Simon Robinson Editor Urethanes Technology International · The market offers different types of training ranging from the traditional classroom style to ... 2012 2016 2017 Verification

Simon Robinson

Editor

Urethanes Technology International

24 September 2018

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PRESENTED BY: ORGANIZED BY:

A few words about REACH

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.


Diisocyanates and REACH

We have three speakers today who will address different aspects of polyurea technology and use.

Jörg Palmersheim, Secretary General of Isopa and Alipa, who will talk us though the State of play of the regulatory dossier on diisocyanates

Ronald van den Bosch, PU EH&S at Dow Benelux BV will give us more detail about the measures and training proposed under the restriction

Luc Thys, Group Director Marketing and R&D at Soudal, Exemptions for low risk products


ISOPA, ALIPA and Urethanes Technology International invite you to join a webinar about the latest news and developments related to Diisocyanates restriction dossier.

Diisocyanates REACH Dossier:

“Update on Regulatory Process

and Implications“

6 | 24 September 2018

Who are ISOPA and ALIPA?

ISOPA is the European trade association

for producers of diisocyanates and

polyols - the main building blocks of

polyurethanes.

ALIPA is the European Aliphatic

Isocyanates Producers Association

PRODUCT STEWARDSHIP

Isopa and ALIPA members continuously improve safety, health

and environmental standards across the European

polyurethanes industry

ADVOCACY

Isopa and ALIPA members engage with policy makers at EU &

national level to deliver most relevant information and data

COMMUNICATION

Isopa and ALIPA communicate with all stakeholders inside and

outside industry

ALIPA

ISOPA


Diisocyanate production sites in Europe

Germany

Stade, Brunsbüttel, Dormagen, Krefeld, Leverkusen, Marl, Ludwigshafen

Belgium

Antwerp

The Netherlands

Terneuzen, Rozenburg

Portugal

Estarreja

Spain

Tarragona

France

Pont de Claix

Hungary

Kazincbarcika

World (2016)

Mill. Tons

8,7

EMEA (2016)

Mill. Tons

2,3


31%

01 Flexible Foam

15%

04 Coatings

4%

05 Binders

34%

02 Rigid Foam

06 Elastomers8%

4,815,650 t

03 Adhesives & Sealants

Polyurethane Production in Europe (2016)

8%


Scope of the RestrictionIndustrial & Professional Use

User`s are not

affected

< 0,1 % of cumulative

diisocyanates concentration

Only very few

product/use

combinations

Exemption

> 0,1 % of cumulative


Mainly construction

chemicals, sealants &

adhesives and coatings

and paintings

Training & Measures

required

> 0,1 % of cumulative


Car Seating

Furniture

Insulation

Specialites

(e.g. Footwear)

Coating & Painting

Risk for exposure

requires specific training

of users, e.g. sectors as


Concrete amendments to SEAC‘ &

RAC‘s proposed legal text

Exposure & Training

Table listing generic

uses and the

corresponding

‘measure groups’

industrial and

professional should

be included back in

the legal text –

reduces scope for

interpretation

Amendment Two

Training for

Management

Amendment Three

As proposed by

BAuA, a training for

management should

be part of the text.

SEAC’ & RAC’s text

speaks about a

training for trainers

which is different

Training type

Amendment Four

The market offers

different types of

training ranging from

the traditional

classroom style to

more modern e-

learning solutions.

Industry prefers to be

given flexibility on the

best format of

training

Transition Period

Amendment Five

SEAC & RAC propose

a 4 years period but

industry feels a 6

years period is

necessary to create

a training

infrastructure and to

train the millions of

workers affected by

the restriction

Appendix Y

Amendment Six

Legal text should not

include a list of

technical and

organisational

measures applicable

to all professional

and industrial users of

diisocyanates – this is

better done in

guidelines

Textual incoherences

Wording of

paragraphs 8 and 9 is

not aligned with the

requirements of

Appendixes X and Y.

I. e. workers would

have to be trained

on applications not

performed at their

employer’s

Amendment One


Teaching Material Requiring all 28 member states to approve the content of the

Training Material is NOT feasible. Supervisory Board to be created

Qualified Trainer Need for a definition of qualified trainers and how will the

qualifications of trainers be recognized in member states

Evaluation Trained workers should be evaluated to ensure supervision of the

progress

CommunicationConcerted approach by industry and authorities.

Reach out concept for communication required

Also important to note


Discussion OSH regulation via REACH

REACH enables level playing field!

Advantages of the REACH framework:

Restriction under REACH will create a level playing field across the EU

Employees will receive a unified training across all member states

Training will be at the highest standards and the content could be reviewed by a

supervisary board

All employees will receive a certificate after a sucessful examen

Training will be recognised across EU and therefore support the principle of free movement


Regulatory Status of the Restriction

Germany:

Proposal for Restriction

ECHA Committees:

Comment

EU Commission:

Draft proposal Annex XVII

Dossier:

hazard and risk

argumentation for EU wide

action

alternativeseconomic impact

2012 2016 2017

Verification of the dossier

and endorsement for the proposal

2018

Political decision

Enactment ?

ISOPA & ALIPA decided on a joint project of both associations (PSSF) and decided to involve Downstream

Associations (PU Exchange Panel) for efficient facilitation of the cross value chain activities.


Regulatory Process

Regulatory Procedure with Scrutiny (RPS)

Although RPS is not part of the Lisbon Treaty framework, it is still applicable in certain

EU legislative acts before 1 Dec 2009 (.i.e. REACH)

Navigating through the RPS

The Commission kicks off the RPS by submitting a draft quasi-legislative measure to

the Regulatory Committee (in our case the REACH Commitee).

The Committee is made up of representatives from each Member State (28 at

present) and is chaired by a Commission official who decides the agenda of the

meetings. The Regulatory Committe votes by qualified majority (QMV).

A QMV requires at least 55% of Member States (currently 16 out of 28) representing at least 65% of the

population of the European Union.

A blocking minority requires at least 4 Member States representing more than 35% of the population of the

European Union.


Regulatory Process

Commission proposal

Regulatory (REACH) Committeevoting by qualified majority

Option A Option B

Approves draft measure:

Stage 2 – option A

No or negative opinion:

Stage 2 – option B


Regulatory Process

Option A – If the Committee approves the draft measure, the European

Parliament and Council come into play

Even if the Regulatory Committee votes by QMV in favour of the Commission draft measure, the green light has

not yet been given. The Commission must then forward the draft measure to the European Parliament (EP) and

the Council.

Both the EP and the Council have the right to issue a veto against the draft measure within a deadline of 3

months. The deadline begins to run when all official language versions of the draft have been received by the

EP and the Council


Regulatory Process

Possible veto by the EP or Council

A veto right means the right to say “no”, but is important to note that it does not give the right to amend. For a

veto to occur:

• The Council needs a qualified majority; or

• The EP needs an absoute majority (at present, 376 MEPs)

The veto has to be justified by invoking one of 3 specific reasons:1) The draft exceeds the Commission`s implementing power under the legislative act;

2) The draft violates the principles of subsidiarity or proportionality; or

3) The draft goes against the aim or content of the legislative act

If no veto is expressed by either the EP or the Council, the draft quasi-legislative measure is adopted. If the veto

is expressed, the draft cannot be adopted.


Research to support the restriction

Key parameters and objectives of the feasibility study

Prospective Cohort study

Recruitment of approx. 2000 participants, 1500 exposed employees, 500 non exposed test persons

Expected cases of diisocyanate associated respiratory and lung diseases

(approx. 1 case per 500 MJ) should be detectable

Feasibility study: 2 years Full study : another 5 years ( 7500 MJ estimated 15 cases)

2018 2019 2020 2025

Feasibility Study

Preparation of full studyCohort study


Germany: confirmed cases

BK 1315 (respiratory) & BK 5101 (dermal)

BK 1315; 44

BK 5101 ; 14

0

40

80

120

Nu

mb

er

of

case

s

General

downward trend,

taken into

consideration the

steady growth of

polyurethane

production along

with increase of

employment


More about the measures and training

proposed under the restrictionby Ronald van den Bosch


Training and Measures

Single Task at the workplace

Dermal Exposure +

Inhalation Exposure

= Assessment

Measure Group

1,2 or 3

Route

of Exposure

Exposure

Stage

Probability

of Exposure

Dermal

Exposure

1Potential skin contact rare, small areas and immediately appropriately

removed; e.g. splashes

2 Potential repeated short term skin contact (max 4*15 min per 8 hr shift)

3 Potential repeated prolonged skin contact(> than 60 min per 8 hr shift)

Inhalation

Exposure

1 Low vapour formation

2 Moderate vapour and/or aerosol formation

3 High vapour and/or aerosol formation


Training and Measures The Current Logic of Training / to be repeated every 4 years

Measure Group

1, 2 and 3

Measure Group 3

Training (Workers)

Training

MG1

Training

MG 2

Training

MG 38 h

Classroom, Written,

e-learning, Workplace

Measure Group 1

Training Workers

Training

Manager

Qualified Trainers

Classroom,

Written,

Workplace Ev

alu

atio

n

Measure Group 2

Training (Workers)Measure Group 1

Training Workers

Measure Group 2

Training (Workers)

4 h

Measure Group 1

Training Workers

Ev

alu

atio

n

Classroom,

Workplace

Class room /

On-Site instructions

where required

Ev

alu

atio

nEv

alu

atio

n

4 h

4 h

4 h

4 h

Product Stewardship Programmes

Key Messages:

■ Safety is everybody's responsibility■ Safety is more than 80% behavior related■ Through stimulating the dialog■ Requires continuous Improvement

First launched in 2006



One step ahead – outreach to Middle East & Africa

ISOPA organizes 1 or 2 times per year a 1day training for foamers in Middle East and Africa.

Since 1999, ISOPA has conducted almost 40 seminars with an average parctipation of 50

persons.

International Interactive Communicative



Driver Training Programme

Established in year 2000

Training of truck drivers,

transporting diisocyanates

Train the Trainer concept

> 6.000 drivers trained Effort across the value chain

In an unique effort ISOPA created almost 20 years ago a driver training scheme which

ensures that each driver transporting diisocyanates,

is familiar with the key aspects of the substance


PU Exchange PanelEuropean/National Associations teamed up

ALIPACEC

APPLIA

CEPE

EFCC

EFIC

EPF

EPDLA

Euratex

Euromoulders

Europur

CotanceFEICA

ISOPA PPAPU Europe

ICOMIA

OnderhoudNL

PDA Europe

Deutsche Bauchemie

Kennisplatform

Vdl

ZVEI

IVPU

FSKIVK

Joint Industry Effort


Joint Industry Effort

•Master trainer specialised in creating

education and training materials hired to put

together the training materials for the different

measure group levels

•The whole value chain is participating at his

effort and providing sector specific information

to the master trainer

•First demo of the Learning Management

System (LMS) will be available soon

SafeUseDiisocyanates.eu

website to go live this

September


Exemptions by Luc Thys


Exemptions foreseen in the Restriction

Exemptions are part of the draft restriction

“Paragraphs 1 and 2 shall (referring to the restriction to place in the market) not apply to those use(s)

where the supplier (manufacturer, importer or formulator) ensures that

the specific use of a ready-to-use product containing ≥ 0.1% diisocyanates in the substance or mixture leads to very low risk of exposure for the dermal and inhalation route.”

There are specific criteria for a product to be granted an exemption:

• aerosols are not generated, and

• warming or heating the substance or mixture above 45 °C is not required, and

• the sum of the concentrations for all diisocyanates measured during air monitoring shall be < 1 ppb

as a time-weighted average of 8 hours, and

• very low dermal exposure is demonstrated by a recognised dermal assessment tool.


Exemptions foreseen in the Restriction

Clear criteria for exemptions

• To ensure a European level playing field it is important that exemptions for products and its

applications are accepted EU wide.

• Therefore clearly described criteria for exemption dossiers, commonly agreed by European and

national authorities on the basis of the legal text are required.

• Industry is prepared to contribute to the development of such criteria together with other

stakeholders, e.g. in the form of a guidance document or manual.


Industry pro-active actions on

exemptions foreseen in the restriction

2 draft exemption dossiers have been prepared by Deutsche BauChemie and FEICA

(Sealants and One Component Foam respectively)

These draft dossiers have been developed to illustrate the added value of exemptions

and to show a workable format for a dossier to demonstrate the inherent safety of the

product concerned

In particular the OCF dossier was shared with authorities and also positively received by

BAuA and ECHA

European OCF manufacturers estimate that over 100.000.000 cans of PU foam are used in the EU

every year by well over 500.000 professional end users


Product / use combinations which are

possible candidates for exemptions

One Component PU foam (OCF) PU construction sealant


Communication

Coming Soon

http://www.safeusediisocyanates.eu

You can type your questions in the

box on the bottom or top of your

screen.

To access the Question Box, click Q&A button on the bottom of your screen.

ASKING QUESTIONS


CONTACT:

Jörg Palmersheim

Secretary General

Av. Van Nieuwenhuyse laan 4, B - 1160

Brussels

Tel: +32 2 / 676 74 76

[email protected]

www.isopa.org

www.alipa.org

www.polyurethanes.org

Thank you for your attention

mailto:[email protected]

http://www.isopa.org/

http://www.alipa.org/

http://www.polyurethanes.org/

Documents

Simon Robinson Editor Urethanes Technology International · The market offers different types of training ranging from the traditional classroom style to ... 2012 2016 2017 Verification