LegalizeCommission 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.)
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 elaborated by the Member States.
ANNEX VI
PRACTICAL ARRANGEMENTS FOR OFFICIAL CONTROLS ON FISHERY PRODUCTS IN ACCORDANCE WITH ARTICLE 70
CHAPTER I
GENERAL PROVISIONS
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 (21).
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.
When the organoleptic examination gives rise to any doubt that previously frozen fish is commercially presented as fresh, samples may be taken for verification purposes and subjected to laboratory tests such as the Hydroxyacyl-coenzyme A dehydrogenase (HADH) test, histology, ultraviolet–visible–near–infrared (UV-VIS/NIR) spectroscopy and hyperspectral imaging.
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 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) No 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.
For wild caught fishery products monitoring arrangements shall be established to control compliance with the EU legislation on contaminants, in accordance with Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in food.
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.
CHAPTER II
CONTROLS ON TOTAL VOLATILE BASIC NITROGEN (TVB-N)
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 Part B of this Chapter;
(b) 30 mg of nitrogen/100 g of flesh for the species referred to in point 2 of Part B of this Chapter;
(c) 35 mg of nitrogen/100 g of flesh for the species referred to in point 3 of Part 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 higher level for certain species pending the establishment of specific Union 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 Part C below.
2.Distillation as referred to in point 1 shall be performed using apparatus which complies with the diagram in Part 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 (1933);
(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 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 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.
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:
(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). When using an automatic distillation apparatus, titration must 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.
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.
The following instruments and accessories shall be used:
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:
Sample extract
Steam injection tube
Distillation tube
Steam generator
Flask or breaker
(Boric acid)
End of condenser
Cool water
Cooler
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