Article 1Sampling for the official control of the levels of mycotoxins...
Article 2Sample preparation and methods of analysis used for the official...
Article 3Directives 98/53/EC, 2002/26/EC, 2003/78/EC and 2005/38/EC are repealed. References to...
Article 4This Regulation shall enter into force on the 20th day...
ANNEX IMETHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF MYCOTOXINS IN FOODSTUFFS
A.GENERAL PROVISIONS A.1.Purpose and scope A.2.Definitions A.3.General provisions A.3.1.Personnel A.3.2.Material to be sampled A.3.3.Precautions to be taken A.3.4.Incremental samples A.3.5.Preparation of the aggregate sample A.3.6.Replicate samples A.3.7.Packaging and transmission of samples A.3.8.Sealing and labelling of samples A.4.Different types of lots B.METHOD OF SAMPLING FOR CEREALS AND CEREAL PRODUCTS B.1.Weight of the incremental sample B.2.General survey of the method of sampling for cereals and...B.3.Method of sampling for cereals and cereal products for lots...B.4.Method of sampling for cereals and cereal products for lots...B.5.Sampling at retail stage B.6.Acceptance of a lot or sublot C.METHOD OF SAMPLING FOR DRIED FRUIT, INCLUDING DRIED VINE FRUIT...C.1.Weight of the incremental sample C.2.General survey of the method of sampling dried fruit, with...C.3.Method of sampling for dried fruit (lots ≥ 15 tonnes),...C.4.Method of sampling for dried fruit (lots < 15 tonnes),...C.5.Sampling at retail stage C.6.Specific sampling provisions for dried fruit with the exception of...C.7.Acceptance of a lot or sublot D.METHOD OF SAMPLING FOR DRIED FIGS, GROUNDNUTS AND NUTS D.1.Method of sampling for dried figs D.1.1.Weight of the incremental sample D.1.2.General survey of the method of sampling for dried figs...D.1.3.Method of sampling for dried figs (lots ≥ 15 tonnes)...D.1.4.Method of sampling for dried figs (lots < 15 tonnes)...D.1.5.Method of sampling for derived products and compound foods D.1.5.1.Derived products with very small particle weight (homogeneous distribution of...D.1.5.2.Other derived products with a relatively large particle size (heterogeneous...D.1.6.Sampling at retail stage D.1.7.Specific method of sampling of dried figs and derived products...D.1.7.1.Dried figs D.1.7.2.Products derived from dried figs with small particle size D.1.8.Acceptance of a lot or sublot D.2.Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels...D.2.1.Weight of the incremental sample D.2.2.General survey of the method of sampling for groundnuts (peanuts),...D.2.3.Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels...D.2.4.Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels...D.2.5.Method of sampling for derived products, with the exception of...D.2.5.1.Derived products (other than vegetable oil) with small particle size,...D.2.5.2.Derived products with a relatively large particle size (heterogeneous distribution...D.2.6.Sampling at retail stage D.2.7.Specific method of sampling for groundnuts (peanuts), other oilseeds, apricot...D.2.7.1.Pistachios, groundnuts (peanuts), Brazil nuts D.2.7.2.Apricot kernels, tree nuts other than pistachios and Brazil nuts,...D.2.7.3.Products derived from tree nuts, apricot kernels and groundnuts (peanuts)...D.2.8.Acceptance of a lot or sublot E.METHOD OF SAMPLING FOR SPICES E.1.Weight of the incremental sample E.2.General survey of the method of sampling for spices E.3.Method of sampling for spices (lots ≥ 15 tonnes) E.4.Method of sampling for spices (lots < 15 tonnes) E.5.Sampling at retail stage E.6.Specific method of sampling for spices traded in vacuum packs...E.7.Acceptance of a lot or sublot F.METHOD OF SAMPLING FOR MILK AND MILK PRODUCTS; INFANT FORMULAE...F.1.Method of sampling for milk, milk products, infant formulae and...F.2.Sampling at retail stage F.3.Acceptance of a lot or sublot G.METHOD OF SAMPLING FOR COFFEE, COFFEE PRODUCTS, LIQUORICE ROOT AND...G.1.Weight of the incremental sample G.2.General survey of the method of sampling for roasted coffee,...G.3.Method of sampling for roasted coffee beans, ground roasted coffee,...G.4.Method of sampling for roasted coffee beans, ground roasted coffee,...G.5.Method of sampling for roasted coffee beans, ground roasted coffee,...G.6.Sampling at retail stage G.7.Acceptance of a lot or sublot H.METHOD OF SAMPLING FOR FRUIT JUICES INCLUDING GRAPE JUICE, GRAPE...H.1.Method of sampling H.2.Sampling at retail stage H.3.Acceptance of a lot or sublot I.METHOD OF SAMPLING FOR SOLID APPLE PRODUCTS I.1.Method of sampling I.2.Sampling at retail stage I.3.Acceptance of a lot or sublot J.METHOD OF SAMPLING FOR BABY FOODS AND PROCESSED CEREAL BASED...J.1.Method of sampling J.2.Sampling at retail stage J.3.Acceptance of a lot or sublot K.METHOD OF SAMPLING FOR VEGETABLE OILS K.1.Method of sampling for vegetable oils K.2.Method of sampling for vegetable oils at retail stage K.3.Acceptance of a lot or sublot L.METHOD OF SAMPLING FOR VERY LARGE LOTS OR LOTS STORED...L.1.General principles L.2.Number of incremental samples to be taken in the case...L.3.Large lots transported by ship L.3.1.Dynamic sampling of large lots transported by ship L.3.2.Sampling of lots transported by ship by static sampling L.4.Sampling of large lots stored in warehouses L.5.Sampling of storage facilities (silos) L.5.1.Sampling of silos (easily) accessible from above L.5.2.Sampling of silos not accessible from above (closed silos) L.5.2.1.Silos not accessible from above (closed silos) with individual sizes...L.5.2.2.Silos not accessible from above (closed silos) with individual sizes...L.6.Sampling of loose food in large closed containers M.METHOD OF SAMPLING OF FOOD SUPPLEMENTS BASED ON RICE FERMENTED...Sampling procedure and sample size
ANNEX IICRITERIA FOR SAMPLE PREPARATION AND FOR METHODS OF ANALYSIS USED FOR THE OFFICIAL CONTROL OF THE LEVELS OF MYCOTOXINS IN FOODSTUFFS
1.INTRODUCTION 1.1.Precautions 1.2.Calculation of proportion of shell/kernel of whole nuts 2.TREATMENT OF THE SAMPLE AS RECEIVED IN THE LABORATORY 3.REPLICATE SAMPLES 4.METHOD OF ANALYSIS TO BE USED BY THE LABORATORY AND...4.1.Definitions 4.2.General requirements 4.3.Specific requirements 4.3.1.Specific requirements for confirmatory methods 4.3.1.1.Performance criteria 4.3.1.2.‘ Fitness-for-purpose ’ approach 4.3.2.Specific requirements for semi-quantitative screening methods 4.3.2.1.Scope 4.3.2.2.Terminology 4.3.2.3.Validation procedure 4.3.2.3.1.Initial validation by single laboratory validation 4.3.2.3.2.Initial validation through collaborative trials 4.3.2.4.Determination of cut-off level and rate of false suspected results...4.3.2.5.Extension of the scope of the method 4.3.2.5.1.Extension of scope to other mycotoxins: 4.3.2.5.2.Extension to other commodities: 4.3.2.6.Verification of methods already validated through collaborative trials 4.3.2.7.Continuous method verification/on-going method validation 4.3.2.8.Validation report 4.3.3.Requirements for qualitative screening methods (methods that do not give...4.4.Estimation of measurement uncertainty, recovery calculation and reporting of results...4.4.1.Confirmatory methods 4.4.2.Screening methods 4.5.Laboratory quality standards

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules1, in particular Article 11(4),

Whereas:

(1)

Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs2 provides for maximum limits for certain mycotoxins in certain foodstuffs.

(2)

Sampling plays a crucial part in the precision of the determination of the levels of mycotoxins, which are very heterogeneously distributed in a lot. It is therefore necessary to fix general criteria which the sampling method should comply with.

(3)

It is also necessary to fix general criteria which the method of analysis should comply with in order to ensure that control laboratories use methods of analysis with comparable levels of performance.

(4)

Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs3 establishes sampling methods and performance criteria for the methods of analysis to be used for the official control of levels of aflatoxins in foodstuffs.

(5)

Commission Directive 2002/26/EC of 13 March 2002 laying down the sampling methods and the methods of analysis for the official control of the levels of ochratoxin A in foodstuffs4, Commission Directive 2003/78/EC of 11 August 2003 laying down the sampling methods and the methods of analysis for the official control of the levels of patulin in foodstuffs5 and Commission Directive 2005/38/EC of 6 June 2005 laying down the sampling methods and the methods of analysis for the official control of the levels of Fusarium-toxins in foodstuffs6 similarly establish sampling methods and performance criteria for ochratoxin A, patulin and Fusarium-toxins respectively.

(6)

It is appropriate to apply whenever possible the same sampling method to the same product for the control of mycotoxins. Therefore, the sampling methods and performance criteria for the methods of analysis to be used for the official control of all mycotoxins should be brought together in a single legal act in order to make them easier to apply.

(7)

Aflatoxins are very heterogeneously distributed in a lot, in particular in a lot of food products with a large particle size such as dried figs or groundnuts. In order to obtain the same representativeness, for batches with food products with large particle size, the weight of the aggregate sample should be larger than in case of batches with food products with a smaller particle size. Since the distribution of mycotoxins in processed products is generally less heterogeneous than in the unprocessed cereal products, it is appropriate to provide for simpler sampling provisions for processed products.

(8)

Directives 98/53/EC, 2002/26/EC, 2003/78/EC and 2005/38/EC should therefore be repealed.

(9)

It is appropriate that the date of application of this Regulation coincides with the date of application of Commission Regulation (EC) No 856/2005 of 6 June 2005 amending Regulation (EC) No 466/2001 as regards Fusarium toxins7.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION: