Prováděcí nařízení Komise (EU) 2021/808 ze dne 22. března 2021 o provádění analytických metod pro rezidua farmakologicky účinných látek používaných u zvířat určených k produkci potravin a o interpretaci výsledků, jakož i o metodách, které se mají používat pro odběr vzorků, a o zrušení rozhodnutí 2002/657/ES a 98/179/ES (Text s významem pro EHP)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)OJ L 95, 7.4.2017, p. 1 . , and in particular Article 34(6) thereof,

This Regulation lays down rules concerning the methods of analysis used for sampling and for laboratory analyses in relation to residues of pharmacologically active substances in live food-producing animals, their body parts and fluids, excrements, tissues, products of animal origin, animal by-products, feed and water. It also lays down rules for the interpretation of analytical results of these laboratory analyses.

This Regulation applies to official controls aimed at verifying compliance with the requirements on the presence of residues of pharmacologically active substances.

OJ L 95, 7.4.2017, p. 1 .

(1) Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities by the competent authorities of the Member States to verify compliance with Union legislation, inter alia, in the area of food safety at all stages of production, processing and distribution. It provides for specific rules on official controls in relation to substances whose use may result in residues in food and feed and sets general requirements for the methods to be used for sampling, laboratory analyses and tests during official controls and other official activities.

(2) Commission Decision 2002/657/ECCommission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (OJ L 221, 17.8.2002, p. 8 ). sets requirements for the performance of analytical methods and the interpretation of results of analyses of certain substances and residues thereof in live animals and animal products and Commission Decision 98/179/ECCommission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products (OJ L 65, 5.3.1998, p. 31 ). lays down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products. Both Decisions were adopted on the basis of Council Directive 96/23/ECCouncil Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10 ). , which was repealed by Regulation (EU) 2017/625. In view of new scientific developments, those rules should be updated and they should be integrated into the framework for official controls defined by Regulation (EU) 2017/625.

(3) In accordance with Article 1(2) of Decision 2002/657/EC, that Decision is not to apply to substances for which more specific rules have been laid down in other Union legislation. Those substances are mycotoxins in foodstuffs, dioxins and dioxins-like polychlorinated biphenyls (PCBs) in foodstuffs and lead, cadmium, mercury and benzo(a)pyrene in foodstuffs. Mycotoxins in foodstuffs are to fulfil the requirements set by Commission Regulation (EC) No 401/2006Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12 ). laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs. Commission Regulation (EU) 2017/644Commission Regulation (EU) 2017/644 of 5 April 2017 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014 (OJ L 92, 6.4.2017, p. 9 ). laying down methods of sampling andCommission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (OJ L 88, 29.3.2007, p. 29 ). .

(4) For reasons of clarity and legal certainty, it is appropriate to merge the provisions applicable to sampling and analysis for pharmacologically active substances into one legal act as in case of mycotoxins, dioxins, dioxin-like PCBs, lead, cadmium, mercury and benzo(a)pyrene in foodstuffs.

(5) Decisions 98/179/EC and 2002/657/EC should therefore be repealed and replaced by this Regulation.

(6) In accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilRegulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29 ). coccidiostats and histomonostats can be used as feed additives, therefore Commission Regulation (EC) No 152/2009Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1 ). laying down the methods of sampling and analysis for the official control of feed applies to analyses of their content in feed. However, this Regulation should apply where feed are analysed as part of follow-up actions during investigations of the source of non-compliant samples in cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances.

(7) In order to ensure continuity in the performance of official controls and other official activities on residues of pharmacologically active substances and in order to avoid that all methods need to be re-validated at once, methods which have been validated before the date of entry into force of this Regulation may remain in use for a limited period, subject to the requirements of points 2 and 3 of Annex I to Decision 2002/657/EC. It is therefore appropriate to provide the Member States with sufficient time to apply the requirements laid down in this Regulation to all analytical methods.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

For the purposes of this Regulation, the definitions in Article 2 of Commission Delegated Regulation (EU) 2019/2090Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317, 9.12.2019, p. 28 ). , in Commission Regulation (EU) 2019/1871Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC (OJ L 289, 8.11.2019, p. 41 ). , in Article 2 of Regulation (EC) No 470/2009 of the European Parliament and of the CouncilRegulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11 ). and in Council Regulation (EEC) No 315/93Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1 ). shall apply.

The following definitions shall also apply:

Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (OJ L 221, 17.8.2002, p. 8 ).

Article 1 Article 1 Subject matter and scope

Article 2 Article 2 Definitions

Article 3 Article 3 Methods of analysis

Article 4 Article 4 Quality control

Article 5 Article 5 Interpretation of results (1)The result of an analysis shall be considered non-compliant where it is equal to or above the decision limit for confirmation (CCα). (2)For authorised substances for which an MRL or ML has been established, the decision limit for confirmation (CCα) shall be the concentration at and above which it can be decided with a statistical certainty of numerical value 1 – α that the permitted limit has been exceeded. (3)For unauthorised or prohibited substances or for authorised substances for which no MRL or ML has been established in a specific species or product, the decision limit for confirmation (CCα) shall be the lowest concentration level at which it can be decided with a statistical certainty of numerical value 1 – α that the particular analyte is present. (4)For unauthorised or prohibited pharmacologically active substances the α error shall be 1 % or lower. For all other substances, the α error shall be 5 % or lower.

Article 6 Article 6 Methods for sampling

Article 7 Article 7 Repeals and transitional measures

Article 8 Article 8 Entry into force

(1) absolute recovery means the yield of the final stage of an analytical process for an analyte divided by the amount of the analyte in the original sample, expressed as a percentage;

(2) accuracy means the closeness of agreement between a test result and the accepted true reference value, determined by estimating trueness and precisionISO 3534-1: 2006 Statistics – Vocabulary and symbols – Part 1: General statistical terms and terms used in probability (Chapter 1). ;

(3) alpha (α) error means the probability that the tested sample is compliant, even though a non-compliant measurement result has been obtained;

(4) analyte means the component of a system to be analysed;

(5) authorised substance means a pharmacologically active substance authorised for use in food-producing animals in accordance with Directive 2001/82/EC of the European Parliament and of the CouncilDirective 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1 ). ;

(6) beta (β) error means the probability that the tested sample is truly non-compliant, even though a compliant measurement result has been obtained;

(7) bias means the difference between the estimated value of the test result and an accepted reference value;

(8) calibration standard means a traceable reference for measurements that represents the quantity of substance of interest in a way that ties its value to a reference base;

(9) certified reference material (CRM) means a reference material, accompanied by documentation issued by a delegated body and providing one or more specified property values with associated uncertainties and traceabilities, using valid proceduresJCGM 200:2008, International vocabulary of metrology – Basic and general concepts and associated terms (VIM), Third Edition 2008: https://www.iso.org/sites/JCGM/VIM-JCGM200.htm (Chapter 5 Measurement standards (Etalons)). ;

(10) co-chromatography means a technique in which an unknown substance is applied to a chromatographic support together with one or more known compounds, in the expectation that the relative behaviour of the unknown and known substances will assist in the identification of the unknown one;

Member States shall ensure that the samples taken in accordance with Article 34 of Regulation (EU) 2017/625 are analysed using methods that comply with the following requirements:

Commission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products (OJ L 65, 5.3.1998, p. 31 ).

(11) collaborative study means analysing the same sample(s) by using the same method to determine performance characteristics of the method in different laboratories, where the study allows to calculate the random measurement error and laboratory bias for the method used;

(1) they are documented in test instructions, preferably according to Annexes of ISO 78-2:1999 Chemistry-Layouts for standards – Part 2: Methods of chemical analysisISO 78-2: 1999 Chemistry – Layouts for standards – Part 2: Methods of chemical analysis (Annexes). ;

(12) confirmatory method means a method that provides full or complementary information enabling the substance to be unequivocally identified and if necessary quantified in one of the following manners:(a) at the maximum residue level or maximum level for authorised substances;(b) at the reference points for action (RPA) for prohibited or unauthorised substances, for which a reference point for action is established;(c) at a concentration as low as reasonably achievable for prohibited or unauthorised substance, for which no reference point for action is established;

(a) at the maximum residue level or maximum level for authorised substances;

(b) at the reference points for action (RPA) for prohibited or unauthorised substances, for which a reference point for action is established;

(c) at a concentration as low as reasonably achievable for prohibited or unauthorised substance, for which no reference point for action is established;

(2) they comply with the performance criteria and other requirements for analytical methods laid down in Chapter 1 of Annex I to this Regulation;

(13) coverage factor (k) means a number which expresses the desired level of confidence and which is associated with the expanded measurement uncertainty;

(3) they have been validated in accordance with the requirements laid down in Chapters 2 and 4 of Annex I to this Regulation;

(14) decision limit for confirmation (CCα) means the limit at and above which it can be concluded with an error probability of α that a sample is non-compliant and the value 1 – α means statistical certainty in percentage that the permitted limit has been exceeded;

(4) they allow enforcement of the reference points for action laid down in Regulation (EU) 2019/1871, the identification of the presence of prohibited and unauthorised substances and the enforcement of maximum levels (MLs), which have been set on the basis of Regulation (EEC) No 315/93 and Regulation (EC) No 124/2009 and maximum residue limits (MRLs), which have been set on the basis of Regulations (EC) No 1831/2003 and (EC) No 470/2009.

(15) detection capability for screening (CCβ) means the smallest content of the analyte that may be detected or quantified in a sample with an error probability of β:(a) in the case of prohibited or unauthorised pharmacologically active substances, the CCβ is the lowest concentration at which a method is able to detect or quantify, with a statistical certainty of 1 – β, samples containing residues of prohibited or unauthorised substances;(b) in the case of authorised substances, the CCβ is the concentration at which the method is able to detect concentrations below the permitted limit with a statistical certainty of 1 – β;

(a) in the case of prohibited or unauthorised pharmacologically active substances, the CCβ is the lowest concentration at which a method is able to detect or quantify, with a statistical certainty of 1 – β, samples containing residues of prohibited or unauthorised substances;

(b) in the case of authorised substances, the CCβ is the concentration at which the method is able to detect concentrations below the permitted limit with a statistical certainty of 1 – β;

(16) fortified sample material means a sample enriched with a known amount of the analyte to be detected or quantified;

(17) inter-laboratory study means the organisation, performance and evaluation of tests on the same sample(s) by two or more laboratories in accordance with predetermined conditions to evaluate testing performance, either as a collaborative study or a proficiency test;

(18) internal standard (IS) means a substance not contained in the sample and having physico-chemical properties as similar as possible to those of the analyte to be identified or quantified;

(19) level of interest means the concentration of a substance or analyte in a sample that is significant to determine its compliance with the legislation as regards:(a) the maximum residue level or maximum level for authorised substances in accordance with Commission Regulation (EC) No 124/2009Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed (OJ L 40, 11.2.2009, p. 7 ). and Commission Regulation (EU) No 37/2010Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1 ). ;(b) reference points for action for prohibited or unauthorised substances, for which a reference point for action is established in accordance with Regulation (EU) 2019/1871;(c) a concentration as low as analytically achievable for prohibited or unauthorised substance, for which no reference point for action is established;

(a) the maximum residue level or maximum level for authorised substances in accordance with Commission Regulation (EC) No 124/2009Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed (OJ L 40, 11.2.2009, p. 7 ). and Commission Regulation (EU) No 37/2010Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1 ). ;

(b) reference points for action for prohibited or unauthorised substances, for which a reference point for action is established in accordance with Regulation (EU) 2019/1871;

(c) a concentration as low as analytically achievable for prohibited or unauthorised substance, for which no reference point for action is established;

(20) lowest calibrated level (LCL) means the lowest concentration on which the measuring system has been calibrated;

Member States shall ensure the quality of the results of analyses performed pursuant to Regulation (EU) 2017/625, in particular by monitoring tests or calibration results in accordance with ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories and with the requirements for quality control during routine analysis as laid down in Chapter 3 of Annex I to this Regulation.

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10 ).

(21) matrix means the material from which a sample is taken;

(22) matrix effect means the difference in analytical response between a standard dissolved in the solvent and a matrix-matched standard either without a correction using an internal standard or with correction using an internal standard;

(23) matrix-matched standard means a blank (i.e. analyte-free) matrix to which the analyte is added at a range of concentrations after sample processing;

(24) matrix-fortified standard means a blank (i.e. analyte-free) matrix, which prior to solvent extraction and sample processing, is spiked with the analyte at a range of concentrations;

(25) measurand means the particular quantity subject to measurement;

(26) measurement uncertainty means a non-negative parameter associated with the result of measurement, which characterises the dispersion of values that could reasonably be attributed to the measurand, based on the information used;

(27) performance criteria means requirements for a performance characteristic according to which it can be judged that the analytical method is fit for the intended use and generates reliable results;

(28) precision means the closeness of agreement between independent test results obtained under stipulated conditions and is expressed as the standard deviation or coefficient of variation of the test results;

(29) qualitative method means an analytical method, which detects or identifies a substance or a group of substances on the basis of its chemical, biological or physical properties;

(30) quantitative method means an analytical method, which determines the amount or mass fraction of a substance so that it may be expressed as a numerical value of appropriate units;

The result of an analysis shall be considered non-compliant where it is equal to or above the decision limit for confirmation (CCα).

For authorised substances for which an MRL or ML has been established, the decision limit for confirmation (CCα) shall be the concentration at and above which it can be decided with a statistical certainty of numerical value 1 – α that the permitted limit has been exceeded.

For unauthorised or prohibited substances or for authorised substances for which no MRL or ML has been established in a specific species or product, the decision limit for confirmation (CCα) shall be the lowest concentration level at which it can be decided with a statistical certainty of numerical value 1 – α that the particular analyte is present.

For unauthorised or prohibited pharmacologically active substances the α error shall be 1 % or lower. For all other substances, the α error shall be 5 % or lower.

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12 ).

(31) recovery means the recovery corrected amount of an analyte divided by the fortified amount of the analyte in the matrix sample, expressed as a percentage;

(32) recovery correction means the use of internal standards, the use of a matrix calibration curve as well as the use of a recovery correction factor and also a combination of these approaches;

(33) reference material means a material sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process or in examination of nominal propertiesCodex Alimentarius Commission, Food and Agriculture Organization of the United Nations/World Health Organization, Guidelines on analytical terminology (CAC/GL 72-2009). ;

(34) relative matrix effect means the difference in analytical response between a standard dissolved in the solvent and a matrix-matched standard with a correction using an internal standard;

(35) repeatability means precision under conditions, where independent test results are obtained with the same method on identical test items in the same laboratory by the same operator using the same equipment within short intervals of time;

(36) reproducibility means precision under conditions, where test results are obtained with the same method on identical test items in different laboratories with different operators using different equipmentISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions (Chapter 3). ;

(37) ruggedness means the susceptibility of an analytical method to changes in experimental conditions under which the method can be applied as presented or with specified minor modifications;

(38) screening method means a method that is used for screening of a substance or class of substances at the level of interest;

(39) screening target concentration (STC) means the concentration lower than or equal to the CCβ at which a screening measurement categorises the sample as potentially non-compliant Screen Positive and triggers a confirmatory testing;

(40) selectivity means the ability of a method to distinguish between the analyte being measured and other substances;

Member States shall ensure that samples are taken, handled and labelled in accordance with the detailed methods for sampling laid down in Annex II to this Regulation.

Commission Regulation (EU) 2017/644 of 5 April 2017 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014 (OJ L 92, 6.4.2017, p. 9 ).

(41) single laboratory study or in-house validation means an analytical study involving a single laboratory using one method to analyse the same or different test materials under different conditions over justified long time intervals;

(42) standard addition means a procedure in which one part of the sample is analysed as such and known amounts of the standard analyte are added to the other test portions before analysis;

(43) standard analyte means an analyte of known and certified content and purity to be used as a reference in the analysis;

(44) substance means matter of constant composition characterised by the entities which compose it and by certain physical properties;

(45) test portion means the quantity of material drawn from the sample on which the test or observation is carried out;

(46) trueness means the closeness of agreement between the average value obtained from a large series of test results and an accepted reference value;

(47) units means those units described in ISO 80000ISO 80000-1:2009 Quantities and units – Part 1: General (Introduction). and Council Directive 80/181/EECCouncil Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40 ). ;

(48) validation means the demonstration by examination and the provision of effective evidence that the particular requirements of a specific intended use are fulfilledISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories (Chapter 3). , through a single laboratory study or a collaborative study;

(49) within-laboratory reproducibility or intermediate precision/in-house reproducibility means measurement precision under a set of within-laboratory conditions in a specific laboratory.

Decisions 2002/657/EC and 98/179/EC are repealed from the date of entry into force of this Regulation.

However, until 10 June 2026 , the requirements laid down in points 2 and 3 of Annex I to Decision 2002/657/EC shall continue to apply to methods, which have been validated before the date of entry into force of this Regulation.

Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (OJ L 88, 29.3.2007, p. 29 ).

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29 ).

Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1 ).

Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317, 9.12.2019, p. 28 ).

Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC (OJ L 289, 8.11.2019, p. 41 ).

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11 ).

Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1 ).

ISO 3534-1: 2006 Statistics – Vocabulary and symbols – Part 1: General statistical terms and terms used in probability (Chapter 1).

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1 ).

JCGM 200:2008, International vocabulary of metrology – Basic and general concepts and associated terms (VIM), Third Edition 2008: https://www.iso.org/sites/JCGM/VIM-JCGM200.htm (Chapter 5 Measurement standards (Etalons)).

Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed (OJ L 40, 11.2.2009, p. 7 ).

Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1 ).

Codex Alimentarius Commission, Food and Agriculture Organization of the United Nations/World Health Organization, Guidelines on analytical terminology (CAC/GL 72-2009).

ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions (Chapter 3).

ISO 80000-1:2009 Quantities and units – Part 1: General (Introduction).

Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40 ).

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories (Chapter 3).

ISO 78-2: 1999 Chemistry – Layouts for standards – Part 2: Methods of chemical analysis (Annexes).

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