G/SPS/N/MKD/10  
 
21 November 2019  
(19-7929) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  NORTH MACEDONIA  
If applicable, name of local government involved:   
2. Agency responsible:  Food and Veterinary Agency of the Republic of North Macedonia  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Plastic materials and articles in contact with food  
4. Regions or countries likely to be affected, to the extent relevant o r practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Rulebook on plastic materials and articles intended to 
come into contact with food . Language(s):  Macedonian . Number of pages:  16+100  
6. Description of content:  This Rulebook establishes specific requirements for the 
manufacture and marketing of plastic m aterials and articles intended to come into contact 
with food, or already in contact with food, or which can reasonably be expected to come 
into contact with food.  
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 standard? 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:   G/SPS/N/MKD/10  
 
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  9. Other relevant documents and language(s) in which these are available:   
− Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and 
articles intended to come into contact with food  
− Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011 amending 
Regulation (EU) No 10/2011 as regards the restriction of use of Bisphenol A in plastic 
infant feeding bottles  
− Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and 
correcting Commission Regulation (EU) No 10/2011 on plastic materials and articles 
intended to come into contact wi th food  
− Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and 
correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to 
come into contact with food  
− Commission Regulation (EU) No 202/2014 of 3 March 2014 amending  Regulation (EU) 
No 10/2011 on plastic materials and articles intended to come into contact with food  
− Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting 
Regulation (EU) No 10/2011 on plastic materials and articles intended to co me into 
contact with food  
− Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting 
Regulation (EU) No 10/2011 on plastic materials and articles intended to come into 
contact with food  
− Commission Regulation (EU) 2018/79 of 18 January 201 8 amending Regulation (EU) 
No 10/2011 on plastic materials and articles intended to come into contact with food  
− Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of bisphenol 
A in varnishes and coatings intended to come into contact with f ood and amending 
Regulation (EU) No 10/2011 as regards the use of that substance in plastic food 
contact materials  
− Commission Regulation (EU) 2018/831 of 5 June 2018 amending Regulation (EU) 
No 10/2011 on plastic materials and articles intended to come int o contact with food   
10. Proposed date of adoption (dd/mm/yy) : To be determined.  
Proposed date of publication (dd/mm/yy) : To be determined.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : Eight days after its publication in the Official Journal of North 
Macedonia.  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 30 days from the date of circulat ion of the 
notification.  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body: