28.6.2012 Official Journal of the European Union L 16821 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) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings ('), and in particular Article 9(1) thereof, After consulting the European Food Safety Authority, Whereas: 1 ( ( ( ( 2 3 ) ) ) ) Pursuant to Article 5(2) of Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regu- lation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (), the application dossier shall include all the available data relevant for the purpose of the risk assessment. Pursuant to Article 8(1) of Regulation (EU) No 234/2011 concerning specific data required for risk assessment of food enzymes, information shall be provided on the biological and toxicological data. A number of food enzymes currently placed on the Union market have been evaluated and authorised under national provisions in France and Denmark in accordance with the guidelines for the presentation of data on food enzymes of the Scientific Committee on Food ("the SCF") set out in opinion expressed on 11 April 1991 (published in 1992) (). A few food enzymes (e.g. chymosin, invertase and urease) have also been evaluated by the SCF (*. With regard to the toxicological properties of enzyme preparations, the SCF guidelines indicated that food enzymes which are derived from edible parts of (non genetically modified) plants and animals are generally considered as posing no health problems. According to the guidelines no special documentation for safety needs ) O] 354, 31.12.2008, p. 1. OJ L 64, 11.3.2011, p. 15. http://ec.europa.cu/food/fs[sc[scfreports/scf_reports_27.pdf 4 http:/[ec.europa.euffood|fs[sc/scf[reports_en.html to be supplied provided that the potential consumption under normal use does not lead to an intake of any components which is larger than can be expected from normal consumption of the source as such, and provided that satisfactory chemical and microbiological specifi- cations can be established. The European Food Safety Authority (“the Authority") has also indicated in its guidance on data requirements for the evaluation of food enzyme applications (°) that the justification for not supplying toxicological data for food enzymes from edible parts of animals and non genetically modified plants may include a documented history on the safety of the source of the food enzymes, the composition and the properties of the food enzyme as well as its use in food which demon- strates no adverse effects on human health when consumed in a comparable way, supported by any existing toxicological studies. Therefore, the enzyme application for food enzymes from such edible sources should not be required to include toxicological data. The concept of Qualified Presumption of Safety (here- inafter referred to as "QPS") (°) was established by the Authority as a tool for the assessment of the safety of micro-organisms that are introduced into the food chain either directly or as a source of additives or food enzymes. This concept means that, where a strain of micro-organism is assigned to a QPS group and satisfies the qualifications specified, the Authority does not need to carry out any further safety assessment of the production strain. Therefore, if the micro-organism used in the production of a food enzyme has a status of QPS according to the most recent list of QPS recom- mended biological agents adopted by the Authority, the enzyme application should not be required to include toxicological data. However, if residues, impurities, degra- dation products linked to the total enzyme production process (production, recovery and purification) could give rise for concern the Authority, pursuant to Article 6(1) of Regulation (EC) No 1331/2008, may request additional data for risk assessment, including toxicological data. Pursuant to Article 6(a) of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes () a food enzyme may be included in the Union list only if it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed. The reduction (%) http:/|www.efsa.europa.cu/en/efsajournal/pub/1305.htm () http://www.efsa.europa.eu/en/efsajournal/doc/587.pdf () OJ L 354, 31.12.2008, p. 7.