http://www.legislation.gov.uk/id/eur/2017/2468

http://www.legislation.gov.uk/eur/2017/2468/article/4/2020-01-31

Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 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 (Text with EEA relevance)

Commission Implementing Regulation (EU) 2017/2468

2024-06-20

King's Printer of Acts of Parliament

https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R2468

text

text/xml

2017-12-20

Art. 4(1)

The Novel Food (Amendment) (EU Exit) Regulations 2019

reg. 42

reg. 1

Art. 5(a)

The Novel Food (Amendment) (EU Exit) Regulations 2019

reg. 43

reg. 1

Signature

The Novel Food (Amendment) (EU Exit) Regulations 2019

reg. 49

reg. 1

Article 4Structure, content and presentation of an application

1

An application shall be submitted electronically to the Commission and shall consist of the following:

a

a cover letter;

b

a technical dossier;

c

a summary of the dossier;

d

duly reasoned safety objections referred to in Article 15(2) of Regulation (EU) 2015/2283;

e

the applicant's response to duly reasoned safety objections.

2

The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex II.

3

The technical dossier referred to in paragraph 1(b) shall contain:

a

the administrative data as provided for in Article 5;

b

the scientific data as provided for in Article 6.

4

Where the applicant submits an application to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes not affect the results of the existing safety assessment.

5

The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.