EU Regulation 2022/617 — Mercury Maximum Levels in Fishery Products

Commission Regulation (EU) 2022/617 of 12 April 2022 replaced Section 3.3 (Mercury) of Regulation (EC) No 1881/2006 in its entirety. The key structural change was the introduction of a lower-mercury fish species tier at 0.30 mg/kg wet weight for 19 species and two non-fish seafood categories that the previous single general limit (0.50 mg/kg) did not distinguish. The 1.0 mg/kg tier for high-mercury predatory species was retained. The regulation was published in the Official Journal of the European Union on 13 April 2022 and entered into force on the twentieth day following publication, making the applicability date 3 May 2022.

The scientific basis is two EFSA opinions: the November 2012 opinion establishing the tolerable weekly intake (TWI) for inorganic mercury and the June 2014 statement on the risks and benefits of fish consumption during pregnancy. EFSA found that the 95th percentile dietary exposure to mercury was at or above the TWI for all age groups, and that high fish consumers, including pregnant women, could exceed the TWI by up to six-fold. Unborn children were identified as the most vulnerable group. Recital 6 of the regulation states that recent occurrence data showed there was “a margin to lower the maximum levels for mercury in various fish species,” providing the empirical basis for the new 0.30 mg/kg tier.

Scope

This regulation applies to mercury (reported as total mercury, tHg) in fishery products and fish muscle meat placed on the EU market. The matrix scope covers fish muscle meat, cephalopods, marine gastropods, food supplements, and salt. Crustaceans are covered under the general 3.3.1 tier; muscle meat from crustacean appendages and abdomen is the applicable fraction. The regulation does not cover mercury in drinking water, non-seafood foods, or terrestrial animal products, which are governed by other sections of Regulation 1881/2006. The geographic scope is the entire EU single market. Products lawfully placed on market before the regulation’s entry into force may remain available until their date of minimum durability or use-by date (transitional provision, Recital 10).

Exact limits and units

All values are milligrams of total mercury per kilogram wet weight (mg/kg ww), measured in the edible portion.

Section 3.3.1 — General fishery products (0.50 mg/kg)

Fishery products and muscle meat of fish, excluding species listed in 3.3.2 and 3.3.3. For crustaceans, the limit applies to muscle meat from appendages and abdomen.

Section 3.3.2 — High-mercury species (1.0 mg/kg)

The following 26 species or species groups are subject to the 1.0 mg/kg limit:

Section 3.3.3 — Lower-mercury species (0.30 mg/kg)

The following 19 species or species groups, plus cephalopods and marine gastropods, are subject to the 0.30 mg/kg limit:

Section 3.3.4 — Food supplements (0.10 mg/kg)

Section 3.3.5 — Salt (0.10 mg/kg)

The salt limit at 0.10 mg/kg aligns with the Codex Alimentarius standard for mercury in salt (Recital 8).

How tested (official method)

The regulation does not specify a dedicated official analytical method for the mercury MLs in this amending regulation. Enforcement analysis under EU food law is governed by Regulation (EC) No 333/2007 (and its amendments), which covers sampling procedures and analytical methods for heavy metals in food. For total mercury determination in fish muscle, reference methods typically include cold-vapour atomic absorption spectrometry (CV-AAS), direct mercury analyser (DMA), and ICP-MS. The Blanco et al. 2023 Valencian surveillance study used CV-AAS, AAS-AMA-254, and ICP-MS depending on laboratory and period, all consistent with enforcement practice. Speciation between tHg and MeHg is not required for compliance with these MLs; the limits apply to total mercury.

Enforcement posture

The limits are enforceable maximum levels under EU food law. Operators placing fishery products on the EU market bear the primary responsibility for compliance. Official control authorities in member states conduct market surveillance. Products lawfully placed on market before 3 May 2022 may remain in circulation until their date of minimum durability or use-by date.

Shark and swordfish are explicitly retained at the 1.0 mg/kg limit rather than receiving a stricter limit; Recital 7 states this was “pending further data collection,” signalling that the Commission acknowledged the literature supports concern at 1.0 mg/kg for these species but deferred further tightening.

History of changes

Regulation (EC) No 1881/2006 originally structured Section 3.3 with a general fishery-product limit and a higher-limit tier for predatory species. The 2022 amendment replaced Section 3.3 entirely. The central structural change was the introduction of Section 3.3.3: a 0.30 mg/kg tier for lower-accumulating species (salmon, cod, herring, mackerel, anchovy, sardine, and related groups) that had previously fallen under the 0.50 mg/kg general limit. This represents a tightening by 40 percent for these species. The 1.0 mg/kg tier for high-mercury predatory species (shark, swordfish, tuna, and associated species) was carried forward unchanged. The salt limit at 0.10 mg/kg in the new Section 3.3.5 was a new addition, harmonising with Codex. The food supplements limit at 0.10 mg/kg in Section 3.3.4 was also codified in the replacement text, whether newly added or carried forward. Recital 7’s language on shark and swordfish suggests the Commission regards 1.0 mg/kg for these species as a provisional hold, not a determination that 1.0 mg/kg is the appropriate final limit.

The precise prior values for each species tier in the pre-2022 version of Regulation 1881/2006 are stated in the consolidated version bearing the applicability date before 3 May 2022; that consolidated version was not retrievable during this ingest. The above history is drawn from the recitals of 2022/617 and the structure of the replacement text. Any session needing the exact pre-amendment values should retrieve the consolidated version at CELEX:02006R1881-20210601 or an earlier consolidation date.

How it compares to Codex, EU, and US law

Codex Alimentarius: The Codex General Standard for Contaminants and Toxins in Food and Feed (GSCTFF, CXS 193-1995) sets a general mercury ML of 0.5 mg/kg for fish (wet weight) and 1.0 mg/kg for predatory fish (shark, swordfish, marlin, tuna). The EU’s new 0.30 mg/kg tier for lower-mercury species is therefore stricter than Codex for those species. The EU and Codex are aligned at 0.50 mg/kg for the general tier and 1.0 mg/kg for predatory species. The Codex salt limit for mercury (0.1 mg/kg) matches the EU’s new Section 3.3.5 value.

US FDA: The US does not have a finalized federal ML for mercury in fish applied uniformly across commercial fisheries the way the EU does. FDA’s primary mercury guidance for fish operates via consumption advisories rather than maximum levels in the food itself. FDA’s action level for methylmercury in fish and shellfish is 1.0 mg/kg (applicable to MeHg, not tHg), with the practical scope covering commercial species. The EPA and FDA jointly issue advice on fish consumption for pregnant women and young children, identifying high-mercury species (swordfish, king mackerel, shark, tilefish) as species to avoid and lower-mercury species (salmon, sardine, light canned tuna) as preferred options. The EU’s 0.30 mg/kg tier for lower-mercury species makes the EU framework considerably more protective than the US for species in that tier: a salmon sample compliant with the EU 0.30 mg/kg limit could still be below the US 1.0 mg/kg action level with large headroom, but the EU limit is the operative floor for EU market access.

Relationship to EFSA TWI and dietary exposure: The EFSA 2012 TWI for methylmercury is 1.3 µg/kg body weight per week. For a 70 kg adult consuming a 150 g portion of fish at the general EU ML of 0.50 mg/kg tHg (assuming approximately 90% as MeHg), the MeHg dose from that single portion is approximately 67.5 µg, or approximately 0.96 µg/kg body weight — about 74% of the weekly TWI in a single meal. For swordfish at 1.0 mg/kg, a single 150 g portion delivers approximately 1.93 µg/kg body weight, already exceeding the TWI. These exposure calculations illustrate why the EFSA-driven recitals emphasize limiting high-mercury species for pregnant women and young children, and why the 0.30 mg/kg tier matters for population-level exposure reduction for frequently-consumed lower-mercury species.

Sources

• EUR-Lex CELEX:32022R0617 — Commission Regulation (EU) 2022/617 of 12 April 2022, OJ L 115, 13.4.2022, pp. 60–63. Access: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32022R0617
• blanco2023-mercury-fish-valencia — Real-world surveillance data from Valencian Community, Spain, 2011–2017: median THg 0.80 mg/kg in swordfish (31.8% of samples exceeded the 1.0 mg/kg limit); median 0.46 mg/kg in fresh tuna. Primary trigger source for this regulation page.
• efsa-mercury-twi — EFSA 2012 TWI for inorganic mercury; the risk assessment underpinning the 2022/617 recitals.
• efsa-methylmercury-twi — EFSA TWI for methylmercury; relevant to exposure calculations against the fish MLs.
• jecfa-methylmercury-ptwi — JECFA provisional tolerable weekly intake for MeHg; international comparator.

Cross-links

• mercury-total — tHg in food matrices, toxicology, occurrence data
• mercury-methyl — MeHg speciation, the toxicologically relevant fraction in fish
• fish — general fish contamination profile; this regulation is the primary EU ML reference for fish
• seafood — broader seafood context including cephalopods and crustaceans
• canned-tuna — tuna as the highest-volume commercial species under the 1.0 mg/kg tier

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