Questionnaire envoyé à la commission européenne

Introduction
As an introduction, it is useful to mention that a lot of information on the endocrine disruptors' file is available on the Commission's website: https://ec.europa.eu/health/endocrine_disruptors/policy_en Information concerning the EU plant protection products legislation and procedures for the approval of active substances and authorisation of plant protection products can be found here: http://ec.europa.eu/food/plant/pesticides_en Information concerning the EU biocidal products legislation and procedures for the approval of active substances and authorisation of biocidal products can be found here: https://ec.europa.eu/health/biocides/policy_en

1. What is your role inside the European Commission (specifically around endocrine disruptors)?

Since the start of the Juncker Commission (November 2014), DG SANTE is in charge of both legislations where the Commission has a legal mandate to set criteria to identify endocrine disruptors, namely the pesticides and biocides legislation ( Plant Protection Products Regulation (EC) 1107/2009 and the Biocidal Products Regulation (EU) 528/2012). Article 5(3) of the Biocidal Products Regulation (BPR) and point 3.6.5 of Annex II to the Plant Protection Products Regulation (PPPR) provide the legal basis for the Commission to establish scientific criteria for the determination of endocrine-disrupting properties.

2. When did the DG Environment start working on this topic? When and why did it transfer the subject to the DG Santé?

Endocrine disruptors (ED) are recognised in EU policy and legislation since 1999 (EU Strategy on Endocrine Disruptors) and work has been done since then. For instance, EDs have been specifically considered in chemical legislation, i.e. REACH (2006), Cosmetics and Plant Protection Products (2009), Biocidal Products (2012), Medical Devices (2017). The pesticides and biocides legislation (Plant Protection Products Regulation (EC) 1107/2009 and the Biocidal Products Regulation (EU) 528/2012)) give a legal mandate to the Commission to set criteria to identify endocrine disruptors. In the previous Commission, the pesticides and biocides legislations were dealt with by two different DGs (DG SANTE and DG ENV, respectively). As a logical consequence, the impact assessment on criteria to identify endocrine disruptors under these legislations, which was launched in 2013, was initiated under the responsibility of both DGs. When the new Commission took office (November 2014), the biocides legislation was transferred to DG SANTE, which since then is responsible for the criteria to identify endocrine disruptors under the BP and PPP legislation. However, as is customary in the Commission's preparation for any legislative proposal, all relevant services of the Commission are involved in the preparation through interservice group meetings. In the specific case of the endocrine disruptors criteria, DG AGRI, CLIMA, COMP, CNECT, ENV, EMPL, GROW, JRC, LS, MARE, RTD, TRADE, SANTE and SG were involved. Moreover, the draft criteria were endorsed by the College of the Commission before publishing them. The College also took note of the impact assessment and adopted a Communication on the topic.

3. Is the work of the European Commission based on scientific researches it ordered or on independent researches? What are the names of the main programs ? Which laboratories are today at the forefront of research on this topic ?

The criteria for the identification of endocrine disruptors proposed by the Commission on 15 June 2016 are based on the World Health Organisation's definition of an endocrine disruptor, for which there is wide consensus amongst scientists and regulators worldwide. The Commission also referred to work of European Agencies, of its Scientific Committees and of its Joint Research Center, as well as work of OECD and of national institutes (e.g. BfR, ANSES). The Commission is also funding research via its Research Programmes and procurements. A good summary (by 2016) of the scientific information considered in the preparation of the criteria for the identification of endocrine disruptors proposed by the Commission is available in the published impact assessment report.

4. Do the negotiations already have concrete results in the legislation adopted ? What is the type of legislation the Commission is moving towards (will it be similar to the one for carcinogenic substances) ?

The draft criteria presented by the European Commission in June 2016 (implementing legislation under both the PPP and BP legislation) need to be adopted following specific procedures which involve Member States (MS), Commission, Council and European Parliament. The first step is to find agreement among MS. Discussions with experts and MS are still ongoing. Since their endorsement in June 2016, the criteria under the pesticides legislation have been discussed with MS at 5 occasions and the criteria under the biocides legislation have been discussed with experts at 6 occasions. All revised versions of the texts and minutes of the meetings are publicly available on the website of the Commission: https://ec.europa.eu/health/endocrine_disruptors/next_steps_en.

Around the controversy 1. Could you characterize the current situation (scientific and administrative) around endocrine disruptors from your position at the DG ?

The criteria were endorsed by the Commission on 15 June 2016 and are now undergoing the foreseen adoption procedures under the PPP and BP legislation. The draft criteria are based on the WHO definition of an endocrine disruptor for which there is wide consensus amongst scientists and regulators in the world.

2. Do you consider the debates around endocrine disruptors as a scientific controversy ? (do you think there is still a doubt about their harmfulness both for humans and animals) ?

There is scientific consensus that endocrine disruption can represent a potential hazard to humans or animals. However, there is still scientific controversy around some aspects: in particular, on the existence and the relevance of non-monotonic dose response (NMDR) curves for endocrine disruptors, on the possibility to establish safe thresholds for these chemicals, on whether their assessment should be risk-based or hazard-based, i.e. ultimately on how to regulate these chemicals.

3. Any decision on endocrine disruptors would probably have major consequences on industries, can you tell us how these industries work to document the issue ? How do these industries work with the EU Commissioners ?

Decisions on endocrine disruptors may have impacts in several areas. That is why the Commission worked in close contact with all stakeholders. Interested parties such as industry, NGOs, third countries, members of the academia, farmers, medical doctors and general public, submitted comments to the public consultation on criteria to identify endocrine disruptors (September 2014 to January 2015). The answers to this public consultation, as well as the report of the public consultation are available on the Commission's website. Stakeholders were also present at the round-tables, conference and technical workshop that were organised in 2015. Stakeholders are further regularly informed about the progress via the Advisory Forum, which meets in plenary regularly and for which a specific meeting on the topic was organised in June 2016. Minutes of all these meetings are available on-line. Following the endorsement of the criteria, stakeholders submitted their comments through the feedback mechanism: all answers are available online (http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2016-3071834_en and http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2016-3071671_en).

4. It has been well documented that, during the debates around the health effects of tobacco, the tobacco industry funded research to distract regulators from curbing the release of a clearly harmful product. Do you see the same phenomenon these days with endocrine disruptors?

Pesticides and biocides are regulated products in the EU which means that each active substance and each PPP or BP use needs to be authorised based on sound scientific assessments and robust, extensive data requirements defined by law. The EU pesticides and biocides legislations are among the strictest and most protective in the world: substances are only approved if a comprehensive assessment carried out by Member State experts and peer reviewed by EFSA or ECHA, demonstrates that under realistic conditions of use, the substances do not produce unacceptable effects on human or animal health, or on the environment. In this regulatory process, the burden of proof is on the applicant (industry and not public has to pay the costs for the authorisation of a product). As mentioned before, the data requirements are defined by law. These mandatory regulatory studies need to be conducted according to international guidelines and they need to be performed in accordance with Good Laboratory Practice (GLP – a certification system granted by national authorities based on an OECD quality system and guaranteeing reliability). In addition, scientific peer-reviewed open literature is considered in the regulatory assessment. Therefore for each substance, the scientific agencies look not only at studies/research done by industry but also at independent scientific peer-reviewed open literature.

5. The European Commission has been condemned by the General Court of the EU in December 2015 for failing in defining endocrine disruptors before the deadline set in December 2013. Could you explain if the Commission finally reached an agreement and why it took so long ? What obstacles have you met during the process ?

On 15 June 2016, the Commission endorsed two drafts acts containing criteria to identify endocrine disruptors: one under the pesticides legislation and another one under the biocides legislation. These draft acts are still under discussion with Member States and experts and the decision making is on-going. The Commission did not respect the 2013 deadline because it decided in 2013 to carry out an impact assessment to analyse different options for defining the criteria for the identification of endocrine disruptor, with the aim to enable an informed decision on the criteria, knowing the potential impacts. The impact assessment summarises the potential impacts on health, environment, agriculture, trade and industry of the different options for setting the criteria. The impact assessment report was not only useful to the European Commission to take an informed decision when proposing the draft criteria, but is also available to Member States, the European Parliament and the Council, all involved in the decision making. The main difficulties encountered were the complexity of the topic: from a scientific and a regulatory point of view, for the different areas covered, for the different interests and for the political pressure. In some areas, data were partial or lacking to quantify impacts. The impact assessment could only be carried out following a technical screening to estimate the number and name of the chemicals that would fall under different options for the criteria. In order to carry out this screening, a methodology had to be developed and this also took time. Furthermore, the scale and the novelty of the project added complexity. It is the 1st time worldwide that criteria to identify ED are set for regulatory purposes. The screening of substances done for the impact assessment covered around 600 chemicals and was the first estimate of the number and name of the chemicals that could be identified as endocrine disruptors in various sectors (pesticides, biocides, industrial chemicals, cosmetics and water pollutants). The main difficulty in the current decision making process (since the endorsement of the criteria by the Commission in June 2016) is represented by the diverging views between Member States which have not allowed so far to adopt the criteria. This is partly due to the fact that this topic is very technical (investigating toxicological modes of action is a relatively new approach), but discussed at political level because of the high sensitivity and the potentially significant impacts on various sectors.

6. Are there leading countries which urge the European Commission to adopt regulations on endocrine disruptors ?

All EU MS but also all stakeholders (see report from the public consultation) want new scientific criteria to be adopted and enter into force because the current interim criteria which are in place are not considered to be fit for purpose.

7. Activists working on endocrine disruptors claim that this controversy reveals that the EU suffers from a lack of transparency. What is your point of view on this topic ?

The Commission has been very transparent on this topic. Stakeholders were broadly consulted (cf public consultation, round tables, conference, technical workshop, feedback mechanism) and information was shared with them (Advisory Forum, publication of all the revised versions of the criteria, publication of all the minutes of the meetings on a dedicated public website).