Changes from report parliamentary committee draft to plenary report

Change 7

RemovedAnnex I concerns all hazardous substances covered in this directive, including ‘mutagens’.

Directive 2004/37/EC

Change 8

ChangedArticle 2 – paragraph -11 – point 2 (new), Article 2 –point– point ba: (2) in Article 2(1), point (ba) is replaced by the following: / "(ba) ‘reprotoxic substance’ means: / (i) a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008; / (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex;"Annex; "

Change 9

RemovedAnnex I concerns all hazardous substances covered in this directive, including ‘reprotoxic substances’

Directive 2004/37/EC

Change 10

ChangedArticle 2 – paragraph -11 – point 3 (new), Article 2 ––– point e a (new): (3) in Article 2(1), the following point is added: / “(ea) 'hazardous medicinal products’ or HMP’‘HMP’ means medicinal products that contain one or more substances that meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008.”1272/2008.”;

Change 11

RemovedThis definition is used the European Commission “Guidance for the safe management of hazardous medicinal products at work. Source: https://ec.europa.eu/social/main.jsp?langId=en&catId=89&furtherNews=yes&newsId=10564&pk_source=newsletter&pk_medium=email&pk_campaign=eu_social_newsletter

Directive 2004/37/EC

Change 12

ChangedArticle 2 – paragraph -11 – point 4 (new), Article 5 – paragraph 4 a (new):4: (4) in Article 5, the following paragraph 4a4 is inserted: / “4a.replaced Inby the case of exposure tofollowing: a/ combination“4. ofExposure substancesshall actingnot byexceed the samelimit modevalue of action or at the samea targetcarcinogen, cellmutagen or tissue,a thereprotoxic implementationsubstance ofas theset possibleout limitin valuesAnnex ofIII. thoseBiological substanceslevels shall be adaptednot toexceed takethe intobiological accountlimit thevalue combinedfor effectsa incarcinogen, accordancemutagen withor Uniona guidelinesreprotoxic tosubstance beas developedset pursuantout toin ArticleAnnex 18a.”IIIa.”

Change 13

RemovedThis amendment was put forward in the European Parliament report 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 of 7 April 2021 (CMD4). Source: https://www.europarl.europa.eu/doceo/document/A-9-2021-0114_EN.pdf

Directive 2004/37/EC

Change 14

ChangedArticle 2 – paragraph - 1 – point 5 (new), Article 5 – paragraph 54 a (new): (5) in Article 5, the following paragraph is added: / “5a.“4a. BiologicalIn levelsthe shallcase notof exceedexposure to a combination of substances acting by the biologicalsame limitmode valueof foraction aor carcinogen,at mutagenthe same target cell or atissue, reprotoxicthe substanceimplementation setof outthe possible limit values of those substances shall be adapted to take into account the combined effects of such substances in Annexaccordance IIIa.”with Union guidelines, pursuant to Article 18a, paragraph 7a.”;

Directive 2004/37/EC

Change 15

ChangedArticle 2 – paragraph -11 – point 6 (new), Article 18a – paragraph 7 a (new):7: (6) in Article 18a, the following paragraph is added: / “By ...7 [oneis yearreplaced afterby the date offollowing: entry/ into“No forcelater ofthan this31 amendingDecember Directive],2023, the Commission shall, taking into account the latest developments in scientific knowledge and the opinionafter ofconsulting the Committee forACSH, Risktaking Assessmentinto ofaccount the European Chemicals Agency established by Regulation (EC)RAC’s No2018 1907/2006,opinion and after appropriate consultation of relevant stakeholders, prepare Union guidelines on how the implementation of the limit values referred to in Article 5(4) and 5(4b) are to belatest adapteddevelopments in thescientific caseknowledge, ofwhere exposureappropriate, tosubmit a combination of substances. Thoselegislative guidelinesproposal shallto beintroduce publisheda onlimit thevalue EU-OSHAfor websitecobalt and shall be disseminated in all Member States by the relevantinorganic competentcobalt authorities.”compounds.”;

Change 16

RemovedThis amendment was put forward in the European Parliament report 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 of 7 April 2021 (CMD4). Source: https://www.europarl.europa.eu/doceo/document/A-9-2021-0114_EN.pdf

Directive 2004/37/EC

Change 17

ChangedArticle 2 – paragraph -11 – point 7 (new), Article 18a – paragraph 7 ba (new): (7) in Article 18a, the following paragraph is added: / “By ... [x[one monthsyear after the date of entry into force of this amending directive],Directive], the Commission shallshall, reviewtaking into account the implementationlatest developments in scientific knowledge and the opinion of thisthe Directive.Committee Infor Risk Assessment of the contextEuropean Chemicals Agency established by Regulation (EC) No 1907/2006, and after appropriate consultation of thatrelevant review,stakeholders, itsprepare shallUnion considerguidelines whetheron furtherhow amendmentsthe implementation of the limit values referred to thisin DirectiveArticle 5(4a) are appropriate,to shallbe assessadapted in the feasibilitycase of includingexposure endocrineto disruptersa withincombination theof scopesubstances. ofThose thisguidelines Directiveshall and,be wherepublished appropriate,on the EU-OSHA website and shall presentbe adisseminated legislativein proposal.”all Member States by the relevant competent authorities.”;

Directive 2004/37/EC

Change 18

ChangedArticle 2 – paragraph -11 – point 8 (new), Article 18a – paragraphpoint 7 cb (new): (8) in Article 18a, the following paragraph is added: / “By ... [twelve[12 months after the date of entry into force of this amending Directive],directive], the Commission shall,shall afterreview consultingthe implementation of this Directive. In the ACSH,context developof athat definitionreview, it shall consider whether further amendments to this Directive are appropriate, shall assess the feasibility of ‘carcinogenicincluding occupations’.endocrine Adisrupters non-exhaustivewithin listthe scope of suchthis occupationsDirective shalland beshall, annexedwhere appropriate, submit to thisthe Directive.”European Parliament and to the Council a legislative proposal.”;

Directive 2004/37/EC

Change 19

ChangedArticle 2 – paragraph -11 – point 9 (new), Article 18a – paragraph 7 dc (new): (9) in Article 18a, the following paragraph is added: / “By ...‘By... [twelve[five monthsyears after the date of entry into force of this amending Directive],directive] theand Commissionevery shall,five afteryears consultingthereafter, the ACSH,Commission developshall guidelinesreview asthe regardsOccupational historicalExposure occupationalLimit exposureValue toand lead,the inBiological particularLimit Values including the protectionlimit andvalue reductionfor ofhistorical exposure and the guidance value for female workers whoseof blood-levelchildbearing levelsage, arelaid abovedown thein biologicalAnnex limitIII value.and ThoseIIIa, guidelinestaking shallinto beaccount publishedthe negative impacts on the EU-OSHAreproductive websitecapacity andof shallfemale beworkers disseminatedof childbearing age as well as on foetal development in order to ensure equal protection for all Memberworkers Statesregardless byof their gender as well as taking into account up-to-date scientific data and the relevantclassification competentof authorities.”lead as a non-threshold reprotoxic.’

Change 20

AddedDirective 2004/37/EC

AddedArticle 2 – paragraph 1 – point 10 (new), Article 18a – paragraph 7 d (new): (10) in Article 18a, the following paragraph is added: / “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the Advisory Committee for Safety and Health at Work (ACSH), develop a definition of ‘carcinogenic occupations’ and assess the appropriateness to include such occupations in the scope of this Directive.”;

AddedDirective 2004/37/EC

AddedArticle 2 – paragraph 1 – point 11 (new), Article 18a – paragraph 7 e (new): (11) in Article 18a, the following paragraph is added: / “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, after consulting the ACSH, develop guidelines as regards historical occupational exposure to lead with a view to increasing the protection and reduction of the exposure of workers whose blood-lead levels are above the biological limit value as well as to further protect female workers of childbearing age. Those guidelines shall be published on the EU-OSHA website and shall be disseminated in all Member States by the relevant competent authorities.”

AddedDirective 2004/37/EC

AddedArticle 2 – paragraph 1 – point 12 (new), Article 18a – paragraph 7 f (new): (12) in Article 18a, the following paragraph is added: / “By [one year after the entry into force of this Directive], the Commission shall, after consulting the ACSH and taking into account existing recommendations made by relevant agencies, stakeholders and the World Health Organization with regard to priority carcinogens, mutagens and reprotoxic substances for which limit values are needed, revise its action plan to achieve occupational exposure limits values for substances, or groups of substances or process-generated substances additional to those referred to in this Directive. This shall in particular include lithium and lithium compounds, methyl hydrazine, 1,3-propanesultone, welding fumes and leather dust. By [two years after the entry into force of this Directive], the Commission shall, taking into account that revised action plan to achieve limit values for additional substances or group of substances or process-generated substances, the latest developments in scientific knowledge, and after consulting the ACSH, submit to the European Parliament and the Council, where appropriate, a legislative proposal.”;

AddedDirective 2004/37/EC

AddedArticle 2 – paragraph 1 – point 13 (new), Article 18a – paragraph 7 g (new): (13) in Article 18a, the following paragraph is added: / “By ... [twelve months after the date of entry into force of this amending Directive], the Commission shall, in consultation with social partners, consider targeted and limited exemptions for cultural and heritage-related work activities to existing Occupational Exposure Limit Values and Biological Limit Values, and take appropriate action.”

AddedDirective 2004/37/EC

AddedArticle 2 – paragraph 1 – point 14 (new), Article 18a – paragraph 7 h (new): (14) in Article 18a, the following paragraph is added: / “By 1 January 2028, the Commission shall, taking into account the RAC’s 2018 opinion and the latest developments in scientific knowledge, assess the feasibility of a further reduction of the limit value for benzene and shall, by 1 January 2030, where appropriate, submit to the European Parliament and the Council the necessary legislative amendments to this Directive.”;

Article 2 – paragraph 1: Annexes I, III and IIIa to Directive 2004/37/EC are amended in accordance with Annex II to this Directive.

Directive 98/24/EC

Annex II – introductory wording: Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:

Change 21

RemovedAnnex I concerns all hazardous substances covered in this directive, including ‘mutagens’ and ‘reprotoxic substances’

Directive 2004/37/EC

Change 22

ChangedAnnex II – point -1 a (new), Annex I – title: (-1) in Annex I, the title is amended as follows: / "List of substances, preparations and processes / (Article 2(a)(ii), 2(b)(ii), 2(ba)(ii))”2(ba)(ii))”;

Change 23

RemovedAnnex I concerns all hazardous substances covered in this directive, including ‘mutagens’ and ‘reprotoxic substances’

Directive 2004/37/EC

Change 24

ChangedAnnex II – point -1 a (new), Annex I – point 8 a (new): (-1a) in Annex I, the following point is added: / “8 a.“8a. Work involving exposure to hazardous medicinal products.”products.”;

Directive 2004/37/EC

Directive 2004/37/EC

Change 25

ChangedAnnex II – point 2, Annex IIIa: 4.5 μgLead Pb/100and mlits bloodinorganic (1)compounds / MedicalIf surveillancethe isresults carriedof outthe ifmedical exposuresurveillance toreveal a concentration ofblood-lead leadlevel inof aira isworker greater than 0,00230 mg/m3,μg calculatedPb/100 asml ablood, time-weightedthe averageemployer overand 40the hoursauthority perresponsible week,for orthe ahealth blood-leadsurveillance levelof greaterthat thanworker 2.7shall μgensure Pb/100that mlthe bloodworker is measuredno longer exposed to lead in individualaccordance workers.with the guidelines developed pursuant to Article 18a. / If the results of the medical surveillance reveal a blood-lead level of a worker greaterbetween than15-30 theμg biologicalPb/100 ml blood and if a declining trend towards the limit value duein toforce historicalis occupationalestablished, then that worker may continue working with tasks that involve exposure to lead,lead. the/ employerSpecific measures, shall be put in place with regard to risk management, including specific and theregular authorityhealth responsiblesurveillance, high standards for thepersonal healthprotective surveillanceequipment ofand thatregular workerblood-lead shallchecks. takeUnder the necessarygeneral measuresrequirement of Directive 2004/37/EC, employers are obliged to ensure athe decreasesubstitution of the worker’ssubstances blood-leadwhen technically possible, the use of closed systems, or the reduction of exposure to as low as technically possible. / Medical surveillance is carried out regularly for all workers exposed to lead and its inorganic compounds. / (1) It is recommended that the blood lead level in accordancefemale withworkers of childbearing age does not exceed the guidelinesreference developedvalues pusuantof the general population not occupationally exposed to Articlelead 18a.in /the (deleted)respective EU Member State. When national reference levels are not available, it is recommended that blood lead leve…