EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2012) /10/2012 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN BRAZIL FROM 23 TO 31 MAY 2012 IN ORDER TO EVALUATE POST HARVEST TREATMENTS OF FOOD OF PLANT ORIGIN INTENDED FOR EXPORT TO THE EUROPEAN UNION

2 Executive Summary This report describes the outcome of a Food and Veterinary Office (FVO) audit in Brazil, carried out between 23-31May The objectives of the audit were to evaluate the post harvest treatment (PHT) of food of plant origin intended for export to the European Union (EU) and to follow up on the last pesticide mission undertaken in 2009 by Health and Consumers Directorate General (DG SANCO). For the purpose of this audit the term PHT refers to the use of plant protection products (PPPs) and food additives (FAs), including those not authorised in the EU such as morpholine, during storage, processing, packaging and transport of fruit. Overall progress has been made in relation to the follow up of recommendations from Mission DG(SANCO) relating to PPPs. The official controls undertaken by the Ministry of Agriculture, Livestock and Food Supply for post harvest PPP use were considered unsatisfactory. In relation to official controls of FA used as post harvest treatments there are a number of serious omissions; there is no authorisation / approval of wax products containing FAs, there is no programme for monitoring or undertaking official controls in the area of FAs in fruit exported to the EU. The official control system cannot ensure that fresh fruit imported into the EU from Brazil fully complies, in the area of PHTs, with the relevant requirements of food law or conditions recognised by the EU to be at least equivalent thereto as required by Article 11 of Regulation (EC) No 178/2002. The report makes a number of recommendations to the competent authorities, aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES AND SCOPE LEGAL BASIS AND STANDARDS LEGAL BASIS STANDARDS AND GUIDELINES BACKGROUND FINDINGS AND CONCLUSIONS RELEVANT NATIONAL LEGISLATION COMPETENT AUTHORITIES OFFICIAL CONTROLS OF POST HARVEST TREATMENTS LABORATORY SERVICES NON COMPLIANT PRODUCTS AND RESPONSE TO RASFF NOTIFICATIONS OVERALL CONCLUSION CLOSING MEETING RECOMMENDATIONS...14 ANNEX 1 - LEGAL REFERENCES...16 ANNEX 2 STANDARDS QUOTED IN THE REPORT...17 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ADAGRO ANVISA CA(s) CAC CCA(s) CGAL CODEX DG (SANCO) DIPOV EU FA(s) FBO(s) FNAO FVO GL(s) INMETRO ISO LANAGRO Explanation Secretariat for Animal and Plant Health Inspection of the State of Pernambuco National Health Surveillance Agency Competent Authority(ies) Codex Alimentarius Commission Central Competent Authority(ies) General Co-ordination of Laboratory Supply Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and World Health Organization Health and Consumers Directorate-General Department of Inspection of Plant Origin Products European Union Food Additive(s) Food Business Operator(s) Food of Non Animal Origin Food and Veterinary Office Guideline(s) National Institute of Meteorology, Normalization and Industrial Quality International Organisation for Standardisation National Agriculture and Livestock Laboratories of MAPA III

5 MAPA MRL(s) MS(s) PHT(s) PNCRC/Vegetal PPP(s) PT(s) RASFF SDA SFA TC(s) Ministry of Agriculture, Livestock and Food Supply Maximum Residue Level(s) Member State(s) Post Harvest Treatment(s) National Plan for the control of Residues and Contaminants in Plant Origin Products Plant Protection Product(s) Proficiency Test(s) Rapid Alert System for Food and Feed Secretariat of Animal and Plant Health and Inspection Services of Inspection of Agricultural and Livestock Products of the State Agriculture Secretariat Third Country(ies) IV

6 1 INTRODUCTION The audit took place in Brazil from May 2012 in order to assess controls on post harvest treatments (PHTs) of food of non animal origin (FNAO) intended for export to the European Union (EU) and to follow up the Health and Consumers Directorate-General DG (SANCO) mission published as DG (SANCO) The audit team comprised two auditors from the Food and Veterinary Office (FVO) and one Member State (MS) expert. The audit was undertaken as part of the FVO's annual audit programme in the context of a wider series of audits in third countries (TCs) to evaluate control systems and operational standards in this sector. The FVO team was accompanied during the audit by a representative of the central competent authority (CCA) the Ministry of Agriculture, Livestock and Food Supply (MAPA). An opening meeting was held on the 23 May 2012 with representatives of the MAPA and the National Health Surveillance Agency (ANVISA), the Department of Inspection of Plant Origin Products (DIPOV) At this meeting, the objectives of and itinerary for the audit were confirmed. 2 OBJECTIVES AND SCOPE The objectives of the audit was to evaluate: the PHT of food of plant origin intended for export to the European Union to follow up on the recommendations of pesticide mission DG (SANCO) For the purpose of this audit the term PHT refers to the use of plant protection products (PPPs) and food additives (FAs), including those not authorised in the EU such as morpholine, during storage, processing, packaging and transport of fruit. In terms of scope, the audit reviewed the controls in place for PHTs of fruit intended for export to the EU, including a review of national legislation, competent authorities (CAs) organisation, their controls and enforcement capability, facilities and measures in place for the determination of pesticide residues and morpholine. As regards products concerned, the audit covered papaya and mangoes. In pursuit of these objectives, the following sites were visited: Table 1: Audit meetings and visits. Competent Authorities Comments Competent Authority Central 3 MAPA, ANVISA, DIPOV Laboratory Private Approved Laboratories 1 Pesticides Laboratory Establishments Fruit Producers 2 1 Producer of Mangoes 1 Producer of Papaya 1

7 Exporters / Packhouses 3 Fruit processing and exporting companies using PHTs 3 LEGAL BASIS AND STANDARDS 3.1 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in particular Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council which stipulates that EU controls in TCs may verify compliance or equivalence of TC legislation and systems with EU feed and food law and EU animal health legislation. These controls shall have particular regard to the assurances which the TC can give regarding compliance with, or equivalence to, EU requirements. EU legal acts quoted in this report refer, where applicable, to the last amended version. Full references to the EU acts quoted in this report are given in Annex STANDARDS AND GUIDELINES Additionally Guidelines (GL) of the EU and Codes of Practice of the Codex Alimentarius Commission (CAC) of the Food and Agriculture Organization of the United Nations and World Health Organisation (CODEX) were taken into account in the frame of the audit. A full list of applicable standards referred to in this report is provided in Annex 2. Reference to specific provisions of these texts is provided at the beginning of each section. 4 BACKGROUND Morpholine is a FA which can improve the solubility of wax formulations and enhance the shine of wax coated fruit thus making them more appealing for the consumer. In some TCs the use of morpholine for the production and application of fruit wax coatings is permitted. It was assumed that since morpholine is very volatile, after such coatings are applied the morpholine evaporates and is not present on the fruit. Consequently, official controls for morpholine were considered a low priority for exporting countries. In 2010, a number of MSs detected morpholine on fruit imported into the EU. As morpholine is not authorised in the EU, such products were required to be removed from the market to ensure the safety of consumers. Information on foodstuffs found to have public health implications are disseminated as alert notifications through the EU Rapid Alert System for Food and Feed (RASFF) to all MSs and to the exporting country. From 2009 to the time of the audit five notifications relating to morpholine in papaya and three notifications relating to PPP residues in papaya from Brazil have been notified through the RASFF. In view of the number of notifications, the FVO decided to undertake this audit with the aim of assessing the official controls in place for PHTs of fruit destined for the EU market. The volume of fruit exports from Brazil to the EU is presented in Table 2. 2

8 The FVO has carried out audits in a number of exporting countries to assess official controls for pesticide residues in food of plant origin originating from these countries. The reports on these missions are available on DG (SANCO)'s web site at An overview report summarising findings and conclusions of these missions has also been published: Consequently, another part of this audit focused on a follow-up of recommendations made in DG(SANCO) report on controls on pesticides in food of plant origin in Brazil published: The first recommendation indicated that an increase in the number of samples taken was required and the third recommendation requested the inclusion of PHTs of PPPs in the official control programmes. Table 2. Fruit Exported from Brazil to the EU Brazil Exports to EU (metric tonnes) Number of RASFF notifications Fresh Papaya ( ) (PPP) 5 (Morpholine) Fresh or dried guavas mangoes and mangosteens ( ) Source: Statistical Office of the EU, Comext database 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION Legal Requirements Article 46 (1) (a) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia particular regard to the legislation of the TC. Annex V to European Parliament and Council Directive No 95/2/EC indicates the permitted carriers and carrier solvents in the EU. Regulation (EC) No 396/2005 lays down the maximum residue levels (MRLs) of pesticides in or on food and feed of plant and animal origin. 3

9 Findings Food Additives In Brazil legislation relating to FAs is drafted and enforced by ANVISA. Approved FAs must be included on a positive list. For a FA to be approved in Brazil, internationally accepted references are taken into account, such as the Codex Alimentarius, the EU and the United States Food and Drug administration. The FAs that are permitted in surface treatment of fresh fruit such as papaya, melon, mango, avocado, pineapple and citrus fruit, and their respective limits are contained in the Board Resolution ANVISA Decree No. 71, of 6th October In addition the following waxes are permitted: bees wax (white and yellow), candelilla wax, carnauba wax, shellac and microcrystalline wax. By default waxes containing substances such as morpholine are not permitted for use as PHTs in Brazil as morpholine is not on the positive list of FAs and should not be used in any PHT of fruit destined for the domestic or export market. Formulated substances for PHT such as waxes only need to be notified to ANVISA. However these products do not require any official authorisation. According to ANVISA Decree No 23 of 23 March 2000, there are general principles to be followed: all the facilities must be inspected and licensed by the CA and all products must meet certain basic standards. These standards could be checked in monitoring programs and non compliances would involve the application of penalties. In addition when the producers of these formulated substances commence marketing the formulated substances for PHT they must make a declaration to the CA that they are producing the product according to the legislation and provide information regarding the ingredients, processing and labelling of the product. After the communication, the CA has 60 days to inspect the facilities and to check the information. This period may vary according to the risk of the product, the date of the last inspection and the compliance history of the establishment. Pesticides Legislation for authorisation and control of the marketing and use of PPPs has been introduced at Federal level by Law No of 11 July 1989 and Decree No of 4 January Regulations for implementation of the controls are developed at Federal and at State level. National MRLs are set in Brazil based on the values and the principles of the CODEX for setting MRLs. Additional Federal legislation, Law No of 6 June 2000 requires that empty PPP packaging must be returned after use to specified collection points for recycling or safe disposal. The follow-up of RASFF notifications is regulated by Legal Act 2009/53 which is in force since March DIPOV is the contact point responsible for handling the follow-up of RASFF notifications in Brazil. Conclusions Legislation is in place for the authorisation and control of FAs. There is no legislation in place for the authorisation of formulated substances used for PHT such as 4

10 waxes that may contain FAs. Legislation is in place for the authorisation, control, marketing, and use of PPPs. The legislation covers the enforcement of MRLs and traceability. Legislation in relation to handling RASFF notifications is in place. 5.2 COMPETENT AUTHORITIES Legal Requirements Article 46 (1) (b) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the organisation of the TC's CAs, their powers and independence, the authority they have to enforce the applicable legislation effectively, and the training of staff in the performance of official controls. Findings Food Additives FAs on the domestic market are subject to control and supervision by ANVISA, as provided by Law No. 9782, of 26th January However, the audit team was informed that the MAPA as the national contact point for handling RASFF notifications which form the basis of the concerns relating to morpholine were initially handled solely by MAPA on the assumption that it was a pesticide. This was based on the practice developed over the past seven years. However, as the preparation for this audit proceeded it became evident that ANVISA were ultimately responsible for issues relating to FAs. It was only at that point that the MAPA formally notified the ANVISA that this CA needed to be involved through an official letter Oficio CGQV/DIPOV No 083/2012). ANVISA stated that morpholine had been considered a low priority and did not feature in any of its domestic monitoring programmes for FAs because it is a non authorised substance and it is used in a non-edible part of the fruit. ANVISA has no formal responsibility for the official control of FAs in FNAO. In response to the RASFF notifications, MAPA sent out a letter to all exporters reminding them of the legislation in relation to the use of morpholine and advising them that morpholine should not be present in any FNAO products whether for the domestic market or for export. The audit team was informed that this lack of coordination between MAPA and ANVISA had been acknowledged by both CAs as a weakness and already a draft procedure to ensure better cooperation in the area of issues relating to FAs was already underway. It was anticipated that a formal agreement would be in operation by the end of Pesticides There are three federal agencies bodies that work with the registration of pesticides, as set out below. For registration to be granted, guidelines and requirements of all three agencies bodies must be complied with: MAPA: in charge of evaluating the agronomic effectiveness of PPPs, and issuing the Certificate of Registration; ANVISA: responsible for toxicological assessment and classification of pesticides as well as setting the MRLs; Ministry of Environment: responsible for environmental assessment and classification of potential environmental hazards as regards PPPs. 5

11 Conclusions The CA is designated for official controls of FAs in the domestic market. There is no CA designated for official controls of FAs in FNAO for export markets. The CA is designated and operational for registration and official controls of PPPs in the domestic and export market. 5.3 OFFICIAL CONTROLS OF POST HARVEST TREATMENTS Legal Requirements Article 11 of Regulation (EC) No 178/2002 stipulates that food and feed imported into the EU for placing on the market within the EU shall comply with the relevant requirements of food law or conditions recognised by the EU to be at least equivalent thereto. Article 3 of Regulation (EC) No 882/2004 stipulates that official controls are carried out regularly, on a risk basis and with appropriate frequency. Article 46 (1)(b), (c), (d), (e) and (h) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to: the existence and operation of documented control procedures and control systems based on priorities, the CA's capability to enforce applicable legislation, the resources including diagnostic facilities available to CAs, the training of staff in the performance of official controls and the assurances which the TC can give regarding compliance with, or equivalence to, EU requirements. Article 10 of Regulation (EC) No 852/2004 in connection with Article 6 of the same Regulation requires that every food business operator (FBO) shall notify the appropriate CA of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment Article 18 of Regulation (EC) No 396/2005 requires that products covered by Annex I of the same Regulation shall not contain, from the time they are placed on the EU market as food or feed, any pesticide residue exceeding EU MRLs, or 0.01 mg/kg for those products for which no specific MRL is set. The CODEX has also established MRLs for pesticide residues, which are considered for the establishment of EU MRLs (CAC/MRL ). Annex V to European Parliament and Council Directive No 95/2/EC indicates the permitted carriers and carrier solvents in the EU. Findings Food Additives ANVISA reported that their official control activities in relation to FAs is restricted to the domestic market and includes checking of labelling, authorisation of FAs, registration and inspection of the facilities prior to commencing production and its follow-up inspections. Monitoring programmes 6

12 focus on products obtained at retail outlets. However, morpholine was never considered a high priority and to date no official control activities had been undertaken. Pesticides The CA stated that official controls on PHT with PPPs in packhouses was initiated in the State of Pernambuco at the beginning of 2012 by the Secretariat for Animal and Plant Health Inspection of the State of Pernambuco (ADAGRO). Consequently, the third recommendation from report DG(SANCO) relating to the inclusion of PHTs with PPPs in official control programmes has not been fully addressed. Although generally there are no specific controls on PHTs with PPPs the Secretariat of Animal and Plant Health and Inspection (SDA) of MAPA has a National Plan for Control of Residues and Contaminants in Plant Origin Products (PNCRC/Vegetal). The legal provisions regarding the PNCRC/Vegetal are based upon the Normative Instruction SDA No. 42, of 31st December 2008 that institutionalises the referred plan, and the Normative Instruction No. 25, of 9th August 2011, that establishes the PNCRC/Vegetal for the crop year 2011/2012 and lists all monitored substances with their respective MRLs for each crop. The PNCRC/Vegetal does not include FAs. The Coordination of Residues and Contaminants office of the MAPA is responsible for the executive management of the PNCRC/Vegetal, through sampling procedures and laboratory analysis, with the collaboration of other SDA sectors, as DIPOV, the Department of Surveillance of Agricultural Inputs and General Coordination of Laboratory Supply (CGAL). The function of the PNCRC/Vegetal is to monitor the quality of plant products produced in the entire national territory, in relation to the occurrence of residues of pesticides, chemical and biological contaminants. Plant products are monitored for the domestic and export market, currently, approximately 80% of the analysis are directed towards the domestic market. Since the introduction of PNCRC/Vegetal, in crop year 2009/2010, the number of monitored crops increased from 17 to 24 crops, the number of collected samples increased from 790 to 2,100 samples and the scope of analysed substances increased from 160 to 280 substances. The criteria for the choice of crops as well as for the monitored substances can be found in articles 15 and 16 of the Normative Instruction SDA No 42/2008. The sampling plan follows the recommendation of the Codex Alimentarius. This addresses the first recommendation of DG (SANCO) that recommended an increase of the number of samples taken. Official samples are collected by Federal Inspectors of MAPA in farms, pack houses, processing plants, supply centres and border posts as goods are imported. An essential feature of official controls and the proper functioning of the PNCRC/Vegetal is product traceability which is guaranteed by means of the registration of the sampled establishments, as well as by the invoices accompanying the products. The laboratory analysis are carried out by MAPA s official laboratories or private laboratories authorised by MAPA. The DIPOV is responsible for the management of registers of the exporting establishments. At state level, the Services of Inspection of Agricultural and Livestock Products of the State Agriculture Secretariat (SFA) list packhouses cleared to export and list establishments that are included in the database for the monthly draw of samples of the PNCRC/Vegetal. There is also an annual program to monitor pesticide residues in plant products on the domestic Brazilian market which is coordinated by ANVISA. In 2010 this program was conducted in partnership with 21 states in Brazil, and the analyses are undertaken by four official public laboratories. Overall, 2488 samples (of which, 2187 samples were of fresh fruit and vegetables) of 18 foods were analysed through multi-residual analytical method. 7

13 Site Visits The audit team visited a papaya producer in the State of Espirito Santo. The farm was 1,400 ha of which 700 ha was devoted to fruit production. In relation to FAs, the Farm Manager confirmed that he had recently received a letter from MAPA outlining the legislation relating to the use of morpholine in waxed fruit. He informed the audit team that no waxing process was used on papaya produced on this particular farm in the past three years as most of the product was exported by air to the EU and consequently the preservation properties associated with waxing was not required by customers. The audit team was informed that no official control on PHTs with PPPs were conducted. The autocontrols indicated different PPPs were used for different export destinations. The audit team visited a mango producer and packhouse in the State of Pernambuco. This farm was 200 ha and generally produced 25 tonnes of mangoes per ha. At the time of the audit the farm was not producing mangoes as it was in the process of planting a new variety of mango which would produce higher yields and better quality fruit. The farm was inspected four times in the past year, however, these inspections were not focussed specifically on PHT issues. The audit team reviewed the reports of these inspections and they were considered satisfactory. The packhouse was part of the same enterprise as the grower and was the main focus of the visit. The agronomist and environmental scientist met from the FBO confirmed that a letter had been received from MAPA reiterating the prohibition on using morpholine as an FA to enhance the application of waxes on fruit as a preservation agent. The FBO stated that this letter had no relevance to them as they had not used waxes in the past two years. This was a requirement from their clients in the EU. The packhouse received fruit from its own farm as well as from other producers. It packs 12,000 tonnes of mangoes for export per year, 70% of which was destined for the EU. The current PHT of mangoes consisted of washing the fruit in water at ambient temperature, followed by washing in hypochlorite solution. In addition the company had installed a sophisticated ozone treatment system in the wash stage and at the beginning of the cold chain which extended the shelf life of the product and eliminated the need for use of post harvest fungicides. To compensate for no longer using wax as a preserving agent the company includes ethylene absorption filters in the shipping containers, which prevents premature ripening occurring during the voyage. The audit team visited a packhouse in the state of Bahia which had been involved in a RASFF notification. The farm was 5,000 ha and produced soya beans, corn, coffee as well as papaya, which was the object of this visit. Papaya was the main crop from this farm, with 200 ha being grown each year, giving a yield of 60 tonnes per ha. The pack house exported approximately 8,000 tonnes to the EU based on 2012 figures. The owner explained that his product was aimed at the high end of the EU market and for over a decade he had always used a wax which contained morpholine and which was manufactured and marketed in Brazil. The owner said that the wax was available on the market and was even labelled that it contained morpholine. He had never realised that morpholine was an unauthorised FA in the EU, until his agent in Germany contacted him in October 2010 to inform him of the outcome of laboratory results from Austria relating to his papaya fruit which had been analysed as part of an Austrian national monitoring programme. According to the owner, there is no legal obligation on FBOs to inform the CAs in Brazil if a non compliance is detected, consequently the CAs were not aware of the situation which was unfolding. However later the CAs clarified that recent legislation, Portaria 487 (18th March 2012) and Resolution No 725/2012 obliges the FBO to notify CAs if non compliant products are detected and are likely to cause harm to consumers. In such instances it is 8

14 necessary to recall the product from the market. The owner immediately took action to source another wax which was also made and marketed on the Brazilian market but did not contain morpholine. The audit team reviewed an invoice for the wax which contained morpholine and which was subject to a RASFF notification. ANVISA confirmed that this wax manufacturer had not been inspected to date. The owner had received the recent notification from MAPA on the legal situation relating to morpholine being an unauthorised FA in Brazil as well as the EU. He had not been aware that morpholine was unauthorised in Brazil. The audit team asked the federal inspector from SFA/Bahia who was responsible for this establishment how he responded to the problems of morpholine being reported in the RASFF system. He reported that although the RASFF notification had been recorded in Brazilia in November 2010, it took three months for this information to reach Salvador. As previously described in Section 5.2 there had been some confusion about how to handle RASFF notifications concerning morpholine at the national contact point, DIPOV, and it took some time to realise that the issue was concerned with an unauthorised FA and that ANVISA was officially responsible for it. The audit team was informed by the CCA that approximately 95% of papaya are transported by air however, each individual packhouse has different market requirements regarding waxes. Conclusions The official controls in Brazil cannot fully assure that fresh fruit imported into the EU from Brazil fully complies, in the area of PHTs, with the relevant requirements of food law or conditions recognised by the EU to be at least equivalent thereto as required by Article 11 of Regulation (EC) No 178/2002. Official controls by ANVISA inspectors were not undertaken in establishments where wax was manufactured and or distributed nor in establishments using wax solutions as a PHT as required by Article 3 of Regulation (EC) No 882/2004. FAs are not included in official control programmes for FNAO destined for the EU. There is no specific monitoring programme for FAs in PHTs in place. Technical progress to avoid the use of waxes and eliminate / reduce the use of PHT was evident in the packhouses. There is a monitoring programme for residues of PPPs including PHTs in place. Recommendation No 1 of DG (SANCO) that recommended an increase of the number of samples taken has been fully addressed. Recommendation No 3 of DG(SANCO) that recommends the inclusion of PHTs of PPPs in official control programmes has not been fully addressed. 9

15 5.4 LABORATORY SERVICES Legal Requirements Requirements pertaining to the capacity and capability of laboratories are described in Article 4(2) (c) of Regulation (EC) No 882/2004. Requirements for accreditation of laboratories are laid down in Article 12(2) and (3) of Regulation (EC) No 882/2004. General criteria for methods of analysis used in the context of official controls are laid down Article 11 and Annex III of Regulation (EC) No 882/2004. Requirements for designating laboratories are laid down in Article 12(1) of Regulation (EC) No 882/2004. Articles 46(1)(d) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, interalia, particular regard to the resources including diagnostic facilities available to CAs, and the training of staff in the performance of official control. Article 28 of Regulation (EC) No 396/2005 requires that the methods of analysis of pesticide residues shall comply with the criteria set out in the relevant provisions of EU law relating to official controls for food and feed. Method Validation and Quality Control Procedures for pesticide residues analysis in food and feed, developed under Article 28 of Regulation (EC) No 396/2005 are published in Document SANCO/12495/2011. Point 41 of Guidelines of CODEX CAC/GL on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems lays down that inspection services should utilize laboratories that are evaluated and/or accredited under officially recognized programmes to ensure that adequate quality controls are in place to provide for the reliability of test results. In accordance with Guidelines of CODEX CAC/GL , point 3, the laboratories should comply with the International Organisation for Standardisation (ISO) / International Electrochemical Commission Guide Findings In Brazil, there are two laboratory networks for pesticide residues, contaminants and FAs; the National Agriculture and Livestock Laboratories (LANAGRO) are the official laboratories of MAPA and the ANVISA network of laboratories. The LANAGRO includes six official and two contracted and authorised laboratories. The laboratories in the LANAGRO network have a well defined structure and are coordinated by the MAPA, which is responsible for regular quality control, new method development and training activities. All the laboratories of the LANAGRO network are accredited to ISO and additionally have specific authorisations and annual controls given by MAPA to develop routine analytical controls. The ANVISA network includes two pesticide laboratories accredited according to ISO and an additional 15 laboratories which frequently participate in national proficiency test (PT) schemes. 10

16 Both of these networks have overlapping competences for pesticides, contaminants and FAs. In the case of ANVISA, at the time of the audit, no laboratory was accredited to ISO and the audit team did not see any evidence of any analyses being performed. For ANVISA s pesticide monitoring, samples were collected in the national market and the results are available on the ANVISA website: The audit team observed a good exchange of information at the technical level between both networks. However there is no coordinated structure to decide (i.e. morpholine in wax) which network is responsible for which analysis and in general FAs are not tested / covered by either of the laboratories. Laboratory Visit The audit team visited the authorised laboratory situated in the State of Pernambuco. There is a formal contract between MAPA and this laboratory. The audit team noted the preliminary activities undertaken by this laboratory to develop an analytical method for morpholine. Given that this laboratory has no formal role to undertake analysis for ANVISA the audit team requested clarification on this situation. MAPA explained that, there has been no formal decision taken as to which CA should be responsible for the control of unauthorised FAs in food of plant origin destined for export to the EU. Up to now ANVISA has focussed on public health and food safety issues at the national level. Until an official decision is taken on which CA is responsible this unsatisfactory situation of not having a validated method of analysis for morpholine will continue. The audit team was informed that any extension of the scope of analysis of the laboratory would require a formal request from CGAL / DIPOV. The visited laboratory is accredited to ISO by the National Institute of Meteorology, Normalization and Industrial Quality (INMETRO) since 2003 for pesticide residues and a group of contaminants in vegetables. The accredited scope of the laboratory for pesticide residues covers more than 300 gas chromatography and liquid chromatography amenable pre- and post harvest residues in fruit and vegetables. The laboratory is extending the scope of the residues by adequate validations following the SANCO Guidelines (SANCO/12495/2011). This anticipated extension of the accreditation includes new commodities and chemicals. This laboratory is responsible for part of the national monitoring program for fruit and vegetables for pesticide residues and contaminants through a contract signed with the MAPA. The laboratory employs 17 staff in the fruit and vegetable area. The audit team reviewed some of the staff training records and these were considered to be satisfactory. For 2012, seven training activities are planned. During 2011 a total number of 828 samples were performed that represents more than 40% of the whole national monitoring program for fruit and vegetables. The number of apples, lemons, papaya and mango samples analysed in 2011 were 441. The number of positive findings of PHT (prochloraz, casbendazine, thiabendazole and imazalil) were 298 which represents approximately 70 % of the total samples analysed. From these figures there were 10 exceedences of the Brazilian MRL. The laboratory participates regularly in the European PTs for Multi residue Methods organised by the EU Reference Laboratory for fruit and vegetables. All of the scope results obtained during the last three years have been satisfactory including the combined Z scores. Post and pre harvest pesticides are analysed by the same analytical methods. It comprise the sample 11

17 preparation following the Quechers Method followed by analysis by gas chromatograph coupled to tandem mass spectrometer and liquid chromatograph coupled to tandem mass spectrometers as detailed in the web page Identification and quantification criteria followed the Guidelines (SANCO/12495/2011). Calibration curves with three points are constructed daily, recovery is checked daily and samples are run together with the calibration curve and a recovery check (spiked and blank samples). Although the obtained results are not corrected for recovery the methods reviewed illustrated good precision with recoveries ranging around 100% and the uncertainty applied is calculated from the quality control data. In the near future a value of 50% will be applied. However, the analytical reports for the private sector analysis do not contain any information relating to the measurement of uncertainty applied. The development of an analytical method for the analysis of morpholine by liquid chromatograph coupled to tandem mass spectrometers has been initiated in this laboratory. However, a validated method is not anticipated in the near future as no formal request has been made by the MAPA or CGAL. Conclusions The second recommendation from DG (SANCO) related to the extension of scope of analyses in the pesticide residues laboratory has been addressed and continues to progress. The laboratory visited has good analytical capacity and is accredited to ISO There is no analytical procedure validated for morpholine in either of the laboratory networks. There is no official laboratory designated to carry out the official controls on morpholine for FNAO destined for the EU. 5.5 NON COMPLIANT PRODUCTS AND RESPONSE TO RASFF NOTIFICATIONS Legal Requirements: Article 54 of Regulation (EC) No 882/2004 lays down the principles to be followed in the application of national enforcement measures and actions to be taken in cases of non-compliance. Point 6 of the CODEX Guidelines CAC/GL specifies that upon information about a rejection of a food consignment presented for import, the food control authorities in the exporting country should undertake the necessary investigation to determine the cause of any problem that has led to the rejection of the consignment. 12

18 Findings Food Additives ANVISA informed the audit team that a product can only be considered to be non compliant if it is confirmed by definitive result from an official analysis or from an investigation (including inspection). The CA collects three samples, one sample is retained by the FBO and two samples are sent to the laboratory for analysis. If the first laboratory sample is analysed and the result indicates the product is non compliant the FBO may contest the result and present his sample to be analysed in the presence of an expert nominated by him. If the second analysis confirms the first one, the result is considered definitive, otherwise the third sample will be analysed. When a product is confirmed as non compliant the penalties outlined in the relevant legislation, Law 6437/77, can be invoked which can result in a number of sanctions such as a warning being given, seizure and destruction of the non compliant product, prohibition, cancellation of registration, and / or a fine. Such penalties are applied after the finalisation of the Administrative Process. Pesticides In accordance with the Normative Instruction N 42/2008 when a non compliance relating to food of plant origin is confirmed the producer / exporter must submit samples for laboratory analysis until such time as five consecutive batches have been found to be compliant. In addition the registration of the producer / exporter with MAPA as per Normative Instruction 66/2003 is assessed with an on the spot inspection conducted by the agricultural federal inspector of the Plant Inspection Service of the SFA and the plant health and inspection bodies at state level to verify the processes, good practices, the traceability of the system as well as the marketing and use of PPPs. Relevant laboratory analysis are also carried out. Depending on the outcome of these assessments an establishment could be suspended from the official register. In accordance with Law No 7801/1989, if food is found to be contaminated with pesticide residues, fines can be applied and the non compliant product can be destroyed. There is a legal act (54/2009) under discussion concerning to the legal issues involved stages of that complements the Normative Instruction SDA 66, 2003 and lays down the criteria for traceability. In addition, the exporter must demonstrate traceability for phytosanitary certification. Traceability systems were implemented in the pack houses visited. The systems allowed tracing back to the farmer or even to the plot. There is a legal requirement for keeping records of the use of PPPs. Since March 2009 the follow up of RASFF notifications in Brazil is regulated by Legal Act 53/2009. The RASFF notifications are received by MAPA through the Ministry of Foreign Affairs that is informed by the EU Delegation. In parallel the MAPA receives an automatic notification from the RASFF system. The growers and the pack-houses involved were contacted by MAPA. The inspectors checked the records and the prescriptions. In the cases checked a report was drafted. Since September 2010 there has been 18 RASFF notifications relating to morpholine, five of which involve Brazil. As described in the Section 5.2 the five RASFF notifications related to morpholine have not been 13

19 dealt in a satisfactory manner to-date. This situation is being remedied and ANVISA stated that they had already commenced a follow up action with the establishments wax producers involved. However, at the time of the audit the investigations were still on going. Conclusions Legislation is in place to deal with non compliant products. The follow up of RASFF notifications related to morpholine have been incomplete. 6 OVERALL CONCLUSION Overall progress has been made in relation to the follow up of Mission DG(SANCO) relating to PPPs. The official controls undertaken by MAPA for post harvest PPP use were considered unsatisfactory. In relation to official controls of FA used in post harvest treatment there are a number of serious omissions; there is no authorisation / approval of wax products containing FAs, there is no programme for monitoring or undertaking official controls in the area of FAs in fruit exported to the EU. The official control system does not ensure that fresh fruit imported into the EU from Brazil fully complies, in the area of PHTs, with the relevant requirements of food law or conditions recognised by the EU to be at least equivalent thereto as required by Article 11 of Regulation (EC) No 178/ CLOSING MEETING A closing meeting was held on 31 st May 2012 with representatives of the CCA. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit. The CAs were broadly in agreement with the audit team's findings and provided clarifications on some points. 8 RECOMMENDATIONS The CAs are invited to provide details of the actions taken and planned, including for deadlines for their completion ("action plan"), aimed at addressing the recommendations set out below, within 25 working days of receipt of this report. The CA should: N. Recommendation 1. Ensure that all establishments exporting produce of plant origin to the EU are subject to official food safety controls equivalent to those of Directive 95/2/EC. 2. Ensure that a laboratory method for the analysis of food additves e.g morpholine is developed and validated equivalent to the requirements of Article 12(1) of Regulation (EC) No 882/

20 N. Recommendation 3. Ensure that internal investigations are undertaken in response to EU RASFF notifications taking into account the CODEX Guidelines CAC/GL point 6 for the exchange of information between countries on rejections of imported food in order to determine the cause of any problem. The competent authority's response to the recommendations can be found at: 15

21 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, , p Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 396/2005 OJ L 70, , p Reg. 1333/2008 OJ L 354, , p Dir. 95/2/EC OJ L 61, , p Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety 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 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners 16

22 ANNEX 2 STANDARDS QUOTED IN THE REPORT Reference number Full title Publication details CODEX Guidelines CAC/GL CODEX Guidelines CAC/GL CODEX Guidelines CAC/GL Guidelines for the exchange of information between countries on rejections of imported food (CAC/GL ). Guidelines on the design, operation, assessment and accreditation of food import and export inspection and certification systems (CAC/GL ). Guidelines for the Assessment of the competence of testing laboratories involved in the import and export control of food (CAC/GL ). CAC/MRL Maximum Residue Limits (MRLs) for Pesticides. ISO/IEC SANCO/12495/20 11 General Requirements for the Competence of Testing and Calibration Laboratories. Method validation and quality control procedures for pesticides residues analysis in food and feed. web/standard_list.jsp web/standard_list.jsp web/standard_list.jsp mrls/pestdes/jsp/pest_q-e.jsp ection/pesticides/publications_eu. htm