DRAFT OPINION. EN United in diversity EN. European Parliament 2016/0130(COD)

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1 European Parliament Committee on the Environment, Public Health and Food Safety /0130(COD) DRAFT OPINION of the Committee on the Environment, Public Health and Food Safety for the Committee on Employment and Social Affairs on the proposal for a Directive of the European Parliament and of the Council amending on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (COM(2016)0248 C8-0181/ /0130(COD)) Rapporteur: Joëlle Mélin PA\ docx PE v01-00 United in diversity

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3 SHORT JUSTIFICATION Justification for the role of the European Union The proposal for a Directive of the European Parliament and of the Council amending is needed, even from the point of view of those who advocate subsidiarity in the field of social protection. Its purpose is to protect workers against the risks presented by carcinogenic and mutagenic products. In our view, international conventions or other instruments could perfectly well have played the role that this directive is intended to play. But it is clear that this is an urgent matter, as the mobility of workers in the various Member States renders them subject to regulations which are in some cases inconsistent for a given trade or exposure. It is therefore in the interest of everyone employees, employers and States guaranteeing their social protection systems that recommendations based on state-ofthe-art science should be universally accepted as soon as possible. Substantiation of the requisite prudence concerning the subject A directive on this subject should not be binding, and should not impose excessively short deadlines. It should merely provide an incentive, enabling businesses to comply with the standards as quickly as possible but, despite everything, taking account of economic realities in each Member State. Similarly, it is not possible to impose coercive rules in the absence of precise research validated by the majority of researchers. But, on the other hand, a particular feature of occupational diseases is the very long time lag, as long as 10 to 40 years, between exposure through inhalation or any other contact to a carcinogen or mutagen and unequivocal diagnosis of the disease. As the most recent Directive dates from 2004, there is therefore an urgent need to revise the list of toxic agents and exposure rates. Moreover, in the 1970s mining, metallurgy and industrial operations boomed: there are therefore very large numbers of workers who as well as, indirectly, their families were exposed to numerous agents. An additional issue, incidentally, is the concept of cancers caused by multiple agents, which is already beginning to complicate legislation. Justification for a strategy Accordingly, in order to be logical and effective, harmonisation, whose sole purpose is to apply the precautionary principle, should entail various actions in succession: 1. Determination by Member States of the substances or groups of substances which definitely and directly cause cancer. 2. Adoption of the list of types of work entailing exposure to inhalation or any other form of contact with the substance. 3. The minimum period of exposure to the product and the time lags before an occupational disease appears. 4. Maximum rates of exposure. These are already very amply codified in France s legislation on recognised occupational diseases. The tables concerned are very complete, and it would be appropriate to use them as PA\ docx 3/13 PE v01-00

4 one of the technical bases for harmonisation of the recommendations adopted by each Member State if the latter do not already have equivalent provisions. Justification for the drafting of this opinion The rapporteur is therefore happy to include in her opinion the new substances which crossover studies have demonstrated to be carcinogenic, and for which those studies have also provided assessments or reassessments of their toxicity rates in the short, medium and long term. But the rapporteur adds a list of products which at least one Member State has defined by legislation or regulation as being directly and unequivocally responsible for cancers. The rapporteur therefore includes the complementary concept of monitoring, and hopes that each Member State will arrange for such increased monitoring, if it has not already done so, pending the setting at national level of maximum exposure rates. AMDMTS The Committee on the Environment, Public Health and Food Safety calls on the Committee on Employment and Social Affairs, as the committee responsible, to take into account the following amendments: 1 Recital 17 a (new) (17a) Chromic acid and alkaline or alkaline-earth chromates and dichromates, and zinc chromate, meet the criteria for classification as carcinogens in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance of primary bronchopulmonary cancers and cancers of the nasal cavities. These substances should therefore be subject to regular monitoring and evaluation, at least every two years; PE v /13 PA\ docx

5 2 Recital 17 b (new) (17b) The following aromatic amines and their salts: 4-aminobiphenyl and salts (xenylamine); 4,4 -diaminobiphenyl and salts (benzidine); 2-naphtylamine and salts; 4,4 -methylene bis (2-chloroaniline) and salts (MBOCA); 3,3 dimethoxybenzidine and salts (odianisidine); 3,3 dimethylbenzidine and salts (o-tolidine); 4-chloro-2- methylaniline and salts (p-chloro-otoluidine); auramine (technical grade); and the following benzidine-based dyes: CI direct black 38, CI direct blue 6 and CI direct brown 95 meet the criteria for classification as carcinogens in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance of cancers of the bladder and urinary tract. These substances should therefore be subject to regular monitoring and evaluation, at least every two years; 3 Recital 17 c (new) (17c) Arsenic, inhalation of cobalt dust or vapour and inhalation of dust or vapours containing gold-bearing arsenopyrites meet the criteria for classification as carcinogens in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance PA\ docx 5/13 PE v01-00

6 of angiosarcoma of the liver, primary bronchopulmonary cancers and skin cancers. These substances should therefore be subject to regular monitoring and evaluation, at least every two years; 4 Recital 17 d (new) (17d) The following petroleum products: unrefined or less refined mineral oils and regenerated mineral oils used in operations to machine and treat metals, aromatic extracts, cracking residues, used engine oils and soot from the combustion of petroleum products meet the criteria for classification as carcinogens in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance of skin cancers. These substances should therefore be subject to regular monitoring and evaluation, at least every two years; 5 Recital 17 e (new) (17e) Formaldehyde meets the criteria for classification as a carcinogen in the labour legislation of at least one Member State. That legislation has recognised that this agent is responsible for the PE v /13 PA\ docx

7 appearance of cancers of the nasopharynx. This substance should therefore be subject to regular monitoring and evaluation, at least every two years; 6 Recital 17 f (new) (17f) Hepatitis A, B, C, D and E viruses meet the criteria for classification as carcinogens in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance of liver cancers. These substances should therefore be subject to regular monitoring and evaluation, at least every two years; 7 Recital 17 g (new) (17g) Dust or smoke containing cadmium meet the criteria for classification as carcinogens in the labour legislation of at least one Member State; that legislation has recognised that these agents are responsible for the appearance of primary bronchopulmonary cancers. These substances should therefore be subject to regular monitoring and evaluation, at least every two years; PA\ docx 7/13 PE v01-00

8 8 Recital 17 h (new) (17h) Inhalation of cobalt dust associated with tungsten carbide before sintering meets the criteria for classification as a carcinogen in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance of primary bronchopulmonary cancers. This substance should therefore be subject to regular monitoring and evaluation, at least every two years; 9 Recital 17 i (new) (17i) Bis (chloromethyl) ether meets the criteria for classification as a carcinogen in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance of primary bronchopulmonary cancers. This substance should therefore be subject to regular monitoring and evaluation, at least every two years; PE v /13 PA\ docx

9 10 Recital 17 j (new) (17i) One or other of the following agents: N-methyl N nitro N- nitrosoguanidine; N-ethyl N nitro N- nitrosoguanidine; N-methyl N- nitrosourea; N-ethyl N-nitrosourea meets the criteria for classification as a carcinogen in the labour legislation of at least one Member State. That legislation has recognised that these agents are responsible for the appearance of brain tumours. These substances should therefore be subject to regular monitoring and evaluation, at least every two years; 11 Annex I point 6 a (new) 6a. Work entailing exposure to chromic acid and alkaline or alkalineearth chromates and dichromates, and zinc chromate. 12 Annex I point 6 b (new) PA\ docx 9/13 PE v01-00

10 6b. Work entailing exposure to the following aromatic amines and their salts: 4-aminobiphenyl and salts (xenylamine); 4,4 -diaminobiphenyl and salts (benzidine); 2-naphtylamine and salts; 4,4 -methylene bis (2-chloroaniline) and salts (MBOCA); 3,3 dimethoxybenzidine and salts (o-dianisidine); 3,3 dimethylbenzidine and salts (otolidine); 4-chloro-2-methylaniline and salts (p-chloro-o-toluidine); auramine (technical grade); the following benzidine-based dyes: CI direct black 38, CI direct blue 6, CI direct brown Annex I point 6 c (new) 6c. Work entailing exposure to arsenic, inhalation of arsenic dust or vapours, inhalation of dust or vapours containing gold-bearing arsenopyrites. 14 Annex I point 6 d (new) PE v /13 PA\ docx

11 6d. Work entailing exposure to the following petroleum products: unrefined or less refined mineral oils and regenerated mineral oils used in operations to machine and treat metals, aromatic extracts, cracking residues, used engine oils and soot from the combustion of petroleum products. 15 Annex I point 6 e (new) 6e. Work entailing exposure to formaldehyde. 16 Annex I point 6 f (new) 6f. Substances released and inhaled during underground working in iron ore mines. PA\ docx 11/13 PE v01-00

12 17 Annex I point 6 g (new) 6g. Work entailing exposure to hepatitis A, B, C, D and E viruses. 18 Annex I point 6 h (new) 6h. Work entailing exposure to dust or smoke containing cadmium. 19 Annex I point 6 i (new) 6i. Work entailing exposure to cobalt dust associated with tungsten carbide before sintering. PE v /13 PA\ docx

13 20 Annex I point 6 j (new) 6j. Work entailing exposure to bis (chloromethyl) ether. 21 Annex I point 6 k (new) 6k. Work entailing exposure to one or other of the following agents: N-methyl N nitro N-nitrosoguanidine; N-ethyl N nitro N-nitrosoguanidine; N-methyl N- nitrosourea; N-ethyl N-nitrosourea. PA\ docx 13/13 PE v01-00