PART 6Amendments relating to novel foods

Amendment of Regulation (EU) 2015/2283 on novel foods, etc.

regulation 17 + 17.—(1) Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc.(1) is amended as follows.

(2) In Article 3(2), omit point (k).

(3) After Article 3, insert—

“Article 3ADetermination of authorisation status

1.  For the purposes of this Regulation, determining the authorisation status of a novel food is to consist of the appropriate authority determining whether or not to:

(a)authorise the placing on the market, or the use in or on food, of a novel food;

(b)modify the authorisation of a novel food, including modifying any conditions of use, post-market monitoring requirements, restrictions, specific labelling requirements or specifications associated with the authorisation of the novel food concerned;

(c)revoke or suspend the authorisation of a novel food.

2.  For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—

(a)existing stocks of the novel food concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)the novel food concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)the labelling of the novel food concerned, and any products derived from it or containing it, may continue to be applied.

3.  The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation.

Article 3BDomestic list of authorised novel foods

1.  The Food Safety Authority must establish and maintain a list (the “domestic list”) of novel foods, the placing on the market or use of which has been authorised in accordance with this Regulation, including the details described in Article 9(3).

2.  The domestic list must be made available to the public.”.

(4) For Article 6, substitute—

“Article 6Requirement for authorisation

Only novel foods authorised by the appropriate authority in accordance with this Regulation may be placed on the market within Great Britain as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified in the authorisations concerned.”.

(5) In Article 7—

regulation 17 5 a + (a)in the heading, for “inclusion of novel foods in the list” substitute “authorisation of novel foods”;

regulation 17 5 b + (b)in the words before point (a), for “and include a novel food in the list” substitute “a novel food”.

(6) In Article 9—

regulation 17 6 a + (a)for the heading, substitute “Obligations of the appropriate authority in relation to the procedure for determining authorisation status and content of an authorisation”;

regulation 17 6 b + (b)in paragraph 1, in the words before point (a), for “authorise a novel food and update the list” substitute “determine the authorisation status of a novel food”;

regulation 17 6 c + (c)omit paragraph 2;

regulation 17 6 d + (d)in paragraph 3, in the words before point (a), for “The entry for a novel food in the list provided for in paragraph 2” substitute “The authorisation of a novel food”.

(7) In Article 10—

regulation 17 7 a + (a)for the heading, substitute “Procedure for determining authorisation status”;

regulation 17 7 b + (b)in paragraph 1, in the first sentence—

regulation 17 7 b i + (i)for “authorising the placing on the market within Great Britain” substitute “determining the authorisation status”;

regulation 17 7 b ii + (ii)omit “and updating the list”;

regulation 17 7 c + (c)in paragraph 3, for “update” substitute “proposed determination of authorisation status”;

regulation 17 7 d + (d)in paragraph 5—

regulation 17 7 d i + (i)omit “and updating the list”;

regulation 17 7 d ii + (ii)for “prescribes an update of the list in respect” substitute “determines the authorisation status”;

regulation 17 7 e + (e)in paragraph 6—

regulation 17 7 e i + (i)for “an update of the list” substitute “a determination of the authorisation status of the novel food concerned”;

regulation 17 7 e ii + (ii)for “an update”, in the second place it occurs, substitute “a determination”.

(8) In Article 12—

regulation 17 8 a + (a)in the heading, omit “and updates of the list”;

regulation 17 8 b + (b)in paragraph 1, in the words before point (a), for “, by prescribing an update of the list, authorise the placing on the market within Great Britain” substitute “determine the authorisation status”;

regulation 17 8 c + (c)after paragraph 2, insert—

“2A.  Where the appropriate authority determines the authorisation status of a novel food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.”.

(9) In Article 15—

regulation 17 9 a + (a)in paragraph 4—

regulation 17 9 a i + (i)in the first sentence, omit “by prescribing an update to the list”;

regulation 17 9 a ii + (ii)in the second sentence, for “entry in the list” substitute “authorisation”;

regulation 17 9 b + (b)in paragraph 5, omit “or update the list”.

(10) In Article 18—

regulation 17 10 a + (a)in the heading, omit “and updates of the list”;

regulation 17 10 b + (b)in paragraph 1, in the words before point (a), omit “by prescribing an update of the list”;

regulation 17 10 c + (c)in paragraph 2—

regulation 17 10 c i + (i)in the first sentence—

regulation 17 10 c i aa + (aa)for “update”, in the first place it occurs, substitute “authorisation”;

regulation 17 10 c i bb + (bb)for “proceed with an update of the list where it considers that such an update” substitute “authorise the placing on the market of the traditional food where it considers that authorisation”;

regulation 17 10 c ii + (ii)in the second sentence, for “not considering the update to be justified” substitute “its decision”;

regulation 17 10 d + (d)after paragraph 3, insert—

“4.  Where the appropriate authority determines the authorisation status of a traditional food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.”.

(11) For Article 19, substitute—

“Article 19Application of provisions to authorised traditional foods from third countries

Articles 3A and 3B and 9 to 12 apply to modifying any specifications, conditions of use, specific labelling requirements or post-market monitoring requirements associated with the authorisation of a traditional food from a third country or to suspending or revoking an authorisation of a traditional food from a third country.”.

(12) In Article 23, in the heading, for “updates of the list” substitute “authorisation”.

(13) In Article 27—

regulation 17 13 a + (a)in the heading, omit “and inclusion in the list”;

regulation 17 13 b + (b)in paragraph 1—

regulation 17 13 b i + (i)in the words before point (a)—

regulation 17 13 b i aa + (aa)omit “and included in the list”;

regulation 17 13 b i bb + (bb)for “entry of that novel food in the list” substitute “authorisation of that novel food”;

regulation 17 13 b ii + (ii)in point (a), for “inclusion of the novel food in the list” substitute “authorisation”.

(14) In Article 35(2A), for point (d) substitute—

“(d)there is a determination of the authorisation status of the novel food concerned.”.