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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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