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- Point in Time (31/12/2020)
- Original (As adopted by EU)
Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (Text with EEA relevance)
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Name/number
Full address
Telephone number
Electronic address if available
Total number of animals (by species)
Identification problems (if any)
Number of animals affected
Type/class/age
Observations
Number of animals affected
Type/class/age
Observations
Date of inspection
Number of animals affected
Type/class/age
Organ or site of animal(s) affected
Date of slaughter
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
Name
Full address
Telephone number
Electronic address if available
Signature and stamp
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:
when applied in an establishment located in Great Britain, the abbreviation “UK” or “GB” or the words “UNITED KINGDOM”;
when applied in an establishment located in Northern Ireland, abbreviation “UK(NI)” or the words “UNITED KINGDOM (NORTHERN IRELAND)”;
when applied in an establishment located in a third country, 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;
the approval number of the slaughterhouse.
Products imported into Great Britain from establishments located outside the United Kingdom must not be marked in any way which indicates or suggests that they were produced in the United Kingdom.]
Textual Amendments
Textual Amendments
F2Words in Annex 2 para. 3 substituted (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(27)(b) (with regs. 33-36)
EN ISO 4833-1 for the plate count at 30 °C;
EN ISO 13366-1 for the somatic cell count.
for the plate count at 30 °C, where the methods are validated 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 relationship between an alternative method and the reference method mentioned in point 1 of Part A is established according to standard EN ISO 21187.
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.
The reference 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 the criteria in ISO 16140.
okadaic acid group toxins: OA, DTX1 and DTX2, including their esters (DTX3);
pectenotoxins group toxins: PTX1 and PTX2;
yessotoxins group toxins: YTX, 45 OH YTX, homo YTX and 45 OH homo YTX;
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.
[F3Total toxicity equivalence shall be calculated by the food safety authority. TEFs identified by EU or international bodies may be used to support calculations.]
Textual Amendments
F3Words in Annex 5 Ch. 3 Pt. A substituted (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(28)(a) (with regs. 33-36)
either alone or combined they can detect at least the analogues identified in Part A; more appropriate criteria shall be defined where necessary;
they meet the method performance criteria stipulated by the EURL LC-MS/MS method. Such methods must be intra-laboratory validated and successfully tested under a recognised proficiency test scheme. The European Reference Laboratory for marine biotoxins shall support activities toward inter-laboratory validation of the technique to allow for formal standardisation;
their implementation provides an equivalent level of public health protection.
Chemical methods, alternative methods with appropriate detection, or the mouse bioassay can be used during the periodic monitoring of production areas and relaying areas for detecting new or emerging marine toxins on the basis of the national control programmes F4....
Textual Amendments
F4Words in Annex 5 Ch. 4 omitted (31.12.2020) by virtue of The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(28)(b) (with regs. 33-36)
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 the 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 accordance with Council Regulation (EC) No 2406/96(4).
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 authorities shall use the criteria laid down in this Regulation.
When the organoleptic examination gives cause to suspect the presence of other conditions that may affect human health, appropriate samples shall be taken for verification purposes.
Random testing for histamine shall be carried out to verify compliance with the permitted levels laid down in Regulation (EC) No 2073/2005.
Monitoring arrangements shall be established F5... to control compliance with the F6... legislation on:
Textual Amendments
F5Words in Annex 6 Ch. 1 Pt. D omitted (31.12.2020) by virtue of The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(29)(a)(i)(aa) (with regs. 33-36)
F6Word in Annex 6 Ch. 1 Pt. D omitted (31.12.2020) by virtue of The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(29)(a)(i)(bb) (with regs. 33-36)
maximum residue limits for pharmacologically active substances, in accordance with Regulations (EU) No 37/2010 and (EU) No 2018/470;
prohibited and non-authorised substances, in accordance with Regulation (EU) No 37/2010, [F7the Residues Regulations] 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.
Textual Amendments
F7Words in Annex 6 Ch. 1 Pt. D substituted (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(29)(a)(ii) (with regs. 33-36)
Where necessary, microbiological controls shall be performed in accordance with the relevant rules and criteria laid down in Regulation (EC) No 2073/2005.
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 II to Regulation (EC) No 2074/2005.
Controls shall take place to ensure that:
fishery products derived from poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae;
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;
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.
25 mg of nitrogen/100 g of flesh for the species referred to in point 1 of Part B of this Chapter;
30 mg of nitrogen/100 g of flesh for the species referred to in point 2 of Part B of this Chapter;
35 mg of nitrogen/100 g of flesh for the species referred to in point 3 of Part B of this Chapter;
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, [F8the appropriate authority] may set limits at a higher level for certain species pending the establishment of specific [F9national] legislation.
Textual Amendments
F8Word in Annex 6 Ch. 2 Pt. A para. 1(d) substituted (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(29)(b)(i)(aa) (with regs. 33-36)
F9Word in Annex 6 Ch. 2 Pt. A para. 1(d) substituted (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(29)(b)(i)(bb) (with regs. 33-36)
The reference method to be used for checking the TVB-N limits involves distilling an extract deproteinised by perchloric acid as set out in Part C below.
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).
[F10The food safety authority] 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 regarding the results of analysis performed by one of the routine methods, only the reference method may be used to check the results.
Textual Amendments
F10Word in Annex 6 Ch. 2 Pt. A para. 4 substituted (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 16(29)(b)(ii) (with regs. 33-36)
TVB-N limit values are fixed for the following species categories:
Sebastes spp., Helicolenus dactylopterus, Sebastichthys capensis;
species belonging to the Pleuronectidae family (with the exception of halibut: Hippoglossus spp.);
Salmo salar, species belonging to the Merlucciidae family, species belonging to the Gadidae family.
This method describes a reference procedure for identifying the nitrogen concentration 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.
‘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:
perchloric acid solution = 6 g/100 ml;
sodium hydroxide solution = 20 g/100 ml;
hydrochloric acid standard solution 0,05 mol/l (0,05 N). When using an automatic distillation apparatus, titration must take place with a hydrochloric acid standard solution of 0,01 mol/l (0,01 N);
boric acid solution = 3 g/100 ml;
silicone anti-foaming agent;
phenolphtalein solution = 1 g/100 ml 95 % ethanol;
indicator solution (Tashiro mixed indicator) = 2 g methyl-red and 1 g methylene-blue dissolved in 1 000 ml 95 % ethanol.
The volatile nitrogenous bases are extracted from a sample using a solution of 0,6 mol/l 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.
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.
a meat grinder to produce a sufficiently homogenous fish mince;
high-speed blender with a speed of 8 000 to 45 000 revolutions/min;
fluted filter, diameter 150 mm, quick-filtering;
burette, 5 ml, graduated to 0,01 ml;
apparatus for steam distillation. The apparatus must be able to regulate various amounts of steam and produce a constant amount of steam over a given period of time. It must ensure that, during the addition of alkalising substances, the resulting free bases cannot escape.
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 following instructions:
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 perchloric 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;
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 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 distillation 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 receiver 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 must be 5,0 ± 0,1;
Titration
Duplicate analyses are required. The applied method is correct if the difference between the duplicates is not greater than 2 mg/100 g;
Blank
A blind test is carried out as described in point (b). Instead of the extract, 50,0 ml perchloric acid solution is used.
By titration of the receiver solution with hydrochloric acid standard solution, the TVB-N concentration is calculated using the following equation:
where:
=
volume of 0,01 mol hydrochloric acid standard solution in ml for sample;
=
volume of 0,01 mol hydrochloric acid standard solution in ml for blank;
=
mass of sample in g.
In addition, the following is required:
duplicate analyses. The applied method is correct if the difference between duplicates is not greater than 2 mg/100 g;
equipment check. The equipment is checked by distilling solutions of NH4Cl equivalent to 50 mg TVB-N/100 g;
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.
Microbiological, chemical, serological, etc. (include results as attached).
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, they must be readily available to the food business operator with a suitable explanation of their meaning.
Microbiological, chemical, serological, etc. (include results as attached).
Council Regulation (EC) No 2406/96 of 26 November 1996 laying down common marketing standards for certain fishery products (OJ L 334, 23.12.1996, p. 1).
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