http://www.legislation.gov.uk/eur/2012/562/bodyCommission 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)Commission Implementing Regulation (EU) No 562/2012Commission 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)2020-12-13King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0562texttext/xmlen2012-06-27 Article 1 Regulation (EU) No 234/2011 is amended as follows: The following Article 1a is inserted: Definitions Article 1a For the purposes of this Regulation the following definitions shall apply: "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. "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. . 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. 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. . Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 June 2012. For the Commission The President José Manuel Barroso http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_27.pdf". OJ L 125, 21.5.2009, p. 75".