European Communities (Infant Formulae and Follow-On Formulae) Regulations, 2007

JurisdictionIreland
CitationIR SI 852/2007
Year2007

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 18th 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

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

(2) These Regulations (other than Regulation 30(2)) come into operation on 1 January 2008.

(3) Regulation 30(2) comes into operation on the 31 December 2009.

2. (1) In these Regulations—

“Act of 1998” means the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998);

“approved examiner” means—

(a) an Agricultural Inspector located at a Dairy Science Laboratory,

(b) an Assistant Agricultural Inspector located at a Dairy Science Laboratory,

(c) a Chief Medical Scientist located at an official laboratory,

(d) a Consultant Microbiologist located at an official laboratory,

(e) a Deputy Public Analyst located at a Public Analyst’s Laboratory,

(f) an Executive Analytical Chemist located at a Public Analyst’s Laboratory,

(g) a Public Analyst located at a Public Analyst’s Laboratory,

(h) a person, or member of a class of persons, designated by the Minister pursuant to Regulation 24;

“authorised officer” means an authorised officer appointed under section 49 of the Act of 1998;

“Authority” means the Food Safety Authority of Ireland established under section 9 of the Act of 1998;

“claim”, “health claim”, “nutrition claim” and “reduction of disease risk claim” shall be defined in accordance with Article 2(2) of Regulation (EC) No 1924/2006 4 ;

Directive 2006/141/EC” means Commission Directive 2006/141/EC 1 of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC 2 ;

Directive 92/52/EEC” means Council Directive 92/52/EEC 3 of 18 June 1992 on infant formulae and follow-on formulae intended for export to third countries;

“Directives” means Directive 2006/141/EC 1 and Directive 92/52/EEC 3 ;

“follow-on formulae” means foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants, and cognate words shall be construed accordingly;

“General Food Law Regulation” means Regulation (EC) No 178/2002 5 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;

“health care system” includes institutions or organisations engaged, directly or indirectly, in health care for mothers, infants and pregnant women, including nurseries or child-care institutions, and includes health workers in private practice;

“Health Service Executive” (HSE) means the Heath Service Executive established under section 6 of the Health Act 2004 (No. 42 of 2004);

“infant formulae” means foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants, until the introduction of appropriate complementary feeding, and cognate words shall be construed accordingly;

“infants” means children under the age of 12 months;

“Minister” means the Minister for Health and Children;

“official agency” means an official agency carrying out functions under a service contract and acting on behalf of the Authority pursuant to section 48 of the Act of 1998;

“Official Controls Regulation” means Regulation (EC) No 882/2004 6 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules;

“official laboratory” means—

(a) Dairy Science Laboratory, Backweston,

(b) Public Analyst’s Laboratory, Cork,

(c) Public Analyst’s Laboratory, Dublin,

(d) Public Analyst’s Laboratory, Galway,

(e) Public Health Laboratory, HSE, Dublin Mid-Leinster,

(f) Public Health Laboratory, Sligo,

(g) Public Health Laboratory, Waterford,

(h) Public Health Microbiology Laboratory, Cork,

(i) Public Health Microbiology Laboratory, Galway,

(j) Public Health Microbiology Laboratory, Limerick,

(j) a laboratory designated by the Minister pursuant to Regulation 24;

“pesticide residue” means the residue in infant formulae and follow-on formulae of a plant protection product, as defined in point 1 of Article 2 of Directive 91/414/EEC 7 , including its metabolites and products resulting from its degradation or reaction, and cognate words shall be construed accordingly;

“service contract” means a contract entered into between the Authority and an official agency pursuant to section 48 of the Act of 1998;

“young children” means children aged between one and three years.

(2) A word or expression which is used in these Regulations and which is also used in the Directives or in the General Food Law Regulation has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directives or in the General Food Law Regulation.

(3) (a) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended.

(b) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

(c) A reference in these Regulations to a Schedule is to a Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended.

(d) A reference in these Regulations to an Article is to an Article of the Directives, unless it is indicated that reference to some other instrument is intended.

PART 2

Infant Formulae and Follow-On Formulae Intended to be Placed on the Market in a Member State

3. (1) These Regulations concern infant formulae and follow-on formulae, and this Part is concerned with infant formulae and follow-on formulae intended to be placed on the market in a Member State.

(2) A person shall not—

(a) manufacture infant formulae or place infant formulae on the market unless the requirements of this Part applicable to infant formulae are complied with,

(b) use the description ‘infant formula’ in the marketing of any product which is not infant formulae as defined in Regulation 2(1), or

(c) represent any product which is not infant formulae as defined in Regulation 2(1) as being suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first months of life until the introduction of appropriate complementary feeding.

(3) Infant formulae shall be placed on the market under the name ‘infant formula’, save where it is manufactured entirely from cows’ milk proteins, in which case it shall be sold under the name ‘infant milk’.

(4) A person shall not—

(a) manufacture follow-on formulae or place follow-on formulae on the market 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 which is not follow-on formulae as defined in Regulation 2(1).

(5) Follow-on formula shall be placed on the market under the name ‘follow-on formula’, save where it is manufactured entirely from cows’ milk proteins, in which case it shall be sold under the name ‘follow-on milk’.

(6) The other names listed in Articles 11 and 12 of the Directive, or any of them, may also be included in addition to the names indicated in paragraphs (3) and (5).

(7) A person shall not distribute, publish or issue any materials containing information on infant or young child feeding, unless the requirements of this Part are complied with.

4. (1) Infant formulae shall be manufactured from protein sources defined in point 2 of Schedule 1 and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data, and demonstrated in accordance with paragraph (2).

(2) Suitability shall be demonstrated through a systematic review of the available data relating to the expected benefits and to safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.

(3) The prohibitions and limitations on the use of food ingredients in infant formulae set down in Schedule 1 shall be observed.

(4) Subject to paragraphs (5) and (6), infant formulae shall comply with the compositional criteria specified in Schedule 1 taking into account the specifications in Schedule 5.

(5) In the case of infant formulae manufactured from cows’ milk proteins specified in point 2.1 of Schedule 1 with a protein content between the minimum and 0.5g/100 kJ (2g/100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.

(6) In the case of infant formulae manufactured from protein hydrolysates specified in point 2.2 of Schedule 1 with a protein...

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