Infant Formula and Follow-on Formula (Northern Ireland) Amendment Regulations 2014 (S.R.No. 11 of 2014)

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. S T A T U T O R Y R U L E S O F N O R T H E R N I R E L A N D 2014 No. 11 FOOD The Infant Formula and Follow-on Formula (Amendment) Regulations (Northern Ireland) 2014 Made - - - - 20th January 2014 Coming into operation 28th February 2014 The Department of Health, Social Services and Public Safety(1) makes the following Regulations in exercise of the powers conferred on it by Articles 15(1)(e), 16(1), and 47(2) of the Food Safety (Northern Ireland) Order 1991(2) and section 2(2) of the European Communities Act 1972(3). The Department of Health, Social Services and Public Safety has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to food (including drink) including the primary production of food(4). In accordance with section 47(3A) of the Food Safety (Northern Ireland) Order 1991, the Department of Health, Social Services and Public Safety has had regard to any relevant advice given by the Food Standards Agency. As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council 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(5) there has been open and transparent public consultation during the preparation of the following Regulations. Citation, commencement and interpretation 1. (1) These Regulations may be cited as the Infant Formula and Follow-on Formula (Amendment) Regulations (Northern Ireland) 2014 and come into operation on 28th February 2014. (2) The Interpretation Act (Northern Ireland) 1954(6) applies to these Regulations as it applies to an Act of the Northern Ireland Assembly. (1) Formerly the Department of Health and Social Services; see S.I. 1999/283 (N.I.1) Article 3(6) (2) S.I. 1991/762 (N.I.7) as amended by S.I. 1996/1663 (N.I.12), paragraphs 26 to 42 of Schedule 5 and Schedule 6 to the Food Standards Act 1999 c.28 and S.R.2004 Nos.482 and 505 (3) 1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7) (4) S.I. 2003/2901 (5) OJ No. L31, 1.2.2002, p.1, as last amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny Part Four (OJ No. L188, 18.7.2009, p.14) (6) 1954 c.33 (N.I.) http://www.legislation.gov.uk/european/regulation/2002/0178 http://www.legislation.gov.uk/european/regulation/2002/0178 http://www.legislation.gov.uk/id/nisi/1999/283 http://www.legislation.gov.uk/id/nisi/1991/762 http://www.legislation.gov.uk/id/nisi/1996/1663 http://www.legislation.gov.uk/id/ukpga/1999/28 http://www.legislation.gov.uk/id/ukpga/1972/68 http://www.legislation.gov.uk/id/ukpga/2006/51 http://www.legislation.gov.uk/id/ukpga/2008/7 http://www.legislation.gov.uk/id/uksi/2003/2901 http://www.legislation.gov.uk/european/regulation/2009/0596 http://www.legislation.gov.uk/european/regulation/2009/0596 http://www.legislation.gov.uk/european/decision/1999/0468 http://www.legislation.gov.uk/id/apni/1954/33 Document Generated: 2014-02-08 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 2 Amendment of the Infant Formula and Follow-on Formula Regulations (Northern Ireland) 2007 2. (1) The Infant Formula and Follow-on Formula Regulations (Northern Ireland) 2007(7) are amended as follows. (2) In regulation 2(1) (interpretation) at the end of the definition of “the Directive” insert “as amended by Commission Directive 2013/46/EU amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow on formulae”;(8) (3) In regulation 8(2) (compositional criteria for infant formula) after “cows’ milk proteins” insert “or goats’ milk proteins”. (4) For regulation 9 (compositional criteria for follow-on formula) substitute— “Compositional criteria for follow-on formula 9. (1) Subject to paragraph (2), follow-on formula shall comply with the compositional criteria set out in Annex II taking into account the specifications in Annex V. (2) In the case of follow-on formula manufactured from those protein hydrolysates specified in point 2.2 of Annex II with a protein content between the minimum and 0.56g/100kj (2.25g/100kcal)— (a) the suitability of the follow-on formula for satisfying the nutritional requirements of normal healthy infants in conjunction with complementary feeding shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies; and (b) the follow-on formula shall be in accordance with the appropriate specifications set out in Annex VI.” (5) In regulation 15 (naming of infant formula) in both paragraphs, after “cows’ milk proteins” insert “or goats’ milk proteins”. (6) In regulation 16 (naming of follow-on formula) in both paragraphs, after “cows’ milk proteins” insert “or goats’ milk proteins”. Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 20th January 2014. Julie Thompson A senior officer of the Department of Health, Social Services and Public Safety (7) S.R. 2007 No. 506. There are other amending regulations but none is relevant (8) OJ No L 230, 29.08.2013, p.16 http://www.legislation.gov.uk/european/directive/2006/0141 http://www.legislation.gov.uk/id/nisr/2007/506 Document Generated: 2014-02-08 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 3 EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations amend the Infant Formula and Follow-on Formula Regulations (Northern Ireland) 2007 in order to implement Commission Directive 2013/46/EU in Northern Ireland. Regulation 2(3), (5) and (6) enables the use of goats’ milk proteins in the manufacture of infant formula and follow-on formula. Regulation 2(4) lowers the minimum protein levels permitted in follow-on formula manufactured from protein hydrolysates to bring it in line with infant formula.