EN Official Journal of the European Union L 364/32

COMMISSION REGULATION (EC) No 1883/2006

of 19 December 2006

laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain 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 rules (1), and in particular Article 11 (4) thereof,

Whereas:

(1) Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (2) provides for maximum levels for dioxins and furans and for the sum of dioxins, furans and dioxin-like PCBs in certain foodstuffs.

(2) Commission Directive 2002/69/EC of 26 July 2002 laying down the sampling methods and the methods of analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs (3) establishes specific provisions concerning the sampling procedure and the methods of analysis to be applied for the official control.

(3) The application of new maximum levels for the sum of dioxins, furans and dioxin-like PCBs requires amendments to Directive 2002/69/EC. For reasons of clarity, it is appropriate to replace Directive 2002/69/EC by this Regulation.

(4) The provisions laid down in this Regulation relate only to the sampling and analysis of dioxins and dioxin-like PCBs for the implementation of Regulation (EC) No 1881/2006 and do not affect the sampling strategy, sampling levels and frequency as specified in Annexes III and IV of 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 (4). They do not affect the targeting criteria for sampling as laid down in 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 (5).

(5) A screening method of analysis with proven, widely acceptable validation and high throughput should be used to select the samples with significant levels of dioxins and dioxin-like PCBs. The levels of dioxins and dioxin-like PCBs in these samples need to be determined by a confirmatory method of analysis. It is therefore appropriate to establish strict requirements for the confirmatory methods of analysis and minimum requirements for the screening method.

(6) For the sampling of very large fishes, it is necessary that the sampling is specified in order to ensure a harmonised approach throughout the Community.

(7) In fishes of the same species and originating from the same region, the level of dioxins and dioxin-like PCBs in the fish can be different dependent on the size and or age of the fish. Moreover the level of dioxins and dioxin-like PCBs is not necessarily the same in all parts of the fish. Therefore in case of sampling of fishes, it is necessary that the sampling and sample preparation is specified in order to ensure a harmonised approach throughout the Community.

(8) It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach throughout the Community.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Sampling for the official control of the levels of dioxins, furans and dioxin-like PCBs in foodstuffs listed in Section 5 of the Annex to Regulation (EC) No 1881/2006 shall be carried out in accordance with the methods set out in Annex I to this Regulation.

Article 2

Sample preparation and analyses for the official control of the levels of dioxins, furans and dioxin-like PCBs in foodstuffs listed in Section 5 of the Annex to Regulation (EC) No 1881/2006 shall be carried out in accordance with the methods set out in Annex II to this Regulation.

Article 3

Directive 2002/69/EC is hereby repealed. References to the repealed Directive shall be construed as references to this Regulation.

Article 4

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 March 2007.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 19 December 2006. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 165, 30.4.2004, p. 1, as corrected by OJ L 191, 28.5.2004, p. 1. Regulation amended by Commission Regulation (EC) No 776/2006 (OJ L 136, 24.5.2006, p. 3).

(2) See page 5 of this Official Journal.

(3) OJ L 209, 6.8.2002, p. 5. Directive as last amended by Directive 2004/44/EC (OJ L 113, 20.4.2004, p. 17).

(4) OJ L 125, 23.5.1996, p. 10. Directive as last amended by Regulation (EC) No 882/2004 of the European Parliament and of the Council (OJ L 165, 30.4.2004, p. 1, as corrected by OJ L 191, 28.5.2004, p. 1).

(5) OJ L 65, 5.3.1998, p. 31. Decision as amended by the 2003 Act of Accession.

ANNEX I METHODS OF SAMPLING FOR OFFICIAL CONTROL OF LEVELS OF DIOXINS (PCDD/PCDF) AND DIOXIN-LIKE PCBs IN CERTAIN FOODSTUFFS 1. SCOPE Samples intended for the official control of the levels of dioxins (PCDD/PCDF) and dioxin like PCBs in foodstuffs shall be taken according to the methods described in this Annex. Aggregate samples thus obtained shall be considered as representative of the lots or sublots from which they are taken. Compliance with maximum levels laid down in Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs shall be established on the basis of the levels determined in the laboratory samples. 2. DEFINITIONS Lot: an identifiable quantity of food delivered at one time and determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings. In the case of fish and fishery products, also the size of fish shall be comparable. In case the size and/or weight of the fish is not comparable within a consignment, the consignment may still be considered as a lot but a specific sampling procedure has to be applied. — Sublot: designated part of a large lot in order to apply the sampling method on that designated part. Each sublot must be physically separated and identifiable. — Incremental sample: a quantity of material taken from a single place in the lot or sublot. — Aggregate sample: the combined total of all the incremental samples taken from the lot or sublot. — Laboratory sample: a representative part/quantity of the aggregate sample intended for the laboratory. 3. GENERAL PROVISIONS 3.1. Personnel Sampling shall be performed by an authorised person as designated by the Member State. 3.2. Material to be sampled Each lot or sublot, which is to be examined, shall be sampled separately. 3.3. Precautions to be taken In the course of sampling and preparation of the samples, precautions shall be taken to avoid any changes, which would affect the content of dioxins and dioxin-like PCBs, adversely affect the analytical determination or make the aggregate samples unrepresentative. 3.4. Incremental samples As far as possible incremental samples shall be taken at various places distributed throughout the lot or sublot. Departure from such procedure shall be recorded in the record provided for under part 3.8 of this Annex. 3.5. Preparation of the aggregate sample The aggregate sample shall be made up by combining the incremental samples. It shall be at least 1 kg unless not practical, e.g. when a single package has been sampled. 3.6. Replicate samples The replicate samples for enforcement, defence and reference purposes shall be taken from the homogenised aggregate sample, unless such procedure conflicts with Member States’ rules as regard the rights of the food business operator. The size of the laboratory samples for enforcement shall be sufficient to allow at least for duplicate analyses. 3.7. Packaging and transmission of samples Each sample shall be placed in a clean, inert container offering adequate protection from contamination, from loss of analytes by adsorption to the internal wall of the container and against damage in transit. All necessary precautions shall be taken to avoid any change in composition of the sample, which might arise during transportation or storage. 3.8. Sealing and labelling of samples Each sample taken for official use shall be sealed at the place of sampling and identified following the rules of the Member States. A record shall be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst. 4. SAMPLING PLANS The sampling method applied shall ensure that the aggregate sample is representative for the (sub)lot that is to be controlled. 4.1. Division of lots into sublots Large lots shall be divided into sublots on condition that the sublot can be separated physically. For products traded in large bulk consignments (e.g. vegetable oils) Table 1 shall apply. For other products Table 2 shall apply. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %. Table 1 Subdivision of lots into sublots for products traded in bulk consignments Lot weight (ton) Weight or number of sublots ≥ 1 500 500 tonnes > 300 and < 1 500 3 sublots ≥ 50 and ≤ 300 100 tonnes < 50 —

Table 2 Subdivision of lots into sublots for other products Lot weight (ton) Weight or number of sublots ≥ 15 15-30 tonnes < 15 — 4.2. Number of incremental samples The aggregate sample uniting all incremental samples shall be at least 1 kg (see part 3.5 of this Annex). The minimum number of incremental samples to be taken from the lot or sublot shall be as given in Tables 3 and 4. In the case of bulk liquid products the lot or sublot shall be thoroughly mixed insofar as possible and insofar it does not affect the quality of the product, by either manual or mechanical means immediately prior to sampling. In this case, a homogeneous distribution of contaminants is assumed within a given lot or sublot. It is therefore sufficient to take three incremental samples from a lot or sublot to form the aggregate sample. The incremental samples shall be of similar weight. The weight of an incremental sample shall be at least 100 grams. Departure from this procedure must be recorded in the record provided for under part 3.8 of this Annex. In accordance with the provisions of Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products (1), the aggregate sample size for hen eggs is at least 12 eggs (for bulk lots as well for lots consisting of individual packages, Tables 3 and 4). Table 3 Minimum number of incremental samples to be taken from the lot or sublot Weight or volume of lot/sublot (in kg or litre) Minimum number of incremental samples to be taken < 50 3 50 to 500 5 > 500 10 If the lot or sublot consists of individual packages or units, then the number of packages or units which shall be taken to form the aggregate sample is given in Table 4. Table 4 Number of packages or units (incremental samples) which shall be taken to form the aggregate sample if the lot or sublot consists of individual packages or units Number of packages or units in the lot/sublot Number of packages or units to be taken 1 to 25 at least 1 package or unit 26 to 100 about 5 %, at least 2 packages or units > 100 about 5 %, at maximum 10 packages or units 4.3. Specific provisions for the sampling of lots containing whole fishes of comparable size and weight Fishes are considered as being of comparable size and weight in case the difference in size and weight does not exceed about 50 %. The number of incremental samples to be taken from the lot are defined in Table 3. The aggregate sample uniting all incremental samples shall be at least 1 kg (see point 3.5). — In case the lot to be sampled contains small fishes (individual fishes weighing < about 1 kg), the whole fish is taken as incremental sample to form the aggregate sample. In case the resulting aggregate sample weighs more than 3 kg, the incremental samples may consist of the middle part, weighing each at least 100 grams, of the fishes forming the aggregate sample. The whole part to which the maximum level is applicable is used for homogenisation of the sample. The middle part of the fish is where the centre of gravity is. This is located in most cases at the dorsal fin (in case the fish has a dorsal fin) or halfway between the gill opening and the anus. — In case the lot to be sampled contains larger fishes (individual fishes weighing more than about 1 kg), the incremental sample consists of the middle part of the fish. Each incremental sample weighs at least 100 grams. For fishes of intermediate size (about 1 to 6 kg) the incremental sample is taken as a slice of the fish from backbone to belly in the middle part of the fish. For very large fishes (e.g. > about 6 kg), the incremental part is taken from the right side (frontal view) dorso-lateral muscle meat in the middle part of the fish. In case the taking of such a piece of the middle part of the fish would result in a significant economic damage, taking of three incremental samples of at least 350 grams each may be considered as being sufficient, independently of the size of the lot or alternatively an equal part of the muscled meat close to the tail part and the muscle meat close to the head part of one fish may be taken to form the incremental sample being representative for the level of dioxins in the whole fish. 4.4. Sampling of lots of fish containing whole fishes of different size and/or weight — The provisions of point 4.3 as regards sample constitution are applicable. — In case a size or weight class/category is predominant (about 80 % or more of the batch), the sample is taken from fishes with the predominant size or weight. This sample is to be considered as being representative for the whole batch. — In case no particular size or weight class/category predominates, then it must be ensured that the fishes selected for the sample are representative for the consignment. Specific guidance for such cases is provided in ‘Guidance document for the sampling of lots of fish containing whole fishes of different size and/or weight (2).’ 4.5. Sampling at retail stage Sampling of foodstuffs at retail stage shall be done where possible in accordance with the sampling provisions set out in part 4.2 of this Annex. Where this is not possible, an alternative method of sampling at retail stage may be used provided that it ensures sufficient representativeness for the sampled lot or sublot. 5. COMPLIANCE OF THE LOT OR SUBLOT WITH THE SPECIFICATION The lot is accepted if the analytical result of a single analysis does not exceed the respective maximum level of dioxins and the sum of dioxins and dioxin-like PCBs as laid down in Regulation (EC) No 1881/2006 taking into account the measurement uncertainty. The lot is non-compliant with the maximum level as laid down in Regulation (EC) No 1881/2006, if the upperbound (3) analytical result, confirmed by duplicate analysis (4), exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty. The taking into account of the measurement uncertainty may be done according to one of the following approaches: — by calculating the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %. A lot or sublot is non-compliant if the measured value minus U is above the established permitted level. In case of a separate determination of dioxins and dioxin-like-PCBs the sum of the estimated expanded uncertainty of the separate analytical results of dioxins and dioxin-like PCBs has to be used for the sum of dioxins and dioxin-like PCBs, — by establishing the decision limit (CCα) according to the provisions of Commission Decision 2002/657/EC of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (5) (point 3.1.2.5 of the Annex — the case of substances with established permitted level) a lot or sublot is non-compliant if the measured value is equal to or above the CCα. The present interpretation rules apply for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply. (1) OJ L 303, 6.11.1997, p. 12. (2) http://ec.europa.eu/food/food/chemicalsafety/contaminants/dioxins_en.htm (3) The concept of ‘upperbound’ requires using the limit of quantification for the contribution of each non-quantified congener to the Toxic Equivalent (TEQ). The concept of ‘lowerbound’ requires using zero for the contribution of each non-quantified congener to the TEQ. The concept of ‘mediumbound’ requires using half of the limit of quantification calculating the contribution of each non-quantified congener to the TEQ. (4) The duplicate analysis is necessary to exclude the possibility of internal cross-contamination or an accidental mix-up of samples. The first analysis, taking into account the measurement uncertainty is used for verification of compliance. In case the analysis is performed in the frame of a dioxin contamination incident, confirmation by duplicate analysis might be omitted in case the samples selected for analysis are through traceability linked to the dioxin contamination incident. (5) OJ L 221, 17.8.2002, p. 8. Decision as amended by Decision 2004/25/EC (OJ L 6, 10.1.2004, p. 38).