S.I. No. 506/2007 - European Communities (Food Supplements) Regulations 2007

1. VITAMIN A

2. VITAMIN D

(

a

) pyridoxine hydrochloride

(

a

) cholecalciferol

(

b

) pyridoxine 5’-phosphate

(

b

) ergocalciferol

3. VITAMIN E

(a) pteroylmonoglutamic acid

(

a

) D-alpha-tocopherol

(b) calcium-L-methylfolate

(

b

) DL-alpha-tocopherol

4. VITAMIN K

(a) D-biotin

(

a

)

phylloquinone (phytomenadione)

5. VITAMIN B1

(a) L-ascorbic acid

(

a

) thiamin hydrochloride

(b) sodium-L-ascorbate

(

b

) thiamin mononitrate

(c) calcium-L-ascorbate

6. VITAMIN B2

(d) potassium-L-ascorbate

(

a

) riboflavin

(e) L-ascorbyl 6-palmitate

(

b

) riboflavin 5’-phosphate, sodium

7. NIACIN

(

a

) nicotinic acid

(

b

) nicotinamide

B. Minerals

calcium carbonate

zinc acetate

calcium chloride

zinc chloride

calcium salts of citric acid

zinc citrate

calcium gluconate

zinc gluconate

calcium glycerophosphate

zinc lactate

calcium lactate

zinc oxide

calcium salts of orthophosphoric acid

zinc carbonate

calcium hydroxide

zinc sulphate

calcium oxide

manganese carbonate

magnesium acetate

manganese chloride

magnesium carbonate

manganese citrate

magnesium chloride

manganese gluconate

magnesium salts of citric acid

manganese glycerophosphate

magnesium gluconate

manganese sulphate

magnesium glycerophosphate

sodium bicarbonate

magnesium salts of orthophosphoric acid

sodium carbonate

magnesium lactate

sodium chloride

magnesium hydroxide

sodium citrate

magnesium oxide

sodium gluconate

magnesium sulphate

sodium lactate

ferrous carbonate

sodium hydroxide

ferrous citrate

sodium salts of orthophosphoric acid

ferric ammonium citrate

potassium bicarbonate

ferrous gluconate

potassium carbonate

ferrous fumarate

potassium chloride

ferric sodium diphosphate

potassium citrate

ferrous lactate

potassium gluconate

ferrous sulphate

potassium glycerophosphate

ferric diphosphate (ferric pyrophosphate)

potassium lactate

ferric saccharate

potassium hydroxide

elemental iron

potassium salts of orthophosphoric acid

(carbonyl+electrolytic+hydrogen reduced)

sodium selenate

ferrous bisglycinate

sodium hydrogen selenite

cupric carbonate

sodium selenite

cupric citrate

chromium (III) chloride

cupric gluconate

chromium (III) sulphate

cupric sulphate

ammonium molybdate

copper lysine complex

(molybdenum (VI))

sodium iodide

sodium molybdate

sodium iodate

(molybdenum (VI))

potassium iodide

potassium fluoride

potassium iodate

sodium fluoride

SCHEDULE 3

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

EUROPEAN COMMUNITIES (FOOD SUPPLEMENTS) REGULATIONS 2007

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 located at 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 my Official Seal,

16 July 2007

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, which may be cited as the European Communities (Food Supplements) Regulations 2007, 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 the Member States relating to food supplements. They also give effect to Commission Directive 2006/37/EC of 30 March 2006 amending Annex II to Directive 2002/46/EC.

These Regulations 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 revoke the European Communities (Food Supplements) Regulations 2003 (

S.I. No. 539 of 2003

).

1 OJ L 183, 12.7.2002, p. 51.

2 OJ L 94, 1.4.2006, p. 32.

3 OJ L 31, 1.2.2002, p. 1.

4 OJ L 165, 30.4.2004, p. 1, as affected by Corrigendum to Regulation (EC) No. 882/2004, OJ L 191, 28.5.2004, P.1.

5 OJ L 311, 28.11.2001, p. 67.

6 OJ L 109, 6.5.2000, p. 29, as affected by Corrigendum to Directive 2000/13/EC, OJ L 124, 25.5.2000, p. 66.

7 OJ L 276, 6.10.1990, p. 40.

8. PANTOTHENIC ACID

(

a

) retinol

(

a

) D-pantothenate, calcium

(

b

) retinyl acetate

(

b

) D-pantothenate, sodium

(

c

) retinyl palmitate

(

c

) dexpanthenol

(

d

) beta-carotene

9. VITAMIN B6

10. FOLATE

11. VITAMIN B12

(

c

) D-alpha-tocopheryl acetate

(a) cyanocobalamin

(

d

) DL-alpha-tocopheryl acetate

(b) hydroxocobalamin

(

e

) D-alpha-tocopheryl acid succinate

12. BIOTIN

13. VITAMIN C

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

(2) An authorised officer may, with the consent in writing of the seller, 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.

15. Where an authorised officer has reasonable grounds for believing that a person has contravened any provision of these Regulations and so informs such person; the authorised officer may require such person to state his or her name and address and, if the authorised officer thinks it necessary, to produce corroborative evidence of same.

16. (1) A person who fails to comply with these Regulations is guilty of an offence.

(2) Paragraph (1) shall not apply to an authorised officer or an approved examiner acting in the course of his or her duties pursuant to these Regulations.

(3) A person who—

(

a

) obstructs or interferes with an authorised officer in the exercise of the officer’s powers under these Regulations,

(

b

) fails or refuses to state his or her name or address in compliance with a request under these Regulations,

(

c

) fails to comply with a request or notice from an authorised officer under these Regulations,

(

d

) makes a statement to an authorised officer which the person knows is false or misleading, or

(

e

) gives in purported compliance with a request under these Regulations a name, address or corroborative evidence which is false or misleading,

is guilty of an offence.

17. Where an offence under these Regulations is committed by a body corporate or by a person acting on behalf of a body corporate and is proved to have been so committed with the consent, connivance or approval of, or to be attributed to any neglect or default on the part of, any director, manager, secretary or any other officer of such body, or a person who was purporting to act in any such capacity, such person shall also be guilty of an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

18. (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.

(5) A person who falsely represents himself or herself to be an authorised officer is guilty of an offence.

19. (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 €5,000 or at the discretion of the Court to imprisonment for a term not exceeding 6 months or both.

20. An offence under these Regulations may be prosecuted by—

(

a

) the Authority, or

(

b

) an official agency,

or both.

PART 4

Revocations

21. (1) The European Communities (Food Supplements) Regulations 2003 (

S.I. No. 539 of 2003

) are revoked.

(2) References in any other instrument to the Regulations revoked under paragraph (1) shall be construed as references to these Regulations, as appropriate.

SCHEDULE 1

VITAMINS AND MINERALS WHICH MAY BE USED IN THE MANUFACTURE OF FOOD SUPPLEMENTS

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

20

th July

, 2007.

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

1

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, and for the purpose of giving effect to Commission Directive 2006/37/EC

2

of 30 March 2006 amending Annex II to Directive 2002/46/EC

1

of the European Parliament and of the Council as regards the inclusion of certain substances, hereby make the following regulations—

PART 1

Preliminary