Regulation (EU) No 234/2011 is amended as follows:
(1)
The following Article 1a is inserted:
"Article 1a
Definitions
For the purposes of this Regulation the following definitions shall apply:
(a)
"Status of Qualified Presumption of Safety" means the safety status assigned by the Authority to selected groups of micro-organisms on the basis of an assessment showing no safety concerns.
(b)
"SCF guidelines of 1992" means the guidelines for the presentation of data on food enzymes set out in the opinion expressed by the Scientific Committee for Food on 11 April 1991 ( 11 ) .
( 11 ) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_27.pdf"."
(2)
In Article 8 the following paragraphs 3, 4, 5 and 6 are added:
"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 ( 12 ) . 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.
( 12 )
OJ L 125, 21.5.2009, p. 75
"."