In recent years, many recalls happened because the MRLs were exceeded. We, as Food Safety Experts, investigated these recalls for our clients to determine if the MRL was exceeded and if the recall was justified or wrongly enforced by the authorities. These MRLs were specified in Regulation (EC) No. 1881/2006. On May 25, 2023, this Regulation was withdrawn and replaced by Regulation (EU) No. 2023/915. We explored the reasons behind the withdrawal of Regulation (EC) No. 1881/2006 and the new changes in Regulation (EU) No. 2023/915.
Regulation (EU) No. 2023/915
On April 25, 2023, the European Commission introduced Regulation (EU) No. 2023/915. This regulation sets maximum levels for certain contaminants in food and replaces Regulation (EC) No. 1881/2006. The reason behind this new regulation is that Regulation (EC) No. 1881/2006 has undergone significant changes over time and needed further adjustments. The aim is to establish strict and attainable maximum levels by considering good practices in agriculture, fishing, and manufacturing, as well as the risks associated with consuming food. When there are potential health risks, the maximum levels for contaminants will be set as low as reasonably possible (ALARA). This approach ensures that businesses involved in food take steps to prevent or reduce contamination for the sake of public health. Moreover, it is important to establish the lowest achievable maximum levels by carefully selecting raw materials used in the production of food for vulnerable groups like infants and young children. This thorough ingredient selection also applies to specific food products for consumers, where strict maximum levels are set to protect vulnerable population groups.
The reasons for replacing Regulation (EC) No. 1881/2006
To keep people healthy, producers need to make sure that foods with contaminants above the maximum levels are not sold or used in other foods.
If there are no specific maximum levels set for dried, diluted, processed, and composite foods, food business operators need to give the authorities details about the concentration, dilution, and processing factors. For composite foods, they should also provide ingredient ratios and experimental data to support the factors they propose.
It will not be allowed to treat food with chemical purification methods that create metabolites without safety evidence or information about their effects on health.
Labeling and marketing
The European Commission knows that sorting or other physical treatments can lower contaminant levels in food. To avoid trade issues, certain products not meant for consumers or as food ingredients should be allowed to have higher contaminant levels. However, when setting maximum levels for contaminants in these cases, you must consider if the treatments can bring the contaminant levels below the maximum levels set for products intended for consumers or used as ingredients. To prevent misuse of these higher maximum levels, rules will be put in place for marketing, labeling, and use of these specific products.
No Maximum levels
Certain products may have uses other than as food, for which less stringent or no maximum levels for specific contaminants apply. To enable effective enforcement of maximum levels for contaminants in these food products, appropriate labeling requirements will be established.
Fish from the Baltic Sea region
Fish species from the Baltic Sea region may contain high levels of dioxins, dioxin-like polychlorinated biphenyls (dl-PCBs), and non-dioxin-like polychlorinated biphenyls (ndl-PCBs). A significant portion of these fish species from the Baltic Sea region does not comply with the maximum levels, and implementing these levels would lead to their exclusion from the menu. However, excluding fish from the diet can have negative consequences for the health of the population in the Baltic Sea region.
Latvia, Finland, and Sweden have systems to inform consumers about dietary recommendations regarding fish from the Baltic Sea. This is done to prevent health risks. Given this, it is suitable to continue allowing an exemption for Finland, Sweden, and Latvia. This exemption permits the trade of certain fish species from the Baltic Sea region, even if they have higher levels of dioxins, dl-PCBs, and ndl-PCBs than what is set in the regulation. This exemption has no time restrictions. To keep track of the situation, Finland, Sweden, and Latvia will provide annual reports to the Commission. These reports will include information about the actions taken to effectively inform consumers about the dietary recommendations. They will also ensure that fish and its products, which do not meet the maximum levels, are not traded in other Member States. The reports will also evaluate the effectiveness of these measures.
Smoked meat, meat products, fish and fishery products
Despite efforts to use appropriate smoking methods, it is difficult to meet the current maximum levels for polycyclic aromatic hydrocarbons (PAHs) in certain traditionally smoked meat, meat products, fish, and fishery products in several Member States. Changing the smoking methods would greatly affect the taste and qualities of these foods. Applying the maximum levels would force these traditionally smoked products off the market, causing many small and medium-sized businesses to close. This situation applies to certain traditionally smoked meat and meat products in Ireland, Spain, Croatia, Cyprus, Latvia, Poland, Portugal, Slovakia, Finland, and Sweden, as well as certain traditionally smoked fish and fishery products in Latvia, Finland, and Sweden. Therefore, in specific cases, exemptions will be granted indefinitely for locally produced and consumed certain traditionally smoked meat, meat products, fish, and fishery products.
What is new in Regulation (EU) No. 2023/915
The maximum levels of Regulation (EC) No. 1881/2006 have been included in Regulation (EU) No. 2023/915. To improve readability, the decision was made to avoid the extensive use of footnotes. Additionally, there is a reference to Annex I of Regulation (EC) No. 396/2005 for definitions, and these categories have been expanded.
It is clarified that lower limit concentrations should be used when multiple compounds have maximum levels (sum of concentrations), unless stated otherwise. Furthermore, it is specified to which parts of shellfish the maximum levels apply.
The exemption for cadmium has been extended to include all grains used for the production of beer or distillates. This provides that the remaining grain residue is not traded as food. This is because cadmium primarily remains in the grain residue, resulting in very low cadmium levels in beer.
The European Commission believes that instant/soluble coffee should be exempted from the maximum levels set for powdered plant-based foods used in beverages because it has been found to contain only small amounts of polycyclic aromatic hydrocarbons (PAHs). Additionally, the maximum levels for PAHs in complete infant formula, follow-on formula, food for infants and young children, and medical nutrition for infants and young children apply to the products as they are sold, regardless of their physical form. This means that the maximum levels are applicable to the ready-to-use product, whether it is sold in that state or prepared according to the manufacturer’s instructions.
The Codex Alimentarius has established a maximum level for melamine in liquid infant formula in addition to the maximum level for powdered infant formula. This maximum level has been included in Regulation (EU) No. 2023/915.