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(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

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核心提示:该委员会条例对指令2002/46/EC和条例(EC)No 1925/2006作了相关修改和替代。主要包括:指令2002/46/EC的附件Ⅰ和附件Ⅱ由本条例的附件Ⅰ和附件Ⅱ代替;条例(EC)No 1925/2006 的附件Ⅰ中,“硼”字加在列表中的第二条,附件Ⅱ由本条例的附件Ⅲ代替。附件的内容为用于食物营养增补剂的维生素、矿物质的清单列表和组成配方。
发布单位
欧盟委员会
欧盟委员会
发布文号 (EC) No 1170/2009
发布日期 2009-11-30 生效日期 2009-12-21
有效性状态 废止日期 暂无
备注 该委员会条例对指令2002/46/EC和条例(EC)No 1925/2006作了相关修改和替代。主要包括:指令2002/46/EC的附件Ⅰ和附件Ⅱ由本条例的附件Ⅰ和附件Ⅱ代替;条例(EC)No 1925/2006 的附件Ⅰ中,“硼”字加在列表中的第二条,附件Ⅱ由本条例的附件Ⅲ代替。附件的内容为用于食物营养增补剂的维生素、矿物质的清单列表和组成配方。

  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."
 

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