Statutory Instruments
Food, England
Food Safety
Made
14th January 2019
Laid before Parliament
18th January 2019
Coming into force
22nd February 2019
The Secretary of State in exercise of powers conferred by sections 17(1) and (2), 26(1) and (3) and 48(1)(b) and (c) of the Food Safety Act 1990 M1 as read with paragraph 1A(1) of Schedule 2 to the European Communities Act 1972 M2 makes the following Regulations.
These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain provisions of Commission Delegated Regulation (EU) 2016/128 M3 to be construed as a reference to those provisions as amended from time to time.
The Secretary of State has had regard to relevant advice given by the Food Standards Agency in accordance with section 48(4A) of that Act M4.
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 M5, during the preparation and evaluation of these Regulations.
Marginal Citations
M11990 c. 16. Section 17 was amended by paragraphs 8 and 12 of Schedule 5 to the Food Standards Act 1999 (c. 28) (“the 1999 Act”) and S.I. 2011/1043. Section 26(3) was partially repealed by paragraph 1 of Schedule 6 to the 1999 Act. Section 48(1) was amended by paragraph 8 of Schedule 5 to the 1999 Act. Functions formerly exercisable by “the Ministers” (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the 1999 Act.
M21972 c. 68. Paragraph 1A(1) of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c. 51).
M3Commission Delegated Regulation (EU) 2016/128 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 (OJ No. L 25, 02.02.2016, p 30).
M4Section 48(4A) was inserted by section 40(1) and paragraph 21 of Schedule 5 to the 1999 Act.
M5OJ No. L 31 1.2.2002, p 1, last amended by Commission Regulation (EU) No. 2017/228 (OJ No. L 35, 10.02.17, p 10).
1. These Regulations may be cited as the Food for Specific Groups (Information and Compositional Requirements) (Amendment) (England) Regulations 2019 and they come into force on 22nd February 2019.
2. In these Regulations, “the 2016 Regulations” means the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 M6.
3.—(1) The 2016 Regulations are amended as follows.
(2) In regulation 2 (interpretation) —
(a)in paragraph (1) —
(i)after the definition of “the Act” insert —
““the Delegated Regulation” means Commission Delegated Regulation (EU) 2016/128 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;”M7;
(ii)after the definition of “food authority” insert —
““food for special medical purposes” has the same meaning in these Regulations as in the EU Regulation M8;
“infant” means a child under the age of 12 months;”;
(iii)in the definition of “specified EU requirement”, after “the EU Regulation” insert “ or the Delegated Regulation ”.
(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 7 (review) insert —
8. 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 (England) Regulations 2000 are met.”.
Commencement Information
Marginal Citations
M7OJ No. L 25, 2.2.2016, p.30
M8Article 2(2)(g) of the EU Regulation states “ ‘food for special medical purposes’ means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone.”
4. For the table in Schedule 1 to the 2016 Regulations substitute the following:
| 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 and 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 | Articles 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 4 (name of the food) | Article 1 and Annex 4 |
| 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 |
F15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
Signed by the authority of the Secretary of State for Health and Social Care.
Steve Brine
Parliamentary Under-Secretary of State,
Department of Health and Social Care
(This note is not part of the Regulations)
These Regulations make provision to enforce, in England, Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific information and compositional requirements for food for special medical purposes (“the Delegated Regulation”). They do this by amending the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 (S.I. 2016/688) (“the 2016 Regulations”), which make provision to enforce the requirements of Regulation (EU) No. 609/2013 of the European Parliament and of the Council on the provisions of food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (“the EU Regulation”). The EU Regulation sets out the general information and compositional requirements for certain categories of food and the 2016 Regulations provide for the enforcement of those requirements by applying, with modifications, certain provisions of the Food Safety Act 1990. The Delegated Regulation sets out the specific information and compositional requirements for food for special medical purposes.
Regulation 4 amends the 2016 Regulations so that specified provisions of the Delegated Regulation become ‘specified EU requirements’, to which the modified provisions of the Food Safety Act 1990 apply. This enables an improvement notice to be served requiring compliance. Failure to comply with an improvement notice is a criminal offence.
References to the provisions of the Delegated Regulation are to be read as references to those provisions as amended from time to time.
A definition of food for special medical purposes is contained in the EU Regulation and this includes such food for infants. However, from 22 February 2019 the Delegated Regulation applies only to food for special medical purposes other than that developed to satisfy the nutritional needs of infants. Regulation 3(2)(b) therefore ensures that enforcement of the Delegated Regulation is similarly limited. Regulation 5 amends the definition of medical food in the Medical Food (England) Regulations 2000 (S.I. 2000/845) (“the 2000 Regulations”), which will continue to apply to medical food developed to satisfy the nutritional needs of infants, so that they only apply to such food.
Regulation 3(3) includes transitional provisions for medical food that is labelled or placed on the market before 22 February 2019. Such food may continue to be marketed until stocks are exhausted as long as they are sold in compliance with specified requirements of the EU Regulation and regulation 3(1) and (2) of the 2000 Regulations.
A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.