On Tuesday 18 February, the European Parliament Environment Committee adopted its position on the ‘one substance, one assessment’ package proposed by the European Commission.
Part of the strategy on chemicals for a more sustainable and toxic substance-free EU, the initiative comprises three texts aimed at making risk assessment processes more transparent and simpler by creating a common data platform and a “one-stop shop” for accessing data on chemical substances (see EUROPE 13542/9).
“Today’s vote is an important step towards better data collection on chemicals and towards assessing their safety”, said rapporteur Dimitris Tsiodras (EPP, Greek). The challenge was to improve “predictability for stakeholders while preserving data confidentiality and protecting intellectual property rights”.
Jutta Paulus (Greens/EFA, German) welcomed that the data platform would “make toxicity data available to citizens and science”. MEPs are going further than the Commission on transparency by requiring the inclusion of information on the presence of chemical substances in products and on safer alternatives to substances of concern.
With this position, the Environment Committee is seeking to impose an obligation on economic operators to contribute to the Common Data Platform (CDP) for all studies on chemical substances carried out in order to support an application, notification or regulatory file, as well as studies commissioned on their own products as part of a risk or safety assessment.
However, MEPs were unable to agree on the extent of the data provided to the CPD by the European Medicines Agency (EMA). Renew Europe, S&D, the Greens/EFA and The Left wanted the EMA to be obliged to provide data on all active substances, whereas the EPP wanted to maintain the limit of data on “relevant active substances”.
With regard to collaboration between agencies, MEPs strengthened the provisions for resolving differences in scientific opinion between EU agencies, with the possibility of adapting resources to meet needs.
The ‘one substance, one assessment’ package will be voted on at the plenary session of the European Parliament between 31 March and 3 April. If it is adopted, interinstitutional negotiations can begin. (Original version in French by Florent Servia)