G/TBT/N/EU/384  
 
23 June 2016  
(16-3406)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: European Commission 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above : 
European Commission 
EU-TBT Enquiry Point 
Fax: +(32) 2 299 80 43 E-mail: grow-eu-tbt@ec.europa.eu   
Website: http://ec.europa.eu/growth/tools-databases/tbt/   
3. Notified under Article 2.9.2 [X], 2.10 .1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Biocidal active 
substances 
5. Title, number of pages and language(s) of the notified document: Draft Commission 
Delegated Regulation setting out scientific criteria for the determination of endocrine-
disrupting properties pursuant to Regulation (EU) No 528/2012 (4 pages + Annex 4 pages, 
in English) 
6. Description of content: This draft Commission Regulation sets the specific scientific 
criteria in relation to the endocrine disrupti ng properties for the approval of the active 
substances for use in biocidal products in accordance with Regulation (EU) No 528/2012.  
The criteria are based on the definition of endocrine disruptors published in 2002 by the 
World Health Organisation (WHO) through its International Programme for Chemical Safety 
(WHO/IPCS). 
The draft regulation was preceded by an impact assessment and a public consultation. 
In accordance with Regulation (EU) No 528/2012 if an active substance is found to be an 
endocrine disruptor according to the criteria set in this draft regulation, it shall not be approved for use in biocidal products or treated articles unless the conditions in Article 
5(2) are met. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human and animal health; protection of the environment.  
Regulation (EU) No 528/2012 requires the Commission to adopt specific scientific criteria 
for the determination of endocrine disrupting properties. 
When adopted these criteria will replace the interim criteria which are now applicable. 
The new criteria are based on the latest scienti fic information and are designed to ensure a 
better protection of human health, animal health, and the environment. G/TBT/N/EU/384 
 
- 2 - 
 
  8. Relevant documents:  
 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: http://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1464708384175&uri=CELEX:02012R0528-20140425  
 Commission Communication: 
http://ec.europa.eu/health/endocrine_disruptors/docs/com_2016_350_en.pdf  
 Public consultation report: ( http://ec.europa.eu/dgs/health_food-
safety/dgs_consultations/food /consultation_20150116_endocrine-
disruptors_en.htm ) 
 Impact assessment: 
http://ec.europa.eu/health/endocrine_disruptors/policy/index_en.htm  
9. Proposed date of adoption: Fourth quarter 2016 
Proposed date of entry into force: 1 January 2017   
10. Final date for comments: 60 days from notification 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
European Commission 
EU-TBT Enquiry Point 
Fax: + (32) 2 299 80 43 
E-mail: grow-eu-tbt@ec.europa.eu   
The text is available on the Website: http://ec.europa.eu/growth/tools-databases/tbt/   
https://members. wto.org/crnattachments/2016/TBT/EEC/16_2525_00_e.pdf   
https://members. wto.org/crnattachments/2016/TBT/EEC/16_2525_01_e.pdf