G/SPS/N/EU/127  
 
29 April 2015  
(15-2325)  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: Directorate General for Health and Food 
Safety 
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 including 
catering containers and materials and articles in contact with drinking water (HS Codes: 
3919, 3920, 3923, 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: Draft Commission Regulation amending and correcting 
Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into 
contact with food (Text with EEA relevance)  Language(s): English  Number of pages: 
9 and 11 
http://members.wto.org/crnattachments/2015/SPS/EEC/15_1816_00_e.pdf  
http://members.wto.org/crnattachments/2015/SPS/EEC/15_1816_01_e.pdf  
6. Description of content: The proposed Commission Regulation would amend 
Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food. Regulation (EU) No. 10/2011 is a specific Regulation within 
the framework Regulation (EC) No. 1935/20 04. The latter sets out principles and 
procedures applicable to food contact materials. 
This amendment changes the enacting terms, adds 8 substances [FCM 871:dodecanoic 
acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro- ω-hydroxypoly 
(oxy-1,2-ethanediyl) and 1-propene; FCM 1031: furan-2,5-dicarboxylic acid; FCM 1034: 
1,7-octadiene; FCM 1045: perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt; FCM 1048: ethylene glycol dipalmitate; FCM 1051: N,N'-
bis(2,2,6,6-tetramethyl-4-piperidinyl) Isophthalamide; FCM 1052: 2,4,8,10-
tetraoxaspiro[5.5] undecane-3,9-diethanol, β3,β3,β9,β9-tetramethyl- ('SPG'); FCM 1053: 
fatty acids, C16–18 saturated, esters with dipentaerythritol] to Table 1 of Annex 1 (list 
of approved substances) and sets new limits for aluminium, nickel and zinc. It also 
proposes to set migration limits for oligomers related to three substances and would require that methods to detect these oligomers are publicly available before the substances can be used. 
Moreover the amendment would define rubbe r for the purpose of the Regulation and 
prolong the derogation for the use of constituents of silicone sizing agents is applicable. G/SPS/N/EU/127 
 
- 2 - 
 
  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 number of Codex 
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 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:  
10. Proposed date of adoption (dd/mm/yy) : December 2015 
Proposed date of publication (dd/mm/yy) : December 2015 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days following its publication in the Official Journal of the 
European Union. 
[ ] Trade facilitating measure   
12. Final date for comments: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 28 June 2015 
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 G6 – Multilateral international relations 
Rue Froissart 101 B 1049 Brussels Tel: +32 (0) 2 29 68185/59922 
Fax: +32 (0) 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 G6 – Multilateral international relations 
Rue Froissart 101 B 1049 Brussels 
Tel: +32 (0) 2 29 68185/59922 
Fax: +32 (0) 2 29 98090 E-mail: sps@ec.europa.eu