Revision of the Chemical Agents Directive

European Trade Unions InstituteSeminar on workers’ protection & chemicals

29th June 2021

Alick Morris

Policy officer - Chemicals

Health and Safety at Work Unit

European Commission

DG Employment, Social Affairs and Inclusion

Luxembourg

« The European Pillar of Social Rights has been our

reference point for building a strong social Europe. Now we

breathe new life into it, turning its principles into actions. »

Nicolas Schmit, European Commissioner for Jobs and

Social Rights

#SocialRights

• The EPSR Action Plan was adopted on 4 March 2021

• Action Plan outlines concrete actions to further implement the principles of

the EPSR

• Joint effort by MSs and the EU, with the active involvement of social partners

and civil society

• Porto Social Summit in May 2021

EU Pillar of Social Rights Action Plan

EU Pillar of Social Rights Action Plan

5

Housing and

assistance for

the homeless

Access to

essential

services

Long-term care

Inclusion of people

with disabilities

Healthcare

Old-age

income and

pensions

Minimum

income

Unemployment

benefits

Social

protectionChildcare

and support

to children

Healthy, safe

and well-adapted

work environment

and data

protection

Work-life

balance

Social dialogue

and involvement

of workers

Information about

employment conditions

and protection in case

of dismissals

Wages

Secure and

adaptable

employment

Active support

to employment

Equal

opportunities

Gender

equality

Education,

training

and life-long

learning

EPSR Action Plan – OSH related Actions

Adopted on 28th June 2021 - COM(2021) 323 final

Revision of Chemical Agents Directive Key steps in setting OELs & BLVs

1Selection of chemicals for Scientific Evaluation

DG EMPL establishes lists of priorities for scientific evaluation based on inputs from various sources and application of priority criteria.

2Scientific Opinion

DG EMPL mandates ECHA for RAC the scientific committee to deliver an Opinion. This includes the dose response relationship or exposure-risk-relationships (ERR) for non-threshold carcinogens, or a practical threshold when possible. ECHA scientific reports are subject to external consultation.

3 WPC - ACSH

The Working Party on Chemicals (WPC) discusses the scientific Opinion and various feasibility issues and comes up with a consensus based suggestion for the OEL value. This is integrated in a draft opinion for adoption by the Plenary of ACSH.

4 Impact Assessment (IA)

DG EMPL drafts IA containing policy options and associated impacts. IA is discussed within an Interservice Steering Group and submitted to the Regulatory Scrutiny Board (RSB). A positive reply is required.

5 Draft legislative proposal

DG EMPL prepares the draft legislative proposal and submits it to inter-service consultation. Thereafter, a final draft legislative proposal is prepared.

6 College of Commissioners

The College of Commissioners adopts the proposal and sends it to Council and Parliament for negotiation and subsequent adoption as a Directive.

7 Adopted Directive published in EU Official Journal

MSs will transpose the legal text into national legislation by the date set in the Directive.

For binding limit values need also to consult social

partners in two stages in accordance with social policy

requirements of Article 154 TFEU

➢ Protects workers' health.

➢ Defines effective control of exposure.

➢ Indicates level of exposure considered to be safe (health based) or appropriate (where feasibility

factors are also taken into consideration).

➢ Provides a "level playing field" for all users – promotes consistency.

➢ Provides a benchmark for new users and designers of process plant.

➢ Defines a common objective for employers, workers and enforcement agencies.

➢ Contributes to more effective health surveillance.

Practical benefits of EU OELs & BLVs

➢ Two stage social partners consultation at EU level (in accordance with TFEU Article 154).

➢ Selecting priority chemicals for scientific evaluation (WPC).

➢ Public consultation for the draft scientific reports (done by ECHA/RAC).

➢ Participate in RAC as WPC experts.

➢ Represented in the Working Party on Chemicals where they prepare the draft opinion for the Advisory Committee

on Safety and Health.

➢ Adoption of Opinion of ACSH.

➢ External study to support the Impact Assessments makes use of data provided by external stakeholders. Social

partners are also present in the steering group for the study.

➢ Bilateral discussions with DG EMPL.

Social partners participation

• RAC Opinions adopted in June 2020

• Ongoing External Study with a deadline of

September 2021 - supports WPC in preparing

draft Opinion & EMPL to prepare impact

assessment. WPC members in study steering

group

• Social Partners Consultation first stage

launched in December 2020, second stage

planned for mid - 2021

• Discussions initiated within the WPC to prepare

draft Opinion

• Opinion of ACSH planned adoption by end of

2021

• Impact Assessment and Commission

proposal expected by summer 2022

Ongoing OSH initiatives – Lead* & Diisocyanates

*Lead and its compounds = major

reprotoxic substance

LEAD

Top left: Demolition of lead painted

metal structure. Top right: Casting

of molten lead with a suction ring

at the crucible.

Mid left: Recycling of WEE. Mid

right. Recovery of lead-acid

batteries.

Bottom: Glass works. Separation

of lead seals (left) and lead

painting on a window.

Pictures from made available from

INRS, 2018

(https://www.inrs.fr/dms/inrs/Gener

ationPDF/accueil/risques/plomb/Pl

omb.pdf)

11

Health endpoints

Lead and its compounds

➢ Brain cancer

➢ Neurotoxicity

➢ Haematotoxicity

➢ Nephrotoxicity

➢ Cardiovascular effects

➢ Reproductive toxicity (male)

➢ Reproductive toxicity (female)

➢ Developmental toxicity

Current limit values

➢ Existing Binding OEL and BLV under CAD – need updating to reflect scientific

and technical developments

➢ Biomonitoring of high importance due to combination of exposure routes

Lead and its compounds = major

reprotoxic substance

Lead – study scenario optionsOccupational Exposure Limit – options for analaysis

µg/m3 mg/m³ Reason for inclusion

150 0.15 Existing EU level in the Chemical Agents directive

100*0.10* Intermediate level of current OELs in EU Member States as agreed by the steering group of the study.

50 0.05Lowest OEL in EU Member States (Bulgaria, Czech Republic, Denmark, Estonia, Latvia, Poland,

Sweden)

20 0.02Intermediate level between lowest national OEL and the level proposed by RAC as agreed by the

steering group of the study.

4 0.004 OEL at the level proposed by RAC

Biological Limit Value – options for analysis

µg/L µg/100 mL Reason for inclusion

700 70 Existing EU level in the Chemical Agents directive

300 30 Intermediate level of BLV in EU Member States

200* 20*Lowest national BLV in EU Member States for all workers (Denmark). Voluntary target of International

Lead Association.

150 15 BLV at the level proposed by RAC

100* 10*

The ILA voluntary programme recommendation for females of reproductive capacity (defined as ≤45

years of age or as agreed by the company medical advisor) based on DNEL set under REACH.

Included as agreed by the steering group of the study.

45 4.5

Biological guidance value related to background exposure of the general population. Applies to women

of child-bearing age (under 50 years of age). Included following agreement of the steering group of the

study

DIISOCYANATES

14

This Photo by Unknown Author is licensed under CC BY

➢ Sensitisation in the respiratory tract (allergic asthma) key health endpoint

➢ Group approach for all isocyanates➢ Dose Response Relationships (DRRs) based on NCO air concentration

➢ NCO refers to the nitrogen, carbon, and oxygen component of the diisocyanate group

➢ Around 5m workers exposed

➢ Widely used in the manufacture of polyurethane foams, plastics, coatings,

varnish, two-pack paints and adhesives

➢ No EU OEL, several national OELs. STEL important due to short term peak

exposures

DIISOCYANATES – study scenario optionsLevel, µg NCO/m3 OEL - Reason for inclusion

17.5 The median level for a national OEL

6 Intermediate level that some companies are achieving

3 Half the maximum STEL recommended by RAC

2 Intermediate level

1 This is the lowest OEL in a MS

0.5 Intermediate level for modelling

0.1 Intermediate level for modelling

0.025 The air concentration with the lowest excess risk given by RAC (0.1%)

Level, µg NCO/m3 STEL - Reason for inclusion

35 The median level for a national STEL

12 Two times intermediate OEL level

6 The maximum STEL recommended by RAC

4 Intermediate level

2 Two times the lowest OEL in a MS

1 Intermediate level for modelling

0.2 Intermediate level for modelling

0.05Two times the air concentration with lowest excess risk given by RAC

(0.1%)

15

RAC recommend that the STEL

is at most twice the OEL.

• June First substantive discussion already held in WPC - study

team present

• June Planned launch of 2nd stage social partner consultation

• June OSH Strategic Framework 2021-2027 adopted COM(2021) 323 final

• Mid July Study team submit Draft Final report

• End July Study team present DFR to steering group

• End August Study team submit Final Report – end of project

• October WPC finalise draft Opinions

• November Possible additional meeting of WPC (if necessary)

• November ACSH adopt Opinions

First half 2022 EMPL prepare IA and legislative proposal

Immediate key steps in process (2021)

Thank you

© European Union 2020

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