Hostilities have begun in the European Parliament over the ‘One substance - one assessment’ package. On 3 December, MEPs on the Environment Committee tabled their amendments to three texts relating to the restructuring of the European Chemicals Agency (ECHA), the collaboration between European agencies and the creation of a common data platform for chemicals.
The challenge is to make risk assessment processes simpler and more transparent. This initiative is part of the chemicals strategy for a more sustainable and toxic substance-free EU.
Studies in the EU show the increasing presence of chemicals in the human body and polluting the environment. According to the NGO ChemSec, for example, over a quarter of the more than 16,000 chemical substances contained in modern plastics are recognised as dangerous to human health and the environment (see EUROPE 13531/26).
On Monday 9 December, the European Environment Agency (EEA) highlighted the extent of PFAS pollution in European waters (see EUROPE 13542/30).
Under the new rules, requests for exemption from the list will now be submitted to the ECHA agency. The legislators intend to take advantage of the reassignment of the task of examining chemical substances to the ECHA to redesign the scope of chemical substance monitoring.
Towards better assessment performance?
An application for renewal of an exemption will have to be submitted no later than 18 months before the exemption expires, according to the Commission’s proposal. The exemption then remains valid until a decision is made.
In their amendments, the political groups propose the imposition of a three-month period for the EU to take a decision, following receipt of the request.
On Monday 21 October, the European Ombudsman, Emily O’Reilly, noted delays in the preparation of decisions on the authorisation of dangerous chemical substances (see EUROPE 13508/6). According to the Commission (see EUROPE 13469/2), these delays are linked to the overloading of the authorisation system, with ECHA believing itself capable of adopting “around 60 opinions per year”.
The cost and benefits of restructuring
To do more, the ECHA’s Committee for Risk Assessment and Committee for Socio-economic Analysis will have to be strengthened, according to Dimitris Tsiodras (EPP, Greek). The EU Council wishes to grant ECHA a transitional period of 24 months, “insofar as it is not planned to allocate any resources (either financial or human) to ECHA until the text is adopted and enters into force”.
The European Conservatives and Reformists (ECR) agree with this transitional period, which the S&D intend to leave at 12 months.
ECHA, which will be asked to revise the list of restricted substances periodically, will have to do more, without ignoring competitiveness. The aim of reallocation is also to “promote profitability and competitiveness by simplifying regulatory procedures and reducing administrative burdens”, points out Beatrice Timgren (ECR, Swedish) in recital 1 of the text. With the economy as her guide once again, the MEP insists that requests for exemption will require “the expertise of the Committee for Socio-economic Analysis”.
Similarly, the improved cooperation between agencies proposed by the Commission should “reduce duplication of effort”, according to the Swede.
For its part, the S&D wants this text to “lay the foundations for a common approach to assessing the hazards of chemicals”. In the event of a divergence between EFSA and ECHA, “priority should be given to the most protective opinion in order to protect nature and the environment”, according to the S&D, The Left and Greens/EFA groups.
The common data platform. The S&D has tabled 122 amendments to the plan to create a common data platform. At the heart of the discussions will be the need to make data accessible and interoperable.
The political groups draw different conclusions.
Whereas the S&D and the Greens/EFA advocate transparency and extend the scope of the platform of relevant substances to all chemical substances, the Greek MEP devotes his first amendments to protecting the confidentiality of the data incorporated into the platform and stresses the difference between the framework of the European Medicines Agency and that of this text.
The S&D’s shadow rapporteur, the French MEP Christophe Clergeau, intends to combat attempts to reduce the scope of the data covered by the platform. On the contrary, he wants to open up contributions to the platform from independent research to civil society, which is directly threatened by pollution from chemical substances. The latter should be able to obtain justifications for agency decisions within six months, and even launch administrative or legal proceedings.
Guided by the precautionary principle, the S&D Group also expects the European Environment Agency to establish an “indicator to monitor the exposure of populations to individual or multiple chemicals”, the famous “cocktail effects”, the full consequences of which are not yet known. (Original version in French by Florent Servia)