S.I. No. 539/2003 - European Communities (Food Supplements) Regulations 2003

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

4. VITAMIN K

(a) phylloquinone (phytomenadione)

5. VITAMIN B1

(a) thiamin hydrochloride

(b) thiamin mononitrate

6. VITAMIN B2

(a) riboflavin

(b) riboflavin 5'-phosphate, sodium

7. NIACIN

(a) nicotinic acid

(b) nicotinamide

8. PANTOTHENIC ACID

(a) D-pantothenate, calcium

(b) D-pantothenate, sodium

(c) dexpanthenol

9. VITAMIN B6

(a) pyridoxine hydrochloride

(b) pyridoxine 5'-phosphate

10. FOLIC ACID

(a) pteroylmonoglutamic acid

11. VITAMIN B12

(a) cyanocobalamin

(b) hydroxocobalamin

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

B. Minerals

calcium carbonate

calcium chloride

calcium salts of citric acid

calcium gluconate

calcium glycerophosphate

calcium lactate

calcium salts of orthophosphoric acid

calcium hydroxide

calcium oxide

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 sulphate

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 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 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 salts of orthophosphoric acid

sodium selenate

sodium hydrogen selenite

sodium selenite

chromium (III) chloride

chromium (III) sulphate

ammonium molybdate

(molybdenum (VI))

sodium molybdate

(molybdenum (VI))

potassium fluoride

sodium fluoride

Schedule 3

Form of official certificate to be given by an approved examiner to an authorised officer

.

European Communities (Food Supplements) Regulations 2003

Certificate of Analysis

To

(1)

.................................................

I, the undersigned

(2)

................................................. being an Approved Examiner for the purpose of the above Regulations certify that on the ................................day of ........................... 20............. a sample marked

(3)

.................................................

Date .................................................

Number .................................................

Weight or Measure .................................................

was submitted to me by you and I certify that the sample was prepared and analysed/examined by me or under my direction

(4)

and as a result I am of the opinion that

(5)

Observations

(6)

I further certify that the sample has undergone no change which would affect my opinion/observations expressed above.

Certified by me this .................... day of ........................... 20.....

at

(7)

.................................................

Name in BLOCK LETTERS .................................................

Status .................................................

Signature .................................................

_________________

Official Stamp

NOTES

(1) Insert the name and address of the person submitting the sample for analysis.

(2) Insert description (e.g. Executive Analytical Chemist in a Public Analyst's Laboratory).

(3) Insert particulars of marking (e.g. name, date etc.) and the weight or measure (this may be left unanswered if the sample cannot be conveniently weighed or measured or if the weight or measurement is not material to the result of analysis).

(4) Indicate whether the approved examiner carried out the analysis himself or herself or whether it was carried out by another under the direction of the approved examiner.

(5) Here the approved examiner should specify the result of the analysis having regard to the provisions of the relevant legislation.

(6) Here the approved examiner may insert, at his or her discretion, his or her opinion whether the analysis indicates any addition, abstraction, deficiency or the presence of foreign matter or other defect and whether the composition or quality is thereby affected; any physical, chemical or other properties bearing on the composition or quality of the article; whether the article is injurious to health or unfit for human consumption; whether and in what respect a label and description relating to the sample is incorrect or misleading; and he or she may add any other observations as he or she may consider relevant.

(7) Insert the name and address of the laboratory carrying out the analysis/examination.

GIVEN under the Official Seal of the Minister for Health and Children this 11 day of November, 2003.

Micheál Martin,

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 effect to Directive 2002/46/EC

15

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. They set certain requirements in respect of the content and packaging of food supplements. The packaging of food supplement products is required to bear certain particulars and to be free from certain other claims or statements.

These Regulations may be cited as the European Communities (Food Supplements Regulations 2003, and they come into effect on the day they are signed by the Minister.

DEPARTMENT OF HEALTH AND CHILDREN

November, 2003.

1

OJ L 31, 1.2.2002, p. 1.

2

OJ L 183, 12.7.2002, p. 51.

3

OJ L 183, 12.7.2002, p. 51.

4

OJ L 330, 5.12.98, p. 32.

5

OJ L 229, 30.8.80, p. 11.

6

OJ L 330, 5.12.98, p. 32.

7

OJ 22, 9.2.1965, p. 369.

8

OJ L 297, 13.10.1992, p. 8.

9

OJ L 262, 27.9.1976, p. 169.

10

OJ L 359, 8.12.1989, p. 1.

11

OJ L 311, 28.11.2001, p. 67.

12

OJ L 109, 6.5.2000, p. 29.

13

OJ L 109, 6.5.2000, p. 29.

14

OJ L 276, 6.10.1990, p. 40.

15

OJ L 183, 12.7.2002, p. 51.

14. (1) Where a sample of food supplements is taken pursuant to these Regulations and where the division of the sample is reasonably practicable, the authorised officer concerned may divide the sample into not more than three approximately equal parts each of which he or she shall mark in such a way as to identify it as a part of the sample taken by the officer. The authorised officer shall mark, seal and fasten each part in such a manner as its nature will permit, forward one part to the approved examiner in an official laboratory for analysis, give or send one part to the seller, owner or person in apparent charge or control of the food supplements, and retain the third part.

(2) Where an authorised officer takes a sample consisting of food supplements contained in unopened containers and its division into parts -

(a) is not reasonably practicable, or

(b) might affect the composition or impede the proper analysis of the sample,

the provision of paragraph (1) of this Regulation as regards the division of samples into parts shall be deemed to be complied with if the authorised officer divides the containers into three lots and deals with each lot as if it were a sample as specified under paragraph (1) of this Regulation.

(3) In proceedings for an offence under these Regulations, the result of any test examination or analysis of, or report on a sample of food supplements taken pursuant to these Regulations shall not be adduced unless before the proceedings were instituted the sample was divided as specified in paragraphs (1) and (2) of this Regulation. The part, package or container retained by the authorised officer shall be produced at the hearing.

15. (1) The approved examiner or a person under his or her direction shall analyse as soon as possible any sample of food supplements submitted to him or her in pursuance of these Regulations and the approved examiner shall certify to the person who submitted the sample to him or her the result of such analysis. The form of certificate set out in Schedule 3 to these Regulations or a certificate in like form shall be used.

(2) An official certificate given in accordance with paragraph (1) of this Regulation shall be

prima facie

evidence of the matters contained therein until the contrary is proved.

16. Where a sample of food supplements is taken by an authorised officer in pursuance of these Regulations for analysis by an approved examiner, and where the seller owner or person in apparent charge or control of the food supplements requests in writing the results of such analysis the request shall be made to -

(a) the Authority, where the officer was appointed by the Authority, or

(b) the official agency, where the officer was appointed by an official agency

and the Authority, or the official agency (as the case may be) shall comply with such request.

17. An authorised officer may, for the purposes of these Regulations, inspect and take copies, or samples, of labels used on food supplements.

18. (1) An authorised officer may, for the purposes of these Regulations, seize remove, detain or direct the withdrawal from the market of any food supplements which are suspected by him or her to fail to comply with the provisions of these Regulations.

(2) An authorised officer may, with the consent in writing of the owner or person in apparent charge or control of such food supplements, or in accordance with an order of a judge of the District Court under paragraph (4) of this Regulation, destroy or otherwise dispose of same as to prevent them being used for human consumption.

(3) An authorised officer who has seized, removed, detained or directed the withdrawal from the market of, food supplements in pursuance of the provisions of this Regulation may, on giving notice in writing to the owner or person in apparent charge or control of such food supplements of his or her intention to do so, apply to a judge of the District Court for an order directing that such food supplements be destroyed or otherwise disposed of.

(4) A judge of the District Court, to whom an application is made for an order under paragraph (3), may, if satisfied that such food supplements fail to comply with these Regulations, order that they be destroyed or otherwise disposed of, after such period, not exceeding 14 days, as may be specified in such order, and an authorised officer shall destroy or dispose of them accordingly.

19. (1) Any person who forges, or utters knowing it to be forged, a certificate of analysis or other document purporting to be issued, granted or given under these Regulations, or required for the purposes of these Regulations (hereafter in this Regulation referred to as “a forged document”), is guilty of an offence.

(2) Any person who alters with intent to defraud or deceive, or who utters knowing it to be so altered, a certificate of analysis or other document issued granted or given under these Regulations, or required for the purposes of these Regulations (hereafter in this Regulation referred to as “an altered document”), is guilty of an offence.

(3) Any person who, without lawful authority, has in his or her possession a forged document or an altered document is guilty of an offence.

(4) Any person who, with intent to defraud or deceive -

(a) tampers with any thing so as to procure that any sample taken pursuant to these Regulations does not correctly represent the substance sampled, or

(b) tampers or interferes with any sample taken under these Regulations

is guilty of an offence.

20. (1) For the purposes of these Regulations, every contravention of a Regulation shall be deemed a separate contravention and every contravention of a paragraph or a subparagraph shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any Regulation of these Regulations.

(2) A person who is guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding €3,000 or at the discretion of the Court to imprisonment for a term not exceeding 12 months or both.

21. An offence under these Regulations may be prosecuted by -

(1) the Authority, or

(2) an official agency.

Schedule 1

Vitamins and Minerals which may be used in the Manufacture of Food Supplements

I, Micheál Martin, 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), having regard to Regulation (EC) No. 178/2002

1

of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety and for the purpose of giving effect to Directive 2002/46/EC

2

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, hereby make the following regulations

PART 1

Preliminary