9 Feb 2018
EU Member States Revise Identification Criteria for “Endocrine Disruptors”; Could Lead to Future Restriction of Substances in Consumer Goods
A Commission delegated Regulation setting out scientific criteria for the determination of endocrine-disrupting properties under the Biocidal Products Regulation will become applicable on 7 June 2018. Biocidal products are widely used to protect livestock and crops from disease and insects, but can also contain substances with harmful effects on human or animal health or the environment.
Substances which can potentially interfere with the body’s endocrine system which produces hormones to control and coordinate a range of important body functions are called endocrine disruptors. The European Commission was forced to make revisions to its earlier-proposed EU regulatory definition of endocrine disrupting chemicals, in an attempt to address Member States’ concerns that the earlier proposals would have weakened protection for human and animal health, as well as the environment.
Endocrine disrupting substances are chemicals that, according to experts, can be found in food and daily-use consumer products. Such products include several that may be commonly sold to EU customers such as cosmetics, clothes, sports equipment, carpets and plastics. The chemicals, which are believed to be able to imitate hormones, have been linked to serious adverse health effects, including hormonal cancers, fertility problems and autism.
In addition to the biocides development mentioned above, on 13 December 2017, Member State experts in the Standing Committee for Plant, Animals, Food and Feed, endorsed a Commission proposal for new identification criteria of endocrine disruptors in the context of the plant protection products legislation.
The draft proposal for a Commission Regulation amending Annex II of the Plant Protection Products Regulation sets out scientific criteria for the determination of endocrine disrupting properties of substances. The draft still needs to be approved by the European Parliament and Council of EU Member State ministers.
With this amendment, the European Commission aims for a high level of protection from harm caused by pesticides to all species and the environment. Active substances contained in pesticides which are identified as endocrine disruptors according to the new criteria will have to be withdrawn from the market immediately. Member States may decide to grant a grace period of up to six months.
As hormones help regulate energy levels, reproduction, growth, development, as well as one’s response to stress or injury, endocrine disruptors are believed to have a role in many health conditions ranging from obesity to infertility.
Currently, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) are developing a technical guidance document for the implementation of scientific criteria to identify substances with endocrine disrupting properties in the context of the Biocides and Plant Protection Products Regulations. The guidance is intended for both applicants and the Member States’ regulatory authorities. The agencies conducted their own public consultation on the guidance document.
The new endocrine disrupting criteria received criticism from activist group Health and Environment Alliance (HEAL). HEAL stated that the new criteria in their current form are still unfit for regulation, and voiced concerns about the very high burden of proof which is required to identify pesticides as endocrine disruptors. According to HEAL, this does not reflect current scientific knowledge on endocrine disruptors.
Despite the controversy that the Commission’s proposals have generated, it is expected that, eventually, the endocrine disrupting criteria can be used in other product safety-related legislation as well, and not only for biocides and plant protection products sold in the EU. Pursuant to such use, Hong Kong sellers should take note that consumer goods that may contain the defined or definable substances may become restricted on the EU market.