ANNEX IITEMPLATE 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.
| |
| |
| |
|
| |
A. Organisms (microorganisms, fungi, algae, plants, animals) | |
---|---|
| |
| |
| |
| |
B. Chemical substances | |
| |
| |
| |
| |
|
| |
| |
| |
|
| |
|
| |
| |
| |
| |
|
| |
| |
|
| |
| |
|
| |
| |
| |
|
| |
| |
| |
|
(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).
(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).