1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals - Main contents

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dossier	COM(2023)783 - Amendment of Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and ...
document	COM(2023)783
date	December 7, 2023

(1) The European Green Deal ⁴⁴ sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability ⁴⁵ (‘the Strategy’) is a crucial delivery of the zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation.

(2) In order to achieve this objective, a part of the scientific and technical work on chemicals performed at Union level in support of Union legislation needs to be consolidated in the relevant Union agencies, while obligations on Union agencies to cooperate for the development of assessment methodologies and exchange of data and information should be introduced. This would simplify the current set-up, improve quality and coherence of safety assessments across Union legislation and ensure more efficient use of existing resources.

(3) The reattribution of certain existing scientific and technical tasks to the European Chemicals Agency, as well as the attribution of new tasks, were proposed as part of ongoing revisions of Union acts. This horizontal proposal aims to provide for further attribution of tasks in respect of those Union acts which are not in the process of being revised and is necessary in order to ensure that the European Chemicals Agency is involved in tasks pertaining to its expertise and developed capacities on chemicals. This is in line with the ‘one substance, one assessment’ aim to ensure that technical and scientific work is performed by the appropriate Union agency, benefiting from demonstrated experience and established tools in its field. The proposal for a Regulation is accompanied by a proposal for a Directive for the amendment of Directive 2011/65/EU of the European Parliament and of the Council ⁴⁶, aiming to achieve the same objectives.

(4) As part of the coordinated consolidation and attribution of tasks under the ‘one substance, one assessment’ approach, provisions to allocate a mandate to the European Medicines Agency to develop and cooperate on the development of assessment methodologies, standard formats and controlled vocabularies and exchange of data and information on chemicals have been introduced in Article 138(1), subparagraphs (zd) and (ze), as well as new procedures for ensuring the coherence between scientific opinions in Article 139 of the proposal for a Regulation amending Union pharmaceutical legislation. ⁴⁷

(5) To ensure the coherence of methodologies for assessments related to chemicals at Union level, all relevant Union agencies should have an equal mandate to develop such methodologies in the areas falling within their respective missions and should be subject to the same obligations to cooperate amongst each other to develop such methodologies.

(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.

(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.

(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.

(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.

(10) To comply with the obligation laid down in Section 10.4.3 of Annex I to Regulation (EU) 2017/745 of the European Parliament and of the Council⁴⁸, the Commission has provided the Scientific Committee on Health, Environmental and Emerging Risks (‘SCHEER’) with a mandate to prepare guidelines on the benefit-risk assessment of the presence of phthalates 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 ⁴⁹. The SCHEER issued those guidelines in 2019 and the Commission has issued a mandate to the SCHEER to perform a first update of those guidelines.

(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.

(12) The European Chemicals Agency already provides scientific advice on chemical substances, including on phthalates, endocrine disruptors and carcinogens, mutagens and reproductive toxicants under Regulation (EC) No 1907/2006. Several key capacities of the agency can be reused, including hazard, risk, exposure and socio-economic assessment capacities, the Committee opinion development and IT capabilities for stakeholder consultation and dissemination. To enable timely future updates on the presence of phthalates and to ensure that the appropriate Union agency develops new guidelines on other substances on the basis of the latest scientific evidence, these tasks should be attributed to the European Chemicals Agency.

(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 2022 ⁵⁰, 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.

(14) To make best use of the European Chemicals Agency’s knowledge and expertise gained through its involvement in the nomination and assessment processes under the Stockholm Convention on Persistent Organic Pollutants, the European Chemicals Agency should, upon request, assist the Commission in complying with its obligation to amend Annexes IV and V to Regulation (EU) 2019/1021 ⁵¹. Where the opinion of the Committee for Socio-Economic analysis is required, and in order to allow for the necessary capacity and resources for the effective functioning of that committee, Member States should be given the opportunity to cover for the specific expertise required for the effective performance of the task by nominating experts. In order to ensure that the Committee for Socio-Economic analysis benefits from sufficient resources, when the committee appoints one of their members as a rapporteur, that person, or his employer should be remunerated.

(15) In order to amend certain non-essential elements of Regulation (EU) 2019/1021 of the European Parliament and of the Council, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annexes IV and V in order to adapt them to the changes to the list of substances set out in the Annexes to the Stockholm Convention or the Protocol or adapt them to scientific and technical progress.

(16) As part of their reporting obligations under the Regulation (EU) 2019/1021 of the European Parliament and of the Council, Member States must report to the European Chemicals Agency information on the presence of substances listed in Part A of Annex III in the environment. The use of the Information Platform for Chemical Monitoring (‘IPCHEM’) is encouraged as a means for Member States to comply with their obligations to report that chemical occurrence data and to simplify and reduce their reporting obligations. Where Member States make data available through IPCHEM, they no longer need to report it to the European Chemicals Agency, as the agency may retrieve it from the platform.

(17) The revision of the Directive (EU) 2020/2184 of the European Parliament and of the Council ⁵² requires Member States to share with European Environmental Agency all chemical occurrence or monitoring data in water. Additionally, the monitoring data on the presence of POPs in air are already being reported by Member States to the EEA as part of the Union air quality legislation. The proposal for a Regulation of the European Parliament and the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable, and reusable and establishing a monitoring and outlook framework for chemicals ⁵³ will require all chemical occurrence data to be held by the EEA. As a result, chemical occurrence data provided to and held in IPCHEM by the Commission will thus be collected and held by the EEA, instead of by the Commission. Therefore, it is necessary to simplify the reporting obligations for Member States to ensure that, where Member States have already submitted that information to the EEA as part of fulfilling obligations required by the provisions of other pieces of Union environmental legislation, Member States should be considered to have fulfilled their reporting obligations under Regulation (EU) 2019/1021.

(18) Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 should therefore be amended accordingly,