26 Amendments of Lucia ĎURIŠ NICHOLSONOVÁ related to 2023/0033(COD)
Amendment 39 #
Proposal for a directive
Recital 2
Recital 2
(2) Pursuant to its Article 1(3), Directive 98/24/EC is to apply to carcinogens, mutagens and reprotoxic substances at work without prejudice to more stringent or specific provisions set out in Directive 2004/37/EC. To ensure legal certainty and avoid ambiguities and possible confusion over the applicable limit values for lead and its inorganic compounds, those Directives should be amended. This will provide for a revised binding occupational exposure limit value and biological limit value in Directive 2004/37/EC only, more specifically its Annexes III and IIIa containing more specific provisions on reprotoxic substances such as lead and its inorganic compounds. Therefore, the specific provisions setting the occupational exposure limit value for lead and its inorganic compounds in Annex I to Directive 98/24/EC and a biological limit value for lead and its ionorganic compounds in Annex II to Directive 98/24/EC should be deleted.
Amendment 43 #
Proposal for a directive
Recital 6
Recital 6
(6) Lead and its inorganic compounds are key occupational reprotoxicants that can affect both fertility and the development of the foetus and meet the criteria for classification as toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are therefore a reprotoxic substances within the meaning of Article 2, point (ba), of Directive 2004/37/EC. It is not scientifically possible to identify a level below which exposure to lead and its inorganic compounds would not have adverse health effects for the development of the offspring of workers of childbearing age. A notation as “non- threshold reprotoxic substance” should therefore be introduced for lead and its inorganic compounds and employers should ensure that the level of exposure of workers is reduced to as low a level as is technically possible.
Amendment 64 #
Proposal for a directive
Recital 8
Recital 8
(8) Moreover, to strengthen the health surveillance of workers exposed to lead and its inorganic compounds and thus contribute to the prevention and protection measures to be undertaken by the employer, it is necessary to amend the existing requirements that apply when workers are exposed to certain levels of lead and its inorganic compounds. To that end, detailed medical surveillance should be required whenfor all workers exposured to lead and its inorganic compounds exceeds 0.015 mg/m3 in air (50% of current OEL) or 9 µg/100ml blood (approx. 60% of the current BLV).
Amendment 74 #
Proposal for a directive
Recital 9
Recital 9
(9) Specific measures should be put in place with regard to risk management, including hygiene measures, the use of personal protective equipment and specific health surveillance that should take into consideration the circumstances of individual workers. Under the general requirements of Directive 2004/37/EC, employers are obliged to ensure the substitution of the substance when technically possible, the use of closed systems, or the reduction of exposure to as low as technically possible. In addition, as suggested in the opinion of the Advisory Committee on Safety and Health at Work90 , the blood level of lead and its inorganic compounds in women of childbearing age should not exceed the reference values of the general population not occupationally exposed to lead and its inorganic compounds in the respective Member State. The Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council91 , advised the use of a biological guidance value (BGV) as there was insufficient scientific evidence to set a BLV for women of childbearing age. When national reference levels are not available, blood levels of lead and its inorganic compounds in women of childbearing age should not exceed the BGV of 4.5 µg/100ml, as recommended by the opinion of the RAC92. Due to a continuous decline in environmental lead exposure levels, this value should be revisited every five years. The BGV is an indicator of exposure but not of identifiable adverse health effects. Therefore, it acts as a sentinel marker to alert employers on the need to pay specific attention to this specific potential risk and to introduce measures to ensure that any exposure to lead and its inorganic compounds does not result in adverse developmental health effects in the foetus or offspring of female workers. __________________ 90 ACSH opinion on lead (2021). https://circabc.europa.eu/ui/group/cb9293b e-4563-4f19-89cf- 4c4588bd6541/library/60b206e1-ee10- 40c2-9540-fb6510c11a0c/details 91 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1.) 92 On the evaluation of the occupational exposure limits for lead and its compounds, delivered on 11 June 2020. (See section 8.2.4. of the annex to the opinion). https://echa.europa.eu/documents/10162/ed 7a37e4-1641-b147-aaac-fce4c3014037
Amendment 75 #
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) Lead accumulates in the bones and is released slowly from there into the circulatory system. Blood lead levels may thus remain high long after exposure to lead has been reduced. If the results of the medical surveillance reveal a blood-lead level of a worker greater than the biological limit value due to historical occupational exposure to lead, the employer should take into account the advice of the occupational health-care professional in implementing any measures required to ensure a decrease of the worker’s blood-lead level, including the possibility of assigning the worker to alternative work where there is no risk of further exposure. A worker may be allowed to continue working with tasks that involve exposure to lead only if that worker is under continuous medical surveillance and if a declining trend of the blood-lead level is established.
Amendment 79 #
Proposal for a directive
Recital 9 b (new)
Recital 9 b (new)
(9b) To ensure the implementation of the necessary hygiene measures and to take into account the specific situation of vulnerable workers, the Commission should, in consultation with the ACSH, develop and publish guidelines on the protection and reduction of exposure for workers whose blood-lead levels are above the biological limit value, on the special protection of women of childbearing age and on the hygiene measures necessary to limit the blood lead level of all workers. Those guidelines should be published on the EU-OSHA website and be disseminated in all Member States by the relevant competent authorities.
Amendment 83 #
Proposal for a directive
Recital 12
Recital 12
(12) Diisocyanates can be absorbed through the skin and exposure to diisocyanates at the place of work may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish an occupational exposure limit of 6 µg NCO/m³ and a short-term exposure limit of 12 µg NCO/m³ for this group of chemical agents and to assign a skin, dermal and respiratory sensitisation notation to it.
Amendment 86 #
Proposal for a directive
Recital 13
Recital 13
(13) It may be difficult to comply with an occupational exposure limit equal to 6 µg NCO/m³ for diisocyanates, accompanied by an associated short-term exposure limit equal to 12 µg NCO/m³. This difficulty is due to technical measurement feasibility issues and the time needed to implement risk management measures in particular in downstream sectors involving activities such as applications of paints, work with lead metal, demolition, repair and scrap management, other waste management and soil remediation. Therefore, a transitional value of 10 µg NCO/m³ with an associated short- term exposure limit equal to 20 µg NCO/m³ should apply until 31 December 2028.
Amendment 92 #
Proposal for a directive
Recital 14
Recital 14
(14) The Commission has consulted the Committee for Risk Assessment) which provided opinions on both substances. The Commission has carried out a two-stage consultation of management and labour at Union level in accordance with Article 154 of the Treaty. It has also consulted the Advisory Committee on Safety and Health at Work, which adopted opinions regarding the revision of the limit values for lead and its inorganic compounds93 and establishment of an occupational limit value for diisocyanates94, with recommendations for appropriate notations and a review of the limit values for diisocyanates starting in 2029. __________________ 93 See footnote 8. 94 ACSH opinion on diisocyanates (2021) https://circabc.europa.eu/ui/group/cb9293b e-4563-4f19-89cf- 4c4588bd6541/library/0d11d394-b1e8- 4e1a-a962-5ad60f4ab2ae/details
Amendment 98 #
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15a) In the workplace, workers are often exposed to a cocktail of hazardous substances, which can increase risks and cause adverse health effects. In the case of exposure to a combination of substances acting by the same mode of action or at the same target cell or tissue, it is necessary to adapt the implementation of their possible limit values to take into account the combined effects.
Amendment 99 #
Proposal for a directive
Recital 15 b (new)
Recital 15 b (new)
Amendment 120 #
Proposal for a directive
Article 1 – paragraph 1 – point -1 (new)
Article 1 – paragraph 1 – point -1 (new)
Directive 98/24/EC
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
(-1) in Article 12, the following paragraph is added: 2a. In line with the opinion of the Advisory Committee on Health and Safety at Work, the Commission shall, no later than 31st December 2029, launch a revision process for the occupational exposure limit and short-term occupational exposure limit for diisocyanates, taking especially into account the evaluation of the REACH Restriction, as Member States should report to the Commission the number of reported cases on occupational asthma, and any relevant data available. The Commission shall, where appropriate, subsequently propose necessary amendments and modifications related to that group of substances in a subsequent revision of this Directive.
Amendment 123 #
Proposal for a directive
Article 2 – paragraph 1 – introductory wording (new)
Article 2 – paragraph 1 – introductory wording (new)
Directive 2004/37/EC is amended as follows:
Amendment 130 #
Proposal for a directive
Article 2 – paragraph -1 – point 3 (new)
Article 2 – paragraph -1 – point 3 (new)
Directive 2004/37/EC
Article 2 – point e a (new)
Article 2 – point e a (new)
(3) in Article 2(1), the following point is added: “(ea) 'hazardous medicinal products’ or HMP’ means medicinal products that contain one or more substances that meet the criteria for classification as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008.’
Amendment 134 #
Proposal for a directive
Article 2 – paragraph -1 b (new)
Article 2 – paragraph -1 b (new)
Directive 2004/37/EC
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 143 #
Proposal for a directive
Article 2 – paragraph -1 – point 6 (new)
Article 2 – paragraph -1 – point 6 (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 a (new)
Article 18 a – paragraph 7 a (new)
(6) in Article 18a, the following paragraph is added: ‘No later than [one year after the date of entry into force of this amending directive] the Commission shall, after consulting the ACSH, develop and publish guidelines on the protection and reduction of exposure for workers whose blood-lead levels are above the biological limit value, on the special protection of women of childbearing age and on the hygiene measures necessary to limit the blood lead level of all workers. Those guidelines shall be published on the EU- OSHA website and shall be disseminated in all Member States by the relevant competent authorities.’
Amendment 144 #
Proposal for a directive
Article 2 – paragraph -1 – point 7 (new)
Article 2 – paragraph -1 – point 7 (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 b (new)
Article 18 a – paragraph 7 b (new)
(7) in Article 18a, the following paragraph is added: ‘No later than [five years after the date of entry into force of this amending directive] and every five years thereafter, the Commission shall, taking into account up-to-date scientific data, review the Biological Guidance Value laid down in annex IIIa, in order to take into account the declining trend of environmental lead exposure levels.’
Amendment 145 #
Proposal for a directive
Article 2 – paragraph -1 – point 8 (new)
Article 2 – paragraph -1 – point 8 (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 c (new)
Article 18 a – paragraph 7 c (new)
(8) in Article 18a, the following paragraph is added: ‘No later than [one year after the date of entry into force of this amending directive], the Commission shall, taking into account the latest developments in scientific knowledge and the opinion of RAC, and after appropriate consultation of relevant stakeholders, prepare Union guidelines on how the implementation of the limit values referred to in Article 5(4) are to be adapted in the case of exposure to a combination of substances. Those guidelines shall be published on the EU- OSHA website and be disseminated in all Member States by the relevant competent authorities.’
Amendment 146 #
Proposal for a directive
Article 2 – paragraph -1 – point 9 (new)
Article 2 – paragraph -1 – point 9 (new)
Directive 2004/37/EC
Article 18 a – paragraph 7 d (new)
Article 18 a – paragraph 7 d (new)
(9) in Article 18a, the following paragraph is added: ‘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, evaluate the need to include endocrine disrupters within the scope of this Directive. The Commission shall, where appropriate, subsequently propose necessary amendments and modifications related to endocrine disrupters in a subsequent revision of this Directive.’
Amendment 164 #
Proposal for a directive
Annex I
Annex I
Directive 98/24/EC
Annex I
Annex I
Amendment 172 #
Proposal for a directive
Annex II – point -1 a (new)
Annex II – point -1 a (new)
Directive 2004/37/EC
Annex I – point 8 a (new)
Annex I – point 8 a (new)
(-1a) in Annex I, the following point is added: “8a. Work involving exposure to hazardous medicinal products.”
Amendment 177 #
Proposal for a directive
Annex II – point 1
Annex II – point 1
Directive 2004/37/EC
Annex III – point A – row 31
Annex III – point A – row 31
(1) in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following: Limit values EC No CAS 8 hours (3) Short-term (4) Transitional Name of agent (1) No (2) Notati 3 3 measures mg/m3 Ppm f/ml mg/m3 ppm f/ml on (5) (6) (7) Inorganic lead and 0.03 its compounds Non- its compounds treshol d reproto xic substan ce (1) EC No, i.e. Einecs, ELINCS or NLP, is the official number of the substance within the European Union, as defined in Section 1.1.1.2 in Annex VI, Part 1, to Regulation (EC) No 1272/2008. (2) CAS No: Chemical Abstract Service Registry Number. (3) Measured or calculated in relation to a reference period of eight hours time-weighted average (TWA) (4) Short-term exposure limit (STEL). A limit value above which exposure should not occur and which is related to a 15-minute period unless otherwise specified. (5) mg/m3 = milligrams per cubic metre of air at 20 °C and 101,3 kPa (760 mm mercury pressure) (6) ppm = parts per million by volume in air (ml/m3). (7) f/ml = fibres per millilitre.’;
Amendment 183 #
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
Directive 2004/37/EC
ANNEX III a
ANNEX III a
Lead and its ionorganic compounds
Amendment 188 #
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
Directive 2004/37/EC
ANNEX III a
ANNEX III a
Medical surveillance is carried out if exposure to a concentration of lead in air is greater than 0,015 mg/m3, calculated as a time-weighted average over 40 hours per week, or a blood-lead level greater than 9 μg Pb/100 ml blood is measured in individual workerfor all workers exposed to lead and its inorganic compounds.
Amendment 189 #
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
Directive 2004/37/EC
Annex III a
Annex III a
If the results of the medical surveillance reveal a blood-lead level of a worker greater than the biological limit value due to historical occupational exposure to lead, the employer shall, after receiving the advice of the occupational health-care professional responsible for the health surveillance of that worker, take the necessary measures to ensure a decrease of the worker’s blood-lead level in accordance with the guidelines developed pursuant to Article 18a. A worker may be allowed to continue working with tasks that involve exposure to lead only if that worker is under continuous medical surveillance and if a declining trend of the blood-lead level is established.
Amendment 192 #
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
Directive 2004/37/EC
Annex III a
Annex III a
(1) It is recommended that the blood lead level in women of childbearing age does not exceed the reference values of the general population not occupationally exposed to lead in the respective EU Member State. When national reference levels are not available, it is recommended that blood lead levels in women of childbearing age do not exceed the Biological Guidance Value of 4.5 µg/100ml. Due to a continuous decline in environmental lead exposure levels, this value shall be revisited every five years.