What changed between the draft committee report and the plenary report

Directive 2004/37/EC

Change 11

Removed:Article 1 – paragraph 1 – point -1 d (new), Article 18a – point 7: (-1d) in Article 18a, point 7 is replaced by the following: / ‘7. No later than ... [four years after the date of entry into force of this amending Directive], the Commission shall, taking into account the latest developments in scientific knowledge, evaluate the limit value for cobalt and inorganic cobalt compounds by carrying out a new impact assessment taking into account evolving geopolitical realities and the Union's strategic independence, while preserving the highest possible protection for exposed workers. Where appropriate, the Commission shall, in consultation with relevant stakeholders, including the social partners, submit a legislative proposal to lower that limit value.’;

Added:Article 1 – paragraph 1 – point -1 d (new), Article 2 – paragraph 1 – point ba: (-1d) in Article 2, 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 point 9 of Annex I to this Directive as well as a substance or mixture released by a process referred to in that point, where it has reprotoxic effects;’

Removed:(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004L0037-20240408)

Added:(32004L0037 (Document 02004L0037-20240408))

Directive 2004/37/EC

Change 12

Removed:Annex – paragraph 1 – point -1 (new), Annex I – title: (-1) in Annex I, the title is replaced by the following: / 'List of substances, mixtures and processes (Article 2, points (a)(ii), (b)(ii) and (ba)(ii))’;

Added:Article 1 – paragraph 1 – point -1 e (new), Article 2 – paragraph 1 – point e a (new): (-1e) in Article 2, the following point is added. / ‘(ea) “hazardous medicinal products” means medicinal products that contain one or more substances that meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic as set out in Annex I to Regulation (EC) No 1272/2008.’

Directive 2004/37/EC

Change 13

Removed:Annex – paragraph 1 – point 1, Annex I – point 9: 9. Work involving exposure to fumes from welding and from processes that generate fumes in a similar way, containing substances that meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/20081;

Added:Article 1 – paragraph 1 – point -1 f (new), Article 2 – paragraph 1 – point e b (new): (-1f) in Article 2, the following point is added: / '(eb) “medicinal products” means medicinal products as defined in Article 1 paragraph 2 of Directive 2001/83/EC.’

Directive 2004/37/EC

Change 14

Added:Article 1 – paragraph 1 – point -1 g (new), Article 5 – paragraph 5 – subparagraph 1 a (new): (-1g) in Article 5(5), the following subparagraph is added: / ‘Individual protection measures as referred to in point (g) shall include personal protective equipment (PPE), in particular respiratory protective devices, where, despite putting in place the technical and organisational measures for prevention or reduce exposure in accordance with this Article, residual exposure cannot be reduced to levels below the limit values set out in Annex III. In such cases, compliance with the limit values shall be determined taking into account the protection afforded by PPE. PPE shall be correctly maintained, selected and adjusted to fit the wearer, including by means of individual fitting, in accordance with Article 4 of Council Directive 89/656/EEC.’

Directive 2004/37/EC

Change 15

Added:Article 1 – paragraph 1 – point -1 h (new), Article 10 – paragraph 2 a (new): (-1h) in Article 10, the following paragraph is added: / ‘2a. When wearing personal protective equipment, workers shall be entitled to regular breaks of an appropriate duration in an area where there is no risk of contamination by carcinogens, mutagens or reprotoxic substances.’

Directive 2004/37/EC

Change 16

Removed:Annex – paragraph 1 – point 3, Annex IIIa: The binding biological limit value is 45 mg HEAA*in urine/g creatinine, measured at the end of exposure or shift.'

Added:Article 1 – paragraph 1 – point -1 i (new), Article 11 – paragraph 1 – subparagraph 1 – point a: (-1i) in Article 11(1), subparagraph 1, point (a) is replaced by the following: / ‘ a) potential risks to health, including the additional risks due to tobacco consumption and the existence of residual risks linked to binding limit values listed in Annex III, with reference to information published by EU OSHA, where available;’

Added:Directive 2004/37/EC

Added:Article 1 – paragraph 1 – point -1 j (new), Article 18a – paragraph 11 a (new): (-1j) in Article 18a, the following paragraph is added: / ‘11a. No later than ... [12 months after the entry into force of this directive] and taking into consideration the recent classification by the World Health Organization of occupational exposure in certain occupations as carcinogenic, the Commission shall begin a consultation with the ACSH on the need to update Commission Recommendation (EU) 2022/2337, with a view to encouraging Member States to introduce provisions ensuring more adequate compensation for diseases suspected of being linked to occupational exposure in certain professions.’

Added:Directive 2004/37/EC

Added:Article 1 – paragraph 1 – point -1 k (new), Article 18a – paragraph 11 b (new): (-1k) in Article 18a, the following paragraph is added: / ‘11b. The Commission’s proposal shall include ‘work involving exposure to aircraft engine emissions’ in Annex I of Directive 2004/37/EC.’

Added:Directive 2004/37/EC

Added:Article 1 – paragraph 1 – point -1 l (new), Article 18a – paragraph11 c (new): (-1l) in Article 18a, the following paragraph is added: / ‘11c. No later than ... [3 years after the entry into force of this amending directive], the Commission shall, taking into account the latest developments in scientific knowledge, the opinion of RAC and after appropriate consultation with relevant stakeholders, propose, where appropriate, limit value(s) for welding fumes as defined in Annex I to Directive 2004/37/EC.’

Added:Directive 2004/37/EC

Added:Article 1 – paragraph 1 – point -1 m (new), Article 18a – paragraph 11d (new): (-1m) in Article 18a, the following paragraph is added: / '11d. Where the Commission submits a legislative proposal amending the occupational exposure limit values set out in this Directive, it shall take into account any opinions of the Committee for Risk Assessment of the European Chemicals Agency established by Regulation (EC) No 1907/2006 and the opinions of the ACSH, as appropriate. In the absence of any such opinion, the Commission shall set out, in its proposal, the reasons underpinning it, on the basis of scientific evidence.'

Added:Article 2 – paragraph 1: Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by no later than … [two years after its entry into force]. They shall immediately inform the Commission thereof.

Added:Directive 2004/37/EC

Added:Annex – paragraph 1 – point -1 (new), Annex I – title: (-1) in Annex I, the title is replaced by the following: / ‘List of substances, mixtures and processes (Article 2, point (a)(ii) and (iii), point (b)(ii) and point (iii) and (ba)(ii))’

Added:(32004L0037 (Document 02004L0037-20240408))

Added:Directive 2004/37/EC

Added:Annex II – paragraph 1 – point 1, Annex I – point 9: 9. Work involving exposure to welding fumes and fumes from other processes that generate fumes in a similar way, containing substances or mixtures that meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/20081 ;

Added:Directive 2004/37/EC

Added:Annex – paragraph 1 – point 1, Annex I – point 9 a (new): 9a. Work involving exposure to hazardous medicinal products containing substances that meet the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic as set out in Annex I to Regulation (EC) No 1272/2008.

Added:Directive 2004/37/EC

Added:1 Exposure shall not exceed the limit value of a carcinogen, mutagen or a reprotoxic substance as set out in Annex III when those substances are released during the welding process.

Added:Directive 2004/37/EC

Added:Directive 2004/37/EC

Added:Directive 2004/37/EC

Added:Annex II – paragraph 1 – point 3, Annex IIIa: The binding biological limit value is 45 mg HEAA*in urine/g creatinine, measured at the end of exposure or shift.’