Commission Regulation (EU) 2023/915
Article 3
Dried, diluted, processed and compound food
1. Where no specific Union maximum levels are set out in Annex I for food which is dried, diluted, processed or compound food (i.e. composed of more than one ingredient), the following aspects shall be taken into account when applying the maximum levels set out in Annex I to such food:
(a) changes of the concentration of the contaminant caused by drying or dilution processes;
(b) changes of the concentration of the contaminant caused by processing;
(c) the relative proportions of the ingredients in the product;
(d) the analytical limit of quantification.
2. Where the competent authority carries out an official control, the food business operator shall provide and justify the specific concentration, dilution or processing factors for the drying, diluting or processing operations concerned or the specific concentration, dilution or processing factors for the dried, diluted, processed or compound food concerned as well as the proportion of ingredients for mixing operations concerned.
Where the food business operator does not provide the necessary concentration, dilution or processing factor or where the competent authority deems that factor inappropriate in view of the justification given, the competent authority shall itself define that factor, based on the available information and with the objective of maximum protection of human health.
Commission Regulation (EU) 2023/915
Notes by ANNEX I
(1) Fruits, tree nuts, vegetables, cereals, oilseeds and spices as listed in the relevant category as defined in Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). For the purpose of this Regulation tree nuts are not covered by the maximum level for fruits.
(2) Food as defined in Annex I 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 (OJ L 139, 30.4.2004, p. 55).
(3) Food as defined in Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L181, 29.6.2013, p. 35).
(4) ‘Young-child formulae’ refers to milk-based drinks and similar protein-based products intended for young children. These products are outside the scope of Regulation (EU) No 609/2013 (Report from the Commission to the European Parliament and the Council on young-child formulae (COM(2016) 169 final) https://eur-lex.europa.eu/legal-content/EN/ TXT/?uri=CELEX%3A52016DC0169&qid=1620902871447).
(5) Dry matter is determined according to Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12).
(6) First stage processing means any physical or thermal treatment, other than drying, of or on the grain. Cleaning, including scouring, sorting (colour sorting where applicable) and drying procedures are not considered to be ‘first-stage processing’ insofar as the whole grain remains intact after cleaning and sorting. Scouring means cleaning cereal by brushing and/or scrubbing it vigorously, combined with dust removal (e.g. aspiration). The scouring could be followed by a colour sorting before milling.
(7) Food as defined in Part II and Part VIII of Annex VII to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347 20.12.2013, p. 671).
(8) Food as defined in Article 3 of Regulation (EU) No 251/2014 of the European Parliament and of the Council of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 (OJ L 84, 20.3.2014, p. 14).
(9) Food as defined in Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).
(10) Food as defined in Article 2 of Regulation (EU) 2019/787 of the European Parliament and of the Council of 17 April 2019 on the definition, description, presentation and labelling of spirit drinks, the use of the names of spirit drinks in the presentation and labelling of other foodstuffs, the protection of geographical indications for spirit drinks, the use of ethyl alcohol and distillates of agricultural origin in alcoholic beverages, and repealing Regulation (EC) No 110/2008 (OJ L 130, 17. 5. 2019, p.1).
(11) The font size as specified in Article 13(2) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (OJ L 304 22.11.2011, p. 18).
(12) ‘Flavoured tea’ is tea with a ‘flavouring’ or a ‘food ingredient with flavouring properties’ as defined in Article 3 of Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).
(13) Botanical preparations for food supplements are obtained from botanicals (e.g. whole, plant parts, fragmented or cut plants) by various processes (e.g. pressing, squeezing, extraction, fractionation, distillation, concentration, drying up and fermentation). Botanical preparations include comminuted or powdered plants, plant parts, algae, fungi, lichen, tinctures, extracts, essential oils (other than the vegetable oils and fats (excluding butter and coconut oil) intended for direct human consumption or use as an ingredient in food), expressed juices and processed exudates.
(14) ‘Cocoa and chocolate products’ are any of the products defined in points 2, 3 and 4 of part A of Annex I to Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption (OJ L 197, 3.8.2000, p. 19).