2017/625 - Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products

This document specifies a method for the determination of total mercury in foodstuffs by cold vapour atomic fluorescence spectrometry (AFS) after pressure digestion.
This method was tested in an interlaboratory study carried out in connection with the pressure digestion method EN 13805 on seven different materials with a mercury concentration in the range from 0,006 mg/kg to 5,38 mg/kg and successfully validated in this range.
The following foodstuffs were analysed:
—   Saithe (dried);
—   Celery (dried);
—   Wheat noodle powder;
—   Wild mushrooms (dried);
—   Pig liver (dried);
—   Cacao powder;
—   Tuna fish (dried).
The lower limit of the method’s applicability varies depending on the food matrix and the water content of the foodstuff. It is a laboratory-specific value and is defined by the laboratory when calculating the limit of quantification (see 9.2).

This document specifies a method for the determination of total mercury in foodstuffs by cold vapour atomic fluorescence spectrometry (AFS) after pressure digestion.
This method was tested in an interlaboratory study carried out in connection with the pressure digestion method EN 13805 on seven different materials with a mercury concentration in the range from 0,006 mg/kg to 5,38 mg/kg and successfully validated in this range.
The following foodstuffs were analysed:
—   Saithe (dried);
—   Celery (dried);
—   Wheat noodle powder;
—   Wild mushrooms (dried);
—   Pig liver (dried);
—   Cacao powder;
—   Tuna fish (dried).
The lower limit of the method’s applicability varies depending on the food matrix and the water content of the foodstuff. It is a laboratory-specific value and is defined by the laboratory when calculating the limit of quantification (see 9.2).

This document specifies a method for the identification of single fish and fish fillets to the level of genus or species. It allows the identification of a large number of commercially important fish species using DNA barcoding.
This method was validated on raw fish. Laboratory experience indicates additional applicability to processed fish products (e.g. cold smoked, hot smoked, salted, frozen, cooked, fried and deep-fried samples).
The described method is usually unsuitable for the analysis of highly processed foods (e.g. tins of fish with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets). Furthermore, it does not apply to complex fish products containing mixtures of two or more fish species.
The identification of fish species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI), or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies a method for the identification of single fish and fish fillets to the level of genus or species. It allows the identification of a large number of commercially important fish species using DNA barcoding.
This method was validated on raw fish. Laboratory experience indicates additional applicability to processed fish products (e.g. cold smoked, hot smoked, salted, frozen, cooked, fried and deep-fried samples).
The described method is usually unsuitable for the analysis of highly processed foods (e.g. tins of fish with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets). Furthermore, it does not apply to complex fish products containing mixtures of two or more fish species.
The identification of fish species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI), or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies a method for the taxonomic identification of a single bivalve or piece of bivalve to the genus or species level using DNA barcoding. It allows the identification of a large number of commercially important bivalve species.
This method was validated on raw mussels. Laboratory experience indicates additional applicability to processed bivalve products, e.g. cold smoked, hot smoked, salted, frozen, cooked, fried, and deep-fried samples.
The described method is usually unsuitable for the analysis of highly processed foods, e.g. tins of mussels, with highly degraded DNA where the fragment lengths are not sufficient for amplification of the target. Furthermore, it is not applicable for complex seafood products containing mixtures of two or more bivalve species.
The identification of bivalve species is carried out by PCR amplification of a segment of the mitochondrial 16S rRNA gene, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies a method for the identification of meat derived from mammals and birds to the level of genus or species and allows the identification of a large number of commercially important as well as exotic meat species using DNA barcoding.
This method was validated on DNA isolated from single pieces of raw meat. This method can also be used for the identification of single meat animal species in some processed products.
The described method is unsuitable for the analysis of highly processed foods with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets. Furthermore, it is not applicable for complex meat products containing mixtures of two or more meat species.
The identification of meat species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI) or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies a method for the taxonomic identification of a single bivalve or piece of bivalve to the genus or species level using DNA barcoding. It allows the identification of a large number of commercially important bivalve species.
This method was validated on raw mussels. Laboratory experience indicates additional applicability to processed bivalve products, e.g. cold smoked, hot smoked, salted, frozen, cooked, fried, and deep-fried samples.
The described method is usually unsuitable for the analysis of highly processed foods, e.g. tins of mussels, with highly degraded DNA where the fragment lengths are not sufficient for amplification of the target. Furthermore, it is not applicable for complex seafood products containing mixtures of two or more bivalve species.
The identification of bivalve species is carried out by PCR amplification of a segment of the mitochondrial 16S rRNA gene, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies a method for the identification of meat derived from mammals and birds to the level of genus or species and allows the identification of a large number of commercially important as well as exotic meat species using DNA barcoding.
This method was validated on DNA isolated from single pieces of raw meat. This method can also be used for the identification of single meat animal species in some processed products.
The described method is unsuitable for the analysis of highly processed foods with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets. Furthermore, it is not applicable for complex meat products containing mixtures of two or more meat species.
The identification of meat species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI) or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies the detection of Clostridium (C.) perfringens.
This document is applicable to:
—     products intended for human consumption;
—     products intended for animal feeding;
—     environmental samples in the area of food and feed production and handling;
—     samples from the primary production stage.
This horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
NOTE          Interlaboratory studies with a small number of participating laboratories (<10) were conducted for the following food categories:
—      ready-to-eat, ready-to-reheat meat products;
—      eggs and egg products (derivates);
—      ready-to-eat, ready-to-reheat fishery products;
—      processed fruits and vegetables;
—      infant formula and infant cereals (with probiotics);
—      multi-component foods or meal components.
It has also been validated with a small number of participating laboratories for the following other category:
—      environmental samples (food or feed production).
Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category. The method has not been validated for the category ‘pet food and animal feed’, as the test samples used for the interlaboratory study were already naturally contaminated with C. perfringens. Given the limited number of participating laboratories in the interlaboratory studies, the calculated performance characteristics can be used as indicative values of the method performance. For detailed information on the validation, see Clause 11 and Annexes C to F.

This document specifies the detection of Clostridium (C.) perfringens.
This document is applicable to:
—     products intended for human consumption;
—     products intended for animal feeding;
—     environmental samples in the area of food and feed production and handling;
—     samples from the primary production stage.
This horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
NOTE          Interlaboratory studies with a small number of participating laboratories (<10) were conducted for the following food categories:
—      ready-to-eat, ready-to-reheat meat products;
—      eggs and egg products (derivates);
—      ready-to-eat, ready-to-reheat fishery products;
—      processed fruits and vegetables;
—      infant formula and infant cereals (with probiotics);
—      multi-component foods or meal components.
It has also been validated with a small number of participating laboratories for the following other category:
—      environmental samples (food or feed production).
Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category. The method has not been validated for the category ‘pet food and animal feed’, as the test samples used for the interlaboratory study were already naturally contaminated with C. perfringens. Given the limited number of participating laboratories in the interlaboratory studies, the calculated performance characteristics can be used as indicative values of the method performance. For detailed information on the validation, see Clause 11 and Annexes C to F.

This document specifies the enumeration of Clostridium (C.) perfringens by colony-count technique.
This document is applicable to:
—    products intended for human consumption;
—    products for feeding animals;
—    environmental samples in the area of food and feed production and handling;
—    samples from the primary production stage.
NOTE            This method has been validated in an interlaboratory study for the following food categories:
—     ready-to-eat, ready-to-reheat meat products;
—     eggs and egg products (derivates);
—     processed fruits and vegetables;
—     infant formula and infant cereals;
—     multi-component foods or meal components.
It has also been validated for the following other categories:
—     pet food and animal feed;
—     environmental samples (food or feed production).
As this method has been validated for at least five food categories, this method is applicable for a broad range of food. For detailed information on the validation, see Clause 11 and Annex C. Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category.
This horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
This technique is suitable for, but not limited to, the enumeration of microorganisms in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of contamination that is expected to be higher than 10 cfu/ml for liquid samples or higher than 100 cfu/g for solid samples.

This document specifies the enumeration of Clostridium (C.) perfringens by colony-count technique.
This document is applicable to:
—    products intended for human consumption;
—    products for feeding animals;
—    environmental samples in the area of food and feed production and handling;
—    samples from the primary production stage.
NOTE            This method has been validated in an interlaboratory study for the following food categories:
—     ready-to-eat, ready-to-reheat meat products;
—     eggs and egg products (derivates);
—     processed fruits and vegetables;
—     infant formula and infant cereals;
—     multi-component foods or meal components.
It has also been validated for the following other categories:
—     pet food and animal feed;
—     environmental samples (food or feed production).
As this method has been validated for at least five food categories, this method is applicable for a broad range of food. For detailed information on the validation, see Clause 11 and Annex C. Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category.
This horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
This technique is suitable for, but not limited to, the enumeration of microorganisms in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of contamination that is expected to be higher than 10 cfu/ml for liquid samples or higher than 100 cfu/g for solid samples.

This document specifies the enumeration of sulfite-reducing Clostridium spp. by the colony-count technique.
This document is applicable to:
—    products intended for human consumption;
—    products for feeding animals;
—    environmental samples in the area of food and feed production and handling;
—    samples from the primary production stage.
NOTE      This method has been validated in an interlaboratory study for the following food categories:
—    ready-to-eat, ready-to-reheat meat products;
—    eggs and egg products (derivates);
—    processed fruits and vegetables;
—    infant formula and infant cereals;
—    multi-component foods or meal components.
It has also been validated for the following other categories:
—    pet food and animal feed;
—    environmental samples (food or feed production).
As this method has been validated for at least five food categories, this method is applicable for a broad range of food. For detailed information on the validation, see Clause 11 and Annex C. Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category.
This horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
This technique is suitable for, but not limited to, the enumeration of microorganisms in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of contamination that is expected to be higher than 10 cfu/ml for liquid samples or higher than 100 cfu/g for solid samples.

This document specifies the enumeration of sulfite-reducing Clostridium spp. by the colony-count technique.
This document is applicable to:
—    products intended for human consumption;
—    products for feeding animals;
—    environmental samples in the area of food and feed production and handling;
—    samples from the primary production stage.
NOTE      This method has been validated in an interlaboratory study for the following food categories:
—    ready-to-eat, ready-to-reheat meat products;
—    eggs and egg products (derivates);
—    processed fruits and vegetables;
—    infant formula and infant cereals;
—    multi-component foods or meal components.
It has also been validated for the following other categories:
—    pet food and animal feed;
—    environmental samples (food or feed production).
As this method has been validated for at least five food categories, this method is applicable for a broad range of food. For detailed information on the validation, see Clause 11 and Annex C. Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category.
This horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
This technique is suitable for, but not limited to, the enumeration of microorganisms in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of contamination that is expected to be higher than 10 cfu/ml for liquid samples or higher than 100 cfu/g for solid samples.

This document describes a method for the determination of T-2 toxin and HT-2 toxin in cereals and cereal-based products, e.g. oats, intended for nutrition of infants and young children by high performance liquid chromatography (HPLC) coupled with tandem mass spectrometry (MS/MS) after cleanup by solid phase extraction (SPE) [5].
The method has been validated for HT-2 toxin in oat flour at levels of 9,3 µg/kg and 28,1 µg/kg, oat flakes at levels of 16,5 µg/kg and 21,4 µg/kg, and breakfast cereals (containing oat flakes) at a level of 8,1 µg/kg and for T-2 toxin in oat flour at levels of 4,4 µg/kg and 8,3 µg/kg, oat flakes at levels of 4,9 µg/kg and 6,6 µg/kg and breakfast cereals (containing oat flakes) at a level of 3,5 µg/kg.
Laboratory experiences [6] have shown that the method is also applicable to highly swelling materials (dry cereal-based porridges and modified starches), but these were not examined in the method validation study. Details are outlined in 7.3.
The method can also be applied to oat-by-products at higher levels of T-2- and HT-2 toxin. In this case, the dilution steps need to be considered [6].
The method can also be applied to cereals and cereal products for infants and young children based on e.g. wheat, barley and rice. In this case, the method needs to be in-house-validated for each material. At the time of the interlaboratory study, planned range was 10 µg/kg to 100 µg/kg, and it is known from the pre-study that the method works well in the whole range, although final validation was only done in the range from 3,5 µg/kg to 28,1 µg/kg.

This document describes a method for the determination of T-2 toxin and HT-2 toxin in cereals and cereal-based products, e.g. oats, intended for nutrition of infants and young children by high performance liquid chromatography (HPLC) coupled with tandem mass spectrometry (MS/MS) after cleanup by solid phase extraction (SPE) [5].
The method has been validated for HT-2 toxin in oat flour at levels of 9,3 µg/kg and 28,1 µg/kg, oat flakes at levels of 16,5 µg/kg and 21,4 µg/kg, and breakfast cereals (containing oat flakes) at a level of 8,1 µg/kg and for T-2 toxin in oat flour at levels of 4,4 µg/kg and 8,3 µg/kg, oat flakes at levels of 4,9 µg/kg and 6,6 µg/kg and breakfast cereals (containing oat flakes) at a level of 3,5 µg/kg.
Laboratory experiences [6] have shown that the method is also applicable to highly swelling materials (dry cereal-based porridges and modified starches), but these were not examined in the method validation study. Details are outlined in 7.3.
The method can also be applied to oat-by-products at higher levels of T-2- and HT-2 toxin. In this case, the dilution steps need to be considered [6].
The method can also be applied to cereals and cereal products for infants and young children based on e.g. wheat, barley and rice. In this case, the method needs to be in-house-validated for each material. At the time of the interlaboratory study, planned range was 10 µg/kg to 100 µg/kg, and it is known from the pre-study that the method works well in the whole range, although final validation was only done in the range from 3,5 µg/kg to 28,1 µg/kg.

This document specifies a method for the detection of foodstuff containing cellulose which have been treated with ionizing radiation, by analysing the electron spin resonance (ESR) spectrum, also called electron paramagnetic resonance (EPR) spectrum, of the foodstuff, see [1] to [13].
Interlaboratory studies have been successfully carried out with pistachio nut shells, [14] to [18], paprika powder [19] and [20] and fresh strawberries [21]. However, it has been shown that chemical bleaching of nuts in shells can lead to comparable signals. For further information, see Clause 8 on limitations.

This document specifies a method for the detection of foodstuff containing crystalline sugars which have been treated with ionizing radiation, by analysing the electron spin resonance (ESR) spectrum, also called electron paramagnetic resonance (EPR) spectrum, of the foodstuff, see [1] to [7].
Interlaboratory studies have been successfully carried out on dried figs, dried mangoes, dried papayas and raisins, see [1] to [3].

This document specifies a method for the detection of foodstuff containing crystalline sugars which have been treated with ionizing radiation, by analysing the electron spin resonance (ESR) spectrum, also called electron paramagnetic resonance (EPR) spectrum, of the foodstuff, see [1] to [7].
Interlaboratory studies have been successfully carried out on dried figs, dried mangoes, dried papayas and raisins, see [1] to [3].

This document specifies a method for the detection of foodstuff containing cellulose which have been treated with ionizing radiation, by analysing the electron spin resonance (ESR) spectrum, also called electron paramagnetic resonance (EPR) spectrum, of the foodstuff, see [1] to [13].
Interlaboratory studies have been successfully carried out with pistachio nut shells, [14] to [18], paprika powder [19] and [20] and fresh strawberries [21]. However, it has been shown that chemical bleaching of nuts in shells can lead to comparable signals. For further information, see Clause 8 on limitations.

This document specifies a method for the analysis of pesticide residues in foods of plant and of animal origin by ethyl acetate extraction using GC- and LC-MS/MS (SweEt).

This document specifies a method for the analysis of pesticide residues in foods of plant and of animal origin by ethyl acetate extraction using GC- and LC-MS/MS (SweEt).

This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or cold smoked.
This method is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature.
This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or smoked. It is also suitable for visceral organs as a confirmatory method for a visual inspection scheme.
The artificial digestion method[4][5][6] is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature and, when applied to fresh fish or lightly processed fish products (never frozen before processing), determining the viability of Anisakidae L3, which can be present.
This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

This document describes a procedure for the determination of the citrinin content in food (cereals, red yeast rice (RYR)), herbs and food supplements by liquid chromatography tandem mass spectrometry (LC-MS/MS).
This method has been validated for citrinin in red yeast rice and in the formulated food supplements in the range of 2,5 μg/kg to 3 000 μg/kg and in wheat flour in the range of 2,5 μg/kg to 100 μg/kg.
Laboratory experiences have shown that this method is also applicable to white rice, herbs such as a powder of ginkgo biloba leaves and the formulated food supplements in the range of 2,5 μg/kg to 50 μg/kg.

This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or cold smoked.
This method is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature.
This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or smoked. It is also suitable for visceral organs as a confirmatory method for a visual inspection scheme.
The artificial digestion method[4][5][6] is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature and, when applied to fresh fish or lightly processed fish products (never frozen before processing), determining the viability of Anisakidae L3, which can be present.
This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

This document describes a procedure for the determination of the citrinin content in food (cereals, red yeast rice (RYR)), herbs and food supplements by liquid chromatography tandem mass spectrometry (LC-MS/MS).
This method has been validated for citrinin in red yeast rice and in the formulated food supplements in the range of 2,5 μg/kg to 3 000 μg/kg and in wheat flour in the range of 2,5 μg/kg to 100 μg/kg.
Laboratory experiences have shown that this method is also applicable to white rice, herbs such as a powder of ginkgo biloba leaves and the formulated food supplements in the range of 2,5 μg/kg to 50 μg/kg.

This document describes the performance characteristics and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

This document describes the performance characteristics and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.