Irish Statutory Instruments

Notice of the making of this Statutory Instrument was published in

"Iris Oifigiúil" of 20th July, 2010.

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), and for the purpose of giving further effect to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 ¹ on the approximation of the laws of the Member States relating to food supplements, and for the purpose of giving partial effect to Commission Regulation (EC) No. 1170/2009 of 30 November 2009 ² amending Directive 2002/46/EC of the European Parliament and of the 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, hereby make the following regulations:

1. (1) These Regulations may be cited as the European Communities (Food Supplements) (Amendment) Regulations 2010.

(2) The Principal Regulations and these Regulations may be cited together as the European Communities (Food Supplements) Regulations 2007 and 2010 and shall be construed together as one.

2. In these Regulations, "Principal Regulations" means European Communities (Food Supplements) Regulations 2007 ( S.I. No. 506 of 2007 ).

3. The Principal Regulations are amended-

(a) in Regulation 2(1), by substituting for the definition of "Directive" the following-

"Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 1 on the approximation of the laws of the Member States relating to food supplements, as amended by Commission Directive 2006/37/EC of 30 March 2006 2 and Commission Regulation (EC) No. 1170/2009 of 30 November 2009 2A "

And by the addition of the following footnote to the definition of "Directive"-

" 2A OJ L 314, 1.12.2009, p. 36"

(b) in Regulation 19, by substituting for paragraph (2) the following-

"A person who is guilty of an offence under these Regulations is liable:

(a) on summary conviction to a fine not exceeding €5,000 or at the discretion of the Court to imprisonment for a term not exceeding 6 months or both, or

(b) on conviction on indictment, to a fine not exceeding €500,000, or imprisonment for a term not exceeding 3 years, or both."

(c) in Regulation 19 by inserting after paragraph (2) the following-

"(3) Where a person is convicted of an offence under these Regulations, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the Authority or the official agency, as the case may be, the costs and expenses, measured by the court, incurred by the Authority or official agency in relation to the investigation, detection and prosecution of the offence, including costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisors engaged by the Authority or official agency.

(4) An order for costs and expenses under subsection (3) is in addition to, and not instead of, any fine or penalty the court may impose under subsection (2)."

(d) by substituting for Regulation 20 the following-

"Notwithstanding section 57 of the Act of 1998, a summary offence under these Regulations may be prosecuted by:

(a) the Authority, or

(b) an official agency."

(e) by substituting for Schedule 1 the Schedule set out in Schedule 1 to these Regulations.

(f) by substituting for Schedule 2 the Schedule set out in Schedule 2 to these Regulations.

Schedule 1 Vitamins and minerals which may be used in the manufacture of food supplements

(*) 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.

Schedule 2 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.'

GIVEN under my Official Seal,

15 July 2010.

MARY HARNEY,

Minister for Health and Children.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation).

These Regulations give partial effect to Commission Regulation (EC) No. 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of the 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.

These Regulations contain enforcement provisions to give further effect to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of Member States relating to food supplements and amend the European Communities (Food Supplements) Regulations 2007 ( S.I. No. 506 of 2007 ) in the manner specified in these Regulations.

These Regulations may be cited as the European Communities (Food Supplements) (Amendment) Regulations 2010.

1 OJ L 183, 12.7.2002, p. 51.

2 OJ L 314, 1.12.2009, p. 36

(*) 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.