Article 18a / Evaluation

The Commission shall, as part of the next evaluation of the implementation of this Directive in the context of the evaluation referred to in Article 17a of Directive 89/391/EEC, also evaluate the need to modify the limit value for respirable crystalline silica dust. The Commission shall launch this process in 2022 and, where appropriate, shall subsequently propose necessary amendments and modifications related to that substance in a subsequent revision of this Directive.

No later than 11 July 2022, the Commission shall assess the option of amending this Directive to add provisions on a combination of an airborne occupational exposure limit and a biological limit value for cadmium and its inorganic compounds.

No later than 31 December 2022, where appropriate, after consulting the Advisory Committee for Safety and Health at Work (ACSH) and taking into account the existing recommendations of different agencies, stakeholders and the World Health Organization, on priority carcinogens, mutagens and reprotoxic substances for which limit values are needed, the Commission shall present an action plan to achieve new or revised occupational exposure limits values for at least 25 substances, groups of substances or process-generated substances. Where appropriate, taking into account that action plan, the latest developments in scientific knowledge, and after consulting the ACSH, the Commission shall present legislative proposals pursuant to Article 16 without delay.

Where appropriate and no later than 5 April 2025, taking into account the latest developments in scientific knowledge and after appropriate consultation of relevant stakeholders, the Commission shall develop a definition and establish an indicative list of hazardous medicinal products or the substances contained therein, which meet the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008, a mutagen or a reprotoxic substance.

No later than 31 December 2022, the Commission shall, after appropriate consultation of relevant stakeholders, prepare Union guidelines for the preparation, administration, and disposal of hazardous medicinal products at the place of work. Those guidelines shall be published on the website of EU-OSHA and shall be disseminated in all Member States by the relevant competent authorities.

Where appropriate, after receipt of an opinion from the ACSH, the Commission shall, taking into account the existing methodology for setting limit values for carcinogens in some Member States and the opinion of the ACSH, establish upper and lower risk levels. No later than 12 months after receipt of the ACSH opinion, the Commission shall, after appropriate consultation of relevant stakeholders, prepare Union guidelines on the methodology establishing risk-based limit values. Those guidelines shall be published on the EU-OSHA website and disseminated in all Member States by the relevant competent authorities.

No later than 31 December 2024, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation of relevant stakeholders, propose, where appropriate, a limit value for cobalt and inorganic cobalt compounds.

No later than 30 June 2024, the Commission shall initiate an assessment of the effects of exposure to a combination of substances with a view to preparing Union guidelines thereon where appropriate. The Commission shall take into account the latest developments in scientific knowledge, the opinion of the Committee for Risk Assessment of the European Chemicals Agency established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 4 ), the opinion of the ACSH and the best practices in the Member States, and shall conduct appropriate consultations of relevant stakeholders. Those guidelines shall be published on the EU-OSHA website and disseminated in all Member States by the relevant competent authorities.

No later than 9 April 2026, the Commission shall initiate the procedure to obtain a scientific assessment of endocrine disruptors that can affect the health and safety of workers, with a view to evaluating the appropriateness of including them within the scope of this Directive in order to better protect the health and safety of workers. Where appropriate the Commission shall, after consulting the ACSH, submit a legislative proposal.

In the context of its evaluation pursuant to Article 17a(4) of Directive 89/391/EEC, the Commission shall, no later than 9 April 2029, assess the occupational limit values for lead and its inorganic compounds. Where appropriate, the Commission shall, taking into account the latest developments in scientific knowledge and after consulting the ACSH, submit a legislative proposal to amend those limit values.

No later than 9 April 2026, the Commission shall, after appropriate consultation of relevant stakeholders, draw up Union guidelines for health surveillance, including biological monitoring. Those guidelines shall include advice on the implementation of provisions regarding blood lead level, taking into account the slow removal of lead from the body and the special protection of female workers of childbearing age.