
2019 No. 70 (W. 22)
Food, WalesFood Safety
The Food for Specific Groups (Information and Compositional Requirements) (Amendment) (Wales) Regulations 2019
Made 17 January 2019
Laid before the National Assembly for Wales 21 January 2019
Coming into force 22 February 2019
The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 17(1) and (2), 26(1) and (3) and 48(1)(b) and (c) of the Food Safety Act 1990  as read with paragraph 1A(1) of Schedule 2 to the European Communities Act 1972 .These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972, and it appears to the Welsh Ministers that it is expedient for certain provisions of Commission Delegated Regulation (EU) 2016/128 , referred to in these Regulations, to be construed as references to those provisions as amended from time to time.The Welsh Ministers have had regard to relevant advice given by the Food Standards Agency in accordance with section 48(4A)  of the Food Safety Act 1990.There has been consultation 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 , during the preparation and evaluation of these Regulations.
Title, application, commencement and interpretation
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(1) The title of these Regulations is the Food for Specific Groups (Information and Compositional Requirements) (Amendment) (Wales) Regulations 2019.
(2) These Regulations apply in relation to Wales.
(3) These Regulations come into force on 22 February 2019.
(4) In these Regulations—
 “the 2000 Regulations” (“Rheoliadau 2000”) means the Medical Food (Wales) Regulations 2000 ;
 “the 2016 Regulations” (“Rheoliadau 2016”) means the Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016 .
Amendment of regulation 2 of the 2000 Regulations
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of the 2016 Regulations
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(1) The 2016 Regulations are amended as follows.
(2) In regulation 2 (interpretation)—
(a) in paragraph (1)—
(i) at the appropriate place insert—““the Delegated Regulation” (“y Rheoliad Dirprwyedig”) means Commission Delegated Regulation (EU) 2016/128 as amended from time to time supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes ;”;““food for special medical purposes” (“bwyd at ddibenion meddygol arbennig”) has the same meaning in these Regulations as in the EU Regulation ;”;““infant” (“baban”) means a child under the age of 12 months;”; and
(ii) in the definition of  “specified EU requirement”, after  “the EU Regulation” insert “
                        or the Delegated Regulation
                      ”; and
(b) after paragraph (4) insert—“
(5) Any reference to a provision of the Delegated Regulation contained in the table in Schedule 1 is a reference to that provision as amended from time to time.
(6) Any reference to the Delegated Regulation is a reference to the Delegated Regulation only insofar as it applies to food for special medical purposes other than that developed to satisfy the nutritional requirements of infants.”
(3) After regulation 6 (amendments to statutory instruments) insert—“
Transitional arrangements
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Food for special medical purposes, other than that developed to satisfy the nutritional requirements of infants, that does not comply with the specified provisions of the Delegated Regulation may continue to be marketed until stocks of such food are exhausted provided—
(a) it complies with the specified provisions of the EU Regulation;
(b) it was placed on the market or labelled before 22 February 2019; and
(c) the requirements of regulation 3(1) and (2) of the Medical Food (Wales) Regulations 2000 are met.”
Amendment of Schedule 1 to the 2016 Regulations
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For the Table in Schedule 1 to the 2016 Regulations substitute—“
Column 1 Column 2
Specified provision of the EU Regulation Provisions to be read with the specified provision of the EU Regulation
Article 4(2) (requirement for relevant food to be pre-packed) Articles 1(1) and 4(1)
Article 9(1) (requirement for the composition of food to be nutritionally appropriate and suitable) Articles 1(1), 4(1) and 9(3)
Article 9(2) (prohibition on substances in dangerous quantities) Articles 1(1) and 4(1)
Article 9(5) (requirements as to labelling, presentation and advertising of relevant food) Articles 1(1), 4(1) and 9(6)
Article 10 (additional requirements for infant formula and follow-on formula) Article 4(1)
Article 15(1) (Union list) Articles 1(1)(c), 4(1) and the Annex insofar as it applies to food for special medical purposes
Specified provision of the Delegated Regulation Provisions to be read with the specified provision of the Delegated Regulation
Article 2(2) (requirement for the formulation of food to be based on sound medical and nutritional principles) Article 1
The second sub-paragraph of Article 2(3) (food to comply with compositional requirements in Part B of Annex 1) Articles 1, 2(4) and Part B of Annex 1
Article 3(2) (requirement relating to residue levels) insofar as it applies to young children rather than infants Article 1 and 3(1), (3) and (5) and Annex 2
Article 3(4) (prohibition on the use of plant protection products) insofar as it applies to young children rather than infants Articles 1 and 3(1) and (5) and Annex 3
Article 5(2) (specific requirements on food information) Articles 1 and 5(1) and (3)
Article 6 (specific requirements on the nutrition declaration) Article 1 and Part B of Annex 1
Article 7 (nutrition and health claims) Article 1
Article 9 (notification requirement) Article 1”
Vaughan Gething

Minister for Health and Social Services, one of the Welsh Ministers
