Commission Regulation (EU) 2024/1987 of 30 July 2024 amending Regulation (EU) 2023/915 as regards maximum levels of nickel in certain foodstuffs
Commission Regulation (EU) 2024/1987of 30 July 2024amending Regulation (EU) 2023/915 as regards maximum levels of nickel in certain foodstuffs(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 foodOJ L 37, 13.2.1993, p. 1, ELI: http://data.europa.eu/eli/reg/1993/315/oj., and in particular Article 2(3) thereof,Whereas:(1)Commission Regulation (EU) 2023/915Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103, ELI: http://data.europa.eu/eli/reg/2023/915/oj). sets maximum levels for certain contaminants in foodstuffs.(2)Nickel is a widespread component of Earth’s crust and is ubiquitous in the biosphere. Its presence in food can arise from both natural and anthropogenic sources.(3)In 2015, the European Food Safety Authority ("the Authority") adopted its Scientific Opinion on the risks to public health related to the presence of nickel in food and drinking waterEFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on the risks to public health related to the presence of nickel in food and drinking water. EFSA Journal 2015;13(2):4002, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2015.4002.. The opinion identified reproductive and developmental toxicity as the critical effect for the risk characterization of chronic oral exposure to nickel. Eczematous flare-up reactions and worsening of allergic reactions were identified as the critical effect for acute oral exposure to nickel of nickel-sensitised humans.(4)Data related to the occurrence of nickel in food and drinking water were available in 15 Member States. However, as 80 % of the total collected data were collected in one Member State, the Authority concluded that a more geographically diverse data set would be needed to verify the occurrence of nickel in food throughout the Union.(5)By means of Commission Recommendation (EU) 2016/1111Commission Recommendation (EU) 2016/1111 of 6 July 2016 on the monitoring of nickel in food (OJ L 183, 8.7.2016, p. 70, ELI: http://data.europa.eu/eli/reco/2016/1111/oj). Member States were recommended to monitor the presence of nickel in food in 2016, 2017 and 2018, in order to collect more occurrence data.(6)Taking into account these new occurrence data as well as the availability of new scientific information, on 24 September 2020 the Authority adopted an update of the risk assessment of nickel in food and drinking waterEFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on an update of the risk assessment of nickel in food and drinking water. EFSA Journal 2020;18(11):6268, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6268..(7)The Authority concluded that nickel may cause both chronic and acute effects. On the basis of the critical chronic effect of pregnancy loss, the Authority established a tolerable daily intake (TDI) of 13 μg/kg bw and the Authority concluded that this TDI was exceeded in toddlers, children between 36 months and 10 years old and also, in some cases, in infants. Even though pregnancy loss is not a relevant effect for the young age groups, the TDI is also protective for other effects relevant for the younger age groups such as neurotoxic effects. Therefore, the Authority concluded that exceedance of the TDI may raise health concerns in those young age groups. The Authority concluded that the critical acute effects are eczematous flare-up reactions in the skin elicited in nickel-sensitised humans, which concerns about 15 % of the population, that the lowest observed adverse effect level for those acute effects is 4,3 μg nickel/kg bw and that a margin of exposure (MOE) of 30 or higher is needed to protect against those effects. This MOE of 30 is not achieved for the mean and 95th percentile exposure, which raises a health concern for nickel-sensitised individuals.(8)Maximum levels for nickel in food should therefore be set to ensure a high level of human health protection.(9)Regulation (EU) 2023/915 should therefore be amended accordingly.(10)A reasonable period should be provided to allow for the food business operators to adapt to the maximum levels set out in this Regulation.(11)Taking into account that certain foodstuffs covered by this Regulation have a long shelf life or may be processed into products with such a long shelf life, foodstuffs that were lawfully placed on the market before the date of application of this Regulation should be allowed to remain on the market.(12)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 1Regulation (EU) 2023/915 is amended as follows:(1)Article 10(1) is amended as follows:(a)the introductory phrase is replaced by the following:"Food lawfully placed on the market prior to the dates referred to in points (a) to (p) may remain on the market until their date of minimum durability or use-by date:";(b)the following points are added:"(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.";(2)Annex I is amended in accordance with the Annex to this Regulation.
Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 July 2025.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 30 July 2024.For the CommissionThe PresidentUrsula von der LeyenANNEXIn Section 3: "Metals and other elements" of Annex I to Regulation (EU) 2023/915, the following entry is added:
Dry matter is determined in accordance with Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (OJ L 88, 29.3.2007, p. 29, ELI: http://data.europa.eu/eli/reg/2007/333/oj).".
"3.6NickelMaximum level (mg/kg)Remarks
3.6.1Tree nutsThe maximum level applies to the edible part. The maximum level does not apply to tree nuts for crushing and oil refining, provided that the remaining pressed tree nuts are not placed on the market as food. In case the remaining pressed tree nuts are placed on the market as food, the maximum level applies, taking into account Article 3(1) and (2).
3.6.1.1Tree nuts except products listed in 3.6.1.23,5
3.6.1.2Chestnuts, pine nuts, walnuts, Brazil nuts, and cashew nuts10
3.6.2Root and tuber vegetables and bulb vegetables0,90The maximum level applies to the wet weight.The maximum level applies after washing and separating the edible part.For potatoes, the maximum level applies to peeled potatoes.
3.6.3Fruiting vegetables0,40The maximum level applies to the wet weight.The maximum level applies after washing and separating the edible part.
3.6.4Brassica vegetables0,50The maximum level applies to the wet weight.The maximum level applies after washing and separating the edible part.
3.6.5Leafy vegetablesThe maximum level applies to the wet weight.The maximum level applies after washing and separating the edible part.
3.6.5.1Leafy vegetables except products listed in 3.6.5.20,50
3.6.5.2Fresh herbs1,2
3.6.6Legume vegetablesThe maximum level applies to the wet weight.The maximum level applies after washing and separating the edible part.
3.6.6.1Legume vegetables except products listed in 3.6.6.21,0
3.6.6.2Soy beans / edamame (Glycine max)6,0
3.6.7Stem vegetables0,40The maximum level applies to the wet weight.The maximum level applies after washing and separating the edible part.
3.6.8SeaweedFor dry seaweed the maximum level applies to the product as placed on the market.For fresh seaweed the maximum level applies after washing and separating the edible part. For fresh seaweed the maximum level applies on a dry matter basis.
3.6.8.1Seaweed except products listed in 3.6.8.230
3.6.8.2Wakame40
3.6.9Pulses
3.6.9.1Pulses except products listed in 3.6.9.24,0
3.6.9.2Dry beans and dry lupins / lupini beans12
3.6.10OilseedsThe maximum level does not apply to oilseeds for crushing and oil refining, provided that the remaining pressed oilseeds are not placed on the market as food. In case the remaining pressed oilseeds are placed on the market as food, the maximum level applies, taking into account Article 3(1) and (2).
3.6.10.1Sunflower seed8,0
3.6.10.2Peanuts12
3.6.10.3Soy beans15
3.6.11CerealsThe maximum level does not apply to cereals used for the production of beer or distillates, provided that the remaining cereal residue is not placed on the market for the final consumer as food. In case the remaining cereal residue is placed on the market for the final consumer as food, the maximum level applies, taking into account Article 3(1) and (2).
3.6.11.1Cereals except products listed in 3.6.11.2, 3.6.11.3, 3.6.11.4 and 3.6.11.50,80As from 1 July 2026
3.6.11.2Durum wheat (Triticum durum) and rice except products listed in 3.6.11.31,5As from 1 July 2026
3.6.11.3Husked rice2,0As from 1 July 2026
3.6.11.4Pseudo cereals and millet3,0As from 1 July 2026
3.6.11.5Oats5,0As from 1 July 2026The maximum level applies to oats grains without the inedible husk. To calculate the maximum level for oats grains with the inedible husk a processing factor of 1,5 needs to be applied, resulting in an maximum level of 7,5 mg/kg for oats with the inedible husk.
3.6.12Cocoa and chocolate products (14)
3.6.12.1Milk chocolate with < 30 % total dry cocoa solids2,5
3.6.12.2Milk chocolate with ≥ 30 % total dry cocoa solids and chocolate7,0
3.6.12.3Cocoa powder and fat reduced cocoa powder placed on the market for the final consumer or as an ingredient in sweetened cocoa powder or powdered chocolate placed on the market for the final consumer (drinking chocolate)15
3.6.13Infant formulae, follow-on formulae, food for special medical purposes intended for infants and young children (3) and young-child formulae (4)The maximum level applies to the product as placed on the market.
3.6.13.1placed on the market as powder except products listed in 3.6.13.20,25
3.6.13.2placed on the market as powder and manufactured from soy protein isolates, alone or in a mixture with cow’s milk proteins0,40
3.6.13.3placed on the market as liquid0,10
3.6.14Processed cereal-based food for infants and young children (3)3,0The maximum level applies to the product as placed on the market.
3.6.15Baby food (3) except products listed in 3.6.16.0,50The maximum level applies to the product as placed on the market.
3.6.16Fruit juices (9), fruit nectars (9) and vegetable juices including fruit juices (9), fruit nectars (9) and vegetable juices intended as babyfood (3).
3.6.16.1Fruit juices, fruit nectars and vegetable juices except products listed in 3.6.16.20,25
3.6.16.2Fruit juices and fruit nectars containing juices and nectars from passion fruits, cocoa fruits, and from small fruits and berries and coconut water1,0
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Dry matter is determined in accordance with Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (OJ L 88, 29.3.2007, p. 29, ELI: http://data.europa.eu/eli/reg/2007/333/oj).".