(1)

Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. Food business operators are required to comply, inter alia, with the specific requirements laid down in Annex III to that Regulation.

(2)

Annex III, Section I, Chapter VI, to Regulation (EC) No 853/2004 provides that food business operators are to ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if the meat complies with the requirements laid down in that Chapter. Point 5 of that Chapter VI requires a declaration by the food business operator to accompany the slaughtered animal to the slaughterhouse. The content of that declaration is included in the food chain information required in accordance with Point 3 of Section III of Annex II of Regulation (EC) No 853/2004. For clarity and the avoidance of possible duplication, point 5 of Chapter VI of Annex III to Regulation (EC) No 853/2004 should be replaced by a reference to the food chain information required in accordance with Section III of Annex II to that Regulation.

(3)

Annex III, Section VIII, Chapter I, Part I.C, point 1, to Regulation (EC) No 853/2004 requires freezer vessels to have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C. Point 2 of that Part requires freezing vessels to have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004, where the whole fish intended for canning is frozen in brine, its temperature is to be not more than – 9 °C. This point also lays down that even if the whole fish initially frozen in brine at a temperature of not more than – 9 °C is subsequently frozen at a temperature of – 18 °C, it is to be destined for canning.

(4)

Official controls carried out by Member States and audits and official controls carried out by the Commission both in Member States and in third countries, have shown that, in practice, freezer vessels could not reach the temperature of – 18 °C for freezing tuna in brine. The audit reports have also shown that certain food business operators have illegally placed on the market as unprocessed tuna for direct human consumption, tuna frozen in brine at – 9 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004 such tuna can only be destined for canning. This practice can expose consumers to health risks, as an excessive production of histamine results in scombroid syndrome.

(5)

An increasing number of notifications have been issued on the Rapid Alert System for Food and Feed (RASFF) regarding the presence of histamine above the limit set in row 1.26 of Chapter I of Annex I to Commission Regulation (EC) No 2073/2005 (2) in vacuum-packed thawed tuna loins, treated with additives, and of scombroid food poisoning associated with the consumption of such products. Member States have taken measures following official controls but recent RASFF notifications demonstrated that these measures have not solved the issue.

(6)

Commission consultations with the competent authorities of the Member States and stakeholders’ organisations showed that freezing technologies on board certain vessels have substantially improved and it is now possible to freeze tuna in brine at – 18 °C while maintaining their organoleptic characteristics and ensuring the safety of the tuna where subject to certain conditions. It is therefore appropriate to lay down requirements regarding the freezing of tuna in brine at – 18 °C intended for the production of prepared fishery products. These requirements should also ensure that the operators carry out appropriate own-checks and facilitate the official controls to be carried out by the competent authorities, necessary to differentiate those freezing vessels from those freezing tuna in brine at – 9 °C and only destined for canning.

(7)

Those requirements should ensure that the freezer vessels are equipped so as to be able to freeze tuna in brine at – 18 °C for a pre-determined period of time. In addition, the food business operators concerned should be able to monitor the temperature of the brine in real-time, using remote means of communication. Such data should be kept available to Member State competent authorities. The appropriate freezing capacity of freezer vessels freezing tuna in brine should be identified during the approval procedure of such freezer vessels to enable the competent authorities to identify tuna coming from such freezer vessels during official controls and to take action against operators illegally placing on the market tuna not frozen at – 18 °C. Those measures should ensure the proper functioning of the internal market while protecting consumers, in accordance with the objectives of Regulation (EC) No 853/2004.

(8)

In addition, it is necessary to set strict time/temperature parameters for freezing tuna in brine at – 18 °C at core in freezer vessels approved for that activity. The decrease of temperature should be carried out in a continuous process, and subject to compliance with established requirements. In particular, the total duration of the freezing process should be established.

(9)

Section VIII, Chapter I, Parts I and II of Annex III to Regulation (EC) No 853/2004 should be amended accordingly.

(10)

Annex III, Section XVI, to Regulation (EC) No 853/2004 lays down specific requirements for certain highly refined products where food business operators must ensure that the treatment of the raw materials eliminates any animal or public health risk. Products of animal origin authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council (3) are also such highly refined products since the production of such additives eliminates these risks and should therefore be included in Section XVI of that Annex. Some of these additives are derived from insects and therefore insects should be allowed as raw materials for highly refined products. Annex III, Section XVI to Regulation (EC) No 853/2004 should therefore be amended accordingly.

(11)

In order to allow the interested parties the necessary time to put in place procedures to comply with new requirements resulting from the amendments to Section VIII to Annex III to Regulation (EC) No 853/2004, by this Regulation, it should apply from 27 January 2026,