(EC) No 1170/2009 修订关于维生素、矿物质列表及其可添加到食品中的形式（包括食品补充剂）的委员会指令2002/46/EC和欧洲议会和理事会条例(EC)No 1925/2006

　　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） [*]

　　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）

　　"

　　[*] 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 [*]

　　（g） tocotrienol tocopherol [**]

　　4. VITAMIN K

　　（a） phylloquinone （phytomenadione）

　　（b） menaquinone [***]

　　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 [****]

　　（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 [*****]

　　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 [******]

　　"

　　[*] alpha-tocopherol < 20 %, beta-tocopherol < 10 %, gamma-tocopherol 50-70 % and delta-tocopherol 10-30 %

　　[**] 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）,

　　[***] Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.

　　[****] May contain up to 2 % of threonate.

　　[*****] 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.

　　[******] 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 [*]

　　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 [**]

　　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

　　"

　　[*] Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.

　　[**] 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."