(1)

Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators.

(2)

Regulation (EC) No 853/2004 allows the slaughter on the farm of poultry subject to certain requirements, including the requirement that the slaughtered animals are to be accompanied by a certificate in accordance with the model set out in Commission Implementing Regulation (EU) 2020/2235 (3). However, Annex III to Regulation (EC) No 853/2004 refers to the wrong certificate, and that reference should therefore be corrected.

(3)

Regulation (EU) 2017/625, as amended by Regulation (EU) 2021/1756 (4), extends the possibility to derogate from the requirement to classify the production and relaying areas to all echinoderms which are not filter feeders, and not only to Holothuroidea. Consequently, Chapters IX and X of Section VII to Annex III to Regulation (EC) No 853/2004 should be amended to take account of that possibility.

(4)

In addition, Annex III to Regulation (EC) No 853/2004 lays down temperature requirements and transport conditions for fishery products. It provides, inter alia, that fishery products are to be transported at the temperature of melting ice, if chilled, or at – 18 °C, if frozen. New transport techniques entailing lowering the fish temperature to between the initial freezing point of the fish and about 1 °C to 2 °C lower and allowing the transport in boxes without ice are now available, as is superchilling. These new techniques should be provided for in Regulation (EC) No 853/2004 and their use permitted taking into account the Scientific Opinion of the European Food Safety Authority (EFSA) of 28 January 2021 on the use of the so-called ‘superchilling’ technique for the transport of fresh fishery products (5).

(5)

In accordance with Part A of Chapter III of Section VIII to Annex III to Regulation (EC) No 853/2004, fresh fishery products are to be stored under ice in appropriate facilities and re-icing is to be carried out as often as necessary. Moreover, whole and gutted fresh fishery products may be transported and stored in cooled water until they arrive at the first establishment on land carrying out any activity other than transport or sorting.

(6)

Food business operators operating in the fishery products sector requested that Annex III to Regulation (EC) No 853/2004 be amended to allow the transport of whole and gutted fresh fishery products in cooled water after their arrival at the first establishment on land. This transport should be carried out in ‘tubs’, namely boxes of three-layered polyethylene, filled with water and ice.

(7)

On 19 March 2020, EFSA adopted a Scientific Opinion on the use of tubs for transporting and storing fresh fishery products (6). In that Opinion, EFSA concluded that there are no substantial differences for public health between the storage and transport of fresh fishery products in accordance with the requirements laid down in Part A of Chapter III of Section VIII of Annex III to Regulation (EC) No 853/2004 and the use of tubs, and gave some recommendations for their use. Annex III to Regulation (EC) No 853/2004 should therefore be amended in order to allow the use of tubs for the transport of whole and gutted fresh fishery products in water and ice after their arrival at the first establishment on land carrying out any activity other than transport or sorting.

(8)

Chapter VIII of Section VIII of Annex III to Regulation (EC) No 853/2004 lays down detailed rules for the transport of fishery products. In particular, fresh fishery products are to be maintained during their transport at a temperature approaching that of melting ice and frozen fishery products must be maintained during transport at temperature of not more than – 18 °C in all parts of the product, possibly with short upward fluctuations of not more than 3 °C.

(9)

On 10 December 2020, EFSA adopted a Scientific Opinion on the use of the so-called ‘superchilling’ technique for the transport of fresh fishery products (7). In that Opinion, EFSA made a comparison between the temperature of superchilled fresh fishery products in boxes without ice, and products subject to the currently authorised practice in boxes with ice. EFSA concluded that, under appropriate conditions, there are no differences from a public health point of view between the traditional transport temperatures and the superchilling techniques. As regards analytical methods capable of detecting whether a previously frozen fish is commercially presented as superchilled, EFSA identified five methods that could be considered as fit for purposes. The use of the technique of superchilling should therefore be allowed under certain conditions for the transport of fresh fishery products referred to in point 1 of Chapter VIII of Section VIII of Annex III to Regulation (EC) No 853/2004.

(10)

Chapter I of Section X of Annex III to Regulation (EC) No 853/2004 lays down hygiene rules for the production of eggs. The main pathogen posing a major risk of egg-borne diseases in the Union is Salmonella Enteritidis, and its growth in eggs is positively influenced by the temperature during the storage and transportation of eggs. As in many Member States there are no requirements regarding time and temperature conditions during the storage and transportation of eggs, it is important that ‘a date of minimum durability’, as defined in in Article 2(2), point (r), of Regulation (EU) No 1169/2011 of the European Parliament and of the Council (8) for eggs be laid down in Regulation (EC) No 853/2004, to provide a uniform basis for final consumers to make informed choices and the safest use of their food. The EFSA Opinion of 10 July 2014 on the public health risks of table eggs due to deterioration and development of pathogens (9) concludes that the date of minimum durability for eggs produced by hens of the species Gallus gallus should be set at a maximum 28 days, as any increase in the shelf-life of these eggs over 28 days results in an increase of the relative risk of illness. The current requirement laid down in Chapter I of Section X of Annex III to Regulation (EC) No 853/2004 that eggs are to be delivered to the consumer within a maximum period of 21 days after laying is a marketing standard with limited influence on the safety of eggs while contributing to food waste at retail level. An increase of this period from 21 days to 28 days would significantly reduce this food waste, notably for eggs produced by hens of the species Gallus gallus as these eggs would be removed from sale at the same time as their date of minimum durability would expire.

(11)

Section XVI of Annex III to Regulation (EC) No 853/2004 lays down specific requirements for the production of certain highly refined products intended for human consumption when a treatment of the raw material eliminates any public or animal health risk. Certain fat derivatives, such as cholesterol and Vitamin D3 derived from lanolin are also subject to specific treatments, eliminating such risks and should therefore be considered as highly refined products.

(12)

Flavourings are used in food in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council (10). Their manufacturing process includes a complex physical, enzymatic or microbiological process that eliminates, on the basis of the scientific evidence available, any public or animal health risk. Flavourings derived from products of animal origin should therefore be considered as highly refined products.

(13)

Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly.

(14)

Commission Delegated Regulation (EU) 2019/624 (11) lays down specific rules concerning the performance of the official controls referred to in Article 18(1) of Regulation (EU) 2017/625. More particularly, Article 1, point (v), and Article 11 of that Delegated Regulation concern rules for derogations from Article 18(6) of Regulation (EU) 2017/625 regarding the classification of production and relaying areas in relation to Pectinidae, marine gastropods and Holothuroidea. Article 18 of Regulation (EU) 2017/625, as amended by Regulation (EU) 2021/1756, extends the possibility for derogations from the requirement to classify the production and relaying areas to all echinoderms which are not filter feeders, and not only to Holothuroidea. Accordingly, Delegated Regulation (EU) 2019/624 should be amended so that the classification of production and relaying areas is not required in relation to the harvesting of echinoderms which are not filter feeders.

(15)

Regulation (EC) No 853/2004 and Delegated Regulation (EU) 2019/624 should be amended by a single Delegated Regulation, as a number of the amendments to be made to them are linked to the recent amendments made to Regulation (EU) 2017/625 by Regulation (EU) 2021/1756. In addition, the amendment to be made to Delegated Regulation (EU) 2019/624 concerning echinoderms is of ancillary nature, as it is only an alignment with an amendment made to Regulation (EU) 2017/625 by Regulation (EU) 2021/1756. Furthermore, for the sake of consistency of Union rules, the amendments to be made to Regulation (EC) No 853/2004 and Delegated Regulation (EU) 2019/624 should take effect on the same date.

(16)

Regulation (EC) No 853/2004 and Delegated Regulation (EU) 2019/624 should therefore be amended accordingly,

(1)

In Article 1, point (a)(v) is replaced by the following:

(2)

Article 11 is replaced by the following: