10 Amendments of Claudiu Ciprian TĂNĂSESCU related to 2018/0081(COD)
Amendment 9 #
Proposal for a directive
Recital 8
Recital 8
(8) The assessment of health effects of carcinogens subject to this proposal was based on the relevant scientific expertise from the SCOEL and the RAC(for cadmium and its inorganic compounds, beryllium and its inorganic compounds, and formaldehyde) and the RAC (for arsenic acid and its salts, inorganic arsenic acid compounds and MOCA).
Amendment 33 #
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) Directive 2004/37/EC of the European Parliament and of the Council aims to cover substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen and/or mutagen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council as well as substances, mixtures or processes referred to in Annex I to this Directive. The substances which meet the criteria for classification as a category 1A or 1B carcinogen or mutagen set out in Annex I to Regulation (EC) No 1272/2008 are those with a harmonised classification or a self-classification notified to the European Chemicals Agency (ECHA). Those substances are listed in the public Classification and Labelling Inventory maintained by ECHA. Substances classified by IARC as carcinogens category 1 or 2A are also deemed to meet the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council 1a . __________________ 1a Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Amendment 41 #
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
Amendment 45 #
Proposal for a directive
Recital 4 b (new)
Recital 4 b (new)
(4b) For new technology with significantly reduced diesel engine exhaust and elemental carbon mass concentrations, elemental carbon may not be an equally useful exposure indicator. Nitrogen dioxide is likely to be a more relevant exposure indicator for new technology diesel engine exhaust. Since the age and type of engines and exhaust after-treatment systems applied vary within and between workplaces, it may be appropriate to set an occupational exposure limit value for diesel exhaust both as respirable elemental carbon and as nitrogen dioxide. The Commission should review those limit values by using the most up-to-date scientific and socio- economic data. Both of those values should be fulfilled at workplaces where diesel engines are applied. Although data allowing a direct comparison of the carcinogenic potential of the diesel engine exhaust emitted by new technology and older technology diesel engines are not available, new diesel engine technology has changed the quality and quantity of diesel emissions and the associated carcinogenic risks have been reduced but not eliminated. The significant reduction of the diesel engine exhaust mass concentration in exhaust from new technology diesel engines is expected to reduce the risk of lung cancer (per kWh). This is supported by the findings from a single set of animal studies showing reduced or negligible in vivo lung genotoxicity and oxidative DNA damage after inhalation exposure to diesel exhaust from new technology diesel engines. Determination of relevant exposure indicators for new technology diesel engine exhaust, including consideration of the particle size distribution and different particle exposure metrics (e.g. number vs mass concentration) would be valuable. In addition, it is important to compare the hazard per mass unit of diesel engine exhaust from new and older technology diesel engines. Further information is also needed on exposure levels at workplaces where new diesel engines are in use.
Amendment 51 #
Proposal for a directive
Recital 6
Recital 6
(6) This Directive strengthens the protection of workers’ health and safety at their workplace. New limit values should be set out in Directive 2004/37/EC in the light of available information, including new scientific and technical data and evidence-based best practices, techniques and protocols for exposure level measurement at the workplace. That information should, if possible, include data on residual risks to the health of workers, recommendations of the Scientific Committee on Occupational Exposure Limits (SCOEL) and opinions of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), as well as opinions of the Advisory Committee on Safety and Health at Work (ACSH). Information related to residual risk, made publicly available at Union level, is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens. Transparency of such information should be further encouraged. This Directive follows the specific recommendations of the SCOEL and the ACSH, the importance of which has been highlighted in previous revisions.
Amendment 56 #
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
(7a) Work involving exposure to carcinogenic or mutagenic substances resulting from the preparation, administration or disposal of hazardous drugs (including cytotoxic drugs) which are carcinogenic and classified as IARC group 1, and in some cases substances that are classified as IARC group 2A and group 2B, or substances with a similar chemical structure or pharmacologic class as those described herein, could be considered for inclusion in the directive. Individual substances that should be evaluated for inclusion in the list of hazardous drugs (including cytotoxic drugs) in the Directive including substances such as alkylating agents Oxaliplatin, Carboplatin, Cyclophosphamide, Cisplatin, Bendamustine, Ifosfamide, Mechlorethamine, Melphalan, Busulfan, and Thiotepa. Alkylating agents are among the oldest and most prevalent drugs used to treat cancer but also widely regarded as the most hazardous class of carcinogenic drugs. Substances to be considered for inclusion should be able to comply with all provisions in the directive to ensure the occupational safety of workers handling those hazardous drugs and, in accordance with article 168(1) TFEU, access to the best available treatments for patients should not be questioned or jeopardised.
Amendment 58 #
Proposal for a directive
Recital 7 b (new)
Recital 7 b (new)
(7b) The first obligation set out in Directive 2014/37/EC is the substitution requirement. This key provision is what sets that directive apart as the most stringent directive in the field of health and safety. The substances considered for that Directive should be appropriate for consideration with this obligation in mind. Simultaneously dangerous substances in the directive can have very important functions which oblige their use. This can relate to the role that for instance some cytotoxic substances play as part of life-saving drugs, (such as in the case of formalin and formaldehyde). The health and autonomy of patients and health care providers should be taken into account as part of the consideration when employers evaluate replacement of the substance "in so far as is technically possible", when it is necessary.
Amendment 84 #
Proposal for a directive
Article 1 – paragraph -1 (new)
Article 1 – paragraph -1 (new)
Directive 2004/37/EC
Article 18 b (new)
Article 18 b (new)
The following article is inserted after Article 18a: “Article 18b By the fourth quarter of 2019 the European Commission shall present a legislative proposal aimed at insertion of a list of hazardous drugs (including cytotoxic drugs), which are carcinogenic or mutagenic, on the basis of scientific data and appropriate consultation, in Annex I.”
Amendment 95 #
Proposal for a directive
Annex
Annex
Directive 2004/37/EC
Annex III – Part A – table – row 5 a (new)
Annex III – Part A – table – row 5 a (new)
Diesel engine - - 0,051a - - - - - - exhaust emissions ____________________ 1a Measured as elemental carbon
Amendment 98 #
Proposal for a directive
Annex
Annex
Directive 2004/37/EC
Annex III – Part A – table – row 5 b (new)
Annex III – Part A – table – row 5 b (new)
Diesel engine - - 0,51a - - - - - - exhaust emissions ____________________ 1a Measured as nitrogen dioxide