Amen­de­menten Hazekamp over de herschikking van weten­schap­pe­lijke en tech­nische taken en verbe­tering van de samen­werking tussen agent­schappen van de Unie op het gebied van chemische stoffen

Amendments on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals of the Committee on the Environment, Public Health and Food Safety.

Amendment 1

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Recital 6

Text proposed by the Commission

(6) To ensure the coherence and efficiency of assessments related to chemicals across Union legislation, it is also important to enable data interoperability and easy exchange of data between the relevant Union agencies, as well as to encourage cooperation on the development of standard formats and controlled vocabularies. Thus, to facilitate data exchange between agencies, any new data formats defined by the European Food Safety Authority or by the European Environmental Agency should be set in cooperation with other relevant Union agencies working on chemicals. To this end, relevant provisions should be introduced in Regulation (EC) No 401/2009 of the European Parliament and of the Council and, in Regulation (EC) No 178/2002 of the European Parliament and of the Council, existing provisions should be strengthened and, where relevant, new ones be introduced. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation.

Amendment

(6)    To ensure the coherence and efficiency of assessments related to chemicals across Union legislation, it is also important to enable data interoperability and easy exchange of data between the relevant Union agencies, as well as to encourage cooperation on the development of standard formats and controlled vocabularies. Thus, to facilitate data exchange between agencies, any new data formats defined by the European Food Safety Authority or by the European Environmental Agency should be set in cooperation with other relevant Union agencies working on chemicals. To this end, relevant provisions should be introduced in Regulation (EC) No 401/2009 of the European Parliament and of the Council and, in Regulation (EC) No 178/2002 of the European Parliament and of the Council, existing provisions should be strengthened and, where relevant, new ones be introduced. Similar provisions should also be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, which should be proposed as soon as possible and no later than 31 December 2025.

Amendment 2 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Recital 7

Text proposed by the Commission

(7)    To promote the coherence and efficiency of assessments related to chemicals across Union legislation, steps should be taken by the relevant Union agencies to avoid divergent scientific opinions. Existing cases of divergent opinions have lead to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision making. Proposals to address and strengthen procedures for resolving divergence of scientific opinions concerning the European Medicines Agency with other scientific bodies is proposed as part of the revision of Union pharmaceutical legislation. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, whilst such provisions are not relevant and applicable to the European Environmental Agency, since this agency does not issue scientific opinions on individual chemicals such as to be part in divergent outcomes.

Amendment

(7)    To promote the transition towards a toxic-free environment and zero pollution, and the robustness, coherence and efficiency of assessments related to chemicals across Union legislation, steps should be taken by the relevant Union agencies to avoid divergent scientific opinions. Existing cases of divergent opinions have lead to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision making. Proposals to address and strengthen procedures for resolving divergence of scientific opinions concerning the European Medicines Agency with other scientific bodies is proposed as part of the revision of Union pharmaceutical legislation. Similar provisions should also be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, whilst such provisions are not relevant and applicable to the European Environmental Agency, since this agency does not issue scientific opinions on individual chemicals such as to be part in divergent outcomes.

Amendment 3 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Recital 8

Text proposed by the Commission

(8)    Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues, and only when they are not able to resolve the divergence, should they refer to risk managers.

Amendment

(8)    Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues, optimising the protection of health and the environment. Diverging scientific opinions and their causes, including in methodological differences, should be duly explained and clarified. Where diverging scientific opinions exist, the most protective opinion from the One Health perspective should be agreed on. Only when they are not able to resolve the divergence, should they refer to risk managers.

Amendment 4 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Recital 9

Text proposed by the Commission

(9)     In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long-standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance the Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.

Amendment

(9)    In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long-standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance the Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union, optimising the protection of health and the environment. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.

Amendment 5 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Recital 11

Text proposed by the Commission 

(11)  To comply with the obligation laid out in Section 10.4.4. of Annex I to Regulation (EU) 2017/745, the Commission should mandate the relevant scientific committee to prepare guidelines for substances other than phthalates and which are classified as either carcinogenic, mutagenic or toxic to reproduction category 1A or 1B, or which have endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council.

Amendment

(11)  To comply with the obligation laid out in Section 10.4.4. of Annex I to Regulation (EU) 2017/745, the Commission should mandate the relevant scientific committee to prepare guidelines for substances other than phthalates and which are classified as either carcinogenic, mutagenic or toxic to reproduction category 1A or 1B, or which have endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health or the environment and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council.

Amendment 6 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Recital 13

Text proposed by the Commission

(13)  Taking account of the new hazard classes and criteria for classification, labelling and packaging of substances introduced by Commission Delegated Regulation (EU) 2023/707 of 19 December 20227 , reference to endocrine disruptors for human health, of Category 1, should be specified in 10.4.1., point (b) of Annex I of Regulation (EU) 2017/745 in light of the relevance of that hazard class to the type of substances in medical devices.

7 Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7–39).

Amendment

(13)  Taking account of the new hazard classes and criteria for classification, labelling and packaging of substances introduced by Commission Delegated Regulation (EU) 2023/707 of 19 December 20227 , reference to endocrine disruptors for human health or the environment, of Category 1, should be specified in 10.4.1., point (b) of Annex I of Regulation (EU) 2017/745 in light of the relevance of that hazard class to the type of substances in medical devices.

7 Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7–39).

Amendment 7 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Article 1 - paragraph 1 - point 2 

Regulation (EC) No 178/2002 

Article 30

Text proposed by the Commission

The Authority and the body concerned shall cooperate to resolve the divergence. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues and identify the relevant uncertainties in the data and be made publicly available.

Amendment

The Authority and the body concerned shall cooperate to resolve the divergence, with the aim of optimising the protection of health and the environment, prioritising the most protective opinion. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify the relevant uncertainties in the data and the possible causes for the diverging opinions, including on methodological differences and be made publicly available.

Amendment 8 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Article 1 - paragraph 1 - point 2 

Regulation (EC) No 178/2002 

Article 30

Text proposed by the Commission

3.      Where relevant, and where the divergence concerns conflicting scientific opinions of the Authority and another Union body or agency on whether a substance fulfils the criteria laid out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council11 , the Commission may request the European Chemicals Agency to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof following the procedure laid out in Article 37 of Regulation (EC) No 1272/2008. The Authority and the Union body or agency concerned shall co-operate with the European Chemicals Agency in developing that proposal..

11 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 – 1355.

Amendment

3.      Where relevant, and where the divergence concerns conflicting scientific opinions of the Authority and another Union body or agency on whether a substance fulfils the criteria laid out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council11 , the Commission may request the European Chemicals Agency to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof following the procedure laid out in Article 37 of Regulation (EC) No 1272/2008, with the aim of optimising the protection of health and the environment. The Authority and the Union body or agency concerned shall co-operate with the European Chemicals Agency in developing that proposal..

11 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 – 1355.

Amendment 9 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Article 2 - paragraph 1 - point 1 a (new)

Regulation (EC) No 401/2009 

Article 15, paragraph 4

Amendment

(1 a) In Article 15, paragraph 4 is amended as follows:

4. The cooperation referred to in paragraphs 1, 2 and 3 must in particular take account of the need to reduce animal testing and to avoid any duplication of effort.

Amendment 10 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Article 2 - paragraph 1 - point 2

Regulation (EC) No 401/2009

Article 15, paragraph 5

Text proposed by the Commission

5.      The Agency shall cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, and the European Medicines Agency, on the exchange of data and information on chemicals, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies for the assessment of chemicals..

Amendment

5.      The Agency shall cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, and the European Medicines Agency, on the exchange of data and information on chemicals, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies for the assessment of chemicals. This cooperation shall aim to support the development of innovative methods and tools, notably non animal approaches and aim to ensure that animal testing takes place only as last resort.

Amendment 11 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Article 3 - paragraph 1 - point 1

Regulation (EU) 2017/745

Annex I, Section 10.4.1, point (b)

Text proposed by the Commission

(b)    substances which are identified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council12 and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012.

12 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

(b)    substances which are endocrine disruptors for human health or the environment, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council12 or substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health or the environment and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine disrupting properties relevant to human health or the environment identified in accordance with Regulation (EU) No 528/2012.

12 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 12 

Anja Hazekamp, Jonas Sjöstedt, Emma Fourreau, Lynn Boylan, Sebastian Everding, Catarina Martins, Per Clausen

Proposal for a regulation 

Article 3 - paragraph 1 - point 3

Regulation (EU) 2017/745

Annex I, Section 10.4.3

Text proposed by the Commission

When deemed appropriate based on the latest scientific evidence, but at least every 5 years, the Commission shall request the European Chemicals Agency (ECHA) to update guidelines on the benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1., points (a) and (b). The benefit-risk assessment shall consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments

Amendment

When deemed appropriate based on the latest scientific evidence, but at least every 3 years, the Commission shall request the European Chemicals Agency (ECHA) to update guidelines on the benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1., points (a) and (b). The benefit-risk assessment shall consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments