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Endocrine Disruptors

An endocrine disruptor is an exogenous substance or mixture of substances that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, its progeny or its (sub)populations.

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The EU Biocidal Products Regulation (BPR) governs the approval, placing on the market, and use of biocidal products (i.e. products containing biocidal active substances) in the European Union (EU). In February 2020, building on COM(2018) 743 concerning a comprehensive European Union framework on endocrine disruptors, the European Commission (EC) triggered the early review of the approval of biocidal active substances. This initiative aims to reassess the safety of active substances in biocidal products, including iodine, to ensure a high level of protection of human health and the environment at EU and Member State (MS) level.

Since the EC confirmed ECHA’s assessment that iodine is considered to be an endocrine disruptor,, it no longer qualifies for Union Authorisation, in line with Article 5(1) of the BPR.  After discussions with EU Member States and ECHA, the EC has opted for a compromise approach whereby existing Union Authorisation will remain valid until August 2025 while new or pending requests for the authorisation of biocidal products have to be re-submitted and individually assessed by the competent authorities at national level.

Strategy on Endocrine disruptors

The EU strategy on endocrine disruptors aims to promote an integrated and inclusive approach to endocrine disruptors, with dispositions and principles that cross-cut the various relevant pieces of legislation. The Commission focuses on the precautionary principle and the ‘safe threshold’ principle. For this, a methodology will be developed to measure the exposure to endocrine disruptors.

The EU intends to work in collaboration with international organisations, e.g. by possibly requesting the inclusion of endocrine disruptors in the international system for classification of chemicals.

At the Annual Forum on Endocrine Disruptors held by the EC on 17 – 18 December 2020, the Commission announced its intention to create a new set of hazard classes for endocrine disrupting chemicals (EDCs) under the CLP Regulation. The treatment of EDCs under the CLP regulation would then mirror that of carcinogens, mutagens, and reprotoxicants (CMRs) regarding the resulting classifications. Separate classes would be introduced for human and environmental health.

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Impact on the iodine sector

The classification of iodine as an endocrine disruptor and the associated revocation of the Union Authorisation could have severe consequences for healthcare professionals and the patient community, as the placing on the market of biocides containing either iodine or povidone-iodine will no longer be permitted in Europe, unless authorised by the competent national authorities on a case-by-case basis. As iodine-based biocides play a crucial role in surface disinfection, pre-operative skin preparation, or impregnated dressings, the revocation of the Union Authorisation could affect existing infection control practices and adversely affect patient safety. Moreover, the decision to consider iodine as an endocrine disruptor poses the risk of setting precedence for other sectors, potentially affecting the placing on the market of iodine-containing products such as processed food, feed, fortified crops, x-ray contrast media, cosmetics, colorants, or dyes. Lastly, the early review of the BPR is closely monitored outside of the EU, for instance in the US and APAC region, risking a similar classification of iodine and the same implications for healthcare professionals and the patient community in these regions. 

Should you wish to receive more detailed information about this topic, or specific applications of iodine within your sector, please feel free to contact the World Iodine Association

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