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

REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS	REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS	REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS	REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS	REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS
Part I – Supplier	I.1  IMSOC Reference number	I.1  IMSOC Reference number	I.2  Internal reference number	I.2  Internal reference number
Part I – Supplier	I.3  Supplier Name Address Registration or Approval No Country ISO Country code Activity	I.3  Supplier Name Address Registration or Approval No Country ISO Country code Activity	I.4  Receiving food business operator Name Address Registration or Approval No Country ISO Country code Activity	I.4  Receiving food business operator Name Address Registration or Approval No Country ISO Country code Activity
Part I – Supplier	I.5  Description of goods Aquaculture□ Natural Banks□ • CN code or FAO 3-Alpha code | species | quantity | package | batch | date of harvesting| date of starting of conditioning | date of end of conditioning | place of conditioning| date of starting of re-immersion | date of end of re-immersion |place of re-immersion| date of starting of grouping | date of end of grouping | production area | health status including, if applicable, harvested in accordance with Article 62(2) of Implementing Regulation (EU) 2019/627	I.5  Description of goods Aquaculture□ Natural Banks□ • CN code or FAO 3-Alpha code | species | quantity | package | batch | date of harvesting| date of starting of conditioning | date of end of conditioning | place of conditioning| date of starting of re-immersion | date of end of re-immersion |place of re-immersion| date of starting of grouping | date of end of grouping | production area | health status including, if applicable, harvested in accordance with Article 62(2) of Implementing Regulation (EU) 2019/627	I.5  Description of goods Aquaculture□ Natural Banks□ • CN code or FAO 3-Alpha code | species | quantity | package | batch | date of harvesting| date of starting of conditioning | date of end of conditioning | place of conditioning| date of starting of re-immersion | date of end of re-immersion |place of re-immersion| date of starting of grouping | date of end of grouping | production area | health status including, if applicable, harvested in accordance with Article 62(2) of Implementing Regulation (EU) 2019/627	I.5  Description of goods Aquaculture□ Natural Banks□ • CN code or FAO 3-Alpha code | species | quantity | package | batch | date of harvesting| date of starting of conditioning | date of end of conditioning | place of conditioning| date of starting of re-immersion | date of end of re-immersion |place of re-immersion| date of starting of grouping | date of end of grouping | production area | health status including, if applicable, harvested in accordance with Article 62(2) of Implementing Regulation (EU) 2019/627
Part I – Supplier	I.6  From relaying area Yes□ No□ Relaying area Duration of relaying Date of starting Date of end	I.6  From relaying area Yes□ No□ Relaying area Duration of relaying Date of starting Date of end	I.7  From purification/dispatch centre Auction hall Yes□ No□ Purification/dispatch centre/auction hall approval number Date of entry Date of exit Duration of purification	I.7  From purification/dispatch centre Auction hall Yes□ No□ Purification/dispatch centre/auction hall approval number Date of entry Date of exit Duration of purification
Part I – Supplier	I.8  From Intermediary operator Yes□ No□ Name Address Registration or Approval No Country ISO Country code Activity Date of arrival Date of exit	I.8  From Intermediary operator Yes□ No□ Name Address Registration or Approval No Country ISO Country code Activity Date of arrival Date of exit
Part I – Supplier	I.9  Declaration of the supplier I, the undersigned food business operator responsible for dispatching the consignment declare that, to the best of my knowledge and belief, the information provided in Part I of this document is true and complete.	I.9  Declaration of the supplier I, the undersigned food business operator responsible for dispatching the consignment declare that, to the best of my knowledge and belief, the information provided in Part I of this document is true and complete.	I.9  Declaration of the supplier I, the undersigned food business operator responsible for dispatching the consignment declare that, to the best of my knowledge and belief, the information provided in Part I of this document is true and complete.	I.9  Declaration of the supplier I, the undersigned food business operator responsible for dispatching the consignment declare that, to the best of my knowledge and belief, the information provided in Part I of this document is true and complete.
	Date	Name of signatory	Name of signatory	Signature
Part II – Receiving operator	II.1  Internal reference number (receiving)	II.1  Internal reference number (receiving)	II.1  Internal reference number (receiving)	II.1  Internal reference number (receiving)
Part II – Receiving operator	II.2  Declaration of the receiving food business operator I, the undersigned food business operator responsible for receiving the consignment declare that the consignment has arrived on [DATE] in my premises.	II.2  Declaration of the receiving food business operator I, the undersigned food business operator responsible for receiving the consignment declare that the consignment has arrived on [DATE] in my premises.	II.2  Declaration of the receiving food business operator I, the undersigned food business operator responsible for receiving the consignment declare that the consignment has arrived on [DATE] in my premises.	II.2  Declaration of the receiving food business operator I, the undersigned food business operator responsible for receiving the consignment declare that the consignment has arrived on [DATE] in my premises.
	Name of signatory	Name of signatory	Signature	Signature

Explanatory notes

Box	Description
Part I – Supplier This part of the document shall be filled by the food business operator dispatching a batch of live bivalve molluscs.	Part I – Supplier This part of the document shall be filled by the food business operator dispatching a batch of live bivalve molluscs.
I.1	IMSOC reference number This is the unique alpha-numeric code assigned by the IMSOC
I.2	Internal reference number This box may be used by the dispatching food business operator to indicate an internal reference number.
I.3	Supplier Indicate the name and address (street, city and region/province/state, as appropriate), country and ISO country code of the establishment of origin. In the case of production areas, please indicate the area as authorised by the competent authorities (CAs). In the case of live pectinidae, marine gastropods or echinoderms, indicate the location of the harvesting area. Where applicable, indicate the registration or approval number of the establishment. Indicate the activity (gatherer, purification centre, dispatch centre, auction hall or intermediary activities). Where the batch of live bivalve molluscs is sent from a purification centre/dispatch centre, or, in case of pectinidae, marine gastropods and echinoderms which are not filter feeders harvested outside classified production areas, from a fish auction, indicate the approval number and the address of the purification centre/dispatch centre or fish auction.
I.4	Receiving food business operator Indicate the name and address (street, city and region/province/state, as appropriate), country and ISO country code of the establishment of destination. In the case of production or relaying areas please indicate the area as authorised by the CAs. Where applicable, indicate the registration or approval number of the establishment Indicate the activity (gatherer, purification centre, dispatch centre, processing establishment or intermediary activities).
I.5	Description of goods Indicate as required, the Combined Nomenclature code or FAO 3-Alpha code, species, quantity, type of packaging (bags, bulk, etc.), batch, date of harvesting, date of starting and end of conditioning (when applicable), place of conditioning (indicate the classification of the production area and its location or the approval number of the establishment, when applicable), date of starting and end of re-immersion (when applicable), place of re-immersion (indicate the classification of the production area and its location or the approval number of the establishment when applicable), date of starting and end of grouping (when applicable), production area and its health status (classification of the production area when applicable). When LBMs have been harvested in accordance with Article 62(2) of the Implementing Regulation 2019/627 then this should be explicitly stated. When grouping of live bivalve molluscs is performed, the batch must refer to bivalves of the same species, harvested on the same day and coming from the same production area. Delete as appropriate
I.6	From relaying area Where the batch of live bivalve molluscs is sent from a relaying area, indicate the relaying area, as authorised by the CAs, and the duration of the relaying (date of starting and end).
I.7	From purification centre/dispatch centre or fish auction Where the batch of live bivalve molluscs is sent from a purification centre/dispatch centre, or, in case of pectinidae, marine gastropods and echinoderms which are not filter feeders harvested outside classified production areas, from an auction hall, indicate the approval number and the address of the purification centre/dispatch centre or auction hall. If sent from a purification centre, the duration of the purification and the dates on which the batch entered and left the purification centre. Delete as appropriate.
I.8	From intermediary operator Indicate the name and address (street, city and region/province/state, as appropriate), country and ISO country code of the intermediary operator. Where applicable, indicate the registration or approval number and the activity.
1.9	Declaration of the supplier Include the date, name of the signatory and the signature.
Part II – Receiving food business operator This part of the document shall be filled by the food business operator receiving a batch of live bivalve molluscs.	Part II – Receiving food business operator This part of the document shall be filled by the food business operator receiving a batch of live bivalve molluscs.
II.1	Internal reference number (receiving) This box may be used by the food business operator receiving the batch to indicate an internal reference number.
II.2	Declaration of the receiving food business operator Indicate the date of arrival of the batch of live bivalve molluscs at the premises of the receiving food business operator. In the case of an intermediary operator without premises indicate the date of purchase of the batch. Include the name of the signatory and the signature.

SECTION VIII:   FISHERY PRODUCTS

• 1.This Section shall not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods if they are still alive when placed on the market. With the exception of Chapters I and II, it shall apply to such animals when they are not placed on the market live, in which case they must have been obtained in accordance with Section VII.

• For the purpose of this Section, ‘superchilling’ means a process by which the temperature of fresh fishery product is lowered to between the initial freezing point of the fish and about 1 to 2 °C lower.

• This Section shall apply to thawed unprocessed fishery products and fresh fishery products to which food additives have been added in accordance with the appropriate Union legislation.

• 2.Chapter III, Parts A, C and D, Chapter IV, Part A and Chapter V apply to retail.

• 3.The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:

• (a) In the case of establishments, including vessels, engaged in primary production and associated operations they supplement the requirements of Annex I to that Regulation.

• (b) In the case of other establishments, including vessels, they supplement the requirements of Annex II to that Regulation.

• (c) In the case of water supply, they supplement the requirements of Annex II, Chapter VII to that Regulation; clean seawater may be used for the handling and washing of fishery products, the production of ice used to chill fishery products and the rapid cooling of crustaceans and molluscs after their cooking.

• By way of derogation from point (a), point 7 of Part A of Annex I to Regulation (EC) No 852/2004 may not apply to operators engaged in small-scale coastal fishing within the meaning of Article 26(1) of Council Regulation (EC) No 1198/2006 ([^E0027]), and carrying out their activities only for short periods of less than 24 hours.

• 4.In relation to fishery products:

• (a) primary production covers the farming, fishing and collection of live fishery products with a view to their being placed on the market; and

• (b) associated operations cover any of the following operations, if carried out on board fishing vessels: slaughter, bleeding, heading, gutting, removing fins, refrigeration and wrapping; they also include:
• 1. the transport and storage of fishery products the nature of which has not been substantially altered, including live fishery products, within fish farms on land; and
• 1. the transport of fishery products the nature of which has not been substantially altered, including live fishery products, from the place of production to the first establishment of destination.

CHAPTER I:   REQUIREMENTS FOR VESSELS

Food business operators must ensure that:

• 1. vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, and reefer vessels comply with the structural and equipment requirements laid down in Part I; and

• 1. operations carried out on board vessels take place in accordance with the rules laid down in Part II.

I. STRUCTURAL AND EQUIPMENT REQUIREMENTS

A. Requirements for all vessels

• 1.Vessels must be designed and constructed so as not to cause contamination of the products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances.

• 2.Surfaces with which fishery products come into contact must be of suitable corrosion-resistant material that is smooth and easy to clean. Surface coatings must be durable and non-toxic.

• 3.Equipment and material used for working on fishery products must be made of corrosion-resistant material that is easy to clean and disinfect.

• 4.When vessels have a water intake for water used with fishery products, it must be situated in a position that avoids contamination of the water supply.

• 1. Vessels must be designed and constructed so as not to cause contamination of the fishery products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances. Holds, tanks, or containers used for storing, cooling or freezing unprotected fishery products including those destined for the production of feed, shall not be used for other purposes than the storing, cooling or freezing those products, as well as ice or brine used for such purposes. In the case of reefer vessels, the provisions applicable to unprotected fishery products apply to all the products transported.

B. Requirements for vessels designed and equipped to preserve fresh fishery products for more than 24 hours

• 1.Vessels designed and equipped to preserve fishery products for more than 24 hours must be equipped with holds, tanks or containers for the storage of fishery products at the temperatures laid down in Chapter VII.

• 2.Holds must be separated from the engine compartments and from the crew quarters by partitions which are sufficient to prevent any contamination of the stored fishery products. Holds and containers used for the storage of fishery products must ensure their preservation under satisfactory conditions of hygiene and, where necessary, ensure that melt water does not remain in contact with the products.

• 3.In vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices for achieving a uniform temperature throughout the tanks. Such devices must achieve a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 3 °C six hours after loading and not more than 0 °C after 16 hours and allow the monitoring and, where necessary, recording of temperatures.

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.

• 1. 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.

• 1. 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.

• 1. 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.

• 1. 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.

D. Requirements for factory vessels

• 1.Factory vessels must have at least:

• (a) a receiving area reserved for taking fishery products on board, designed to allow each successive catch to be separated. This area must be easy to clean and designed so as to protect the products from the sun or the elements and from any source of contamination;

• (b) a hygienic system for conveying fishery products from the receiving area to the work area;

• (c) work areas that are large enough for the hygienic preparation and processing of fishery products, easy to clean and disinfect and designed and arranged in such a way as to prevent any contamination of the products;

• (d) storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste-processing unit operates on board, a separate hold must be designated for the storage of such waste;

• (e) a place for storing packaging materials that is separate from the product preparation and processing areas;

• (f) special equipment for disposing waste or fishery products that are unfit for human consumption directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to its sanitation, separate areas must be allocated for that purpose;

• (g) a water intake situated in a position that avoids contamination of the water supply; and

• (h) hand-washing equipment for use by the staff engaged in handling exposed fishery products with taps designed to prevent the spread of contamination.

• 2.However, factory vessels on board which crustaceans and molluscs are cooked, chilled and wrapped, need not meet the requirements of point 1 if no other form of handling or processing takes place on board such vessels.

• 1. 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).

E. Requirements for reefer vessels

• 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.

II.   HYGIENE REQUIREMENTS

• 1.When in use, the parts of vessels or containers set aside for the storage of fishery products must be kept clean and maintained in good repair and condition. In particular, they must not be contaminated by fuel or bilge water.

• 2.As soon as possible after they are taken on board, fishery products must be protected from contamination and from the effects of the sun or any other source of heat.  —————

• 3.Fishery products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to move large fish or fish which might injure them, provided that the flesh of the products suffers no damage.

• 4.Fishery products other than those kept alive must undergo chilling as soon as possible after loading. However, when chilling is not possible, fishery products must be landed as soon as possible.

• 1. Where fish are headed and/or gutted on board, such operations must be carried out hygienically as soon as possible after capture, and the fishery products must be washed immediately. The viscera and parts that may constitute a danger to public health must be removed as soon as possible and kept apart from fishery products intended for human consumption. Livers and roes intended for human consumption must be refrigerated or preserved under ice, at a temperature approaching that of melting ice, or be frozen.

• 1. Where freezing in brine of the whole fish intended for canning is practiced, a temperature of not more than – 9 °C must be achieved for the fishery product. Even if it is subsequently frozen at a temperature of – 18 °C, the whole fish initially frozen in brine at a temperature of not more than – 9 °C must be destined for canning. The brine must not be a source of contamination for the fish.

• 1. 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.

CHAPTER II:   REQUIREMENTS DURING AND AFTER LANDING

• 1.Food business operators responsible for the unloading and landing of fishery products must:

• (a) ensure that unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness; and

• (b) avoid contamination of fishery products during unloading and landing, in particular by:
• (i) carrying out unloading and landing operations rapidly;
• (ii) placing fishery products without delay in a protected environment at the temperature specified in Chapter VII; and
• (iii) not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.

• 2.Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.

• (a) - (i) There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable facilities for the storage of fishery products declared unfit for human consumption.
• (ii) If the competent authority so requires, there must be an adequately equipped lockable facility or, where needed, room for the exclusive use of the competent authority.

• (b) At the time of display or storage of fishery products:
• (i) the premises must not be used for other purposes;
• (ii) vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises;
• (iii) persons having access to the premises must not introduce other animals; and
• (iv) the premises must be well lit to facilitate official controls.

• 3.When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.

• 4.Food business operators must cooperate with relevant competent authorities so as to permit them to carry out official controls in accordance with Regulation (EC) No 854/2004, in particular as regards any notification procedures for the landing of fishery products that the competent authority of the Member State the flag of which the vessel is flying or the competent authority of the Member State where the fishery products are landed might consider necessary.

CHAPTER III:   REQUIREMENTS FOR ESTABLISHMENTS, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS

Food business operators must ensure compliance with the following requirements, where relevant, in establishments handling fishery products.

A. REQUIREMENTS FOR FRESH FISHERY PRODUCTS

• 1. Whole and gutted fresh fishery products may be transported and stored in cooled water on board vessels. They may also continue to be transported in cooled water after landing, and be transported from aquaculture establishments, until they arrive at the establishment on land carrying out any activity other than transport or sorting. When three-layered polyethylene containers filled with water and ice are used, the whole and gutted fresh fishery products may be transported after arriving at the establishment on land carrying out other activity than transport provided that the requirements of Chapter VIII, point 1(a) are met.

• 1. Where chilled, unpackaged products are not distributed, dispatched, prepared or processed immediately after reaching an establishment on land, they must be stored under ice in appropriate facilities or in case of whole or gutted fresh fishery products, in three-layered polyethylene containers made of insulating material filled with ice and water.

• 1. Re-icing must be carried out as often as necessary. When three-layered polyethylene containers filled with water and ice are used, they must be clean and undamaged. The water must have a temperature as close to 0 °C as possible and cover all the fish. Ice shall cover the whole surface of the water within containers, making sure that all fish is below the ice layer.

• 1. Packaged fresh fishery products must be chilled to a temperature approaching that of melting ice.

• 1. Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed. The products must be washed thoroughly immediately after these operations.

• 1. Operations such as filleting and cutting must be carried out so as to avoid contamination or spoilage of fillets and slices. Fillets and slices must not remain on the work tables beyond the time necessary for their preparation. Fillets and slices must be wrapped and, where necessary, packaged and must be chilled as quickly as possible after their preparation.

• 1. Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water is drained away and does not remain in contact with any fishery products.

B. REQUIREMENTS FOR FROZEN PRODUCTS

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).

C. REQUIREMENTS FOR MECHANICALLY SEPARATED FISHERY PRODUCTS

Food business operators manufacturing mechanically separated fishery products must ensure compliance with the following requirements.

• 1. The raw materials used must satisfy the following requirements.
• (a) Only whole fish and bones after filleting may be used to produce mechanically separated fishery products;
• (b) All raw materials must be free from guts.

• 1. The manufacturing process must satisfy the following requirements:
• (a) Mechanical separation must take place without undue delay after filleting.
• (b) If whole fish are used, they must be gutted and washed beforehand.
• (c) After production, mechanically separated fishery products must be frozen as quickly as possible or incorporated in a product intended for freezing or a stabilising treatment.

D. REQUIREMENTS CONCERNING PARASITES

• 1. Food business operators placing on the market the following fishery products derived from finfish or cephalopod molluscs:
• (a) fishery products intended to be consumed raw; or
• (b) marinated, salted and any other treated fishery products, if the treatment is insufficient to kill the viable parasite; must ensure that the raw material or finished product undergo a freezing treatment in order to kill viable parasites that may be a risk to the health of the consumer.

• 1. For parasites other than trematodes the freezing treatment must consist of lowering the temperature in all parts of the product to at least:
• (a) – 20 °C for not less than 24 hours; or
• (b) – 35 °C for not less than 15 hours.

• 1. Food business operators need not carry out the freezing treatment set out in point 1 for fishery products:
• (a) that have undergone, or are intended to undergo before consumption a heat treatment that kills the viable parasite. In the case of parasites other than trematodes the product is heated to a core temperature of 60 °C or more for at least one minute;
• (b) that have been preserved as frozen fishery products for a sufficiently long period to kill the viable parasites;
• (c) from wild catches, provided that:
• (i) there are epidemiological data available indicating that the fishing grounds of origin do not present a health hazard with regard to the presence of parasites; and
• (ii) the competent authority so authorises;
• (d) derived from fish farming, cultured from embryos and have been fed exclusively on a diet that cannot contain viable parasites that present a health hazard, and one of the following requirements is complied with:
• (i) have been exclusively reared in an environment that is free from viable parasites; or
• (ii) the food business operator verifies through procedures, approved by the competent authority, that the fishery products do not represent a health hazard with regard to the presence of viable parasites.

• 1. • (a) When placing on the market, except when supplied to the final consumer, fishery products referred to in point 1 must be accompanied by a document issued by the food business operator performing the freezing treatment, stating the type of freezing treatment that the products have undergone.
• (b) Before placing on the market fishery products referred to in points 3(c) and (d) which have not undergone the freezing treatment or which are not intended to undergo before consumption a treatment that kills viable parasites that present a health hazard, a food business operator must ensure that the fishery products originate from a fishing ground or fish farming which complies with the specific conditions referred to in one of those points. This provision may be met by information in the commercial document or by any other information accompanying the fishery products.

CHAPTER IV:   REQUIREMENTS FOR CERTAIN PROCESSED FISHERY PRODUCTS

Food business operators must ensure compliance with the following requirements in establishments handling certain processed fishery products.

A. REQUIREMENTS FOR COOKING OF CRUSTACEANS AND MOLLUSCS

• 1.Rapid cooling must follow cooking. If no other method of preservation is used, cooling must continue until a temperature approaching that of melting ice is reached.

• 2.Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such operations are done by hand, workers must pay particular attention to washing their hands.

• 3.After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible to the temperature set out in Chapter VII.

B. REQUIREMENTS FOR FISH OIL INTENDED FOR HUMAN CONSUMPTION

• 1.Raw materials used in the preparation of fish oil for human consumption must:

• (a) come from establishments, including vessels, registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation;

• (b) derive from fishery products which are fit for human consumption and which comply with the provisions set out in this Section;

• (c) be transported and stored in hygienic conditions;

• (d) be chilled as soon as possible and remain at the temperatures set out in Chapter VII.

• By way of derogation from point 1(d), the food business operator may refrain from chilling the fishery products when whole fishery products are used directly in the preparation of fish oil for human consumption, and the raw material is processed within 36 hours after loading, provided that the freshness criteria are met and the total volatile basic nitrogen (TVB-N) value of the unprocessed fishery products do not exceed the limits set out in point 1 of Chapter I of Section II of Annex II to Commission Regulation (EC) No 2074/2005 ([^E0028]).

• 2.The production process for fish oil must ensure that all raw material intended for the production of crude fish oil is subject to a treatment including, where relevant, heating, pressing, separation, centrifugation, processing, refining and purification steps before being placed on the market for the final consumer.

• 3.Provided that the raw materials and the production process comply with the requirements applying to fish oil intended for human consumption a food business operator may produce and store both fish oil for human consumption and fish oil and fish meal not intended for human consumption in the same establishment.

• 4.Pending the establishment of specific Community legislation food business operators must ensure compliance with national rules for fish oil being placed on the market for the final consumer.

CHAPTER V:   HEALTH STANDARDS FOR FISHERY PRODUCTS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No 852/2004, food business operators must ensure, depending on the nature of the product or the species, that fishery products placed on the market for human consumption meet the standards laid down in this Chapter.   The requirements of Parts B and D shall not apply to whole fishery products that are used directly for the preparation of fish oil intended for human consumption.

A. ORGANOLEPTIC PROPERTIES OF FISHERY PRODUCTS

Food business operators must carry out an organoleptic examination of fishery products. In particular, this examination must ensure that fishery products comply with any freshness criteria.

B. HISTAMINE

Food business operators must ensure that the limits with regard to histamine are not exceeded.

C. TOTAL VOLATILE NITROGEN

Unprocessed fishery products must not be placed on the market if chemical tests reveal that the limits with regard to TVB-N or TMA-N have been exceeded.

D. PARASITES

Food business operators must ensure that fishery products have been subjected to a visual examination for the purpose of detecting visible parasites before being placed on the market. They must not place fishery products that are obviously contaminated with parasites on the market for human consumption.

E. TOXINS HARMFUL TO HUMAN HEALTH

• 1.Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae.

• Fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may only be placed on the market in wrapped/packaged form and must be appropriately labelled to provide information to the consumer on preparation/cooking methods and on the risk related to the presence of substances with adverse gastrointestinal effects.

• The scientific name of the fishery products must accompany the common name on the label.

• 2.Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII and comply with the standards laid down in Chapter V, point 2, of that section.

CHAPTER VI:   WRAPPING AND PACKAGING OF FISHERY PRODUCTS

• 1.Receptacles in which fresh fishery products are kept under ice must be water-resistant and ensure that melt-water does not remain in contact with the products.

• 2.Frozen blocks prepared on board vessels must be adequately wrapped before landing.

• 3.When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping material:

• (a) is not a source of contamination;

• (b) is stored in such a manner that it is not exposed to a risk of contamination;

• (c) intended for re-use is easy to clean and, where necessary, to disinfect.

CHAPTER VII:   STORAGE OF FISHERY PRODUCTS

Food business operators storing fishery products must ensure compliance with the following requirements.

• 1. Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice.

• 1. Frozen fishery products must be kept at a temperature of not more than – 18 °C in all parts of the product; however, whole fish initially frozen in brine intended for the manufacture of canned food may be kept at a temperature of not more than – 9 °C.

• 1. Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety or their viability.

• 1. Where fresh fishery products, thawed unprocessed fishery products, or processed fishery products need to be at a temperature lower than that of melting ice to permit the use of machines that slice or cut fishery products, they may be maintained at such technologically required temperature for a period of time as short as possible and in any case not exceeding 96 hours. Storage and transport at that temperature shall not be allowed. Where frozen fishery products need to be at a temperature higher than – 18 °C to permit the use of machines that slice or cut fishery products, they may be maintained at such technologically required temperature for a period of time as short as possible and in any case not exceeding 96 hours. Storage and transport at that temperature shall not be allowed.

CHAPTER VIII:   TRANSPORT OF FISHERY PRODUCTS

Food business operators transporting fishery products must ensure compliance with the following requirements.

• 1. During transport, fishery products must be maintained at the required temperature. In particular:
• (a) fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice. When three-layered polyethylene containers filled with water and ice are used for transporting whole and gutted fresh fishery products, ice must be present during the whole storage/transport, which must be carried out at controlled temperature. The transport and storage of whole and gutted fresh fishery products in three-layered polyethylene containers filled with water and ice must not exceed 3 days;
• (b) frozen fishery products, with the exception of whole fish initially frozen in brine intended for the manufacture of canned food, must be maintained during transport at an even temperature of not more than – 18 °C in all parts of the product, possibly with short upward fluctuations of not more than 3 °C;
• (c) if the superchilling process is used for transporting fresh fishery products, the transport in boxes without ice shall be permitted under the condition that those boxes clearly indicate that they contain superchilled fishery products. During transport, superchilled fishery products must respect temperature requirements included in a range between – 0.5 and – 2 °C temperature in the core of the product. The transport and storage of superchilled fishery products must not exceed 5 days.

• 1. Food business operators need not comply with point 1(b) when frozen fishery products are transported from a cold store to an approved establishment to be thawed on arrival for the purposes of preparation and/or processing, if the journey is short and the competent authority so permits.

• 1. If fishery products are kept under ice, melt water must not remain in contact with the products.

• 1. Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food safety or their viability.

SECTION IX:   RAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM-BASED PRODUCTS

For the purpose of this Section,

• 1. ‘Colostrum’ means the fluid secreted by the mammary glands of milk-producing animals up to three to five days post parturition that is rich in antibodies and minerals, and precedes the production of raw milk.

• 1. ‘Colostrum-based products’ means processed products resulting from the processing of colostrum or from the further processing of such processed products.

CHAPTER I:   RAW MILK AND COLOSTRUM — PRIMARY PRODUCTION

Food business operators producing or, as appropriate, collecting raw milk and colostrum must ensure compliance with the requirements laid down in this Chapter.

I. HEALTH REQUIREMENTS FOR RAW MILK AND COLOSTRUM PRODUCTION

• 1.Raw milk and colostrum must come from animals:

• (a) that do not show any symptoms of infectious diseases communicable to humans through milk and colostrum;

• (b) that are in a good general state of health, present no sign of disease that might result in the contamination of milk and colostrum and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder;

• (c) that do not have any udder wound likely to affect the milk and colostrum;

• (d) to which no unauthorised substances or products have been administered and that have not undergone illegal treatment within the meaning of Directive 96/23/EC;

• (e) in respect of which, where authorised products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed.

• 1. (a) In particular, as regards brucellosis, raw milk and colostrum must come from: (i) cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC ([^E0029]), is free or officially free of brucellosis; (ii) sheep or goats belonging to a holding officially free or free of brucellosis within the meaning of Directive 91/68/EEC ([^E0030]); or (iii) females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that disease under a control plan that the competent authority has approved. (b) As regards tuberculosis, raw milk and colostrum must come from: (i) cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC, is officially free of tuberculosis; or (ii) females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this disease under a control plan that the competent authority has approved. (c) If goats are kept together with cows, such goats must be inspected and tested for tuberculosis.

• 3.However, raw milk or colostrum from animals that does not meet the requirements set out in point 2 may be used with the authorisation of the competent authority:

• (a) in the case of cows, buffaloes, sheep or goats or females from other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, and in the case of sheep or goats which have been vaccinated against brucellosis as part of an approved eradication programme and do not show any symptom of that disease, after having undergone a heat treatment such as to show, where applicable, a negative reaction to the alkaline phosphatase test. When the alkaline phosphatase test is not suitable to demonstrate the effectiveness of the heat treatment applied, such as situations where raw milk is produced from non-bovine species or separated in different fractions before being heat-treated, food business operators shall be permitted to provide the competent authority with the necessary assurances and keep associated records as part of their procedures based on hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004;

• (b) in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been vaccinated against brucellosis as part of an approved eradication programme, and which do not show any symptom of that disease, for the manufacture of cheese with a maturation period of at least two months.

• 4.Raw milk and colostrum from any animal not complying with the appropriate requirements of points 1 to 3, and in particular, any animal showing individually a positive reaction to the prophylactic tests vis-à-vis tuberculosis or brucellosis as laid down in Directive 64/432/EEC and Directive 91/68/EEC, must not be used for human consumption.

• 5.The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in point 1 or 2 must be effective to avoid any adverse effect on other animals' milk and colostrum.

II.   HYGIENE ON MILK AND COLOSTRUM PRODUCTION HOLDINGS

A. Requirements for premises and equipment

• 1.Milking equipment and premises where milk and colostrum are stored, handled or cooled must be located and constructed so as to limit the risk of contamination of milk and colostrum.

• 2.Premises for the storage of milk and colostrum must be protected against vermin, have adequate separation from premises where animals are housed and, where necessary to meet the requirements laid down in Part B, have suitable refrigeration equipment.

• 3.Surfaces of equipment that are intended to come into contact with milk and colostrum (utensils, containers, tanks, etc. intended for milking, collection or transport) must be easy to clean and, where necessary, disinfect and must be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials.

• 4.After use, such surfaces must be cleaned and, where necessary, disinfected. After each journey, or after each series of journeys when the period of time between unloading and the following loading is very short, but in all cases at least once a day, containers and tanks used for the transport of milk and colostrum must be cleaned and disinfected in an appropriate manner before re-use.

B. Hygiene during milking, collection and transport

• 1.Milking must be carried out hygienically, ensuring in particular:

• (a) that, before milking starts, the teats, udder and adjacent parts are clean;

• (b) that milk and colostrum from each animal is checked for organoleptic or physico-chemical abnormalities by the milker or a method achieving similar results and that milk and colostrum presenting such abnormalities is not used for human consumption;

• (c) that milk and colostrum from animals showing clinical signs of udder disease are not used for human consumption otherwise than in accordance with the instructions of a veterinarian;

• (d) the identification of animals undergoing medical treatment likely to transfer residues to the milk and colostrum, and that milk and colostrum obtained from such animals before the end of the prescribed withdrawal period are not used for human consumption; and

• (e) that teat dips or sprays are used only after authorisation or registration in accordance with the procedures laid down in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ([^E0031]):

• (f) that colostrum is milked separately and not mixed together with raw milk.

• 2.Immediately after milking, milk and colostrum must be held in a clean place designed and equipped to avoid contamination.

• (a) Milk must be cooled immediately to not more than 8 ^oC in the case of daily collection, or not more than 6 ^oC if collection is not daily;

• (b) Colostrum must be stored separately and immediately cooled to not more than 8 ^oC in the case of daily collection, or not more than 6 ^oC if collection is not daily, or frozen.

• 3.During transport the cold chain must be maintained and, on arrival at the establishment of destination, the temperature of the milk and the colostrum must not be more than 10 ^oC.

• 4.Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk meets the criteria provided for in Part III and either:

• (a) the milk is processed within two hours of milking; or

• (b) a higher temperature is necessary for technological reasons related to the manufacture of certain dairy products and the competent authority so authorises.

C. Staff hygiene

• 1.Persons performing milking and/or handling raw milk and colostrum must wear suitable clean clothes.

• 2.Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available near the place of milking to enable persons performing milking and handling raw milk and colostrum to wash their hands and arms.

III.   CRITERIA FOR RAW MILK AND COLOSTRUM

• 1. (a) The following criteria for raw milk apply pending the establishment of standards in the context of more specific legislation on the quality of milk and dairy products. (b) National criteria for colostrum, as regards plate count, somatic cell count or antibiotic residues, apply pending the establishment of specific Community legislation.

• 2.A representative number of samples of raw milk and colostrum collected from milk production holdings taken by random sampling must be checked for compliance with points 3 and 4 in case of raw milk and with the existing national criteria referred to in point 1(b) in case of colostrum. The checks may be carried out by, or on behalf of:

• (a) the food business operator producing the milk;

• (b) the food business operator collecting or processing the milk;

• (c) a group of food business operators; or

• (d) in the context of a national or regional control scheme.

• 1. (a) Food business operators must initiate procedures to ensure that raw milk meets the following criteria: (i) for raw cows' milk:

Plate count at 30 ^oC (per ml) ≤ 100 000  [^E0032] Somatic cell count (per ml) ≤ 400 000  [^E0033] (¹) Rolling geometric average over a two-month period, with at least two samples per month. (2) Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies another methodology to take account of seasonal variations in production levels. (ii) for raw milk from other species:

Plate count at 30 ^oC (per ml) ≤ 1 500 000  [^E0034] (^*1) Rolling geometric average over a two-month period, with at least two samples per month. (b) However, if raw milk from species other than cows is intended for the manufacture of products made with raw milk by a process that does not involve any heat treatment, food business operators must take steps to ensure that the raw milk used meets the following criterion:

Plate count at 30 ^oC (per ml) ≤ 500 000  [^E0035] (^*1) Rolling geometric average over a two-month period, with at least two samples per month.

• 4.Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is not placed on the market if either:

• (a) it contains antibiotic residues in a quantity that, in respect of any one of the substances referred to in Annexes I and III to Regulation (EEC) No 2377/90 ([^E0036]), exceeds the levels authorised under that Regulation; or

• (b) the combined total of residues of antibiotic substances exceeds any maximum permitted value.

• 5.When raw milk fails to comply with point 3 or 4, the food business operator must inform the competent authority and take measures to correct the situation.

CHAPTER II:   REQUIREMENTS CONCERNING DAIRY AND COLOSTRUM-BASED PRODUCTS

I. TEMPERATURE REQUIREMENTS

• 1.Food business operators must ensure that, upon acceptance at a processing establishment,

• (a) milk is quickly cooled to not more than 6 ^oC;

• (b) colostrum is quickly cooled to not more than 6 ^oC or maintained frozen,

• and kept at that temperature until processed.

• 2.However, food business operators may keep milk and colostrum at a higher temperature if:

• (a) processing begins immediately after milking, or within four hours of acceptance at the processing establishment; or

• (b) the competent authority authorises a higher temperature for technological reasons concerning the manufacture of certain dairy or colostrum-based products.

II.   REQUIREMENTS FOR HEAT TREATMENT

• 1.When raw milk, colostrum, dairy or colostrum-based products undergo heat treatment, food business operators must ensure that this satisfies the requirements laid down in Chapter XI of Annex II to Regulation (EC) No 852/2004. In particular, they shall ensure, when using the following processes, that they comply with the specifications mentioned:

• (a) Pasteurisation is achieved by a treatment involving:
• (i) a high temperature for a short time: at least 72 °C for 15 seconds;
• (ii) a low temperature for a long time: at least 63 °C for 30 minutes; or
• (iii) any other combination of time-temperature conditions to obtain an equivalent effect. The treatment referred to in (i), (ii) and (iii) shall ensure that the products show, where applicable, a negative reaction to an alkaline phosphatase test immediately after such treatment. When the alkaline phosphatase test is not suitable to demonstrate the effectiveness of the pasteurisation, such as situations where products are derived from non-bovine species or separated in different fractions before being pasteurised, food business operators shall be permitted to provide the competent authority with the necessary assurances and keep associated records as part of their procedures based on hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004.

• (b) Ultra high temperature (UHT) treatment is achieved by a treatment:
• (i) involving a continuous flow of heat at a high temperature for a short time (not less than 135 ^oC in combination with a suitable holding time) such that there are no viable microorganisms or spores capable of growing in the treated product when kept in an aseptic closed container at ambient temperature, and
• (ii) sufficient to ensure that the products remain microbiologically stable after incubating for 15 days at 30 ^oC in closed containers or for seven days at 55 ^oC in closed containers or after any other method demonstrating that the appropriate heat treatment has been applied.

• 2.When considering whether to subject raw milk and colostrum to heat treatment, food business operators must:

• (a) have regard to the procedures developed in accordance with the HACCP principles pursuant to Regulation (EC) No 852/2004; and

• (b) comply with any requirements that the competent authority may impose in this regard when approving establishments or carrying out checks in accordance with Regulation (EC) No 854/2004.

III.   CRITERIA FOR RAW COWS' MILK

• 1.Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before being heat treated and if its period of acceptance specified in the HACCP-based procedures is exceeded:

• (a) raw cows’ milk used to prepare dairy products has a plate count at 30 °C of less than 300 000 per ml; and

• (b) heat treated cows’ milk used to prepare dairy products has a plate count at 30 °C of less than 100 000 per ml.

• 2.When milk fails to meet the criteria laid down in paragraph 1, the food business operator must inform the competent authority and take measures to correct the situation.

CHAPTER III:   WRAPPING AND PACKAGING

Sealing of consumer packages must be carried out immediately after filling in the establishment where the last heat treatment of liquid dairy products and colostrum-based products, takes place by means of sealing devices that prevent contamination. The sealing system must be designed in such a way that, after opening, the evidence of its opening remains clear and easy to check.

CHAPTER IV:   LABELLING

• 1.In addition to the requirements of Directive 2000/13/EC, except in the cases envisaged in Article 13(4) and (5) of that Directive, labelling must clearly show:

• (a) in the case of raw milk intended for direct human consumption, the words ‘raw milk’;

• (b) in the case of products made with raw milk, the manufacturing process for which does not include any heat treatment or any physical or chemical treatment, the words ‘made with raw milk’;

• (c) in case of colostrum, the word ‘colostrum’;

• (d) in case of products made with colostrum, the words ‘made with colostrum’.

• 2.The requirements of paragraph 1 apply to products destined for retail trade. The term ‘labelling’ includes any packaging, document, notice, label, ring or collar accompanying or referring to such products.

CHAPTER V:   IDENTIFICATION MARKING

By way of derogation from the requirements of Annex II, Section I:

• 1. rather than indicating the approval number of the establishment, the identification mark may include a reference to where on the wrapping or packaging the approval number of the establishment is indicated;

• 1. in the case of the reusable bottles, the identification mark may indicate only the initials of the consigning country and the approval number of the establishment.

SECTION X:   EGGS AND EGG PRODUCTS

CHAPTER I:   EGGS

• 1.At the producer’s premises, and until sale to the consumer, eggs must be kept clean, dry, free of unintended extraneous odour, effectively protected from shocks and out of direct sunshine. Any intentional application of extraneous odour to eggs must not be aimed at hiding a pre-existing odour.

• 2.Eggs must be stored and transported until sale to the final consumer at a temperature, preferably constant, that is best suited to assure optimal conservation of their hygiene properties, unless the competent authority imposes national temperature requirements for egg storage facilities and for vehicles transporting eggs between such storage facilities.

• 3.Eggs must be delivered to the consumer within a maximum time limit of 28 days of laying.

• 4.For eggs produced by hens of the species Gallus gallus, the ‘date of minimum durability’ as defined in Article 2(2), point (r), of Regulation (EU) No 1169/2011 shall be fixed at not more than 28 days after the laying. Where the period of laying is indicated, this date shall be determined from the first day of that period.

CHAPTER II:   EGG PRODUCTS

I. REQUIREMENTS FOR ESTABLISHMENTS

Food business operators must ensure that establishments for the manufacture of egg products are constructed, laid out and equipped so as to ensure separation of the following operations:

• 1. washing, drying and disinfecting dirty eggs, where carried out;

• 1. breaking eggs, collecting their contents and removing parts of shells and membranes; and

• 1. operations other than those referred to in points 1 and 2.

II.   RAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that raw materials used to manufacture egg products comply with the following requirements.

• 1. The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks. However, cracked eggs may be used for the manufacture of liquid egg or egg products if the establishment of production or a packing centre delivers them directly to an establishment approved for the manufacture of liquid egg or a processing establishment, where they must be broken as soon as possible.

• 1. Liquid egg obtained in an establishment approved for that purpose may be used as raw material. Liquid egg must be obtained in accordance with the requirements of points 1, 2, 3, 4 and 7 of Part III.

III.   SPECIAL HYGIENE REQUIREMENTS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that all operations are carried out in such a way as to avoid any contamination during production, handling and storage of egg products, in particular by ensuring compliance with the following requirements.

• 1. Eggs must not be broken unless they are clean and dry.

• 1. Eggs must be broken in a manner that minimises contamination, in particular by ensuring adequate separation from other operations. Cracked eggs must be processed as soon as possible.

• 1. Eggs other than those of hens, turkeys or guinea fowl must be handled and processed separately. All equipment must be cleaned and disinfected before processing of hens', turkeys' and guinea fowls' eggs is resumed.

• 1. Egg contents may not be obtained by the centrifuging or crushing of eggs, nor may centrifuging be used to obtain the remains of egg whites from empty shells for human consumption.

• 1. After breaking, each particle of the liquid egg must undergo processing as quickly as possible to eliminate microbiological hazards or to reduce them to an acceptable level. A batch that has been insufficiently processed may immediately undergo processing again in the same establishment if this processing renders it fit for human consumption. Where a batch is found to be unfit for human consumption, it must be denatured to ensure that it is not used for human consumption.

• 1. Processing is not required for egg white intended for the manufacture of dried or crystallised albumin destined subsequently to undergo heat treatment.

• 1. If processing is not carried out immediately after breaking, liquid egg must be stored either frozen or at a temperature of not more than 4 °C. The storage period before processing at 4 °C must not exceed 48 hours. However, these requirements do not apply to products to be de-sugared, if de-sugaring process is performed as soon as possible.

• 1. Products that have not been stabilised so as to be kept at room temperature must be cooled to not more than 4 °C. Products for freezing must be frozen immediately after processing.

IV.   ANALYTICAL SPECIFICATIONS

• 1.The concentration of 3-OH-butyric acid must not exceed 10 mg/kg in the dry matter of the unmodified egg product.

• 2.The lactic acid content of raw material used to manufacture egg products must not exceed 1 g/kg of dry matter. However, for fermented products, this value must be the one recorded before the fermentation process.

• 3.The quantity of eggshell remains, egg membranes and any other particles in the processed egg product must not exceed 100 mg/kg of egg product.

V. LABELLING AND IDENTIFICATION MARKING

• 1.In addition to the general requirements for identification marking laid down in Annex II, Section I, consignments of egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a label giving the temperature at which the egg products must be maintained and the period during which conservation may thus be assured.

• 2.In the case of liquid egg, the label referred to in point 1 must also bear the words: ‘non-pasteurised liquid egg — to be treated at place of destination’ and indicate the date and hour of breaking.

SECTION XI:   FROGS' LEGS AND SNAILS

Food business operators preparing frogs' legs or snails for human consumption must ensure compliance with the following requirements.

• 1. Frogs and snails must be killed in an establishment constructed, laid out and equipped for that purpose.

• 1. Establishment in which frogs' legs are prepared must have a room reserved for the storage and washing of live frogs, and for their slaughter and bleeding. This room must be physically separate from the preparation room.

• 1. Frogs and snails that die otherwise than by being killed in the establishment must not be prepared for human consumption.

• 1. Frogs and snails must be subjected to an organoleptic examination carried out by sampling. If that examination indicates that they might present a hazard, they must not be used for human consumption.

• 1. Immediately following preparation, frogs' legs must be washed fully with running potable water and immediately chilled to a temperature approaching that of melting ice, frozen or processed.

• 1. After killing, snails' hepato-pancreas must, if it might present a hazard, be removed and not be used for human consumption.

• 1. The requirements laid down in points 1, 3, 4 and 6, also apply to any other snails of the Family of Helicidae, Hygromiidae or Sphincterochilidae, when intended for human consumption.

• 1. The requirements laid down in points 1 to 5 also apply to frogs’ legs of the genus Pelophylax from the Family of Ranidae, and the genus Fejervarya, Limnonectes and Hoplobatrachus from the Family of Dicroglossidae, when intended for human consumption.

SECTION XII:   RENDERED ANIMAL FATS AND GREAVES

CHAPTER I:   REQUIREMENTS APPLICABLE TO ESTABLISHMENTS COLLECTING OR PROCESSING RAW MATERIALS