IE
S.I. No. 242/2004 - European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004
Table of Provisions (30)
Statutory Text (30 Articles)
1. Adapted protein
The protein content is lower than 0.6 g/100 kJ (2.5 g/100 kcal) and the whey protein/casein ratio is not less than 1.0.
2. Low sodium
The sodium content is lower than 9 mg/100 kJ (39 mg/100 kcal).
3. Sucrose free
No sucrose is present.
4. Lactose only
Lactose is the only carbohydrate present.
5. Lactose free
No lactose is present.
6. Iron enriched
Iron is added.
7. Reduction of risk to allergy to milk proteins. This claim may include terms referring to reduced allergen of reduced antigen properties.
(
a
) The formulae shall satisfy the provisions laid down in Section 2.2 of Schedule 1 and the amount of immunoreactive protein measured with methods generally acceptable as appropriate shall be less than 1% of nitrogen containing substances in the formulae;
(
b
) The label shall indicate that the product must not be consumed by infants allergic to the intact proteins from which it is made unless generally accepted clinical tests provide proof of the formulae’s tolerance in more than 90% of infants (confidence interval 95%) hypersensitive to proteins from which the hydrolysate is made;
(
c
) The formulae administered orally should not induce sensitisation from which the formulae are derived;
(
d
) Objective and scientifically verified data as proof to the claimed properties must be available.
SCHEDULE 5
Essential and semi-essential amino acids in breast milk
For the purpose of this Regulation, the essential and semi-essential amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following
Per 100 kJ
Per 100 kcal
Arginine
16
69
Cystine
6
24
Histidine
11
45
Isoleucine
17
72
Leucine
37
156
Lysine
29
122
Methionine
7
29
Phenylalanine
15
62
Threonine
19
80
Tryptophan
7
30
Tyrosine
14
59
Valine
19
80
SCHEDULE 6
Amino acid composition of casein and breast milk protein
Casein
Breast milk
Arginine
3.7
3.8
Cystine
0.3
1.3
Histidine
2.9
2.5
Isoleucine
5.4
4.0
Leucine
9.5
8.5
Lysine
8.1
6.7
Methionine
2.8
1.6
Phenylalanine
5.2
3.4
Threonine
4.7
4.4
Tryptophan
1.6
1.7
Tyrosine
5.8
3.2
Valine
6.7
4.5
SCHEDULE 7
The mineral elements in cows’ milk
As a reference, the contents of mineral elements in cows’ milk expressed per 100 g of solids-non-fat (SNF) and per g of proteins are the following
Per 100g of SNF
Per g of proteins
Sodium (mg)
550
15
Potassium (mg)
1680
43
Chloride (mg)
1050
28
Calcium (mg)
1350
35
Phosphorus (mg)
1070
28
Magnesium (mg)
135
3.5
Copper (µg)
225
6
Iodine
Not specified
Not specified
SCHEDULE 8
Reference values for nutrition labelling for foods intended for Infants and young children
Nutrient
Labelling reference value
Vitamin A
(µg) 400
Vitamin D
(µg) 10
Vitamin C
(mg) 25
Thiamin
(mg) 0.5
Riboflavin
(mg) 0.8
Niacin equivalents
(mg) 9
Vitamin B
6
(mg) 0.7
Folate
(µg) 100
Vitamin B
12
(µg) 0.7
Calcium
(mg) 400
Iron
(mg) 6
Zinc
(mg) 4
Iodine
(µg) 70
Selenium
(µg) 10
Copper
(mg) 0.4
SCHEDULE 9
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
Haloxfop (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 10
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 demetron-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 11
Form of official certificate to be given by an approved examiner to an authorised officer.
European Communities
(Infant Formulae and Follow-On Formulae) Regulations 2004
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 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 himsel for 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, 27th day of May 2004.
MICHEÁL MARTIN, T.D.,
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 91/321/EEC of 14 May 1991, Council Directive 92/52/EEC of 18 June 1992, Commission Directive 96/4/EC of 16 February 1996, Commission Directive 1999/50/EC of 25 May 1999 and Commission Directive 2003/14/EC of 10 February 2003 on compositional, labelling, marketing and informational requirements for infant formulae and follow-on formulae intended for infants in good health.
These Regulations revoke the European Communities (Infant Formulae and Follow-on Formulae) Regulations 1998 (
S.I. No. 243 of 1998
) and the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2000 (
S.I. No. 446 of 2000
).
These Regulations may be cited as the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2004.
1
OJ L 186, 30.6.1989, p. 27.
2
OJ L 48, 19.2.1997, p. 20.
3
OJ L 172, 8.7.1999, p. 38.
4
OJ L 52, 22.2.2001, p. 19, as amended
5
OJ L 175, 4.7.1991, p. 35.
6
OJ L 179, 1.7.1992, p. 129.
7
OJ L 49, 28.2.1996, p. 12.
8
OJ L 139, 2.6.1999, p. 29.
9
OJ L 41, 14.2.2003, p. 37.
5
OJ L 175, 4.7.1991, p. 35.
6
OJ L 179, 1.7.1992, p. 129.
7
OJ L 49, 28.2.1996, p. 12.
8
OJ L 139, 2.6.1999, p. 29.
9
OJ L 41, 14.2.2003, p. 37.
10
OJ L 330, 5.12.1998, p. 32.
11
OJ L 229, 30.8.1980, p. 11.
10
OJ L 330, 5.12.1998, p. 32.
12
OJ L 22, 9.2.1965, p. 369.
13
OJ L 297, 13.10.1992, p. 8.
14
OJ L 262, 27.9.1976, p. 169.
15
OJ L 359, 8.12.1989, p. 1.
16
OJ L 230, 19.8.1991, p. 1.
17
OJ L 109, 6.5.2000, p. 29.
17
OJ L 109, 6.5.2000, p. 29.
18
OJ L 186, 30.6.1989, p. 21, as amended.
18
OJ L 186, 30.6.1989, p. 21, as amended.
8. (1) Advertising of infant formulae shall be restricted to publications specializing in baby care and scientific publications.
(2) The requirements, prohibitions and restrictions referred to in paragraphs (3) to (7) of Regulation 6 shall also apply to advertising, and advertisements for infant formulae shall be subject to the conditions laid down therein.
(3) Advertisements for infant formulae shall contain only information of a scientific and factual nature.
(4) Advertisements for infant formulae shall not imply or create a belief that bottle-feeding is equivalent or superior to breast-feeding.
(5) There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formulae directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales.
(6) Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers.
(7) In accordance with Article 8 of the Directive, the Minister may by Order impose further restrictions on the advertising or promotion of infant formulae.
9. (1) Where information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition, such information shall be objective and consistent.
(2) Paragraph (1) shall apply to the planning, provision, design and dissemination of information and their control.
(3) Informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear information on all the following points —
(
a
) the benefits and superiority of breast-feeding,
(
b
) the importance of maternal nutrition and the preparation for and maintenance of breast-feeding,
(
c
) the possible negative effect on breast-feeding of introducing partial bottle-feeding,
(
d
) the difficulty of reversing the decision not to breast-feed, and
(
e
) where needed, the proper use of infant formulae, whether manufactured industrially or home-prepared.
(4) Where the materials referred to at paragraph (3) contain information about the use of infant formulae, they shall include information on the social and financial implications of its use, the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of improper use of infant formulae.
(5) The materials referred to at paragraph (3) shall not use any pictures which may idealise the use of infant formulae.
(6) Donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the Authority or within guidelines issued by the Authority for that purpose.
(7) The equipment and materials referred to at paragraph(6) may bear the donating company’s name or logo, but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health care system.
(8) Donations and low-price sales of supplies of infant formulae to institutions or organisations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be fed on infant formulae and only for as long as required by such infants.
PART 3
Infant and Follow-On Formulae intended for export to Third Countries
10. This Part is concerned with infant and follow-on formulae intended for export to third countries.
11. (1) A person shall not—
(
a
) export infant formulae unless the requirements of this Part applicable to infant formulae are complied with,
(
b
) use the descriptions ‘infant formula’ or ‘infant formulae’ in the marketing of any product intended for export, which is not infant formula as defined in Regulation 2(1), or
(
c
) represent any product intended for export, which is not infant formula as defined in Regulation 2(1), as being suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first 4 to 6 months of life.
(2) A person shall not export infant formulae unless
(
a
) either the requirements set down in Regulation 4 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 (7) of Regulation 6 of these Regulations are complied with, and
(
c
) the provisions of Council Directive 89/396/EEC
18
of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs, are complied with.
(3) A person is not required to comply with paragraph (2)where the authorities of the importing country have requested otherwise, or where such compliance would be incompatible with the laws, regulations, standards, codes of practice or other legal or administrative procedures in force in the importing country.
(4) The stipulations, prohibitions and restrictions laid down in paragraphs (1) to (7) of Regulation 6 of these Regulations shall also apply to the presentation of infant formulae intended for export, and in particular their form, aspect or packaging and the packaging materials used.
12. (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 descriptions ‘follow-on formula’ or ‘follow-on formulae’ in the marketing of any product intended for export which is not follow-on formula as defined in Regulation 2(1).
(2) 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
18
of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs, are complied with.
(3) A person is not required to comply with paragraph (2)where the authorities of the importing country have requested otherwise, or where such compliance would be incompatible with the laws, regulations, standards, codes of practice or other legal or administrative procedures in force in the importing country.
(4) 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.
13. (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
14. Control of the foodstuffs affected by these Regulations and the enforcement of these Regulations shall be carried out in accordance with the provisions of these Regulations.
15. These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998.
16. These Regulations shall be enforced by the Authority or by an official agency pursuant to a service contract with the Authority and without prejudice to Regulation 14, the enforcement provisions contained in the Act of 1998 shall apply for the purposes of ensuring compliance with these Regulations.
17. (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.
(2) An authorised officer may, for the purpose of taking a sample of infant formulae or follow-on formulae, open any receptacle.
(3) 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 which are 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 seller, owner or person in apparent charge or control of such infant formulae or follow-on formulae, prohibit the removal of the infant formulae or follow-on formulae 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 detention of the sample.
(4) Where an authorised officer purchases or takes without payment a sample of infant formulae or follow-on formulae with the intention of having it analysed, he or she shall after purchasing or taking the sample forthwith notify the seller, owner or person in apparent charge or control of the infant formulae or follow-on formulae of his or her intention of having the sample analysed.
18. (1) Where a sample of infant formulae or follow-on formulae 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 infant formulae or follow-on formulae and retain the third part.
(2) Where an authorised officer takes a sample consisting of infant formulae or follow-on formulae 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) 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 infant formulae or follow-on formulae 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.
19. (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 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 11 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.
20. Where a sample of infant formulae or follow-on formulae 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 infant formulae or follow-on formulae 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.
21. (1) The provisions of Regulations 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,
(
b
) any other products which the authorised officer suspects are being treated, manufactured or placed on the market in contravention of these Regulations.
(2) 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.
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, follow-on formulae or any 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 owner or person in apparent charge or control of such infant formulae, 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, follow-on formulae or other products 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 products 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 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. 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.
24. (1) A person who fails to comply with these Regulations shall be guilty of an offence.
(2) Paragraph (1) shall not apply to an authorised officer acting in the course of his or her duties pursuant to these Regulations.
25. 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.
26. (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 ordeceive, 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.
27. (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.
28. An offence under these Regulations may be prosecuted by —
(
a
) the Authority, or
(
b
) an official agency.
PART 5
Revocations
29. (1) The following are revoked—
(
a
) the European Communities (Infant Formulae and Follow-on Formulae) Regulations 1998 (
S.I. No. 243 of 1998
), and
(
b
) the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2000 (
S.I. No. 446 of 2000
).
(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
Essential composition of Infant Formulae when reconstituted as instructed by the Manufacturer
NB: The values refer to the product ready for use
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 Council Directive 89/398/EEC
1
of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, as amended by Directive 96/84/EC
2
of the European Parliament and of the Council of 19 December 1996, and Directive 1999/41/EC
3
of the European Parliament and of the Council of 7 June 1999, and Commission Directive 2001/15/EC
4
of 15 February 2001, and for the purpose of giving effect to Commission Directive 91/321/EEC
5
of 14 May 1991 on infant formulae and follow-on formulae, as amended by Council Directive 92/52/EEC
6
of 18 June 1992, and Commission Directive 96/4/EC
7
of 16 February 1996, and Commission Directive 1999/50/EC
8
of 25 May 1999, and Commission Directive 2003/14/EC
9
of 10 February 2003, hereby make the following regulations
PART 1
Preliminary