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Commission Implementing Regulation (EU) 2018/456Show full title
Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 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 (Text with EEA relevance)
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ANNEX IU.K. TEMPLATE COVER LETTER ACCOMPANYING A CONSULTATION REQUEST FOR DETERMINATION OF THE NOVEL FOOD STATUS
Competent authority of the Member State
Date: …
Subject: Consultation request for determination of the novel food status of …
…
The Food business operator(s)/consulting party:
Company: …
Address: …
Telephone: …
Email: …
Contact person: …
submit(s) the present consultation request in order to determine the novel food status of …
Yours sincerely,
Signature …
Enclosures:
☐
Technical dossier
☐
Documents in support of the consultation request
☐
Explanatory note
ANNEX IIU.K. TEMPLATE TECHNICAL DOSSIER
The connection between the different pieces of information shall be explained in an explanatory note. In particular, as regards the evidence presented to support a human consumption to a significant degree within the Union before 15 May 1997, where documents from a range of sources must be considered to be able to reach a conclusion.
Where only parts of the documents are relevant for the determination of the novel food status, those parts shall be highlighted.
For all foods, Section 1 must be completed.
For extracts, in addition to Section 1, Section 2 must be completed.
For foods resulting from a production process not used for food production within the Union before 15 May 1997, Section 1 (points 1 to 3, and point 7) and Section 3 must be completed.
Section 1: All foods (for foods resulting from a production process not used for food production within the Union before 15 May 1997 only points 1 to 3 and point 7)
4. Production process | |
4.1Detailed description of the production process. Include a flow process chart to describe the production process. | |
Section 2: Extracts
Section 3: Foods resulting from a production process not used for food production within the Union before 15 May 1997
(1)Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).U.K.
(2)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).U.K.
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