G/SPS/N/EU/159  
 
14 March 2016  
(16-1443)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: EUROPEAN UNION 
If applicable, name of local government involved:   
2. Agency responsible: European Commission: Health and Food Safety Directorate-
General 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Materials and articles in contact with food 
(HS Codes: 3919, 3920, 3923 and 3924; ICS Code: 67.250) 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Commission Regulation on the use of bisphenol A in 
varnishes and coatings intended to come into contact with food and amending 
Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact 
materials (Text with EEA relevance)   Language(s): English  Number of pages: 6+3 
http://members.wto.org/crnattachments/2016/SPS/EEC/16_1018_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_1018_01_e.pdf  
6. Description of content: The draft regulation lowers the specific migration limit (SML) 
for BPA from plastic food contact materials in line with the EFSA opinion published in 
January 2015. It therefore amends Commissio n Regulation (EU) No 10/2011 on plastic 
materials and articles intended to come into contact with food. 
In addition, it applies the same SML to BPA from a varnish or coating applied to 
materials and articles. The notified draft also sets out the criteria for verification of compliance concerning varnishes and coatings, as well as laying down the requirements for the written declaration of compliance (DoC) for varnished or coated materials and 
articles. 
7. Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   
8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None G/SPS/N/EU/159 
 
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  Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language (s) in which these are available:  
 Regulation (EC) 1935/2004 of the European Parliament and of the Council of 
27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13 November 
2004, p. 4) 
http://eur-lex.europa.eu/legal-conte nt/en/ALL/?uri=CELEX%3A32004R1935  
 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials 
and articles intended to come into co ntact with food (OJ L 12, 15 January 2011, 
p. 1-89) 
http://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1456844842696&uri=CELEX:32011R0010  
 EFSA opinion (available in English only) 
The EFSA Journal 2015; 13(1):3978 
(available in English) 
10. Proposed date of adoption (dd/mm/yy) : September 2016  
Proposed date of publication (dd/mm/yy) : September 2016  
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : On the 20th day following its publication in the Official Journal of 
the European Union (the provisions shall apply from six months after the entry into force 
of the Regulation). 
[ ] Trade facilitating measure   
12. Final date for comments: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 13 May 2016 
Agency or authority designated to hand le comments: [X] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
European Commission 
DG Health and Food Safety, Unit D2 - Multilateral international relations 
Rue Froissart 101 
B 1049 Brussels Tel: +(32 2) 29 68185/59922 
Fax: +(32 2) 29 98090 
E-mail: sps@ec.europa.eu 
13. Text(s) available from: [X] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 - Multilateral international relations 
Rue Froissart 101 
B 1049 Brussels Tel: +(32 2) 29 68185/59922 
Fax: +(32 2) 2998090 
E-mail: sps@ec.europa.eu