Date: 2025-09-18Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2025/1891 of 17 September 2025 amending Regulation (EU) 2023/915 as regards maximum levels of inorganic arsenic in fish and other seafood
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Regulation (EU) 2025/1891 amends Regulation (EU) 2023/915, setting maximum levels for inorganic arsenic in fish and other seafood. This action follows scientific assessments indicating potential health risks from dietary exposure to inorganic arsenic. The regulation enters into force twenty days after its publication in the Official Journal of the European Union, with specific dates for compliance regarding products already on the market.
Key Points / Main Content:
* **Amendment of Regulation (EU) 2023/915:** Regulation (EU) 2023/915 is updated concerning maximum levels of inorganic arsenic in specific foodstuffs.
* **Maximum Levels for Inorganic Arsenic:**
* The maximum level for inorganic arsenic applies to products listed in 3.4.1 to 3.4.8, referring to the sum of As(III) and As(V).
* **Fish:**
* Species other than those listed under 3.4.5.2: 0.10 mg/kg wet weight.
* Anglerfish, monkfish, giant stargazer, flatfishes, haddock, herring, ray and shark: 0.50 mg/kg wet weight.
* **Crustaceans:**
* Crabs, crablike crustaceans, prawn, and shrimps: 0.10 mg/kg wet weight (muscle meat from appendages and abdomen, cephalothorax excluded).
* Crustaceans other than those listed under 3.4.6.1 and 3.4.6.3: 0.20 mg/kg wet weight.
* Langoustine and rock lobster: 1.5 mg/kg wet weight.
* **Bivalve molluscs:**
* Scallops: 0.10 mg/kg wet weight (adductor muscle and gonad only for Pecten maximus).
* Bivalve molluscs other than scallops: 0.50 mg/kg wet weight.
* **Cephalopods:** 0.050 mg/kg wet weight (animal without viscera).
* **Salt:**
* Total arsenic: 0.50 mg/kg.
* **Application Notes:**
* Maximum levels apply to wet weight unless otherwise specified.
* For dried, diluted, processed, and/or compound foods, Article 3(1) and (2) apply.
* Where fish are intended to be eaten whole, the maximum level applies to the whole fish
* **Transitional Measures:** Food lawfully placed on the market before October 8, 2025, may remain on the market until its date of minimum durability or use-by date.
Impact Analysis:
**Food Producers/Processors:**
* *Impact:* Must ensure that fish and seafood products comply with the new maximum levels of inorganic arsenic. This may require changes in sourcing, processing, and testing procedures.
* *Action Required:* Review current arsenic testing protocols, adjust sourcing and processing methods as needed, and ensure compliance with the new limits by October 8, 2025, for products placed on the market after the regulation's entry into force.
**EU Member States:**
* *Impact:* Responsible for enforcing the new regulation and ensuring that food businesses within their jurisdiction comply with the updated maximum levels.
* *Action Required:* Update national regulations to reflect the changes, implement monitoring programs, and ensure that control measures are in place to verify compliance.
**Consumers:**
* *Impact:* Benefit from reduced exposure to inorganic arsenic in fish and seafood, potentially lowering health risks associated with long-term consumption.
* *Action Required:* No direct action is required, but consumers may observe changes in the availability or pricing of certain fish and seafood products.
**Food Retailers/Distributors:**
* *Impact:* Need to ensure that the products they sell comply with the new maximum levels.
* *Action Required:* Work with suppliers to verify compliance, adjust purchasing practices as needed, and ensure that products on the market after the entry into force date meet the new requirements.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EU) 2023/915: A European Union regulation setting maximum levels for certain contaminants in food.
Inorganic Arsenic: A chemical compound that is a contaminant in various food products and water, subject to maximum levels set by regulations.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Council Regulation (EEC) No 315/93: A Council Regulation laying down Community procedures for contaminants in food.
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinion on measures provided for in the Regulation
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2025/1891 18.9.2025
COMMISSION REGULATION(EU) 2025/1891
of 17 September 2025
amending Regulation (EU) 2023/915 as regards maximum levels of inorganic arsenic in fish and other
seafood
(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 (EU) 2023/915(2) sets maximum levels for certain contaminants in foodstuffs, including
inorganic arsenic in a range of foodstuffs.
(2) Arsenic is a ubiquitous metalloid present at low concentrations in rocks, soil and natural ground water.
Anthropogenic activity has contributed to increasing the levels of arsenic in the environment through industrial
emissions (mining, smelting of non-ferrous metals and burning of fossil fuels) as well as through the use of arsenic as
an ingredient in fertilisers, wood preservatives, insecticides or herbicides. Although dermal and inhalation exposure is
possible, food and drinking water are the principal routes of exposure to arsenic.
(3) On 12 October 2009, the European Food Safety Authority (‘the Authority’) adopted an opinion on arsenic in food(3)
in which it concluded that inorganic arsenic can cause lung, bladder and skin cancers and skin lesions and it identified
a range of ‘benchmark dose lower confidence limit’ (BMDL ) values between 0,3 and 8 μg/kg b.w. per day. As the
01
estimated dietary exposures to inorganic arsenic for average and high consumers in Europe are within the range of
the BMDL values identified, the possibility of a risk to some consumers cannot be excluded. Therefore, maximum
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levels were set for inorganic arsenic in various terrestrial foods by means of Commission Regulation
(EU) 2015/1006(4).
(4) In its scientific report of 2021(5), the Authority assessed the chronic dietary exposure of the European population to
inorganic arsenic, taking into account the most recent occurrence data for inorganic arsenic in food and besides
confirming the relevance of terrestrial foods to the exposure, it also concluded that in the adult population food
groups such as ‘fish and other seafood’ were among the apparent sources of inorganic arsenic exposure in certain
countries.
(5) On the basis of the most recent occurrence data, and pending consultations as regards potential maximum levels for
arsenic in fish and other seafood, Commission Regulation (EU) 2023/465(6) lowered the maximum level for
inorganic arsenic in white rice and laid down maximum levels for certain terrestrial foods.
(1) OJ L 37, 13.2.1993, p. 1, ELI: http://data.europa.eu/eli/reg/1993/315/oj.
(2) Commission 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).
(3) EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Arsenic in Food, EFSA Journal,2009; 7(10):1351,
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.1351.
(4) Commission Regulation (EU) 2015/1006 of 25 June 2015 amending Regulation (EC) No 1881/2006 as regards maximum levels of
inorganic arsenic in foodstuff (OJ L161, 26.6.2015, p. 14, ELI: http://data.europa.eu/eli/reg/2015/1006/oj).
(5) Scientific report of EFSA on the chronic dietary exposure to inorganic arsenic, EFSA Journal, 2021; 19(1):6380, https://efsa.
onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6380.
(6) Commission Regulation (EU) 2023/465 of 3 March 2023 amending Regulation (EC) No 1881/2006 as regards maximum levels of
arsenic in certain foods (OJ L 68, 6.3.2023, p. 51, ELI: http://data.europa.eu/eli/reg/2023/465/oj).
ELI: http://data.europa.eu/eli/reg/2025/1891/oj 1/4EN
OJ L, 18.9.2025
(6) On 28 November 2023, the Authority adopted its scientific opinion on an update of the risk assessment on inorganic
arsenic in food.(7)It concluded that epidemiological studies show that the chronic intake of inorganic arsenic via the
diet and/or drinking water is associated with an increased risk of several adverse outcomes including lung, bladder
and skin cancers. The Authority used the BMDL of 0,06 μg /kg b.w. per day and applied a margin of exposure
05
(MOE) approach. It considered that in adults the MOEs are low (range between 2 and 0,4 for average consumers and
between 0,9 and 0,2 at the 95th percentile exposure) and it concluded that, therefore, the current exposure to
inorganic arsenic raises a health concern despite the uncertainties.
(7) In order to continue lowering the exposure of the population to inorganic arsenic, it is therefore appropriate to
establish maximum levels for fish and other seafood, which contribute to that exposure.
(8) Regulation (EU) 2023/915 should therefore be amended accordingly.
(9) Taking into account that certain foodstuffs covered by this Regulation have a long shelf life and in order to prevent
food waste, fish and other seafood that were lawfully placed on the market before the date of entry into force of this
Regulation should be allowed to remain on the market until their date of minimum durability or use-by date.
(10) 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 (q) may remain on the market
until their date of minimum durability or use-by date:’;
(b) the following point is added:
‘(q) 8 October 2025 as regards the maximum levels for inorganic arsenic set out in points 3.4.5, 3.4.6, 3.4.7
and 3.4.8 of Annex I’;
(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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 September 2025.
For the Commission
The President
Ursula VON DER LEYEN
(7) Scientific opinion on an update of the risk assessment on inorganic arsenic in food, EFSA Journal, 2024; 22:e8488, https://efsa.
onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8488.
2/4 ELI: http://data.europa.eu/eli/reg/2025/1891/ojANNEX
In Annex I to Regulation (EU) 2023/915, in section 3 (Metals and other elements), subsection 3.4 (Arsenic) is amended as follows:
(1) the second row is replaced by the following:
‘Inorganic arsenic (sum The maximum level for inorganic arsenic applies to products listed in 3.4.1 to
of As(III)and As(V)) 3.4.8.’
(2) entry 3.4.5 and the row above are replaced by the following:
‘3.4.5 Muscle meat of the following fish: The maximum level applies to the wet weight.
Where fish are intended to be eaten whole, the maximum level applies to the
whole fish.
In case of dried, diluted, processed and/or compound food, Article 3(1) and (2)
applies.
3.4.5.1 Species other than those listed under 3.4.5.2 0,10
3.4.5.2 Anglerfish, monkfish and giant stargazer 0,50
(Lophiusspecies; Kathetostoma giganteum), flatfishes
(Pleuronectiformesspecies), haddock (Melanogrammus
aeglefinus), herring (Clupeaspecies), ray (Rajidae
species) and shark (all species).
3.4.6 Crustaceans The maximum level applies to the wet weight.
The maximum level applies to muscle meat from appendages and abdomen,
which means that the cephalothorax of crustaceans is excluded. In case of crabs
and crab-like crustaceans (Brachyuraand Anomura) the maximum level applies to
the muscle meat from appendages.
In case of dried, diluted, processed and/or compound food, Article 3(1) and (2)
applies.
3.4.6.1 Crabs and crab-like crustaceans (Brachyura and 0,10
Anomura), prawn and shrimps (all species).
3.4.6.2 Crustaceans other than those listed under 3.4.6.1 0,20
and 3.4.6.3.
3.4.6.3 Langoustine (Nephrops norvegicus) and rock lobster 1,5
(Jasusspecies)
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EN3.4.7 Bivalve molluscs The maximum level applies to the wet weight.
In case of Pecten maximus, the maximum level applies to the adductor muscle
and gonad only.
In case of dried, diluted, processed and/or compound food, Article 3(1) and (2)
applies.
3.4.7.1 Scallops 0,10
3.4.7.2 Bivalve molluscs other than those listed under 0,50
3.4.7.1
3.4.8 Cephalopods 0,050 The maximum level applies to the wet weight.
The maximum level applies to the animal without viscera.
In case of dried, diluted, processed and/or compound food, Article 3(1) and (2)
applies.
Total arsenic The maximum level for total arsenic applies to the products listed in 3.4.9.
3.4.9 Salt 0,50’
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