CHAPTER III AUTHORISATION PROCEDURES FOR A NOVEL FOOD

SECTION II Specific rules for traditional foods from third countries

Article 14 Notification of a traditional food from a third country
Instead of following the procedure referred to in Article 10, an applicant, who intends to place on the market within Great Britain a traditional food from a third country, may opt to submit a notification of that intention to the appropriate authority.
The notification shall include the following information:
(a) the name and address of the applicant;
(b) the name and description of the traditional food;
(c) the detailed composition of the traditional food;
(d) the country or countries of origin of the traditional food;
(e) documented data demonstrating the history of safe food use in a third country;
(f) 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.
Words in Art. 14 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 20(a) (as substituted by S.I. 2020/1504, regs. 1(2), 15(8)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 20(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 15 Procedure for notifying the placing on the market of a traditional food from a third country
1. The appropriate authority must forward the valid notification provided for in Article 14 without delay, and not later than one month after having verified its validity, to the Food Safety Authority.
2. Within four months from the date on which a valid notification under Article 14 is received by the appropriate authority, the Food Safety Authority may issue to the appropriate authority duly reasoned safety objections to the placing on the market within Great Britain of the traditional food concerned.
3. The appropriate authority must inform the applicant of any duly reasoned safety objection as soon as it is issued.
4. Where no duly reasoned safety objections have been issued in accordance with paragraph 2 within the time limit laid down in that paragraph, the appropriate authority must authorise the placing on the market within Great Britain of the traditional food concerned ... without delay. The authorisation must specify that it concerns a traditional food from a third country. Where applicable, certain conditions for use, specific labelling requirements, or post market monitoring requirements may be specified.
Words in Art. 15(4) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(9)(a)(i) (with reg. 23)
Word in Art. 15(4) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(9)(a)(ii) (with reg. 23)
5. Where duly reasoned safety objections have been issued in accordance with paragraph 2, the appropriate authority must not authorise the placing on the market within Great Britain of the traditional food concerned .... In that case, the applicant may submit an application to the appropriate authority in accordance with Article 16.
Words in Art. 15(5) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(9)(b) (with reg. 23)
Art. 15 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 21 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)

Article 16 Application for the authorisation of a traditional food from a third country
Where the appropriate authority does not authorise the placing on the market within Great Britain of a traditional food from a third country, the applicant may submit an application including, in addition to the information already provided in accordance with Article 14, documented data relating to the duly reasoned safety objections issued in accordance with Article 15(2). The appropriate authority must, without delay, forward the valid application to the Food Safety Authority.
Art. 16 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 22 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)

Article 17 Opinion of the Food Safety Authority on a traditional food from a third country
1. The Food Safety Authority must adopt its opinion within six months from the date of receipt of a valid application.
2. In assessing the safety of a traditional food from a third country, the Food Safety Authority must consider the following matters—
(a) whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant in accordance with Articles 14 and 16;
(b) whether the composition of the food and the conditions of its use do not pose a safety risk to human health in Great Britain;
(c) where the traditional food from the third country is intended to replace another food, whether it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
3. The Food Safety Authority must forward its opinion to the appropriate authority and the applicant.
4. In duly justified cases, where the Food Safety Authority requests additional information from the applicant, the six month period provided for in paragraph 1 may be extended. After consulting the applicant, the Food Safety Authority must specify a period within which that additional information is to be provided and the six month period provided for in paragraph 1 is extended by that additional period.
5. Where the additional information referred to in paragraph 4 is not provided to the Food Safety Authority within the additional period referred to in that paragraph, the Food Safety Authority must draw up its opinion on the basis of the available information.
6. Where an applicant submits additional information on its own initiative, it must send that information to the Food Safety Authority. In such cases, the Food Safety Authority must give its opinion within the six month period provided for in paragraph 1.
7. The Food Safety Authority must make the additional information provided in accordance with paragraphs 4 and 6 available to the appropriate authority.
Art. 17 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 23 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)

Article 18 Authorisation of a traditional food from a third country ...
1. Within three months of the date of publication of the Food Safety Authority's opinion, the appropriate authority must authorise the placing on the market within Great Britain of the traditional food from a third country ..., taking into account the following—
(a) the conditions provided for in points (a) and (b) of Article 7 and, where applicable, point (c) of that Article;
(b) any relevant provision of law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No. 178/2002;
(c) the Food Safety Authority's opinion;
(d) any other legitimate factors relevant to the application under consideration.
Words in Art. 18(1) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(10)(b) (with reg. 23)
2. By way of derogation from paragraph 1, the appropriate authority may, having taken account of the Food Safety Authority's opinion and any other legitimate factors relevant to the authorisation under consideration, terminate the procedure at any stage and decide not to authorise the placing on the market of the traditional food where it considers that authorisation is not justified. The appropriate authority must inform the applicant of the reasons for its decision.
Word in Art. 18(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(10)(c)(i)(aa) (with reg. 23)
Words in Art. 18(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(10)(c)(i)(bb) (with reg. 23)
Words in Art. 18(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(10)(c)(ii) (with reg. 23)
3. The applicant may withdraw its application referred to in Article 16 at any time, thereby terminating the procedure.
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.
Art. 18(4) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(10)(d) (with reg. 23)
Art. 18 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 24 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 18 heading omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(10)(a) (with reg. 23)

Article 19 Application 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.
Art. 19 substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(11) (with reg. 23)

Article 20 Implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries
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Art. 20 omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 26; 2020 c. 1, Sch. 5 para. 1(1)