Commission Regulation (EC) No 2074/2005Show full title

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

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:

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

1. Unprocessed fishery products belonging to the species categories listed in Chapter II 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.

The reference method to be used for checking the TVB-N limit involves distilling an extract deproteinised by perchloric acid as set out in Chapter III.

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 S_r = 1,2 mg/100 g. Standard deviation of comparability S_R = 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.

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. The biological testing method may be carried out in association, if necessary, with another method for detecting Saxitoxin and any of its analogues for which standards are available.

2. If the results are challenged, the reference method shall be the biological method.

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 recognised method.

If the results are challenged, the reference method shall be the HPLC method.

CHAPTER III LIPOPHILIC TOXIN DETECTION METHODS

A. Biological methods

1. 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 used 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. 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.

2. A single mouse bioassay involving acetone extraction may be used to detect okadaic acid, dinophysistoxins, 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. Azaspiracid detection at regulatory levels by means of this procedure shall involve the use of the whole body as the test portion.

3. 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.

4. 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.

5. 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.

B. Alternative detection methods

1. A series of methods, such as high-performance liquid chromatography (HPLC) with fluorimetric detection, liquid chromatography (LC), mass spectrometry (MS), immunoassays and functional assays, such as the phosphatase inhibition assay, shall be used as alternatives or supplementary to the biological testing methods, provided that either alone or combined they can detect at least the following analogues, that they are not less effective than the biological methods and that their implementation provides an equivalent level of public health protection:

• okadaic acid and dinophysistoxins: a hydrolysis step may be required to detect the presence of DTX3,

• pectenotoxins: PTX1 and PTX2,

• yessotoxins: YTX, 45 OH YTX, homo YTX, and 45 OH homo YTX,

• azaspiracids: AZA1, AZA2 and AZA3.

2. If new analogues of public health significance are discovered, they should be included in the analysis. Standards must be available before chemical analysis is possible. Total toxicity shall be calculated using conversion factors based on the toxicity data available for each toxin.

3. The performance characteristics of these methods shall be defined after validation following an internationally agreed protocol.

4. Biological methods shall be replaced by alternative detection methods as soon as reference materials for detecting the toxins prescribed in Chapter V of Section VI of Annex III to Regulation (EC) No 853/2004 are readily available, the methods have been validated and this Chapter has been amended accordingly.

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.

ANNEX V LISTS OF APPROVED FOOD ESTABLISHMENTS

CHAPTER I ACCESS TO LISTS OF APPROVED FOOD 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.

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 Community.

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.

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.

ANNEX VI MODEL HEALTH CERTIFICATES FOR IMPORTS FOR FROGS' LEGS, SNAILS, GELATINE AND COLLAGEN

SECTION I FROGS' LEGS AND SNAILS

Health certificates as referred to in Article 6(1)(d) of Regulation (EC) No 853/2004 for imports of frogs' legs and snails shall comply with the models laid down respectively in Part A and Part B of Appendix I to this Annex.

SECTION II GELATINE

Without prejudice to other specific Community legislation, at least including but not limited to legislation on transmissible spongiform encephalopathies and hormones, health certificates as referred to in Article 6(1)(d) of Regulation (EC) No 853/2004 for imports of gelatine and raw materials for the production of gelatine shall comply with the models laid down respectively in Part A and Part B of Appendix II to this Annex.

SECTION III COLLAGEN

Without prejudice to other specific Community legislation, at least including but not limited to legislation on transmissible spongiform encephalopathies and hormones, health certificates as referred to in Article 6(1)(d) of Regulation (EC) No 853/2004 for imports of collagen and raw materials for the production of collagen shall comply with the models laid down respectively in Part A and Part B of Appendix III to this Annex.

Appendix I to Annex VI

PART A MODEL HEALTH CERTIFICATE FOR IMPORTS OF CHILLED, FROZEN OR PREPARED FROGS' LEGS INTENDED FOR HUMAN CONSUMPTION

PART B MODEL HEALTH CERTIFICATE FOR IMPORTS OF SHELLED, COOKED, PREPARED OR PRESERVED SNAILS INTENDED FOR HUMAN CONSUMPTION

Appendix II to Annex VI

PART A MODEL HEALTH CERTIFICATE FOR IMPORTS OF GELATINE INTENDED FOR HUMAN CONSUMPTION

PART B MODEL HEALTH CERTIFICATE FOR IMPORTS OF RAW MATERIALS FOR THE PRODUCTION OF GELATINE INTENDED FOR HUMAN CONSUMPTION

Appendix III to Annex VI

PART A MODEL HEALTH CERTIFICATE FOR IMPORTS OF COLLAGEN INTENDED FOR HUMAN CONSUMPTION

PART B MODEL HEALTH CERTIFICATE FOR IMPORTS OF RAW MATERIALS FOR THE PRODUCTION OF COLLAGEN INTENDED FOR HUMAN CONSUMPTION

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(2).’;

(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 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.

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 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.’;

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.’

(1)

OJ L 358, 18.12.1986, p. 1.

(2)

OJ L 123, 24.4.1998, p. 1.’;