Last Friday rules to introduce new hazard classes for the classification, labelling and packaging of substances in the EU were finally published in the Official Journal of the European Union. It lays out newly established criteria for identifying endocrine disrupting properties of substances for the use across sectors. This is a world first.
The delegated act, which amends Annex 1 to the EU`s Regulation for the classification, labelling and packaging of substances and mixtures (CLP), introduces new hazard classes for identifying endocrine disruptors and also persistent and mobile chemicals.
Long history
The controversial debate on updated rules to better identify endocrine disrupting chemicals (EDCs) goes back more than a decade. In 2018, after many years of discussion, the EU established criteria for endocrine disrupting biocides and pesticides. However, these sector-specific criteria were not suitable to be implemented across all pieces of EU legislation. The EU Commission’s Chemicals Strategy for Sustainability, published in 2020, sought to address this by establishing cross-cutting criteria for the identification of EDCs under the CLP law.
CHEM Trust as an active partner of the EDC-Free Europe coalition has followed and contributed to this outcome. We made several inputs to the long process:
- We presented our proposal for EDC criteria in 2011 and presented a policy paper in 2020 on a new path for EU control of endocrine disruptors;
- We contributed and commented at many EU policy and scientific meetings/initiatives over the years;
- We actively participate in the expert subgroup on endocrine disruptors guiding the Commission on the establishment of EDC criteria that can be implemented across all pieces of EU legislation, including proposing specific legal text revisions.
CHEM Trust assessment
CHEM Trust very much welcomes the introduction of new hazard classes for:
- endocrine disrupting properties;
- persistent, bioaccumulative and toxic (PBT);
- very persistent, very bioaccumulative (vPvB) properties;
- persistent, mobile and toxic (PMT) and
- very persistent, very mobile (vPvM) properties;
This will contribute to an improved protection of human health and the environment.
In particular, CHEM Trust welcomes the two hazard categories for EDCs; Cat 1: endocrine disruptors, and Cat 2: suspected endocrine disruptor. It is particularly important to have two categories to achieve more protection. This allows better reflection of the current scientific evidence as there is still a huge data gap for many specific endocrine disrupting properties, as well as a lack of sufficient test methods that cover all relevant effects. This can make it difficult to identify substances as an EDC Cat. 1.
The new hazard classes will ensure better classification and labelling of these chemicals, more transparency in the supply chains on which chemicals are hazardous and should be substituted, and will have global implications. The EU has already started work on the process to the inclusion of the new hazard classes in the globally harmonised system for classification and labelling of chemicals (UN GHS).
The importance of introducing these new hazard classes and the impact of increased protection is reflected by industry estimates that the new delegated act may affect 12,000 chemical substances and many more products and value chains than currently.
What needs to happen to deliver real protection?
- First of all, a new guidance document accompanying the criteria is under development. The level of evidence needed to be classified as an EDC is still very high. CHEM Trust will closely monitor the development of the guidance to ensure that the latest science is taken on board and all information is properly evaluated in the assessment.
- Second, the regulatory identification processes need to start. This will take a long time and past experience tells us that there will be a lot of discussions with industry on every substance that is subject to ED identification.
- Third, measures for controls under REACH and other EU laws such as cosmetics, toys or regulation of food contact materials need to include the suspected EDs, i.e. ED Cat 2. Only then will the current slow speed of regulatory action increase, and more substitution efforts in supply chains triggered.
Dr Ninja Reineke, Head of Science at CHEM Trust said
It is great news for all EU citizens that the new hazard classes will be used to identify additional hazardous substances and improve transparency. But too many substances with these harmful properties are still used in everyday products we come into contact with. Therefore, the EU needs to act on endocrine disruptors and long-lasting and mobile chemicals and prevent them from being used for consumer uses or uses leading to pollution of the environment. In CHEM Trust’s view the Commission should set a target for 2030 ensuring that all hazardous substances are out of consumer products.
Other changes: general CLP revision
In parallel to the introduction of the new hazard classes the Commision had also worked on a revision to the overall CLP law and published their proposals in December 2022. These are currently being discussed by the Council and European Parliament.
Last week CHEM Trust submitted comments as part of a public consultation to the Commission. Amending the CLP law according to the proposals will fulfill some of the commitments in the EU Chemicals Strategy for Sustainability, contribute to more transparency and provide the necessary basis for minimisation of exposure to EDCs and other harmful substances.
