1. Consumers, Health And Food Executive Agency Sampling methods for agricultural contaminants of food and feed (Summary) 1

2. Consumers, Health And Food Executive Agency EU FOOD legislation on sampling 2

3. Consumers, Health And Food Executive Agency Commission regulation (EC) 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 Commission regulation (EC) 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 amended by Commission Regulation (EU) n. 178/2010 amending regulation (EC) 401/2006 as regards groundnuts (peanuts), other oilseeds, tree nuts, apricot kernels, liquorice and vegetable oil Commission Regulation (EU) n. 178/2010 amending regulation (EC) 401/2006 as regards groundnuts (peanuts), other oilseeds, tree nuts, apricot kernels, liquorice and vegetable oil Commission Regulation (EU) n. 519/2014 of 16 May 2014 amending Regulation (EC) No 401/2006 as regards methods of sampling of large lots, spices and food supplements, performance criteria for T- 2, HT-2 toxin and citrinin and screening methods of analysis EU legislation on Sampling - Mycotoxins 3

4. Consumers, Health And Food Executive Agency Regulation (CE) 333/2007 of 28 March 2007 (Pb, Cd, Hg, Sn, 3-MCPD and benzo(a)pyrene) Regulation (CE) 1882/2006 of 19 December 2006 (Nitrates) EU legislation on Sampling – other Agri-contaminants 4

5. Consumers, Health And Food Executive Agency Population SAMPLE SAMPLE ANALYSIS Extension of the result to the whole population = INFERENCE SAMPLING By definition “Sampling” is a process implying the collection of an aggregate sample from the whole population in order to verify through analysis, the compliance with feed or food law or animal health rules. The main objective of a reliable sampling plan is to collect data from a sample from which it is possible to extend the acquired information to the whole population. In statistics this process is called «inference». Definition and meaning 5

6. Consumers, Health And Food Executive Agency Preliminary remark For unevenly distributed analytes for instance, wrong sampling procedures can grossly affect the trueness and the reliability of the analytical measurements Sampling variance is the most relevant contributor to the total variance for analytes heterogeneously distributed in bulk commodities Control activities are made to establish the compliance of a LOT and NOT of the analytical sample 6

7. Consumers, Health And Food Executive Agency ProductLevelRole of sampling GrainVery high+++++ FlourModerately high+++ Liquid (oil, milk)None- PasteNone- Level of Heterogeneity Control of Heterogeneously distributed analytes in F/F 7

8. Consumers, Health And Food Executive Agency 8 From the DG SANTE Orientation document http://ec.europa.eu/food/food/chemicalsafety/contaminan ts/docs/guidance-2010.pdf.. Enforcement sample Defence sample Reference sample ISAS

9. Consumers, Health And Food Executive Agency Groundnuts – Reg. EC/178/2010 9

10. Consumers, Health And Food Executive Agency Sampling of groundnuts, other oilseeds, apricot kernels and tree nuts for direct human consumption. Example of a Lot weight of 15 T From the DG SANTE Orientation document – WEB page: http://ec.europa.eu/food/food/chemicalsafety/contaminants/d ocs/guidance-2010.pdf 10 Special case

11. Consumers, Health And Food Executive Agency Four approaches can be identified within the Member States if the defence sample generates a compliant result 1.the consignment is considered compliant and released (the result of the defence samples supersedes the outcome of the official result). This approach is followed in France, Greece, Sweden, Belgium, and Finland 2.the reference sample is analysed in the national reference laboratory. If the analytical result is compliant with the legislation, the consignment is considered compliant and released. This approach is followed in UK, Estonia, Hungary, Spain, Poland, Czech Republic, The Netherlands, Portugal, Ireland, Slovak Republic, Romania, Italy, and Latvia Right of second opinion in case of non-compliance

12. Consumers, Health And Food Executive Agency Four approaches can be identified within the Member States if the defence sample generates a compliant result 3.the operator must challenge the analytical result of the official sample before a Court. This approach is followed in Denmark, Slovenia, Germany, Luxembourg, and Lithuania 4.the operator must demonstrate that the consignment is compliant by organising at least an additional sampling of the lot and analysis of these samples by an accredited laboratory, associated with an expert approved by the competent authority to carry out expertise on such samples taken during official controls. If the analytical result is compliant with the legislation, the rest of the consignment is considered compliant and released. This approach is followed in Austria. Right of second opinion in case of non-compliance

13. Consumers, Health And Food Executive Agency Groundnuts – Reg. EC/178/2010 13

14. Consumers, Health And Food Executive Agency 14 Acceptance criteria of a lot (Reg. EC/401 – 333 - 1882)

15. Consumers, Health And Food Executive Agency Spices 15 Only for nutmeg, the same sampling procedure of PEANUTS must be used Large lots of cereals Number of incremental samples= 100+ Equivalence between ISO EN 24333:2009 and GAFTA Rules 124 with Regulation 519/2014 (For FBO) t Mycotoxins – New Regulation 519/2014

16. Consumers, Health And Food Executive Agency Mycotoxins – New Regulation 519/2014 16 Sampling of a part of the lot is ALLOWED, on the condition that the quantity of the sampled portion is at least 10% of the lot to be sampled. If the sampling procedure is questioned by the FBO, CA shall be allowed to sample throughout the whole lot, at owner’s cost

17. Consumers, Health And Food Executive Agency From DG SANCO Guidance document Article 14(6) of Regulation (EC) 178/2002 provides that “where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe”. However this article is not detrimental to the right of a second opinion for the operator as provided for in Article 11(5) of Regulation (EC) 882/2004. II.5.1 Consignment/lot of several containers 17

18. Consumers, Health And Food Executive Agency Regulation 401/2006 - Sampling at retail For units more than 100 grams, the aggregate samples weighs more than 10 kg. For unit size more than 100 grams, then 100 grams shall be taken from each individual unit as an IS. In case where a valuable product is marketed in retail packs of 500 grams or 1 kg, the AS can be obtained by a lower number of incremental samples than the number indicated in the Regulation, on the condition that the weight of AS is equal to the required weight of the AS. Where the unit is less than 100 grams and if the difference is not very large, one retail pack is to be considered as one incremental sample, even if it results in an aggregate sample of less than 10 kg. If the weight of the unit is much less than 100 grams, one IS consists of two or more units, whereby the 100 grams are approximated as closely as possible. 18

19. Consumers, Health And Food Executive Agency EU Legislation on feeds sampling Regulation EU/691/2013 of 19 July 2013 amending Regulation EC/152/2009 as regards methods of sampling and analysis -Field of application (GMOs, Additives, Undesirable substances, Pesticides) -Quantitative requirements regarding the number of IS, AS and FS -Specific sampling provisions for large lots 19

20. Consumers, Health And Food Executive Agency Quantitative requirements for IS Uniformly distributed substances in for feed sampled portion ≤500t Type of feedSize of Sampled PortionMinimum number of IS Loose solid feed≤2,5t7 >2,5t Loose liquid feed≤2,5t or ≤2,500 lt4 >2,5t or >2,500 lt7 Packaged feed1-20 units1 unit 21-150 units3 units 151-400 units5 units > 400 units¼ of the √n.units, up to 40 Roughages/forage≤5t5 >5t√5 x t, up to 40 20 Regulation EU/691/2013 20 x t up to 40 FEEDS

21. Consumers, Health And Food Executive Agency Type of feedSize of Sampled PortionMinimum number of IS Any type ≤80t SEE UNIFORMLY DISTRIBUTED SUBSTANCES IN FEED (previous slide BUT MULTIPLIED by 2,5) > 80t100 21 Non-uniformly distributed substances for feed sampled portion ≤500t Quantitative requirements for IS Regulation EU/691/2013

22. Consumers, Health And Food Executive Agency Peanuts – Reg. EC/178/2010 22

23. Consumers, Health And Food Executive Agency Exercise 1 Lot weight: 8 tons of shelled peanuts intended for human consumption Contaminant: Aflatoxins Number of Incremental Samples Weight of Aggregate Sample: Number of Laboratory Samples Acceptance/rejection criterion: direct

24. Consumers, Health And Food Executive Agency Quantitative requirements for IS Uniformly distributed substances in for feed sampled portion ≤500t Type of feedSize of Sampled PortionMinimum number of IS Loose solid feed≤2,5t7 >2,5t√20 x t, up to 40 Loose liquid feed≤2,5t or ≤2,500 lt4 >2,5t or >2,500 lt7 Packaged feed1-20 units1 unit 21-150 units3 units 151-400 units5 units > 400 units¼ of the √n.units, up to 40 Roughages/forage≤5t5 >5t√5 x t, up to 40 24

25. Consumers, Health And Food Executive Agency Type of feedSize of Sampled PortionMinimum number of IS Any type ≤80t SEE UNIFORMLY DISTRIBUTED SUBSTANCES IN FEED (previous slide BUT MULTIPLIED by 2,5) > 80t100 25 Non-uniformly distributed substances for feed sampled portion ≤500t Quantitative requirements for IS

26. Consumers, Health And Food Executive Agency Undesirable substance Sampled portion (t) Number of ISWeight of each IS (g) Weight of AS (kg or L) Homogeneously distributed 60 NON_homogeneousl y distributed 60 26 Exercise 2 – Loose solid feed