Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 (Text with EEA relevance)

Article 1

Definitions

For the purposes of this Regulation, the following definitions apply:

(a) ‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (¹);

(b) ‘food business operator’ means food business operator as defined in Article 3, point 3, of Regulation (EC) No 178/2002;

(c) ‘placing on the market’ means placing on the market as defined in Article 3, point 8, of Regulation (EC) No 178/2002;

(d) ‘final consumer’ means final consumer as defined in Article 3, point 18, of Regulation (EC) No 178/2002;

(e) ‘processing’ means processing as defined in Article 2(1), point (m) of Regulation (EC) No 852/2004 of the European Parliament and of the Council (²);

(f) ‘unprocessed products’ means unprocessed products as defined in Article 2(1), point (n), of Regulation (EC) No 852/2004; and

(g) ‘processed products’ means processed products as defined in Article 2(1), point (o), of Regulation (EC) No 852/2004.

Article 2

General rules

Article 3

Dried, diluted, processed and compound food

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.

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.

Article 4

Prohibition on detoxification

Food containing contaminants listed in Annex I shall not be deliberately detoxified by chemical treatments.

Article 5

Food to be subjected to sorting or other physical treatment before placing on the market for the final consumer or use as a food ingredient

Where a maximum level for a contaminant is set out in Annex I specifically as regards food to be subjected to sorting or other physical treatment before placing on the market for the final consumer or use as a food ingredient, such food may be placed on the market provided that:

(a) it is not placed on the market for the final consumer or use as a food ingredient;

(b) it complies with the maximum level set out in Annex I for that contaminant in that food to be subjected to sorting or other physical treatment before placing on the market for the final consumer or use as a food ingredient; and

(c) it is labelled and marked in accordance with paragraph 2.

The consignment/batch identification code shall be indelibly marked on each individual package of the consignment and on the original accompanying document.

Article 6

Labelling provisions for groundnuts (peanuts), other oilseeds, derived products thereof and cereals

The consignment/batch identification code shall be indelibly marked on each individual package of the consignment and on the original accompanying document. The business activity of the consignee of the consignment given on the accompanying document shall be compatible with the intended use.

The exception of groundnuts (peanuts) and other oilseeds for crushing from the application of the maximum levels set out in Annex I, shall only apply to consignments, which:

(a) are clearly labelled showing their intended use;

(b) bear the following information ‘Product to be subject to crushing for the production of refined vegetable oil’ on the label of each individual package and on the original accompanying document; and

(c) have a crushing plant as the final destination.

Article 7

Derogations from Article 2

By way of derogation from Article 2, Latvia, Finland and Sweden may authorise the placing on their respective market for the final consumer, within their annual quota as set in Regulation (EU) No 1380/2013 of the European Parliament and of the Council (³), of wild caught salmon (Salmo salar) and products thereof originating in the Baltic region with levels of dioxins and/or DL-PCBs and/or NDL-PCBs higher than those set out in point 4.1.5 of Annex I, provided that:

(a) a system is in place to ensure that final consumers, are fully informed of the national dietary recommendations with regard to the restrictions on the consumption of wild caught salmon from the Baltic region and products thereof by identified vulnerable groups of the population in order to avoid potential health risks;

(b) Latvia, Finland and Sweden continue to apply the necessary measures to ensure that wild caught salmon and products thereof not complying with point 4.1.5 of Annex I are not marketed in other Member States;

(c) Latvia, Finland and Sweden report yearly to the Commission the measures they have taken to effectively inform final consumers of the dietary recommendations and to ensure that wild caught salmon and products thereof not compliant with the maximum levels are not marketed in other Member States and provide evidence of the effectiveness of those measures.

By way of derogation from Article 2, Finland and Sweden may authorise the placing on their respective market, within their annual quota as set in Regulation (EU) No 1380/2013, wild caught Baltic herring larger than 17 cm (Clupea harengus membras), of wild caught char (Salvelinus spp.), wild caught river lamprey (Lampetra fluviatilis) and wild caught trout (Salmo trutta) and products thereof originating in the Baltic region with levels of dioxins and/or DL-PCBs and/or NDL-PCBs higher than those set out in point 4.1.5 of Annex I, provided that:

(a) a system is in place to ensure that final consumers are fully informed of the dietary recommendations with regard to the restrictions on the consumption of wild caught Baltic herring larger than 17 cm, wild caught char, wild caught river lamprey and wild caught trout from the Baltic region and products thereof by identified vulnerable groups of the population in order to avoid potential health risks;

(b) Finland and Sweden continue to apply the necessary measures to ensure that wild caught Baltic herring larger than 17 cm, wild caught char, wild caught river lamprey and wild caught trout and products thereof not complying with point 4.1.5 of Annex I are not marketed in other Member States;

(c) Finland and Sweden report yearly to the Commission the measures they have taken to effectively inform the identified vulnerable sections of the population of the dietary recommendations and to ensure that fish and products thereof not compliant with the maximum levels is not marketed in other Member States and provide evidence of the effectiveness of those measures.

By way of derogation from Article 2, the following Member States may authorise the placing on their respective market for the final consumer of the following traditionally smoked meat and smoked meat products, smoked in their territory with levels of PAHs higher than those set out in point 5.1.6 of Annex I, provided that those products dot not contain more than 5,0 μg/kg for benzo(a)pyrene and 30,0 μg/kg for the sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene:

(a) Ireland, Croatia, Cyprus, Spain, Poland and Portugal: traditionally smoked meat and meat products;

(b) Latvia: traditionally smoked pork, hot smoked chicken meat, hot smoked sausages and hot smoked game meat;

(c) Slovakia: salted traditionally smoked meat, traditionally smoked bacon, traditionally smoked sausage (klobása), where ‘traditionally smoked’ means developing smoke by burning woods (wood logs, wood sawdust, wood chips) in a smokehouse;

(d) Finland: traditionally hot smoked meat and meat products;

(e) Sweden: meat and meat products smoked over glowing wood or other plant materials. Those Member States and concerned food business operators shall continue to monitor the presence of PAHs in traditionally smoked meat and smoked meat products referred to in the first subparagraph and shall ensure that good smoking practices are implemented where possible, without losing typical organoleptic characteristics of those products.

By way of derogation from Article 2, the following Member States may authorise the placing on their respective market for the final consumer of the following traditionally smoked fish and smoked fishery products, smoked in their territory with levels of PAHs higher than those set out in point 5.1.7 of Annex I, provided that those smoked products do not contain more than 5,0 μg/kg for benzo(a)pyrene and 30,0 μg/kg for the sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene:

(a) Latvia: traditionally hot smoked fish;

(b) Finland: traditionally hot smoked small fish and fishery products made from small fish;

(c) Sweden: fish and fishery products smoked over glowing wood or other plant materials. Those Member States and concerned food business operators shall continue to monitor the presence of PAHs in traditionally smoked fish and smoked fishery products referred to in the first subparagraph and shall ensure that good smoking practices are implemented where possible, without losing typical organoleptic characteristics of those products.

Article 8

Monitoring and reporting

Member States and interested parties shall report every year to the European Food Safety Authority (‘Authority’) the occurrence data on ergot sclerotia and ergot alkaloids in rye and rye milling products and on ergot alkaloids in milling products of barley, wheat, spelt and oats grains.

Member States and interested parties shall report on a regular basis to the Authority the occurrence data on T-2 and HT-2 toxins in oats and oat products.

Article 9

Repeal

Regulation (EC) No 1881/2006 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.

Article 10

Transitional measures

Food lawfully placed on the market prior to the dates referred to in points (a) to (q) may remain on the market until their date of minimum durability or use-by date:

(a) 19 September 2021 as regards the maximum levels for tropane alkaloids in baby foods and processed cereal-based foods for infants and young children, containing maize or its derived products set out in point 2.2.1 of Annex I;

(b) 1 January 2022 as regards the maximum levels for ergot sclerotia and ergot alkaloids set out in point 1.8 of Annex I;

(c) 3 May 2022 as regards the maximum levels for mercury set out in point 3.3 of Annex I;

(d) 1 July 2022 as regards the maximum levels for opium alkaloids set out in point 2.5 of Annex I;

(e) 1 September 2022 as regards the maximum levels for tropane alkaloids set out in points 2.2.2 to 2.2.9 of Annex I;

(f) 1 January 2023 as regards the maximum levels for ochratoxin A set out in point 1.2 of Annex I;

(g) 1 January 2023 as regards the maximum levels for hydrocyanic acid set out in point 2.3 of Annex I;

(h) 1 January 2023 as regards the maximum levels for the sum of Δ⁹-THC and Δ⁹-THCA set out in point 2.6 of Annex I;

(i) 1 January 2023 as regards the maximum levels for the sum of dioxins and for the sum of dioxins and DL-PCBs set out in points 4.1.1, 4.1.2, 4.1.11 and 4.1.12 of Annex I;

(j) 1 January 2023 as regards the maximum levels for the sum of perfluoroalkyl substances set out in point 4.2 of Annex I;

(k) 26 March 2023 as regards the maximum levels for arsenic set out in point 3.4 of Annex I;

(l) 1 July 2024 as regards the maximum levels for ergot alkaloids set out in point 1.8.2.1 of Annex I;

(m) 1 July 2025 as regards the maximum levels for ergot sclerotia set out in point 1.8.1.2 of Annex I;

(n) 1 July 2028 as regards the maximum levels for ergot alkaloids set out in points 1.8.2.1a and 1.8.2.3 of Annex I;

(o) 1 July 2025 as regards the maximum levels for nickel set out in the entry 3.6 of Annex I, with the exception of the maximum levels for nickel set out in points 3.6.11.1 to 3.6.11.5 of Annex I;

(p) 1 July 2026 as regards the maximum levels for nickel set out in points 3.6.11.1 to 3.6.11.5 of Annex I;

(q) 8 October 2025 as regards the maximum levels for inorganic arsenic set out in points 3.4.5, 3.4.6, 3.4.7 and 3.4.8 of Annex I.

Article 11

Entry into force

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.

ANNEX I

Maximum levels for certain contaminants in food(¹)