Commission Regulation (EU) 2018/1497 of 8 October 2018 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards food category 17 and the use of food additives in food supplements (Text with EEA relevance.)
Date: 2018-10-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, food additive, food safety, food supplement, foodstuff, market approval








L_2018253EN.01003601.xml










9.10.2018   


EN


Official Journal of the European Union


L 253/36








            COMMISSION REGULATION (EU) 2018/1497
of 8 October 2018
         
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards food category 17 and the use of food additives in food supplements
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,


Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,

Whereas:







(1)


Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use.












(2)


Only food additives included in the Union list in Annex II to Regulation (EC) No 1333/2008 may be placed on the market as such and used in foods under the conditions of use specified therein.












(3)


That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.












(4)


The Union list includes food additives which are listed on the basis of the categories of food to which they may be added. In Part D of that list, food category 17 covers food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) excluding food supplements for infants and young children. Food category 17 includes three subcategories: 17.1 ‘Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms’, 17.2 ‘Food supplements supplied in a liquid form’ and 17.3 ‘Food supplements supplied in a syrup-type or chewable form’. Part E of the Union list sets out the authorised additives for each of these subcategories and their conditions of use.












(5)


It followed from the discussions with Member States (at the Working Party of Governmental Experts on Additives) that there are difficulties with the implementation of Annex II to Regulation (EC) No 1333/2008 on food additives, in particular for food subcategory 17.3 ‘Food supplements supplied in a syrup-type or chewable form’. This classification has led to misinterpretation and in order to avoid it, syrup- and chewable-forms should be categorised as liquid and solid forms, respectively.












(6)


Therefore, it is appropriate to delete food subcategory 17.3 and to reword the titles of food subcategories 17.1 and 17.2 to ‘Food supplements supplied in a solid form, excluding food supplements for infants and young children’ and ‘Food supplements supplied in a liquid form, excluding food supplements for infants and young children’ respectively. This will better reflect which products are covered by/included in each of the food subcategories. As a result of the deletion of food subcategory 17.3 food additives' entries which were included in that food subcategory should be transferred to either food subcategory 17.1 or 17.2 to ensure that there is transparency and legal certainty regarding the use of food additives in those foods. For clarity and enforcement purposes also the title of food category 17 should be amended to ‘Food supplements as defined in Directive 2002/46/EC’.












(7)


It also followed from the discussions with Member States that it should be clarified whether a maximum (use) level for the food additives in food category 17 applies to the food as marketed or to the food ready for consumption. Therefore, an introduction section should be included referring to certain food additives authorised in that food category. This is in line with the previous entries of those food additives within the Directives of the European Parliament and of the Council 94/35/EC (4), 94/36/EC (5) and 95/2/EC (6).












(8)


Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where such update is not liable to have an effect on human health. Since the Union list is amended to provide clarification to the current authorised uses of additives, it constitutes an update of that list which is not liable to have an effect on human health. Therefore, it is not necessary to seek the opinion of the Authority.












(9)


Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.












(10)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 October 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 354, 31.12.2008, p. 16.

(2)  
            OJ L 354, 31.12.2008, p. 1.

(3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

(4)  European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (OJ L 237, 10.9.1994, p. 3).

(5)  European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (OJ L 237, 10.9.1994, p. 13).

(6)  European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (OJ L 61, 18.3.1995, p. 1).




ANNEX
Annex II to Regulation (EC) No 1333/2008 is amended as follows:






(1)


in Part D, the entries for food category 17. ‘Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council excluding food supplements for infants and young children’ are replaced by the following:






‘17.




Food supplements as defined in Directive 2002/46/EC





17.1


Food supplements supplied in a solid form, excluding food supplements for infants and young children




17.2


Food supplements supplied in a liquid form, excluding food supplements for infants and young children’














(2)


Part E is amended as follows:






(a)


the entry for food category 17. ‘Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children’ is replaced as follows:






‘17.




Food supplements as defined in Directive 2002/46/EC





 


INTRODUCTION PART, APPLIES TO ALL SUBCATEGORIES




 


The maximum levels of use indicated for colours, polyols, sweeteners, and E 200-213, E 338-452, E 405, E 416, E 426, E 432-436, E 459, E 468, E 473-475, E 491-495, E 551-553, E 901-904, E 961, E 1201-1204, E 1505 and E 1521 refer to the food supplements ready for consumption prepared following the instructions of use provided by the manufacturer.
The dilution factor for those food supplements that have to be diluted or dissolved has to be communicated together with the instructions of use.’














(b)


the entry for food subcategory 17.1 is amended as follows:






(i)


the title is replaced by the following:






‘17.1


Food supplements supplied in a solid form, excluding food supplements for infants and young children’














(ii)


all the entries therein are replaced by the following entries, inserted in their numerical order:










 


‘Group I


Additives


 


 


E 410, E 412, E 415, E 417 and E 425 may not be used to produce dehydrated food supplements intended to rehydrate on ingestion




 


Group II


Colours at quantum satis




quantum satis



 


Period of application: until 31 July 2014




 


Group II


Colours at quantum satis




quantum satis



(69)


Period of application: from 1 August 2014




 


Group III


Colours with combined maximum limit


300


 


Period of application: until 31 July 2014




 


Group III


Colours with combined maximum limit


300


(69)


Period of application: from 1 August 2014




 


Group IV


Polyols



quantum satis



 


 




 


E 104


Quinoline Yellow


35


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 104


Quinoline Yellow


35


(61)(69)


Period of application: from 1 August 2014
except food supplements in chewable form




 


E 104


Quinoline Yellow


10


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 104


Quinoline Yellow


10


(61)(69)


Period of application: from 1 August 2014
only food supplements in chewable form




 


E 110


Sunset Yellow FCF/Orange Yellow S


10


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 110


Sunset Yellow FCF/Orange Yellow S


10


(61)(69)


Period of application: from 1 August 2014




 


E 124


Ponceau 4R, Cochineal Red A


35


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 124


Ponceau 4R, Cochineal Red A


35


(61)(69)


Period of application: from 1 August 2014
except food supplements in chewable form




 


E 124


Ponceau 4R, Cochineal Red A


10


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 124


Ponceau 4R, Cochineal Red A


10


(61)(69)


Period of application: from 1 August 2014
only food supplements in chewable form




 


E 160d


Lycopene


30


 


 




 


E 200-213


Sorbic acid — sorbates; Benzoic acid — benzoates


1 000 


(1) (2)


only food supplements in dried form and containing preparations of vitamin A and of combinations of vitamins A and D, except in chewable form




 


E 310-321


Propyl gallate, TBHQ, BHA and BHT


400


(1)


 




 


E 338-452


Phosphoric acid — phosphates — di-, tri- and polyphosphates



quantum satis



 


 




 


E 392


Extracts of rosemary


400


(46)


 




 


E 405


Propane-1, 2-diol alginate


1 000 


 


 




 


E 416


Karaya gum



quantum satis



 


 




 


E 426


Soybean hemicellulose


1 500 


 


 




 


E 432-436


Polysorbates



quantum satis



 


 




 


E 459


Beta-cyclodextrin



quantum satis



 


only food supplements in tablet and coated tablet form




 


E 468


Cross-linked sodium carboxy methyl cellulose


30 000 


 


except food supplements in chewable form




 


E 473-474


Sucrose esters of fatty acids — sucroglycerides



quantum satis



(1)


 




 


E 475


Polyglycerol esters of fatty acids



quantum satis



 


 




 


E 491-495


Sorbitan esters



quantum satis



(1)


 




 


E 551-559


Silicon dioxide — silicates



quantum satis



 


Period of application: until 31 January 2014




 


E 551-553


Silicon dioxide — silicates



quantum satis



 


Period of application: from 1 February 2014




 


E 900


Dimethyl polysiloxane


10


(91)


only food supplements in effervescent tablet form




 


E 901


Beeswax, white and yellow



quantum satis



 


 




 


E 902


Candelilla wax



quantum satis



 


 




 


E 903


Carnauba wax


200


 


 




 


E 904


Shellac



quantum satis



 


 




 


E 950


Acesulfame K


500


 


 




 


E 950


Acesulfame K


2 000 


 


only food supplements in chewable form




 


E 951


Aspartame


2 000 


 


 




 


E 951


Aspartame


5 500 


 


only food supplements in chewable form




 


E 952


Cyclamic acid and its Na and Ca salts


500


(51)


 




 


E 952


Cyclamic acid and its Na and Ca salts


1 250 


(51)


only food supplements in chewable form




 


E 954


Saccharin and its Na, K and Ca salts


500


(52)


 




 


E 954


Saccharin and its Na, K and Ca salts


1 200 


(52)


only food supplements in chewable form




 


E 955


Sucralose


800


 


 




 


E 955


Sucralose


2 400 


 


only food supplements in chewable form




 


E 957


Thaumatin


400


 


only food supplements in chewable form




 


E 959


Neohesperidine DC


100


 


 




 


E 959


Neohesperidine DC


400


 


only food supplements in chewable form




 


E 960


Steviol glycosides


670


(60)


 




 


E 960


Steviol glycosides


1 800 


(60)


only food supplements in chewable form




 


E 961


Neotame


60


 


 




 


E 961


Neotame


185


 


only food supplements in chewable form




 


E 961


Neotame


2


 


only as flavour enhancer, except food supplements in chewable form




 


E 961


Neotame


2


 


only vitamins and/or mineral based food supplements in chewable form, as a flavour enhancer




 


E 962


Salt of aspartame-acesulfame


500


(11)a (49) (50)


 




 


E 962


Salt of aspartame-acesulfame


2 000 


(11)a (49) (50)


only food supplements in chewable form




 


E 969


Advantame


20


 


 




 


E 969


Advantame


55


 


only food supplements in chewable form




 


E 1201


Polyvinylpyrrolidone



quantum satis



 


only food supplements in tablet and coated tablet form




 


E 1202


Polyvinylpolypyrrolidone



quantum satis



 


only food supplements in tablet and coated tablet form




 


E 1203


Polyvinyl alcohol (PVA)


18 000 


 


only food supplements in capsule and tablet form




 


E 1204


Pullulan



quantum satis



 


only food supplements in capsule and tablet form




 


E 1205


Basic methacrylate copolymer


100 000 


 


except food supplements in chewable form




 


E 1206


Neutral methacrylate copolymer


200 000 


 


except food supplements in chewable form




 


E 1207


Anionic methacrylate copolymer


100 000 


 


except food supplements in chewable form




 


E 1208


Polyvinylpyrrolidone-vinyl acetate copolymer


100 000 


 


except food supplements in chewable form




 


E 1209


Polyvinyl alcohol-polyethylene glycol-graft-co-polymer


100 000 


 


except food supplements in chewable form




 


E 1505


Triethyl citrate


3 500 


 


only food supplements in capsule and tablet form




 


E 1521


Polyethylene glycol


10 000 


 


only food supplements in capsule and tablet form’


















(c)


the entry for food subcategory 17.2 is amended as follows:






(i)


the title is replaced by the following:






‘17.2


Food supplements supplied in a liquid form, excluding food supplements for infants and young children’














(ii)


all the entries therein are replaced by the following entries, inserted in their numerical order:










 


‘Group I


Additives


 


 


 




 


Group II


Colours at quantum satis




quantum satis



 


 




 


Group II


Colours at quantum satis




quantum satis



 


Period of application: until 31 July 2014




 


Group II


Colours at quantum satis




quantum satis



(69)


Period of application: from 1 August 2014
only food supplements in syrup form




 


Group III


Colours with combined maximum limit


100


 


 




 


Group IV


Polyols



quantum satis



 


 




 


E 104


Quinoline Yellow


10


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 104


Quinoline Yellow


10


(61)(69)


Period of application: from 1 August 2014




 


E 110


Sunset Yellow FCF/Orange Yellow S


10


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 110


Sunset Yellow FCF/Orange Yellow S


10


(61)(69)


Period of application: from 1 August 2014




 


E 124


Ponceau 4R, Cochineal Red A


10


(61)


Period of application: from 1 January 2014 to 31 July 2014




 


E 124


Ponceau 4R, Cochineal Red A


10


(61)(69)


Period of application: from 1 August 2014




 


E 160d


Lycopene


30


 


 




 


E 200-213


Sorbic acid — sorbates; Benzoic acid — benzoates


2 000 


(1) (2)


except food supplements in syrup form




 


E 310-321


Propyl gallate, TBHQ, BHA and BHT


400


(1)


 




 


E 338-452


Phosphoric acid — phosphates — di-, tri- and polyphosphates



quantum satis



 


 




 


E 392


Extracts of rosemary


400


(46)


 




 


E 405


Propane-1, 2-diol alginate


1 000 


 


 




 


E 416


Karaya gum



quantum satis



 


 




 


E 426


Soybean hemicellulose


1 500 


 


 




 


E 432-436


Polysorbates



quantum satis



 


 




 


E 473-474


Sucrose esters of fatty acids — sucroglycerides



quantum satis



(1)


 




 


E 475


Polyglycerol esters of fatty acids



quantum satis



 


 




 


E 491-495


Sorbitan esters



quantum satis



(1)


 




 


E 551-559


Silicon dioxide — silicates



quantum satis



 


Period of application: until 31 January 2014




 


E 551-553


Silicon dioxide — silicates



quantum satis



 


Period of application: from 1 February 2014




 


E 950


Acesulfame K


350


 


 




 


E 950


Acesulfame K


2 000 


 


only food supplements in syrup form




 


E 951


Aspartame


600


 


 




 


E 951


Aspartame


5 500 


 


only food supplements in syrup form




 


E 952


Cyclamic acid and its Na and Ca salts


400


(51)


 




 


E 952


Cyclamic acid and its Na and Ca salts


1 250 


(51)


only food supplements in syrup form




 


E 954


Saccharin and its Na, K and Ca salts


80


(52)


 




 


E 954


Saccharin and its Na, K and Ca salts


1 200 


(52)


only food supplements in syrup form




 


E 955


Sucralose


240


 


 




 


E 955


Sucralose


2 400 


 


only food supplements in syrup form




 


E 957


Thaumatin


400


 


only food supplements in syrup form




 


E 959


Neohesperidine DC


50


 


 




 


E 959


Neohesperidine DC


400


 


only food supplements in syrup form




 


E 960


Steviol glycosides


200


(60)


 




 


E 960


Steviol glycosides


1 800 


(60)


only food supplements in syrup form




 


E 961


Neotame


20


 


 




 


E 961


Neotame


185


 


only food supplements in syrup form




 


E 961


Neotame


2


 


only as flavour enhancer, except food supplements in syrup form




 


E 961


Neotame


2


 


only vitamins and/or mineral based food supplements in syrup form, as a flavour enhancer




 


E 962


Salt of aspartame-acesulfame


350


(11)a (49) (50)


 




 


E 962


Salt of aspartame-acesulfame


2 000 


(11)a (49) (50)


only food supplements in syrup form




 


E 969


Advantame


6


 


 




 


E 969


Advantame


55


 


only food supplements in syrup form’