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) represent a projected revision – the European Commission is currently conducting a review, and the draft amending regulation has not yet been formally published. The status of the legislative process is available in the CIRCABC register of DG SANTE.

My supplier provides a Certificate of Analysis (COA) with test results. Is that sufficient to exempt the producer from liability?

No. A COA 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, that is the producer; in the case of imports, that 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 a raw material rather than the finished product.

I manufacture food supplements containing 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 set out in 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 in Section 5.3 of Annex I (expressed per gram of fat). Both limits must be met independently. The supplement manufacturer 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 five times the financial benefit obtained from placing the product on the market may be imposed (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.

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 amend the limits in Regulation (EU) 2023/915 and is not directly binding on producers. However, the European Commission is required to take it into account when reviewing the limits (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.

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

No. Section 13 of Annex I to Regulation (EU) 2023/915 sets out separate, stricter limits for processed cereal-based food and baby food for infants and young children. Producers in this category must apply the limits in Section 13, not those in 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 are likely to be the first 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 as a food business operator the importer 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 once a supplier with a compliance track record has been established.

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

Working documents of the European Commission relating to 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 legislative timetable.

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

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

Producers of fish, vegetable oils and omega-3 food supplements face a problem that many of them have not yet recognised. The EFSA scientific opinion of 2023 (EFSA Journal 2023;21(11):8333) challenged the existing TWI for dioxins and dioxin-like PCBs, reducing the tolerable weekly intake to a level that renders some of the current limits in Commission Regulation (EU) 2023/915 insufficient in light of the latest scientific evidence. The European Commission is currently reviewing these values, and industry signals indicate that a revision of the Regulation introducing new, stricter limits may enter into force in 2026. Those who wait for the official publication before taking action will find themselves adapting after an inspection, not before it.

Author: Tomasz Krawczyk | Date: 15 June 2026

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 on which a new regulation enters into force.

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 (d

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

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

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