G/SPS/GEN/1594  
G/TBT/GEN/241  
 
20 December 2017  
(17-7110) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  
Committee on Technical Barriers to Trade  Original: English  
 
INFORMATION TO WTO M EMBERS  
ON THE LATEST DEVELO PMENTS ON ENDOCRINE DISRUPTORS  
COMMUNICATION FROM T HE EUROPEAN UNION  
The following communication, received on 1 8 December 2017, is being circulated at the request of 
the Delegation of  the European Union . 
 
_______________  
 
 
The European Union (EU) would like to inform WTO Members of the latest developments as 
regards the setting of scientific criteria to identify endocrine disruptors (EDs) in the context of the 
implementation of the plant protection products1 and biocidal products2 Regulations.  
1  BACKGROUND  
1.1.  On 15 June 2016, two draft legal acts setting criteria to identify endocrine disruptors under 
the plant protection products and biocidal products Regulations were issued by the European 
Commission (Commissio n). Both proposals were notified to the WTO in notifications 
G/SPS/N/EU/166, G/TBT/N/EU/383 and G/TBT/N/EU/384. The EU reply to the comments received 
on the SPS notification was sent to all WTO Members on 24 February 2017. The EU replies  to the 
comments re ceived on the TBT notifications were sent to each commenting Member on 
22 February 2017.  
1.2.  During the consultation and decision making process that took place after the publication of 
the draft legal acts the Commission introduced changes in the drafts takin g into account the 
comments received from EU member States, stakeholders and non -EU countries. These changes 
were considered non -substantial compared to the texts notified to the WTO.  
1.3.  In December 2016, the draft Regulation setting criteria for identifying endocrine disruptors 
for plant protection products was split into two parts without any change in content: one text 
containing the criteria for identifying EDs, and the other containing a proposed amendment to the 
derogation possibility based on negligible  exposure. This allows EU member States and co -
legislators (the European Council and the European Parliament) to express their opinion on each 
act separately and in sequence.  
1.4.  The draft act on the derogation possibility was put on hold until agreement is re ached on the 
criteria by the EU co -legislators.  
1.5.  As reported by the European Union at the last SPS Committee meeting, the draft Regulation 
setting criteria for plant protection products was endorsed by EU member States on 4 July 2017 
and was then subjected to the scrutiny of the co -legislators.  
                                                
1 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/E EC 
and 91/414/EEC (OJ L 309, 24 November 2009, p. 1 –50). 
2 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 
concerning the making available on the market and use of biocidal products (OJ L 167, 27  June 2012, p. 1 –
123). G/SPS/GEN/1594 • G/TBT/GEN/241  
 
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  1.6.  On 4 October 2017, the European Parliament objected to this draft Regulation on the basis 
that a specific provision related to active substances with an intended endocrine mode of action 
exceeded the Commission's impl ementing powers.  
2  LATEST DEVELOPMENTS AND NEXT STEPS  
2.1.  At a meeting on 13 December 2017, EU member States endorsed a new version of the draft 
Regulation on setting criteria for plant protection products, recently proposed by the Commission, 
which takes into a ccount the views of the European Parliament. The text endorsed does not differ 
significantly from the text notified to the WTO in 2016.  
2.2.  The endorsed draft criteria will now be sent to the co -legislators for their scrutiny. It will be 
eventually adopted by the Commission if there are no objections from any of these institutions.  
2.3.  As far as the proposed Regulation setting criteria to identify endocrine disruptors under the 
biocidal products Regulation is concerned, it was adopted on 4 September 2017 and follow ing the 
completion of the scrutiny period of co -legislators, it was published on 17 November 2017 as 
Regulation (EU) 2017/21003. The criteria entered into force on 7 December 2017 and will be 
applicable from 7 June 2018, including for substances still unde r evaluation at that time.  
2.4.  Finally, the European Union would like to report that the European Chemicals Agency and the 
European Food Safety Authority have launched a public consultation on the draft technical 
Guidance document to implement the criteria onc e they become applicable for biocides and 
pesticides. The public consultation is open until 31 January 2018 and WTO Members are invited to 
submit comments4. 
2.5.  The European Union remains committed to keeping its trade partners fully informed of further 
develo pments.  
2.6.  All relevant information on the matter is available on the Commission's website5. 
 
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3 Commission Delegated Regulation (EU) 2017/2100 of 4 September setting out scientific criteria for the 
determination of endocrine -disrupting properties pursuant to Regulation (EU) No 528/2012 of the European 
Parliament and Council (OJ L 301, 17  Novembe r 2017, p. 1 –5). 
4 https://comments.echa.europa.eu/comments_cms/PC_ED_Guidance.aspx . 
5 http://ec.europa.eu/health/endocrine_disruptors/next_steps_en .