G/SPS/GEN/1448  
 
2 October 2015  
(15-5113)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
REPORT ON PUBLIC CONSULTATION ON DEFINING CRITERIA FOR IDENTIFYING 
ENDOCRINE DISRUPTORS IN THE CONTEXT OF THE IMPLEMENTATION OF THE PLANT 
PROTECTION PRODUCT REGULATION AND THE BIOCIDAL PRODUCTS REGULATION 
COMMUNICATION FROM THE EUROPEAN UNION 
The following communication, received on 1 October 2015, is being circulated at the request of the 
Delegation of the European Union. 
 
_______________ 
  
1.  This communication provides a summary of the report of the public consultation on defining 
criteria for identifying endocrine disruptors in the context of the implem entation of the plant 
protection product regulation and the biocidal products regulation which was launched by the 
European Commission in September 2014. The report was published on 24 July 2015 and is 
available on the website
1 of the Directorate General for Health and Food Safety of the European 
Commission. 
2.  In the European Union open public online  consultations are systematically part of the 
consultation strategy for initiatives subject to impact assessments. A public consultation on defining criteria for identifying endocrine disrupto rs in the context of the implementation of the 
plant protection products regulation and the bi ocidal products regulation took place from 
26 September 2014 to 16 January 2015 by means of an on-line consultation questionnaire. 
3.  The usual consultation period (12 weeks) was extended by three weeks to provide interested 
stakeholders with sufficient time for comments. Submissions were accepted in any official 
EU language. Responses were received throug h the online questionnaire or via e-mails. 
4.  The public consultation generated over 27,000 re sponses. This illustrates the significant public 
interest in the EU's policy on endocrine disruptors. The submissions received online can also be 
found on the website
2 of the Directorate General for Health and Food Safety of the European 
Commission. 
5.  Respondents came from various parts of society and included doctors, farmers, non-
governmental organizations, chemical, electron ic, food and medical devices industry, water 
companies and scientists. This shows how widely these chemicals are used. 
6.  Submissions from individuals accounted for mo re than 90% of all the responses received. Of 
these individual responses, 88% came from seven EU member States, i.e. Austria, Denmark, 
France, Germany, Spain, Sweden and the United Kingdom. 
7.  863 responses were made on behalf of an organization and 64% of them came from one 
EU member State, i.e. the United Kingdom. Almo st 26% of responses on behalf of organizations 
came from industry or trade organizations and 5% from consumer/non-governmental 
organizations. Only two health institutions and ho spitals responded. Three EU-governments as well 
as 18 EU public authorities have sent comments. 
                                               
1 http://ec.europa.eu/health/endocrine_disruptors/docs/2015_public_consultation_report_en.pdf . 
2 http://ec.europa.eu/dgs/health_food-
safety/dgs_consultations/food/consultation_20150116_endocrine-disruptors_en.htm . G/SPS/GEN/1448 
 
- 2 - 
 
  8.   Six public authorities and six governments in non-EU countries sent their comments: the 
Australian Government, the Kenya Plant Health In spectorate Service; the Norwegian Food Safety 
Authority, le Ministère de l'Agriculture de Côte d'Ivoire; the Government of Canada; Health Canada; Instituto Colombia Agropecuario (ICA); the Ministry of Agriculture, Livestock and Supply 
of Brazil; the Ministry for Primary Industries, Environmental Protection Authority and  Ministry of 
Foreign Affairs and Trade of New Zealand; Repúb lica Argentina and the United States Government. 
9.  The objective of this consultation was to gather information for the impact assessment on the 
establishment of criteria to identify endocrine di sruptors. This objective was reached as there were 
many respondents that provided information. The public consultation generated a great deal of 
data consisting of scientific articles, studies, reports, views and legal opinions. 
10.  The opinions of respondents varied signific antly on the options proposed in the road map
3 for 
defining criteria for identifying endocrine disrup tors and for approaches to regulatory decision 
making. The report provides an overview on the submitted arguments by respondents in favour or 
against the options as included in the roadmap. In general, respondents expressed diverging views 
on how to define criteria and how endocrine disruptors should be regulated. Overall, responses 
suggested that there was a need for the European Union to establish definitive criteria by the European Union for endocrine disruptors. The option of no policy change (the interim criteria set in 
the plant protection products and biocidal produc ts regulations continue to apply) was therefore 
not supported by the consultation. 
11.  Many respondents raised issues in relation to food safety, the threat that endocrine disrupting 
substances might pose to human health and/or the environment and the impact of the different 
options proposed in the roadmap on agriculture, industry, health and environment. In particular 
farmers and agri-business highlighted the potential high implications of setting criteria to identify endocrine disruptors on agriculture. Authorities from non-EU countries stressed the potential 
impact on international trade. A risk-based approach for regulating endocrine disruptors was 
proposed by many respondents who identified themselves as farmers, private companies, industrial or trade organzsations, or authorities in non-EU countries. Many respondents supported 
the use of the WHO/IPC 2002 definition as a starting point for defining an endocrine disruptor. 
Authorities in non-EU countries noted that any decision on endocrine disruptors must respect the principles of the World Trade Organization. 
12.  The public consultation provided an overview  on the type and size of impacts that may occur 
if a chemical would be identified as an endocrine disruptor, the methodologies that may be used to 
obtain this type of information and also data and references to studies and articles to be considered in the impact assessment. The outcome of  the public consultation provided useful input 
for impact assessment process that addresses the economic, environmental and health impacts of 
the different policy options. 
 
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3 http://ec.europa.eu/smart-
regulation/impact/planned_ia/docs/2014_env_009_endocrine_disruptors_en.pdf .