EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10382/2021 
(POOL/E2/2021/10382/10382 -EN.docx) 
D077105/03  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of mercury in fish 
and salt  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of mercury in fish 
and salt  
(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 19 93 laying down 
Community procedures for contaminants in food1, and in particular Article 2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No 1881/20062 sets maximum levels for certain 
contaminants , including mercury , in foodstuffs.  
(2) On 22 Novemb er 2012, t he European Food Safety Authority ( ‘the Authority’ ) adopted 
an opinion on mercury and methylmercury in food3. In that opinion, the Authority  
established a tolerable weekly intake ( ‘TWI ’) for inorganic mercury of 4 μg/kg body 
weight (‘ b.w.’) and for methylmercury of 1.3 μg/kg b.w. (both expressed as mercury) 
and concluded that the 95th percentile dietary exposure is close to or above the TWI 
for all age groups. High fish consumers , which might include pregnant women, may 
exceed the TWI by up to approximately six -fold. Unborn children constitute the most 
vulnerable group. The opinion concluded that exposure to methylmercury above the 
TWI is of concern , but advised tak ing into account the beneficial effects of fish 
consumption, if measures to re duce methylmercury exposure were considered.  
(3) On 27 June 2014, the Authority  adopted an opinion on the health benefits of seafood 
consumption in relation to the health risks associated with exposure to 
methylmercury4. In that opinion, the Authority  reviewed  the role of seafood in 
European diets and evaluated the beneficial effects of seafood consumption in relation 
to health outcomes, including the effects of seafood consumption during pregnancy on 
functional outcomes of children’s neurodevelopment and the e ffects of seafood 
consumption on cardiovascular disease risk in adults. The Authority  concluded that 
consumption of about 1  to 2 servings of seafood per week and up to 3  to 4 servings per 
week during pregnancy has been associated with better functional out comes of 
neurodevelopment in children compared to no consumption of seafood.  Such amounts 
have also been associated with a lower coronary heart disease mortality in adults . 
                                                 
1 OJ L 37, 13.2.1993, p. 1.  
2 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain 
contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).  
3 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on the risk for public  
health related to the presence of mercury and methylmercury in food. EFSA Jou rnal 2012;10(12):2985.  
4 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion 
on health benefits of seafood (fish and shellfish) consumption in relation to health risks associated with 
exposure to  methylmercury. E FSA Journal 2014;1 2(7):3761.   
EN 2  EN (4) On 19 December 2014, the Authority  adopted a statement on the benefits of 
fish/seaf ood consumption compared to the risks of methylmercury in fish/seafood5, 
where it concluded  that, to achieve the benefits of fish consumption associated with 1 
to 4 fish servings per week and to protect against neurodevelopmental toxicity of 
methylmercury,  the consumption of fish/seafood species with a high content of 
mercury should be limited.  
(5) Taking into account the outcome of the Authority’ s scientific opinions and statement, 
the maximum levels for mercury should be reviewed , to reduc e further the dietar y 
exposure to mercury in food.  
(6) As recent occurrence data show that there would be a margin to lower the maximum 
levels for mercury in various fish species, t he maximum levels for those fish species  
should be modified  accordingly .  
(7) In view of the related health concerns, the level of mercury for shark and swordfish 
should be maintained at the current level, pending further data collection, scientific 
assessment and knowledge on the effectiveness of consumption advice in reducing the 
exposure.   
(8) The Codex Al imentarius sets a maximum level of 0.1 mg/kg for mercury in salt6. It is 
appropriate to set the same maximum level in  the Union legislation.  
(9) Regulation (EC) No 1881/2006 should therefore be amended accordingly.  
(10) Taking into account that certain foodstuffs c overed by this Regulation have a  long 
shelf  life, it is appropriate to provide for a transitional period during which  such 
foodstuff s not comp lying with the new maximum l evels and  lawfully placed on the 
market before the date of entry into force of this Re gulation , may remain on the 
market . 
(11) 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  
The Annex to Regulation (EC) No 1881/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2  
The f oodstuff s listed in the Annex , lawfully placed on the market before the entry into force 
of this Regulation , may remain on the market until the date of minimum durability or use -by-
date. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
                                                 
5 EFSA Scientific Committee, 2015. Statement on the benefits of fish/seafood consumption compared to 
the risks of methylmercury in fish/seafood . EFSA Journal 2015;13(1):3982.  
6 Codex General Standard for Contaminants and Toxin in Foods and Fee ds – GSCTFF (CODEX STAN 
193-1995) .  
EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN