CELEX: 32009R1170
Language: en
Date: 2009-11-30 00:00:00
Title: Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements (Text with EEA relevance)

1.12.2009   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 314/36
            
         
      COMMISSION REGULATION (EC) No 1170/2009
   of 30 November 2009
   amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to 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 (1), and in particular Article 4(5) thereof,
   Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (2), and in particular Article 3(3) thereof,
   After consulting the European Food Safety Authority,
   Whereas:
   
               (1)
            
            
               Annexes I and II to Directive 2002/46/EC establish the lists of vitamins and minerals, and for each of them the forms, that may be used for the manufacture of food supplements. Modifications to these lists are to be adopted in compliance with the requirements laid down in Article 4 of that Directive and in accordance with the procedure referred to in its Article 13(3).
            
         
               (2)
            
            
               Annexes I and II to Regulation (EC) No 1925/2006 establish the lists of vitamins and minerals, and for each of them the forms, that may be added to food. Modifications to these lists are to be adopted in compliance with the requirements laid down in Article 3 of that Regulation and in accordance with the procedure referred to in its Article 14(3).
            
         
               (3)
            
            
               New vitamin and mineral forms have been evaluated by the European Food Safety Authority. The substances which have received a favourable scientific opinion and for which the requirements laid down in Directive 2002/46/EC and in Regulation (EC) No 1925/2006 are complied with should be added to the respective lists in those acts.
            
         
               (4)
            
            
               Interested parties were consulted and the provided comments were taken into consideration.
            
         
               (5)
            
            
               Following the scientific evaluation by the European Food Safety Authority, it is appropriate to introduce specifications for some vitamin and mineral substances for their identification.
            
         
               (6)
            
            
               Directive 2002/46/EC and Regulation (EC) No 1925/2006 should therefore be amended accordingly.
            
         
               (7)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   Annexes I and II to Directive 2002/46/EC are replaced respectively by the texts in Annex I and II to this Regulation.
   Article 2
   Regulation (EC) No 1925/2006 is amended as follows:
   
               1)
            
            
               In Annex I, the word ‘Boron’ is added in the list in point 2.
            
         
               2)
            
            
               Annex II is replaced by the text in Annex III to this Regulation.
            
         Article 3
   This Regulation shall enter into force on the 20th day following 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, 30 November 2009.
      
         
            For the Commission
         
         Androulla VASSILIOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 183, 12.7.2002, p. 51.
   
      (2)  OJ L 404, 30.12.2006, p. 26.
   
      ANNEX I
      
         
            ‘ANNEX I
            
               Vitamins and minerals which may be used in the manufacture of food supplements
            
            1.   Vitamins
            
            Vitamin A (μg RE)
            Vitamin D (μg)
            Vitamin E (mg a-TE)
            Vitamin K (μg)
            Vitamin B1 (mg)
            Vitamin B2 (mg)
            Niacin (mg NE)
            Pantothenic acid (mg)
            Vitamin B6 (mg)
            Folic acid (μg) (1)
            
            Vitamin B12 (μg)
            Biotin (μg)
            Vitamin C (mg)
            2.   Minerals
            
            Calcium (mg)
            Magnesium (mg)
            Iron (mg)
            Copper (μg)
            Iodine (μg)
            Zinc (mg)
            Manganese (mg)
            Sodium (mg)
            Potassium (mg)
            Selenium (μg)
            Chromium (μg)
            Molybdenum (μg)
            Fluoride (mg)
            Chloride (mg)
            Phosphorus (mg)
            Boron (mg)
            Silicon (mg)
         
      
      
         (1)  Folic acid is the term included in Annex I of Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions for nutrition labelling purposes and covers all forms of folates.’
   
   
      ANNEX II
      
         
            ‘ANNEX II
            
               Vitamin and mineral substances which may be used in the manufacture of food supplements
            
            A.   Vitamins
            
            1.   VITAMIN A
            
                        (a)
                     
                     
                        retinol
                     
                  
                        (b)
                     
                     
                        retinyl acetate
                     
                  
                        (c)
                     
                     
                        retinyl palmitate
                     
                  
                        (d)
                     
                     
                        beta-carotene
                     
                  2.   VITAMIN D
            
                        (a)
                     
                     
                        cholecalciferol
                     
                  
                        (b)
                     
                     
                        ergocalciferol
                     
                  3.   VITAMIN E
            
                        (a)
                     
                     
                        D-alpha-tocopherol
                     
                  
                        (b)
                     
                     
                        DL-alpha-tocopherol
                     
                  
                        (c)
                     
                     
                        D-alpha-tocopheryl acetate
                     
                  
                        (d)
                     
                     
                        DL-alpha-tocopheryl acetate
                     
                  
                        (e)
                     
                     
                        D-alpha-tocopheryl acid succinate
                     
                  
                        (f)
                     
                     
                        mixed tocopherols (1)
                        
                     
                  
                        (g)
                     
                     
                        tocotrienol tocopherol (2)
                        
                     
                  4.   VITAMIN K
            
                        (a)
                     
                     
                        phylloquinone (phytomenadione)
                     
                  
                        (b)
                     
                     
                        menaquinone (3)
                        
                     
                  5.   VITAMIN B1
            
                        (a)
                     
                     
                        thiamin hydrochloride
                     
                  
                        (b)
                     
                     
                        thiamin mononitrate
                     
                  
                        (c)
                     
                     
                        thiamine monophosphate chloride
                     
                  
                        (d)
                     
                     
                        thiamine pyrophosphate chloride
                     
                  6.   VITAMIN B2
            
                        (a)
                     
                     
                        riboflavin
                     
                  
                        (b)
                     
                     
                        riboflavin 5′-phosphate, sodium
                     
                  7.   NIACIN
            
                        (a)
                     
                     
                        nicotinic acid
                     
                  
                        (b)
                     
                     
                        nicotinamide
                     
                  
                        (c)
                     
                     
                        inositol hexanicotinate (inositol hexaniacinate)
                     
                  8.   PANTOTHENIC ACID
            
                        (a)
                     
                     
                        D-pantothenate, calcium
                     
                  
                        (b)
                     
                     
                        D-pantothenate, sodium
                     
                  
                        (c)
                     
                     
                        dexpanthenol
                     
                  
                        (d)
                     
                     
                        pantethine
                     
                  9.   VITAMIN B6
            
                        (a)
                     
                     
                        pyridoxine hydrochloride
                     
                  
                        (b)
                     
                     
                        pyridoxine 5′-phosphate
                     
                  
                        (c)
                     
                     
                        pyridoxal 5′-phosphate
                     
                  10.   FOLATE
            
                        (a)
                     
                     
                        pteroylmonoglutamic acid
                     
                  
                        (b)
                     
                     
                        calcium-L-methylfolate
                     
                  11.   VITAMIN B12
            
                        (a)
                     
                     
                        cyanocobalamin
                     
                  
                        (b)
                     
                     
                        hydroxocobalamin
                     
                  
                        (c)
                     
                     
                        5′-deoxyadenosylcobalamin
                     
                  
                        (d)
                     
                     
                        methylcobalamin
                     
                  12.   BIOTIN
            
                        (a)
                     
                     
                        D-biotin
                     
                  13.   VITAMIN C
            
                        (a)
                     
                     
                        L-ascorbic acid
                     
                  
                        (b)
                     
                     
                        sodium-L-ascorbate
                     
                  
                        (c)
                     
                     
                        calcium-L-ascorbate (4)
                        
                     
                  
                        (d)
                     
                     
                        potassium-L-ascorbate
                     
                  
                        (e)
                     
                     
                        L-ascorbyl 6-palmitate
                     
                  
                        (f)
                     
                     
                        magnesium L-ascorbate
                     
                  
                        (g)
                     
                     
                        zinc L-ascorbate
                     
                  B.   Minerals
            
            calcium acetate
            calcium L-ascorbate
            calcium bisglycinate
            calcium carbonate
            calcium chloride
            calcium citrate malate
            calcium salts of citric acid
            calcium gluconate
            calcium glycerophosphate
            calcium lactate
            calcium pyruvate
            calcium salts of orthophosphoric acid
            calcium succinate
            calcium hydroxide
            calcium L-lysinate
            calcium malate
            calcium oxide
            calcium L-pidolate
            calcium L-threonate
            calcium sulphate
            magnesium acetate
            magnesium L-ascorbate
            magnesium bisglycinate
            magnesium carbonate
            magnesium chloride
            magnesium salts of citric acid
            magnesium gluconate
            magnesium glycerophosphate
            magnesium salts of orthophosphoric acid
            magnesium lactate
            magnesium L-lysinate
            magnesium hydroxide
            magnesium malate
            magnesium oxide
            magnesium L-pidolate
            magnesium potassium citrate
            magnesium pyruvate
            magnesium succinate
            magnesium sulphate
            magnesium taurate
            magnesium acetyl taurate
            ferrous carbonate
            ferrous citrate
            ferric ammonium citrate
            ferrous gluconate
            ferrous fumarate
            ferric sodium diphosphate
            ferrous lactate
            ferrous sulphate
            ferric diphosphate (ferric pyrophosphate)
            ferric saccharate
            elemental iron (carbonyl + electrolytic + hydrogen reduced)
            ferrous bisglycinate
            ferrous L-pidolate
            ferrous phosphate
            iron (II) taurate
            cupric carbonate
            cupric citrate
            cupric gluconate
            cupric sulphate
            copper L-aspartate
            copper bisglycinate
            copper lysine complex
            copper (II) oxide
            sodium iodide
            sodium iodate
            potassium iodide
            potassium iodate
            zinc acetate
            zinc L-ascorbate
            zinc L-aspartate
            zinc bisglycinate
            zinc chloride
            zinc citrate
            zinc gluconate
            zinc lactate
            zinc L-lysinate
            zinc malate
            zinc mono-L-methionine sulphate
            zinc oxide
            zinc carbonate
            zinc L-pidolate
            zinc picolinate
            zinc sulphate
            manganese ascorbate
            manganese L-aspartate
            manganese bisglycinate
            manganese carbonate
            manganese chloride
            manganese citrate
            manganese gluconate
            manganese glycerophosphate
            manganese pidolate
            manganese sulphate
            sodium bicarbonate
            sodium carbonate
            sodium chloride
            sodium citrate
            sodium gluconate
            sodium lactate
            sodium hydroxide
            sodium salts of orthophosphoric acid
            potassium bicarbonate
            potassium carbonate
            potassium chloride
            potassium citrate
            potassium gluconate
            potassium glycerophosphate
            potassium lactate
            potassium hydroxide
            potassium L-pidolate
            potassium malate
            potassium salts of orthophosphoric acid
            L-selenomethionine
            selenium enriched yeast (5)
            
            selenious acid
            sodium selenate
            sodium hydrogen selenite
            sodium selenite
            chromium (III) chloride
            chromium (III) lactate trihydrate
            chromium nitrate
            chromium picolinate
            chromium (III) sulphate
            ammonium molybdate (molybdenum (VI))
            potassium molybdate (molybdenum (VI))
            sodium molybdate (molybdenum (VI))
            calcium fluoride
            potassium fluoride
            sodium fluoride
            sodium monofluorophosphate
            boric acid
            sodium borate
            choline-stabilised orthosilicic acid
            silicon dioxide
            silicic acid (6)
            
         
      
      
         (1)  alpha-tocopherol < 20 %, beta-tocopherol < 10 %, gamma-tocopherol 50-70 % and delta-tocopherol 10-30 %
      
         (2)  Typical levels of individual tocopherols and tocotrienols:
      
                  —
               
               
                  115 mg/g alpha-tocopherol (101 mg/g minimum),
               
            
                  —
               
               
                  5 mg/g beta-tocopherol (< 1 mg/g minimum),
               
            
                  —
               
               
                  45 mg/g gamma-tocopherol (25 mg/g minimum),
               
            
                  —
               
               
                  12 mg/g delta-tocopherol (3 mg/g minimum),
               
            
                  —
               
               
                  67 mg/g alpha-tocotrienol (30 mg/g minimum),
               
            
                  —
               
               
                  < 1 mg/g beta-tocotrienol (< 1 mg/g minimum),
               
            
                  —
               
               
                  82 mg/g gamma-tocotrienol (45 mg/g minimum),
               
            
                  —
               
               
                  5 mg/g delta-tocotrienol (< 1 mg/g minimum),
               
            
         (3)  Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.
      
         (4)  May contain up to 2 % of threonate.
      
         (5)  Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dried form as marketed, not more than 2,5 mg Se/g. The predominant organic selenium species present in the yeast is selenomethionine (between 60 and 85 % of the total extracted selenium in the product). The content of other organic selenium compounds including selenocysteine shall not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally shall not exceed 1 % of total extracted selenium.
      
         (6)  In the form of gel.’
   
   
      ANNEX III
      
         
            ‘ANNEX II
            
               Vitamin formulations and mineral substances which may be added to foods
            
            1.   Vitamin formulations
            
            VITAMIN A
            retinol
            retinyl acetate
            retinyl palmitate
            beta-carotene
            VITAMIN D
            cholecalciferol
            ergocalciferol
            VITAMIN E
            D-alpha-tocopherol
            DL-alpha-tocopherol
            D-alpha-tocopheryl acetate
            DL-alpha-tocopheryl acetate
            D-alpha-tocopheryl acid succinate
            VITAMIN K
            phylloquinone (phytomenadione)
            menaquinone (1)
            
            VITAMIN B1
            thiamin hydrochloride
            thiamin mononitrate
            VITAMIN B2
            riboflavin
            riboflavin 5′-phosphate, sodium
            NIACIN
            nicotinic acid
            nicotinamide
            PANTOTHENIC ACID
            D-pantothenate, calcium
            D-pantothenate, sodium
            dexpanthenol
            VITAMIN B6
            pyridoxine hydrochloride
            pyridoxine 5′-phosphate
            pyridoxine dipalmitate
            FOLIC ACID
            pteroylmonoglutamic acid
            calcium-L-methylfolate
            VITAMIN B12
            cyanocobalamin
            hydroxocobalamin
            BIOTIN
            D-biotin
            VITAMIN C
            L-ascorbic acid
            sodium-L-ascorbate
            calcium-L-ascorbate
            potassium-L-ascorbate
            L-ascorbyl 6-palmitate
            2.   Mineral substances
            
            calcium carbonate
            calcium chloride
            calcium citrate malate
            calcium salts of citric acid
            calcium gluconate
            calcium glycerophosphate
            calcium lactate
            calcium salts of orthophosphoric acid
            calcium hydroxide
            calcium malate
            calcium oxide
            calcium sulphate
            magnesium acetate
            magnesium carbonate
            magnesium chloride
            magnesium salts of citric acid
            magnesium gluconate
            magnesium glycerophosphate
            magnesium salts of orthophosphoric acid
            magnesium lactate
            magnesium hydroxide
            magnesium oxide
            magnesium potassium citrate
            magnesium sulphate
            ferrous bisglycinate
            ferrous carbonate
            ferrous citrate
            ferric ammonium citrate
            ferrous gluconate
            ferrous fumarate
            ferric sodium diphosphate
            ferrous lactate
            ferrous sulphate
            ferric diphosphate (ferric pyrophosphate)
            ferric saccharate
            elemental iron (carbonyl + electrolytic + hydrogen reduced)
            cupric carbonate
            cupric citrate
            cupric gluconate
            cupric sulphate
            copper lysine complex
            sodium iodide
            sodium iodate
            potassium iodide
            potassium iodate
            zinc acetate
            zinc bisglycinate
            zinc chloride
            zinc citrate
            zinc gluconate
            zinc lactate
            zinc oxide
            zinc carbonate
            zinc sulphate
            manganese carbonate
            manganese chloride
            manganese citrate
            manganese gluconate
            manganese glycerophosphate
            manganese sulphate
            sodium bicarbonate
            sodium carbonate
            sodium citrate
            sodium gluconate
            sodium lactate
            sodium hydroxide
            sodium salts of orthophosphoric acid
            selenium enriched yeast (2)
            
            sodium selenate
            sodium hydrogen selenite
            sodium selenite
            sodium fluoride
            potassium fluoride
            potassium bicarbonate
            potassium carbonate
            potassium chloride
            potassium citrate
            potassium gluconate
            potassium glycerophosphate
            potassium lactate
            potassium hydroxide
            potassium salts of orthophosphoric acid
            chromium (III) chloride and its hexahydrate
            chromium (III) sulphate and its hexahydrate
            ammonium molybdate (molybdenum (VI))
            sodium molybdate (molybdenum (VI))
            boric acid
            sodium borate
         
      
      
         (1)  Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.
      
         (2)  Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dried form as marketed, not more than 2,5 mg Se/g. The predominant organic selenium species present in the yeast is selenomethionine (between 60 and 85 % of the total extracted selenium in the product). The content of other organic selenium compounds including selenocysteine shall not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally shall not exceed 1 % of total extracted selenium.’