“The Chemicals Strategy for Sustainability has brought together more than 10 years of discussions at once with almost 60 changes to chemicals legislations. The list of proposed measures sends a clear signal towards faster, stricter and more preventive regulatory action” says Sylvie Lemoine, Cefic’s Executive Director of Product Stewardship at the 2021 ChemicalWatch Biocides Symposium on 6 May.
The Biocidal Product Regulation (BPR) is not mentioned in the Chemicals Strategy for Sustainability, but this does not mean it will not have an impact on biocides. Major changes will be introduced in the overarching chemical regulations that apply to all chemicals, including to components of biocidal products: the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation, better known as REACH; and the Classification, Labelling and Packaging of substances and mixtures regulation or CLP.
The changes to come open many questions, for instance:
1. Introduction of new hazard categories for Endocrine Disruptors (EDs), Persistent Bioaccumulative and Toxic (PBT) chemicals, and Persistent Mobile and Toxic (PMT) chemicals under CLP. What if the categorisation EU policymakers propose to manage EDs differs from the one applicable under the BPR? Active and non-active substances alike fall under the CLP and more hazard classes will apply to them.
2. More data requirements under REACH to better identify the possible properties of substances. Will this have an impact on the availability of co-formulants?
3. Safe and Sustainable-by-Design and Innovation angle. Will there be new funding opportunities for biocides? Will the uncertain regulatory framework continue to act as barrier to introducing green chemistry -based preservatives?
Regulation is not as fast as innovation
The overarching aim of EU chemicals legislation is to avoid harm to people and planet and boost innovation towards the production and use of safe and sustainable chemicals. The focus of innovation in microbial control technologies is on solutions where only the unwanted microorganisms are targeted, and humans and environment remain unharmed. However, whereas regulation aims to boost innovation in general, for biocides the lengthy and repetitive (re-)authorisation procedures can form a hurdle for companies to invest in research and development.
It is already difficult for biocide producing companies to justify investing in the innovation of new active substances under current legislation, because they often face high costs caused by long development and legislative review timeframes. Furthermore, companies run the risk of entering into this process without any guarantee that their new product will pass the scrutiny of the approval process in the future.
MCEC and its members wish to avoid that legislation becomes a barrier to creating green alternatives. We therefore call for coherence across the different instruments of chemicals management. In other words, coherence between the BPR on the one hand, and REACH, CLP and the concept of Safe and Sustainable-by-Design on the other. Clarity on which legislation prevails over another for the active and non-active substances that a biocidal product is composed of, is essential.