Legal feasibility study on the introduction of a nanoproduct register

Final report Produced with the support of the Federal Environment Agency and with funding from the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety

Prepared by: Andreas Hermann, LL.M., Berlin office Martin Mller, Freiburg office

Berlin, Freiburg, May 2010

ko-Institut e.V. Freiburg Head Office P.O. Box 50 02 40 D-79028 Freiburg. Germany Street address Merzhauser Strasse 173 D-79100 Freiburg. Germany Tel. +49 (0) 761 - 4 52 95-0 Fax +49 (0) 761 - 4 52 95-88

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Berlin office Novalisstrasse 10 D-10115 Berlin. Germany Tel. +49 (0) 30 40 50 85 - 0 Fax +49 (0) 30 40 50 85 - 388

Final Report Nanoproduct Register: a feasibility study

Table of contents

1 Zusammenfassung ..................................................................7

2 Executive Summary .................................................................9

3 Scope and objectives ............................................................11

4 Purpose of a nanoproduct register and mandatory

reporting requirement............................................................14

5 Information on nanomaterials in products under the legal

provisions currently in force .................................................16

5.1 Nanomaterials ....................................................................................................16 5.1.1 Substance registration obligations under REACH ...............................................16 5.1.2 Conclusions regarding registration of nanoscale phase-in substances ...............19 5.1.3 Authorisation and restrictions...............................................................................20 5.1.4 Evaluation of authorisation and restriction procedures for nanomaterials ...........21 5.1.5 Provision of information in the supply chain (Safety Data Sheets) ......................21 5.1.6 Evaluation of the Safety Data Sheet as a tool for communicating information on

nanomaterials.......................................................................................................23 5.1.7 Provisions on articles in REACH ..........................................................................23 5.1.8 Evaluation regarding provision of information on nanomaterials .........................24 5.1.9 The German Hazardous Substances Ordinance / CLP Regulation - compensating

for the shortcomings of REACH ...........................................................................25 5.2 Conclusions........................................................................................................26 5.3 Legislation on products ....................................................................................26 5.3.1 Scope of study .....................................................................................................27 5.3.2 Cosmetics (Cosmetics Regulation) ......................................................................29 5.3.3 Evaluation of the Cosmetics Regulation with regard to introduction of a

nanoproduct register ............................................................................................30 5.3.4 Novel foods (Novel Food Regulation) ..................................................................31 5.3.5 Evaluation of the Novel Food Regulation with regard to introduction of a

nanoproduct register ............................................................................................34

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5.3.6 Food additives, enzymes and flavourings ........................................................... 34 5.3.7 Evaluation of the legislation on food additives, food enzymes and food

flavourings with regard to the introduction of a nanoproduct register.................. 35 5.3.8 Articles intended to come into contact with foodstuffs......................................... 36 5.3.9 Evaluation of legislation on food contact materials and articles with regard to

introduction of a nanoproduct register ................................................................. 37 5.3.10 Articles................................................................................................................. 38 5.3.11 The German Equipment and Product Safety Act (Directive on general product

safety).................................................................................................................. 38 5.3.12 Evaluation of the GPSG with regard to the introduction of a nanoproduct register39 5.4 Conclusions....................................................................................................... 40

6 The need for legislation and the precautionary principle .. 41

6.1 The precautionary principle ............................................................................. 41 6.2 Grounds for invoking the precautionary principle for nanomaterials .......... 42 6.2.1 Eco-toxicology: potential concerns...................................................................... 42 6.2.2 Human toxicology: potential concerns................................................................. 43 6.3 Evaluation of the grounds for invoking the precautionary principle ........... 44 6.4 Nanoproduct register as a precautionary measure ....................................... 45 6.4.1 Proportionality ..................................................................................................... 46

6.4.2 Non-discrimination............................................................................................... 49 6.4.3 Consistency......................................................................................................... 50 6.4.4 Examination of the benefits and costs of action and inaction.............................. 50 6.4.5 Review of scientific developments ...................................................................... 50

7 Regulatory measures in other countries ............................. 52

8 Requirements concerning content of legislation on a

product register and mandatory reporting scheme ........... 53

8.1 Scope.................................................................................................................. 53

8.1.1 Exclusions from the scope of the provisions ....................................................... 53 8.1.2 Phased introduction of mandatory reporting........................................................ 54 8.2 Definitions.......................................................................................................... 55 8.2.1 Definition of nanomaterial for the purposes of the nanoproduct register .......... 55 8.2.2 Proposed definitions of nanomaterial for the purposes of the product register ... 57 8.2.3 Discussion of proposed definitions...................................................................... 57 8.2.4 Definition of nanoproduct for the purposes of a nanoproduct register .............. 59

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Final Report Nanoproduct Register: a feasibility study

8.3 Addressees of the mandatory reporting requirement ....................................60 8.4 Information to be reported ................................................................................61 8.5 Exemptions from the mandatory reporting requirement................................62 8.6 Obligations relating to testing and evidence ..................................................64 8.7 Sanctions for infringements of the mandatory reporting requirement .........64 8.8 Publication of information from the register ...................................................64

9 Institutional framework for a nanoproduct register............66

9.1 Federal Institute for Risk Assessment (BfR) ...................................................66 9.2 Federal Institute for Occupational Safety and Health (BAuA) .......................67 9.3 Federal Environment Agency (UBA) ................................................................68 9.4 Expert body ........................................................................................................69 9.5 Conclusions........................................................................................................69

10 Basis for authority to introduce a mandatory reporting

requirement and nanoproduct register ................................70

10.1 Regulatory competence of the Federation ......................................................70 10.1.1 Legislative competence of the Federation ...........................................................70 10.1.2 Administrative competence of the Federation......................................................72 10.2 Legislative framework for provisions on mandatory reporting and a

nanoproduct register .........................................................................................73 10.2.1 Chemicals Act (ChemG) ......................................................................................73 10.2.2 Equipment and Product Safety Act (GPSG) ........................................................74 10.3 Voluntary reporting ............................................................................................75 10.4 Conclusions........................................................................................................75

11 Compatibility of mandatory reporting / nanoproduct

register with EU law .........