Ref. Ares(2019)290814-18/01/2019 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) 2018-6428 FINAL REPORT OF AN AUDIT CARRIED OUT IN PORTUGAL FROM 10 SEPTEMBER 2018 TO 18 SEPTEMBER 2018 IN ORDER TO EVALUATE THE OFFICIAL CONTROL SYSTEM IN PLACE GOVERNING FOOD IMPROVEMENT AGENTS
Executive Summary This report describes the outcome of an audit carried out in Portugal from 10 to 18 September 2018 as part of the published Directorate General for Health and Food Safety's audit programme. The objective of this audit was to evaluate the official control system in place concerning the implementation of EU legal requirements on food improvement agents. The audit found that the system of official controls in place covering food improvement agents - including import, marketing and their use- is overall fit for purpose, and includes appropriate provisions for action in case of non-compliance. Both competent authorities avail at central level of dedicated staff which provide support to inspection units, while the staff in these units and which perform the official controls, are knowledgeable. The two competent authorities combined cover food improvement agents in all types of food in official controls, either by documentary checks or sampling, even if not all food categories are included in the sampling plan. However, the present laboratory capacity is currently limited to analysis in beverages, but this limitation is being addressed. The report includes a recommendation to the competent authorities to further enhance compliance with the EU legal requirements on food improvement agents. I
Table of Contents 1 Introduction...1 2 Objectives and scope...1 3 Legal Basis...2 4 Background...2 5 Findings and Conclusions...3 5.1 National Measures...3 5.2 Competent Authority...3 5.3 Official controls of Food Business Operators providing or using FIAs...5 5.3.1 Organisation and implementation of Official Controls...5 5.3.1.1 Sampling...7 5.3.2 Measures in case of non-compliance...7 5.3.3 Rapid Alert System for Food and Feed (RASFF) and Administrative Assistance and Cooperation (AAC) system...8 5.3.4 Challenges encountered by the CA in the organisation and performance of controls over production, marketing and use of FIAs...8 6 Overall Conclusions...9 7 Closing Meeting...9 8 Recommendations...9 Annex 1 - Legal references II
ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ASAE BTSF CA(s) DGAV DG Health and Food safety DRAP DSAVR EC EU FIAs MS PACE PCAI PNCA PNFA RASFF Explanation Economic and Food Safety Authority of the Ministry of Economy Better Training for Safer Food Competent Authority (ies) Directorate-General for Food and Veterinary of the Ministry of Agriculture, Forestry and Rural Development Directorate-General for Health and Food Safety of the European Commission Regional Directorate for Agriculture and Fisheries Regional Food and Veterinary Directorates of DGAV European Commission European Union Food Improvement Agents Member State(s) Plan for Approval and Control of Establishments Agri-Industry Control Plan National Sampling Plan National Inspection Plan of ASAE Rapid Alert System for Food and Feed III
1 INTRODUCTION This audit took place in Portugal from 10 to 18 September 2018 and was undertaken as part of the planned audit programme of the Directorate-General for Health and Food Safety (DG Health and Food Safety). It was the second audit in a series of three in Member States (MS) in 2018 to evaluate the official control systems in place concerning Food Improvement Agents (FIAs). The audit team comprised two auditors from DG Health and Food Safety and one national expert from a MS. The team was accompanied throughout the audit by representatives from the central Competent Authority (CA), the Directorate-General for Food and Veterinary (DGAV) under the Ministry of Agriculture, Forestry and Rural Development. An opening meeting was held in Lisbon on 10 September 2018 with the representatives from the DGAV, the Regional Directorate for Agriculture and Fisheries (DRAPs) and the Economic and Food Safety Authority (ASAE) under the Ministry of Economy. At this meeting, the audit team confirmed the objective and itinerary for the audit, and requested additional information required for the satisfactory completion of the audit. 2 OBJECTIVES AND SCOPE The objective of this audit was to evaluate the official control system in place concerning the implementation of EU and national legal requirements on FIAs. In particular, the audit team verified whether the official controls are organised and carried out in accordance with the relevant provisions of 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 and with specific EU requirements applicable to the sector audited. For the purpose of this audit, the term FIA comprised food additives 1, flavourings and certain food ingredients with flavouring properties for use in and on foods 2 and smoke flavourings used or intended for use in or on foods 3. Food enzymes were not included in the scope of this audit. 1 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives 2 Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No110/2008 and Directive 2000/13/EC 3 Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods and Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings 1
In pursuit of this objective, the following sites were visited: COMPETENT AUTHORITIES No. COMMENTS Competent Authorities Regional level 2 Central level 2 DGAV and ASAE DRAP in Lisbon/Vale do Tejo region and in the central region FOOD BUSINESS OPERATORS (FBOS) FIA importer/formulator/distributer FIA users 4 2 Food business operators using FIAs in their products 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation and, in particular, Article 45 of Regulation (EC) No 882/2004. All EU legislation relevant to this audit is listed in Annex I and all EU legal references refer, where applicable, to the latest amended version. 4 BACKGROUND The Commission carried out a series of audits in 2007 2010 to check the implementation of the European Union (EU) legislation in the area of food additives in 18 MS. The results of this series of audits were published in an overview report (ref. DG (SANCO)/2010-6204 MR Final) which is available at the link below: http://ec.europa.eu/food/audits-analysis/overview_reports/details.cfm?rep_id=13 The Commission also carried out a series of fact-finding missions in six MS on controls on food additives and smoke flavourings from January to December 2015. The results of this series of audits were published in an overview report (ref. DG (SANTE) 2016-8978) which is available at the link below: http://ec.europa.eu/food/audits-analysis/overview_reports/details.cfm?rep_id=115 Both overview reports concluded that these controls were, at the time, not a priority issue for the CAs and, as a consequence, controls were either not performed or were ineffective. As a follow-up to the series of fact-finding missions the Commission services organised meetings with experts to support the MS in addressing problematic issues associated with official controls on FIAs. The Commission continues to offer Better Training for Safer Food (BTSF) on FIAs and has identified opportunities for MS to support the implementation of EU legislation on FIAs. 2
The aim of this new audit series is to evaluate whether EU and national legislation on FIAs is appropriately implemented and enforced in a uniform way and that FIAs produced, imported and used on the EU market are subject to adequate official controls. 5 FINDINGS AND CONCLUSIONS 5.1 NATIONAL MEASURES Legal requirements Article 291 of the Treaty on the Functioning of the EU Findings 1. Aside from the EU legislation applicable to FIAs, national Decree Law 28/84, amending the Regime of Economic Infringements and Against Public Health, which establishes enforcement measures to be taken in case of non-compliances with regard to foodstuffs, (except when this is regulated under specific legislation); and Decree Law 26/2016, which contains requirements regarding information to consumers on non-prepacked food, as well as a sanctioning regime covering Regulation (EU) No 1169/2011. 2. DGAV has developed checklists, including questions regarding labelling and FIAs, and guidelines for official controls that are available on the website. 3. ASAE uses the same checklists and, in addition, issues operational orders that are adapted to different types of food production, to assist and guide the inspectors during inspections. 4. DGAV has produced some leaflets with information to food business operators and consumers on how to label certain products, e.g. cheese when natamycin is used and meat preparations. This information is available on the CA website. Conclusions on national measures 5. Correct implementation of requirements related to FIA is supported national guidance documents available to food business operators and consumers, while the provision of guidelines and checklists facilitate uniformity of official controls to verify compliance. Appropriate enforcement provisions are in place. 5.2 COMPETENT AUTHORITY Legal requirements Articles 4 and 6 of Regulation (EC) No 882/2004, Article 27 of Regulation (EC) No 1333/2008, Article 20 of Regulation (EC) No 1334/2008 3
Findings 6. Detailed information on the structure and organisation of the Portuguese competent authorities can be found in the country profile for Portugal at: http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=pt 7. DGAV is responsible for official controls in the areas of animal health, food of animal origin, food and feed of plant origin and imports thereof, animal nutrition, animal byproducts, veterinary medicinal products and residues, animal welfare and manages the national seed database. 8. DGAV coordinates the implementation of controls carried out by five Regional Food and Veterinary Directorates (DSAVR), which report directly to the central level of DGAV. 9. There are five DRAPs, which operate autonomously and carry out food safety controls of food of non-animal origin. 10. DSAVR and DRAP carry out official controls in processing establishments, and DGAV -together with the Custom and Tax Authority- concerning imports. 11. ASAE works in parallel with DGAV, and is responsible for enforcing legislation related, as appropriate, to food safety issues throughout the food chain including retail. It has administrative independence and responsibilities in the area of inspection of economic activity, and in the evaluation and communication of food risks. 12. ASAE, through three operational regional divisions, focus their controls at retail level and samples food in 13 food categories. The inspectors have the right to inspect food business operators along the entire production chain including, if necessary, in the context of investigations. 13. ASAE has established a yearly inspection plan (PNFA) for official controls of establishments. 14. Training of staff includes FIA requirements, and staff from DGAV and DRAP at all levels have participated in trainings given by DGAV. ASAE staff participate in those courses as well. 15. Mainly staff from DGAV have participated in BTSF trainings. ASAE staff have not participated in the BTSF trainings, as the level 1 training (a precondition for entering level 2) has not organised lately, while ASAE staff that attended previous training have changed jobs. The audit team could inform the CAs that a new series of training starts next year, with ten level 1 and four level 2 courses. 16. DGAV gave specific training to DSAVR staff on nitrate/nitrite and sulphites in food of animal origin. 4
17. DRAP had all divisions trained on flavourings and sweeteners in food of non-animal origin and food supplements, e.g. sorbates in syrups. 18. Both CAs have a back-up function at central level and ASAE inspectors call the office during inspections, e.g. to check on authorisations and maximum allowed levels of FIAs used. Inspectors met during the audit stated that they can take information with them to the offices to re-calculate recipes and amounts of additives used. 19. Inspectors met during the audit showed good knowledge of the area. Conclusions on competent authority 20. There are CAs designated for official controls of FIAs at all levels of the food chain, including imports and placing on the market. These CAs avail of sufficient numbers of suitably qualified staff, with adequate facilities and equipment to perform official controls. 5.3 OFFICIAL CONTROLS OF FOOD BUSINESS OPERATORS PROVIDING OR USING FIAS 5.3.1 Organisation and implementation of Official Controls Legal requirements Article 17 of Regulation (EC) No 178/2002, Articles 3, 4, 8, 9, 10, 11 and 12 of Regulation (EC) No 882/2004, Articles 22 and 23 of Regulation (EC) No 1333/2008. Findings 21. During the inspections observed by the audit team, all the inspectors checked labels of products, recipes with ingredients of the products, weight slips of each ingredient and specifications/certificates of contents in the raw materials and specifications of premixes to assess/evaluate compliance with the requirements for the use of FIAs and the maximum limits allowed. Documents could be taken to the office after the inspection to recalculate the amounts of FIAs used and check their compliance. 22. Inspectors checked traceability to raw material via internal codes, formulations in computer system and production records. 23. The DRAP inspectors used the EU regulations and the Commission website database during inspections to check compliance of the used FIAs. 24. ASAE inspectors used the actual day's production for their checks. The inspectors had received operational orders from headquarters on what to look for targeting the actual production type, and contacted the back-up function at the office for verification of authorisations of FIAs and maximum allowable limits. 25. DGAV stated that official controls take place at establishments in the context of: 5
regular checks, based on risk criteria combined with category/type of production and inspection frequency, verification to follow-up on actions taken, etc., suspicion of wrongdoing and when there is knowledge of food safety risks, and specific checks for other reasons. 26. EFSA scientific opinions are used for prioritisation of official controls of FIAs. 27. The audit team observed two inspections of food business operators importing, mixing and/or distributing FIAs and four inspections of food producers where FIAs were used in the products. 28. Non-compliances noted by the inspectors during the audit were the specification of a premix which did not mention an added smoke flavouring, and the specification of a tailor made mix did not mention all ingredients, one with a maximum limit and one allowed to quantum satis. 29. In addition, the certificate from a supplier of cinnamon did not mention the presence of coumarin, as required in Regulation (EC) No 1334/2008. 30. In one soft drink, the energy content was reduced by more than 30% by a sweetener as a substitute for sugar. The food business operator could by comparing the previous and the present recipe and laboratory analyses show that this was the case and therefore the use of sweetener was compliant. The CA also checked the energy content of a similar product on the market. 31. In previous inspections, non-compliances had been found concerning: Technical specifications for pre-mixes used in a soft drink production did not contain all ingredients and could therefore not be assessed, The amount of added polypropylene glycol exceeded the maximum limit allowed, Technical specifications for mixtures to be used in meat preparations were not translated correctly to Portuguese and information to the users were not correct. 32. At a food supplement producer, the inspectors found that preservatives used (sorbate E202, benzoate E211) exceeded the maximum limit, both in a test product and in a product placed on the market. 33. DGAV stated that official controls of FIAs regularly find non-compliances concerning the use of preservatives in liquid form, and sweeteners in liquid or solid form in food supplements. 34. There is no monitoring programme of food additive intake, as required by Article 27 of Regulation (EC) No 1333/2008. However, DGAV informed the audit team that currently a pilot project is in progress and it includes evaluation of the intake of additives with acceptable daily intake in children and adolescents in Portuguese schools. 6
5.3.1.1 Sampling 35. DGAV establishes plans for official controls of food animal origin (PACE), and food of non-animal origin (PCAI). FIAs are part of their checks, but there is no sampling plan specific to FIA. 36. A third plan, PCSA, for food supplements and food for special purposes, is also established. 37. Imports of additives are checked via a list of TARIC codes, created in cooperation with customs, of products that can be used in food production. During 2017-2018 preservatives, sulphites and sorbates were prioritised in terms of controls. 38. A risk assessment unit in ASAE has 13 food categories risk assessed on a general hazard assessment basis taking into account microbiology, chemical and physical risks and also previous findings of official controls, e.g. sulphites in minced meat. 39. ASAE take food samples in accordance with a yearly plan (PNCA). At present, this plan consists of 1500 samples to check safety requirements and 300 samples, not risk based, to check for possible fraud and other non-compliances. Labels and consumer information are checked on all samples. 40. ASAE has an own laboratories that perform analyses. The laboratories can at present not analyse colours in solid food, only beverages. ASAE informed the audit team that there is an ongoing development of the methodology, to be able to cover more food categories. 5.3.2 Measures in case of non-compliance Legal requirements Article 54 and Article 55 of Regulation (EC) No 882/2004 Findings 41. When sufficient information was not available during inspections, the inspectors required the food business operators to immediately call to suppliers to have the necessary information sent over. The food business operators were requested to ensure that all relevant information would be available at next inspection. 42. In the case of a product placed on the market with preservatives exceeding maximum limits, the CA immediately ordered a recall. In addition, the CA demanded to have full documentation of all products produced by this food business operator, to evaluate and assess the use of FIAs. 7
5.3.3 Rapid Alert System for Food and Feed (RASFF) and Administrative Assistance and Cooperation (AAC) system Legal requirements Article 50 of Regulation (EC) No 178/2002 and Commission Implementing Decision (EU) 2015/1918 Findings 43. There is a system in place for the timely and appropriate handling of RASFF notifications. The national contact point is within DGAV. There is also a contact point at ASAE, with direct access to the RASFF platform. 44. DGAV investigates in establishments with veterinary control numbers, and ASAE in all other cases, and have the right to order recalls of products on the market. 45. Two examples seen by the audit team at ASAE of documentation of investigations and follow-up of RASFF notifications, and decisions taken in connection with them, confirmed the operation of the procedures in place. 46. The audit team was also informed about a notification concerning a sugar paste exceeding maximum permitted limits for two colours found in official controls in Spain. The investigation found that the food business operator had applied outdated legislation and had missed changes made in Regulation (EC) No. 1333/2008 from 2011 to 2012. 5.3.4 Challenges encountered by the CA in the organisation and performance of controls over production, marketing and use of FIAs 47. Compliance with legal requirements for some international brands of soft drinks could not be checked by the CA, as the food business operator was provided with pre-mixes without all necessary information on the composition of ingredients and FIAs. 48. It is a problem to evaluate the Quantum satis principle regarding the use of FIAs. Food business operators are reluctant to indicate the quantity used of those FIAs, or are not aware of the meaning of the principle and do not present the evidence (studies or tests for the food formulations) that justifies the quantity used, mostly because they use pre-mixtures they buy already prepared. 49. The correct categorisation within the food categories established in Regulation No 1333/2008 is a challenge, in particular in borderline cases. This may affect the enforcement of relevant EU provisions. 8
Conclusions on official controls of FBOs providing or using FIAs 50. There a system of official controls in place, based on adequate procedures, supported by checklists, and applied as required by performing inspections and sampling. The present laboratory capacity is currently limited to analysis in beverages, but this limitation is being addressed. Adequate enforcement measures are in place and used when required. RASFF notifications are followed up satisfactorily. 51. The absence of a monitoring programme of food additive intake impedes efforts to update Community law on food additives in a proportionate and effective way. 6 OVERALL CONCLUSIONS The audit found that the system of official controls in place covering food improvement agents -including import, marketing and their use- is overall fit for purpose, and includes appropriate provisions for action in case of non-compliance. Both competent authorities avail at central level of dedicated staff which provide support to inspection units, while the staff in these units and which perform the official controls, are knowledgeable. The two competent authorities combined cover food improvement agents in all types of food in official controls, either by documentary checks or sampling, even if not all food categories are included in the sampling plan. However, the present laboratory capacity is currently limited to analysis in beverages, but this limitation is being addressed. 7 CLOSING MEETING A closing meeting was held on 18 September 2018 with representatives of the CAs involved in this audit. At this meeting the audit team presented the main findings and preliminary conclusions of the audit. The CAs acknowledged the findings and preliminary conclusions and made some comments for clarification of details presented. 8 RECOMMENDATIONS No. Recommendation 1. The CA should, after completing the pilot project, and based on the results, implement a monitoring programme of food additive intake in line with the requirements of Article 27 of Regulation (EC) No 1333/2008. Recommendation based on conclusion: 51 9
No. Recommendation Associated finding: 34 The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2018-6428 10
ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24 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 Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Reg. 2065/2003 OJ L 309, 26/11/2003, p. 1-8 Reg. 1331/2008 OJ L 354, 31.12.2008, p. 1-6 Reg. 1333/2008 OJ L 354, 31.12.2008, p. 16-33 Reg. 1334/2008 OJ L 354, 31.12.2008, p. 34-50 Reg. 231/2012 OJ L 83, 22.3.2012, p. 1-295 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 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council
Reg. 872/2012 OJ L 267, 2.10.2012, p. 1-161 Reg. 1321/2013 OJ L 333, 12/12/2013, p. 54-67 Reg. 1169/2011 OJ L 304, 22.11.2011, p. 18-63 Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004