Source: EURLEX
Language: en
Format: md

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| CALL FOR EVIDENCE  FOR AN INITIATIVE (without an impact assessment) | |
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| Title of the initiative | Chemical safety – better access to chemicals data for safety assessments |
| Lead DG – responsible unit | ENV B.2 |
| Likely Type of initiative | Proposal for a Regulation |
| Indicative Timing | Q1 2023 |
| Additional Information | Implementation of the chemicals strategy – Implementation (europa.eu). |
| This document is for information purposes only. It does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content. All elements of the initiative described by this document, including its timing, are subject to change. | |

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| A. Political context, problem definition and subsidiarity check |
| Political context |
| The EU has a comprehensive framework for regulating chemicals, involving over 40 legislative instruments. These instruments often require assessments of chemicals by a number of regulatory bodies or agencies. As part of the chemicals strategy for sustainability (CSS) under the European Green Deal, the Commission will move towards a ‘one substance – one assessment’ approach and implement the following three key actions as part of this approach.  ·It will remove legislative obstacles to the re-use of data and better streamline the flow of data on chemicals between EU and national authorities.  ·It will extend the principle of ‘open data’ and the relevant transparency principles from the EU’s food safety sector to other pieces of legislation on chemicals.  ·It will enable EU and national authorities to commission the testing and monitoring of chemical substances as part of the regulatory framework when further information is considered necessary.  The initiative will also: (i) facilitate access to monitoring data to support the framework for zero-pollution monitoring and zero-pollution outlook; and (ii) help implement the EU data strategy in the area of chemicals. |
| Problem the initiative aims to tackle |
| Assessments of the safety of chemicals are initiated under various pieces of legislation, by various actors and at different points in time. These assessments are also carried out by different organisations. The ‘fitness check’ of the most relevant chemicals legislation (excluding REACH) found that there are shortcomings in: (i) the discoverability, accessibility and availability of good-quality and reliable data; and (ii) the sharing and re-using of data on chemicals across legislative frameworks. That fitness check also reported that stakeholders had concerns about these shortcomings in the past (e.g. concerns about inefficiencies caused by double reporting; concerns about difficulties in identifying and accessing data; concerns about inconsistencies between outcomes of different safety assessments as a result of the assessments being based on different datasets; and concerns that not all available data was being considered in safety assessments). There is not enough coordination by interested parties (EU bodies, authorities, industry, NGOs) in this area. Nor is there enough awareness by these parties of what information is available, and of where and how the existing data can be used and accessed. Moreover, data re-use rights are sometimes restricted by the application of intellectual property or other rights. Unnecessary duplication of effort in data generation still occurs due to a lack of data sharing, caused by various factors including confidentiality and intellectual property rights. The fitness check identified the need for a more comprehensive approach across EU chemicals legislation. This more comprehensive approach included an ‘open data’ policy and the better use of smart technologies as ways to both improve the overall efficiency of the EU’s legislative framework for chemicals and contribute to the Commission’s commitment towards more transparency.  The zero-pollution action plan refers to data held by national authorities but not used for EU-level policy making as an underexploited resource. It also identifies inefficiencies and ineffectiveness in providing monitoring data for the environment. These problems are caused by both fragmented data flows under different pieces of legislation and a failure to consider the possible re-use of data. Through the CSS in particular, the zero-pollution ambition provides an impetus and mandate to: (i) improve knowledge on the presence, effects and flows of pollutants in the environment; and (ii) integrate this knowledge into a coherent and holistic framework. This can be achieved by: (i) complying with fully open data policies; and (ii) enabling the discovery of, access to, licensing of, and use of environmental data originating from different data custodians and regimes. This initiative builds on the horizontal rules on data sharing (Data Governance Act and Open Data Directive) and applies them to the specific features of the chemicals sector. |
| Basis for EU action (legal basis and subsidiarity check) |
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| Legal basis |
| Article 114 TFEU, and possibly others depending on acts being amended. |
| Practical need for EU action |
| This initiative will consider amending in a targeted manner existing pieces of chemicals legislation (EU Regulations and Directives) to include provisions necessary to: (i) streamline data flows on chemicals; (ii) increase interoperability of data, dissemination of data, and data re-use; and (iii) better implement the requirement to consider all available data in a chemical safety assessment. Amendments will be based on Article 114 (and possibly other articles depending on the specific acts being amended) of the Treaty on the Functioning of the European Union (TFEU). The amendments will target the provision of, access to, sharing of, and re-use of data at the Member State and EU level. This cannot be sufficiently achieved by the Member States alone, by reason of its scale and effects, and can therefore be better achieved at EU level. This initiative will build on the Data Governance Act, Open Data Directive and other relevant rules on data, taking into account the specific scope of chemicals as well as the intention to more generally extend the ‘open data’ policy to privately held data by default. |
| B. What does the initiative aim to achieve and how |
| This initiative aims to improve access to chemicals data originating from public authorities, private entities or scientific literature by removing technical and administrative obstacles to that access. The initiative aims to uphold the principle that data should be easily findable, available, secure, shared and re-usable. It aims to strengthen the use of all available data and increase transparency. Furthermore, it will enable EU and national authorities, where necessary, to commission the testing and monitoring of chemical substances as part of a regulatory framework if they find that data generation by business operators is not sufficient or appropriate.  The initiative will:  ·mandate relevant EU bodies to adopt data and metadata formats for chemicals data and information, and oblige EU bodies and potentially Member States and industry to use these formats;  ·mandate relevant EU bodies and set up processes to draw up, create, and maintain controlled vocabularies and dictionaries and oblige EU bodies and duty holders to use these vocabularies and dictionaries;  ·streamline the flow of data on chemicals to relevant agencies;   ·improve the provision of chemical-monitoring data from Member States to EU bodies;   ·move from data reporting to data harvesting from the holder’s data system, in particular for monitoring data for chemicals;  ·oblige the Commission and EU agencies to operate an open platform for data on chemicals and its building blocks;  ·make data and information available to – and via – the relevant information systems while ensuring proper access management by user type (authority, agency, citizen);  ·facilitate the use of all available data in assessments;   ·remove legal barriers for the re-use of data across legislation and authorities/agencies;  ·harmonise transparency rules across legislation based on the most transparent rules and extend those rules if appropriate;  ·create a data-generation mechanism for EU and national authorities and oblige industry and (external) testing laboratories to notify these authorities of any studies they commission, based on existing notification rules in the food sector. |
| Likely impacts |
| The initiative will enable the creation of an open, common collection of chemicals-related data for use in assessments of the safety of chemicals. It will make the functioning of the chemicals regulatory framework both more efficient (e.g. by avoiding duplication of efforts, and providing a clear overview of what data are available thus potentially reducing animal testing) and more coherent (e.g. reducing the risk of diverging outcomes of hazard/risk assessments at EU level).  The initiative is expected to have positive impacts through simplification and reduction of administrative burden. It will be beneficial for all stakeholders, including businesses (industry, SMEs, etc.), civil society organisations, Member State authorities, Commission DGs and EU agencies. Other than the potential for simplification, the initiative is not expected to have any major significant negative economic, social or environmental impact. |
| Future monitoring |
| The impact of the initiative will be assessed specifically through surveys as part of future evaluations of chemicals legislation to determine the level of improvement in coherence and efficiency in performing assessments of the safety of chemicals. |
| C. Better regulation |
| Impact assessment |
| There is no need for an impact assessment as: (i) the initiative is largely of an administrative and technical nature; (ii) there is little discretion on the policy choices; and (iii) no significant negative economic, social or environment impacts are expected. There will be no new obligations on industry or Member States to generate data. The aim of the initiative is to streamline existing reporting obligations and strengthen them as necessary. The impact on resources and capacity for industry, Member States, agencies and the Commission will be identified in a Commission staff working document, together with an identification of costs and benefits, quantified to the extent possible. |
| Consultation strategy |
| An expert working group of Member States, Commission DGs and EU agencies was set up to support the implementation of actions under the ‘one substance, one assessment’ approach. This expert working group will be consulted during the implementation of the initiative.  No open public consultation will be undertaken because of the mainly technical nature of the changes. However, a targeted stakeholder consultation will be organised through the study that will be commissioned to support the development of the legislative proposal. This targeted consultation will include bilateral discussions with Member State experts and stakeholders as appropriate. That consultation is planned for Q3 2022. |
| Why we are consulting? |
| The consultation will collect the views of stakeholders, EU agencies and Member States – based on their knowledge and experience – on how to improve data access, how to strengthen the use of all available data, and how to increase transparency. |
| Target audience |
| Member State authorities, EU agencies, businesses, civil society, and other relevant stakeholders. |

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