CHAPTER II

CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

Specific data required for risk assessment of food enzymes
Article 8
1
In addition to data to be provided pursuant to Article 5, information shall be provided on:
a
name(s), synonyms, abbreviations and classification(s);
b
Enzyme Commission Number;
c
the proposed specifications, including the origin;
d
the properties;
e
the reference to any similar food enzyme;
f
the source material;
g
the manufacturing process;
h
the stability, reaction and fate in foods in which the food enzyme is used;
i
where applicable the existing authorisations and evaluations;
j
the proposed uses in food and, where applicable, the proposed normal and maximum use levels;
k
the dietary exposure assessment;
l
the biological and toxicological data.
2
As regards to the biological and toxicological data, referred to in point (1) of paragraph 1, the following core areas shall be covered:
a
subchronic toxicity;
b
genotoxicity.
3
By way of derogation from point (l) of paragraph 1 the dossier submitted in support of an application for the safety evaluation of a food enzyme does not need to include toxicological data if the food enzyme in question is obtained from:
a
edible parts of plants or animals intended to be or reasonably expected to be ingested by humans; or
b
micro-organisms having the status of Qualified Presumption of Safety.
4
Paragraph 3 shall not apply where the plants or animals concerned are genetically modified organisms as defined in point 5 of Article 2 of Regulation (EC) No 1829/2003 or where the micro-organism concerned is a genetically modified micro-organism as defined in Article 2 (b) of Directive 2009/41/EC
. However, paragraph 3, point (b) shall apply to micro-organisms where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, point 4 of Directive 2009/41/EC.
5
Food enzymes may be grouped under one application provided that they have the same catalytic activity, are processed from the same source material (e.g. at species level) and with a substantially same production process, and have been obtained from:
a
edible parts of plants or animals intended to be or reasonably expected to be ingested by humans; or
b
micro-organisms having the status of Qualified Presumption of Safety; or
c
micro-organisms which have been used in the production of food enzymes that have been evaluated and authorised by the competent authorities in either France or Denmark in accordance with the SCF guidelines of 1992.
6
Paragraph 5 shall not apply where the plants or animals concerned are genetically modified organisms as defined in point 5 of Article 2 of Regulation (EC) No 1829/2003 or where the micro-organism concerned is a genetically modified micro-organism as defined in Article 2 (b) of Directive 2009/41/EC.
OJ L 125, 21.5.2009, p. 75 .
Inserted by Commission Implementing Regulation (EU) No 562/2012 of 27 June 2012 amending Commission Regulation (EU) No 234/2011 with regard to specific data required for risk assessment of food enzymes (Text with EEA relevance).