implementing transport regulations relating to transport by road,regional rail systems and via regionally-owned ports and waterways as well as regulations con-cerning port safety. In addition, there are agreements between the coastal Länder and the Fed-eral government concerning the fulfilment of enforcement duties by maritime and inland-waterway police which relate, inter alia, to the monitoring of the transport of dangerous goodsby sea and inland-waterway vessels (§ 5 of the law on the transport of dangerous goods).

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5.3.3 Chemical weapons

The Chemical Weapons Convention of the 13.01.1993 (Federal Law Gazette II p. 806) is a dis-armament and arms control treaty whose aims are the prohibition of chemical weapons world-wide and the destruction of existing stocks of chemical weapons. Apart from the prohibition ofchemical weapons, the Chemical Weapons Convention also includes a comprehensive notifica-tion and inspection system for the production, processing, consumption of, and trade in, chemi-cals which may be misused for the purpose of producing chemical weapons.

The Federal Republic of Germany dispensed with the production of chemical weapons morethan 40 years ago and, the only country to do so, has submitted to voluntary controls. Conse-quently, the Chemical Weapons Convention was ratified � with Germany among the leadinggroup of countries - on the 12.08.1994 and transposed into national law by means of the imple-menting statute and the implementing regulation relating to the Chemical Weapons Convention.The Chemical Weapons Convention includes lists of the chemicals it controls:

• highly effective warfare agents (e.g. soman, sarin, tabun) and certain of their direct precur-sors. In Germany, their production is prohibited as a matter of principle. Almost any form ofhandling requires notification and approval;

• key chemicals which are used, for example, in the production of insecticides, herbicides,flame retardants, lubricants and pharmaceuticals etc. as well as plastics (e.g. amiton, thiodi-glycol). Their production, processing and consumption are notifiable as from certain tonnagethresholds (1 kg, 100 kg, 1 t per year);

• Intermediates with wide civilian uses, for example, in the production of insecticides, pharma-ceuticals, paints, coating agents and lubricants etc. (e.g. phosgene, phosphorus oxygenchloride). A notification duty exists at annual production levels of 30 t and above.

In addition, the Chemical Weapons Convention also includes �certain organic chemicals� (BOC)which do not feature in the above-mentioned lists but which can be characterized on the basisof a chemical name, structural formula and, possibly, a CAS no. The production of BOCs is no-tifiable as from 200 t per year.

Certain organic chemicals containing phosgene, sulphur or fluorine (PSF chemicals) are re-corded separately and are notifiable at annual production levels of 30 t and above. Furthermore,a notification duty exists in the case of the import and export of certain of the chemicals namedin the above. Export to countries which are not signatories to the treaty always requires ap-proval. Compliance with the treaty is monitored by the international Organization for the Pro-hibition of Chemical Weapons (OVCW) which is based in Den Haag (NL). The organizationexamines the accuracy of the notified data by undertaking on-site inspections. The inspectionsare carried out after a relatively short announcement period and may include, inter alia, the in-spection of plant, the examination of company books, interviews as well as analyses of sam-ples. They are repeated at irregular intervals.

The Federal Export Office (BAFA) is responsible for granting licences and gathering and proc-essing notification data. It additionally makes the organizational preparations for the sequenceof events during the inspections and provides the group of persons accompanying the inspec-tors.

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Chapter 6 Non-governmental organizations

The complex and highly differentiated German industrial landscape is reflected by the existenceof a variety of non-governmental interest groups. Industry associations, trade unions, environ-mental and consumer protection associations as well as scientific organizations participate inchemicals management at national level. A few important organizations are listed here as ex-amples together with a brief description of their particular areas of activity.

6.1 Industry associations

6.1.1 The Chemicals Industry Association (VCI)

The VCI represents the economic-policy interests of 1,600 German chemical companies andGerman subsidiaries of foreign groups of companies vis-à-vis legislators, authorities, other ar-eas of the economy, science and the media.

The headquarters of the VCI is in Frankfurt am Main. The VCI maintains a liaison office to par-liament and the government in Berlin and a liaison bureau in Brussels. Eight regional associa-tions are active in the regions. A large part of the member companies have additionally organ-ized themselves into a total of 30 specialist societies and associations which are corporatemembers of the VCI (e.g. the Industrial Association for Agriculture - see also 6.1.2 in this re-gard).

The VCI provides its member companies with a great deal of information, advice and support inthe area of safe chemicals management. The "Environmental Advisory Society for the ChemicalIndustry - CUB", which provides advice on all matters relating to the protection of the environ-ment and health, occupational safety and technical safety, was founded specifically to serve theneeds of small and medium-sized companies. The "Monitoring Association of Chemical PlantOperators - ÜChem" supports companies which handle water pollutants in their plants.

The VCI and the specialist associations have introduced a number of voluntary self-imposedobligations which, in some cases, have since been adopted as part of national legislation.These include, for example, the decision to stop using PCBs, the introduction of the safety datasheet and the VCI guideline for classification and labelling. In 1983 the Advisory Committee onExisting Substances Relevant to the Environment, the forerunner of the Advisory Committee onExisting Chemicals of Environmental Relevance (BUA), was formed at the suggestion of theVCI. In 1986 the VCI conducted a survey which aimed to record relevant existing chemicals.Comprehensive data sets, which are distributed worldwide in disk form, were created for allsubstances produced in large volumes, i.e. > 1,000 tonnes t/y.

In 1996 the companies which had come together within the framework of the VCI decided toparticipate in the worldwide Responsible Care (RC) Initiative of the International Council ofChemical Associations (ICCA).

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6.1.2 The Agricultural Industry Association (IVA)

The specialist association IVA is a corporate member of the VCI. Its 49 member companiesdevelop and market plant protection products and fertilizers for agriculture and horticulture aswell as pesticides for the area relating to hygiene, the home and garden and they develop prod-ucts and processes using biotechnology. The industry association represents matters of com-mon concern among its members and commits itself here to an open information policy vis-à-visall groups in society.

Together with its member companies, the IVA has published a so-called "active-substancebook". This book describes active substances as well as plant protection products and pesti-cides in terms of their physico-chemical and toxicological properties, signs of intoxication, thecourse of intoxication and therapeutic measures. In addition, specimen instructions for use weredeveloped for the less comprehensively regulated non-agricultural pesticides. Above and be-yond the labelling required by law, the plant protection industry voluntarily provides safety in-formation or safety data sheets to the wholesale and retail trades as well as to professional us-ers of these products.

1990 saw the development and introduction of a voluntary disposal concept (known asPAMIRA) which enables the return of used plant protection product packaging. The collectedplastic packaging is comminuted, processed and gasified in furnaces for use in steel productionin place of heavy oil.

6.1.3 The Chemical Trading Association (VCH)

The VCH comprises over 90 member companies from the area relating to the German whole-sale and foreign trade in chemicals. Their aim is to follow the �guiding principle of sustainabledevelopment� in connection with product responsibility, plant safety, occupational and transportsafety, health and environmental protection as well as in the sphere of information provided tothe public.

6.2 German Statutory Accident Insurance Institutions and trade un-ions

6.2.1 The Federation of German Statutory Accident Insurance Institutions for theIndustrial Sector (HVBG)

Divided up according to particular branches of industry, the 28 German Statutory Accident In-surance Institutions are public corporations responsible for statutory accident insurance in Ger-many. Their umbrella organization is the HVBG, the Federation of German Statutory AccidentInsurance Institutions for the Industrial Sector. The relevant institution for the chemical industry(BG Chemie) plays a particularly important role within the framework of chemicals management.Supported by internal and external expert advisers from the fields of toxicology, occupationalsafety and health, it examines the properties of chemicals in the case of conspicuous phenom-ena or unclear situations. In addition, within the framework of the "Programme of the StatutoryAccident Insurance Institution for the Chemical Industry for the Prevention of Damage to Healthas a result of Working Substances", it has published toxicological assessments for a large num-ber of industry-relevant substances. The plant safety section is concerned with the safety ofchemical plant in an advisory role and on committees.

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The statutory accident insurance institutions create and manage databases. Their data is gath-ered in particular by performing measurements of the concentrations of hazardous substancesin the workplace atmosphere. The data are collated, archived and evaluated within the frame-work of the "Statutory Accident Insurance Institutions� Measurement System for HazardousSubstances" (BGMG). Over 1.2 million records from all branches are already available here.The preparatory work performed by the Statutory Accident Insurance Institutions' working groupon existing substances during the process of "working through" the EU priority lists is based toan essential degree on the results provided by this measurement system.

The BG Institute for Occupational Safety (BGIA) is a research and test institute belonging to theGerman statutory accident insurance institutions. Inter alia, it produces and maintains the GES-TIS database. This database contains information on the safe handling of chemical substancesin the workplace such as, for example, the effects of the substances on man, the necessaryprotective measures and the measures in the case of danger (incl. first aid). The user is addi-tionally informed about important physico-chemical data (e.g. characteristic dust-explosion data)of the substances as well as about special rules on the individual substances from laws and thestatutory accident insurance institutions. Further data acquisition and investigations are per-formed in the laboratory belonging to the German statutory accident insurance institution for thechemical industry (BG Chemie). In addition, within the framework of the database GisChem, theBG Chemie makes available information on the safe handling of hazardous substances in vari-ous branches related to the different processes.

The reduction of risks to workers in the workplace is one main aspect of the prevention workundertaken by the statutory accident insurance institutions. Relevant advice is provided to com-panies by the technical supervisory services belonging to the insurance institutions. The statu-tory accident insurance institutions work hard to supply workers with the necessary information,e.g. by means of informational publications, posters and video films, electronic media as well aspublications in specialist journals and on the Internet.

On the basis of the rules contained in the code of social law (SGB VII), the statutory accidentinsurance institutions are both entitled and obliged to issue accident prevention rules asautonomous law which can also be regarded as a form of self-imposed obligation on the part ofthe industry. These accident prevention rules have the same immediately binding effect onthose subject to the law as state statutory regulations and, if necessary, can be enforced usingstate means. In addition, the experts from the statutory accident insurance institutions inten-sively advise state institutions on the development and design of state statutory regulations,also offering advice in the area of chemicals law. Furthermore they are active on scientific andstandardization bodies.

6.2.2 The Industrial Trade Union for the Mining, Chemicals and Energy Industries(IG BCE)

Through its specialist departments for occupational safety and environmental protection, eco-nomic, research and technology policy, the industrial trade union for the mining, chemicals andenergy industries (IG BCE) participates in the national discourse on chemicals policy andchemicals management.

Questions of design concerning the safe production and handling of chemicals are subjectsconstantly discussed in statutory accident insurance institution committees, state bodies as wellas, however, in work groups with the Chemicals Industry Association. The aim here is to de-velop standards and recommendations for industrial chemicals management.

In addition to these national activities, the topic complexes of chemicals policy, chemicals man-agement and the chemical industry are regularly discussed within the "European Federation ofTrade Unions for the Mining, Chemical and Energy Industries" as well as within the "Interna-tional Federation of Trade Unions for Chemical, Mining and Factory Workers".

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6.3 Environmental and consumer protection organizations

6.3.1 Exemplified by Greenpeace

The environmental protection organization Greenpeace, which was founded in 1971, has alsohad a German office since 1980. Greenpeace does not enter into any relationships with politicalparties and remains independent of governments or economic interest groups. The organizationdraws attention to environmental problems, names polluters and employs positive projects toindicate possible solutions. Greenpeace has divided the area with which it is concerned into fourgeneral topic areas:

- nuclear power, energy, disarmament - climate, transport- chemistry, gene technology - diversity of species (seas and forests)

Each of these areas concentrates on individual campaigns which are carried out after interna-tional consultation.

Greenpeace maintains extensive databases, produces political analyses and informs the publicwith regard to the problem areas of gene technology in agriculture, chlorine chemistry, CFCs,PVC, toxic waste exports, chemical accidents, pollution of the ground water as well as sustain-able chemistry.

6.3.2 Exemplified by the non-profit Federation of German Consumer Organiza-tions (vzbv)

The non-profit Federation of German Consumer Organizations (formerly the non-profit Con-sumer Associations' Working Party [AgV]) has been in existence since 1953. It is the nationalumbrella organization for the 16 consumer centres of the Länder and for 22 consumer-orientedassociations.

The vzbv represents the interests of the consumers in public and vis-à-vis legislators, the pri-vate sector and civil society. The tasks of the vzbv are:

• Representation of consumer interests vis-à-vis legislators and administrative authorities

• Coordination of the consumer-policy work of the member organizations

• Collective legal protection through legal action by the Federation

• Promotion of consumer information

• Development of national advisory standards

• Professional qualification in consumer work

The vzbv is a member of CI (Consumers International) and BEUC (European Office of Con-sumer Organizations).

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With regard to the area relating to chemicals the vzbv is committed to:

• European chemicals legislation which protects consumers from health risks and createsmore transparency regarding the use of chemicals in products

• The promotion of environmentally friendly product design and marketing

• The clear expansion of ecological agriculture

6.4 Scientific organizations

Exemplified by the Society of German Chemists (GDCh)

With almost 27,000 members, the Society of German Chemists is the largest comprehensivescientific body representing chemists in Germany and, in the European context, numbersamong the societies with the richest tradition. It provides the forum for the exchange of scientificopinion. Its members are chemists, biochemists, food chemists, chemical engineers, teachersas well as other scientists from various disciplines with an interest in chemistry and studentsengaged in study courses related to the above-mentioned areas.

The 22 specialist groups - ranging from analytical chemistry, environmental chemistry and eco-toxicology through to hydrochemistry - form the main basis of the work performed by the Soci-ety. They use their specialist knowledge and experience to define and assess new fields of re-search, presenting the latest information from the particular disciplines at their conferences andvia their own publications. They also promote active cooperation by members. Each year theSociety initiates and organizes 20 to 30 national and international congresses, symposia andconferences of various sizes. In addition to the large international events, particular importanceattaches to the conferences for expert groups. The expert groups represent the specialstrengths of the Society to the outside world: work of a highly scientific nature and neutrality.

The 60 local associations - chemists have local organizations throughout Germany - regularlyorganize a large number of regional events. Scientists from home and abroad report, for exam-ple, on the results of current research, new methods and technologies. Chemists are thus of-fered more than 1,000 scientific talks every year throughout Germany.

The public relations work performed by the Society aims to make the benefit and importance ofchemistry understandable to a wider public and promote knowledge of chemistry among thegeneral public. The Society publishes comments on particular issues as well as information pro-vided by the expert groups and local associations. Represented in international bodies, the So-ciety cooperates with national and international sister societies. The "Scientific Press Service forChemistry" provides daily newspapers, specialist magazines, radio and television with currentnews from the world of chemistry.

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Chapter 7 Cooperation between the federal and regional authorities as well as with further participating institutions

7.1 Interministerial commissions and general coordination mecha-nisms

As already explained (see chapters 4 and 5), chemicals management in Germany is character-ized by a high regulation density as well as by a large number of participating authorities andinstitutions with different levels of responsibility. Harmonization of activities, both among thefederal authorities themselves and between the federal authorities and regional authorities, iscrucial if efforts in the area of environmental and health protection are to be successful.Achieving this requires coordination efforts which go beyond the statutory framework. This ex-plains the existence of a large number of committees and working groups for the different areastargeted for protection. The Environment Ministers' Conference, involving the EnvironmentMinisters from the Länder and the Federal Environment Minister, is of particular importance inthis connection.

The committees and working groups listed in the following as an example only represent a smallselection from the large number of institutions in the field of environmental protection.Discussions about restructuring the federal/regional bodies are currently in progress. Conse-quently, there could be changes as from 2005.

Federal/regional Committee on the Safety of Chemicals (BLAC)Members: The highest regional authorities, the Federal Environment MinistryTopics: Specialist questions relating to the enforcement of the Chemicals

Act, legal questions, GLP and further quality assurance systems

Federal/regional Working Group on Environmental Information Systems (BLAK-UIS)

Members: The highest federal and regional authorities responsible for information about the environment

Topics: The exchange of environment-related data between the federalgovernment and the Länder, e.g. a joint pool of substance datashared between the federal government and the Länder (GSBL)

Federal/regional Expert Committee "Transport of Dangerous Goods"(BLFA-GG)

Members: The highest regional authorities, Federal Ministry of Transport and Housing

Topics: Harmonization of specialist and legal matters as well asprocedures for amendment of the law relating to thetransport of dangerous goods

Commission for the Identification and Treatment of Symptoms of Poisoning (Poi-son Information Centres, GIZ)

Members: Federal Institute for Risk Assessment, the highest regional authoritiesTopics: The exchange of information on symptoms of poisoning

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Regional Committee on Protection against Immissions (LAI)Members: The regional authorities responsible for immission control and the Fed-

eral Environmental AgencyTopics: Specialist questions and legal questions relating to the implementation

of the Federal Immission Control Act

Regional Working Group on Water (LAWA)Members: The highest regional authorities responsible for water legislation and

water management. The Federal Government is a permanent guest.Topics: Specialist questions and legal questions relating to the implementation

of water legislation.

Regional Working Group on Waste (LAGA)Members: The highest regional authorities responsible for waste legislation and

waste management. The Federal Government, represented by theFederal Environment Ministry, participates in an advisory role. TheFederal Environmental Agency is a member of working groups.

Topics: Specialist and legal questions relating to waste management and haz-ardous waste sites.

Regional Committee on Soil Protection (LABO)Members: The highest federal and regional authorities with responsibility for soil

protectionTopics: Protection of the soil

Regional Committee on Occupational Safety and Safety Technology (LASI)Members: The highest federal authorities responsible for occupational safety, the

Federal Government is a guest, the Federal Institute for OccupationalSafety and Health

Topics: Occupational safety and safety technology

Committees for the Harmonization of Procedures for the Notification of New andExisting Chemical Substances

Members: Authorities participating in the procedures for new and existing chemi-cal substances (see chapters 5.1.1 and 5.1.2)

Topics: Harmonization of the notification procedure within the framework ofthe Chemicals Act/Council Regulation (EEC) No 793/93, theexchange of information (statutory regulations, test methods)

Committee for Harmonization Within the Biocide ProcedureMembers: Authorities participating in the biocide procedure (see chapter 5.2.1)Topics: Harmonization within the biocide procedure, the exchange of informa-

tion (statutory regulations, test methods)

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Committee on Hazardous Substances (AGS)Members: Industry, trade unions, authorities, the scientific community and

associationsTopics: Questions concerning occupational safety including the classification

and labelling of dangerous substances and preparations

MAK CommissionMembers: Scientists from different areas of specialization (chemistry, medicine)Topics: The assessment of substances and the establishment of MAK values

(MAK = maximum workplace concentration) as well as the classifica-tion of carcinogenic substances

Advisory Committee on Existing Chemicals of Environmental Relevance (BUA)Members: Industry, Federal Institute for Risk Assessment, the Federal Environ-

mental Agency, the Federal Institute for Occupational Safety andHealth, scientists

Topics: Participation in the assessment of existing substances

7.2 Enforcement at regional level

In accordance with the German Constitution, the Länder are entrusted with the task of enforcingenvironmental legislation. The organizational arrangements required here are determined by theLänder themselves. Consequently, there is room for a wide variety of organizational forms todevelop. As a rule, there are three administrative levels: the Regional Environment Ministry, thedistrict level and the local level. Tasks are frequently delegated to a lower regional administra-tive level or to parish level. In cases where extensive technical knowledge is required, specialauthorities are commissioned to undertake enforcement.The city-states of Hamburg and Saxony serve here as examples for the 16 Länder.

7.2.1 Hamburg Enforcement of the Chemicals Act

In Hamburg the Regional Ministry of Science and Health is mainly responsible for the enforce-ment of the Chemicals Act and the statutory ordinances that are based upon it. This applies inparticular to the control of adherence to

• the classification, labelling and packaging rules for dangerous substances and prepara-tions as well as to the rules relating to the safety data sheets,

• the rules on handling in connection with the Hazardous Substances Ordinance,• prohibitions of, and restrictions on, the production, marketing and use of certain danger-

ous substances,• the sale rules contained in the Prohibition of Chemicals Ordinance,• the notification and announcement rules for existing and new substances including the

obligations according to the EC Export/Import Regulation,

which is the responsibility of the Office of Occupational Safety and Health as well as the tasksassumed by the specialist department Patient Protection and Safety in Medicine in connection

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with the rules on good laboratory practice.

Responsibility for the enforcement of the CFC/halon Prohibition Ordinance and the EC rules onthe protection of the ozone layer lies with the Regional Ministry for City Development and theEnvironment. Examinations to determine expert knowledge, licences and notifications according to the Prohi-bitions of Chemicals Ordinance are covered by the district administration. Chemicals legislation supervision at the Office of Occupational Safety and Health is essentiallyintegrated into the control and advice activities relating to the rules on occupational safety andhealth. A key element is the branch-oriented organization of the department ("specialist dis-tricts"). The specialist districts are supported in their supervisory activity by the occupationalsafety laboratory. Utilization of the specialist chemicals legislation knowledge available to thedepartment is optimized by means of information exchange and the clarification of specificproblems in a specialist working group for "hazardous substances". In addition to event-related inspections and regular inspections at companies with a particularlyhigh risk potential, the performance of branch-oriented projects deserves special mention. Hereis a selection of the projects with a chemicals legislation emphasis that have been performed inrecent years: • Prohibitions of marketing/use, substitution of dangerous substances: performing checks on

selected prohibitions in the wholesale trade, accompanying the implementation of thebranch agreement on �low chromate cement�, substitute substances in offset printing and inmetal cleaning, the substitution of latex-containing gloves in hospitals;

• Notification rules: checking adherence among importers, participation in the projects SENSE(new substances) and EUREX (existing substances);

• Classification and labelling, safety data sheets: performing checks on the production proc-ess of safety data sheets (project run by the Regional Committee on Occupational Safetyand Safety Technology (LASI)/Federal Institute for Occupational Safety and Health (BAuA),participation in the ECLIPS project;

• Handling dangerous substances: In the hairdressing trade, in the metal branch, in motor carpainting companies, in hospitals (inhalation anaesthetics), on maritime ships (heavy oils), inshipping/goods transfer companies, in container cleaning (mineral oils), in screen-processprinting works, in tunnel construction (4th Elbe tunnel section), in dry cleaners.

An essential part of the projects consists in providing information to all companies in the par-ticular branches. In order to pursue this aim effectively, informational material is produced (leaf-lets, press releases), questionnaires are conducted and informational events are held. Coop-eration with institutions such as accident insurance bodies, chambers of trade and crafts, guilds,and trade unions plays a significant role. Projects run by the occupational safety and healthlaboratory concerning the exposure situation in companies serve a special purpose. The resultswhich are determined form the basis for the development of so-called �process and substance-specific criteria�, which are published as �LASI/ALMA� recommendations by the Regional Com-mittee on Occupational Safety and Safety Technology. Such criteria enable companies in aspecific branch to design the safe handling of dangerous substances even without performingtheir own exposure measurements.

Systematic approaches by companies to ensure that their activity is in conformity with the laware expressly supported. Companies which perform well in the system monitoring can be putback in the regular monitoring process. In order to also enable targeted activities in the retail trade, branch-related investigations areperformed by a specially trained member of staff. The monitoring of the rules directed at the

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private end-user is entirely event-driven, for example, whenever complaints are received via theoffice�s occupational safety and health telephone. Specific procedural instructions ensure thatcomplaints from citizens and reports from other authorities in connection with violations ofchemical law are processed with the requisite urgency. Hazardous substance monitoring in figures (Office of Occupational Safety and Health –statistics 2003)

1632 examinations/inspections, 896 complaints, 305 measurements, 5 investigations of occupational diseases, accidents and cases of harm, 323 inquiries and complaints processed, 114 statutorily prescribed notifications processed, 429 comments/reports, 9 cases of granting licences, permits, authorizations and exemptions, 103 notices of appeal, 54 orders, 3 notices rejecting objections (accepted objections: 0), 3 cases of use of coercive measures.

A number of databases and other information systems concerning substances and preparationsare available to the members of staff at the Office of Occupational Safety and Health. In addi-tion, all staff have unrestricted Internet access at their workplace if they require further informa-tion on substances and preparations.

Name of the database Access Name of the database Access GDL (joint Länder database on haz-ardous substances)

A ISI (information system, safety datasheets belonging to the BG Institutefor Occupational Safety (BIA))

B

EDL (joint Länder database on expo-sure)

B GGVS (UB-Media) B

WINGIS (Information system on haz-ardous substances belonging to theGerman Statutory Accident InsuranceInstitution for the building industry -GISBAU)

A GISCHEM (branch-specific hazard-ous substances information system forthe chemical industry)

B

SIMMCHEM (Calculation programmefor the classification and labelling ofpreparations)

B RESY-2000 (stand-by call and firstaction system belonging to the Re-gional Ministry for City Developmentand the Environment in Hamburg)

A

RENOCS (EC new and existingchemical substances)

B IUCLID 3.0 B

IGS list of substances (part forwhich no licence is required, NorthRhine-Westphalia)

B MSDS (Merck) A

CCINFO disk (collection of Canadiandatabases) consisting of:

B NIS/ÖGD (noxious substances in-formation system belong to the stateof North Rhine-Westphalia)

A

RTECS (Registry of Toxic Effects ofChemical Substances)

BGVR full edition (Heymanns) A

NIOSHTIC Occupational safety (UB-Media) A CISILO Hazardous substances legislation

(UB-Media) A

MSDS and numerous smaller da-tabases

Working premises (Opfermann/Streit, Forkel publishing company)

A

Auerdata B A = All members of the department for the protection of workers� health B = Competent authority of the department for the protection of workers� health

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Enforcement of the rules on the transport of dangerous goods

In so far as it is the responsibility of the Länder, enforcement of the rules on the transport ofdangerous goods is mainly the task of the Regional Ministry of the Interior. The technical tasksrelating to the licensing, examination and technical monitoring of tanks, tankers, tank wagons,tank containers, set-down tanks, vessels and battery-driven vehicles have been entrusted to theRegional Ministry of Science and Health. In contrast to other Länder and the Federal Ministry of Transport and Housing, with the excep-tion of the tasks relating to the Regional Ministry of Science and Health, the functions of theregional authority have been centralized under the aspect "safety" at the Regional Ministry ofthe Interior for all forms of transport. A further important feature here was the fact that, evenprior to this, fulfilment of these tasks was the responsibility of the port and river police. Since thispolice force operated in the port region anyway and since, in comparison with the lowlands, theHamburg area is relatively compact, it was active in the rest of the city area, too. In Hamburg, a point of intersection for transport involving various land and sea vehicles, effortshave long been directed towards achieving the highest possible degree of consistency in thenational and international rules applying to all forms of transport, thus eliminating the problemswhich previously occurred as a result of these differences whenever the means of transportchanged (so-called harmonization). Thanks to its activity in all areas of transport as well as inthe port, the port and river police can obtain an overview of all of the relevant dangerous goodstransport rules applying to the different forms of transport. It uses this knowledge both to guar-antee safety and for the benefit of the transport business, too. In Hamburg, the Central Office ofPort Safety and Dangerous Goods � WSPF 22 � of the port and river police assumes the im-plementation duties of the specialist competent authorities. Inter alia, it is responsible for grant-ing exemptions on a case-by-case basis in accordance with § 5 of the Dangerous Goods Ordi-nance � Road, for all specialist questions concerning the implementation of the rules containedin the Port Safety Ordinance which are specific to the state of Hamburg as well as for monitoringtransport by road, regional railways, sea and inland-waterway vessels in the port of Hamburg.The fact that this office's radius of action covers the whole transport spectrum has led to it beingincreasingly contacted for information and advice and consulted in matters related to dangerousgoods. This also helps the office fulfil its tasks as the competent monitoring authority with re-sponsibility for enforcement of the rules on representatives in the area relating to dangerousgoods. Apart from the Central Office, so-called port safety officers from the port and river police districtsare engaged in the monitoring of port safety and application of the rules relating to transport bysea and inland-waterway vessels. Inter alia, the examinations which are undertaken concernthe classification of substances, the prescribed packaging, the stowing and separation of thedangerous goods on ships, the equipment available on ships and the training of personnel withregard to compliance with the relevant transport safety rules. A special office of the port andriver police � WSPF 21 � is involved in police monitoring of transport by road and rail throughoutthe city area. The work of the various offices is supported by a dangerous substance information system(GEGIS) which was developed for the Regional Ministry of the Interior by the Hamburg com-pany DAKOSY-Datenkommunikationssystem GmbH and which is in continuous operation. Thecomponent parts of this system are various databases such as the database for rules andregulations, substance databases (joint Länder database on hazardous substances (GDL), theservice belonging to the Federal Environmental Agency which provides rapid information ondangerous goods (GSA), the stand-by call and first-action system belonging to the RegionalMinistry for City Development and the Environment (Resy) as well as substance registers fromvarious chemical-producing companies) and a database on the places where dangerous goodsawaiting transfer are located at the Hamburg port with information on the type, quantity and lo-

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cation of dangerous goods stowed on the notified sea vessels in the port of Hamburg. Thesedata are used, for example, by the notification system in accordance with the EU directive onminimum requirements for vessels bound for or leaving Community ports and carrying danger-ous or polluting goods and as required, for example, in the case of an accident aboard vesselson the high seas where information on the ship's cargo of dangerous goods is needed to com-bat the effects of the accident.

Enforcement of the Foodstuffs and Commodities Act

The enforcement of the Foodstuffs and Commodities Act as well as of the statutory regulationsbased on the Act, such as the ordinance on the maximum permitted amounts of residues, is theresponsibility of the Länder. In Hamburg the district offices are mainly responsible for enforce-ment. Regional Ministry of Science and Health - and, within it, the specialist Department of FoodSafety and Veterinary Medicine - assumes responsibility for overall control and the HamburgInstitute for Hygiene and the Environment has the task of performing investigations. The mostimportant aims of official foodstuffs monitoring are to protect the consumer from health risks,from being misled or deceived, to protect the interests of all those involved in the trade and toprovide comprehensive information to consumers. Monitoring is performed according to therules contained in the Foodstuffs and Commodities Act as well as Community law and otherregulations relating to foodstuffs.

In order to achieve these aims, interest has focused on the following aspects:

• Monitoring of companies, the frequency of monitoring depending on the risk factors which

are present. Inspections of the companies' own inspection systems at the points of input,production and output are included in the monitoring process. In addition to the inspectionand the checking of documents, samples are also taken for the purpose of further investi-gations. Monitoring of the companies is undertaken by qualified personnel, if necessary, byso-called expert teams whose members possess both scientific knowledge and specialistknowledge about enforcement. The monitoring acts affect all companies involved in theproduction and trade of foodstuffs and commodities such as producers, manufacturers, im-porters, and the wholesale and retail trades.

• Investigation of samples, and their assessment in terms of foodstuffs legislation, according

to the principle of random sampling. Sampling is either performed regularly or in campaignswith a special focus of interest in accordance with a defined sampling concept elaboratedby all of the participating state monitoring authorities. In turn, the sample contingents areallotted on the basis of risk factors which include the type of foodstuff and the distributionlevel in the food trade. A particular focus of interest in Hamburg are the import checks onfoodstuffs from non-EU countries which are intended for import into the EU area. In addi-tion, there are national and EU-wide inspection programmes which lay down the numbersof samples to be taken as well as the range of the particular investigation, especially in thearea relating to checks on residues of substances of concern to health. If grounds for suspi-cion result from the investigations based on random sampling, the frequencies of thechecks are increased up to 100 % (duty to present the foodstuff or commodity in question).Within the framework of import controls, relevant consignments are stopped at the borderand examined. If, for example, it is established that maximum permitted quantities of certainsubstances have been exceeded, the good may not be imported.

• PR means are employed for the purpose of providing consumers with comprehensive in-

formation. Included here are press announcements, annual press conferences with leadingpoliticians at which audits are presented, podium discussions, information sheets, annualreports, talks and the health telephone etc. In the case of a potential risk to health, warningsabout eating certain foodstuffs or using particular commodities are disseminated by theauthorities via the media.

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Hamburg's philosophy is to prevent violations of regulations by offering advice and explanationsto the relevant responsible persons in the companies. In general, foodstuffs and commoditieswhich do not meet legal requirements are unsuited to being placed on the market and aretherefore withdrawn. Should coercive measures be necessary in individual cases, the Food-stuffs and Commodities Act provides for administrative offence procedures, in the case of aproven risk to health, criminal prosecution, too. If necessary, measures can be ordered withinthe administrative procedure.

The structure and aims of foodstuffs monitoring require cooperation between all the participantsin the procedure. In addition to further state authorities in Hamburg such as the customs serv-ice, the Regional Ministry of Economics and Labour and the Regional Ministry of the Interior,these primarily include the producers and traders themselves or the groups representing theirinterests � for example, the Merchandise Society of the Hamburg Stock Exchange or the Asso-ciation of Hanseatic Fruit Importers and Wholesalers, all of whom have, and fulfil, their statutoryduty to exercise due care. Today, control of compliance with foodstuffs legislation is, however,integrated into a nationwide and EU-wide system. EU-wide notification duties for all monitoringactivities, centralized evaluation and an information feedback system extending as far as aninstitutionalized rapid warning system, to which Hamburg is, of course, connected, ensure aneffective flow of information. Additional information can obviously be acquired from the specialistpress, the Internet and relevant databases (e.g. MED-LINE, DIMDI). Information is passed onwithin Hamburg almost in real time via the FHH-Info-Net to which all Hamburg authorities areconnected.

Foodstuffs Monitoring Data for Hamburg in 2003 in figures: 36,761 company inspections, number of violations (administrative offences):

1,127 (= 3.1 %)17,401 examined samples, number of complaints: 2,353 samples (= 13.5 %)

7.2.2 Saxony

Enforcement of the rules and regulations on chemicals

In the Free State of Saxony responsibility for enforcement of the Chemicals Act and relatedstatutory orders lies, in so far as matters relating to the environment and general consumerprotection are concerned, with Dresden�s Regional Council. This ensues from the chemicalslegislation responsibility ordinance of the 9th of May 2000, amended by the ordinance of theState of Saxony�s Ministry of the Environment and Agriculture and the State of Saxony�s Minis-try of Labour and Economic Affairs to amend the chemicals legislation responsibility ordinanceof the 21st of March 2002.

7 district officesExamination of expert knowledge, Permits and noticesaccording to the Prohibition of Chemicals Ordinance,Monitoring according to the Foodstuffs and Commodities Act

Fiscal AuthorityOffice for Districts and Administrative Reform

Office of Health and Consumer ProtectionChemG, ChemVerbotsV, GefStoffV,

EC regulations relating to chemical law, Dangerousgoods transportation, Foodstuff / Commodities Act

Regional Ministry of Science and Health

Office of Immission Control and CompaniesCFC-Halon-Prohibition Ordinance,

Regulation (EC) No. 2037/2000

Regional Ministry for City Developmentand the Environment

Water Protection PoliceDangerous goods transportation

Regional Ministry of the Interior

Senate of the Free and Hanseatic City of Hamburg

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This applies in particular to• the control of compliance with the notification and mini-notification duties for new and exist-

ing chemical substances and• the control of compliance with prohibitions of, and restrictions on, the marketing and use of

certain dangerous substances,• the enforcement of the rules and regulations relating to substances that deplete the ozone

layer (CFC/halon Prohibition Ordinance and Regulation (EC) No 2037/2000 of the EuropeanParliament and of the Council of 29 June 2000 on substances that deplete the ozone layer

• the enforcement of the rules and regulations on biocides (apart from matters relating to oc-cupational safety and health)

On-site inspections are performed by the 5 regional specialist environmental departmentsStUFÄ).

The 5 factory inspectorates, which fall within the scope of the State of Saxony�s Ministry of La-bour and Economic Affairs, are responsible for matters relating to occupational safety andhealth. Enforcement activities performed by the factor inspectorates include, inter alia• control of compliance with the classification, labelling and packaging rules for dangerous

substances and preparations performed on the premises of producers/users,• examination of the safety data sheets required according to § 14 of the Hazardous Sub-

stances Ordinance,• the granting of permission to place on the market substances or preparations which are to

be labelled with the danger symbols T and T+ in accordance with the Hazardous SubstancesOrdinance (§ 2 Prohibition of Chemicals Ordinance),

• control of compliance with the duties to provide information and keep records when sellingcertain dangerous substances and preparations to third parties (§ 3 Prohibition of ChemicalsOrdinance),

• granting of permission for the performance of fumigation,• the licensing of companies to perform demolition and restoration work on plant, buildings or

vehicles containing weakly bound asbestos,• the prohibition of the use of carcinogenic substances.

Note: As a result of the State of Saxony�s law on administrative modernization of the 5th of May2004, by the 1st of January 2005 both the regional specialist environmental departments and thefactory inspectorates will be incorporated into the three regional councils of Dresden, Leipzigand Chemnitz.

Enforcement of the rules and regulations on plant protection

Responsibility for the area relating to plant protection/fertilizers is assigned to the State ofSaxony's Ministry for the Environment and Agriculture in conjunction with Saxony's RegionalInstitute of Agriculture. Areas of competence are laid down in the ordinance on the determina-tion of competences in the sphere of agriculture, forestry and nutrition.

Empowered to do so by the Plant Protection Act (§ 8 of the Plant Protection Act), the Free Stateof Saxony has established regional regulations for specific areas of plant protection, for exam-ple,• an administrative provision on the use of plant protection products on outdoor areas which

are not used for the purpose of agriculture, forestry or horticulture,• an ordinance on the announcement of use of plant protection products,• an ordinance on evidence of expert knowledge concerning the use and sale of plant protec-

tion products as well as• an ordinance on inspection workshops for the examination of plant protection equipment

used in extensive cultivation

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In the area relating to fertilizers the Free State of Saxony has passed an administrative provi-sion relating to the enforcement of the ordinance on the principles of good professional practiceduring the application of fertilizer. The provision is intended to serve as a guidance documentfor enforcement of the individual rules which exist within the framework of current legislation.

Enforcement of the rules and regulations on waste and soil protection

The legal basis for action is created by the Waste Avoidance, Recycling and Disposal Act, theSoil Protection Act, and Saxony's legislation on disposal management and soil protection.

Saxony's State Ministry for the Environment and Agriculture is the highest authority for matterrelating to waste and soil protection, the regional councils being the higher waste and soil pro-tection authorities. The administrative districts and the towns which are districts in their ownright are the subordinate waste authorities and, at the same time, public-service disposal bod-ies. As the bodies responsible for the fulfilment of public-service disposal duties, the administra-tive districts and towns classed as districts in their own right are obliged to devise a waste man-agement concept (waste-management planning measure) and to continue to develop it furtheras well as to produce annual waste audits. The waste-management concept elaborated by theFree State of Saxony provides the basis for the strategies employed in waste management inSaxony and furnishes the bodies responsible for public-service waste disposal with the basicand comparative data they require for their own waste-management concepts.

The subordinate waste authorities are fundamentally responsible for the enforcement of therules on waste. The higher waste authorities assume responsibility for the following tasks inparticular:• granting certain licences (e.g. transport licences, licences for landfill sites)• tasks in connection with the procedure for furnishing proof (e.g. confirmation of the permis-

sibility of an intended form of disposal)• authorization of waste-disposal plants• provision of information about suitable waste-disposal plants.

The specialist Regional Environment Departments are responsible for providing specialist sup-port to the waste authorities.

Enforcement of the rules and regulations on water

Saxony's Water Act forms the legal basis for action in this area. In addition, further rules relatingto water legislation (ordinances, administrative provisions and official decisions) have been an-nounced, for example,• an ordinance on protection provisions and payments to compensate for increased use of

water by agriculture and forestry in water-protection areas,• an ordinance on the type and frequency of self-checks on waste-water plant and waste-

water discharges,• an administrative provision relating to demands on plans for water-management projects as

well as• an administrative provision for the promotion of water-management measures.

The highest water authority is the State of Saxony's Ministry for the Environment and Agricul-ture, the higher water authorities are the regional councils and the subordinate water authoritiesare the rural council departments and the towns which are districts in their own right. The SaxonStae Agency for Environment and Geology acts as a specialist technical authority (for the high-est water authority) as do the specialist Regional Environmental Departments (for the higherand subordinate water authorities).

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Chapter 8 Data stocks and databases

In order to ensure successful chemicals management, those participating in the process havenumerous national and international databases and sources of literature at their disposal. Asmall selection is provided here, taking as an example the Federal Institute for OccupationalSafety and Health � Division 5, Chemicals, Notification and Authorization and a joint projectbetween the Federal Government and the Länder.

8.1 Databases available to the Federal Institute for OccupationalSafety and Health, Division 5 (own and external)

As the Notification Unit within the Chemicals Act, Division 5 of the Federal Institute for Occupa-tional Safety and Health records the data relating to the notifications and mini-notifications ofnew chemical substances. The data stocks also include chemical structural formulae, for whichthe MOLEFile format is used. In the course of fulfilment of its duties the Notification Unit withinthe Chemicals Act uses a variety of databases:

• Admin (administration relating to the Chemicals Act)

The procedure helps keep track of the progress of work on particular notifications and providessupport in monitoring deadlines during enforcement of the Chemicals Act, offering in particularthe following information:� the main data relating to the notification procedures� reproduction of the correspondence in the notification procedures, related to individual

dossiers� documentation of internal deadlines� search functions� monitoring of unanswered letters� monitoring of forthcoming deadlines

� follow-up function in the case of forthcoming expiry dates and letters

� statistical evaluations relating to the notification procedures.

The requisite data are entered on receipt of an announcement and, if necessary, brought up todate.

• NST database for new chemical substances

In the course of the processing of a notification, the identity data (of a new substance submittedin Germany for the purpose of notification or mini-notification) are recorded in the NST data-base. On average, the identity data amount to between three and five DIN A4 forms. The re-maining dossier, which amounts to approx. 80 form sheets (including, inter alia, results of thetests, protection measures), is imported into the database via the EU exchange format SNIF.

The identity data are checked with the help of searches in internal and external online data-bases (e.g. CA registry).

The notification data are exchanged between the national notification units of the EU MemberStates.

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Notifications from other EU Member States that are conveyed on data media are also importedinto the database. The EU exchange format known as SNIF is used not only for the exchange ofinformation with other EU Member States but also in the exchange of data with the federal andregional authorities asked to participate in the process.

• EINECS (European Inventory of Existing Chemical Substances)

The acronym EINECS stands for the European Inventory of Existing Commercial ChemicalSubstances. Produced by the Commission of the European Communities, this inventory liststhose chemical substances which were on the market in the European Community between the1st of January 1971 and the 18th of September 1981. According to Article 1 Section 4 of Coun-cil Directive 67/548/EEC, the notification duty laid down in the Directive does not apply to thesesubstances. EINECS is the only point of reference for identification of these substances. In prin-ciple, the inventory is closed.

The EINECS database contains 100,106 substance entries, 33,000 of which originate from theEuropean Communities' Core Inventory (ECOIN) and 67,000 from additional notifications fromthe chemical industry. Of these, 82,000 substances are regarded as well-defined and about18,000 as inadequately defined or as "substances of unknown or variable composition, complexreaction products and biological materials" (UVCB substances). However, these 18,000 UVCBsubstances include about 5,000 which, in addition to being named are also briefly described.

Besides the EINECS numbers, the database also includes CAS numbers, chemical names,trade names, empirical formulae and, in the case of UVCB substances, a description of the sub-stance.

• IUCLID database for existing chemical substances

Council Regulation (EEC) No 793/93 requires every manufacturer or importer who produces orimports an existing chemical substance in certain quantities to provide data to the Commission(European Chemical Bureau [ECB]) in Ispra. These data include information such as the nameof the substance, the quantity produced, the classification according to hazard classes, risk andsafety phrases, physico-chemical properties, acute and subacute toxicity, ecotoxicity, environ-mental behaviour and use categories. On the basis of the information submitted by the produc-ers and importers and in response to proposals from the Member States, the Commission pro-duces priority lists of substances to be examined on a priority basis. Special attention is paid tothem due to their possible effects on man and the environment.

The producers and importers have submitted their substance information to the ECB in elec-tronic form. The data have been imported into IUCLID (International Uniform Chemical Informa-tion Database) and conveyed to the Notification Unit within the Chemicals Act (Division 5 of theFederal Institute for Occupational Safety and Health) as the national competent authority.

The producers and importers must provide further information in connection with the substancescontained in the priority lists. The extent and quality of this information is orientated towards thetests which are also demanded in the case of new substances. The further information is sent tothe Notification Unit within the Chemicals Act in the form of an updated data set on disk.

The data provided by the companies and the available ECB data are combined to create a sub-stance data sheet. The substance data sheet is exported in a transfer format and sent in thisform to the assessment units for processing. The assessment units utilize the data to producethe risk assessment for the substance. They validate the data set in accordance with their areaof competence and then send the revised data set back to the Notification Unit within theChemicals Act. The validated and confidential data set produced in this way is exported in atransfer format. This data set is then forwarded to the ECB together with the risk assessment

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which has been produced in parallel. At the same time, a non-confidential data set is sent, interalia, to the OECD Member States as well as to the industrial associations participating in thisprocess.

• BUA substance reports

In order to determine systematically the hazard potential of existing chemical substances, in1988 the Federal Government adopted a concept for the systematic recording and assessmentof existing chemical substances. It received advice in this regard from the Advisory Committeeon Existing Chemicals of Environmental Relevance (BUA) which belongs to the GermanChemists' Society (GDCh). In accordance with the principle of cooperation, the BUA comprisesrepresentatives of industry and science who are supported by representatives of the authorities.The BUA provides the opportunity for on-going, science-based dialogue between these threegroups on the subject of existing chemical substances. The BUA substance reports were elabo-rated to act as the basis of decision-making in authorities and industry. The BUA has since pub-lished over 200 reports on about 300 substances. It has been possible to use their contents in anumber of different ways, for example, as an aid to decision-making in the area of the risk man-agement of chemicals. Ad hoc working groups are set up by the BUA when current problemsrequiring special discussion arise, for example, in the case of endocrine disruptors and selectioncriteria for POPs. In order to implement the Federal Goverment's existing chemical substancesprogramme of December 1998 the BUA assumed the task of selecting the existing chemicalsubstances for which reports are to be produced on a priority basis. This work is ongoing. Thereports have been translated into English in order to make them accessible to a wider interna-tional public.

• EDEXIM and the national database EPA notification

Division 5 of the Federal Institute for Occupational Safety and Health is responsible for receivingand forwarding information relating to Regulation (EC) No 034/2003 concerning the export/import of certain dangerous chemicals. According to this regulation, each person intending toexport for the first time one of the substances listed in Annex 1 of the Regulation to a particularcountry must first submit certain items of information to the competent authority of the relevantMember State. Within a specified period of time Division 5 must inform the Commission of theEuropean Communities as well as the recipient country about the intended export by requestingexpress written consent for the export of substances according to Annex I Part 2 and 3 of theRegulation. In addition, the EU and UNEP/FAO PIC procedure (prior informed consent) must be observed.These organizations have asked all countries to report their prohibited substances. Predeter-mined criteria have been used to select particularly relevant substances for which DecisionGuidance Documents relating to these substances are then sent out. An essential aspect of theprocedure is that recipient countries are able to object to the export of a particular substance.

In order to be able to carry out the procedure which has just been described, the EuropeanCommission has developed the "EDEXIM" database (European Database on the Export andImport of certain dangerous chemicals). Inter alia, the US EPA's (United States EnvironmentalProtection Agency's) export notifications are also included in the database if they are notifica-tions which have to be announced to the European Commission.

The core of the database comprises the substances listed in Annex 1 of Regulation (EC) No304/2003. In particular, the substance name, the CAS number, the EINECS number and theclassification and labelling are included. Files containing information on individual events, forexample, the date of an instance of export/import, the exporting and recipient country, are linkedto this database.

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Some of the forms required to carry out the procedure according to Regulation (EC) No304/2003 are generated and printed by PC. Search and list functions / statistics etc. are avail-able as well.

In addition, all of the EPA notifications which are received, even those not relating to a sub-stance prohibited by the USA, are identified and stored in the national database. The databaseconsists of a substance file to which a file containing information on the particular notification islinked. The information includes, inter alia, the notification number, the date of receipt, namesused by the EPA, the IUPAC name, the CAS number, the EINECS number and the empiricalformula.

Inter alia, the following external stocks of literature and databases are available to Division 5 ofthe Federal Institute for Occupational Safety and Health:

- Environmental health criteria documents (WHO)- Material safety data sheets (databases belonging to the Federation of German Statutory

Accident Insurance Institutions for the industrial sector)- OECD guidelines for the testing of chemicals- Good Laboratory Practice principles- Chemical Abstract Services database- STN (Scientific & Technical Information Network) databases.

Evidently, Division 5 of the Federal Institute for Occupational Safety and Health is increasinglybecoming an information pool for stocks of data in the field of the regulation of chemical sub-stances, both in a national and international context.

8.2 Joint substance-data pool shared by the Federal Government andthe Länder (GSBL)

An administrative agreement between the federal and regional environment ministries laysdown the tasks associated with a joint substance data pool. Forms of cooperation in which thereis division of the work required to input and update the substance data are intended to avoidduplication of the work and fill any gaps which may exist. The aim is to set up a joint central substance data pool and to operate the system at the FederalEnvironmental Agency. Users of the joint central substance data pool are, inter alia:

• Federal institutions (Federal Environment Ministry/Federal Environmental Agency, FederalMinistry of Transport and Housing, Federal Institute for Risk Assessment, Federal Institutefor Materials Research and Testing, the Federal Institute for Occupational Safety and Health,the federal fiscal authorities)

• the Länder, local government

The joint data pool was produced by bringing together existing databases, applying uniformregistration rules for substances and utilizing harmonized data models of the factual data.

The joint central substance data pool (GSBL) contains data relating to:

• identification (such as structure, the registration numbers used in other systems)• legal characteristics (such as national and European chemicals law, transport law, immission

law, soil law, water law etc.)• physico-chemical data (such as melting point, solubility, oxidation-reduction potential etc.)• general hazards• health hazards/first aid• advice to the workforce or task forces concerning the handling of the substance• environmental behaviour / ecotoxicology

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• toxicology

All of Germany's public-service institutions and institutions which perform sovereign tasks havethe right of access to the data. Transmission to third parties is intended.

Further national and international databases are to be included in the joint central substancedata pool. For example, the inclusion of data gathered within the framework of the Europeanprogramme for existing chemical substances (IUCLID) is planned as is the inclusion of the non-confidential data from the national notifications of new substances (Federal Gazette publica-tions). Interface programs between IUCLID or the database for new substances (NST) and theGSBL ensure that in future there will be a permanent stream of data from IUCLID or NST to theGSBL. Fairly large gaps in the data are still to be found in the areas of "substance classificationaccording to European and national statutory regulations" and "ecotoxicological data". In thelast mentioned area, valid data-gathering investigations and measurements are also missing.Substance classification data are therefore to be elaborated, in particular in the case of sub-stances which are named in the regulations as a substance group or which appear there undera different summarizing name.

8.3 Joint Länder Database on Hazardous Substances (GDL)

The GDL is an information system for hazardous substances which primarily serves to supportthe competent authorities during enforcement of chemicals legislation. It was established by thespecialist group GDL, which was founded in 1982, with the aid of experts from federal and re-gional authorities responsible for occupational safety and health.

The database currently contains information relating to approx. 24,000 substance entries (puresubstances, substance groups, and products). Included here are basic data such as substancenames with a comprehensive list of synonyms, substance registration numbers, general chemi-cal characterization and physico-chemical properties. In addition, the GDL provides all the sub-stance-related information on current rules and regulations required by the occupational safetyand health authorities. It also takes into account a large number of data on substances andpreparations obtained as a result of enforcement by the occupational safety and health authori-ties.

Together with the GESTIS database belonging to the Federation of German Statutory AccidentInsurance Institutions for the Industrial Sector (HVBG) and the BG Institute for OccupationalSafety (BIA) (http://www.hvbg.de/bia/stoffdatenbank), an Internet version of the GDL(http://www.gefahrstoff-info.de) is offered in the form of a "joint Länder and German StatutoryAccident Insurance Institution database on hazardous substances". Further information can befound at the above Internet address.

8.4 Central substance-data pool

An Internet version of a database known as GEFAHRGUT has been developed in a projectjointly conducted by the Federal Institute for Materials Research and Testing (BAM) in Berlinand the Federal Ministry of Transport and Housing (BMVBW). The main target groups are in-tended to be federal and regional authorities for whom free access or access at cost price isplanned.

The database provides processed information in compact form such as is required for the safetransport of hazardous substances and products. The complex research technology permits apreviously unachievable overview of widely different aspects of regulations on dangerousgoods, e.g. for the purpose of self-monitoring of compliance with current legislation.

http://www.hvbg.de/bia/stoffdatenbank

http://www.gefahrstoff-info.de

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The physico-chemical substance data considered in the substance data records facilitate, interalia, the selection of packaging and means of transport which have been authorized for use.Many substances not expressly mentioned in the rules and regulations relating to dangerousgoods have been included. As a result, the control possibilities have been considerably ex-tended.

8.5 Further databases

The following tables list further databases which are available within the framework of chemicalsmanagement. Due to the large number of participating institutions, the tables only provide anexcerpt of the databases actually in use.

Type of data Location Data source Who has access? How is accessprovided?

Format

Danger catego-ries for existingchemical sub-stances

EuropeanChemicalsBureau of theEC (ECB)

Industry European Chemi-cals Bureau of theEC and competentauthorities of the EUmember states

Via CD-ROM On CD-ROM

Poisoning Federal Insti-tute for RiskAssessment(BfR)

Doctors The general public Doctors report tothe centralauthority (FederalInstitute for RiskAssesment -BfR). The BfRthen forwards thereport on a datacarrier to theregional PoisonInformation Cen-tres which are indirect contactwith citizens.

By telephone

(emergencycall in thecase of poi-soning)

Statistics on theoccurrence ofpoisoning

Federal Insti-tute for RiskAssessment(BfR)

Doctors,regionalPoison In-formationCentres

The general public,EC Commission

Request submit-ted to the FederalInstitute for RiskAssesment - BfR

Informationbrochure

Self-imposedobligation on thepart of industrywith regard tointermediates

At the individ-ual chemicalcompanies

Literature,tests

Each individualcompany, moni-toring authorities

On request, e.g.by telephone inthe case of acci-dents

Varies fromcompany tocompany

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Name Purpose Content Location

Retrieval System Existing AndNotified Substances (RE-NOCS)

Identification of sub-stance identities duringmonitoring measures

EINECS data and data onnotified substances

Federal Institutefor OccupationalSafety andHealth (Division5), the Länder

CHEMIS Assessment of sub-stances; the elaborationof water quality targets

Data on about 12,000 sub-stances with high productionvolumes

Federal Institutefor Risk Assess-ment

Federal Environ-mental Agency

Rapid information service forhazardous substances (GSA)

Information on sub-stances, inter alia, foruse by the fire and policeservices

Substance data for the intro-duction of measures in thecase of accidents and catas-trophes


Database application for usein connection with water pol-lutants (RIGOLETTO)

Classification of sub-stances according towater-hazard classes

Substance data, literaturesources


Database for laundry andcleaning products

Recording of con-stituents; determinationof pollution of aquaticenvironments

Basic recipes, data on envi-ronmental compatibility


Enforcement of the ChemicalsAct

Assessment within theframework of the notifi-cation of new sub-stances

Substance data sets for sub-stances that are to be notified


Information system on hazard-ous and environmentally rele-vant substances (IGS)

Information required forenforcement and in caseof accidents

Laws and rules; substancedata; measures in the case ofdamage; occupational safetymeasures

MURL (NorthRhine-Westphalia)

Stand-by call and first-actionsystem (RESY)

For combating accidentsinvolving hazardous sub-stances for use in con-nection with maritimeshipping, coasts andports

Substance properties; risks tohealth and the environment;protection measures; classifi-cations

The EnvironmentProtectionAuthority inHamburg

Database for the enforcementof the Plant Protection Act

Assessment within theframework of the licens-ing of plant protectionproducts

Substance data sets relatingto preparations and activesubstances


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Chapter 9 Technical infrastructure

The technical infrastructure of the companies, authorities and institutions participating in chemi-cals management corresponds both in terms of quantity and quality to that of a modern indus-trial state. Consequently, detailed enumeration is superfluous. Extensive DP support, sufficientlaboratory capacities, access to international databases and connections to e-mail and theInternet are available. In order to convey a more detailed impression, two areas are presented here as an example.

9.1 GLP Procedure As a consequence of a growing awareness of health and environmental issues, a series ofstatutory regulations have been passed in recent years - above all in western industrial nationsand Japan - with the aim of testing chemical substances for their risk potential to man, animaland the environment before they are actually used.

Producers or importers have been obliged to submit reports on non-clinical, experimental testson safety or harmlessness to the assessment authorities involved in licensing, authorization,registration, notification and/or mini-notification procedures. This applies to all substance areassuch as, for example, chemicals, biocides, pharmaceuticals and plant protection products. Theassessment authorities must then undertake a scientific risk assessment only on the basis ofthe incoming reports on physico-chemical, ecotoxicological and toxicological tests which mayhave been produced by contracted institutes, industrial laboratories or scientific institutes � alsofrom institutions abroad. Particular importance therefore attaches to the reliability and quality ofthe test data.

It is against this background that, as early as 1981, experts from the OECD states elaboratedrules designed to improve the validity, integrity and transparency of experimental test data aswell as to ensure harmonization at international level. The body of rules on good laboratorypractice (GLP) evolved in the course of this work. GLP lays down the quality criteria for both theperformance of laboratory investigations and their monitoring by the authorities. The intentionhere is to provide a framework of conditions to ensure the comprehensibility, reconstructabilityand precision of the demanded tests so that they are of a comparable high standard.

In Germany, the GLP principles were first laid down in law and made obligatory in 1990. Servingas the central coordination and initial contact point for the federal government and the Länderas well as for international matters, the federal GLP office (GLP-BSt) was established at theFederal Institute for Risk Assessment (BfR). As is the case with many other statutory rules inthe Federal Republic of Germany, it is the task of the Länder to control compliance with the GLPprinciples in German test establishments. The most important state control instruments are in-spections of test establishments and retrospective examination of tests which have been per-formed.

The federal GLP office keeps a current inventory of all GLP-inspected test establishments inGermany, publishing the inventory on an annual basis in the Federal Gazette. Among otherthings, the publication provides potential contract-placing companies with an overview of thelaboratories of relevance to their needs.

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A regular, internationally harmonized exchange of information takes place between the MemberStates on the basis of EU rules and OECD recommendations. Lists of foreign test establish-ments are collated at the federal GLP office in order to be able to provide the assessmentauthorities with the information they require. The inventories of the foreign test establishmentsare important with regard to the mutual recognition of GLP-inspected test establishments andthe test results which are produced there. This recognition is assured for the EU Member Stateswhich follow the GLP rules as well as for the USA, Japan and Switzerland.

Test establishments from non-EU states without a mutual agreement for the recognition of GLPwhich are contracted by German companies to perform experiments to GLP standards for sub-mission to German assessment authorities are monitored by the federal GLP office at the re-quest of a German company.

9.2 Good professional practice

In the Plant Protection Act it is laid down that plant protection products may only be used in ac-cordance with good professional practice. Good professional practice includes the need to con-sider the principles of integrated plant protection. Plant protection products may not be em-ployed if the user must expect their use to have harmful effects on human or animal health or onthe ground water or any other effects, particularly on the balance of nature, which cannot bejustified.

Integrated plant protection represents a combination of methods by means of which the use ofchemical plant protection products is limited to the necessary amount, prime consideration be-ing given to biological, plant-breeding as well as cultivation measures. Consequently, non-technical plant-protection measures are preferred and chemical plant protection measures areplaced at the end of a chain of temporary and non-technical defence mechanisms. Integratedplant protection is one of the most important measures for avoiding and reducing any remainingrisks which plant protection products might pose in spite of having been licensed for use. In theFederal Republic of Germany, high priority is given to the further development and widespreadimplementation of integrated plant protection.

Integrated plant protection is promoted and realized thanks to a large number of programmesand activities undertaken by the federal and regional Governments and relevant organizations.In addition, an initiative started by various cultivation associations (e.g. fruit, vegetables, wine,and hops) also exists. These associations voluntarily allow the implementation of integratedplant protection methods to be checked.

In accordance with § 15f of the Hazardous Substances Ordinance, biocidal products must alsobe used properly and according to the principles of good professional practice. However,good professional practice for biocides has not yet been precisely defined. It is an aim of theout-sourced research project F 1929 of the Federal Institute for Occupational Safety and Health� Division 5 � to propose how good professional practice for biocidal products can be specified.The project bearing the title �Description of the proper use and the good professional practicethat it is to be applied during the use and disposal of biocidal products of the product types 1 to14, 16, 18 to 22 of Annex V of Directive 98/8/EC� will end on the 31st of December 2004.

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Chapter 10 International relations

10.1 Participation in international organizations and bodies

The Federal Republic of Germany participates actively, both in terms of personnel and financialsupport, in the EC, OECD as well as in international activities relating to the safety of chemicalssuch as the IPCS, IFCS and SAICM. Efforts also focus on supporting the establishment of spe-cialist units in developing countries within the framework of programmes for the chemicals sec-tor that are organized by UNEP, FAO, UNITAR and other UN organizations.

Within the framework of the environmental programme of the United Nations (UNEP), Germanyand the other members of the European Community are signatories to the Rotterdam Conven-tion on Protection Against the Import of Dangerous Chemicals and the Stockholm Conventionon Persistent Organic Pollutants. The Regulations (EC) No 304/2003 and (EC) No 850/2004were enacted in order to meet the obligations within the framework of the above-mentionedconventions.

10.2 Technical assistance projects

On request and within the financial means available to it, the Federal Republic of Germany sup-ports developing countries in their efforts to introduce and implement internationally acceptedstandards in the field of chemicals management. The guidelines contained in Agenda 21 of theUnited Nations for the Environment and Development, in particular chapter 19 "environmentallycompatible handling of dangerous chemicals", form the basis for cooperation with the partnercountries.

The Federal Ministry for Economic Cooperation and Development (BMZ), which is responsiblefor international cooperation, supports bilateral country-specific and supra-regional projects inthis sphere. The BMZ commissions the German Society for Technical Cooperation (GTZ)GmbH to carry out these projects. Projects involving financial cooperation which mainly relate tothe area of chemicals management are not undertaken.

In an approach coordinated in particular with the Federal Environment Ministry (BMU), the su-pra-regional "convention project on chemical safety" was set up in order to be able to react in afocused manner to questions from developing countries about the handling of dangerouschemicals. As the central coordination unit, this project has the task of promoting contact be-tween the particular competent institutions or partners in Germany and selected developingcountries as well as of bringing together available resources and achieving synergetic effectsthrough the creation of networks with existing projects and programmes, also with those be-longing to other sponsors and other international organizations.

Within the framework of technical cooperation, further supra-regional projects are concernedwith the development of concepts and the implementation of individual foci of chemicals man-agement in developing countries, for example, the substitution of ozone-depleting substancesby natural substances, the largely safe and environmentally compatible use of plant protectionproducts and the disposal of plant protection products that are no longer usable. In addition, theFederal Ministry for Economic Cooperation and Development supports a number of developing

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countries through bilateral projects designed to tackle problems in the area of chemicals man-agement that have been specifically identified by the partner countries (see table for examples).

Country Duration Description of projectSupra-regional 10 years Convention project in the area of chemicals safetySupra-regional 11 years Substitution of ozone-depleting substances by natural

substancesSupra-regional 5 years Disposal of obsolete plant protection productsSupra-regional 3 years Information network for non-chemical plant protection

methods in developing countriesEgypt 13 years Integrated plant protectionAlgeria 5 years Disposal of toxic wastes from industryArgentina 11 years Environmental protection in small and medium-sized

chemical companiesBrazil 12 years Rehabilitation of areas contaminated by toxic wastesChina 5 years Management of obsolete plant protection productsIndia 11 years Support of the Central PolIution Control BoardIndonesia 9 years Environmental protection in industrial companiesCameroon 7 years Environmentally friendly plant protectionMauretania 3 years Disposal of obsolete plant protection productsMarocco 8 years Environmental managementMexiko 10 years Air pollution control in Mexico CityRegional - LatinAmerica

6 years Transport and storage of toxic substances in ports

Regional - CentralAmerica

7 years Promotion of the use of biopesticides in agriculture

Thailand 8 years Transport of dangerous goods(Quelle: GTZ)

In the last 15 years Germany has made available a total of approx. 320 million euros inmore than 140 projects for international cooperation in chemicals safety. Taking into ac-count payments made by the Federal Environment Ministry, the total financial supportamounts to a total of 342 million euros.

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Annexes

Annex 1: List of abbreviations

• A AbfAblV Waste disposal ordinance AbfKlärV Ordinance on waste and sewage

sludge AbfVerbrG Waste shipment law ABl Official Journal AbwAG Waste Water Levy Act AbwV Ordinance on the demands on the

discharge of waste water intoaquatic environments

AGS Committee on Hazardous Sub-stances

AltölV Waste Oil Ordinance AltstoffV Ordinance on Existing Substances AMG German Drugs Act AMG-EV Ordinance for submissions within the German Drugs Act AMSt ChemG Notification Unit within the

Chemicals Act AS Occupational Safety and Health ASEAN Association of South East Asian

Nations • B BAFA Federal Export Office BAM Federal Institute for Materials

Research and Testing BAnz Federal Gazette BArBl Federal Labour Gazette BAuA Federal Institute for Occupational Safety and Health BBA Federal Biological Research Centre for Agriculture and Forestry BbodSchG Federal Soil Protection Act BedGgstV Commodities Ordinance BEUC European Office of Consumer Organizations BfArM Federal Institute for Drugs and

Medical Devices BGBl Federal Law Gazette BG Statutory Accident Insurance Institution BGAA Statutory Accident Insurance

Institutions� working group on existing substances

BGMG Statutory Accident Insurance Institutions� Measurement System

for Hazardous Substances

BfR Federal Institute for Risk Assess-ment

BIA The BG Institute for Occupational Safety BImSchG Federal Immission Control Act BImSchV Ordinance for the Implementation of

the Federal Immission ProtectionAct

BLAC Federal/Regional Committee on the Safety of Chemicals

BLAC-UIS Federal/Regional Working Group on Environmental information systems

BMGS Federal Ministry of Health and So-cial Security

BMU Federal Environment Ministry BMWA Federal Ministry of Economics and

Labour BMVBW Federal Ministry of Transport and

Housing BMVEL Federal Ministry of Consumer Pro-

tection, Food and Agriculture BMVg Federal Ministry of Defence BMZ Federal Ministry for Economic

Cooperation BUA Advisory Committee on Existing

Chemicals of Environmental Relevance

BVL Federal Office of Consumer Protec-tion and Food Safety

BzBIG Lead-free Petrol Act BzBlGDV Ordinance for the Implementation of

the Lead-free Petrol Act

• C CAS Chemical Abstract Service ChemBiozid- Biocide Authorization ZulV Ordinance ChemG Chemicals Act ChemGiftInfoV Ordinance on obligations to provide

information in cases of poisoning ChemKostV Ordinance on the costs of official

acts of the Federal Authorities underthe Chemicals Act

ChemPrüfV Ordinance on evidence of testingand other notification and informa-tion documents under the ChemicalsAct

ChemStrOWiV Ordinance on the enforcement ofCommunity regulations on sub-stances and preparations

108

ChemVerbotsV Ordinance on bans and restrictionson the placing on the market of dan-gerous substances, preparationsand products pursuant to theChemicals Act

ChemVwV General administrative provisionrelating to the Chemicals Act

CI Consumers International CSD Commission on Sustainable De-

velopment CUB Environmental Advisory Society for the Chemical Industry CUS Customs Union Service CWÜ Agreement on Chemical Weapons CWÜAG Implementing statute relating to the

Agreement on Chemical Weapons CWÜVO Implementing ordinance relating to

the Agreement on Chemical Weap-ons

• D

DGD Decision Guidance Documents DüngMG Fertilizer Act DüMV Fertilizer Ordinance DNA Designated National Authorities DüngeV Ordinance on the Principles of Good

Professional Practice in the applica-tion of fertilizers

DV Data processing

• E EC European Commission ECB European Chemicals Bureau ECLIPS European Classification and Label-

ling Inspections of Preparations, in-cluding Safety Data Sheets

ECOIN European Communities Core In-ventory

ECOSOC United Nations Economic and SocialCouncil

EDEXIM European Database on the Export-Import of certain dangerous che-micals

EEC European Economic Communities EFTA European Free Trade Association EG European Community EHC Environment Health Criteria EINECS European Inventory of Existing

Commercial Substances ELINCS European List of Notified Chemical

Substances EMEA European Agency for the Evalua-

tion of Medicinal Products EPA United States Environmental Pro-

tection Agency EU European Union EUREX European enforcement project on

Existing Substances EWG European Economic Community EWR European Economic Area

• F FAO Food and Agriculture Organization

of the United Nations FB 5 Division 5 of the Federal Institute for

Occupational Safety and Health �Chemicals, Notification and Authori-zation

FCKW CFCs

• G GAÄ Factory inspectorates GABI Joint Official Journal GDCh Society of German Chemists GDL Joint Länder database on hazardous substances GefStoffV Hazardous Substances Ordinance GGAV Hazardous Goods Exemption Ordi-

nance GGBefG Transport of Dangerous Goods Act GGVBinSch Dangerous Goods Ordinance � In-

land waterways GGVSE Dangerous Goods Ordinance � road

and railways GGVSee Dangerous Goods Ordinance � sea GISBAU Information system on hazardous

substances belonging to the Ger-man Statutory Accident InsuranceInstitution for the building industry

GIZ Poison Information Centre GLP Good Laboratory Practice GLP-BSt Federal GLP Office GMBI Joint ministerial bulletin GrWV Ordinance for the implementation of

Council Directive 80/68/EEC on the protection of the ground water

GSBL Joint substance data pool shared bythe Federal Government and theLänder

GTZ German Society for Technical Cooperation

GÜG Basic Substances Monitoring Act GÜG-VV Ordinance on violations against the

Basic Substances Monitoring Act

• H HEDSET Harmonized Electronic Data Set HELCOM Helsinki Commission for the

Protection of the Marine Environ-ment of the Baltic

HKWAbfV Ordinance on the Disposal of WasteHalogenated Solvents

HVBG The Federation of German StatutoryAccident Insurance Institutions forthe Industrial Sector

109

• I ICCA International Council of Chemical

Associations IFCS Intergovernmental Forum on

Chemical Safety IG BCE Industrial Trade Union for the Min-

ing, Chemicals and Energy indus-tries

IGS Information system on hazardousand environmentally relevant sub-stances

ILO International Labour Organization IMO International Maritime Organization IPCS International Programme on

Chemical Safety IRPTC International Register of Potentially

Toxic Chemicals IT Information technology IUCLID International Uniform Chemicals

Information Database IUPAC International Union of Pure and

Applied Chemistry IVA Agricultural Industry Association

J

JRC Joint Research Centre

• K KrW-/AbfG Waste Avoidance, Recycling and

Disposal Act - a law to promote re-cycling and ensure environmentallycompatible removal of wastes

KrWaffKontrG War Weapons Control Law

• L LAbfG Regional Waste Act LABO Regional Committee on Soil

Protection LAGA Regional Working Group on Waste LAI Regional Committee on Protection

against Immissions LASI Regional Committee on

Occupational Safety and SafetyTechnology

LAWA Regional Working Group on Water LMBG Foodstuffs and Commodities Act LuftVG Air-transport Act

• M MAK Maximum concentration values in

the workplace MOLEFile Molecule file MURL Ministry for the Environment,

Environmental Planning and

Agriculture MW Megawatt

• N NAFTA North American Trade Association NL Netherlands NP National Profile NST Database for new substances

• O OECD Organization for Economic Coope-

ration and Development OSPAR Oslo-Paris Commission for the

Protection of the Maritime Environment of the North Atlantic

OVCW Organization for the Prohibition of Chemical Weapons

• P PAMIRA Concept for the return of used

agricultural product packaging PflSchAnwV Ordinance on prohibitions of use of

plant protection products PflSchG Plant Protection Act PflSchMGebV Plant protection product fee ordi-

nance PflSchMGV Ordinance on plant protection

products and plant protection equipment

PflSchSachkV Ordinance on evidence of specialist knowledge about plant protection

PIC Prior Informed Consent POPs Persistent Organic Pollutants PSF Phosgene, sulphur, fluorine

• R RC Responsible Care RENOCS Retrieval System Existing and

Notified Substances RESY Stand-by call and first action system RIGOLETTO Database application for water

pollutants RL Directive RTECS Registry of Toxic Effects of Che-

mical Substances

• S SENSE Solid Enforcement of Substances in

Europe SGB Code of social law SHmV Ordinance on the Maximum

Quantities of Hazardous Substancesin Foods

110

SIAR SIDS Initial Assessment Reports SIDS Screening Information Data Sets SNIF Structured Notification Interchange

Format STN Scientific Technical Information

Network STUFÄ Regional specialist environmental

departments

• T t/a Tonnes/year TA Technical instructions TEHG Greenhouse Gas Emissions Trade

Law TierSchG Animal Welfare Act TRGS Technical Rules for Hazardous Sub-

stances TrinkwV Ordinance on drinking water and on

Water for Food Processing Companies

• U UBA Federal Environmental Agency ÜChem Monitoring Association of Chemical

Plant Operators UN United Nations UNCED United Nations Conference on

Environment and Development

UNEP United Nations Environment Pro-gramme

UNITAR United Nations Institute for Trai-ning and Research

UVCB Substances of Unknown or Varia-ble Composition, Complex re-action products and biological materials

• V VCH The Chemical Trading Association VCI The German Chemical Industry

Association VwVwS General administrative provision

relating to the Water Resources Management Act concerning theclassification of water pollutants according to water-hazard classes

vzbv Non-profit Federation of GermanConsumer Organizations

• W WassgefSt- Ordinance relating to water BefV pollutants conveyed through pipe-

linesWHG Water Resources Management Act WHO World Health Organization WRMG Law on the environmental impact of

laundry and cleaning products

111

Annex 2: Address List

Federal Authorities

Bundesministerium für Umwelt, Naturschutzund ReaktorsicherheitRobert-Schuman-Platz 353175 Bonnwww.bmu.de

Bundesministerium für wirtschaftlicheZusammenarbeit und EntwicklungFriedrich-Ebert-Allee 4053113 Bonnwww.bmz.de

Bundesanstalt für Arbeitsschutzund Arbeitsmedizin- FB 5 - Chemikalien, Anmeldung und Zulassun-

gestelle Chemikaliengesetz- FB 4 - Sicherheit und Gesundheit bei chemi-

schen und biologischen ArbeitsstoffenFriedrich-Henkel-Weg 1 � 2544149 Dortmundwww.baua.de

BundesausfuhramtFrankfurter Str. 29-3565760 Eschbornwww.bafa.de

Bundesinstitut für RisikobewertungThielallee 88 - 9214195 Berlinwww.bfr.de

UmweltbundesamtSeecktstr. 6 - 1013581 Berlinwww.umweltbundesamt.de

Bundesministerium für Wirtschaft und ArbeitRochusstraße 153123 Bonnwww.bmwa.bund.de

Biologische Bundesanstalt für Land- undForstwirtschaftMesseweg 11/1238104 Braunschweigwww.bba.de

Bundesamt für Verbraucherschutz und Lebens-mittelsicherheitRochusstr. 6553056 Bonnwww.bvl.bund.de

Bundesanstalt für Materialforschungund �prüfungUnter den Eichen 8712205 Berlinwww.bam.de

Bundesinstitut für Arzneimittelund MedizinprodukteKurt-Georg-Kiesinger-Allee 353175 Bonnwww.bfarm.de

Paul-Ehrlich-InstitutBundesamt für Sera und ImpfstoffePaul-Ehrlich-Str. 51-5963225 Langenwww.pei.de

112

Regional Authorities

Baden-WürttembergMinisterium für Umwelt und VerkehrKernerplatz 970182 Stuttgartwww.uvm.baden-wuerttemberg.de

BavariaStaatsministerium für Umwelt, Gesundheit undVerbraucherschutzRosenkavalierplatz 281902 Münchenwww.stmugv.bayern.de

BerlinSenatsverwaltung für Gesundheit und Sozialesund VerbraucherschutzOranienstr. 10610969 Berlinwww.berlin.de/sengsv

BrandenburgMinisterium für Ländliche Entwicklung, Umweltund VerbraucherschutzHeinrich-Mann-Allee 10314473 Potsdamwww.mlur.brandenburg.de

BremenSenator für Arbeit, Frauen, Gesundheit, Jugendund SozialesDoventorscontrescarpe 17228195 Bremenwww.bremen.de/arbeitssenator

HamburgBehörde für Wissenschaft und GesundheitHamburger Str. 3722083 Hamburgwww.bwg.hamburg.de

HesseMinisterium für Umwelt, ländlicher Raum undVerbraucherschutzMainzer Str. 8065189 Wiesbadenwww.mulf.hessen.de

Mecklenburg-West PomeraniaUmweltministeriumSchloßstr. 6 � 819053 Schwerinwww.um.mv-regierung.de

Lower SaxonyUmweltministeriumArchivstr. 230169 Hannoverwww.mu1.niedersachsen.de

North Rhine-WestphaliaMinisterium für Umwelt und Naturschutz, Land-wirtschaft und VerbraucherschutzSchwannstr. 340476 Düsseldorfwww.munlv.nrw.de

Rhineland-PalatinateMinisterium für Umwelt und ForstenKaiser-Friedrich-Str. 155116 Mainzwww.muf.rlp.de

SaarlandMinisterium für UmweltKeplerstr. 1866117 Saarbrückenwww.umwelt.saarland.de

SaxonySächsisches Staatsministerium für Umweltund LandwirtschaftWilhelm-Buck-Str. 201097 Dresdenwww.sachsen.de

Saxony-AnhaltMinisterium für Landwirtschaft und UmweltOlvenstedter Str. 439108 Magdeburgwww.mlu.sachsen-anhalt.de

113

Schleswig-HolsteinMinisterium für Umwelt, Naturschutz und Land-wirtschaftMercatorst. 324149 Kielwww.landesregierung.schleswig-holstein.de

ThuringiaMinisterium für Landwirtschaft, Naturschutzund UmweltBeethovenplatz 399096 Erfurtwww.thueringen.de

International Institutions

Commission of the European CommunitiesRue de la Loi / Wetstraat 200B - 1049 BrüsselBelgiumwww.europa.eu.int

EMEAEuropean Agency for the Assessment of Phar-maceuticals7 Westferry CircusCanary WharfGB - London E14 4HBGroßbritannienwww.eudra.org/emea.html

ILOInternational Labour Organization4, route des MorillonsCH - 1211 Geneva 22Switzerlandwww.ilo.org

UNEP ChemicalsCase Postale 35611-13, Chemin des AnémonesCH - 1219 Châtelaine, GenévaSwitzerlandwww.unep.org

WHO20 Avenue AppiaCH - 1211 Geneva 27Switzerlandwww.who.org

JRC-ECBEuropean Chemicals BureauJoint Research CentreI - 21020 Ispra (VA)Italyhttp://ecb.ei.jrc.it

IFCSIntergovernmental Forum on Chemical SafetyHealth Protection BranchHealth CanadaTunney's Pasture, PL0701A1CAN - Ottawa, ON K1A 0L2Canada

OECDEnvironmental Health and Safety Division15, Boulevard Amiral BruixF - 750016 ParisFrancewww.oecd.org

UNITARUnited Nations Institute for Trainingand ResearchPalais des NationsCH - 1211 Geneva 10Switzerlandwww.unitar.org

114

Non-governmental Organizations

Verbraucherzentrale Bundesverband e.V.Markgrafenstr. 6610969 Berlinwww.vzbv.de

Gesellschaft Deutscher ChemikerVarrentrappstr. 40 � 4260486 Frankfurt/M.www.gdch.de

Hauptverband der gewerblichenBerufsgenossenschaftAlte Heerstr. 11153757 Sankt Augustinwww.hvbg.de

Industrieverband Agrar (IVA)Karlstr. 2160329 Frankfurt/M.www.iva.de

Berufsgenossenschaft der chemischen IndustrieKurfürsten-Anlage 6269115Heidelbergwww.bgchemie.de

Verband der chemischen Industrie e.V.

Verband der Chemischen Industrie e.V.Deutsche Gesellschaft für TechnischeZusammenarbeit GmbHDag-Hammarskjöld-Weg 1 � 565760 Eschbornwww.gtz.de

GreenpeaceGroße Elbestr. 3922767 Hamburgwww.greenpeace.de

IG Bergbau, Chemie, EnergieKönigsworther Platz 630167 Hannoverwww.igbce.de

Verband ChemiehandelGroße Neugasse 650667 Kölnwww.vch-online.de

Bund für Umwelt und Naturschutz Deutschlande.V. (BUND)Am Köllnischen Park 110179 Berlinwww.bund.net

Karlstr. 2160329 Frankfurt/M.www.vci.de