50 Amendments of Sirpa PIETIKÄINEN related to 2020/0262(COD)
Amendment 12 #
Proposal for a directive
Recital 1
Recital 1
(1) Directive 2004/37/EC of the European Parliament and the Council45 aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens and reprotoxic substances at the workplace. A consistent level of protection from the risks related to the occupational exposure to carcinogens and mutagens and reprotoxic substances is provided for in that Directive by a framework of general principles to enable Member States to ensure the consistent application of minimum requirements. The aim of these minimum requirements is to protect workers at Union level. More stringent provisions can be set by Member States. __________________ 45 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50). (This amendment applies throughout the text)
Amendment 15 #
Proposal for a directive
Recital 1 a (new)
Recital 1 a (new)
(1a) Every worker has a right to a safe and healthy working environment. In order for the right to a safe and healthy working environment to be realised, the precautionary principle needs to be fully implemented with regard to carcinogenic substances;
Amendment 16 #
Proposal for a directive
Recital 1 b (new)
Recital 1 b (new)
Amendment 17 #
Proposal for a directive
Recital 1 c (new)
Recital 1 c (new)
Amendment 19 #
Proposal for a directive
Recital 2
Recital 2
(2) Principle 10 of the European Pillar of Social Rights46 , jointly proclaimed by the European Parliament, the Council and the Commission at the Social Summit for Fair Jobs and Growth on 17 November 2017, provides workers’ right to a high level of protection of their health and safety at work, which includes the protection from the exposure to carcinogens and mutagen, mutagens and reprotoxic substances at the workplace. __________________ 46European Pillar of Social Rights, November 2017, available at : https://ec.europa.eu/commission/sites/beta- political/files/social-summit-european- pillar-social-rights-booklet_en.pdf
Amendment 20 #
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) Hazardous Medicinal Products can cause adverse health effects such as certain types of cancer (breast cancer, haematopoietic cancer) and reproductive disorders (infertility, miscarriages, congenital malformations) in workers who are exposed to them through work resulting from the preparation, administration, or disposal of hazardous drugs. Hazardous Medicinal Products thus affect workers that handle such agents, both directly and indirectly. They include healthcare workers using cytostatic drugs to treat cancer patients in hospitals or at home but also workers in services related to cleaning, transport, laundry, or waste disposal of hazardous drugs or of material contaminated by such drugs. It is therefore important to protect all exposed workers by including relevant pharmacotherapeutic groups of Hazardous Medicinal Products in Annex I of the Directive. The elimination and substitution obligations defined in Article 4 do not apply to Hazardous Medicinal Products because these substances are needed and essential to treat patients. The other provisions, in particular Articles 5 to 18a, are therefore the added value of the Directive to protect exposed workers.
Amendment 22 #
Proposal for a directive
Recital 3
Recital 3
(3) Binding occupational exposure limit values are important component of the general arrangements for the protection of workers established by Directive 2004/37/EC and must not be exceeded. Limit values and other directly related provisions should be established for all those carcinogens or mutagens or reprotoxic substances for which the available information, including scientific and technical data, make this possible.
Amendment 25 #
Proposal for a directive
Recital 4
Recital 4
(4) Compliance with binding occupational exposure limit values is without prejudice to other employers’ obligations pursuant to Directive 2004/37/EC, such as the reduction of the use of carcinogens and mutagen, mutagens and reprotoxic substances at the workplace, the prevention or reduction of workers’ exposure to carcinogens or, mutagens or reprotoxic chemicals and the measures which should be implemented to that effect. Those measures should include, as far as it is technically possible, the replacement of the carcinogen or, mutagen or reprotoxic substance by a substance, mixture or process which is not dangerous or is less dangerous to workers’ health, the use of a closed system or other measures aiming to reduce the level of workers’ exposure.
Amendment 28 #
Proposal for a directive
Recital 5
Recital 5
(5) 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 ofusing a risk-based methodology. All available information should be considered, including new scientific and technical data and should also be based on, a thorough assessment of the socioeconomic impact and the availability of exposure measurement protocols and techniques at the workplace. That information should, if possible, include data on residual risks to the health of workers, 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 mutagen, mutagens and reprotoxic substances.
Amendment 30 #
Proposal for a directive
Recital 6
Recital 6
(6) In accordance with the recommendations of the RAC and the ACSH, where possible, limit values for the inhalation route of exposure are established in relation to a reference period of eight hours time-weighted average (long-term exposure limit values) and, for certain carcinogens or, mutagens or reprotoxic chemicals to a shorter reference period, in general fifteen minutes time-weighted average (short-term exposure limit values), in order to limit, to the extent possible, the effects arising from short-term exposure.
Amendment 33 #
Proposal for a directive
Recital 7
Recital 7
(7) It is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagen, mutagens and reprotoxic substances, including the possibility of uptake through the skin, in order to ensure the best possible level of protection.
Amendment 34 #
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
(7a) In the workplace, workers are often exposed to a cocktail of hazardous substances, which can increase risks and cause adverse health effects. In case of combined exposure to substances acting by the same mode of action and/or at the same target cell or tissue, it is necessary to adapt the implementation of their eventual limit values to take into account the combined effects.
Amendment 40 #
Proposal for a directive
Recital 13
Recital 13
(13) Benzene meets the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and is therefore carcinogen within the meaning of Directive 2004/37/EC. Benzene can also be absorbed through the skin. The limit value set out in Annex III to Directive 2004/37/EC for benzene should be revised in the light of more recent scientific data no later than 1 January 2030 in accordance with the ACSH opinion and it is appropriate to keep the skin notation. The ACSH, based on the RAC opinion, also agreed on the usefulness of the biomonitoring for benzene. This should be considered when developing guidance on the practical use of biomonitoring.
Amendment 43 #
Proposal for a directive
Recital 14 a (new)
Recital 14 a (new)
(14a) Cobalt and cobalt compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/20081a and are therefore carcinogens within the meaning of Directive 2004/37/EC1b. It is possible, on the basis of the available information, including scientific and technical data, to set limit values for that group of carcinogens. Exposure to cobalt and cobalt compounds at workplaces may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish two limit values for both the inhalable and respirable fractions of cobalt and its compounds under the scope of Directive 2004/37/EC and to assign a notation for dermal and respiratory sensitisation. __________________ 1aRegulation (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 1b Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC)
Amendment 45 #
Proposal for a directive
Recital 17
Recital 17
(17) Since the objective of this Directive, namely to protect workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagen, mutagens or reprotoxic substances at work, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
Amendment 49 #
Proposal for a directive
Article -1 (new)
Article -1 (new)
Directive 2004/37/EC
Title
Title
Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagen, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC)
Amendment 51 #
Proposal for a directive
Article -1 a (new)
Article -1 a (new)
Directive 2004/37/EC
Article 1 – paragraph 1 – subparagraph 1
Article 1 – paragraph 1 – subparagraph 1
(-1a) Article 1, paragraph 1, sub paragraph 1 is amended as follows: 1. This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagen, mutagens or reprotoxic substances at work.
Amendment 52 #
Proposal for a directive
Article -1 b (new)
Article -1 b (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point (ba) (new)
Article 2 – paragraph 1 – point (ba) (new)
(-1b) In Article 2, the following point is added: "(ba) 'reprotoxic substance' means: a substance or mixture which meets the criteria for being classified as toxic to reproduction category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008;"
Amendment 54 #
Proposal for a directive
Article -1 c (new)
Article -1 c (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point (c)
Article 2 – paragraph 1 – point (c)
(3) Article 2, point (c) is amended as follows: (c) 'limit value' means, unless otherwise specified, the limit of the time- weighted average of the concentration for a 'carcinogen or, mutagen or reprotoxic substance' in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III to this Directive.
Amendment 56 #
Proposal for a directive
Article -1 d (new)
Article -1 d (new)
Directive 2004/37/EC
Article 2 – paragraph 1 – point (ca) (new)
Article 2 – paragraph 1 – point (ca) (new)
(-1 d) In Article 2, the following point is added: "(ca) ‘risk-based limit value’ means a limit value set at an exposure level corresponding to a risk of developing an adverse health effect (e.g. cancer) in the range between an upper and a lower risk level. These risk levels are to be set out in accordance with the procedure laid down in Article 137(2) of the Treaty."
Amendment 59 #
Proposal for a directive
Article -1 e (new)
Article -1 e (new)
Directive 2004/37/EC
Article 3 – paragraph 1
Article 3 – paragraph 1
(-1 e) Article 3, paragraph 1 is amended as follows: 1. This Directive shall apply to activities in which workers are or are likely to be exposed to carcinogens or mutagen, mutagens or reprotoxic substances as a result of their work.
Amendment 61 #
Proposal for a directive
Article -1 f (new)
Article -1 f (new)
Directive 2004/37/EC
Article 3 – paragraph 2 – subparagraph 1
Article 3 – paragraph 2 – subparagraph 1
(-1 f) Article 3, paragraph 2, subparagraph 1 is amended as follows: In the case of any activity likely to involve a risk of exposure to carcinogens or mutagen, mutagens or reprotoxic substances, the nature, degree and duration of workers' exposure shall be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken.
Amendment 63 #
Proposal for a directive
Article -1 g (new)
Article -1 g (new)
Directive 2004/37/EC
Article 3 – paragraph 2 – subparagraph 2
Article 3 – paragraph 2 – subparagraph 2
(-1 g) Article 3 paragraph 2, subparagraph 2 is amended as follows: The assessment shall be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to carcinogens or mutagen, mutagens or reprotoxic substances.
Amendment 64 #
Proposal for a directive
Article -1 h (new)
Article -1 h (new)
Directive 2004/37/EC
Article 3 – paragraph 4
Article 3 – paragraph 4
(-1 h) Article 3, paragraph 4 is amended as follows: 4. When the risk assessment is carried out, employers shall give particular attention to any effects concerning the health or safety of workers at particular risk and shall, inter alia, take account of the desirability of not employing such workers in areas where they may come into contact with carcinogens or mutagen, mutagens or reprotoxic substances.
Amendment 67 #
Proposal for a directive
Article -1 i (new)
Article -1 i (new)
Directive 2004/37/EC
Article 4 – paragraph 1
Article 4 – paragraph 1
(-1 i) Article 4, paragraph 1 is amended as follows: 1. The employer shall reduce the use of a carcinogen or, mutagen or reprotoxic substance at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous to workers' health or safety, as the case may be.
Amendment 69 #
Proposal for a directive
Article -1 j (new)
Article -1 j (new)
Directive 2004/37/EC
Article 5 – paragraph 2
Article 5 – paragraph 2
(-1 j) Article 5, paragraph 2 is amended as follows: 2. Where it is not technically possible to replace the carcinogen or mutagen, mutagen or reprotoxic substance by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous to health or safety, the employer shall ensure that the carcinogen or, mutagen or reprotoxic substance is, in so far as is technically possible, manufactured and used in a closed system.
Amendment 72 #
Proposal for a directive
Article -1 k (new)
Article -1 k (new)
Directive 2004/37/EC
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 73 #
Proposal for a directive
Article -1 l (new)
Article -1 l (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – introductory part
Article 5 – paragraph 5 – introductory part
(-1 l) Article 5, paragraph 5, introductory part is amended as follows: 5. Wherever a carcinogen, mutagen or reprotoxic substance is used, the employer shall apply all the following measures:
Amendment 75 #
Proposal for a directive
Article -1 m (new)
Article -1 m (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point (a)
Article 5 – paragraph 5 – point (a)
(-1 m) Article 5, paragraph 5, point (a) is amended as follows: (a) limitation of the quantities of a carcinogen or, mutagen or reprotoxic substance at the place of work;
Amendment 77 #
Proposal for a directive
Article -1 n (new) Directive 2004/37/EC
Article -1 n (new) Directive 2004/37/EC
(-1 n) Article 5, paragraph 5, point (c) is amended as follows: (c) design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens or mutagen, mutagens or reprotoxic substances into the place of work;
Amendment 80 #
Proposal for a directive
Article -1 o (new)
Article -1 o (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point (d)
Article 5 – paragraph 5 – point (d)
(-1 o) Article 5, paragraph 5, point (d) is amended as follows: (d) evacuation of carcinogens or, mutagens or reprotoxic substances at source, local extraction system or general ventilation, all such methods to be appropriate and compatible with the need to protect public health and the environment;
Amendment 81 #
Proposal for a directive
Article -1 p – (new)
Article -1 p – (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point (e)
Article 5 – paragraph 5 – point (e)
(-1 p) Article 5, paragraph 5, point (e) is amended as follows: (e) use of existing appropriate procedures for the measurement of carcinogens or mutagen, mutagens or reprotoxic substances, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident;
Amendment 83 #
Proposal for a directive
Article -1 q (new)
Article -1 q (new)
Directive 2004/37/EC
Article 5 – paragraph 5 – point (j)
Article 5 – paragraph 5 – point (j)
(-1 q) Article 5, paragraph 5, point (j) is amended as follows: (j) demarcation of risk areas and use of adequate warning and safety signs including 'no smoking' signs in areas where workers are exposed or likely to be exposed to carcinogens or mutagen, mutagens or reprotoxic substances;
Amendment 88 #
Proposal for a directive
Article -1 r (new)
Article -1 r (new)
Directive 2004/37/EC
Article 6 – paragraph 1 – point (a)
Article 6 – paragraph 1 – point (a)
(-1 r) Article 6, point (a) is amended as follows: (a) the activities and/or industrial processes carried out, including the reasons for which carcinogens or mutagen, mutagens or reprotoxic substances are used;
Amendment 89 #
Proposal for a directive
Article -1 s (new)
Article -1 s (new)
Directive 2004/37/EC
Article 6 – paragraph 1 – point (b)
Article 6 – paragraph 1 – point (b)
(-1 s) Article 6, point (b) is amended as follows: (b) the quantities of substances or mixtures manufactured or used which contain carcinogens or mutagen, mutagens or reprotoxic substances;
Amendment 92 #
Proposal for a directive
Article -1 t (new)
Article -1 t (new)
Directive 2004/37/EC
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
(-1 t) Article 10, paragraph 1, introductory part is amended as follows: 1. Employers shall be obliged, in the case of all activities for which there is a risk of contamination by carcinogens or mutagen, mutagens or reprotoxic substances, to take appropriate measures to ensure that:
Amendment 94 #
Proposal for a directive
Article -1 u
Article -1 u
Directive 2004/37/EC
Article 10 – paragraph 1 – point (a)
Article 10 – paragraph 1 – point (a)
(-1 u) Article 10, paragraph 1, point (a) is amended as follows: (a) workers do not eat, drink or smoke in working areas where there is a risk of contamination by carcinogens or mutagen, mutagens or reprotoxic substances;
Amendment 95 #
Proposal for a directive
Article -1 v (new)
Article -1 v (new)
Directive 2004/37/EC
Article 11 – paragraph 2
Article 11 – paragraph 2
(-1 v) Article 11, paragraph 2 is amended as follows: 2. Employers shall inform workers of installations and related containers containing carcinogens or, mutagens or reprotoxic substances, ensure that all containers, packages and installations containing carcinogens or mutagen, mutagens or reprotoxic substances are labelled clearly and legibly, and display clearly visible warning and hazard signs.
Amendment 98 #
Proposal for a directive
Article -1 w (new)
Article -1 w (new)
Directive 2004/37/EC
Article 14 – paragraph 3 – subparagraph 1
Article 14 – paragraph 3 – subparagraph 1
(-1 w) Article 14, paragraph 3, sub paragraph 1 is amended as follows: If a worker is found to be suffering from an abnormality which is suspected to be the result of exposure to carcinogens or mutagen, mutagens or reprotoxic substances, the doctor or authority responsible for the health surveillance of workers may require other workers who have been similarly exposed to undergo health surveillance.
Amendment 100 #
Proposal for a directive
Article -1 x (new)
Article -1 x (new)
Directive 2004/37/EC
Article 14 – paragraph 8 – subparagraph 1
Article 14 – paragraph 8 – subparagraph 1
Amendment 101 #
Proposal for a directive
Article -1 y (new)
Article -1 y (new)
Directive 2004/37/EC
Article 15 – paragraph 2a (new)
Article 15 – paragraph 2a (new)
(-1 y) In Article 15, the following paragraph is added: "2a. The Member States shall provide the Commission with the information referred to in Article 14(8) of this Directive as part of the implementation reports referred to in Article 17a of Council Directive 89/391/EEC."
Amendment 104 #
Proposal for a directive
Article -1 z (new)
Article -1 z (new)
Directive 2004/37/EC
Article 16 – paragraph 1
Article 16 – paragraph 1
(-1 z) Article 16, paragraph 1 is amended as follows: 1. The Council shall, in accordance with the procedure laid down in Article 137(2) of the Treaty, set out risk-based limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagen, mutagens or reprotoxic substances for which this is possible, and, where necessary, other directly related provisions.
Amendment 105 #
Proposal for a directive
Article -1 aa (new)
Article -1 aa (new)
Directive 2004/37/EC
Article 16 – paragraph 1
Article 16 – paragraph 1
(-1 aa) Article 16, paragraph 1 is amended as follows: 1. The Council shall, in accordance with the procedure laid down in Article 137(2) of the Treaty, set out limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagen, mutagens or reprotoxic substances for which this is possible, and, where necessary, other directly related provisions.
Amendment 107 #
Proposal for a directive
Article -1 ab (new)
Article -1 ab (new)
Directive 2004/37/EC
Article 17 – paragraph 1 – subparagraph 1
Article 17 – paragraph 1 – subparagraph 1
Amendment 109 #
Proposal for a directive
Article -1 ac (new)
Article -1 ac (new)
Directive 2004/37/EC
Article 18a – paragraph 4 a (new)
Article 18a – paragraph 4 a (new)
(-1 ac) In Article 18a, the following paragraph is added: "No later than 1 January 2028, the Commission shall, taking into account the RAC opinion of 2018 and the latest developments in scientific knowledge, start evaluating the feasibility of a further reduction of the limit value for Benzene. No later than 1 January 2030, the Commission shall propose, where appropriate, necessary amendments and modifications related to that substance."
Amendment 110 #
Proposal for a directive
Article -1 ad
Article -1 ad
Directive 2004/37/EC
Article 18a – paragraph 4 b (new)
Article 18a – paragraph 4 b (new)
(-1 ad) In Article 18a, the following paragraph is added: "No later than 1 December 2022, the Commission shall, taking into account the latest developments in scientific knowledge, the opinion of RAC and after appropriate consultation with relevant stakeholders, prepare EU guidelines on how the implementation of the limit values referred to in Article 5(4) should be adapted in case of combined exposure. These guidelines shall be published on the website of the European Agency for Safety and Health at Work (EU-OSHA)."
Amendment 111 #
Proposal for a directive
Article -1 ae
Article -1 ae
Directive 2004/37/EC
Article 18a – paragraph 4c (new)
Article 18a – paragraph 4c (new)
(-1 ae) In Article 18a, the following paragraph is added: "No later than 1 March 2022, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation with relevant stakeholders, in particular health practitioners and health professionals, prepare a definition of Hazardous Medicinal Products and establish the list of substances covered by the related entry in Annex I. This list shall be reviewed every two years. No later than 1 December 2022, the Commission shall, after appropriate consultation with relevant stakeholders, prepare EU guidelines and standards of practice for the preparation, administration, and disposal of Hazardous Medicinal Products. These non-legislative tools shall be published on the website of the European Agency for Safety and Health at Work (EU-OSHA)."
Amendment 112 #
Proposal for a directive
Article -1 af (new)
Article -1 af (new)
Directive 2004/37/EC
Article 18a – paragraph 4 d (new)
Article 18a – paragraph 4 d (new)
(1 af) In Article 18a, the following paragraph is added: "No later than 1 June 2022, the Commission shall, taking into account the existing methodology to set limit values for carcinogens in some Member States and the opinion of the ACSH, define the upper and lower risk levels referred to in Article 2. No later than 1 December 2022, the Commission shall, after appropriate consultation with relevant stakeholders, prepare EU guidelines on the methodology establishing risk-based limit values under this Directive. These guidelines shall be published on the website of the European Agency for Safety and Health at Work (EU-OSHA)."
Amendment 114 #
Proposal for a directive
Article -1 ag (new)
Article -1 ag (new)
Directive 2004/37/EC
Annex I – point 8 a (new)
Annex I – point 8 a (new)
(-1 ag) In Annex I, the following point is added: "8a. Work involving exposure to Hazardous Medicinal Products from the three following pharmacotherapeutic groups: antineoplastic drugs, immunosuppressant drugs and antiviral drugs and, meeting the criteria for classification as carcinogenic, mutagenic and/or toxic for reproduction category 1A or 1B set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council."
Amendment 116 #
Proposal for a directive
Article -1 ah (new)
Article -1 ah (new)
Directive 2004/37/EC
Annex II – point 1
Annex II – point 1
(-1 ah) In Annex II to Directive 2004/37/EC, point 1 is amended as follows: 1. The doctor and/or authority responsible for the health surveillance of workers exposed to carcinogens or, mutagens or reprotoxic substances must be familiar with the exposure conditions or circumstances of each worker.