The Novel Food (Amendment) (EU Exit) Regulations 2019
| Year | 2019 |
2019 No. 702
Exiting The European Union
Food
The Novel Food (Amendment) (EU Exit) Regulations 2019
Made 26th March 2019
Coming into force in accordance with regulation 1
The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 20181.
In accordance with paragraph 1(1) of Schedule 7 to that Act, a draft of the instrument has been laid before Parliament and approved by a resolution of each House of Parliament.
As required by Article 9 of Regulation (EC) No. 178/2002of 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 there has been open and transparent public consultation during the preparation of these Regulations.
PART 1
Introduction
Citation and commencement
1. These Regulations may be cited as the Novel Food (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.
Interpretation
2. In these Regulations—
“Regulation 2015/2283” means Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No. 258/97of the European Parliament and of the Council and Commission Regulation (EC) No. 1852/2001;
“Regulation 2017/2468” means Commission Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods;
“Regulation 2017/2469” means Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods;
“Regulation 2017/2470” means Commission Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods;
“Regulation 2018/456” means Commission Implementing Regulation (EU) 2018/456 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.
PART 2
Amendment of subordinate legislation
Amendment of the Novel Foods (England) Regulations 2018
3. The Novel Foods (England) Regulations 20182are amended as follows.
4. In Schedule 1, in column 2 of the Table—
(a) in the entry which relates to Article 6.2 as read with Article 24, omit “Union”;
(b) in the entry which relates to Article 25, for “Commission”, substitute “Food Safety Authority”.
PART 3
Amendment of retained direct EU legislation
Amendment of Regulation 2015/2283
Regulation 2015/2283 is amended as follows.
5. Regulation 2015/2283 is amended as follows.
6. For Article 1, substitute—
“Subject matter and purpose(1) This Regulation lays down rules for novel foods placed on the market within the United Kingdom.(2) The purpose of this Regulation is to ensure a high level of protection of human health and consumers’ interests.”.
In Article 2 (1), for “Union”, substitute “United Kingdom”.
7. In Article 2 (1), for “Union”, substitute “United Kingdom”.
8. In Article 3—
(a) in paragraph 2—
(i) for the opening words of point (a), substitute—
“(a)
“(a) “novel food’ means any food that was not used for human consumption to a significant degree within the EU or the United Kingdom before 15 May 1997, irrespective of the dates of accession of member States, and that falls under at least one of the following categories—”;
(ii) for point (d), substitute—
“(d)
“(d) “the applicant” means the third country or the interested party;”;
(iii) after paragraph (f), insert—
“(g)
“(g) “third country” means a country or state other than the United Kingdom;
(h)
(h) “prescribe” means prescribe by regulations;
(i)
(i) “appropriate authority” means—
(i) in relation to England, the Secretary of State;
(ii) in relation to Wales, the Welsh Ministers;
(iii) in relation to Scotland, the Scottish Ministers;
(iv) in relation to Northern Ireland, the Northern Ireland devolved authority;
(j)
(j) “Food Safety Authority” means—
(i) as regards England, Wales and Northern Ireland, the Food Standards Agency;
(ii) as regards Scotland, Food Standards Scotland;
(k)
(k) “list” means the list referred to in Article 6(1);
(l)
(l) “Northern Ireland devolved authority” means the Department of Health.”;
(b) in each place in which it occurs, for “Union”, substitute “EU or the United Kingdom”.
9. For Article 4, substitute—
“Procedure for determination of novel food status(1) Food business operators must verify whether or not the food which they intend to place on the market within the United Kingdom falls within the scope of this Regulation.(2) Where they are unsure whether or not a food which they intend to place on the market within the United Kingdom falls within the scope of this Regulation, food business operators must consult the Food Safety Authority. Food business operators must provide the necessary information to the Food Safety Authority to enable it to determine whether or not a food falls within the scope of this Regulation.”.
10. For Article 5, substitute—
“Implementing power concerning the definition of novel foodThe appropriate authority may prescribe that a particular food is a novel food within the meaning of this Regulation.”.
11. In the Title of Chapter 2, for “Union”, substitute “United Kingdom”.
12. For Article 6, substitute—
“List of authorised novel foods(1) The appropriate authority must establish and update a list of novel foods authorised to be placed on the market within the United Kingdom in accordance with Articles 7 and 9.(2) Only novel foods authorised and included in the list may be placed on the market within the United Kingdom as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified in the list.”.
13. In Article 7—
(a) in each place in which it occurs (including the heading), omit “Union”;
(b) for “Commission shall”, substitute “appropriate authority must”.
Omit Article 8.
14. Omit Article 8.
15. In Article 9—
(a) in each place in which it occurs (including the heading), omit “Union”;
(b) in paragraph 1, for “Commission shall”, substitute “appropriate authority must”.
16. For Article 10, substitute—
“Procedure for authorising the placing on the market of a novel food and updating the list(1) The procedure for authorising the placing on the market within the United Kingdom of a novel food and updating the list provided for in Article 9 must start either on the initiative of the appropriate authority or following an application to the appropriate authority by an applicant. The appropriate authority must make the summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.(2) The application for an authorisation must include—(a) the name and address of the applicant;(b) the name and description of the novel food;(c) the description of the production process;(d) the detailed composition of the novel food;(e) scientific evidence demonstrating that the novel food does not pose a safety risk to human health;(f) where appropriate, the analysis method;(g) a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.(3) Upon request by the appropriate authority, the Food Safety Authority must give its opinion as to whether the update is liable to have an effect on human health.(4) When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation must be provided by the applicants of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of those materials.(5) The procedure for authorising the placing on the market within the United Kingdom of a novel food and updating the list as provided for in Article 9 ends when the appropriate authority prescribes an update of the list in respect of that novel food in accordance with Article 12.(6) By way of derogation from paragraph 5, the appropriate authority may terminate the procedure at any stage, and decide not to proceed with an update of the list where the appropriate authority considers that an update is not justified.(7) The...
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