Endocrine disruptors – Recent policy developments and recommendations in the EU

In recent years, the Commission has taken steady actions and acted against EDs in line with the different requirements laid down in the relevant legislation. Specific provisions on how to address EDs are now included in legislation on pesticides and biocides, chemicals in general (REACH), medical devices and water, all of which vary to one another. Other legislation, such as that on food contact materials (FCM), cosmetics, toys or workers’ safety, does not contain specific provisions for EDs. However, substances with endocrine disrupting properties are subject to case-by-case regulatory action on the basis of the general requirements of the legislation.

As specified in the commission published the communication Towards a comprehensive European Union framework on endocrine disruptors, the Commission will consider the following key steps:

• Applying the horizontal criteria for the identification of EDs as per the WHO/IPCS definition of ED across EU legislation;
• Launching a comprehensive screening of the existing legislative framework on EDs that will pay particular attention to those areas where legislation does not contain specific provisions for EDs, such as toys, cosmetics and food contact materials;
• Continuing to ensure the necessary support to research on protecting citizens and environment from exposure to harmful chemicals, including EDs, by building on the work under the current Horizon 2020 framework programme;
• Holding an annual forum on EDs with scientists, public and private stakeholders;
• Studying the possibilities for the inclusion of EDs in the existing international system for classification of chemicals.

Despite significant policy updates included in this Commission communication, NGOs and the European Parliament have criticised the Commission for not taking sufficient action and for its sluggish progress on ED policy.

In March 2019, the Petitions (PETI) Committee of the European Parliament published a report Endocrine Disruptors: from Scientific Evidence to Human Health Protection in which various EU regulatory frameworks were reviewed for ED related aspects. Finally, concluding its review, the PETI committee made the following recommendations:

• Development of a set of trans-sectorial and harmonised regulations to minimise human and environmental exposure to EDs;
• Need to include a definition of EDs valid for all sectors (WHO definition or the current EU definition with slight modifications). Similarly to other hazards, such as CMRs, this cross-sectorial definition requires legislation to distinguish three distinct ED categories according to the level of evidence: known (category 1A), presumed (1B) and suspected (2) EDs;
• Necessity for a guidance document to be developed to explain how EDs should be identified based on the cross-sectorial definition;
• Acceleration of test development and validation, especially for modalities beyond reproductive steroids (Non-EATS), such as disruptors of the thyroid axis, and the related adverse effects;
• Regulations should explicitly require data that would allow for the identification of known, presumed and suspected EDs used or to be used in any sector. The use of ED tests covering all ED modalities and endpoints, should be made compulsory in all application dossiers submitted by the industry;
• EDs should be recognised as a class of hazard of equivalent concern to CMRs in all sectors and not only for pesticides and REACH chemicals, but also cosmetics, toys, food additives and FCM;
• Substances identified as known or presumed EDs should not be authorised in products with general population exposure. For the cosmetic sector specifically, a logic similar to that applied for CMRs should be used for EDs, consisting in banning known, presumed and suspected EDs in cosmetics;
• Planning for surveillance of production, use and exposure to EDs;
• Need to develop new tests and better quantify their population impacts of EDs.

In April 2019, during its last plenary session, the European Parliament passed a resolution on a comprehensive European Union framework on EDs. Again, the European Parliament criticised the Commission for its slow progress on implementing ED guidelines across various legislation. Thus far, the Commission has only implemented ED statutes for REACH, CLP, PPP, BPR, cosmetics, toys, FCM and water. In addition, the European Parliament has requested the Commission to harmonise ED legislation in the cosmetic, toy and FCM sectors before June 2020.

Overall, considering recent policy and political developments related to EDs, the horizontal application of the WHO/IPCS ED identification definition across EU regulatory framework will be a commendable first move to avoid uncertainty and confusion in uniform identification of ED. Also, recent steps by the Commission, including the application of ED criteria as a requirement for biocide and PPP authorisation, the publication of guidance by ECHA/EFSA on ED assessment, and the funding of the R&D under its flagship Horizon Europe programme, are considered as a significant progress towards its policy communication. The experience gained in ED assessment under BPR and PPPR will be very useful reference for the other sectors, e.g. cosmetics, toys and food contact materials, where currently there are no ED-specific criteria. With June 2020 being set as deadline by the European Parliament for the European Commission to update/introduce ED-related regulatory measure in cosmetics, toys and FCMs, it will be very interesting to follow these policy updates once the new Commission convenes in the end of the year.