What changed between the plenary report and the adopted text

Removed:EXPLANATORY STATEMENT

Removed:The proposed regulation for a common data platform on chemicals presents an opportunity for harmonising data management and fostering transparency in the chemical industry. As part of its Chemicals Strategy for Sustainability (CSS), the use of One Substance – One Assessment approach (OSOA) will improve the efficiency, effectiveness, coherence and transparency of issuing safety assessments of chemicals across different pieces of EU legislation. The consolidation of all information and activities on a substance in one place, as proposed by the Regulation establishing a common data platform, is an essential step in the right direction. This would lead to important improvement of communication on planned and ongoing regulatory processes as well as the coordination of such activities and will allow better predictability for the industry.

Removed:The Rapporteur considers that the Commission’s proposal on the establishment of a common data platform on chemicals (CDPC) aims to fulfil the commitment defined in the CSS to start using the OSOA approach and to collate relevant information on the safety and sustainability of chemicals, and thus contributing to the protection of human health and the environment, and on early warning signals for chemicals risks.

Removed:This proposal builds a common data platform and drives a better chemical assessment coherence across pieces of EU legislation to allow timely identification of emerging chemical risks. In addition, the common data platform for chemicals is an important step towards administrative simplification, as it consolidates all information and activities in one place. This platform, as a part of the EU Chemicals Strategy for Sustainability, should be limited to chemicals.

Removed:The Rapporteur believes that centralizing all data for hazard assessment aims to increase efficiency and coherence, with a common starting point. In addition, collecting all available information in one place it makes safety assessments more robust and faster, and consequently reinforcing citizens’ trust in the chemical safety evaluation and in decision-making process for chemicals.

Removed:If the proposal is properly implemented, will boost innovation, support the circular economy and improve the consumer’s protection against hazardous chemicals.

Removed:However, the Rapporteur has identified certain issues and concerns in the OSOA package that may prevent it from achieving its full potential and to address these, he proposes relevant key improvements for the OSOA package.

Removed:The Rapporteur considers that chemicals data in the scope are only those that must be submitted to Union Agencies or the Commission, within the context of a safety assessment. In addition, it is of utmost importance to understand what type of data would be included in the scope, especially whether it would include data on all ingredients or only data on the regulated ingredients, in the case of cosmetic products.

Removed:Since the chemicals data and environmental sustainability related data definitions are very broad and for the data in scope of notification by business operators, the provision of a guidance document will be helpful.

Removed:With regards to the definitions, the difference between “duty holder” and “business operator” is not so clear and a clarification is needed.

Removed:The Rapporteur highlights that a common open data platform on chemicals and tools for accessing relevant academic data is a very good opportunity to streamline scientific work, centralise relevant hazard information and avoid duplication. It is essential to ensure sufficient uptake of independent research, including studies from academia, in regulatory decisions as promised in the CSS.

Removed:However, data inserted in such tools or platform must be robust and reliable. To achieve this, the mechanism that will check/validate the robustness of the data before adding them to the CDPC is important.

Removed:In particular, for medicinal active substances, only data on relevant substances needs to be included.

Removed:The proposal needs to clarify what type of studies should be notified. The Rapporteur considers that only final studies generated, as part of the regulatory obligation within a safety evaluation have to be notified. These studies should be limited to those relevant for hazards/risk identification, while clear acceptability standards and criteria for the studies should be also indicated.

Removed:The Rapporteur emphasises the importance of a high level of security of the confidential information contained in the platform, avoiding unnecessary burden on companies for the notification of commissioned studies and not to duplicate existing mechanisms or processes (such as substance evaluation under REACH). Safeguarding the confidentiality of industry’s sensitive or strategic information is crucial to preserve competition on the market and incentivize innovation. In this regard, the Rapporteur’s proposed measures for the protection of confidentiality and property of data generated by industry are robust enough.

Removed:It should be also clarified whether industry can define any data as confidential or whether there are specific criteria to meet. The Rapporteur considers that data standardization (format and vocabularies) should not create unnecessary burdens for industry and should be relevant to product specific needs.

Removed:The public will have access to chemicals data contained in the CDPC, when such information has been already disclosed in accordance with EU acts under which the data was submitted. However, when providing public access to information on the properties and effects of chemicals on human health and the environment, the Rapporteur has taken into account the legitimate rights of businesses to the protection of commercially valuable information and intellectual property rights.

Removed:Removing obstacles to the re-use of existing data, is important as it aims to reduce the need for generation of new data, saving cost and administrative burden for industry and/or authorities but also reducing animal testing. In this regards, any mechanism for sharing or re-use of data must respect data protection rules and prevent disclosure of confidential business information. The large number and diversity of legislative acts included in Annex I to the proposed Regulation, as well as the vast amount of studies, measurements and analyses performed on a daily basis by the industry should also be taken into account.

Removed:The Rapporteur aims to ensure proportionality and reduce administrative burden mostly for SMEs, by proposing to avoid any potential duplication of information across various platforms.

Removed:The Rapporteur agrees to keep data generation mechanism as agile as possible, but it should involve the stakeholder consultation in the process. The Data Generation mechanism should be used only when there is a clear and specific need for data that cannot be generated under existing processes.

Removed:In addition, standard data formats and controlled vocabularies must be developed in consultation with stakeholders and in particular with the industry. Adopting the principle of using the same data formats and tools across different pieces of legislation as much as possible, this should not increase the burden on industry or delay regulatory processes.

Removed:Regarding the notification, the Rapporteur supports that the scope should be limited to the notification of studies that are relevant for assessing the hazard and safety profiles of chemical substances, and it should be done only when the study is concluded. The proposed obligation for notification of studies commissioned by the industry must be proportionately scoped and focused on studies which would have an added value to the risk or regulatory management of chemicals. This is to avoid an unnecessary administrative burden for companies and subsequently the Agency.