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EXPLANATORY MEMORANDUM

1.CONTEXT OF THE DELEGATED ACT

Regulation (EC) No 853/2004 of the European Parliament and of the Council 1 lays down specific rules on the hygiene of food of animal origin for food business operators. It empowers the Commission to adopt delegated acts amending Annexes II and III thereto.

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, to achieve a core temperature of not more than -18°C. In accordance with Section VIII, Chapter I, Part II, point 7, where the whole fish intended for canning is frozen in brine, the temperature is to be not more than -9°C. It also lays down that even if the whole fish is subsequently frozen at -18°C, it can still only be destined for canning.

Official controls carried out by national competent authorities and audits by the Commission have shown that certain food business operators illegally place on the market as fresh tuna, tuna that had been frozen in brine at -9°C and could therefore only be destined for canning. In addition, operators illegally use additives to change the colour of tuna frozen in brine at -9°C and make the fish look like fresh tuna. This does not correspond to the state of the fish, and it is therefore a fraudulent practice, which exposes consumers to health risks.

Consultations with the competent authorities of the Member States and stakeholders’ organisations have shown that recent technological development has improved the freezing capacity of freezer vessels. Consequently, food business operators have invested in the freezing capacity in brine of their vessels so that their catch of tuna can be frozen in brine at -18°C in accordance with Section VIII, Chapter I, Part I.C, point 1 to Regulation (EC) No 853/2004. As tuna frozen in brine at -18°C under certain conditions does not oxidise, there is no change in colour either. Therefore, such tuna can be placed on the market not only as canned tuna.

The draft Regulation establishes conditions for freezing tuna in brine at -18°C on board freezer vessels. The freezing capacity of the freezer vessel that caught and froze tuna at -18°C in brine, should be identified during their approval. This will facilitate official controls, by making it easier to identify tuna caught and frozen by vessels that have the appropriate freezing capacity.

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

Moreover, Annex III, Section I, Chapter VI to Regulation (EC) No 853/2004 allows emergency slaughter outside the slaughterhouse if complying with certain requirements. Point 5 of that Chapter VI requires a declaration by the food business operator to accompany the slaughtered animal. The content of this declaration is included in the food chain information in accordance with Section III to Annex II of Regulation (EC) No 853/2004. For clarity and avoidance of possible duplication, point 5 of Chapter VI should be replaced by a reference to the food chain information.

Finally, Annex III, Section XVI to Regulation (EC) No 853/2004 lays down specific requirements for highly refined products where 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 2 are also such highly refined products and should therefore be added to this Section XVI. In addition, an alternative treatment to produce fat derivatives (Vitamin D3) is introduced since not posing an animal or public health risk.

2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

Certain of the proposed amendments to Annex III to Regulation (EC) No 853/2004 were requested by the competent authorities of Member States and certain private stakeholders' organisations. They have been discussed during several meetings of the relevant expert group, representing the competent authorities of all Member States, and are largely supported by those experts.

In addition, private stakeholders’ organisations were consulted.

Before adopting this Delegated Regulation, the Commission conducted public consultations in an open and transparent way in accordance with the procedures laid down in the Interinstitutional Agreement of 13 April 2016 between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making 3 .

3.LEGAL ELEMENTS OF THE DELEGATED ACT

The amendments to Annex III to Regulation (EC) No 853/2004 should be made by a Delegated Regulation adopted pursuant to Article 10(1), second subparagraph, points (c), (d) and (e) thereof.

COMMISSION DELEGATED REGULATION (EU) …/...

of XXX

amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council concerning specific hygiene rules for emergency slaughter of domestic ungulates, for tuna frozen in brine and for highly refined products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin 4 , and in particular Article 10 (1), second subparagraph, points (c), (d) and (e) thereof,

Whereas:

(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 Section I 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 freezing in brine of the whole fish intended for canning is practiced, a temperature of not more than -9°C is to be achieved. This point also states 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 freezer vessels could not reach the temperature of –18ºC for freezing tuna in brine. These official controls and audits have shown that certain food business operators have illegally placed on the market as fresh tuna for direct human consumption, tuna that had been frozen in brine at -9°C, whereas 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 is a fraudulent practice that exposes consumers to health risks, as it can lead to an excessive production of histamine and result 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 5 in vacuum-packed thawed tuna loins, treated with additives to change their colour and make them appear as fresh tuna. Other notifications concern the occurrence of scombroid food poisoning associated with the consumption of such tuna products. Member States have taken measures following official controls, but more recent RASFF notifications show that these measures have not resolved the issue. Other measures should therefore be laid down.

(6)Commission consultations with the competent authorities of the Member States and stakeholders’ organisations have shown that freezing technology on board of vessels has substantially improved, and it is now possible to freeze tuna in brine at -18°C, while maintaining its organoleptic characteristics, and ensuring its safety, if certain conditions are met.

(7)It is, therefore, appropriate to lay down hygiene requirements regarding the freezing of tuna in brine at -18°C. These requirements should also: (a) ensure that the operators carry out appropriate own checks and (b) facilitate the official controls by the competent authorities in particular to differentiate freezing vessels able to freeze tuna in brine at -18°C from those that cannot.

(8)The appropriate freezing capacity of freezer vessels freezing tuna in brine should be identified by means of a validation plan 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.

(9)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. It is also necessary to set strict time and temperature parameters when freezing tuna in brine at -18°C at core. The decrease in temperature should be carried out in a continuous process, and in compliance with certain requirements. In particular, this Regulation lays down the total duration of the freezing process.

(10)In addition, to enable competent authorities to check that tuna has been frozen in brine at -18°C throughout the relevant period, freezer vessels should continuously monitor and record the temperature of the brine, using electronic means of temperature measurement. Such equipment should also allow access in real-time and onshore to the temperature of the brine by the concerned food business operators. Food business operators should make these records available, upon request, to Member States’ competent authorities, during official controls.

(11)These measures should ensure the proper functioning of the internal market and a high level of consumer protection with regard to food safety, in accordance with the objectives of Regulation (EC) No 853/2004.

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

(13)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 risk to animal or public health. Products of animal origin authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council 6 are also considered as highly refined products since the production of such additives eliminates such risks and should, therefore, be included within the scope of Section XVI of that Annex. Some of these additives are derived from insects and therefore insects should be allowed to be used as raw materials for highly refined products. Information was provided by stakeholders illustrating that another process for fat derivatives than those laid down in Section XVI of Regulation (EC) No 853/2004 results in a product of animal origin, namely vitamin D3, in which the risks to animal and public health are eliminated. Consultation of the European Food Safety Authority in accordance with Article 13 of Regulation 853/2004 is therefore not required. When fat derivatives are processed in such a way, they should fall within the scope of Section XVI of Annex III to that Regulation. Annex III, Section XVI, to Regulation (EC) No 853/2004 should, therefore, be amended accordingly.

(14)In order to allow the interested parties the necessary time to put in place procedures in order to comply with the new requirements resulting from the amendments to Annex III to Regulation (EC) No 853/2004, by this Regulation, it should apply from […] [Office of publications, please, insert a date corresponding to 90 days as of the entry into force of this Regulation. This should be the same date as in Article 2 of the draft act]

HAS ADOPTED THIS REGULATION:

Article 1

Annex III of Regulation (EC) No 853/2004 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from […][Office of publications, please, insert a date corresponding to 90 days as of the entry into force of this Regulation.]

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Commission

The President

Ursula VON DER LEYEN

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ANNEX

Annex III to Regulation (EC) No 853/2004 is amended as follows:

(1)in Section I, in Chapter VI, point 5 is replaced by the following:

‘5. The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’;

(2)in Section VIII,

(a)Chapter I is amended as follows:

(i)Part I.C. is replaced by the following:

‘C. Requirements for freezer vessels

1. Freezer vessels must:

(a)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;

(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;

(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B., point 2.

2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:

(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;

(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.

3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.

4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:

(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8 (a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;

(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.

5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;

(ii) Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b)’

(iii) Part I.E. is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of part C concerning their capacity to maintain the temperature.’

(iv) In Part II, the following point 8 is added:

‘8. Whole tuna (genus Thunnus and Katsuwonus) may be frozen in brine at -18°C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:

(a)where a direct freezing process in brine is carried out, its total duration to reach -18°C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0°C in less than 24 hours;

(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3°C in less than 6 hours, and 0°C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0°C to -18°C at core, must not exceed 72 hours;

(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan.

(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last;’

(b)in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, part I.C, points 1(a) and 1(b).’

(3) Section XVI is amended as follows:

(a)in point (1), subpoint (h) is replaced by the following:

‘(h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council*;’

*Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI: http://data.europa.eu/eli/reg/2008/1333/oj)’;

(b)point (2) is amended as following:

(i) the following subpoint (4) is added to subpoint (c):

‘ (4) when derived from wool grease, a heat treatment at least at 135°C for at least 90 minutes;’

(ii) the following subpoint (d) is added: ‘(d) insects.’.

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