22.12.2005   

EN

Official Journal of the European Union

L 338/1

(1)

A high level of protection of public health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2). Microbiological hazards in foodstuffs form a major source of food-borne diseases in humans.

(2)

Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health.

(3)

Regulation (EC) No 178/2002 lays down general food safety requirements, according to which food must not be placed on the market if it is unsafe. Food business operators have an obligation to withdraw unsafe food from the market. In order to contribute to the protection of public health and to prevent differing interpretations, it is appropriate to establish harmonised safety criteria on the acceptability of food, in particular as regards the presence of certain pathogenic micro-organisms.

(4)

Microbiological criteria also give guidance on the acceptability of foodstuffs and their manufacturing, handling and distribution processes. The use of microbiological criteria should form an integral part of the implementation of HACCP-based procedures and other hygiene control measures.

(5)

The safety of foodstuffs is mainly ensured by a preventive approach, such as implementation of good hygiene practice and application of procedures based on hazard analysis and critical control point (HACCP) principles. Microbiological criteria can be used in validation and verification of HACCP procedures and other hygiene control measures. It is therefore appropriate to set microbiological criteria defining the acceptability of the processes, and also food safety microbiological criteria setting a limit above which a foodstuff should be considered unacceptably contaminated with the micro-organisms for which the criteria are set.

(6)

According to Article 4 of Regulation (EC) No 852/2004, food business operators are to comply with microbiological criteria. This should include testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective actions, in accordance with food law and the instructions given by the competent authority. It is therefore appropriate to lay down implementing measures concerning the analytical methods, including, where necessary, the measurement uncertainty, the sampling plan, the microbiological limits, the number of analytical units that should comply with these limits. Furthermore, it is appropriate to lay down implementing measures concerning the foodstuff to which the criterion applies, the points of the food chain where the criterion applies, as well as the actions to be taken when the criterion is not met. The measures to be taken by the food business operators in order to ensure compliance with criteria defining the acceptability of a process may include, among other things, controls of raw materials, hygiene, temperature and shelf-life of the product.

(7)

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (3) requires the Member States to ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency. Those controls should take place at appropriate stages of the production, processing and distribution of food to ensure that the criteria laid down in this Regulation are complied with by food business operators.

(8)

The Communication from the Commission on the Community Strategy for setting microbiological criteria for foodstuffs (4) describes the strategy to lay down and revise the criteria in Community legislation, as well as the principles for the development and application of the criteria. This strategy should be applied when microbiological criteria are laid down.

(9)

The Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) issued an opinion on 23 September 1999 on the evaluation of microbiological criteria for food products of animal origin for human consumption. It highlighted the relevance of basing microbiological criteria on formal risk assessment and internationally approved principles. The opinion recommends that microbiological criteria should be relevant and effective in relation to consumer health protection. The SCVPH proposed, while awaiting formal risk assessments, certain revised criteria as interim measures.

(10)

The SCVPH issued at the same time a separate opinion on Listeria monocytogenes. That opinion recommended that it be an objective to keep the concentration of Listeria monocytogenes in food below 100 cfu/g. The Scientific Committee on Food (SCF) agreed with these recommendations in its opinion of 22 June 2000.

(11)

The SCVPH adopted an opinion on Vibrio vulnificus and Vibrio parahaemolyticus on 19 and 20 September 2001. It concluded that currently available scientific data do not support setting specific criteria for pathogenic V. vulnificus and parahaemolyticus in seafood. However, it recommended that codes of practice should be established to ensure that good hygiene practice has been applied.

(12)

The SCVPH issued an opinion on Norwalk-like viruses (NLVs, noroviruses) on 30-31 January 2002. In that opinion it concluded that the conventional faecal indicators are unreliable for demonstrating the presence or absence of NLVs and that the reliance on faecal bacterial indicator removal for determining shellfish purification times is unsafe practice. It also recommended using E. coli rather than faecal coliforms to indicate faecal contamination in shellfish harvesting areas, when applying bacterial indicators.

(13)

On 27 February 2002 the SCF adopted an opinion on specifications for gelatine in terms of consumer health. It concluded that the microbiological criteria set in Chapter 4 of Annex II to Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (5) in terms of consumer health were excessive, and considered it sufficient to apply a mandatory microbiological criterion for salmonella only.

(14)

The SCVPH issued an opinion on verotoxigenic E. coli (VTEC) in foodstuffs on 21 and 22 January 2003. In its opinion it concluded that applying an end-product microbiological standard for VTEC O157 is unlikely to deliver meaningful reductions in the associated risk for the consumers. However, microbiological guidelines aimed at reducing the faecal contamination along the food chain can contribute to a reduction in public health risks, including VTEC. The SCVPH identified the following food categories where VTEC represents a hazard to public health: raw or undercooked beef and possibly meat from other ruminants, minced meat and fermented beef and products thereof, raw milk and raw milk products, fresh produce, in particular sprouted seeds, and unpasteurised fruit and vegetable juices.

(15)

On 26 and 27 March 2003 the SCVPH adopted an opinion on staphylococcal enterotoxins in milk products, particularly in cheeses. It recommended revising the criteria for coagulase-positive staphylococci in cheeses, in raw milk intended for processing and in powdered milk. In addition, criteria for staphylococcal enterotoxins should be laid down for cheeses and powdered milk.

(16)

The SCVPH adopted an opinion on salmonellae in foodstuffs on 14 and 15 April 2003. According to the opinion, food categories possibly posing a high risk to public health include raw meat and some products intended to be eaten raw, raw and undercooked products of poultry meat, eggs and products containing raw eggs, unpasteurised milk and some products thereof. Sprouted seeds and unpasteurised fruit juices are also of concern. It recommended that the decision on the need for microbiological criteria should be taken on the basis of its ability to protect the consumers and its feasibility.

(17)

The Scientific Panel on Biological Hazards (BIOHAZ Panel) of the European Food Safety Authority (EFSA) issued an opinion on the microbiological risks in infant formulae and follow-on formulae on 9 September 2004. It concluded that Salmonella and Enterobacter sakazakii are the micro-organisms of greatest concern in infant formulae, formulae for special medical purposes and follow-on formulae. The presence of these pathogens constitutes a considerable risk if conditions after reconstitution permit multiplication. Enterobacteriaceae, which are more often present, could be used as an indicator for risk. Monitoring and testing of Enterobacteriaceae was recommended in both the manufacturing environment and the finished product by the EFSA. However, besides pathogenic species the family Enterobacteriaceae includes also environmental species, which often appear in the food manufacturing environment without posing any health hazard. Therefore, the family Enterobacteriaceae can be used for routine monitoring, and if they are present testing of specific pathogens can be started.

(18)

International guidelines for microbiological criteria in respect of many foodstuffs have not yet been established. However, the Commission has followed the Codex Alimentarius guideline ‘Principles for the establishment and application of microbiological criteria for foods CAC/GL 21 — 1997’ and in addition, the advice of the SCVPH and the SCF in laying down microbiological criteria. Existing Codex specifications in respect of dried milk products, foods for infants and children and the histamine criterion for certain fish and fishery products have been taken account. The adoption of Community criteria should benefit trade by providing harmonised microbiological requirements for foodstuffs and replacing national criteria.

(19)

The microbiological criteria set for certain categories of food of animal origin in Directives that were repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC (6) should be revised and certain new criteria set in the light of the scientific advice.

(20)

The microbiological criteria laid down in Commission Decision 93/51 EEC of 15 December 1992 on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish (7) are incorporated in this Regulation. It is therefore appropriate to repeal that Decision. Since Commission Decision 2001/471/EC of 8 June 2001 laying down rules for the regular checks on the general hygiene carried out by the operators in establishments according to Directive 64/433/EEC on health conditions for the production and marketing of fresh meat and Directive 71/118/EEC on health problems affecting the production and placing on the market of fresh poultrymeat (8) is repealed with effect from the 1 January 2006, it is appropriate to incorporate microbiological criteria set for carcases in this Regulation.

(21)

The producer or manufacturer of a food product has to decide whether the product is ready to be consumed as such, without the need to cook or otherwise process it in order to ensure its safety and compliance with the microbiological criteria. According to Article 3 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (9), the instructions for use of a foodstuff are compulsory on the labelling when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions. Such instructions should be taken into account by food business operators when deciding appropriate sampling frequencies for the testing against microbiological criteria.

(22)

Sampling of the production and processing environment can be a useful tool to identify and prevent the presence of pathogenic micro-organisms in foodstuffs.

(23)

Food business operators should decide themselves the necessary sampling and testing frequencies as part of their procedures based on HACCP principles and other hygiene control procedures. However, it may be necessary in certain cases to set harmonised sampling frequencies at Community level, particularly in order to ensure the same level of controls to be performed throughout the Community.

(24)

Test results are dependent on the analytical method used, and therefore a given reference method should be associated with each microbiological criterion. However, food business operators should have the possibility to use analytical methods other than the reference methods, in particular more rapid methods, as long as the use of these alternative methods provides equivalent results. Moreover, a sampling plan needs to be defined for each criterion in order to ensure harmonised implementation. It is nevertheless necessary to allow the use of other sampling and testing schemes, including the use of alternative indicator organisms, on condition that these schemes provide equivalent guarantees of food safety.

(25)

Trends in test results should be analysed, as they are able to reveal unwanted developments in the manufacturing process enabling the food business operator to take corrective actions before the process is out of control.

(26)

The microbiological criteria set in this Regulation should be open to review and revised or supplemented, if appropriate, in order to take into account developments in the field of food safety and food microbiology. This includes progress in science, technology and methodology, changes in prevalence and contamination levels, changes in the population of vulnerable consumers, as well as the possible outputs from risk assessments.

(27)

In particular, criteria for pathogenic viruses in live bivalve molluscs should be established when the analytical methods are developed sufficiently. There is a need for development of reliable methods for other microbial hazards too, e.g. Vibrio parahaemolyticus.

(28)

It has been demonstrated that the implementation of control programmes can markedly contribute to a reduction of the prevalence of salmonella in production animals and products thereof. The purpose of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (10) is to ensure that proper and effective measures are taken to control salmonella at relevant stages of the food chain. Criteria for meat and products thereof should take into account the expected improvement in the salmonella situation at the level of primary production.

(29)

For certain food safety criteria, it is appropriate to grant the Member States a transitional derogation, enabling them to comply with less stringent criteria but provided that the foodstuffs would only be marketed on the national market. The Member States should notify the Commission and other Member States where this transitional derogation is used.

(30)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

‘micro-organisms’ means bacteria, viruses, yeasts, moulds, algae, parasitic protozoa, microscopic parasitic helminths, and their toxins and metabolites;

(b)

‘microbiological criterion’ means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch;

(c)

‘food safety criterion’ means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market;

(d)

‘process hygiene criterion’ a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law;

(e)

‘batch’ means a group or set of identifiable products obtained from a given process under practically identical circumstances and produced in a given place within one defined production period;

(f)

‘shelf-life’ means either the period corresponding to the period preceding the ‘use by’ or the minimum durability date, as defined respectively in Articles 9 and 10 of Directive 2000/13/EC;

(g)

‘ready-to-eat food’ means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern;

(h)

‘food intended for infants’ means food specifically intended for infants, as defined in Commission Directive 91/321/EEC (14);

(i)

‘food intended for special medical purposes’ means dietary food for special medical purposes, as defined in Commission Directive 1999/21/EC (15);

(j)

‘sample’ means a set composed of one or several units or a portion of matter selected by different means in a population or in an important quantity of matter, which is intended to provide information on a given characteristic of the studied population or matter and to provide a basis for a decision concerning the population or matter in question or concerning the process which has produced it;

(k)

‘representative sample’ means a sample in which the characteristics of the batch from which it is drawn are maintained. This is in particular the case of a simple random sample where each of the items or increments of the batch has been given the same probability of entering the sample;

(l)

‘compliance with microbiological criteria’ means obtaining satisfactory or acceptable results set in Annex I when testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective action, in accordance with food law and the instructions given by the competent authority.

(a)

that the supply, handling and processing of raw materials and foodstuffs under their control are carried out in such a way that the process hygiene criteria are met,

(b)

that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use.

(a)

guarantee that the appropriate means, including labelling and a special mark, which cannot be confused with the identification mark provided for in Annex II, Section I to Regulation (EC) No 853/2004, are in place to ensure that the derogation applies only to the products concerned when placed on the domestic market, and that products dispatched for intra-Community trade comply with the criteria laid down in Annex I;

(b)

provide that the products to which such transitional derogation applies shall be clearly labelled that they must be thoroughly cooked prior to consumption;

(c)

undertake that when testing against the Salmonella criterion pursuant to Article 4, and for the result to be acceptable as regards such transitional derogation, no more than one out of five sample units shall be found to be positive.

22.12.2005   

EN

Official Journal of the European Union

L 338/27

(1)

Regulation (EC) No 853/2004 lays down specific requirements concerning hygiene rules for food of animal origin. It is necessary to lay down certain implementing measures for meat, live bivalve molluscs, fishery products, milk, eggs, frogs' legs and snails, and processed products thereof.

(2)

Regulation (EC) No 854/2004 lays down specific rules for the organisation of official controls on products of animal origin intended for human consumption. It is necessary to develop certain rules and further specify other requirements.

(3)

Regulation (EC) No 882/2004 establishes at Community level a harmonised framework of general rules for the organisation of official controls. It is necessary to develop certain rules and further specify other requirements.

(4)

Commission Decision 20XX/2005/EC (5) repeals certain Decisions implementing measures provided for in the Directives repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC (6). Certain parts of the relevant Decisions should therefore be retained in this Regulation.

(5)

Regulation (EC) No 852/2004 requires the food business operator to keep and retain records and on request to make relevant information in these records available to the competent authority and receiving food business operator.

(6)

Regulation (EC) No 853/2004 also requires the slaughterhouse operator to request, receive, check and act upon the food chain information for all animals, other than wild game, sent or intended to be sent to the slaughterhouse. In addition, he should make sure the food chain information provides all the details required under Regulation (EC) No 853/2004.

(7)

The food chain information assists the slaughterhouse operator to organise slaughter operations and assists the official veterinarian to determine the required inspection procedures. The food chain information should be analysed by the official veterinarian and used as an integral part of the inspection procedures.

(8)

Existing systems for information flow should be used as much as possible and adapted to comply with the requirements for the food chain information laid down in Regulation (EC) No 854/2004.

(9)

In order to improve animal management at holding level and in accordance with Regulation (EC) No 854/2004, the official veterinarian should record and, if necessary, communicate, to the food business operator of the holding of provenance and to any veterinarian attending the holding of provenance or any competent authority involved, any disease or condition observed at the slaughterhouse in respect of individual animals or the herd/flock and which may affect public or animal health or endanger animal welfare.

(10)

Regulations (EC) Nos 853/2004 and 854/2004 set out the requirements governing parasite checks during handling of fishery products on shore and on board vessels. It is up to food business operators to carry out their own checks at all stages in the production of fishery products in accordance with the rules in Chapter V(D) of Section VIII of Annex III to Regulation (EC) No 853/2004 so that fish which are obviously infested with parasites are not released for human consumption. The adoption of detailed rules relating to visual inspections calls for the concepts of visible parasites and visual inspection to be defined and the type and frequency of the observations to be determined.

(11)

The checks provided for in Regulation (EC) No 853/2004 to prevent fishery products which are unfit for human consumption from being placed on the market may comprise certain chemical checks, including checks of total volatile basic nitrogen (TVB-N). It is necessary to set levels of TVB-N that are not to be exceeded in the case of certain species categories and to specify the analysis methods to be used. The analysis methods that are scientifically recognised for checking TVB-N should continue to be used as a matter of routine, but a reference method should be specified for use where there is doubt regarding the results or in the event of dispute.

(12)

The limits for Paralytic Shellfish Poison (PSP), Amnesic Shellfish Poison (ASP) and lipophilic toxins are laid down in Regulation (EC) No 853/2004. Bioassays are the reference method for detecting certain toxins and preventing toxic shellfish from being harvested. Maximum levels and methods of analysis should be harmonised and implemented by the Member States to protect human health. In addition to biological testing methods, alternative detection methods, such as chemical methods and in vitro assays, should be allowed if it is demonstrated that the performance of the chosen methods is at least as effective as the biological method and that their implementation provides an equivalent level of public health protection. The proposed maximum levels for lipophilic toxins are based on provisional data and should be reassessed once new scientific evidence becomes available. A lack of reference material and the sole use of non-bioassay tests currently means that the level of public health protection provided in respect of all toxins specified is not equivalent to that afforded by biological tests. Provision should be made for the replacement of biological tests as soon as possible.

(13)

Mechanically separated meat (MSM) produced using techniques that do not alter the structure of the bones used in the production of MSM should be treated as different from MSM produced using techniques that alter the structure of the bones.

(14)

MSM of the former type produced under specified conditions and of a specified composition should be permitted in meat preparations that are clearly not intended to be consumed without first undergoing heat treatment. These conditions are linked in particular to the calcium content of MSM, which should be specified in accordance with Article 11(2) of Regulation (EC) No 853/2004. An adjustment should be made to the specified maximum calcium content set in this Regulation once detailed information is available on variations occurring where different types of raw material are used.

(15)

Article 31(2)(f) of Regulation (EC) No 882/2004 provides for Member States to maintain up-to-date lists of approved establishments. A common framework should be laid down for the presentation of relevant information to other Member States and to the public.

(16)

Section XI of Annex III to Regulation (EC) No 853/2004 sets out the requirements governing the preparation of frogs' legs and snails intended for human consumption. Specific requirements, including model health certificates, should also be laid down for imports from third countries of frogs' legs and snails intended for human consumption.

(17)

Sections XIV and XV of Annex III to Regulation (EC) No 853/2004 lay down rules on the production and placing on the market of gelatine and collagen intended for human consumption. Specific requirements, including model health certificates, should also be laid down for imports from third countries of gelatine and collagen and raw materials for the production of gelatine and collagen intended for human consumption.

(18)

Flexibility is needed so foods with traditional characteristics can continue to be produced. Member States have already granted derogations for a wide range of such foods under the legislation in force before 1 January 2006. Food business operators should be able to continue without interruption to apply existing practices after that date. A procedure allowing Member States to exercise flexibility is provided for in Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004. However, in most cases where derogations have already been granted it is only a question of continuing established practices, so applying a full notification procedure, including a complete hazard analysis, may place an unnecessary and disproportionate burden on the Member States. Foods with traditional characteristics should therefore be defined and general conditions applicable to such foods should be laid down, by way of derogation from the structural requirements laid down in Regulation (EC) No 852/2004, with due regard to food health objectives.

(19)

Since Regulations (EC) Nos 853/2004 and 854/2004 were adopted before the accession on 1 May 2004, they did not refer to the new Member States. The ISO codes for those Member States and the abbreviations for the European Community in their languages should therefore be added to the relevant provisions of those Regulations.

(20)

Section I of Annex III to Regulation (EC) No 853/2004 lays down rules on the production and placing on the market of meat from domestic ungulates. Exceptions to the complete skinning of the carcase and other parts of the body intended for human consumption are set out in Chapter IV, point 8 of that Section. Provision should be made to extend these exceptions to feet from adult bovine animals, provided they comply with the same conditions as those applying to feet of calves.

(21)

Certain practices can mislead the consumer regarding the composition of certain products. In particular in order not to disappoint consumer expectations, the sale as fresh meat of poultrymeat treated with water retention agents should be banned.

(22)

The opinion of the European Food Safety Authority adopted on 30 August 2004 has demonstrated that fishery products belonging to the family of Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may have adverse gastrointestinal effects if consumed under certain conditions. The fishery products belonging to this family should therefore be subjected to marketing conditions.

(23)

Section IX of Annex III to Regulation (EC) No 853/2004 lays down specific hygiene rules for raw milk and dairy products. According to Part II (B)(1)(e) of Chapter I, teat dips or other udder cleaning products may be used only if they have been approved by the competent authority. However, no detailed authorisation scheme is provided in this Part. It is therefore necessary, in order to ensure a harmonised approach by Member States, to clarify the procedures under which such authorisations should be given.

(24)

Regulation (EC) No 853/2004 requires food business operators to ensure that heat treatments used to process raw milk and dairy products should conform to an internationally recognised standard. However, owing to the specificity of certain heat treatments used in this sector and their impact on food safety and animal health, clearer guidance should be given to food business operators in this regard.

(25)

Regulation (EC) No 853/2004 introduces a new definition to cover products derived from eggs that, after removal of the shell, have not yet been processed. It is, therefore, necessary to clarify the rules applying to those products and amend Section X, Chapter II of Annex III to Regulation (EC) No 853/2004 accordingly.

(26)

Section XIV of Annex III to Regulation (EC) No 853/2004 lays down specific health rules for gelatine. These rules include requirements covering the type of raw materials that may be used to produce gelatine and the transport and storage of such materials. They also lay down specifications applicable to the manufacture of gelatine. However, the rules applying to labelling of gelatine should also be laid down.

(27)

Scientific progress has led to the establishment of ISO 16649-3 as an agreed reference method for analysis of E. coli in bivalve molluscs. This reference method is already established for live bivalve molluscs from areas A in accordance with Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (7). Consequently, ISO 16649-3 should be specified as the reference MPN (most probable number) method for analysis of E. coli in bivalve molluscs originating in areas B and C too. The use of alternative methods should be allowed only where they are considered equivalent to the reference method.

(28)

Regulations (EC) Nos 853/2004 and 854/2004 should therefore be amended accordingly.

(29)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

recognised historically as traditional products, or

(b)

manufactured according to codified or registered technical references to the traditional process, or according to traditional production methods, or

(c)

protected as traditional food products by a Community, national, regional or local law.

(a)

Chapter II(1) of Annex II to Regulation (EC) No 852/2004 as regards the premises where such products are exposed to an environment necessary for the part-development of their characteristics. Such premises may in particular comprise walls, ceilings and doors that are not smooth, impervious, non-absorbent or of corrosion-resistant material and natural geological walls, ceilings and floors;

(b)

Chapter II(1)(f) and Chapter V(1) of Annex II to Regulation (EC) No 852/2004 as regards the type of materials of which the instruments and the equipment used specifically for the preparation, packaging and wrapping of these products are made.

The cleaning and disinfecting measures for the premises referred in (a) and the frequency with which they are carried out shall be adapted to the activity in order to take account of their specific ambient flora.

The instruments and equipment referred to in (b) shall be maintained at all times in a satisfactory state of hygiene and be regularly cleaned and disinfected.

(a)

provide a short description of the requirements that have been adapted;

(b)

describe the foodstuffs and establishments concerned; and

(c)

give any other relevant information.

22.12.2005   

EN

Official Journal of the European Union

L 338/60

(1)

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 (2), Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on the official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (3) lay down the health rules and requirements regarding food of animal origin and the official controls required.

(2)

In addition to those rules, more specific requirements should be laid down for Trichinella. Meat of domestic swine, wild boar, horses and other animal species may be infested with nematodes of the genus Trichinella. Consumption of meat infested with Trichinella can cause serious disease in humans. Measures should be put in place to prevent human disease caused by the consumption of meat infested with Trichinella.

(3)

On 22 November 2001, the Scientific Committee on Veterinary Measures relating to Public Health adopted an opinion on trichinellosis, epidemiology, methods of detection and Trichinella-free pig production. On 1 December 2004, the Scientific Panel on biological hazards (Biohaz) of the European Food Safety Authority adopted an opinion on the suitability and details of freezing methods to allow human consumption of meat infected with Trichinella or Cysticercus. On 9 and 10 March 2005, Biohaz adopted an opinion on risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella.

(4)

Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine (4) was repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC (5).

(5)

Various laboratory methods have been approved for the detection of Trichinella in fresh meat. The magnetic stirrer method for pooled-sample digestion is recommended as a reliable method for routine use. Sample size for parasitic analysis should be increased if the sample cannot be collected at the predilection site and if the type or species of animal is at higher risk of being infected. Trichinoscopic examination fails to detect non-encapsulated Trichinella species infecting domestic and sylvatic animals and humans and is no longer suitable as a detection method for standard use. The trichinoscopic method should only be used under exceptional circumstances for the examination of a small number of animals slaughtered per week, provided that measures are taken by the food business operator to process the meat in such a way that it is completely safe for consumption. However, the method should be replaced by a more reliable detection method within a transitional period. Other methods, such as serological tests, can be useful for monitoring purposes once the tests have been validated by a Community reference laboratory as soon as such a laboratory has been appointed by the Commission. Serological tests are not suitable for detecting Trichinella infestation in individual animals intended for human consumption.

(6)

Freezing meat under specified conditions can kill any parasites present but certain Trichinella species occurring in game and horses are resistant when freezing is carried out using the recommended temperature and time combinations.

(7)

Holdings should be officially recognised by the competent authority as Trichinella-free, provided specific conditions are met. Fattening pigs coming from such holdings should be exempted from inspection for Trichinella. Categories of holdings should be officially recognised by the competent authority as Trichinella-free, provided specific conditions are met. Such recognition should reduce the number of on-site inspections to be carried out by the competent authority, but is only feasible in Member States with a history of very low disease prevalence.

(8)

Regular monitoring of domestic swine, wild boar, horses and foxes or other indicator animals is an important tool for assessing changes in disease prevalence. The results of such monitoring should be communicated in an annual report in accordance with Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents (6).

(9)

Regulation (EC) No 853/2004 does not apply to wild game or wild game meat directly supplied to the final consumer or to local retail establishments directly supplying the final consumer. It should therefore be the responsibility of the Member States to adopt national measures to mitigate the risk of Trichinella-infested wild boar meat reaching the final consumer.

(10)

The measures provided in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

the reference method of detection set out in Chapter I of Annex I; or

(b)

an equivalent method of detection set out in Chapter II of Annex I.

(a)

Such carcases may be cut up into a maximum of six parts in a slaughterhouse or in a cutting plant on the same premises as the slaughterhouse (the premises).

(b)

By way of derogation from subparagraph (a) and following approval by the competent authority, such carcases may be cut up at a cutting plant attached to or separate from the slaughterhouse provided that:

(a)

a holding or category of holdings that has been officially recognised by the competent authority as free from Trichinella in accordance with the procedure set out in Chapter II of Annex IV;

(b)

(a)

a quality control programme of the tests used to detect Trichinella; and

(b)

a regular assessment of the testing, recording and analysis procedures used in the laboratory.

(a)

where they provide grounds for suspecting Trichinella infestation; or

(b)

when samples coming from the same holding were previously found to be positive using the trichinoscopic method referred to in Article 16(1).

(a)

traceability of infested carcase(s) and parts thereof containing muscle tissue;

(b)

measures for dealing with infested carcase(s) and parts thereof;

(c)

investigation of the source of infestation and any spreading among wildlife;

(d)

any measures to be taken at the retail or consumer level;

(e)

measures to be taken where the infested carcase cannot be identified at the slaughterhouse;

(f)

determination of the Trichinella species involved.

(a)

in the case of holdings, the requirements laid down in Chapter I and Chapter II(A), (B) and (D) of Annex IV;

(b)

in the case of categories of holdings, the requirements laid down in Chapter II(C) and (D) of Annex IV.

(a)

withdraw the holding's official recognition as free from Trichinella;

(b)

examine all domestic swine at the time of slaughter in accordance with Article 2(1) and conduct a serological test on all animals susceptible to Trichinella infestation on the holding once a suitable test has been validated by the Community reference laboratory;

(c)

trace and test all breeding animals that arrived on the holding and, as far as possible, all those that left the holding in at least the six months preceding the positive finding; to that end, meat samples shall be collected and examined for presence of Trichinella parasites using the detection methods in Chapters I and II of Annex I; a serological test may be used once a suitable test is validated by the Community reference laboratory;

(d)

as far as is feasible, investigate the spread of parasite infestation due to the distribution of meat from domestic swine slaughtered in the period preceding the positive finding;

(e)

inform the Commission and the other Member States;

(f)

initiate an epidemiological investigation to elucidate the cause of infestation;

(g)

increase the frequency of testing under, and the scope of the monitoring programme provided for in Article 11;

(h)

take appropriate measures where any infested carcase cannot be identified at the slaughterhouse, including:

(i)

any of the requirements laid down in Chapter I or II of Annex IV is no longer fulfilled;

(ii)

serological results or laboratory findings following sampling of slaughtered swine show that the holding or category of holdings can no longer be considered free from Trichinella.

(a)

the meat has been examined in the third country of origin in accordance with Article 13; or

(b)

the meat satisfies the requirements set out in Article 14(1) or (2).

(a)

single carcases as referred to in Article 2 need to be examined individually in an establishment that does not slaughter more than 15 domestic swine per day or 75 domestic swine per week or prepare for placing on the market more than 10 wild boar per day; and

(b)

the detection methods set out in Chapters I and II of Annex I are not available.

(a)

the meat is marked with a health mark that is clearly different from the health mark provided for in Article 5(1)(a) of Regulation (EC) No 853/2004, and the meat is supplied directly to the final consumer or to retail establishments directly supplying the final consumer; and

(b)

the meat is not used for the production of products where the production process does not kill Trichinella.