02005R2074 — EN — 01.01.2019 — 012.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B COMMISSION REGULATION (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (Text with EEA relevance) (OJ L 338 22.12.2005, p. 27)

Amended by:





Corrected by:









▼B

COMMISSION REGULATION (EC) No 2074/2005

of 5 December 2005

laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

(Text with EEA relevance)







Article 1

Requirements concerning food chain information for the purpose of Regulations (EC) Nos 853/2004 and 854/2004

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.

Article 2

Requirements concerning fishery products for the purpose of Regulations (EC) Nos 853/2004 and 854/2004

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.

Article 3

Recognised testing methods for marine biotoxins for the purpose of Regulations (EC) Nos 853/2004 and 854/2004

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.

Article 4

Calcium content of mechanically separated meat for the purpose of Regulation (EC) No 853/2004

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.

Article 5

Lists of establishments for the purpose of Regulation (EC) No 882/2004

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.

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Article 6

Model health certificates and documents for imports of certain products of animal origin for the purpose of Regulations (EC) Nos 853/2004 and 854/2004

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.

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Article 6a

Testing methods for raw milk and heat-treated milk

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.

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Article 6b

Requirements concerning official controls for the inspection of meat for the purpose of Regulation (EC) No 854/2004

Requirements concerning official controls for the inspection of meat are laid down in Annex VIb.

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Article 6c

Requirements concerning the official controls on fishery products caught by vessels flying the flag of Member States entering the Union after being transferred in third countries with or without storage

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.

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Article 7

Derogation from Regulation (EC) No 852/2004 for foods with traditional characteristics

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.

Article 8

Amendments to Regulation (EC) No 853/2004

Annexes II and III to Regulation (EC) No 853/2004 are amended in accordance with Annex VII to this Regulation.

Article 9

Amendments to Regulation (EC) No 854/2004

Annexes I, II and III to Regulation (EC) No 854/2004 are amended in accordance with Annex VIII to this Regulation.

Article 10

Entry into force and applicability

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.









ANNEX I

FOOD CHAIN INFORMATION

SECTION I

OBLIGATIONS ON FOOD BUSINESS OPERATORS

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.

SECTION II

OBLIGATIONS ON COMPETENT AUTHORITIES

CHAPTER I

PROVISION OF FOOD CHAIN INFORMATION

1. The competent authority at the place of dispatch shall inform the dispatching food business operator of the minimum elements of food chain information to be supplied to the slaughterhouse in accordance with Section III of Annex II to Regulation (EC) No 853/2004.

2. The competent authority at the place of slaughter shall verify that: (a) 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; (b) the food chain information is valid and reliable; (c) feedback of relevant information to the holding, if applicable, is provided.

3. Where animals are dispatched for slaughter to another Member State, the competent authorities at the place of dispatch and the place of slaughter shall cooperate to ensure that the information provided by the dispatching food business operator is easily accessible to the slaughterhouse operator receiving it.

CHAPTER II

FEEDBACK TO HOLDING OF PROVENANCE

1. The official veterinarian may use the model document laid down in Appendix I for the relevant inspection results that must be communicated to the holding where the animals were raised before slaughter in the same Member State in accordance with Chapter I of Section II of Annex I to Regulation (EC) No 854/2004.

2. The competent authority is responsible for communicating the relevant inspection results in cases where the animals are raised on a holding in another Member State and must use a version of the model document laid down in the Appendix in both the language of the dispatching country and the language of the recipient country.









Appendix to Annex I

MODEL DOCUMENT







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 results () 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 used () 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 results () 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: (1) Microbiological, chemical, serological, etc. (include results as attached). (2) 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. (3) Microbiological, chemical, serological, etc. (include results as attached).









ANNEX II

FISHERY PRODUCTS

SECTION I

OBLIGATIONS ON FOOD BUSINESS OPERATORS

This Section lays down detailed rules relating to visual inspections to detect parasites in fishery products.

CHAPTER I

DEFINITIONS

1. ‘Visible parasite’ means a parasite or a group of parasites which has a dimension, colour or texture which is clearly distinguishable from fish tissues.

2. ‘Visual inspection’ means non-destructive examination of fish or fishery products with or without optical means of magnifying and under good light conditions for human vision, including, if necessary, candling.

3. ‘Candling’ means, in respect of flat fish or fish fillets, holding up fish to a light in a darkened room to detect parasites.

CHAPTER II

VISUAL INSPECTION

1. Visual inspection shall be performed on a representative number of samples. The persons in charge of establishments on land and qualified persons on board factory vessels shall determine the scale and frequency of the inspections by reference to the type of fishery products, their geographical origin and their use. During production, visual inspection of eviscerated fish must be carried out by qualified persons on the abdominal cavity and livers and roes intended for human consumption. Depending on the system of gutting used, the visual inspection must be carried out:

(a) in the case of manual evisceration, in a continuous manner by the handler at the time of evisceration and washing;

(b) in the case of mechanical evisceration, by sampling carried out on a representative number of samples being not less than 10 fish per batch.

2. The visual inspection of fish fillets or fish slices must be carried out by qualified persons during trimming and after filleting or slicing. Where an individual examination is not possible because of the size of the fillets or the filleting operations, a sampling plan must be drawn up and kept available for the competent authority in accordance with Chapter II(4) of Section VIII of Annex III to Regulation (EC) No 853/2004. Where candling of fillets is necessary from a technical viewpoint, it must be included in the sampling plan.

SECTION II

OBLIGATIONS ON THE COMPETENT AUTHORITIES

CHAPTER I

TOTAL VOLATILE BASIC NITROGEN (TVB-N) LIMIT VALUES FOR CERTAIN CATEGORIES OF FISHERY PRODUCTS AND ANALYSIS METHODS TO BE USED

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1. Unprocessed fishery products shall be regarded as unfit for human consumption where organoleptic assessment has raised doubts as to their freshness and chemical checks reveal that the following TVB-N limits are exceeded:

(a) 25 mg of nitrogen/100 g of flesh for the species referred to in point 1 of Chapter II;

(b) 30 mg of nitrogen/100 g of flesh for the species referred to in point 2 of Chapter II;

(c) 35 mg of nitrogen/100 g of flesh for the species referred to in point 3 of Chapter II;

(d) 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.

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2. Distillation as referred to in point 1 must be performed using apparatus which complies with the diagram in Chapter IV.

3. The routine methods which may be used to check the TVB-N limit are as follows:

— 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).

4. The sample must consist of about 100 g of flesh, taken from at least three different points and mixed together by grinding.

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.

CHAPTER II

SPECIES CATEGORIES FOR WHICH TVB-N LIMIT VALUES ARE FIXED

1. Sebastes spp., Helicolenus dactylopterus, Sebastichthys capensis.

2. Species belonging to the Pleuronectidae family (with the exception of halibut: Hippoglossus spp.).

3. Salmo salar, species belonging to the Merlucciidae family, species belonging to the Gadidae family.

CHAPTER III

DETERMINATION OF THE CONCENTRATION OF TVB-N IN FISH AND FISHERY PRODUCTS

Reference procedure

1. Purpose and area of application

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.

2. Definition

‘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.

3. Brief description

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.

4. Chemicals

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:

(a) perchloric acid solution = 6 g/100 ml;

(b) sodium hydroxide solution = 20 g/100 ml;

(c) hydrochloric acid standard solution 0,05 mol/l ((0,05 N),

Note: When using an automatic distillation apparatus, titration should take place with a hydrochloric acid standard solution of 0,01 mol/l ((0,01 N);

(d) boric acid solution = 3 g/100 ml;

(e) silicone anti-foaming agent;

(f) phenolphtalein solution = 1 g/100 ml 95 % ethanol;

(g) indicator solution (Tashiro Mixed Indicator) 2 g methyl-red and 1 g methylene-blue are dissolved in 1 000 ml 95 % ethanol.

5. Instruments and accessories

(a) A meat grinder to produce a sufficiently homogenous fish mince.

(b) High-speed blender with a speed of between 8 000 and 45 000 revolutions/min.

(c) Fluted filter, diameter 150 mm, quick-filtering.

(d) Burette, 5 ml, graduated to 0,01 ml.

(e) 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.

6. Execution

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:

(a) 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;

(b) 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 .

(c) Titration

Duplicate analyses are required. The applied method is correct if the difference between the duplicates is not greater than 2 mg/100 g.

(d) 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.

7. Calculation of TVB-N

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

1. Duplicate analyses are required. The applied method is correct if the difference between duplicates is not greater than 2 mg/100 g.

2. Check the equipment by distilling solutions of NH4Cl equivalent to 50 mg TVB-N/100 g.

3. Standard deviation of reproducibility Sr = 1,20 mg/100 g. Standard deviation of comparability SR = 2,50mg/100 g.

CHAPTER IV

TVB-N STEAM DISTILLATION APPARATUS









ANNEX III

RECOGNISED TESTING METHODS FOR DETECTING MARINE BIOTOXINS

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 ( 1 ), elements of replacement, refinement and reduction must be taken into account when biological methods are used.

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CHAPTER I

PARALYTIC SHELLFISH POISON (PSP) DETECTION METHOD

1. The paralytic shellfish poison (PSP) content of edible parts of molluscs (the whole body or any part edible separately) must be detected in accordance with the biological testing method or any other internationally recognised method.

2. If the results are challenged, the reference method shall be the so-called Lawrence method as published in AOAC Official Method 2005.06 (Paralytic Shellfish Poisoning Toxins in Shellfish).

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CHAPTER II

AMNESIC SHELLFISH POISON (ASP) DETECTION METHOD

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.

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CHAPTER III

LIPOPHILIC TOXIN DETECTION METHODS

A. Chemical methodology

(1) The EU-RL LC-MS/MS method shall be the reference method for the detection of marine toxins as referred to in Chapter V(2)(c), (d) and (e) of Section VII of Annex III, to Regulation (EC) No 853/2004. This method shall determine at least the following compounds:

— okadaic acid group toxins : OA, DTX1, DTX2, DTX3 including their esters,

— pectenotoxins group toxins : PTX1 and PTX2,

— yessotoxins group toxins : YTX, 45 OH YTX, homo YTX, and 45 OH homo YTX,

— azaspiracids group toxins : AZA1, AZA2 and AZA3.

(2) Total toxicity equivalence shall be calculated using toxicity equivalent factors (TEFs) as recommended by EFSA.

(3) If new analogues of public health significance are discovered, they should be included in the analysis. Total toxicity equivalence shall be calculated using toxicity equivalent factors (TEFs) as recommended by EFSA.

(4) Other methods, such as liquid chromatography (LC) mass spectrometry (MS) method, high-performance liquid chromatography (HPLC) with appropriate detection, immunoassays and functional assays, such as the phosphatase inhibition assay, can be used as alternatives or supplementary to the EU-RL LC-MS/MS method, provided that:

(a) 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;

(b) 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;

(c) their implementation provides an equivalent level of public health protection.

B. Biological methods

(1) To allow Member States to adapt their methods to the LC-MS/MS method as defined in point A(1) of this Chapter, a series of mouse bioassay procedures, differing in the test portion (hepatopancreas or whole body) and in the solvents used for extraction and purification, may be still used until 31 December 2014 for detecting marine toxins as referred to in Chapter V(2)(c), (d) and (e) of Section VII of Annex III to Regulation (EC) No 853/2004.

(2) Sensitivity and selectivity depend on the choice of solvents used for extraction and purification and this should be taken into account when a decision is made on the method to be used in order to cover the full range of toxins.

(3) A single mouse bioassay involving acetone extraction may be used to detect okadaic acid, dinophysistoxins, azaspiracids, pectenotoxins and yessotoxins. This assay may be supplemented, if necessary, with liquid/liquid partition steps with ethyl acetate/water or dichloromethane/water to remove potential interferences.

(4) Three mice shall be used for each test. Where two out of three mice die within 24 hours of inoculation with an extract equivalent to 5 g hepatopancreas or 25 g whole body, this shall be considered a positive result for the presence of one or more toxins as referred to in Chapter V(2)(c), (d) and (e) of Section VII of Annex III to Regulation (EC) No 853/2004 at levels above those laid down.

(5) A mouse bioassay with acetone extraction followed by liquid/liquid partition with diethylether may be used to detect okadaic acid, dinophysistoxins, pectenotoxins and azaspiracids but it cannot be used to detect yessotoxins as losses of these toxins may take place during the partition step. Three mice shall be used for each test. Where two out of three mice die within 24 hours of inoculation with an extract equivalent to 5 g hepatopancreas or 25 g whole body, this shall be considered a positive result for the presence of okadaic acid, dinophysistoxins, pectenotoxins and azaspiracids at levels above those laid down in Chapter V(2)(c) and (e) of Section VII of Annex III to Regulation (EC) No 853/2004.

(6) A rat bioassay may be used to detect okadaic acid, dinophysistoxins and azaspiracids. Three rats shall be used for each test. A diarrhetic response in any of the three rats shall be considered a positive result for the presence of okadaic acid, dinophysistoxins and azaspiracids at levels above those laid down in Chapter V(2)(c) and (e) of Section VII of Annex III to Regulation (EC) No 853/2004.

C. After the period established in point B(1) of this Chapter, the mouse bioassay shall be used only during the periodic monitoring of production areas and relaying areas for detecting new or unknown marine toxins on the basis of the national control programmes elaborated by the Member States.

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ANNEX IV

CALCIUM CONTENT OF MECHANICALLY SEPARATED MEAT

The calcium content of MSM as referred to in Regulation (EC) No 853/2004 shall:

1. not exceed 0,1 % (=100 mg/100 g or 1 000 ppm) of fresh product;

2. be determined by a standardised international method.

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ANNEX V

Lists of approved establishments

CHAPTER I

ACCESS TO LISTS OF APPROVED ESTABLISHMENTS

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.

CHAPTER II

FORMAT FOR NATIONAL WEBSITES

A. Masterlist

1. Each Member State shall provide the Commission with a linking address to a single national website containing the masterlist of lists of approved food establishments for products of animal origin as defined in point 8.1. of Annex I to Regulation (EC) No 853/2004.

2. The masterlist referred to in point 1 shall consist of one sheet and shall be completed in one or more official languages of the Union.

B. Operational chart

1. The website containing the masterlist shall be developed by the competent authority or, where appropriate, one of the competent authorities referred to in Article 4 of Regulation (EC) No 882/2004.

2. The masterlist shall include links to:

(a) other web pages located on the same website;

(b) 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.

C. Listing through the TRACES system

By way of derogation from Parts A and B, Member States may provide the lists through the TRACES system.

CHAPTER III

LAYOUT AND CODES FOR LISTS OF APPROVED ESTABLISHMENTS

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.

CHAPTER IV

TECHNICAL SPECIFICATIONS

The tasks and activities referred to in Chapters II and III shall be performed in accordance with the technical specifications published by the Commission.

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ANNEX VI

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MODEL HEALTH CERTIFICATES AND DOCUMENTS FOR IMPORTS OF CERTAIN PRODUCTS OF ANIMAL ORIGIN

SECTION I

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CHAPTER IV

FISHERY PRODUCTS

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.

CHAPTER V

LIVE BIVALVE MOLLUSCS

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.

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SECTION II

MODEL DOCUMENT TO BE SIGNED BY THE CAPTAIN

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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Appendix IV to Annex VI

Model health certificate for imports of fishery products intended for human consumption

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Appendix V to Annex VI

PART A

MODEL HEALTH CERTIFICATE FOR IMPORTS OF LIVE BIVALVE MOLLUSCS ECHINODERMS, TUNICATES AND MARINE GASTROPODS INTENDED FOR HUMAN CONSUMPTION

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PART B

ADDITIONAL MODEL HEALTH ATTESTATION FOR PROCESSED BIVALVE MOLLUSCS BELONGING TO THE SPECIES ACANTHOCARDIA TUBERCULATUM

The official inspector hereby certifies that the processed bivalve molluscs of the species Acanthocardia tuberculatum, certified in the health certificate reference No: …

1. were harvested in production areas clearly identified, monitored and authorised by the competent authority for the purpose of Commission Decision 2006/766/EC ( 2 ), and where the PSP level in the edible parts of these molluscs is lower than 300 μg for 100g ;

2. 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);

3. 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;

4. were subjected to the heat treatment to the Annex to Decision 96/77/EC;

5. 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:

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Appendix VII to Annex VI

MODEL DOCUMENT, TO BE SIGNED BY THE CAPTAIN, ACCOMPANYING IMPORTS WHEN FROZEN FISHERY PRODUCTS ARE IMPORTED DIRECTLY INTO THE EUROPEAN UNION FROM A FREEZER VESSEL

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Appendix VIII to Annex VI

Model of health certificate for fishery products intended for human consumption caught by vessels flying the flag of a Member State and transferred in third countries with or without storage

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ANNEX VIa

TESTING METHODS FOR RAW MILK AND HEAT-TREATED MILK

CHAPTER I

DETERMINATION OF PLATE COUNT AND SOMATIC CELL COUNT

1. When checking against the criteria laid down in Annex III, Section IX, Chapter I, Part III to Regulation (EC) No 853/2004, the following standards must be applied as reference methods:

(a) EN/ISO 4833 for the plate count at 30 oC;

(b) ISO 13366-1 for the somatic cell count.

2. The use of alternative analytical methods is acceptable:

(a) For the plate count at 30 oC, 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.

(b) 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.

CHAPTER II

DETERMINATION OF ALKALINE PHOSPHATASE ACTIVITY

1. When determining alkaline phosphatase activity, ISO standard 11816-1 must be applied as reference method.

2. The alkaline phosphatase activity is expressed as milliunits of enzyme activity per litre (mU/l). A unit of alkaline phosphatase activity is the amount of alkaline phosphatase enzyme that catalyses the transformation of 1 micromole of substrate per minute.

3. An alkaline phosphatase test is considered to give a negative result if the measured activity in cow's milk is not higher than 350 mU/l.

4. The use of alternative analytical methods is acceptable when the methods are validated against the reference method mentioned in point 1 in accordance with internationally accepted protocols.

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ANNEX VIb

REQUIREMENTS APPLICABLE TO THE OFFICIAL CONTROLS FOR THE INSPECTION OF MEAT

1. For the purpose of this Annex, the following definitions shall apply: (a) ‘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; (b) ‘young bovine animal’ means a bovine animal of either gender, which is not older than eight months; (c) ‘young ovine animal’ means an ovine animal of either gender, not having any permanent incisor erupted and not older than 12 months; (d) ‘young caprine animal’ means a caprine animal of either gender, not older than six months of age; (e) ‘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; (f) ‘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; (g) ‘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.

2. Post-mortem inspections in establishments carrying out discontinuous slaughter or game handling activities. (a) In accordance with point 2(b) of Chapter II of Section III of Annex I to Regulation (EC) No 854/2004, the competent authority may decide that the official veterinarian need not be present at all times during post-mortem inspection, provided that the following conditions are complied with: (i) 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; (ii) an official auxiliary carries out the post-mortem inspection; (iii) the official veterinarian is present in the establishment at least once a day when slaughter activities take place or have taken place; (iv) 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. (b) The risk analysis carried out by the competent authority as referred to in point 1(g) to identify the establishments that may benefit from the derogation as laid down in point 2(a) shall at least take account of the following elements: (i) the number of animals slaughtered or handled per hour or per day; (ii) the species and class of animals slaughtered or handled; (iii) the throughput of the establishment; (iv) the historical performance of slaughter or handling activities; (v) the effectiveness of any additional measures in the food chain for procurement of animals for slaughter taken to guarantee food safety; (vi) the effectiveness of the HACCP-based system in place; (vii) audit records; (viii) the competent authority’s historical records of ante-mortem and post-mortem inspections.

3. Requirements for a risk-based meat inspection without incisions. ▼M8 ————— ▼M2 (b) By way of derogation from the specific requirements of Chapters I and II of Section IV of Annex I to Regulation (EC) No 854/2004, the post-mortem inspection procedures of young bovine, ovine and caprine animals may be reduced to a visual inspection with limited palpation, provided that the following conditions are complied with: (i) 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; (ii) the food business operator ensures that young bovine animals are reared in an officially bovine tuberculosis-free herd; (iii) 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; (iv) 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; (v) post-mortem inspection of young bovine animals includes at all times palpation of the retropharyngeal, bronchial and mediastinal lymph nodes. (c) In the case of any abnormality detected, the carcass and offal shall be subjected to a full post-mortem inspection as provided for in Chapters I and II of Section IV of Annex I to Regulation (EC) No 854/2004. However, the competent authority may decide on the basis of a risk analysis that meat with certain minor abnormalities as defined by the competent authorities, which pose no risk to animal or human health, does not need to be subjected to a full post-mortem inspection. (d) Young bovine, ovine and caprine animals and weaned pigs that do not go directly from the holding of birth to a slaughterhouse may be moved on one occasion to another holding (for rearing or fattening) prior to dispatch to a slaughterhouse. In such cases: (i) 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; (ii) traceability shall be ensured at the level of the individual animal or batch of animals.

4. Additional requirement for the post-mortem examination of solipeds. (a) Fresh meat from solipeds reared in countries not free of glanders in accordance with Article 2.5.8.2 of the Terrestrial Animal Health Code of the World Organisation for Animal Health shall not be placed on the market, unless such meat is derived from solipeds examined for glanders in accordance with point D of Chapter IX of Section IV of Annex I to Regulation (EC) No 854/2004. (b) Fresh meat from solipeds in which glanders has been diagnosed shall be declared unfit for human consumption as provided for in point D of Chapter IX of Section IV of Annex I to Regulation (EC) No 854/2004.









Appendix to Annex VIb

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:

(a) 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 ( 3 ); when roughage or crops are provided to the animals as feed, it shall be treated appropriately, and where possible, dried and/or pelleted;

(b) 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;

(c) 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;

(d) 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;

(e) if bedding is provided for the animals, the presence or introduction of disease is avoided by appropriate treatment of the bedding material;

(f) holding staff comply with the general hygiene provisions as laid down in Annex I to Regulation (EC) No 852/2004;

(g) procedures are in place that control access to the premises where animals are kept;

(h) 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;

(i) animals do not have access to garbage dumps or household garbage;

(j) a pest management and control plan is in place;

(k) 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;

(l) 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.

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ANNEX VII

AMENDMENTS TO REGULATION (EC) No 853/2004

Annexes II and III to Regulation (EC) No 853/2004 are amended as follows:

1. Annex II, Section I(B) is amended as follows:

(a) 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’;

(b) point 8 is replaced by the following:

‘8. 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’;

2. Annex III is amended as follows:

(a) in Section I, Chapter IV, point 8 is replaced by the following:

‘8. 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;’

(b) in Section II, the following Chapter VII is added:

‘CHAPTER VII: WATER RETENTION AGENTS

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.’

(c) in Section VIII, Chapter V(E), point 1 is replaced by the following:

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

(d) Section IX is amended as follows:

(i) in Chapter I(II)(B)(1), point (e) is replaced by the following:

‘(e) that teat dips or sprays are used only after authorisation or registration in accordance with the procedures laid down in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( *1 ).

(ii) in Chapter II(II), point 1 is replaced by the following:

‘1. 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:

(a) Pasteurisation is achieved by a treatment involving:

(i) a high temperature for a short time (at least 72 oC for 15 seconds);

(ii) a low temperature for a long time (at least 63 oC for 30 minutes); or

(iii) 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.

(b) Ultra high temperature (UHT) treatment is achieved by a treatment:

(i) involving a continuous flow of heat at a high temperature for a short time (not less than 135 oC in combination with a suitable holding time) such that there are no viable micro-organisms or spores capable of growing in the treated product when kept in an aseptic closed container at ambient temperature; and

(ii) sufficient to ensure that the products remain microbiologically stable after incubating for 15 days at 30 oC in closed containers or for 7 days at 55 oC in closed containers or after any other method demonstrating that the appropriate heat treatment has been applied.’;

(e) in Section X, Chapter II is amended as follows:

(i) in Part III, point 5 is replaced by the following:

‘5. 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.’;

(ii) in Part V, point 2 is replaced by the following:

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

(f) in Section XIV, the following Chapter V is added:

‘CHAPTER V: LABELLING

Wrapping and packaging containing gelatine must bear the words “gelatine fit for human consumption” and must indicate the date of preparation.’









ANNEX VIII

AMENDMENTS TO REGULATION (EC) No 854/2004

Annexes I, II and III to Regulation (EC) No 854/2004 are amended as follows:

1. Annex I, Section I, Chapter III(3) is amended as follows:

(a) 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;’

(b) point (c) is replaced by the following:

‘(c) 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’;

2. in Annex II, Chapter II(A), points 4 and 5 are replaced by the following:

‘4. 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 4 600 E. 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.

5. 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 46 000 E. 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.’;

3. in Annex III, Chapter II(G), point 1 is replaced by the following:

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