G/SPS/N/EU/227  
 
4 October 2017  
(17-5332) Page: 1/3 
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; ICS numbers should be provided in addition, 
where applicable): Fine bakery products for special nutritional uses  
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 (EU) amending Annex II to 
Regulation (EC) No 1333/2008 of the  European Parliament and of the Council as regards 
the use of sweeteners in fine bakery wares (Text with EEA relevance) . Language(s): 
English.  Number of pages: 4 and 2  
https://members.wto.org/crnattachments/2017/SPS/EEC/17_4521_00_e.pdf  
https://members.wto.org/crnattachments/2017/SPS/EEC/17_4521_01_e.pdf  
6. Description of content: The text takes away the authorisation of use of nine sweeteners 
(E 950 Acesulfame K, E 951 Aspartame, E952 Cyclamic acid and its Na and Ca salts, E 954 
Saccharin and its Na, K and Ca salts, E 955 Sucralose, E 959 Neohesperidine DC, E 961 
Neotame, E 962 Salt of aspartame -acesulfame and E 969 Advantame) in "fine bakery 
products for special nutritional uses" (food category 07.2 fine bakery wares of Annex II to 
Regulation (EC) No 1333/2008 on food additives).  
In order to allow economic o perators to adapt to the new rules, it is appropriate to provide 
for a transitional period during which fine bakery products for special nutritional uses 
containing any of those sweeteners may continue to be marketed.  
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:  
[X] Codex Alimentarius  Commission (e.g.  title or serial number of Codex 
standard or related text) : General standard for food additives - CODEX 
STAN  192-1995 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  G/SPS/N/EU/227  
 
- 2 - 
 
  Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard : The Codex Alimentarius Standard for food additives includes 
provisions for the use of INS 950 Acesulfame K, INS 951 Aspartame, INS 952 Cyclamates, 
INS 954 Saccharins, INS 955 Sucralose, INS 961 Neotame, and INS 962 aspartame -
acesulfame salt as sweeteners  in food category "07.2 fine bakery wares (sweet, salty, 
savoury) and mixes" for special nutritional uses only (footnote 77) or for use in products 
for special nutritional use only (footnote 165).  
In the European Union the use of sweeteners (E 950 Acesulfa me K, E 951 Aspartame, 
E952 Cyclamic acid and its Na and Ca salts, E 954 Sacchari n and its Na, K and Ca salts, 
E 955 Sucralose, E 959 Neohesperidine DC, E 961 Neotame, E 962 Salt of aspartame -
acesulfame and E 969 Advantame) in "fine bakery products for spe cial nutritional uses" 
was authorised by the European Parliament and Council Directive 94/35/EC. The food "fine 
bakery products for special nutritional uses" covered "food for persons suffering from 
carbohydrate metabolism disorders (diabetes)" regulated b y Council Directive 89/398/EEC. 
This Directive established a common definition for "foodstuffs for particular nutritional 
uses" and provided that specific provisions could be adopted as regards "food for persons 
suffering from carbohydrate metabolism disor ders (diabetes)", a category of food falling 
within the definition of foodstuffs for particular nutritional uses.  
However, as concluded in the Commission's report on foods for persons suffering from 
diabetes, the scientific basis for setting specific compo sitional requirements for those foods 
was lacking. Furthermore, Regulation (EU) No 609/2013 of the European Parliament and of 
the Council has abolished the concept of "foodstuffs for particular nutritional uses", 
including that of "food for persons sufferi ng from carbohydrate metabolism disorders 
(diabetes)".  
On 29 May 2017 the European Commission published the draft Commission Regulation in 
the Better Regulation Portal ( http://ec.europa.eu/info/law/better -regulation/initiatives/isc -
2017-02792_en ) for a feedback mechanism during 4 -weeks; the period of feedback 
mechanism ended on 26 June 2017. The comments received addressed mainly the 
establishment of a transitional period whereby fine bakery products for special nutritional 
uses should continue to be marketed.  
As a result of all the above, the authorisation of use of those nine sweeteners (E 950, 
E 951, E 952, E 954, E 955, E 959, E 961, E 962, E 969) in "fine bakery  products for 
special nutritional uses" in accordance with Article 7(c) of Regulation (EC) No 1333/2008 is 
no longer justified and those products should not continue to be marketed.  
However, the European Commission provides a transitional period during whi ch fine bakery 
products for special nutritional uses containing any of those nine sweeteners (E 950, 
E 951, E 952, E 954, E 955, E 959, E 961, E 962, E 969) that have been lawfully placed on 
the market before the entry into force of the Regulation may cont inue to be marketed until 
the stocks are exhausted.  
9. Other relevant documents and language(s) in which these are available:  
 European Parliament and Council Directive 94/35/EC (OJ L 237, 10 September 1994, 
p. 3) and Council Directive 89/398/EEC (OJ  L 186, 30 June 1989, p. 27)  
 Regulation (EU) No 609/2013 of the European Parliament and of the Council (OJ L 181, 
29 June 2013, p. 35).  
 Report from the Commission to the European Parliament and the Council on foods for 
persons suffering from carbohydrate metabolism disorders (diabetes) of 1 July 2008 
(COM(2008) 392 final)  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : Beginning of 2018  
Proposed date of publication (dd/mm/yy) : Beginning of 2018  G/SPS/N/EU/227  
 
- 3 - 
 
  11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Twenty days after 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) : 2 December 2017  
Agency or authority designated to handle 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 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [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 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu