BETA


2016/0130(COD) Protection of workers from exposure to carcinogens or mutagens at work: exposure limit values

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead EMPL ULVSKOG Marita (icon: S&D S&D) ROLIN Claude (icon: PPE PPE), MCINTYRE Anthea (icon: ECR ECR), WEBER Renate (icon: ALDE ALDE), LE HYARIC Patrick (icon: GUE/NGL GUE/NGL), DELLI Karima (icon: Verts/ALE Verts/ALE), AGEA Laura (icon: EFDD EFDD), MÉLIN Joëlle (icon: ENF ENF)
Committee Opinion ENVI MÉLIN Joëlle (icon: ENF ENF)
Committee Opinion ITRE
Committee Opinion JURI CHRYSOGONOS Kostas (icon: GUE/NGL GUE/NGL)
Committee Legal Basis Opinion JURI GUTELAND Jytte (icon: S&D S&D) Max ANDERSSON (icon: Verts/ALE Verts/ALE), Marie-Christine BOUTONNET (icon: ENF ENF), Therese COMODINI CACHIA (icon: PPE PPE), António MARINHO E PINTO (icon: ALDE ALDE)
Lead committee dossier:
Legal Basis:
TFEU 153-p2

Events

2017/12/27
   Final act published in Official Journal
Details

PURPOSE: to better protect workers from exposure to carcinogens or mutagens in their workplace.

LEGISLATIVE ACT: Directive (EU) 2017/2398 of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.

CONTENT: this Directive amending Directive 2004/37/EC improves workplace conditions and protects workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. It introduces 11 carcinogenic substances to the current list of dangerous substances and revises the limit values for two substances that are already listed.

crystalline silica dust alveolar, 1,2-epoxypropane, 1,3-butadiene, 2-nitropropane, acrylamide, certain chromium (VI) compounds, ethylene oxide, o-toluidine, refractory ceramic fibres, bromoethylene and hydrazine.

Health surveillance : the Member States shall establish, in accordance with national law or practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment reveal a risk to health or safety.

The doctor or authority responsible for the health surveillance of workers may indicate that health surveillance must continue after the end of exposure for as long as they consider it to be necessary to safeguard the health of the worker concerned.

All cases of cancer identified in accordance with national law or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority.

Revision of the exposure limit values : the amending Directive revises the limit values ​​for the following substances:

hardwood dust : the limit value for exposure is set at 3 mg/m3 until 17 January 2023 and at 2 mg/m3 thereafter. The distinction between hardwood and softwood dust should be further assessed as regards the limit value set out in that Annex, as recommended by Scientific Committee on Occupational Exposure Limits (SCOEL) and the International Agency for Research on Cancer; Chromium (VI) compounds which are carcinogens : the Directive provides an initial exposure limit value of 0.010 mg/m3 until 17 January 2025, after which this value will be lowered to 0.005 mg/m3. A derogation is provided for welding and plasma cutting processes or similar processes that generate fumes: the exposure limit value is fixed at 0.025 mg/m3 until 17 January 2025 and will then be 0.005 mg/m3.

Reprotoxic substances : the Commission shall assess the possibility of including reprotoxic substances in the list of dangerous substances by the first quarter of 2019 . On this basis, it shall submit, if necessary, a legislative proposal, after consulting the social partners.

Lastly, as part of the next evaluation of the implementation of the Directive, the Commission will have to evaluate the need to modify the limit value for respirable crystalline silica dust (set at 0.1 mg / m³ in the amending Directive). The Commission shall propose, if necessary, the necessary modifications relating to this substance.

ENTRY INTO FORCE: 16.1.2017.

TRANSPOSITON: by 17.1.2020.

2017/12/13
   CSL - Draft final act
Documents
2017/12/12
   CSL - Final act signed
2017/12/12
   EP - End of procedure in Parliament
2017/12/08
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2017/12/08
   CSL - Council Meeting
2017/12/06
   EC - Commission response to text adopted in plenary
Documents
2017/10/25
   EP - Results of vote in Parliament
2017/10/25
   EP - Decision by Parliament, 1st reading/single reading
Details

The European Parliament adopted by 540 votes to 6 with 119 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.

To recall, the proposed directive aims to improve workplace conditions and protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. It introduces 11 carcinogenic substances to the current list of dangerous substances and revises the limit values for two substances that are already listed.

Information for the competent authority : Directive 2004/37/EC provides that where the results of the risk assessment reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on:

the activities and/or industrial processes carried out, including the reasons for which carcinogens or mutagens are used; the quantities of substances or preparations manufactured or used which contain carcinogens or mutagens; the number of workers exposed; the preventive measures taken; the type of protective equipment used; the nature and degree of exposure.

The amended text provides that Member States shall take into account the above information in their reports submitted to the Commission under Council Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work.

Health surveillance : Member States shall establish arrangements for carrying out relevant health surveillance of workers for whom the results of the risk assessment reveal a risk to health or safety. The doctor or authority responsible for the health surveillance of workers may indicate that health surveillance must continue after the end of exposure for as long as they consider it to be necessary to safeguard the health of the worker concerned.

Furthermore, all cases of cancer identified in accordance with national law or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority.

The amended text stresses that appropriate and consistent data collection by Member States from employers is necessary to ensure the safety and proper care of workers.

Limit values for occupational exposure : Parliament revised the limit values for the following substances:

hardwood dusts : there will be an exposure limit value of 3 mg/m3 for 5 years after the entry into force of the directive and thereafter a limit of 2 mg/m3 ; Chromium VI: there will be an exposure limit value of 0.010 mg/m3 for a period of 5 years after the date of transposition of the directive; after that period a limit of 0.005 mg/m3 will apply.

Evaluation: the Commission shall, as part of the next evaluation of the implementation of the Directive, also evaluate the need to modify the limit value for respirable crystalline silica dust (set at 0.1mg/m3 in the amended text). The Commission shall propose, where appropriate, necessary amendments and modifications related to that substance.

Parliament also required that by the first quarter of 2019, the Commission should assess the option of amending the scope of the Directive to include reprotoxic substances . On that basis, the Commission shall present, if appropriate, and after consulting management and labour, a legislative proposal.

The text goes on to recall that in its opinion on refractory ceramic fibres , the Advisory Committee on Safety and Health at Work (ACSH) agreed that a binding occupational exposure limit value is necessary for this substance. The Commission should therefore encourage the ACSH to submit an up-to-date opinion on refractory ceramic fibres with a view to reaching a common position on the limit value for that substance.

Documents
2017/10/24
   EP - Debate in Parliament
2017/08/30
   EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
2017/07/11
   CSL - Coreper letter confirming interinstitutional agreement
2017/06/20
   EP - Specific opinion
Documents
2017/06/07
   EP - GUTELAND Jytte (S&D) appointed as rapporteur in JURI
2017/04/18
   HR_PARLIAMENT - Contribution
Documents
2017/03/09
   EP - Committee report tabled for plenary, 1st reading/single reading
Details

The Committee on Employment and Social Affairs adopted the report by Marita ULVSKOG (S&D, SE) on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.

The inclusions of reprotoxic substances : Members proposed broadening the scope of the Directive to allow for the inclusion of reprotoxic substances. They stressed that reprotoxic substances were of great concern and that the organisation of workplace prevention should be applied as for carcinogens and mutagens .

The amended text clarifies that the requirements laid down in the Directive should be considered as minimum requirements, with Member States having the possibility of setting more stringent binding occupational exposure limits.

It is essential to take the precautionary principle into account, especially where there are uncertainties as to the impact of dealing with substances and their mixtures on workers’ health or where available scientific and technical data is not sufficient.

Limit values : the report introduced stricter limit values ​​for several substances:

wood dust : Members do not wish to distinguish between hardwood dust and softwood dust. They consider that the limit value of 2 mg/m3 should constitute the EU's common limit value (the Commission proposed a limit value of 3 mg/m3 for hardwood dust); chromium VI : a limit value of 0.001 mg/m3 is proposed (instead of 0.025 mg/m3); respirable crystalline silica dust : a limit value of 0.05 mg/m3 is proposed (instead of 0.1 mg/m3).

The Advisory Committee on Safety and Health at Work (ACSH) should also submit up-to-date opinions on the binding occupational exposure limits on respirable cristalline silica, hardwood dusts, acrylamide, 1,3-butadiene, chromium VI and refractory ceramic fibres.

Health surveillance measures : Members considered that health surveillance should be provided for all workers exposed (i) prior to exposure; (ii) at regular intervals during the exposure period; (iii) after the end of the exposure and the end of their employment.

Data collection : Members called on the Commission to:

support best practices with regard to data collection between Member States and propose how data collection can be improved. The Member States should provide the Commission with information for the purposes of its reports on the implementation of Directive 2004/37/EC; develop a harmonised methodology for measuring workers' exposure to carcinogens, mutagens and reprotoxic substances at Union level.

Documents
2017/03/01
   EP - Amendments tabled in committee
Documents
2017/02/28
   EP - Vote in committee, 1st reading/single reading
2017/02/28
   EP - Committee decision to open interinstitutional negotiations with report adopted in committee
2017/02/01
   EP - Committee opinion
Documents
2017/01/12
   EP - Amendments tabled in committee
Documents
2016/11/22
   EP - Committee draft report
Documents
2016/09/21
   ESC - Economic and Social Committee: opinion, report
Documents
2016/07/25
   IT_SENATE - Contribution
Documents
2016/07/19
   PT_PARLIAMENT - Contribution
Documents
2016/07/11
   EP - CHRYSOGONOS Kostas (GUE/NGL) appointed as rapporteur in JURI
2016/07/01
   EP - MÉLIN Joëlle (ENF) appointed as rapporteur in ENVI
2016/06/16
   CSL - Debate in Council
Documents
2016/06/16
   CSL - Council Meeting
2016/06/02
   EP - ULVSKOG Marita (S&D) appointed as rapporteur in EMPL
2016/05/25
   EP - Committee referral announced in Parliament, 1st reading/single reading
2016/05/13
   EC - Document attached to the procedure
2016/05/13
   EC - Document attached to the procedure
2016/05/13
   EC - Legislative proposal published
Details

PURPOSE: to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents.

PROPOSED ACT: Directive of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: Directive 2004/37/EC aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace and lays down minimum requirements to that effect including limit values, on the basis of the available scientific and technical data.

The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP).

Estimates of the recent and future burden of occupational diseases indicate that work-related cancer is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU . Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases.

Ensuring a safe and healthy work environment for over 217 million workers in the EU is a strategic goal for the Commission according to its recent Communication on the EU Strategic Framework on Health and Safety at Work 2014 – 2020 (setting out an occupational health and safety strategy).

Occupational exposure limit values set under the Directive 2004/37/EC should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors.

IMPACT ASSESSMENT: as regards respirable crystalline silica dust, the option maintained is the one which includes the possibility of inclusion in Annex I to the Directive together with the establishment of a limit value for respirable crystalline silica dust (respirable fraction) in Annex III.

The limit values to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH).

According to the impact assessment, this is estimated to save around 100 000 lives by 2069 . As regards the impact on workers, this proposal should result in benefits in terms of preventing workers from getting avoidable work-related cancer, and thus preventing unnecessary suffering and illness. In addition, this proposal would also prevent unnecessary health costs , as follows:

respirable crystalline silica dust: the proposed limit value at 0.1 mg/m3 will provide for 99,000 avoided cancer cases by 2069 for a total monetized health benefit quantified between EUR 34 and 89 billion; hardwood dust: a limit value of 3 mg/m3 will provide for a total monetized health benefit between EUR 12 and 54 million; benefits are also expected in relation to introducing an exposure limit value at 0.025 mg/m3 for all chromium (VI) compounds.

CONTENT: the proposal seeks to revise the limit values in Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work and to revise or to introduce exposure limit values for 13 chemical agents. More specifically, it aims to:

include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The words ‘respirable crystalline silica dust’ used in Article 1 refer to the dust particles that reach the alveoli; establish in Annex III limit values for further 10 additional carcinogens : certain chromium compounds (VI); some refractory ceramic fibers; 1,2-epoxypropane, 1,3-butadiene, 2 nitropropane; Acrylamide; Bromoethylene; Chromium VI; Ethylene oxide; Hydrazine; o-toluidine. It is appropriate to establish a limit value for hydrazine and to assign to it a notation indicating the possibility of significant dermal uptake. A skin notation assigned to a limit value identifies the possibility of significant uptake through the skin; revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data.

This proposal leaves Member States the possibility to keep or set more favourable standards for workers and the flexibility to take into account specific features in their national situation.

The limit values set in this Directive will be kept under review in the light of the implementation of Regulation (EC) No 1907/2006 , in particular to take account of the interaction between limit values set out under Directive 2004/37/EC and DNELs (Derived No Effect Levels) derived for hazardous chemicals under that Regulation.

Documents

Documents

Activities

Votes

A8-0064/2017 - Marita Ulvskog - Am 54 25/10/2017 13:07:24.000

2017/10/25 Outcome: +: 540, 0: 119, -: 6
DE IT ES FR RO GB BE PT CZ SE EL NL BG PL DK AT IE HR FI SK HU SI LT LV LU EE MT CY
Total
79
60
49
63
31
65
21
20
20
19
16
24
15
46
12
16
10
11
10
10
19
8
8
8
6
6
6
5
icon: S&D S&D
176

Greece S&D

2

Netherlands S&D

3

Ireland S&D

For (1)

1

Croatia S&D

2

Slovenia S&D

For (1)

1

Latvia S&D

1

Luxembourg S&D

For (1)

1

Estonia S&D

For (1)

1

Malta S&D

3

Cyprus S&D

2
icon: PPE PPE
192

Sweden PPE

Against (1)

3

Denmark PPE

For (1)

1

Finland PPE

2

Luxembourg PPE

3

Estonia PPE

For (1)

1

Cyprus PPE

1
icon: ALDE ALDE
58

Germany ALDE

2

Romania ALDE

3

United Kingdom ALDE

1

Portugal ALDE

1

Denmark ALDE

2

Austria ALDE

For (1)

1

Ireland ALDE

For (1)

1

Croatia ALDE

2

Finland ALDE

2

Slovenia ALDE

For (1)

1
2

Latvia ALDE

1

Luxembourg ALDE

For (1)

1

Estonia ALDE

3
icon: GUE/NGL GUE/NGL
46

Italy GUE/NGL

2

Portugal GUE/NGL

3

Sweden GUE/NGL

For (1)

1

Netherlands GUE/NGL

3

Denmark GUE/NGL

For (1)

1

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2
icon: Verts/ALE Verts/ALE
44

Italy Verts/ALE

For (1)

1

Belgium Verts/ALE

2

Netherlands Verts/ALE

2

Denmark Verts/ALE

For (1)

1

Austria Verts/ALE

2

Croatia Verts/ALE

For (1)

1

Finland Verts/ALE

For (1)

1

Hungary Verts/ALE

2

Slovenia Verts/ALE

For (1)

1

Lithuania Verts/ALE

For (1)

1

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1

Estonia Verts/ALE

For (1)

1
icon: EFDD EFDD
34

Czechia EFDD

Abstain (1)

1

Sweden EFDD

2

Poland EFDD

1
icon: ECR ECR
66

Italy ECR

2

Romania ECR

For (1)

1

Czechia ECR

2

Greece ECR

For (1)

1

Netherlands ECR

2

Bulgaria ECR

2

Croatia ECR

Abstain (1)

1

Finland ECR

Abstain (1)

2

Slovakia ECR

Abstain (1)

2

Lithuania ECR

Abstain (1)

1

Latvia ECR

Abstain (1)

1
icon: NI NI
15

Germany NI

2

France NI

Abstain (1)

2

United Kingdom NI

Against (1)

Abstain (2)

3

Poland NI

2
icon: ENF ENF
32

Romania ENF

1

Belgium ENF

For (1)

1

Netherlands ENF

4

Poland ENF

Abstain (1)

1
AmendmentsDossier
287 2016/0130(COD)
2016/12/09 JURI 44 amendments...
source: 595.609
2017/01/10 ENVI 20 amendments...
source: 597.406
2017/01/11 ENVI 53 amendments...
source: 597.405
2017/01/12 EMPL 169 amendments...
source: 595.651
2017/01/18 ENVI 1 amendments...
source: 597.537

History

(these mark the time of scraping, not the official date of the change)

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EMPL
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committees/0
type
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EMPL
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  • date: 2017-02-28T00:00:00 body: unknown type: Committee decision to open interinstitutional negotiations with report adopted in committee
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  • date: 2017-08-30T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/commissions/empl/inag/2017/09-12/EMPL_AG(2017)610591_EN.pdf type: Approval in committee of the text agreed at 1st reading interinstitutional negotiations title: PE610.591 GEDA/A/(2017)008135 body: unknown type: Approval in committee of the text agreed at 1st reading interinstitutional negotiations
  • date: 2017-10-24T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20171024&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2017-10-25T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2017-0410 type: Decision by Parliament, 1st reading/single reading title: T8-0410/2017 body: EP type: Decision by Parliament, 1st reading/single reading
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  • body: CSL type: Council Meeting council: Employment, Social Policy, Health and Consumer Affairs meeting_id: 3583 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3583*&MEET_DATE=08/12/2017 date: 2017-12-08T00:00:00
  • body: CSL type: Council Meeting council: Employment, Social Policy, Health and Consumer Affairs meeting_id: 3475 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3475*&MEET_DATE=16/06/2016 date: 2016-06-16T00:00:00
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  • date: 2016-05-13T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2016:0152:FIN:EN:PDF title: EUR-Lex title: SWD(2016)0152 type: Document attached to the procedure body: EC
  • date: 2016-05-13T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2016:0153:FIN:EN:PDF title: EUR-Lex title: SWD(2016)0153 type: Document attached to the procedure body: EC
  • date: 2016-09-21T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:3439)(documentyear:2016)(documentlanguage:EN) title: CES3439/2016 type: Economic and Social Committee: opinion, report body: ESC
  • date: 2016-11-22T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE593.996 title: PE593.996 type: Committee draft report body: EP
  • date: 2017-01-12T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE595.651 title: PE595.651 type: Amendments tabled in committee body: EP
  • date: 2017-02-01T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE592.336&secondRef=02 title: PE592.336 committee: JURI type: Committee opinion body: EP
  • date: 2017-03-01T00:00:00 docs: title: PE599.603 type: Amendments tabled in committee body: EP
  • date: 2017-06-20T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE606.153 title: PE606.153 committee: JURI type: Specific opinion body: EP
  • date: 2017-07-11T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/commissions/empl/lcag/2017/07-11/EMPL_LA(2017)008135_EN.pdf title: GEDA/A/(2017)008135 type: Coreper letter confirming interinstitutional agreement body: CSL
  • date: 2017-12-06T00:00:00 docs: url: /oeil/spdoc.do?i=29283&j=0&l=en title: SP(2017)766 type: Commission response to text adopted in plenary
  • date: 2017-12-13T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F17&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 00045/2017/LEX type: Draft final act body: CSL
  • date: 2016-07-25T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2016)0248 title: COM(2016)0248 type: Contribution body: IT_SENATE
  • date: 2016-07-19T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2016)0248 title: COM(2016)0248 type: Contribution body: PT_PARLIAMENT
  • date: 2017-04-18T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2016)0248 title: COM(2016)0248 type: Contribution body: HR_PARLIAMENT
events
  • date: 2016-05-13T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2016/0248/COM_COM(2016)0248_EN.pdf title: COM(2016)0248 summary: PURPOSE: to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents. PROPOSED ACT: Directive of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Directive 2004/37/EC aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace and lays down minimum requirements to that effect including limit values, on the basis of the available scientific and technical data. The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP). Estimates of the recent and future burden of occupational diseases indicate that work-related cancer is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU . Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases. Ensuring a safe and healthy work environment for over 217 million workers in the EU is a strategic goal for the Commission according to its recent Communication on the EU Strategic Framework on Health and Safety at Work 2014 – 2020 (setting out an occupational health and safety strategy). Occupational exposure limit values set under the Directive 2004/37/EC should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors. IMPACT ASSESSMENT: as regards respirable crystalline silica dust, the option maintained is the one which includes the possibility of inclusion in Annex I to the Directive together with the establishment of a limit value for respirable crystalline silica dust (respirable fraction) in Annex III. The limit values to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH). According to the impact assessment, this is estimated to save around 100 000 lives by 2069 . As regards the impact on workers, this proposal should result in benefits in terms of preventing workers from getting avoidable work-related cancer, and thus preventing unnecessary suffering and illness. In addition, this proposal would also prevent unnecessary health costs , as follows: respirable crystalline silica dust: the proposed limit value at 0.1 mg/m3 will provide for 99,000 avoided cancer cases by 2069 for a total monetized health benefit quantified between EUR 34 and 89 billion; hardwood dust: a limit value of 3 mg/m3 will provide for a total monetized health benefit between EUR 12 and 54 million; benefits are also expected in relation to introducing an exposure limit value at 0.025 mg/m3 for all chromium (VI) compounds. CONTENT: the proposal seeks to revise the limit values in Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work and to revise or to introduce exposure limit values for 13 chemical agents. More specifically, it aims to: include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The words ‘respirable crystalline silica dust’ used in Article 1 refer to the dust particles that reach the alveoli; establish in Annex III limit values for further 10 additional carcinogens : certain chromium compounds (VI); some refractory ceramic fibers; 1,2-epoxypropane, 1,3-butadiene, 2 nitropropane; Acrylamide; Bromoethylene; Chromium VI; Ethylene oxide; Hydrazine; o-toluidine. It is appropriate to establish a limit value for hydrazine and to assign to it a notation indicating the possibility of significant dermal uptake. A skin notation assigned to a limit value identifies the possibility of significant uptake through the skin; revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data. This proposal leaves Member States the possibility to keep or set more favourable standards for workers and the flexibility to take into account specific features in their national situation. The limit values set in this Directive will be kept under review in the light of the implementation of Regulation (EC) No 1907/2006 , in particular to take account of the interaction between limit values set out under Directive 2004/37/EC and DNELs (Derived No Effect Levels) derived for hazardous chemicals under that Regulation.
  • date: 2016-05-25T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2016-06-16T00:00:00 type: Debate in Council body: CSL docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3475*&MEET_DATE=16/06/2016 title: 3475
  • date: 2017-02-28T00:00:00 type: Vote in committee, 1st reading/single reading body: EP
  • date: 2017-02-28T00:00:00 type: Committee decision to open interinstitutional negotiations with report adopted in committee body: EP
  • date: 2017-03-09T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2017-0064&language=EN title: A8-0064/2017 summary: The Committee on Employment and Social Affairs adopted the report by Marita ULVSKOG (S&D, SE) on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. The inclusions of reprotoxic substances : Members proposed broadening the scope of the Directive to allow for the inclusion of reprotoxic substances. They stressed that reprotoxic substances were of great concern and that the organisation of workplace prevention should be applied as for carcinogens and mutagens . The amended text clarifies that the requirements laid down in the Directive should be considered as minimum requirements, with Member States having the possibility of setting more stringent binding occupational exposure limits. It is essential to take the precautionary principle into account, especially where there are uncertainties as to the impact of dealing with substances and their mixtures on workers’ health or where available scientific and technical data is not sufficient. Limit values : the report introduced stricter limit values ​​for several substances: wood dust : Members do not wish to distinguish between hardwood dust and softwood dust. They consider that the limit value of 2 mg/m3 should constitute the EU's common limit value (the Commission proposed a limit value of 3 mg/m3 for hardwood dust); chromium VI : a limit value of 0.001 mg/m3 is proposed (instead of 0.025 mg/m3); respirable crystalline silica dust : a limit value of 0.05 mg/m3 is proposed (instead of 0.1 mg/m3). The Advisory Committee on Safety and Health at Work (ACSH) should also submit up-to-date opinions on the binding occupational exposure limits on respirable cristalline silica, hardwood dusts, acrylamide, 1,3-butadiene, chromium VI and refractory ceramic fibres. Health surveillance measures : Members considered that health surveillance should be provided for all workers exposed (i) prior to exposure; (ii) at regular intervals during the exposure period; (iii) after the end of the exposure and the end of their employment. Data collection : Members called on the Commission to: support best practices with regard to data collection between Member States and propose how data collection can be improved. The Member States should provide the Commission with information for the purposes of its reports on the implementation of Directive 2004/37/EC; develop a harmonised methodology for measuring workers' exposure to carcinogens, mutagens and reprotoxic substances at Union level.
  • date: 2017-08-30T00:00:00 type: Approval in committee of the text agreed at 1st reading interinstitutional negotiations body: EP docs: url: http://www.europarl.europa.eu/RegData/commissions/empl/inag/2017/09-12/EMPL_AG(2017)610591_EN.pdf title: PE610.591 url: http://www.europarl.europa.eu/RegData/commissions/empl/lcag/2017/07-11/EMPL_LA(2017)008135_EN.pdf title: GEDA/A/(2017)008135
  • date: 2017-10-24T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20171024&type=CRE title: Debate in Parliament
  • date: 2017-10-25T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=29283&l=en title: Results of vote in Parliament
  • date: 2017-10-25T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2017-0410 title: T8-0410/2017 summary: The European Parliament adopted by 540 votes to 6 with 119 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. To recall, the proposed directive aims to improve workplace conditions and protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. It introduces 11 carcinogenic substances to the current list of dangerous substances and revises the limit values for two substances that are already listed. Information for the competent authority : Directive 2004/37/EC provides that where the results of the risk assessment reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on: the activities and/or industrial processes carried out, including the reasons for which carcinogens or mutagens are used; the quantities of substances or preparations manufactured or used which contain carcinogens or mutagens; the number of workers exposed; the preventive measures taken; the type of protective equipment used; the nature and degree of exposure. The amended text provides that Member States shall take into account the above information in their reports submitted to the Commission under Council Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work. Health surveillance : Member States shall establish arrangements for carrying out relevant health surveillance of workers for whom the results of the risk assessment reveal a risk to health or safety. The doctor or authority responsible for the health surveillance of workers may indicate that health surveillance must continue after the end of exposure for as long as they consider it to be necessary to safeguard the health of the worker concerned. Furthermore, all cases of cancer identified in accordance with national law or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority. The amended text stresses that appropriate and consistent data collection by Member States from employers is necessary to ensure the safety and proper care of workers. Limit values for occupational exposure : Parliament revised the limit values for the following substances: hardwood dusts : there will be an exposure limit value of 3 mg/m3 for 5 years after the entry into force of the directive and thereafter a limit of 2 mg/m3 ; Chromium VI: there will be an exposure limit value of 0.010 mg/m3 for a period of 5 years after the date of transposition of the directive; after that period a limit of 0.005 mg/m3 will apply. Evaluation: the Commission shall, as part of the next evaluation of the implementation of the Directive, also evaluate the need to modify the limit value for respirable crystalline silica dust (set at 0.1mg/m3 in the amended text). The Commission shall propose, where appropriate, necessary amendments and modifications related to that substance. Parliament also required that by the first quarter of 2019, the Commission should assess the option of amending the scope of the Directive to include reprotoxic substances . On that basis, the Commission shall present, if appropriate, and after consulting management and labour, a legislative proposal. The text goes on to recall that in its opinion on refractory ceramic fibres , the Advisory Committee on Safety and Health at Work (ACSH) agreed that a binding occupational exposure limit value is necessary for this substance. The Commission should therefore encourage the ACSH to submit an up-to-date opinion on refractory ceramic fibres with a view to reaching a common position on the limit value for that substance.
  • date: 2017-12-08T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2017-12-12T00:00:00 type: Final act signed body: CSL
  • date: 2017-12-12T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2017-12-27T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to better protect workers from exposure to carcinogens or mutagens in their workplace. LEGISLATIVE ACT: Directive (EU) 2017/2398 of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. CONTENT: this Directive amending Directive 2004/37/EC improves workplace conditions and protects workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. It introduces 11 carcinogenic substances to the current list of dangerous substances and revises the limit values for two substances that are already listed. crystalline silica dust alveolar, 1,2-epoxypropane, 1,3-butadiene, 2-nitropropane, acrylamide, certain chromium (VI) compounds, ethylene oxide, o-toluidine, refractory ceramic fibres, bromoethylene and hydrazine. Health surveillance : the Member States shall establish, in accordance with national law or practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment reveal a risk to health or safety. The doctor or authority responsible for the health surveillance of workers may indicate that health surveillance must continue after the end of exposure for as long as they consider it to be necessary to safeguard the health of the worker concerned. All cases of cancer identified in accordance with national law or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority. Revision of the exposure limit values : the amending Directive revises the limit values ​​for the following substances: hardwood dust : the limit value for exposure is set at 3 mg/m3 until 17 January 2023 and at 2 mg/m3 thereafter. The distinction between hardwood and softwood dust should be further assessed as regards the limit value set out in that Annex, as recommended by Scientific Committee on Occupational Exposure Limits (SCOEL) and the International Agency for Research on Cancer; Chromium (VI) compounds which are carcinogens : the Directive provides an initial exposure limit value of 0.010 mg/m3 until 17 January 2025, after which this value will be lowered to 0.005 mg/m3. A derogation is provided for welding and plasma cutting processes or similar processes that generate fumes: the exposure limit value is fixed at 0.025 mg/m3 until 17 January 2025 and will then be 0.005 mg/m3. Reprotoxic substances : the Commission shall assess the possibility of including reprotoxic substances in the list of dangerous substances by the first quarter of 2019 . On this basis, it shall submit, if necessary, a legislative proposal, after consulting the social partners. Lastly, as part of the next evaluation of the implementation of the Directive, the Commission will have to evaluate the need to modify the limit value for respirable crystalline silica dust (set at 0.1 mg / m³ in the amending Directive). The Commission shall propose, if necessary, the necessary modifications relating to this substance. ENTRY INTO FORCE: 16.1.2017. TRANSPOSITON: by 17.1.2020. docs: title: Directive 2017/2398 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32017L2398 title: OJ L 345 27.12.2017, p. 0087 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:345:TOC
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  • 14/03/2017 Decision to enter into interinstitutional negotiations confirmed by plenary (Rule 69c)
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Directive 2017/2398
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  • Amending Directive 2004/37/EC 1999/0085(COD) See also 2017/0004(COD)
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  • 3.40.01 Chemical industry, fertilizers, plastics
  • 4.15.15 Health and safety at work, occupational medicine
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Chemical industry, fertilizers, plastics
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Health and safety at work, occupational medicine
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  • Amending Directive 2004/37/EC
  • See also
activities/8/docs/0/text
  • The European Parliament adopted by 540 votes to 6 with 119 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.

    To recall, the proposed directive aims to improve workplace conditions and protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. It introduces 11 carcinogenic substances to the current list of dangerous substances and revises the limit values for two substances that are already listed.

    Information for the competent authority: Directive 2004/37/EC provides that where the results of the risk assessment reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on:

    • the activities and/or industrial processes carried out, including the reasons for which carcinogens or mutagens are used;
    • the quantities of substances or preparations manufactured or used which contain carcinogens or mutagens;
    • the number of workers exposed; 
    • the preventive measures taken;
    • the type of protective equipment used;
    • the nature and degree of exposure.

    The amended text provides that Member States shall take into account the above information in their reports submitted to the Commission under Council Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work.

    Health surveillance: Member States shall establish arrangements for carrying out relevant health surveillance of workers for whom the results of the risk assessment reveal a risk to health or safety. The doctor or authority responsible for the health surveillance of workers may indicate that health surveillance must continue after the end of exposure for as long as they consider it to be necessary to safeguard the health of the worker concerned.

    Furthermore, all cases of cancer identified in accordance with national law or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority.

    The amended text stresses that appropriate and consistent data collection by Member States from employers is necessary to ensure the safety and proper care of workers. 

    Limit values for occupational exposure: Parliament revised the limit values for the following substances:

    • hardwood dusts: there will be an exposure limit value of 3 mg/m3 for 5 years after the entry into force of the directive and thereafter a limit of 2 mg/m3;
    • Chromium VI: there will be an exposure limit value of 0.010 mg/m3 for a period of 5 years after the date of transposition of the directive; after that period a limit of 0.005 mg/m3 will apply.

    Evaluation: the Commission shall, as part of the next evaluation of the implementation of the Directive, also evaluate the need to modify the limit value for respirable crystalline silica dust (set at 0.1mg/m3 in the amended text). The Commission shall propose, where appropriate, necessary amendments and modifications related to that substance.

    Parliament also required that by the first quarter of 2019, the Commission should assess the option of amending the scope of the Directive to include reprotoxic substances. On that basis, the Commission shall present, if appropriate, and after consulting management and labour, a legislative proposal.

    The text goes on to recall that in its opinion on refractory ceramic fibres, the Advisory Committee on Safety and Health at Work (ACSH) agreed that a binding occupational exposure limit value is necessary for this substance. The Commission should therefore encourage the ACSH to submit an up-to-date opinion on refractory ceramic fibres with a view to reaching a common position on the limit value for that substance.

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  • The Committee on Employment and Social Affairs adopted the report by Marita ULVSKOG (S&D, SE) on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.

    The inclusions of reprotoxic substances: Members proposed broadening the scope of the Directive to allow for the inclusion of reprotoxic substances. They stressed that reprotoxic substances were of great concern and that the organisation of workplace prevention should be applied as for carcinogens and mutagens.

    The amended text clarifies that the requirements laid down in the Directive should be considered as minimum requirements, with Member States having the possibility of setting more stringent binding occupational exposure limits.

    It is essential to take the precautionary principle into account, especially where there are uncertainties as to the impact of dealing with substances and their mixtures on workers’ health or where available scientific and technical data is not sufficient.

    Limit values: the report introduced stricter limit values ​​for several substances:

    • wood dust: Members do not wish to distinguish between hardwood dust and softwood dust. They consider that the limit value of 2 mg/m3 should constitute the EU's common limit value (the Commission proposed a limit value of 3 mg/m3 for hardwood dust);
    • chromium VI: a limit value of 0.001 mg/m3 is proposed (instead of 0.025 mg/m3);
    • respirable crystalline silica dust: a limit value of 0.05 mg/m3 is proposed (instead of 0.1 mg/m3).

    The Advisory Committee on Safety and Health at Work (ACSH) should also submit up-to-date opinions on the binding occupational exposure limits on respirable cristalline silica, hardwood dusts, acrylamide, 1,3-butadiene, chromium VI and refractory ceramic fibres.

    Health surveillance measures: Members considered that health surveillance should be provided for all workers exposed (i) prior to exposure; (ii) at regular intervals during the exposure period; (iii) after the end of the exposure and the end of their employment.

    Data collection: Members called on the Commission to:

    • support best practices with regard to data collection between Member States and propose how data collection can be improved. The Member States should provide the Commission with information for the purposes of its reports on the implementation of Directive 2004/37/EC;
    • develop a harmonised methodology for measuring workers' exposure to carcinogens, mutagens and reprotoxic substances at Union level.
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  • PURPOSE: to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents.

    PROPOSED ACT: Directive of the European Parliament and of the Council.

    ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

    BACKGROUND: Directive 2004/37/EC aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace and lays down minimum requirements to that effect including limit values, on the basis of the available scientific and technical data.

    The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP).

    Estimates of the recent and future  burden  of occupational  diseases indicate that work-related cancer  is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU. Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases.

    Ensuring a safe and healthy work environment for over 217 million workers in the EU is a strategic goal for the Commission according to its recent Communication on the EU Strategic Framework on Health and Safety at Work 2014 – 2020 (setting out an occupational health and safety strategy).

    Occupational exposure limit values set under the Directive 2004/37/EC should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors.

    IMPACT ASSESSMENT: as regards respirable crystalline silica dust, the option maintained is the one which includes the possibility of inclusion in Annex I to the Directive together with the establishment of a limit value for respirable crystalline silica dust (respirable fraction) in Annex III.

    The limit values to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH).

    According to the impact assessment, this is estimated to save around 100 000 lives by 2069. As regards the impact on workers, this proposal should result in benefits in terms of preventing workers from getting avoidable work-related cancer, and thus preventing unnecessary suffering and illness. In addition, this proposal would also prevent unnecessary health costs, as follows: 

    • respirable crystalline silica dust: the proposed limit value at 0.1 mg/m3 will provide for 99,000 avoided cancer cases by 2069 for a total monetized health benefit quantified between EUR 34 and 89 billion;
    • hardwood dust: a limit value of 3 mg/m3 will provide for a total monetized health benefit between EUR 12 and 54 million; benefits are also expected in relation to introducing an exposure limit value at 0.025 mg/m3 for all chromium (VI) compounds.

    CONTENT: the proposal seeks to revise the limit values in Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work and to revise or to introduce exposure limit values for 13 chemical agents. More specifically, it aims to:

    • include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The words ‘respirable crystalline silica dust’ used in Article 1 refer to the dust particles that reach the alveoli;
    • establish in Annex III limit values for further 10 additional carcinogens: certain chromium compounds (VI); some refractory ceramic fibers; 1,2-epoxypropane, 1,3-butadiene, 2 nitropropane; Acrylamide; Bromoethylene; Chromium VI; Ethylene oxide; Hydrazine; o-toluidine. It is appropriate to establish a limit value for hydrazine and to assign to it a notation indicating the possibility of significant dermal uptake. A skin notation assigned to a limit value identifies the possibility of significant uptake through the skin;
    • revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data.

    This proposal leaves Member States the possibility to keep or set more favourable standards for workers and the flexibility to take into account specific features in their national situation.

    The limit values set in this Directive will be kept under review in the light of the implementation of Regulation (EC) No 1907/2006, in particular to take account of the interaction between limit values set out under Directive 2004/37/EC and DNELs (Derived No Effect Levels) derived for hazardous chemicals under that Regulation.

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