CELEX: 
Language: en
Date: 2019-01-23
Title: COMMISSION REGULATION (EU) …/… amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards specific hygiene requirements for insects intended for human consumption

COMMISSION REGULATION (EU) …/…
            
            
               of XXX
            
            
               amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards specific hygiene requirements for insects intended for human consumption
            
            
               (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 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin
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                and in particular Article 10(1) thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. In particular, food business operators are to ensure compliance with specific requirements for food of animal origin set out in Annex III to that Regulation.
            
            
               (2)Insects intended for human consumption are increasingly produced in or exported to the Union, as they are used as a suitable alternative to mainstream food of animal origin.
            
            
               (3)On 5 October 2015, the European Food Safety Authority (EFSA) adopted a scientific opinion providing a risk profile related to production and consumption of insects as food and feed
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                and concluded that for both biological and chemical hazards, the specific production methods, the substrate used, the stage of harvest, the insect species, as well as the methods used for further processing will all have an impact on the possible presence of biological and chemical contaminants in food and feed products derived from insects. 
            
            
               (4)While several issues in the EFSA conclusions are addressed by the general and specific hygiene requirements and procedures based on the hazard analysis and critical control points principles in accordance with Articles 4 and 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council
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               , it is appropriate to lay down specific requirements for substrates for feeding insects and for species of insects intended for human consumption.
            
            
               (5)Such specific requirements are needed in order to ensure that food derived from insects is safe and to ensure a smooth functioning of the internal market by means of harmonised conditions for the production of insects intended for human consumption.
            
            
               (6)Commission Regulation (EU) No 142/2011
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                lays down health rules as regards animal by-products not intended for human consumption. In particular, that Regulation lays down specific requirements for the production of insects intended for the feeding of animals. Since EFSA made similar conclusions for the use of insects in food and feed strict conditions for the primary production of insects intended for human consumption should also be laid down, in particular as regards conditions for the substrate for the feeding of those insects.
            
            
               (7)Food consisting of, isolated from or produced from insects or their parts is subject to authorisation in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council and to listing in Commission Implementing Regulation (EU) 2017/2470. It is appropriate to ensure consistency with these Regulations, when laying down specific requirements as regards the species of insects intended for human consumption.
            
            
               (8)Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly.
            
            
               (9)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
         
         
            
               Annex III to Regulation (EC) No 853/2004 is amended in accordance with the Annex to this Regulation.
            
            
               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,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Jean-Claude JUNCKER
               
            
         
         
      
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               ANNEX
            
            
               In Annex III to Regulation (EC) No 853/2004, the following Section is added:
            
            
               ‘SECTION XVII: INSECTS
            
            
               1.For the purpose of this Section,
            
            
               (a)‘insects’ means food consisting of, isolated from or produced from insects or their parts including any live stadia of insects intended for human consumption, which are authorised in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council (*) and listed in the Annex to Commission Implementing Regulation (EU) 2017/2470 (**);
            
            
               (b)‘manure’ means manure as defined in point 20 of Article 3 of Regulation (EC) 1069/2009 (***);
            
            
               (c)‘catering waste’ means catering waste as defined in point 22 of Annex I to Regulation (EU) No 142/2011 (****);
            
            
               (d)´waste’ means waste as defined in point 1 of Article 3 of Directive 2008/98/EC (*****).
            
            
               2.Insects intended for human consumption must be used for production and placed on the market only if they comply with the specific requirements laid down in points 3 to 6.
            
            
               3.The insects must belong to a species used for food, which is authorised in accordance with Regulation (EU) 2015/2283 and is listed in Implementing Regulation (EU) 2017/2470.
            
            
               4.The substrate for the feeding of the insects must only contain products of non-animal origin or the following products of animal origin of Category 3 material in accordance with Article 10 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council:
            
            
               (a)fishmeal; 
            
            
               (b)blood products from non-ruminants; 
            
            
               (c)di- and tricalcium phosphate of animal origin; 
            
            
               (d)hydrolysed proteins from non-ruminants; 
            
            
               (e)hydrolysed proteins from hides and skins of ruminants; 
            
            
               (f)gelatine and collagen from non-ruminants; 
            
            
               (g)eggs and egg products; 
            
            
               (h)milk, milk based-products, milk-derived products and colostrum; 
            
         
         
            
               (i)honey; or 
            
            
               (j)rendered fats. 
            
            
               5.The substrate for the feeding of insects and the insects themselves during primary production must not have been in contact with any other materials of animal origin other than those mentioned in point 4.
            
            
               6.The substrate for the feeding of insects must not contain manure, catering waste or other waste.
            
            
               (*)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).
            
            
               (**)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
            
            
               (***)Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).’
            
            
               (****)Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
            
            
               (*****)Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives ( OJ-L 312, 22.11.2008, p. 3).’