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THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs(1), and in particular Article 13(2) thereof,
Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(2), and in particular Articles 9, 10 and 11 thereof,
Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption(3), and in particular Articles 16, 17 and 18 thereof,
Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the compliance with feed and food law, animal health and animal welfare rules(4), and in particular Article 63 thereof,
Whereas:
(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(4) Commission Decision 20XX/2005/EC(5) repeals certain Decisions implementing measures provided for in the Directives repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health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,
HAS ADOPTED THIS REGULATION:
Requirements concerning food chain information as referred to in Section III of Annex II to Regulation (EC) No 853/2004 and in Chapter II (A) of Section I of Annex I to Regulation (EC) No 854/2004 are set out in Annex I to this Regulation.
Requirements concerning fishery products as referred to in Article 11(9) of Regulation (EC) No 853/2004 and Article 18(14) and (15) of Regulation (EC) No 854/2004 are set out in Annex II to this Regulation.
The recognised testing methods for detecting marine biotoxins as referred to in Article 11(4) of Regulation (EC) No 853/2004 and Article 18(13)(a) of Regulation (EC) No 854/2004 are as set out in Annex III to this Regulation.
The calcium content of mechanically separated meat as referred to in Article 11(2) of Regulation (EC) No 853/2004 is as set out in Annex IV to this Regulation.
Requirements concerning the lists of establishments as referred to in Article 31(2)(f) of Regulation (EC) No 882/2004 are set out in Annex V to this Regulation.
1. The models of the health certificates and documents, as referred to in Article 6(1)(d) of Regulation (EC) No 853/2004, to be used when importing products of animal origin listed in Annex VI to this Regulation are set out in that Annex.
2. The model of the document to be signed by the captain, that may replace the document required under Article 14 of Regulation (EC) No 854/2004 when fishery products are imported directly from a freezer vessel, as provided for in Article 15(3) of that Regulation, is set out in Annex VI to this Regulation.]
Textual Amendments
The analytical methods set out in Annex VIa to this Regulation shall be used by the competent authorities, and, where appropriate, by food business operators, to check compliance with the limits laid down in Annex III, Section IX, Chapter I, Part III to Regulation (EC) No 853/2004 and to ensure appropriate application of a pasteurisation process to dairy products as referred to in Annex III, Section IX, Chapter II, Part II to that Regulation.]
Textual Amendments
Requirements concerning official controls for the inspection of meat are laid down in Annex VIb.]
Textual Amendments
F3 Inserted by Commission Regulation (EC) No 1244/2007 of 24 October 2007 amending Regulation (EC) No 2074/2005 as regards implementing measures for certain products of animal origin intended for human consumption and laying down specific rules on official controls for the inspection of meat (Text with EEA relevance).
1. Fishery products intended for human consumption caught by vessels flying the flag of a Member State, unloaded, with or without storage, in third countries before entering the Union by a different means of transportation, must be accompanied by a health certificate issued by the competent authority of that third country and completed in accordance with the model health certificate set out in Appendix VIII to Annex VI.
2. The third country where the transfer takes place must be listed as provided for in Article 11(1) of Regulation (EC) No 854/2004.
3. If the fishery products referred to in paragraph 1 are unloaded and transported to storage facility located in the third country referred to in that paragraph, that storage facility shall appear in a list as provided for in Article 12 of Regulation (EC) No 854/2004.
4. If the fishery products referred to in paragraph 1 are loaded in a vessel flying the flag of a third country, that third country must be listed as provided for in Article 11(1) of Regulation (EC) No 854/2004 and the vessel must appear in a list as provided for in Article 12 of Regulation (EC) No 854/2004.
Container vessels used to transport containerised fishery products are excluded from this requirement.]
Textual Amendments
F4 Inserted by Commission Regulation (EU) 2017/1973 of 30 October 2017 amending Regulation (EC) No 2074/2005 as regards official controls on fishery products caught by vessels flying the flag of a Member State and introduced into Union after being transferred in third countries and establishing a model health certificate for those products (Text with EEA relevance).
1.For the purposes of this Regulation, ‘foods with traditional characteristics’ means foods that, in the Member State in which they are traditionally manufactured, are:
(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.
2.Member States may grant establishments manufacturing foods with traditional characteristics individual or general derogations from the requirements set out in:
(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.
3.Member States granting the derogations provided for in paragraph 2 shall notify the Commission and the other Member States of this no later than 12 months after granting individual or general derogations. Each notification shall:
(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.
Annexes II and III to Regulation (EC) No 853/2004 are amended in accordance with Annex VII to this Regulation.
Annexes I, II and III to Regulation (EC) No 854/2004 are amended in accordance with Annex VIII to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2006, except for Chapters II and III of Annex V, which shall apply from 1 January 2007.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Food business operators raising animals dispatched for slaughter shall ensure that the food chain information referred to in to Regulation (EC) No 853/2004 is included as appropriate in the documentation relating to the animals dispatched in such a way as to be accessible to the slaughterhouse operator concerned.
the food chain information is consistently and effectively communicated between the food business operator who raised or kept the animals before dispatch and the slaughterhouse operator;
the food chain information is valid and reliable;
feedback of relevant information to the holding, if applicable, is provided.
a Microbiological, chemical, serological, etc. (include results as attached). | |||
b The competent authorities may introduce the following codes: Code A for OIE-listed diseases; codes B100 and B200 for welfare issues (Chapter II(C) of Section I of Annex I to Regulation (EC) No 854/2004) and C100 to C290 for decisions concerning meat (Chapter V(1)(a) to (u) of Section II of Annex I to Regulation (EC) No 854/2004). The coding system can, if necessary, include further subdivisions (e.g. C141 for a mild generalised disease, C142 for a more severe disease, etc.). If codes are used, they should be readily available to the food business operator with a suitable explanation of their meaning. | |||
c Microbiological, chemical, serological, etc. (include results as attached). | |||
1. | Identification details | ||
1.1. | holding of provenance (e.g. owner or manager) | ||
name/number | |||
full address | |||
telephone number | |||
1.2. | identification numbers (attach separate list) | ||
total number of animals (by species) | |||
identification problems (if any) | |||
1.3. | herd/flock/cage identification (if applicable) | ||
1.4. | animal species | ||
1.5. | reference number of health certificate | ||
2. | Ante-mortem findings | ||
2.1. | welfare | ||
number of animals affected | |||
type/class/age | |||
observations (e.g. tail-biting) | |||
2.2. | animals were delivered dirty | ||
2.3. | clinical findings (disease) | ||
number of animals affected | |||
type/class/age | |||
observations | |||
date of inspection | |||
2.4. | laboratory resultsa | ||
3. | Post-mortem findings | ||
3.1. | (macroscopic) findings | ||
number of animals affected | |||
type/class/age | |||
organ or site of animal(s) affected | |||
date of slaughter | |||
3.2. | disease (codes can be usedb | ||
number of animals affected | |||
type/class/age | |||
organ or site of the animal(s) affected | |||
partially or totally condemned carcase (give reason) | |||
date of slaughter | |||
3.3. | laboratory resultsc | ||
3.4. | other results (e.g. parasites, foreign objects, etc | ||
3.5. | welfare findings (e.g. broken legs) | ||
4. | Additional information | ||
5. | Contact details | ||
5.1. | slaughterhouse (approval number) | ||
name | |||
full address | |||
telephone number | |||
5.2. | electronic address if available | ||
6. | Official veterinarian (print name) | ||
signature and stamp | |||
7. | Date | ||
8. | Number of pages attached to this form: |
This Section lays down detailed rules relating to visual inspections to detect parasites in fishery products.
in the case of manual evisceration, in a continuous manner by the handler at the time of evisceration and washing;
in the case of mechanical evisceration, by sampling carried out on a representative number of samples being not less than 10 fish per batch.
25 mg of nitrogen/100 g of flesh for the species referred to in point 1 of Chapter II;
30 mg of nitrogen/100 g of flesh for the species referred to in point 2 of Chapter II;
35 mg of nitrogen/100 g of flesh for the species referred to in point 3 of Chapter II;
60 mg of nitrogen/100 g of whole fishery products used directly for the preparation of fish oil for human consumption as referred to in the second sub-paragraph of Part B(1) of Chapter IV of Section VIII of Annex III to Regulation (EC) No 853/2004; however, where the raw material complies with points (a), (b) and (c) of Part B(1) of that Chapter, Member States may set limits at a higher level for certain species pending the establishment of specific Community legislation.
The reference method to be used for checking the TVB-N limits involves distilling an extract deproteinised by perchloric acid as set out in Chapter III.]
Textual Amendments
microdiffusion method described by Conway and Byrne (1933),
direct distillation method described by Antonacopoulos (1968),
distillation of an extract deproteinised by trichloracetic acid (Codex Alimentarius Committee on Fish and Fishery Products (1968).
Member States shall recommend that official laboratories use, as a matter of routine, the reference method referred to above. Where the results are dubious or in the event of dispute regarding the results of analysis performed by one of the routine methods, only the reference method may be used to check the results.
This method describes a reference procedure for identifying the nitrogen concentration of TVB-N in fish and fishery products. This procedure is applicable at TVB-N concentrations of 5 mg/100 g to at least 100 mg/100 g.
‘TVB-N concentration’ means the nitrogen content of volatile nitrogenous bases as determined by the procedure described.
The concentration shall be expressed in mg/100 g.
The volatile nitrogenous bases are extracted from a sample using a solution of 0,6 mol perchloric acid. After alkalinisation the extract undergoes steam distillation and the volatile base components are absorbed by an acid receiver. The TVB-N concentration is determined by titration of the absorbed bases.
Unless otherwise indicated, reagent-grade chemicals should be used. The water used must be either distilled or demineralised and of at least the same purity. Unless otherwise indicated, ‘solution’ means an aqueous solution as follows:
perchloric acid solution = 6 g/100 ml;
sodium hydroxide solution = 20 g/100 ml;
hydrochloric acid standard solution 0,05 mol/l ((0,05 N),
When using an automatic distillation apparatus, titration should take place with a hydrochloric acid standard solution of 0,01 mol/l ((0,01 N);
boric acid solution = 3 g/100 ml;
silicone anti-foaming agent;
phenolphtalein solution = 1 g/100 ml 95 % ethanol;
indicator solution (Tashiro Mixed Indicator) 2 g methyl-red and 1 g methylene-blue are dissolved in 1 000 ml 95 % ethanol.
A meat grinder to produce a sufficiently homogenous fish mince.
High-speed blender with a speed of between 8 000 and 45 000 revolutions/min.
Fluted filter, diameter 150 mm, quick-filtering.
Burette, 5 ml, graduated to 0,01 ml.
Apparatus for steam distillation. The apparatus must be able to regulate various amounts of steam and produce a constant amount of steam over a given period of time. It must ensure that during the addition of alkalising substances the resulting free bases cannot escape.
Warning: When working with perchloric acid, which is strongly corrosive, necessary caution and preventive measures should be taken. The samples should, if at all possible, be prepared as soon as possible after their arrival, in accordance with the following instructions:
Preparing the sample
The sample to be analysed should be ground carefully using a meat grinder as described in point 5(a). Exactly 10 g ± 0,1 g of the ground sample is weighed out into a suitable container. This is mixed with 90,0 ml perchloric acid solution as specified in point 4(a), homogenised for two minutes with a blender as described in point 5(b), and then filtered.
The extract thereby obtained can be kept for at least seven days at a temperature of between approximately 2 oC and 6 oC;
Steam distillation
50,0 ml of the extract obtained in accordance with point (a) is put into an apparatus for steam distillation as described in point 5(e). For a later check on the extract's alkalinisation, several drops of phenolphtalein as specified in point 4(f) are added. After adding a few drops of silicone anti-foaming agent, 6,5 ml of sodium hydroxide solution as specified in point 4(b) is added to the extract and steam distillation begins immediately.
The steam distillation is regulated so that around 100 ml of distillate is produced in 10 minutes. The distillation outflow tube is submerged in a receiver with 100 ml boric acid solution as specified in point 4(d), to which three to five drops of the indicator solution as described in point 4(g) have been added. After exactly 10 minutes, distillation is ended. The distillation outflow tube is removed from the receiver and washed out with water. The volatile bases contained in the receiver solution are determined by titration with standard hydrochloric solution as specified in point 4(c).
The pH of the end point should be 5,0 ± 0,1.
Titration
Duplicate analyses are required. The applied method is correct if the difference between the duplicates is not greater than 2 mg/100 g.
Blank
A blind test is carried out as described in point (b). Instead of the extract, 50,0 ml perchloric acid solution as specified in point 4(a) is used.
By titration of the receiver solution with hydrochloric acid as in point 4(c), the TVB-N concentration is calculated using the following equation:
V1 = Volume of 0,01 mol hydrochloric acid solution in ml for sample
V0 = Volume of 0,01 mol hydrochloric acid solution in ml for blank
M = Weight of sample in g.
Remarks
The following analytical methods shall be used by the competent authorities to check compliance with the limits laid down in Chapter V(2) of Section VII of Annex III to Regulation (EC) No 853/2004 and, where appropriate, by food business operators.
In accordance with Article 7(2) and (3) of Council Directive 86/609/EEC(8), elements of replacement, refinement and reduction must be taken into account when biological methods are used.
Textual Amendments
The total content of amnesic shellfish poison (ASP) of edible parts of molluscs (the entire body or any part edible separately) must be detected using the high-performance liquid chromatography (HPLC) method or any other internationally recognised method.
However, for screening purposes, the 2006.02 ASP ELISA method as published in the AOAC Journal of June 2006 may also be used to detect the total content of ASP of edible parts of molluscs.
If the results are challenged, the reference method shall be the HPLC method.]
Textual Amendments
F7 Substituted by Commission Regulation (EC) No 1244/2007 of 24 October 2007 amending Regulation (EC) No 2074/2005 as regards implementing measures for certain products of animal origin intended for human consumption and laying down specific rules on official controls for the inspection of meat (Text with EEA relevance).
:
OA, DTX1, DTX2, DTX3 including their esters,
:
PTX1 and PTX2,
:
YTX, 45 OH YTX, homo YTX, and 45 OH homo YTX,
:
AZA1, AZA2 and AZA3.
either alone or combined they can detect at least the analogues as identified in point A(1) of this Chapter; more appropriate criteria shall be defined when necessary;
they fulfil the method performance criteria stipulated by the EU-RL. Such methods should be intra-laboratory validated and successfully tested under a recognised proficiency test scheme. The EU-RL shall support activities toward inter-laboratory validation of the technique to allow for formal standardisation;
their implementation provides an equivalent level of public health protection.
Textual Amendments
The calcium content of MSM as referred to in Regulation (EC) No 853/2004 shall:
not exceed 0,1 % (=100 mg/100 g or 1 000 ppm) of fresh product;
be determined by a standardised international method.
Textual Amendments
In order to assist Member States in making up-to-date lists of approved food establishments available to other Member States and to the public, the Commission shall provide a website to which each Member State shall provide a link to its national website or inform in case those lists are published through the TRACES system.
other web pages located on the same website;
where certain lists of approved food establishments are not maintained by the competent authority referred to in point 1, websites managed by other competent authorities, units or where appropriate, bodies.
By way of derogation from Parts A and B, Member States may provide the lists through the TRACES system.
Layouts, including relevant information and codes, shall be established to ensure wide availability of the information concerning approved food establishments and to improve the readability of the lists.
The tasks and activities referred to in Chapters II and III shall be performed in accordance with the technical specifications published by the Commission.]
Textual Amendments
[ F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F11 Deleted by Commission Implementing Regulation (EU) 2016/759 of 28 April 2016 drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC (Text with EEA relevance).
F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]
The health certificate as referred to in Article 6(1)(d) of Regulation (EC) No 853/2004 for imports of fishery products shall comply with the model laid down in Appendix IV to this Annex.
The health certificate as referred to in Article 6(1)(d) of Regulation (EC) No 853/2004 for imports of live bivalve molluscs shall comply with the model laid down in Appendix V to this Annex.
[ F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]
The document to be signed by the captain, that may replace that required under Article 14 of Regulation (EC) No 854/2004 when frozen fishery products are imported directly from a freezer vessel, as provided for in Article 15(3) of that Regulation, shall comply with the model document laid down in Appendix VII to this Annex.]
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Textual Amendments
F12 Substituted by Commission Implementing Regulation (EU) No 1012/2012 of 5 November 2012 amending Regulation (EC) No 2074/2005 and Regulation (EC) No 1251/2008 as regards the list of vector species, the health requirements and the certification requirements concerning epizootic ulcerative syndrome and as regards the entry for Thailand in the list of third countries from which imports of certain fish and fishery products into the Union are permitted (Text with EEA relevance).
Textual Amendments
F13 Substituted by Commission Regulation (EC) No 1250/2008 of 12 December 2008 amending Regulation (EC) No 2074/2005 as regards certification requirements for import of fishery products, live bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption (Text with EEA relevance).
The official inspector hereby certifies that the processed bivalve molluscs of the species Acanthocardia tuberculatum , certified in the health certificate reference No: …
were harvested in production areas clearly identified, monitored and authorised by the competent authority for the purpose of Commission Decision 2006/766/EC (9) , and where the PSP level in the edible parts of these molluscs is lower than 300 μg for 100g ;
were transported in containers or vehicles sealed by the competent authority, directly to the establishment:
…
…
(name and official approval number of the establishment, especially authorised by the competent authority to carry out their treatment);
were accompanied during the transport to this establishment by a document issued by the competent authority which authorises the transport, attesting to the nature and quantity of the product, area of origin and establishment of destination;
were subjected to the heat treatment to the Annex to Decision 96/77/EC;
do not contain a PSP level detectable by the bioassay method, as demonstrated by the attached analytical report(s) of the test undertaken on each lot included in the consignment covered by this attestation.
The official inspector hereby certifies that the competent authority has verified that the ‘ own health ’ checks implemented in the establishment referred to in point 2 are specifically applied to the heat treatment referred to in point 4.
The undersigned official inspector hereby declares that he/she is aware of the provisions of Decision 96/77/EC and that the attached analytical report(s) correspond(s) to the test carried out in the products after processing.
Official inspector | |
Name (in capitals): Date: Stamp: | Qualification and title: Signature: |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
EN/ISO 4833 for the plate count at 30 o C;
ISO 13366-1 for the somatic cell count.
For the plate count at 30 o C, when the methods are validated against the reference method mentioned in point 1(a) in accordance with the protocol set out in EN/ISO standard 16140 or other similar internationally accepted protocols.
In particular the conversion relationship between an alternative method and the reference method mentioned in point 1(a) is established according to ISO standard 21187.
For the somatic cell count, when the methods are validated against the reference method mentioned in point 1(b) in accordance with the protocol set out in ISO 8196 and when operated in accordance with ISO standard 13366-2 or other similar internationally accepted protocols.
‘ controlled housing conditions and integrated production systems ’ means a type of animal husbandry where animals are kept under conditions in compliance with criteria set out in the Appendix;
‘ young bovine animal ’ means a bovine animal of either gender, which is not older than eight months;
‘ young ovine animal ’ means an ovine animal of either gender, not having any permanent incisor erupted and not older than 12 months;
‘ young caprine animal ’ means a caprine animal of either gender, not older than six months of age;
‘ herd ’ means an animal or group of animals kept on a holding as an epidemiological unit; if more than one herd is kept on a holding, each of these herds shall form a distinct epidemiological unit;
‘ holding ’ means any establishment, construction or, in the case of an openair farm, any place situated within the territory of the same Member State, in which animals are held, kept or handled;
‘ establishment carrying out discontinuous slaughter or game handling activities ’ means a slaughterhouse or game handling establishment designated by the competent authority on the basis of a risk analysis, in which, in particular, the slaughter or game handling activities do not take place either during the entire working day or during subsequent working days of the week.
the establishment concerned is an establishment carrying out discontinuous slaughter or game handling activities and has sufficient facilities to store meat with abnormalities until a final post-mortem inspection by the official veterinarian can take place;
an official auxiliary carries out the post-mortem inspection;
the official veterinarian is present in the establishment at least once a day when slaughter activities take place or have taken place;
the competent authority has put in place a procedure to assess on a regular basis the performance of official auxiliaries in these establishments, including:
monitoring individual performance,
verification of documentation with regard to inspection findings and comparison with the corresponding carcasses,
checks of carcasses in the storage room.
the number of animals slaughtered or handled per hour or per day;
the species and class of animals slaughtered or handled;
the throughput of the establishment;
the historical performance of slaughter or handling activities;
the effectiveness of any additional measures in the food chain for procurement of animals for slaughter taken to guarantee food safety;
the effectiveness of the HACCP-based system in place;
audit records;
the competent authority’s historical records of ante-mortem and post-mortem inspections.
Textual Amendments
the food business operator ensures that young bovine animals are kept under controlled housing conditions and in an integrated production system as laid down in the Appendix to this Annex;
the food business operator ensures that young bovine animals are reared in an officially bovine tuberculosis-free herd;
the food business operator does not benefit from the transitional arrangements with regard to food chain information as laid down in Article 8 of Regulation (EC) No 2076/2005;
the competent authority implements or orders the implementation of regular serological and/or microbiological monitoring of a selected number of animals based on a risk analysis of food safety hazards which are present in live animals and relevant at the holding level;
post-mortem inspection of young bovine animals includes at all times palpation of the retropharyngeal, bronchial and mediastinal lymph nodes.
regulated assembly centres may be used for young bovine, ovine or caprine animals between the holding of origin and the rearing or fattening holding, as well as between these holdings and the slaughterhouse;
traceability shall be ensured at the level of the individual animal or batch of animals.
For the purposes of this Annex, ‘ controlled housing conditions and integrated production systems ’ means that the food business operator needs to comply with the criteria set out below:
all feed has been obtained from a facility which produces feed in accordance with the requirements provided for in Articles 4 and 5 of Regulation (EC) No 183/2005 of the European Parliament and of the Council (10) ; when roughage or crops are provided to the animals as feed, it shall be treated appropriately, and where possible, dried and/or pelleted;
an all-in/all-out system is applied as far as possible. Where animals are introduced into the herd, they shall be kept in isolation as long as required by the veterinary services to prevent introduction of diseases;
none of the animals has access to outdoor facilities unless the food business operator can show by a risk analysis to the satisfaction of the competent authority that the time period, facilities and circumstances of outdoor access do not pose a danger for introduction of disease in the herd;
detailed information is available concerning the animals from birth to slaughter and their management conditions as laid down in Section III of Annex II to Regulation (EC) No 853/2004;
if bedding is provided for the animals, the presence or introduction of disease is avoided by appropriate treatment of the bedding material;
holding staff comply with the general hygiene provisions as laid down in Annex I to Regulation (EC) No 852/2004;
procedures are in place that control access to the premises where animals are kept;
the holding does not provide facilities for tourists or for camping unless the food business operator can show by a risk analysis to the satisfaction of the competent authority that the facilities are sufficiently separated from the animal rearing units that direct and indirect contact between humans and animals is not possible;
animals do not have access to garbage dumps or household garbage;
a pest management and control plan is in place;
silage feeding is not used unless the food business operator can show by a risk analysis to the satisfaction of the competent authority that the feed can not transmit any hazards to the animals;
effluent and sediment from sewage treatment plants are not released in areas accessible to the animals or be used for fertilising pastures used to grow crops, which are used to feed animals, unless treated appropriately and to the satisfaction of the competent authority.]
Annexes II and III to Regulation (EC) No 853/2004 are amended as follows:
Annex II, Section I(B) is amended as follows:
in point 6, the second subparagraph is replaced by the following:
‘BE, CZ, DK, DE, EE, GR, ES, FR, IE, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, SI, SK, FI, SE and UK’;
point 8 is replaced by the following:
When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK, EY, ES, EÜ, EK, EB or WE’;
Annex III is amended as follows:
in Section I, Chapter IV, point 8 is replaced by the following:
Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves and the feet of bovine, ovine and caprine animals. Heads and feet must be handled in such a way as to avoid contamination;’
in Section II, the following Chapter VII is added:
Food business operators shall ensure that poultrymeat that has been treated specifically to promote water retention is not placed on the market as fresh meat but as meat preparations or used for the production of processed products.’
in Section VIII, Chapter V(E), point 1 is replaced by the following:
Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae. Fresh, prepared 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 must accompany the common name on the label’;
Section IX is amended as follows:
in Chapter I(II)(B)(1), point (e) is replaced by the following:
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(11).’;
in Chapter II(II), point 1 is replaced by the following:
When raw milk or dairy 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:
Pasteurisation is achieved by a treatment involving:
a high temperature for a short time (at least 72 oC for 15 seconds);
a low temperature for a long time (at least 63 oC for 30 minutes); or
any other combination of time-temperature conditions to obtain an equivalent effect,
such that the products show, where applicable, a negative reaction to an alkaline phosphatase test immediately after such treatment.
Ultra high temperature (UHT) treatment is achieved by a treatment:
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 micro-organisms or spores capable of growing in the treated product when kept in an aseptic closed container at ambient temperature; and
sufficient to ensure that the products remain microbiologically stable after incubating for 15 days at 30 oC in closed containers or for 7 days at 55 oC in closed containers or after any other method demonstrating that the appropriate heat treatment has been applied.’;
in Section X, Chapter II is amended as follows:
in Part III, point 5 is replaced by the following:
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.’;
in Part V, point 2 is replaced by the following:
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.’;
Annexes I, II and III to Regulation (EC) No 854/2004 are amended as follows:
Annex I, Section I, Chapter III(3) is amended as follows:
in point (a), the second subparagraph is replaced by the following:
‘BE, CZ, DK, DE, EE, GR, ES, FR, IE, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, SI, SK, FI, SE and UK;’
point (c) is replaced by the following:
when applied in a slaughterhouse within the Community, the mark must include the abbreviation CE, EC, EF, EG, EK, EY, ES, EÜ, EK, EB or WE’;
in Annex II, Chapter II(A), points 4 and 5 are replaced by the following:
The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected and only placed on the market for human consumption after treatment in a purification centre or after relaying so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed 4 600E. coli per 100 g of flesh and intravalvular liquid. The reference method for this analysis is the five-tube, three dilution Most Probable Number (MPN) test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140.
The competent authority may classify as being of Class C areas from which live bivalve molluscs may be collected and only placed on the market after relaying over a long period so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed 46 000E. coli per 100 g of flesh and intravalvular liquid. The reference method for this analysis is the five-tube, three dilutions MPN test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140.’;
in Annex III, Chapter II(G), point 1 is replaced by the following:
Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae. Fresh, prepared 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 must accompany the common name on the label.’
OJ L 139, 30.4.2004, p. 1. Corrected by OJ L 226, 25.6.2004, p. 3.
OJ L 139, 30.4.2004, p. 55. Corrected by OJ L 226, 25.6.2004, p. 22.
OJ L 139, 30.4.2004, p. 206. Corrected by OJ L 226, 25.6.2004, p. 83.
OJ L 165, 30.4.2004, p. 1. Corrected by OJ L 191, 28.5.2004, p. 1.
Not yet published in the Official Journal.
OJ L 157, 30.4.2004, p. 33. Corrected by OJ L 195, 2.6.2004, p. 12.
See page 1 of this Official Journal.
[F10See page 53 of this Official Journal.]
Textual Amendments
F3 Inserted by Commission Regulation (EC) No 1244/2007 of 24 October 2007 amending Regulation (EC) No 2074/2005 as regards implementing measures for certain products of animal origin intended for human consumption and laying down specific rules on official controls for the inspection of meat (Text with EEA relevance).