Is Regulation (EU) 2023/915 already in force, or is it still a draft?

Regulation (EU) 2023/915 of 25 April 2023 is in force. It replaced Regulation (EC) No 1881/2006 and is the current legal basis for maximum levels of dioxins and PCBs in food. The 2026 limits referred to in the EFSA 2023 opinion (EFSA Journal 2023;21(11):8333) are a projected revision – the European Commission is in the process of review, and the draft amending regulation has not yet been formally published. The status of the legislative work is available in the CIRCABC register of DG SANTE.

My supplier provides a COA certificate with test results. Is that sufficient to exempt the producer from liability?

No. A COA certificate from a supplier is an element of due diligence, but it does not exempt the producer from liability for the finished product. Regulation (EC) No 178/2002, Article 17(1) places the obligation to ensure compliance on the food business operator placing food on the market – in the case of own production this is the producer, and in the case of imports this is the importer. The Polish Chief Sanitary Inspectorate (GIS) may challenge a supplier's test result as non-representative of a specific batch or as a test of the raw material rather than the finished product.

I produce food supplements with salmon oil. Which limit applies to me – the one for fish oils or the one for food supplements?

For the finished food supplement, the limit from Section 10 of Annex I to Regulation (EU) 2023/915 applies – the limit is expressed per recommended daily dose of the product (pg WHO-TEQ per daily dose). The raw material – fish oil – must simultaneously comply with the limit from Section 5.3 of Annex I (expressed per gram of fat). Both limits must be met independently. The supplement producer should test both the raw material and the finished product.

What penalties apply for exceeding the dioxin limit in a product?

The primary sanction is an administrative decision by the District Sanitary Inspector ordering the withdrawal of the product from the market (Article 27(1) of the Act of 25 August 2006 on food and nutrition safety). In addition, a financial penalty of up to 5 times the financial benefit obtained from placing the product on the market (Article 103(1)(2) of that Act). In the case of cross-border distribution, the Polish Chief Sanitary Inspectorate (GIS) triggers a RASFF notification, which may result in parallel inspections in other EU Member States and an import ban for the relevant supplier.

Are the dioxin limits for infant food the same as for general food?

No. Section 13 of Annex I to Regulation (EU) 2023/915 contains separate, stricter limits for processed cereal-based food and food for infants and young children. Producers in this category must apply the limits from Section 13, not those from the sections covering general raw material categories. The EFSA 2023 scientific opinion indicates that this population is particularly vulnerable and that limits for this category will likely be the first to be subject to revision.

I import fish from South-East Asia. Do I need to test every batch?

EU law does not specify a minimum frequency for an importer's own testing, but the importer as a food business operator must demonstrate that the product complies with Regulation (EU) 2023/915. In practice, during inspections by the Polish Chief Sanitary Inspectorate (GIS) and at border control posts (Regulation (EU) 2017/625), the absence of test documentation for high-risk categories (fatty fish) is treated as insufficient due diligence. The recommended minimum is testing of representative samples for each batch from a supplier whose results have not previously been verified, followed by spot-check testing for an established supplier with a compliance history.

Where can a producer track the progress of the legislative work on the revision of dioxin limits?

Working documents of the European Commission concerning the revision of Regulation (EU) 2023/915 are available in the CIRCABC register (Collaboration and Communication Space for the European Commission, DG SANTE, group 'Contaminants'). The results of votes by the PAFF Committee (Standing Committee on Plants, Animals, Food and Feed) are published on the DG SANTE website. Industry organisations such as FoodDrinkEurope and EFFA regularly publish updates on the work schedule.

EFSA 2026: New Dioxin and PCB Limits in Food – What Are the Risks for Producers Who Fail to Comply in Time?

Q: Is an EFSA opinion binding law or merely a recommendation?

An EFSA scientific opinion (including EFSA Journal 2023;21(11):8333) is a soft law document – it does not automatically change the limits in Regulation (EU) 2023/915 and is not directly binding on producers. However, the European Commission is legally required to take it into account when reviewing limits under Article 53 of Regulation (EC) No 178/2002. Enforcement authorities may refer to the EFSA scientific opinion when assessing a producer's due diligence in administrative proceedings.

Regulation (EU) 2023/915 of 25 April 2023 on maximum levels of certain contaminants in food replaced Regulation (EC) No 1881/2006 and is the currently applicable legal basis for limits on dioxins (PCDD/F) and PCBs in food. However, EFSA has already signalled that these limits are not sufficiently restrictive – and it is precisely this signal that should serve as the starting point for producers to act, not the date of entry into force of a new regulation.

What are dioxins and PCBs in the regulatory context – terminological precision has legal significance

EU food law distinguishes three groups of contaminants: dioxins (PCDD/F – polychlorinated dibenzo-p-dioxins and dibenzofurans), dioxin-like PCBs (dl-PCBs, 12 congeners), and non-dioxin-like PCBs (ndl-PCBs, 6 indicator congeners). Regulation (EU) 2023/915 establishes separate limits for each of these groups across individual food categories. This distinction is not academic – exceeding the limit for dl-PCBs while remaining within the limit for PCDD/F constitutes two separate violations, two separate grounds for an administrative decision ordering the withdrawal of a product from the market, and two separate entries in a RASFF notification.

PCDD/F + dl-PCBs are expressed in toxicity equivalents (TEQ) according to WHO-TEF factors from 2005 – any change to TEF factors by the WHO automatically alters the effective contamination level of a product without any change in analyte concentration
ndl-PCBs are expressed as the sum of 6 indicator congeners (PCB-28, -52, -101, -138, -153, -180) – other congeners are not included in the regulatory sum
Limits in Regulation (EU) 2023/915 are given on a wet weight basis, meaning that food supplement producers must account for the concentration of the active ingredient in the capsule, not only in the oil as a raw material
Section 5 of Annex I to Regulation (EU) 2023/915 sets limits for oils and fats, Section 3 for meat and meat products, and Section 4 for fish and fishery products

Expert Tip: Producers of food supplements containing cod liver oil or krill oil regularly make the same mistake: they test the raw material for compliance with the limit for fish oils (Section 5 of Annex I), whereas the finished food supplement must comply with the limit for food supplements – which in Regulation (EU) 2023/915 is separate and expressed per daily dose, not per gram of product. Article 1(2) of Regulation (EU) 2023/915 explicitly states that for food supplements the limits from Section 10 of Annex I apply.

What Regulation (EU) 2023/915 specifically changed compared to the previous legal framework

Regulation (EC) No 1881/2006 was in force for 17 years and was amended numerous times by amending regulations. Regulation (EU) 2023/915 is not a revolution – it is a consolidation with several significant changes. Producers who assume regulatory continuity may, however, stumble on the details.

New limits for edible insects (Section 3.4 of Annex I) – a category not present in Regulation 1881/2006 in this form; producers of insect-based food must for the first time apply a specific limit for PCDD/F+dl-PCBs at 1.00 pg WHO-TEQ/g fat
Revision of limits for wild game meat – Regulation (EU) 2023/915 introduces a stricter limit of 4.0 pg WHO-TEQ/g fat for PCDD/F+dl-PCBs in wild boar meat, with direct consequences for importers from third countries
Limits for feed raw materials have been excluded from Regulation (EU) 2023/915 and are regulated separately under Regulation (EC) No 574/2011 as amended – this distinction is critical for operators working at the interface of food and feed production
Regulation (EU) 2023/915 did not change the principle that limits apply to food placed on the market – Article 1(1) – meaning that importers are responsible for compliance at the point of first placing on the EU market, not only at the point of sale to the consumer

For importers from outside the EU, the key distinction is between the operator responsible for placing on the market (the importer) and the producer in the third country. Under Regulation (EC) No 178/2002, Article 17(1), the entity obliged to ensure compliance is the food business operator – in the case of imports, this is the registered importer, not the foreign supplier. A RASFF notification will be directed at the importer, an administrative decision by the District Sanitary Inspector will be directed at the importer, and any prohibition on placing on the market will be imposed on the importer.

The EFSA 2023 opinion and its practical implications for regulatory risk in 2025–2026

In November 2023, EFSA published a scientific opinion on the risks to human health related to the presence of dioxins and dioxin-like PCBs in food and feed (EFSA Journal 2023;21(11):8333). This opinion is a soft law document – it does not automatically change the limits in Regulation (EU) 2023/915. However, the European Commission is legally required to take it into account when reviewing limits under Article 53 of Regulation (EC) No 178/2002 and Article 2 of Regulation (EC) No 315/93.

The key conclusion of the EFSA opinion: the CONTAM Panel lowered the TWI (tolerable weekly intake) for the sum of PCDD/F and dl-PCBs to 2 pg WHO-TEQ/kg body weight per week. For comparison – the previous TWI established by EFSA in 2018 was also 2 pg WHO-TEQ/kg bw/week, but the earlier 2001 opinion applied for many years when setting limits was 14 pg WHO-TEQ/kg bw/week. The current TWI value means that regular consumption of fatty fish by certain population groups (children, pregnant women) may, even under current limits, lead to exceedance of the TWI. This is the basis for a revision of the limits.

The European Commission has initiated a review procedure – information on consultations is available in the CIRCABC DG SANTE register. Industry organisations (e.g. FEAP, EFFA) have submitted comments as part of the public consultation. The projected timeline is: draft amending regulation – 2025, entry into force – 2026, with a possible transitional period for stocks produced before the date of entry into force.

Expert Tip: An EFSA scientific opinion is not binding law, but enforcement authorities – including the Polish Chief Sanitary Inspectorate (GIS) when assessing risk during official controls – may refer to it when evaluating whether a producer has exercised due diligence. A producer who is aware of the EFSA opinion lowering the TWI and has taken no verification steps is in a weaker position in administrative proceedings than one who has documented a risk analysis and taken preventive action.

Which product categories are in the highest-risk group and why

Not all products are equally exposed to a revision of limits. Analysis of the EFSA 2023 opinion identifies categories where consumer exposure is greatest and where EFSA explicitly recommends considering a reduction of limits.

Fatty fish (salmon, herring, mackerel, tuna) and fishery products – Section 4 of Annex I to Regulation (EU) 2023/915; the current limit for PCDD/F+dl-PCBs is 3.5 pg WHO-TEQ/g wet weight for fish; EFSA identified this category as the main source of exposure in adults
Fish oils and fish liver oils – Section 5.3 of Annex I; limit 10.0 pg WHO-TEQ/g fat; raw material for omega-3 food supplements – highest risk of downward revision
Food supplements containing fish oil – Section 10 of Annex I; limit 5.0 pg WHO-TEQ per recommended daily dose; supplement producers must monitor both limits: for the raw material and for the finished product
Liver and liver products from ruminants – Section 3.3 of Annex I; limit 4.5 pg WHO-TEQ/g fat for cattle and sheep; traditional products (pâtés, lard) may be problematic when sourced from suppliers without regular testing
Food for infants and young children – Section 13 of Annex I; limits already stricter than for general food; the particular vulnerability of the target population means that the EFSA revision of the TWI will affect this category first

Producers of eggs and poultry are in a relatively better position – the limit for eggs is 2.5 pg WHO-TEQ/g fat (PCDD/F+dl-PCBs), and consumer exposure through eggs is assessed as moderate in the EFSA 2023 opinion. Nevertheless, organic producers with free-range hens on industrial sites or near old landfills should verify their test results – RASFF regularly records notifications concerning eggs with elevated dioxin content from precisely such farms (current notifications are available on the RASFF Window portal).

Obligations of producers and importers – what specifically follows from current rules, not projections

Regardless of when or whether the European Commission lowers the limits, current rules already impose specific obligations. Regulation (EC) No 178/2002, Article 17(1) states explicitly that a food business operator shall ensure that food satisfies the requirements of food law. This is not a declaration – it is the basis for administrative and criminal liability.

Sampling and analysis: Commission Regulation (EU) 2022/1399 of 11 August 2022 specifies the methods of sampling and methods of analysis for official control of dioxin and PCB content – a producer using other methods must demonstrate their equivalence; results from laboratories not meeting the requirements of Article 34 of Regulation (EU) 2017/625 may be challenged by the enforcement authority
Frequency of testing: there is no provision specifying a minimum frequency for a producer's own testing – but the HACCP plan (required under Regulation (EC) No 852/2004, Article 5) must include dioxins as a chemical hazard in the risk analysis; the absence of this entry or infrequent testing is a gap in the HACCP plan that the Polish Chief Sanitary Inspectorate (GIS) will identify during an inspection
Supplier documentation: Regulation (EU) 2023/915, Article 3 in conjunction with Article 17 of Regulation (EC) No 178/2002 – the operator must be able to demonstrate traceability of the raw material; a COA (Certificate of Analysis) from a supplier does not exempt from liability for the finished product, but is an element of due diligence
Notification of unsafe food: Article 19 of Regulation (EC) No 178/2002 – an operator who finds or has reason to believe that food exceeds a limit is obliged to immediately withdraw it from the market and notify the competent authority (Polish Chief Sanitary Inspectorate (GIS)); failure to fulfil this obligation is a separate ground for sanctions, independent of the exceedance itself

Expert Tip: Enforcement practice of the Polish Chief Sanitary Inspectorate (GIS) shows that authorities increasingly verify not only the test result, but also whether the producer has included the relevant contaminant in the hazard analysis at all. A producer whose HACCP documentation contains the entry 'dioxins – negligible risk' for a fish oil-based product will face a charge of inadequate hazard analysis even if the test result itself is below the limit.

Sanctions and legal consequences – what specifically applies for exceeding limits

Exceeding the maximum level for dioxins or PCBs in food constitutes a violation of Article 14(2)(b) of Regulation (EC) No 178/2002 (unsafe food due to chemical contamination) and a direct violation of Regulation (EU) 2023/915. The consequences operate on several levels.

Administrative decision by the District Sanitary Inspector ordering the withdrawal of the product from the market and prohibiting its further placing on the market – legal basis: Article 27(1) of the Act of 25 August 2006 on food and nutrition safety (consolidated text: Journal of Laws 2023, item 1448); the decision may be immediately enforceable
Financial penalty of up to 5 times the financial benefit obtained or which the offender could have obtained from placing non-compliant food on the market – Article 103(1)(2) of the Act on food and nutrition safety; there is no statutory upper monetary cap, meaning that for large product batches the penalty may be substantial
RASFF notification – where a product is distributed to other Member States, the Polish Chief Sanitary Inspectorate (GIS) is obliged to notify via the RASFF system; a RASFF alert or information for follow-up notification is publicly accessible and may trigger parallel inspections of importers in other EU Member States
Criminal liability: Article 96 of the Act on food and nutrition safety provides for criminal liability (fine, restriction of liberty) for placing on the market food that does not meet health quality requirements – in practice applied less frequently than administrative sanctions, but cannot be excluded in cases of deliberate violation
For importers from third countries: Regulation (EU) 2017/625, Articles 66–68 – food that does not meet requirements may be detained at the border, and the costs of border control and any destruction of goods are borne by the operator responsible for the consignment

It is worth noting a mechanism that is frequently overlooked: the Polish Chief Sanitary Inspectorate (GIS) may issue a withdrawal decision on the basis of an official test result alone, without any prior warning to the producer. The producer learns of the limit exceedance and simultaneously receives the withdrawal decision. The time available to respond is minimal, and the logistical costs of withdrawing a product from the distribution network may far exceed the value of the batch itself.

What to do now – an action plan for producers and importers

Waiting for the final text of the new regulation is the most costly strategy available. A producer who adapts after the regulation is published typically has 6–18 months to implement changes. One who started a year earlier has a competitive advantage and does not place non-compliant products on the market on the day the new rules enter into force.

Step 1 – Product category audit: identify which products in the portfolio fall into the high-risk categories identified in the EFSA 2023 opinion (fatty fish, fish oils, omega-3 food supplements, liver, food for children); for each category, compare the current test result with the existing limit and with the projected tightening
Step 2 – Verification of supplier requirements: contracts with raw material suppliers should include clauses guaranteeing compliance with current and future EU food law requirements and an obligation to provide up-to-date test results; these clauses must be enforceable, not merely declaratory
Step 3 – HACCP update: the hazard analysis should include dioxins and PCBs as chemical hazards with an assessment of probability and severity; the absence of this entry is a gap that the Polish Chief Sanitary Inspectorate (GIS) will identify in the inspection report
Step 4 – Laboratory selection: ensure that the laboratory testing products is accredited in accordance with PN-EN ISO/IEC 17025 and applies methods compliant with Regulation (EU) 2022/1399; results from non-accredited laboratories will not be accepted by enforcement authorities as evidence of due diligence
Step 5 – Legislative monitoring: subscribe to notifications from the CIRCABC DG SANTE register, follow the results of votes in the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) – this is where the draft regulation is considered before formal publication in the Official Journal of the EU

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EFSA 2026: New Dioxin and PCB Limits in Food What specifically changes for producers and importers – and what are the consequences of falling behind?