S.I. No. 852/2007 - European Communities (Infant formulae and Follow-on formulae) Regulations 2007

1. Protein content

Protein content = nitrogen content x 6.25

Minimum 0.44g/100 kJ (1.86g/100 kcal)

Maximum 0.7g/100 kJ (3g/100 kcal)

2.

Protein source

Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of

(

a

) 63% caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95% of dry matter and protein denaturation of less than 70% and a maximum ash content of 3%; and

(

b

) 37% sweet whey protein concentrate with a minimum protein content of 87% of dry matter and protein denaturation of less than 70% and a maximum ash content of 3.5%.

3.

Protein processing

Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.

SCHEDULE 7

REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN

Nutrient

Labelling reference value

Vitamin A

Vitamin D

Vitamin E

Vitamin K

Vitamin C

Thiamin

Riboflavin

Niacin

Vitamin B

6

Folate

Vitamin B

12

Pantothenic acid

Biotin

Calcium

Phosphorus

Potassium

Sodium

Chloride

Iron

Zinc

Iodine

Selenium

Copper

Magnesium

Manganese

(μg) 400

(μg) 7

(mg TE) 5

(μg) 12

(mg) 45

(mg) 0.5

(mg) 0.7

(mg) 7(mg) 0.7

(μg) 125

(μg) 0.8

(mg) 3

(μg) 10

(mg) 550

(mg) 550

(mg) 1000

(mg) 400

(mg) 500

(mg) 8

(mg) 5

(μg) 80

(μg) 20

(mg) 0.5

(mg) 80

(mg) 1.2

SCHEDULE 8

PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF INFANT FORMULAE AND FOLLOW–ON FORMULAE

Table 1

Chemical name of the substance (residue definition)

Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton)

Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion)

Fentin, expressed as triphenyltin cation

Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop)

Heptachlor and

trans

-heptachlor epoxide, expressed as heptachlor

Hexachlorobenzene

Nitrofen

Omethoate

Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos)

Table 2

Chemical name of the substance

Aldrin and dieldrin, expressed as dieldrin

Endrin

SCHEDULE 9

SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES IN INFANT FORMULAE AND FOLLOW-ON FORMULAE

Chemical name of the substance

Maximum residue level (mg/kg)

Cadusafos

0.006

Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl)

0.006

Ethoprophos

0.008

Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil)

0.004

Propineb/propylenethiourea (sum of propineb and propylenethiourea)

0.006

SCHEDULE 10

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

European Communities

(Infant Formulae and Follow-On Formulae) 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,

21 December 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 give effect to Commission Directive 2006/141/EC of 22 December 2006 on compositional, labelling, marketing and informational requirements for infant formulae and follow-on formulae intended for infants and young children, and give further effect to Council Directive 92/52/EEC on infant formulae and follow-on formulae intended for export to third countries. These Regulations do not give effect to those aspects of Commission Directive 2006/141/EC that amend Directive 1999/21/EC.

In order to provide for the transitional arrangements under Commission Directive 2006/141/EC, certain provisions of the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2004 (

S.I. No. 242 of 2004

) are revoked, while the remainder will remain in effect until 31 December 2009.

These Regulations revoke the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2007 (

S.I. No. 242 of 2007

).

These Regulations may be cited as the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007.

1 OJ L 401, 30.12.2006, p. 1.

2 OJ L 91, 7.4.1999, p. 29.

3 OJ L 179, 1.7.1992, p. 129.

4 OJ L 404, 30.12.2006, p. 9, as affected by Corrigendum to Regulation (EC) No. 1924/2006, OJ L 12, 18.1.2007, p. 3.

5 OJ L 31, 1.2.2002, p. 1.

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

7 OJ L 230, 19.8.1991, p. 1.

8 OJ L 109, 6.5.2000, p. 29.

9 OJ L 186, 30.6.1989, p. 21, as amended.

2. Mineral substances

Mineral substances

Permitted salts

Calcium (Ca)

Calcium carbonate

Calcium chloride

Calcium salts of citric acid

Calcium gluconate

Calcium glycerophosphate

Calcium lactate

Calcium salts of orthophosphoric acid

Calcium hydroxide

Magnesium (Mg)

Magnesium carbonate

Magnesium chloride

Magnesium oxide

Magnesium salts of orthophosphoric acid

Magnesium sulphate

Magnesium gluconate

Magnesium hydroxide

Magnesium salts of citric acid

Iron (Fe)

Ferrous citrate

Ferrous gluconate

Ferrous lactate

Ferrous sulphate

Ferric ammonium citrate

Ferrous fumarate

Ferric diphosphate (Ferric pyrophosphate)

Ferrous bisglycinate

Copper (Cu)

Cupric citrate

Cupric gluconate

Cupric sulphate

Copper-lysine complex

Cupric carbonate

Iodine (I)

Potassium iodide

Sodium iodide

Potassium iodate

Zinc (Zn)

Zinc acetate

Zinc chloride

Zinc lactate

Zinc sulphate

Zinc citrate

Zinc gluconate

Zinc oxide

Manganese (Mn)

Manganese carbonate

Manganese chloride

Manganese citrate

Manganese sulphate

Manganese gluconate

Sodium (Na)

Sodium bicarbonate

Sodium chloride

Sodium citrate

Sodium gluconate

Sodium carbonate

Sodium lactate

Sodium salts of orthophosphoric acid

Sodium hydroxide

Potassium (K)

Potassium bicarbonate

Potassium carbonate

Potassium chloride

Potassium salts of citric acid

Potassium gluconate

Potassium lactate

Potassium salts of orthophosphoric acid

Potassium hydroxide

Selenium (Se)

Sodium selenate

Sodium selenite

3. Amino acids and other nitrogen compounds

L-cystine and its hydrochloride

L-histidine and its hydrochloride

L-isoleucine and its hydrochloride

L-leucine and its hydrochloride

L-lysine and its hydrochloride

L-cysteine and its hydrochloride

L-methionine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

L-carnitine and its hydrochloride

L-carnitine-L-tartrate

Taurine

Cytidine 5’-monophosphate and its sodium salt

Uridine 5’-monophosphate and its sodium salt

Adenosine 5’-monophosphate and its sodium salt

Guanosine 5’-monophosphate and its sodium salt

Inosine 5’-monophosphate and its sodium salt

4.

Other nutritional substances

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

SCHEDULE 4

NUTRITION AND HEALTH CLAIMS FOR INFANT FORMULAE AND CONDITIONS WARRANTING A CORRESPONDING CLAIM

4. Lipids

Minimum 0.96g/100 kJ (4.0g/100 kcal)

Maximum 1.4g/100 kJ (6.0g/100 kcal)

4.1 The use of the following substances shall be prohibited

—sesame seed oil,

—cotton seed oil.

4.2 Lauric acid and myristic acid

Minimum No minimum specified

Maximum separately or as a whole:20% of the total fat content.

4.3

The

trans

fatty acid content shall not exceed 3% of the total fat content.

4.4

The erucic acid content shall not exceed 1% of the total fat content.

4.5 Linoleic acid (in the form of glycerides = linoleates)

Minimum 70mg/100 kJ (300mg/100 kcal)

Maximum 285mg/100 kJ (1200mg/100 kcal)

4.6

The alpha-linolenic acid content shall not be less than 12mg/100 kJ (50mg/100 kcal).

The linoleic:alpha-linolenic acid ratio shall not be less than 5 nor greater than 15.

4.7

Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP) may be added. In that case their content shall not exceed

—1% of the total fat content for n-3 LCP, and

—2% of the total fat content for n-6 LCP (1% of the total fat content for arachidonic acid (20:4 n-6))

The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.

The docosahexaenoic (22:6 n-3) acid content shall not exceed that of n-6 LCP.

5. Phospholipids

The amount of phospholipids in follow-on formulae shall not be greater than 2g/l.

6. Carbohydrates

Minimum 2.2g/100 kJ (9g/100 kcal)

Maximum 3.4g/100 kJ (14g/100 kcal)

6.1

The use of ingredients containing gluten shall be prohibited.

6.2 Lactose

Minimum 1.1g/100 kJ (4.5g/100 kcal)

Maximum No maximum specified

This provision shall not apply to follow-on formulae in which soya protein isolates represent more than 50% of the total protein content.

6.3 Sucrose, fructose, honey

Minimum No minimum specified

Maximum separately or as a whole:20% of the total carbohydrate content.

Honey shall be treated to destroy spores of Clostridium botulinum

6.4 Glucose

Glucose may only be added to follow-on formulae manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0.5g/100 kJ (2g/100 kcal).

7. Fructo-Oligosaccharides and Galacto-Oligosaccharides

Fructo-oligosaccharides and galacto-oligosaccharides may be added to follow-on formulae. In that case their content shall not exceed: 0.8g/100 ml in a combination of 90% oligogalactosyl-lactose and 10% high molecular weight oligofructosyl-saccharose. Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used in accordance with Regulation 5(1).

8. Mineral substances

8.1 Follow-on formulae manufactured from cows’ milk proteins or protein hydrolysates

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Sodium (mg)

5

14

20

60

Potassium (mg)

15

38

60

160

Chloride (mg)

12

38

50

160

Calcium (mg)

12

33

50

140

Phosphorus (mg)

6

22

25

90

Magnesium (mg)

1.2

3.6

5

15

Iron (mg)

0.14

0.5

0.6

2

Zinc (mg)

0.12

0.36

0.5

1.5

Copper (μg)

8.4

25

35

100

Iodine (μg)

2.5

12

10

50

Selenium (μg)

0.25

2.2

1

9

Manganese (μg)

0.25

25

1

100

Fluoride (μg)

-

25

-

100

The calcium:phosphorus ratio in follow-on formulae shall not be less than 1.0 nor greater than 2.0.

8.2.

Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk proteins

All requirements of point 8.1 shall apply, except for those concerning iron, and phosphorus, which shall be as follows

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Iron (mg)

0.22

0.65

0.9

2.5

Phosphorus (mg)

7.5

25

30

100

9. Vitamins

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Vitamin A (μg —RE) (

1

)

14

43

60

180

Vitamin D (μg) (

2

)

0.25

0.75

1

3

Thiamin (μg)

14

72

60

300

Riboflavin (μg)

19

95

80

400

Niacin (μg) (

3

)

72

375

300

1500

Pantothenic acid (μg)

95

475

400

2000

Vitamin B

6

(μg)

9

42

35

175

Biotin (μg)

0.4

1.8

1.5

7.5

Folic Acid (μg)

2.5

12

10

50

Vitamin B

12

(μg)

0.025

0.12

0.1

0.5

Vitamin C (mg)

2.5

7.5

10

30

Vitamin K (μg)

1

6

4

25

Vitamin E (mg α—TE) (

4

)

0.5/g poly-unsaturated fatty acids expressed as linoleic acid as corrected for the double bonds ( 5 ) but in no case less than 0.1mg per 100 available kJ

1.2

0.5/g poly-unsaturated fatty acids expressed as linoleic acid as corrected for the double bonds ( 5 ) but in no case less than 0.5mg per 100 available kcal

5

(

1

) RE = all

trans

retinol equivalent.

(

2

) In the form of cholecalciferol, of which 10μg = 400 i.u. of vitamin D.

(

3

) Preformed niacin.

(

4

) α - TE = d- α - tocopherol equivalent.

(

5

) 0.5mg α-TE/1g linoleic acid (18:2 n-6); 0.75mg α-TE/1g -linolenic acid (18:3 n-3); 1.0mg α-TE/1g arachidonic acid (20:4 n-6); 1.25mg α-TE/1g eicosapentaenoic acid (20:5 n-3); 1.5mg α-TE/1g docosahexaenoic acid (22:6 n-3).

10. Nucleotides

The following nucleotides may be added

Maximum(

1

)

(mg/100 kJ)

(mg/100 kcal)

cytidine 5’-monophosphate uridine 5’-monophosphate adenosine 5’-monophosphateguanosine 5’-monophosphate inosine 5’-monophosphate

0.600.420.360.120.24

2.501.751.500.501.00

(

1

) The total concentration of nucleotides shall not exceed 1.2mg/100 kJ (5mg/100 kcal).

SCHEDULE 3

NUTRITIONAL SUBSTANCES

11. This Part is concerned with infant formulae and follow-on formulae intended for export to third countries.

12. Nucleotides

The following nucleotides may be added

Maximum(

1

)

(mg/100 kJ)

(mg/100 kcal)

cytidine 5’-monophosphate

uridine 5’-monophosphate

adenosine 5’-monophosphate

guanosine 5’-monophosphate

inosine 5’-monophosphate

0.60

0.42

0.36

0.12

0.24

2.50

1.75

1.50

0.50

1.00

(

1

) The total concentration of nucleotides shall not exceed 1.2mg/100 kJ (5mg/100 kcal).

SCHEDULE 2

ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

The values set out in this Schedule refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.

13. (1) A person shall not—

(

a

) export follow-on formulae unless the requirements of this Part applicable to follow-on formulae are complied with, or

(

b

) use the description ‘follow-on formula’ in the marketing of any product intended for export which is not follow-on formulae as defined in Regulation 2(1).

(2) Unless otherwise requested or stipulated by provisions established by the importing country, and subject to Article 12 of the General Food Law Regulation, a person shall not export follow-on formulae, unless—

(

a

) either the requirements set down in Regulation 5 of these Regulations or the relevant applicable world standards established by Codex Alimentarius are complied with,

(

b

) the requirements set down in paragraphs (1) to (4) of Regulation 7 of these Regulations are complied with, and

(

c

) the provisions of Council Directive 89/396/EEC 9 of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs, are complied with.

(3) The stipulations, prohibitions and restrictions laid down in paragraphs (1) to (4) of Regulation 7 shall also apply to the presentation of follow-on formulae intended for export, and in particular their form, aspect or packaging and the packaging materials used.

14. (1) Infant formulae and follow-on formulae intended for export shall be labelled in an appropriate language.

(2) Infant formulae and follow-on formulae intended for export shall be labelled in such a way as to avoid any risk of confusion between them.

PART 4

Enforcement

15. (1) The enforcement of these Regulations and of the Directives shall be carried out in accordance with the provisions of these Regulations.

(2) These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998.

(3) These Regulations shall be enforced by the Authority or by an official agency acting pursuant to a service contract with the Authority, or by both, and, without prejudice to paragraph (1), the enforcement provisions contained in the Act of 1998 shall apply for the purposes of ensuring compliance with the requirements of these Regulations.

16. (1) An authorised officer may, for the purposes of these Regulations, purchase or take without payment a sample of infant formulae or follow-on formulae or other relevant substance.

(2) An authorised officer may, for the purpose of taking a sample of infant formulae or follow-on formulae or other relevant substance, open any receptacle.

(3) Where an authorised officer purchases or takes without payment a sample of infant formulae or follow-on formulae or other relevant substance with the intention of having it analysed, he or she shall after purchasing or taking the sample forthwith notify the food business operator, or the person in apparent charge or control of the infant formulae or follow-on formulae or other substance of his or her intention of having the sample analysed.

(4) Where an authorised officer purchases or takes without payment, with the intention of having it analysed, a sample of infant formulae or follow-on formulae or other relevant substance which is suspected by him or her to fail to comply with the provisions of these Regulations, he or she may, by notice in writing to the food business operator, or the person in apparent charge or control of such foods or other substances, prohibit their removal except to any place which may be specified in the notice, during such period as may be specified in the notice, but not exceeding 15 days from the date of the taking of the sample.

17. (1) Where a sample of infant formulae or follow-on formulae or other relevant substance is taken pursuant to these Regulations, for the purposes of official analysis and where the division of the sample is reasonably practicable, the authorised officer concerned may divide the sample into three approximately equal parts, (enforcement, trade (defence) and referee), 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, in the presence of the food business operator, or the person in apparent charge or control of such food

(

a

) mark, seal and fasten each part in such a manner as its nature will permit, and in such a way that the integrity of the sample is not compromised;

(

b

) forward one part to the approved examiner in an official laboratory for analysis;

(

c

) give or send one part to the food business operator, and

(

d

) retain the third part.

(2) Where an authorised officer takes a sample consisting of infant formulae or follow-on formulae or other relevant substance 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 provisions of paragraph (1) 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).

(3) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on a sample of infant formulae or follow-on formulae or other relevant substance 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.

18. (1) The approved examiner or a person under his or her direction shall analyse as soon as possible any sample of infant formulae or follow-on formulae or other relevant substance 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 10 to these Regulations or a certificate in like form shall be used.

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

prima facie

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

19. Where a sample of infant formulae or follow-on formulae or other relevant substance is taken by an authorised officer in pursuance of these Regulations for analysis by an approved examiner, the Authority, or an official agency as the case may be, shall draw up a report in accordance with Article 9 of the Official Controls Regulation, where the certificate given in accordance with Regulation 18 indicates that there has been non-compliance with these Regulations, the Authority, or the official agency, as the case may be, shall provide the food business operator with a copy of the report.

20. An authorised officer may, for the purposes of these Regulations, inspect and take copies, or samples, of

(

a

) labels used on infant formulae, follow-on formulae, or other products being placed on the market as such, or

(

b

) informational materials.

21. The provisions of Regulations 16, 17, 18, 19 and 20 shall also apply in respect of

(

a

) products which are not infant formulae or follow-on formulae, as defined in Regulation 2(1), but which are being placed on the market as such, and

(

b

) any other products which the authorised officer suspects are being treated, manufactured or placed on the market in contravention of these Regulations.

22. (1) An authorised officer may, for the purposes of these Regulations, seize, remove, detain or direct the withdrawal from the market of any infant formulae or follow-on formulae, or other products, 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 food business operator, or the person in apparent charge or control of such infant formulae or follow-on formulae or other products 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 so 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 infant formulae or follow-on formulae or other products in pursuance of the provisions of this Regulation may, on giving notice in writing to the food business operator of his or her intention to do so, apply to a judge of the District Court for an order directing that such products 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 foods or products 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.

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

24. The Minister may, for the purposes of these Regulations designate, by notice in writing published in

Iris Oifigiúil

(

a

) a laboratory as a laboratory at which samples taken under these Regulations may be analysed, and testing and verification may be carried out, and

(

b

) a person as being a person who, or a class of persons the members of which, may, at a designated laboratory, engage in analysis, testing and verification for the purposes of these Regulations.

25. (1) A person is guilty of an offence if he or she fails to comply with these Regulations.

(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 is guilty of an offence if he or she

(

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,

26. 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 is also guilty of an offence and is liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

27. (1) A person is guilty of an offence if he or she 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 referred to as “a forged document”).

(2) A person is guilty of an offence if he or she 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 referred to as “an altered document”).

(3) A person is guilty of an offence if he or she without lawful authority, has in his or her possession a forged document or an altered document, knowing it to be a forged or altered document as the case may be.

(4) A person is guilty of an offence if he or she with the intent to defraud or deceive

(

a

) tampers with any substance or thing with the result that a 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.

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

28. (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.

(2) 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 3 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.

29. 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

or both.

PART 5

Revocations and Transitional Arrangements

30. (1) Regulations 8, 9 and 13 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004 (

S.I. No. 242 of 2004

) Regulations are revoked.

(2) The following are revoked

(

a

) the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2004 (

S.I. No. 242 of 2004

), and

(

b

) the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2007 (

S.I. No. 242 of 2007

).

(3) No person commits an offence under regulation 25(1) consisting of a contravention of or failure to comply with

(

a

) Regulation 3 where there is no contravention of or failure to comply with Regulation 3 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004,

(

b

) Regulation 4 where there is no contravention of or failure to comply with Regulation 4 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004,

(

c

) Regulation 5 where there is no contravention of or failure to comply with Regulation 5 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004,

(

d

) Regulation 6 where there is no contravention of or failure to comply with Regulation 6 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004,

(

e

) Regulation 7 where there is no contravention of or failure to comply with Regulation 7 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004,

(

f

) Regulation 12 where there is no contravention of or failure to comply with Regulation 11 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004,

(

g

) Regulation 13 where there is no contravention of or failure to comply with Regulation 12 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004.

(4) Regulation 24 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004 (

S.I. No. 242 of 2004

) is amended by inserting after paragraph (2) the following paragraph

“(3) No person commits an offence under paragraph (1) consisting of a contravention of or failure to comply with

(

a

) Regulation 3, where there is no contravention of or failure to comply with Regulation 3 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007,

(

b

) Regulation 4 where there is no contravention of or failure to comply with Regulation 4 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007,

(

c

) Regulation 5 where there is no contravention of or failure to comply with Regulation 5 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007,

(

d

) Regulation 6 where there is no contravention of or failure to comply with Regulation 6 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007,

(

e

) Regulation 7 where there is no contravention of or failure to comply with Regulation 7 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007,

(

f

) Regulation 11 where there is no contravention of or failure to comply with Regulation 12 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007,

(

g

) Regulation 12 where there is no contravention of or failure to comply with Regulation 13 of the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007.”.

SCHEDULE 1

ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

The values set out in this Schedule refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

18

th January

, 2008.

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 partial effect to Commission Directive 2006/141/EC

1

of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC

2

, and for the purpose of giving further effect to Council Directive 92/52/EEC

3

of 18 June 1992 on infant formulae and follow-on formulae intended for export to third countries, hereby make the following regulations

PART 1

Preliminary