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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food⁽¹⁾, and in particular Article 2(3) thereof,

Whereas:

1. Commission Regulation (EC) No 1881/2006⁽²⁾ sets maximum levels for certain contaminants in food. That Regulation has already been amended substantially many times and since a number of new amendments are to be made to that Regulation, it should be replaced.

2. Maximum levels should be set at a strict level, which is reasonably achievable by following good agricultural, fishery and manufacturing practices and taking into account the risk related to the consumption of the food. In the case of a possible health risk, maximum levels for contaminants should be set at a level, which is as low as reasonably achievable (ALARA). Such an approach ensures that food business operators apply measures to prevent and reduce the contamination as much as possible in order to protect public health. It is furthermore appropriate for the protection of the health of infants and young children, a vulnerable group, to establish the lowest maximum levels, which are achievable through a strict selection of the raw materials used for the manufacturing of foods for that population, combined, where appropriate, with specific manufacturing practices. This strict selection of the raw materials is also appropriate for the production of specific food placed on the market for the final consumer, for which a strict maximum level has been set out in order to protect vulnerable populations.

3. To ensure an efficient protection of public health, food containing contaminants exceeding the maximum levels not only should not be placed on the market as such, but should also not be used as a food ingredient or be mixed with food.

4. To allow maximum levels to be applied to dried, diluted, processed and compound food, for which no specific Union maximum levels have been set out, food business operators should provide to the competent authorities the specific concentration, dilution and processing factors and, in case of compound food, the proportion of ingredients, accompanied by the appropriate experimental data justifying the factors proposed.

5. Due to the lack of toxicological data and scientific evidence of the safety of the metabolites created by chemical detoxification, it is appropriate to prohibit such treatment of food.

6. It is recognised that sorting or other physical treatments make it possible to reduce the content of contaminants in food. In order to minimise the effects on trade, it is appropriate to allow higher levels of contaminants for certain products, which are not placed on the market for the final consumer or as a food ingredient. In those cases, the maximum levels for contaminants should be set out taking into consideration the effectiveness of such treatments to reduce the content of contaminants in food to levels below the maximum levels set out for those products placed on the market for the final consumer or used as a food ingredient. To avoid that these higher maximum levels are abused, it is appropriate to lay down provisions for the marketing, labelling and use of the concerned products.

7. Certain commodities have uses other than food and for which less strict or no maximum levels for a certain contaminant are applicable. To enable effective enforcement of the maximum levels for contaminants in these foods, it is appropriate to lay down suitable labelling provisions for those foods.

8. Certain fish species originating from the Baltic region may contain high levels of dioxins, dioxin-like polychlorinated biphenyls (‘DL-PCBs’) and non dioxin-like polychlorinated biphenyls (‘NDL-PCBs’). A significant proportion of those fish species from the Baltic region does not comply with the maximum levels and would therefore be excluded from the diet if the maximum levels were applied. However, the exclusion of fish from the diet may have a negative impact on the health of the population of the Baltic region.

9. Latvia, Finland and Sweden have systems in place to ensure that final consumers are informed of the dietary recommendations for identified vulnerable groups of the population to restrict consumption of fish from the Baltic region in order to avoid health risks. Therefore, it is appropriate to maintain a derogation to Latvia, Finland and Sweden allowing them to authorise the placing on their respective market for the final consumer without time limit certain fish species originating in the Baltic region with levels of dioxins and/or DL-PCBs and/or NDL-PCBs higher than those set in this Regulation. In order to allow the Commission to monitor the situation, Latvia, Finland and Sweden should continue to report yearly to the Commission the measures they have taken to effectively inform final consumers of the dietary recommendations and to ensure that fish and products thereof non-compliant with the maximum levels are not marketed in other Member States, as well as the effectiveness of those measures.

10. Despite the application of good smoking practices to the extent possible, the current maximum levels for polycyclic aromatic hydrocarbons (‘PAHs’) are not achievable in several Member States in certain traditionally smoked meats and meat products and traditionally smoked fish and fishery products, where smoking practices cannot be altered without changing significantly the organoleptic characteristics of the food. Consequently, if maximum levels were applied, such traditionally smoked products would disappear from the market resulting in the closure of many small and medium size enterprises. That is the case with certain traditionally smoked meat and smoked meat products in Ireland, Spain, Croatia, Cyprus, Latvia, Poland, Portugal, Slovakia, Finland and Sweden and certain traditionally smoked fish and smoked fishery products in Latvia, Finland and Sweden. Therefore, a derogation for local production and consumption should be maintained without a time limit for certain traditionally smoked meat and smoked meat products and traditionally smoked fish and smoked fishery products only in those Member States.

11. Member States are to collect and report data from official controls and from monitoring of contaminants in accordance with control plans and with the specific requirements on official controls of contaminants laid down in Commission Delegated Regulation (EU) 2022/931⁽³⁾ and in Commission Implementing Regulation (EU) 2022/932⁽⁴⁾. For certain specific contaminants, for which more occurrence data are needed, it is recommended that Member States, food business operators and other interested parties should monitor and report the occurrence data, as well as report on the progress with regard to the application of preventative measures, to allow the Commission to assess the need to modify existing measures or to adopt additional ones. For the same reasons, it is also appropriate that Member States communicate to the Commission the information they have collected as regards other contaminants.

12. Maximum levels as currently set out by Regulation (EC) No 1881/2006, as amended, should be maintained by this Regulation. However, in light of the experience gained with that Regulation and in order to improve the readability of the rules, it is appropriate, on the one hand, to avoid the use of numerous footnotes and, on the other hand, to increase the references to Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council⁽⁵⁾ for the definitions of the categories.

13. Also in light of the experience gained with that Regulation and in order to enable uniform enforcement of the maximum levels, it is appropriate to clarify that lower bound concentrations should be used in those cases where maximum levels are set for multiple compounds (sum of concentrations), except when specified otherwise, and to clarify the body parts of crustaceans to which maximum levels apply.

14. As regards cadmium, it is appropriate to extend the current exemption for malt to all cereals used for the production of beer or distillates, provided that the remaining cereal residue is not placed on the market as food, because cadmium mainly remains in the cereal residue and therefore the content of cadmium in beer is very low.

15. As regards PAHs, based on the available analytical data and on the production method, which showed that negligible amount of those substances was found in instant/soluble coffee, it is appropriate to exclude instant/soluble coffee from the maximum level for powders of food of plant origin for the preparation of beverages. Furthermore, as regards maximum levels for PAHs for infant formulae, follow-on formulae and young-child formulae and for food for special medical purposes intended for infants and young children, they are currently set out for products as placed on the market without the distinction of the physical form of the product. It is therefore appropriate to clarify that these maximum levels refer to the products ready to use (placed on the market as such or after reconstitution as instructed by the manufacturer).

16. As regards melamine, Codex Alimentarius has adopted, additionally to the powdered infant formula, a maximum level for liquid infant formula, which the Union has accepted. It is therefore appropriate to apply that maximum level for melamine in infant formula and follow-on formula accordingly.

17. Therefore, Regulation (EC) No 1881/2006 should be repealed.

18. When the Commission sets out new maximum limits for contaminants in food, it provides, where appropriate, for transitional measures in order to enable economic operators to prepare for the application of the new rules. In order to ensure a smooth transition between Regulation (EC) No 1881/2006 and this Regulation, it is appropriate to maintain the transitional measures as regards those maximum limits taken over by this Regulation, which are still relevant.

19. 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: