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The Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016

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Citation, application and commencementE+W+S

1.—(1) These Regulations may be cited as the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016.

(2) These Regulations apply in England only.

(3) These Regulations come into force on 20th July 2016.

InterpretationE+W+S

2.—(1) In these Regulations—

the Act” means the Food Safety Act 1990;

[F1“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;]

food authority” means—

(a)

a county council;

(b)

a metropolitan district council;

(c)

a non-metropolitan district council for an area for which there is no county council;

(d)

a London borough council;

(e)

the Common Council of the City of London (in their capacity as a local authority); and

(f)

the Council of the Isles of Scilly;

[F2“food for special medical purposes” has the same meaning in these Regulations as in the EU Regulation;]

[F2“infant” means a child under the age of 12 months;]

the EU Regulation” means Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009;

specified EU requirement” means any provision of the EU Regulation [F3or the Delegated Regulation] specified in column 1 of Schedule 1, as read with the provisions in column 2.

(2) Where any functions under the Act are assigned to a port health authority by an order under section 2 or 7 of the Public Health (Control of Disease) Act 1984 M1, any reference in these Regulations to a food authority shall be construed, so far as relating to those functions, as a reference to the port health authority to which they are assigned.

(3) Except where otherwise provided, any reference in these Regulations to—

(a)a regulation is a reference to a regulation of these Regulations;

(b)an Article or Annex is a reference to an Article or Annex of the EU Regulation.

(4) Any reference to a provision of the EU Regulation contained in the table in Schedule 1 describing specified EU requirements, except a reference to Article 1(1), is a reference to that provision as amended from time to time.

[F4(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.

F5(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

EnforcementE+W+S

3.  Each food authority must enforce and execute these Regulations within its area.

Application of provisions of the ActE+W+S

4.—(1) Section 10 of the Act (improvement notices) applies in relation to the enforcement of a specified EU requirement for the purposes of these Regulations, with the modifications specified in Part 1 of Schedule 2.

(2) Section 32 of the Act (powers of entry) applies in relation to the enforcement of a specified EU requirement for the purposes of these Regulations with the modifications specified in Part 2 of Schedule 2.

(3) Section 35 of the Act (punishment of offences) applies in relation to the enforcement of a specified EU requirement for the purposes of these Regulations with the modifications specified in Part 3 of Schedule 2.

(4) Section 37(1), (3), (5) and (6) of the Act (appeals) applies to an improvement notice served in relation to a specified EU requirement with the modifications specified in Part 4 of Schedule 2.

(5) Section 39 of the Act (appeals against improvement notices) [F6applies to an appeal against an improvement notice served in relation to a specified EU requirement] with the modifications specified in Part 5 of Schedule 2.

(6) The provisions of the Act specified in paragraph (7) apply in relation to the enforcement of a specified EU requirement for the purposes of these Regulations, insofar as they relate to the provisions of the Act specified in and modified by paragraphs (1) to (5).

(7) The provisions of the Act specified for the purposes of this paragraph are—

(a)section 3 (presumptions that food intended for human consumption);

(b)section 20 (offences due to fault of another person);

(c)section 21 M2 (defence of due diligence);

(d)section 22 (defence of publication in the course of business);

(e)section 29 (procurement of samples);

(f)section 30(8) (which relates to evidence of certificates given by a food analyst or examiner);

(g)section 33 (obstruction etc. of officers);

(h)section 36 (offences by bodies corporate);

(i)section 36A M3 (offences by Scottish partnerships);

(j)section 44 (protection of officers acting in good faith);

and any reference in those provisions to a section of the Act, including a reference to “any of the preceding provisions of this Part”, is to be read as a reference to such sections of the Act that apply by virtue of, and with the modifications made by, these Regulations.

Textual Amendments

Marginal Citations

M2Section 21(2) was amended by S.I. 2004/3279.

M3Section 36A was inserted by paragraph 16 of Schedule 5 to the Food Standards Act 1999 (c. 28).

RevocationE+W+S

5.  The following are revoked—

(a)The Notification of Marketing of Food for Particular Nutritional Uses (England) Regulations 2007 M4;

(b)regulations 26 and 27 of the Infant Formula and Follow-on Formula (England) Regulations 2007 M5;

(c)The Food for Particular Nutritional Uses (Miscellaneous Amendments) (England) Regulations 2010 M6; and

(d)regulation 3 of the Transfer of Functions (Food) Regulations 2011 M7.

Marginal Citations

M5S.I. 2007/3521, amended by S.I. 2008/2445, 2011/1043, 2011/3012, 2013/3243.

Amendments to statutory instrumentsE+W+S

6.  Schedules 3 and 4 have effect.

ReviewE+W+S

7.—(1) The Secretary of State must from time to time—

(a)carry out a review of the regulatory provision made by these Regulations, and

(b)publish a report setting out the conclusions of the review.

F7(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The report must in particular—

(a)set out the objectives intended to be achieved by the regulatory provision made by these Regulations;

(b)assess the extent to which those objectives are achieved;

(c)assess whether those objectives remain appropriate, and

(d)if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(4) The first report under this regulation must be published before 20th July 2021.

(5) Subsequent reports under this regulation must be published at intervals not exceeding five years.

(6) In this regulation, “regulatory provision” has the meaning given by section 32(4) of the Small Business, Enterprise and Employment Act 2015 M8.

Textual Amendments

Marginal Citations

[F8Transitional ArrangementsE+W+S

8.  Food for special medical purposes that does not comply with any specified provision of the Delegated Regulation specified in Schedule 1 may continue to be marketed until stocks of such food are exhausted provided that—

(a)it complies with the provisions of the EU Regulation specified in Schedule 1;

(b)it was placed on the market or labelled—

(i)before 22nd February 2019; or

(ii)before 22nd February 2020 in the case of food for special medical purposes developed to satisfy the nutritional requirements of infants; and

(c)the requirements specified in regulation 3(1) and (2) of the Medical Food (England) Regulations 2000 (restrictions on sale) are met.]

Signed by the authority of the Secretary of State for Health.

Jane Ellison

Parliamentary Under-Secretary of State,

Department of Health

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