1 
 EN 
 
ANNEX I  
Model document for communication with  the holding of provenance in accordance with 
Article  39(5) 
1.  Identification details  
1.1.  Holding of provenance (owner or manager)  
  Name/number  
  Full address  
  Telephone number  
Electronic address if available  
1.2.  Identification numbers of  ………………[please specify] or attach list  
  Total number of animals (by species)  
  Identification problems (if any)  
1.3.  Herd/flock/cage identification number (if applicable)  
1.4.  Animal species  
1.5.  Reference numbe r of health certificate (if applicable)  
2.  Ante -mortem findings  
2.1.  Welfare  
  Number of animals affected  
  Type/class/age  
  Observations  
2.2.  Animals were delivered dirty  
2.3.  Clinical findings of disease  
  Number of animals affected  
  Type/class/age  
  Observations  
  Date of inspection  
2.4.  Laboratory results1 
3.  Post-mortem findings  
3.1.  Macroscopic findings  
Number of animals affected  
  Type/class/age  
  Organ or site of animal(s) affected  
                                                 
1  Microbiological, chemical, serological, etc. (include results as attached).   
2 
   Date of slaughter  
3.2.  Disease (codes may be used2) 
Numbe r 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 results3 
3.4.  Other results  
3.5.  Welfare findings  
4.  Additional information  
5.  Contact details of slaughterhouse (approval number)  
Name  
Full address  
Telephone number  
Electronic address if available  
6.  Official veterinarian (print name)  
Signature and stamp  
7.  Date  
8.  Number of pages attached to this form:  
  
                                                 
2  The competent authorities may introduce the following codes: code A for OIE -listed diseases; codes 
B100 and B200 for welfare issues and C100 to C290 for decisions concerning meat. 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, th ey 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).   
3 
 ANNEX II  
Practical arrangements for the health mark in accordance with Article 48 
1. The health mark must be an oval mark at least 6.5 cm wide by 4.5 cm high bearing the 
following information in perfectly legible characters:  
(a) the name of the country in which the  establishment is located, which may be 
written out in full in capitals or shown as a two -letter code in accordance with 
the relevant ISO code. In the case of Member States, however, these codes are 
BE, BG, CZ, DK, DE, EE, IE, GR, ES, FR, HR, IT, CY, LV, L T, LU, HU, 
MT, NL, AT, PL, PT, RO, SI, SK, FI, SE and UK;  
(b) the approval number of the slaughterhouse; and  
(c) (when the mark is applied  in an establishment located in the Union) , the 
abbreviation CE, EC, EF, EG, EK, EO, EY, ES, EÜ, EB, EZ, KE or WE. 
Those abbreviations must not appear on marks applied on meat imported into 
the Union from slaughterhouses located outside the Union.  
2. Letters must be at least 0.8 cm high and figures at least 1 cm high. The dimensions of 
the characters  and the mark may be r educed for the health marking of lamb, kids and 
piglets.  
3. The ink used for health marking must be authorised in accordance with Union rules on 
the use of colouring substances in foodstuffs.  
4. The health mark may also include an indication of the officia l veterinarian who carried 
out the health inspection of the meat.  
  
4 
 ANNEX III 
Testing methods for raw milk and heat -treated cow’s milk in accordance with Article  50 
CHAPTER I  
DETERMINATION OF PLATE COUNT AND SOMATIC CELL COUNT  
A. When verifying compliance with the criteria laid down in Part III of Section IX, 
Chapter  I of Annex III to Regulation (EC) No  853/2004, the following standa rds must 
be applied as reference methods:  
1. EN ISO 4833 -1 for the plate count at 30  °C; 
2. EN ISO 13366 -1 for the somatic cell count.  
B. The use of alternative analytical methods is acceptable:  
1. for the plate count at 30  °C, where the methods are valida ted against the 
reference method mentioned in point 1 of Part A in accordance with the 
protocol set out in standard EN ISO 16140 -2, supplemented by standard EN 
ISO 16297 for the specific case of plate count in raw milk.  
In particular, the conversion relati onship between an alternative method and 
the reference method mentioned in point 1 of Part A is established according to 
standard EN ISO 21187.  
2. for the somatic cell count, where the methods are validated against the 
reference method mentioned in point 2  of Part A in accordance with the 
protocol set out in standard ISO  8196 -3 and operated in accordance with 
standard EN ISO  13366 -2 or other similar internationally accepted protocols.  
CHAPTER II  
DETERMINATION OF ALKALINE PHOSPHATASE ACTIVITY IN COW’S MILK  
A. To determine alkaline phosphatase activity in pasteurised cow’s milk, standard EN 
ISO 11816 -1 must be applied as the reference method.  
B. The alkaline phosphatase activity in pasteurised cow’s milk is expressed as milli  units 
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.  
C. 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.  
D. The use of alternative analytical methods is acceptable where they are validated against 
the reference methods mentioned in Part A in accordance with internationally accepted 
protocols and rules of good laboratory practices.   
5 
 ANNEX IV 
Reference testing method for analysis of E. coli in live bivalve molluscs for classification 
of production and relaying areas in accordance with Article 52 (2)  
The refere nce method for analysis of E. coli in live bivalve molluscs shall be the detection and 
‘most probable number’ (MPN) technique specified in ISO 16649 -3. Alternative methods 
may be used if they are validated against this reference method in accordance with t he criteria 
in ISO 16140.  
ANNEX V  
 
Recognised methods for the detection of marine biotoxins in accordance with Article 61  
CHAPTER I  
PARALYTIC SHELLFISH POISON DETECTION METHOD  
A. The paralytic shellfish poisoning (PSP) toxins content of the whole body or a ny part 
edible separately of bivalve molluscs shall be determined using AOAC official method 
OMA  2005.06, as published in AOAC International Journal  88(6), 1714 -1732 
(Lawrence method), the mouse bioassay or any other internationally recognised 
validated me thod.  
B. If the results are challenged, the reference method shall be AOAC official method 
OMA  2005.06 as referred in point A.  
CHAPTER II  
AMNESIC SHELLFISH POISON DETECTION METHOD  
A. The amnesic shellfish poisoning (ASP) toxins content of the entire body o r any part 
edible separately of bivalve molluscs shall be determined using the high -performance 
liquid chromatography with ultraviolet detection (HPLC/UV) method or any other 
internationally recognised validated method.  
B. However, for screening purposes, AOAC official method 2006.02, as published in 
AOAC International Journal 90, 1011 -1027 (ASP enzyme -linked immunosorbent assay 
(ELISA) method), or any other internationally recognised validated method may also be 
used.  
C. If the results are challenged, the reference method shall be the HPLC/UV method.  
CHAPTER  III 
LIPOPHILIC TOXIN DETECTION METHODS  
A. The reference method for the detection of marine toxins as referred to in points (c), (d) 
and (e) in Chapter V(2) of Section VII of Annex III to Regulation (EC)  No 853/2004 
shall be the EU reference laboratory liquid chromatography -mass spectrometry / mass 
spectrometry (EU -RL LC -MS/MS) method. This method shall determine at least the 
following compounds:   
6 
 (a) okadaic acid group toxins: OA, DTX1 and DTX2, including  their esters 
(DTX3);  
(b) pectenotoxins group toxins: PTX1 and PTX2 ; 
(c) yessotoxins group toxins: YTX, 45 OH YTX, homo YTX and 45 OH homo 
YTX;  
(d) azaspiracids group toxins: AZA  1, AZA  2 and AZA  3. 
If new analogues of the above toxins appear, for which a toxicity equivalent factor 
(TEF) has been established, they shall be included in the analysis.  
Total toxicity equivalence shall be calculated using TEFs as recommended by the 
European Food Safety Authority (EFSA) in Journal (2008) 589, 1 -62 or any updated 
EFSA advice.  
B. Methods other than those referred to in point A, such as the LC -MS method, HPLC with 
appropriate detection, immunoassays and functional assays, such as the phosphatase 
inhibition assay, may be used as alternatives to, or as well as, the EUR L LC -MS/MS 
method, provided that:  
(a) either alone or combined they can detect at least the analogues identified in 
point  A; more appropriate criteria shall be defined where necessary;  
(b) they meet the method performance criteria stipulated by the EURL LC -MS/MS 
method. Such methods should be intra -laboratory validated and successfully 
tested under a recognised proficiency test scheme. The EURL LC -MS/MS 
method shall support activities toward inter -laboratory validation of the 
technique to allow for formal s tandardisation;  
(c) their implementation provides an equivalent level of public health protection.  
CHAPTER IV  
DETECTION OF NEW OR EMERGING MARINE TOXINS  
Chemical methods, alternative methods with appropriate detection, or the mouse bioassay can 
be used dur ing the periodic monitoring of production areas and relaying areas for detecting 
new or emerging marine toxins on the basis of the national control programmes elaborated by 
the Member States.  
   
7 
 ANNEX VI  
Practical arrangements for official controls on fishery products  in accordance with 
Article  70 
CHAPTER  I 
GENERAL  
A. ORGANOLEPTIC EXAMINATIONS  
Random organoleptic controls shall be carried out at all stages of production, processing and 
distribution. One aim of the controls is to verify compliance with t he freshness criteria 
established in accordance with this Regulation. In particular, this includes verifying, at all 
stages of production, processing and distribution, that fishery products at least meet the 
baselines of freshness criteria established in a ccordance with this Regulation.  
B. FRESHNESS INDICATORS  
When the organoleptic examination gives rise to any doubt as to the freshness of the fishery 
products, samples may be taken and subjected to laboratory tests to determine the levels of 
total volatile basic nitrogen (TVB -N) and trimethylamine nitrogen (TMA -N) in accordance 
with the technical arrangements in Chapter II.  
The competent authority shall use the criteria laid down in this Regulation.  
When the organoleptic examination gives cause to suspect th e presence of other conditions 
that may affect human health, appropriate samples shall be taken for verification purposes.  
C. HISTAMINE  
Random testing for histamine shall be carried out to verify compliance with the permitted 
levels laid down in Regulation  (EC) No  2073/2005.  
D. RESIDUES AND CONTAMINANTS  
Monitoring arrangements shall be established in accordance with Directive  96/23/EC and 
Decision  97/747/EC to control compliance with the EU legislation on:  
 maximum residue limits for pharmacologically active  substances, in accordance with 
Regulations (EU) No  37/2010 and (EU) 2018/470;  
 prohibited and non -authorised substances, in accordance with Regulation (EU) 
No 37/2010, Directive  96/22/EC  and Decision 2005/34/EC;  
 contaminants, in accordance with Regulation (EC) No  1881/2006 setting maximum 
levels for certain contaminants in food; and  
 pesticide residues, in accordance with Regulation (EC) No  396/2005.  
E. MICROBIOLOGICAL CHECKS  
Where necessary, microbiological controls shall be performed in accordance with the relevant 
rules and criteria laid down in Regulation (EC) No  2073/2005.   
8 
 F. PARASITES  
Risk-based testing shall take place to verify compliance with Part D of Chapter III of 
Section  VIII of Annex III to Regulation (EC) No  853/2004 and Section I of Annex I I to 
Regulation (EC) No  2074/2005.  
G. POISONOUS FISHERY PRODUCTS  
Controls shall take place to ensure that:  
1. fishery products derived from poisonous fish of the following families are not placed 
on the market: Tetraodontidae , Molidae , Diodontidae  and Cant higasteridae ; 
2. fresh, prepared, frozen and processed fishery products belonging to the family 
Gempylidae , in particular Ruvettus pretiosus  and Lepidocybium flavobrunneum , may 
be placed on the market only in wrapped/packaged form and are appropriately 
labelled to inform the consumer about preparation/cooking methods and the risk 
related to the presence of substances with adverse gastrointestinal effects. The 
scientific names of the fishery products and the common names shall appear on the 
label;  
3. fishery  products containing biotoxins such as ciguatera or other toxins dangerous to 
human health are not placed on the market. However, fishery products derived from 
live bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed 
on the market if they have been produced in accordance with Section VII of 
Annex  III to Regulation (EC) No  853/2004 and comply with the standards laid down 
in point 2 of Chapter V of that Section.  
CHAPTER  II 
CONTROLS  ON TOTAL  VOLATILE  BASIC  NITROGEN  (TVB -N) 
A. TVB -N LIM IT VALUES FOR CERTAIN CATEGORIES OF FISHERY 
PRODUCTS AND ANALYSIS METHODS TO BE USED  
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 
Section  B of this Chapter; [  
(b) 30 mg of nitrogen/100  g of flesh for the species referred to in point  2 of Section 
B of thi s Chapter ; 
(c) 35 mg of nitrogen/100  g of flesh for the species referred to in point  3 of Section 
B of this Chapter ; 
(d) 60 mg of nitrogen/100  g of whole fishery product used directly for the 
preparation of fish oil for human consumption, as referred to in  the second 
paragraph of point 1 of Chapter IV.B 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 the first paragraph of that point, Member States may 
set limits at a high er level for certain species pending the establishment of 
specific Union legislation.   
9 
 The reference method to be used for checking the TVB -N limits involves distilling an 
extract deproteinised by perchloric acid as set out in Section C below.  
2. Distillati on as referred to in point 1 shall be performed using apparatus which complies 
with the diagram in Section D below.  
3. The routine methods that may be used to check the TVB -N limit are as follows:  
(a) microdiffusion method described by Conway and Byrne (19 33); 
(b) direct distillation method described by Antonacopoulos (1968);  
(c) distillation of an extract deproteinised by trichloracetic acid (Codex 
Alimentarius Committee on Fish and Fishery Products, 1968).  
4. The sample shall consist of about 100  g of fle sh, 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 
methods referred to above. Where the results are dubious or in the event of dispute reg arding 
the results of analysis performed by one of the routine methods, only the reference method 
may be used to check the results.  
B. SPECIES CATEGORIES FOR WHICH TVB -N LIMIT VALUES ARE FIXED  
TVB -N limit values are fixed for the following species categori es: 
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.  
C. REFERENCE PROCEDURE FOR DETERMINING THE CONCENTRATION 
OF TVB -N IN FISH AND FISHERY PRODUCTS  
1. Purpose and area of application  
This method describes a reference procedure for identifying the nitrogen con centration 
of TVB -N in fish and fishery products. The procedure is applicable at TVB -N 
concentrations of 5 mg/100 g to at least 100 mg/100 g.  
2. Definitions  
‘TVB -N concentration’ means the nitrogen content of volatile nitrogenous bases as 
determined by the  reference procedure described.  
‘Solution’ means an aqueous solution as follows:  
(a) perchloric acid solution = 6 g/100 ml;  
(b) sodium hydroxide solution = 20 g/100 ml;   
10 
 (c) 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);  
(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 dissolved in 1  000 ml 95  % ethanol.  
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. The concentration is expressed 
in mg/100  g. 
4. Chemicals  
Unless otherwise indicated, reagent -grade chemicals shall be used. The water used shall 
be either distilled or demineralised and of at least the same purity.  
5. The following instruments and accessories shall be used:  
(a) a meat grinder to produce a sufficiently homogenous fish mince;  
(b) high-speed blender with a speed of 8  000 to 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 dis tillation. 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 of the reference procedure  
When working with perchloric acid, which is strongly corrosive, necessary caution and 
preventive measures shall be taken. The samples shall be prepared as soon as possible 
after their arrival, in accordance with the follow ing instructions:  
(a) Preparing the sample  
The sample to be analysed is ground carefully using a meat grinder as 
described in point 5(a). An amount of 10 g ± 0.1 g of the ground sample is 
weighed out into a suitable container. This is mixed with 90.0 ml pe rchloric 
acid solution, 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  °C and 6  °C; 
 (b) Steam distillat ion  
11 
 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 solution are added. 
After adding  a few drops of silicone anti -foaming agent, 6.5 ml of sodium 
hydroxide solution 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 disti llation outflow tube is submerged in a 
receiver with 100 ml boric acid solution, to which three to five drops of the 
indicator solution have been added. After exactly 10 minutes, distillation is 
ended. The distillation outflow tube is removed from the rece iver and washed 
out with water. The volatile bases contained in the receiver solution are 
determined by titration with hydrochloric acid standard solution.  
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 is used.  
7. Calculation of TVB -N co ncentration  
By titration of the receiver solution with hydrochloric acid standard solution, the 
TVB -N concentration is calculated using the following equation:  
 
where:  
V1 = volume of 0.01 mol hydrochloric acid standard solution in ml for sample;  
V0 = volu me of 0.01 mol hydrochloric acid standard solution in ml for blank;  
m = weight of sample in g.  
In addition, the following is required:  
(a) duplicate analyses. The applied method is correct if the difference between 
duplicates is not greater than 2 mg/100 g ; 
(b) equipment check. The equipment is checked by distilling solutions of NH 4Cl 
equivalent to 50 mg TVB -N/100 g;  
(c) standard deviations. The standard deviation for repeatability 
Sr = 1.20 mg/100  g and the standard deviation for reproducibility 
SR = 2.50 mg/100  g are calculated.  
 
12 
 D. TVB -N STEAM DISTILLATION APPARATUS