With the publication of Delegated Regulation (EU) 2025/1449, Annex III to Regulation (EC) No 853/2004 has been amended once again. The amendments affect several aspects of the hygiene framework for food of animal origin. The focus is on stricter requirements for fishery products and on explicit regulation of so-called highly processed products of animal origin.
The previous amendment concerning emergency slaughter and food chain information (FCI) is not discussed in further detail here.
The amendment clarifies and tightens the requirements for vessels that freeze and store fishery products on board, particularly in the case of tuna frozen in brine.
Key points:
This stricter requirement is risk-based. In certain fish species, histamine can form if the fish is not chilled quickly and thoroughly enough. Histamine is heat-resistant and cannot be removed by subsequent heating. Temperature control is therefore a critical control measure.
The amendment primarily concerns freezer vessels. Ordinary fishing vessels that use only ice or chilled seawater for cooling and land their catch quickly are subject to different technical requirements. The distinction is based on the nature of the activity, not on the scale of the operation.
Requirements are also being tightened for onshore storage and processing facilities. Cold stores must demonstrate that:
The emphasis is on verifiable control of the cold chain.
The amendment introduces explicit provisions for so-called highly refined products. These are highly processed, molecularly purified or technologically refined substances of animal origin, including certain fat fractions, wool grease derivatives and other specialised ingredients.
Previously, these products were in a legal grey area. They were not explicitly covered by Regulation (EC) No 853/2004, which meant that their authorisation was uncertain. The new provisions provide clarity, but make production subject to specific conditions.
The following, amongst other things, are set out:
Admission is therefore strictly regulated. This is not a general relaxation of the rules, but a legally defined option.
These changes are part of a broader trend within the EU hygiene framework: further harmonisation and standardisation. Differences in interpretation between Member States are being reduced. Technical requirements are being formulated more explicitly. Greater emphasis is being placed on monitoring and documentation.
The regulations do not distinguish between large and small businesses on the basis of size. The distinction is made on the basis of activity and risk profile. In practice, however, this can lead to higher investment and compliance requirements for businesses carrying out activities subject to stricter technical standards.
The recent amendment reflects a consistent approach: further harmonisation, stricter technical safeguards and a greater emphasis on the verifiability of processes.
For the fishing industry, this means stricter requirements as soon as fish is frozen and stored on board. For producers of highly refined animal ingredients, this creates explicit legal scope, but only within strictly regulated frameworks.
This trend points to a food supply chain that is increasingly geared towards standardisation, process control and industrial application. Technical functionality and verifiability are key.
Source: Regulation (EU) 2025/1449
