On September 26th the European Commission launched a public consultation on the development of criteria to identify endocrine disrupting chemicals in biocidal and plant protection products. The consultation is open for contributions until January 16th, 2015, and its results may significantly impact a wide variety of products (e.g., cosmetics, medical devices, pharmaceuticals, consumer products) as well as biocides and plant protection products.
Current Restrictions without Definitions
Endocrine disruptors (EDCs) are chemicals that interfere with hormone systems and may lead to harmful effects on health and the environment. There is substantial controversy regarding the scientific criteria to identify these substances. While a wide variety of EU legislation (e.g., REACH, cosmetics, biocides, medical devices, pesticides, water framework rules) restricts the use of EDCs, it fails to provide criteria to identify them.
For example, the Regulations on biocidal products (Regulation 528/2012) and plant protection products (Regulation 1107/2009) severely restrict the use of EDCs in these products. The European Commission may only in exceptional circumstances grant an authorization for marketing a biocidal or plant protection product containing EDCs “that may cause adverse effects on humans.” Although both Regulations leave it to the Commission to develop criteria to identify EDCs, it has not yet done so. Instead, the Commission applies provisional criteria primarily linked to carcinogenic properties as referred to in the CLP (Classification, Labelling and Packaging) Regulation 1272/2008.
Towards Legally Binding Criteria on Endocrine Disruptors?
The current public consultation is intended to assist the Commission in the preparation of an impact assessment that will form the basis of a legislative proposal on criteria to identify EDCs in biocidal and plant protection products. A Roadmap published by the Commission in June presents the scope of the impact assessment and four policy options that the Commission will assess. These options rely heavily on the definitions of EDCs of the World Health Organization (WHO) and the International Program on Chemical Safety (IPCS). The Roadmap also clarifies that the Commission should be able to allow the marketing of biocidal and plant protection products that contain EDCs on the basis of other factors, such as socio-economic considerations or risk-benefit assessments.
The consultation asks stakeholders to comment on the four options that the Roadmap identifies: (i) continue to apply the current provisional criteria (i.e., maintain the status quo); (ii) apply the WHO/IPCS definitions;
(iii) apply the WHO/IPCS definitions together with additional categories on the basis of strength of evidence for meeting this definition; and (iv) apply the WHO/IPCS definitions and also take into account potency as an element of hazard characterization. In addition to the feedback regarding the scientific criteria that define EDCs, the consultation also gathers input on considerations of a regulatory rather than a purely scientific nature, including the importance of socio-economic arguments.
Importantly, while the consultation focuses on biocidal and plant protection products, it is likely to be a first step towards the adoption of EU horizontal criteria for identifying EDCs in a wide variety of products. In fact, the Roadmap confirms that the Commission’s objective is not only to develop scientific criteria in the context of biocidal and plant protection products, but also to ensure the “possibility to apply these criteria across all relevant Union legislation.”