final report of a mission carried out in brazil from 15 to 24 march ...

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perform routine analyses. According to the CGAL, however, it is in the final stages of submitting arequest for accreditation to standard ISO 17025 by the National Accreditation Body (INMETRO).The mission team noted in the establishments visited that in-house control samples are sent to the 2authorised private laboratories in São Paulo State and a minimum of 8 days are required to receiveresults from these laboratories.The mission team visited the 2 private laboratories.One laboratory is located in Santos. It focuses on inspections and quality certification. Thelaboratory performs chemical analyses for e.g. pesticide residues, GMO and mycotoxins. Thelaboratory is accredited to ISO 17025 by INMETRO. The accreditation certificate was issued on 23September 2008 and is valid until 11 October 2010. The mission team was informed that themethod used for the determination of aflatoxins B1, B2, G1, G2 and total aflatoxins was validatedfor peanuts, but not yet for Brazil nuts. However, the laboratory stated that a similar procedure wasfollowed for the analysis of Brazil nuts. The procedure is in full conformity with European standardEN 12955, using HPLC, Kobra cell and fluorescence detection. LOQ values were around 0.4 μg/kg,well below the limits set in Regulation (EC) No 1881/2006. Calibration curves are constructeddaily, recovery is checked daily and samples are run together with the calibration curve and arecovery check (spiked and blank samples). The laboratory participates in the AOCS LaboratoryProficiency Programme for peanut and corn samples, at a frequency of 8 times per year, as Brazilnut samples are not available. The expanded measurement uncertainty is 25 %, calculated accordingto the 2000 EURACHEM guide. Confirmation of results is based on the uniqueness of the immunoassay,the retention time and the use of control samples. The recovery, the corrected analytical resultand the expanded measurement uncertainty are reported.The whole sample is homogenised. Depending on sample size, an appropriate milling device isused. Up to 3 kg, a meat mincing mill is employed. Above 3 kg, a slurry mixer is used. According tothe Standard Operating Procedure (SOP), a minimum amount of 3 kg is requested, although an idealsize of 10 kg is prescribed. For Brazil nuts, this amount is meant to be without shell. All of thesample is slurried, with a sample/water ratio of 10:15. Four samples are taken from the slurry, foranalysis, reference and defence purposes. The homogenisation process was tested once with asample. A sample of nuts is analysed without shell. If it is delivered with shell, it is unshelled beforeanalysis. The complete unshelled sample is analysed, so without any sorting.The mission team visited a second private laboratory in Sao Paolo. This laboratory had already beenvisited during the first FVO mission to Brazil concerning Brazil nuts in 2003 (SANCO/9027/2003)and the second FVO mission in 2004 (SANCO/7074/2004). The laboratory was accredited byINMETRO to ISO 17025. The accreditation certificate was issued on 25 August 2008 and was validuntil 25 August 2011. The mission team was informed that the method used for the determination ofaflatoxins B1, B2, G1, G2 and total aflatoxins was validated for peanuts and validation for Brazilnuts was ongoing. It is a TLC method, in conformity with method 970.44 of the Official Methods ofAnalysis issued by AOAC International, 18 th edition, 2005. The SOP reported LOQ values of 0.5μg/kg for aflatoxins B1 and G1 and 0.25 for B2 and G2 in Brazil nuts, well below the limits set inregulation (EC) No 1881/2006.Samples are all dry-milled. Up to 3 kg, a meat mincing mill is used, after which furtherhomogenisation is performed using a Stephan mill. For samples up to 30 kg (until now onlyrelevant for peanut samples), portions are first milled in a Stephan mill and then transferred to acement mixer. When the entire pre-milled sample is in the cement mixer, it is homogenised furtherand samples are then taken for analysis, reference and defence purposes. The homogenisationprocess was tested once. A sample of nuts is analysed without shell. If it is delivered with shell, it isunshelled before analysis. The complete unshelled sample is analysed, without any prior sorting.Positive samples are re-run on a second TLC plate, together with calibration standards and a control11
sample. The analytical result is reported together with the recovery. The expanded measurementuncertainty is not reported. Some preliminary calculations (based on an INMETRO method derivedfrom the Eurachem 2000 document) are available, giving 12 % at the LOQ level, but these have tobe confirmed before they are used in the analysis certificates. According to the CCA, the laboratorywas instructed by the CCA to express the measurement uncertainty on the reports of analysis inproducts destined to export to Europe. For other destinations, the report of uncertainty measurementis not mandatory.The mission team was informed by both the laboratories visited that they have difficultiesparticipating in international proficiency test schemes such as FAPAS. This is due to problems withcustoms clearance for the test material. Consequently, the laboratory in São Paulo was able toparticipate in only one FAPAS proficiency test in 2007. Every 3 months they send samples toanother laboratory (using an HPLC method) to obtain confirmation. They performed well in therecent proficiency test by LACQSA/LANAGRO-MG (4 nut samples in 2009 at levels of 0.25-0.5μg/kg). 5ConclusionsThere are three laboratories in Brazil authorised for official Brazil nut analysis, all accredited to ISO17025 however none of them in the area where Brazil nuts are produced and processed.The procedures in place for Brazil nut analysis as observed by the mission team are in accordancewith the criteria established in Commission Regulation (EC) No 401/2006.5.8 RESPONSE TO RASFF NOTIFICATIONSFindingsThe Department of Sanitary and International Relations (DNSF) within MAPA’s Secretariat ofAgribusiness International Relations is the national contact point for the RASFF system. TheDNSF’s coordination unit for Europe and Mercosur affairs is responsible for the daily managementof RASFF notifications received via the RASFF window from the Commission’s RASFF services.Under the RASFF procedure, DNSF forwards all RASFF notifications concerning Brazil nuts toDIPOV at MAPA, which is responsible for follow-up. The results of the follow-up or any requestfor further information, such as details of the consignment or results of the Member State laboratoryanalysis, are communicated to the Commission’s RASFF services directly via the RASFF windowor, if necessary, via the Ministry of External Relations.There are documented procedures in place for RASFF follow-up by DIPOV. The follow-up startswith a request by DIPOV to the company concerned to provide information on the notifiedconsignments. This may also include evidence of internal company controls such as sampling foraflatoxins. The mission team noted that generally no deadline is given to companies to provide therequired information, although Administrative Order No 53/2009 sets a deadline of 6 months forcompletion of the entire follow-up procedure. For RASFF notifications in September 2009(2009.BSQ, 2009.BSP, 2009.BSO and 2009.BSM) concerning in-shell Brazil nuts, the mission teamobserved that no information had yet been received by DIPOV, so the investigation was stillongoing. 65 In their response to the draft report the Brazilian Authorities noted that a workshop with the involved customs bodies(MAPA, ANVISA and federal Revenue) was held in 2009 in order to train the responsible for imports and clarifydoubts about the procedures for the import of laboratory inputs. An imports guideline considering the procedures ofthe 3 bodies mentioned is in its final steps of elaboration, in order to simplify the process and solve difficulties.These guidelines were put to the test on a Trial Run with real FAPAS samples in June 2010, and the customsclearance were successful with rapidity in at least 90% of them.6 In their response to the draft report the Brazilian Authorities noted that the result of the investigation of thementioned RASFFs were already forwarded to the EU for knowledge.12
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