EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/367/2022  
(POOL/E2/2022/367/367 -EN.docx)  
D094932/01  
[…](2024) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 2023/915 as regards maximum levels of nickel in certain 
foodstuffs  
 
(Text with EEA relevance)  
 EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending 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 food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (EU) 2023/9152 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 Safet y Authority (‘the Authority’) adopted its Scientific 
Opinion on the risks to public health related to the presence of nickel in food and drinking water
3. The opinion identified reproductive and developmental toxicity as the 
critical effect for the risk ch aracterization 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 -sensitized 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) 2016/1111
4 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 water.
5 
 
1 OJ L 37, 13.2.1993, p.  1, ELI: http://data.europa.eu/eli/reg/1993/315/oj.  
2 Commission Regulation (E U) 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/2006/1881/oj ). 
3 EFSA 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  
4 Commission Recommendation (EU) 2016/1111 of 6 July 2016 on the monitoring of nickel in food (OJ 
L 183, 8.7.2016, p. 7, ELI:  http://data.europa.eu/eli/reco/2016/1111/oj ). EN 2  EN (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 th ose young age groups. The 
Authority concluded that t he critical acute effects are eczematous flare- up reactions in 
the skin elicited in nickel- sensitised humans, which conce rns about 15% of the 
population, that the lowest observed adverse effect level for those acute effect s is 4,3 
µg nickel/kg bw and that a margin of exposure (MOE) of 30 or higher is needed to protect against those effect s. 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 lif e 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  1 
Regulation (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 .’; 
 
5 EFSA 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 . 
 EN 3  EN (2) Annex I is amended in accordance with the Annex to this Regulation.  
Article  2 
This 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 al l Member States.  
Done at Brussels,  
 For the Commission 
 The President  
 Ursula VON DER LEYEN