EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2017) /10/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) FINAL REPORT OF AN AUDIT CARRIED OUT IN PORTUGAL FROM 09 MAY 2017 TO 18 MAY 2017 IN ORDER TO EVALUATE THE OFFICIAL CONTROL SYSTEMS IN PLACE GOVERNING NUTRITION AND HEALTH CLAIMS ON FOOD

2 Executive Summary This report describes the outcome of an audit in Portugal, from 9 to 18 May 2017, as part of the published Directorate-General for Health and Food Safety work programme. The objective of this audit was to assess the official control system in place concerning the EU and national legal requirements concerning nutrition and health claims on food. The report concludes that the official control system in place meets the requirements of EU legislation. The system includes documented, regular and risk-based controls covering nutrition and health claims made on foods at all stages of production and placing on the market. Official controls can provide guarantees that food businesses meet the main EU requirements as regards nutrition and health claims made on foods and that in cases of non-compliance, enforcement measures are taken. The report contains no recommendations addressed to the competent authorities. I

3 Table of Contents 1 Introduction Objective and scope Legal Basis Background Findings and Conclusions Legislation and Guidelines Organisation and Implementation of Official Controls Designation of Competent Authorities and Resources for Official Controls Organisation and Scope of Official Controls Implementation of Official Controls Overall Conclusions Closing Meeting...9 ANNEX 1 LEGAL REFERENCES II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ASAE CA(s) DGAV DGC DG Health and Food Safety DRAP DSAVR EU FBO MS PACE PCAI PCSA PNCA PNFA Explanation Economic and Food Safety Authority Competent Authority(ies) Directorate-General for Food and Veterinary of the Ministry of Agriculture, Forestry and Rural Development Directorate-General for Consumers 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 Union Food Business Operator Member State/s Plan for Approval and Control of Establishments Plano de Aprovação e Controlo dos Estabelecimentos Agri-Industry Control Plan Plano de Controlo da Agro-indústria Food Supplements Control Plan Plano de Controlo de Suplementos Alimentares National Sampling Plan Plano Nacional de Colheita de Amostras National Inspection Plan Plano Nacional de Fiscalização III

5 1 INTRODUCTION This audit took place in Portugal, from 9 to 18 May The audit formed part of the Directorate-General for Health and Food Safety (DG Health and Food Safety) planned work programme and comprised two auditors from the DG Health and Food Safety and one national expert from a European Union (EU) Member State (MS). This audit was combined with an audit to evaluate the official control systems in place governing food information to consumers (DG (SANTE)/ ). The same Competent Authorities (CAs) are responsible for the controls on both topics. Representatives of the CAs accompanied the audit team for the duration of the audit. An opening meeting was held on 9 May 2017 in Lisbon with representatives from the Directorate-General for Food and Veterinary (DGAV), the Regional Directorate for Agriculture and Fisheries (DRAP), the Economic and Food Safety Authority (ASAE) and the Directorate- General for Consumers (DGC). At this meeting, the objective of, and itinerary for the audit were confirmed by the audit team and the control systems were described by the authorities. 2 OBJECTIVE AND SCOPE The objective of this audit was to assess the official control system in place concerning the EU and national legal requirements concerning nutrition and health claims on food. In particular, to verify 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. The scope covered, in particular, the implementation of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. The audit reviewed official controls intended to ensure that general principles applicable to all claims made on foods are accurate in order to ensure consumer protection, give the consumer the necessary information to make choices in full knowledge of the facts as well as creating equal conditions of competition within the food industry. The audit reviewed planning and implementation of official controls and control procedures particularly in the area of nutrition and health claims in commercial communications, whether in the labelling, presentation or advertising of foods intended for the final consumer. The table below lists the sites visited and the meetings held in order to achieve the above objective: 1

6 Competent Authorities (CAs) Central level 3 Regional level 2 Opening and closing meeting with representatives of DGAV, ASAE, DRAP and DGC, meeting with ASAE. Regional Food and Veterinary Directorates of DGAV (DSAVR) Centro, DRAP Lisbon &Valley of Tagus Food Business Operators (FBOs) Restaurant 1 Health shop in supermarket 1 Food supplements producer 1 Producer of meals 1 Frozen ready-to-eat meals Dairy establishment 1 Yoghurt and yoghurt drinks Producer of pastry products 1 Cake, toast, biscuits, savoury pies Producer of drinks 1 Juices and other soft drinks 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in particular Article 45 of Regulation (EC) No 882/2004. A full list of the EU legal instruments referred to in this report is provided in Annex 1 and refers, where applicable, to the last amended version. 4 BACKGROUND Regulation (EC) No 1924/2006 has been applicable from 1 July 2007 and is complemented by Commission Implementing Decision 2013/63/EU of 24 January 2013 adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006. Information concerning nutrition and health claims is provided on the European Commission's website as "Guidance on the Implementation of Regulation (EC) No 1924/2006 Conclusions of the Standing Committee on the Food Chain and Animal Health. More information is available on the website: The DG Health and Food Safety programmed for 2017 a short audit series to four MS to evaluate the current situation on nutrition and health claim controls, in particular, in relation to use of misleading, non-authorised or unproven health claims, and conditions for the use of claims and nutrition information. This series is being executed in tandem with a second series to the same MS on the official controls in place governing food information to consumers. Once both audit series have been completed, overview reports will be produced on these four MS's implementation and enforcement of the relevant legislation for both topics and possible identified weaknesses and good practices where applicable. 2

7 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION AND GUIDELINES Legal requirements Article 291 of the Treaty on the Functioning of the EU, Article 4 and 8 of Regulation (EC) No 882/2004 and Article 23 of Regulation (EC) No 1924/2006 Findings 1. The audit team was informed by the Portuguese CAs that EU legislation on nutrition and health claims made on foods is applicable as such and no national provisions on nutrition and health claims supplementing Regulation (EC) No 1924/2006 (procedure provided for in Articles 22 and 23 of the Regulation) have been enacted. 2. Decree-Law No 57/2008 of 26 March 2008, containing rules concerning unfair commercial practices, aims to protect consumers' rights by prohibiting advertisements that omit substantial information or that include statements that may mislead consumers. 3. The Advertising Code (approved by Decree-Law No 330/90 of 23 October 1990) establishes the principles and rules applicable to all commercial advertising, including advertisements containing health claims. Article 13 of the Code states that it is an infringement when advertisements encourage behavior that is harmful to consumers' health and safety. 4. Portugal has established a notification system for food supplements. Prior notification of marketing of food supplements by the FBO to DGAV is required by national Decree Law No 118/2015. In this context, there is a procedure in place, available on the website of DGAV, that requires the FBO to indicate in the notification template the nutrition and health claims used and the legal basis for these claims. 5. Decree-Law No 28/84 regulates enforcement measures to be taken in case of non-compliances with regard to foodstuffs except when this is regulated under specific legislation. 6. The audit team noted that the written procedures such as work instructions provided to the staff of the CAs included specific instructions with regard to controls on nutrition and health claims. Checklists contained specific questions about nutrition and health claims. 7. A Guideline on nutrition and health claims has been developed by DGAV for consumers, FBOs and official staff. This guideline is available on the website of DGAV

8 Conclusions on Legislation and Guidelines 8. Official staff have the legal powers to carry out controls in all stages of the food chain and to take necessary measures in cases of non-compliance. 9. Documented procedures, containing information and instructions relevant to nutrition and health claims made on food, enable staff to perform effective official controls in this area. 5.2 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS Designation of Competent Authorities and Resources for Official Controls Legal requirements Article 4 and 6 of Regulation (EC) No 882/2004 Findings Structure 10. The Portuguese official control systems for the food and feed sectors are described in the country profile available at the European Commission's website: Detailed information about the designation of CAs, resources for official controls, coordination and cooperation between and within the CAs as well as general information on staff training and the internal audit system is available in the audit report DG(SANTE)/ in section Therefore this audit report includes only additional information specifically concerning official controls on nutrition and health claims made on foods. 12. All CAs involved in food controls, DGAV, DRAP and ASAE, include controls on nutrition and health claims in their regular control programmes. Training 13. The training programmes for ASAE, DGAV and DRAP staff from 2014 until the time of the audit were provided to the audit team. Several training sessions on nutrition and health claims were carried out. Evidence was provided to the audit team that most of the inspectors met participated in the trainings. During the inspections observed, the inspectors showed good knowledge of these topics. 4

9 Conclusions on Designation of Competent Authorities and Resources for Official Controls 14. The CAs responsible for the official controls over nutrition and health claims made on foods are clearly designated. CAs structures and resources are adequate for the performance of their tasks. 15. Training programmes aimed at ensuring that official staff can execute their tasks effectively and can keep up to date in their areas of competence are in place Organisation and Scope of Official Controls Legal requirements Article 17 of Regulation (EC) No 178/2002 and Articles 3 and 4 of Regulation (EC) No 882/2004 Findings 16. Detailed information on organisation and scope of official controls is provided in the audit report DG (SANTE) , in section DGAV coordinates official controls through its annual controls plans. At central level the tasks in relation to these plans are reviewing, coordinating, monitoring, training, supervising and evaluating. The Directorate for Food Safety has responsibilities in controls over facilities, equipment, hygiene and traceability. The Directorate for Food and Feed is responsible for food supplements, food for specific groups, additives, food contact materials, labelling, claims and contaminants. 18. The Plan for Approval and Control of Establishments (PACE) is implemented by the DSAVR in approved establishments including processing plants and wholesalers for food of animal origin. The Agri-Industry Control Plan (PCAI), covering producers of food of non-animal origin, is implemented by DRAP. The audit team was provided with checklists from these CAs containing specific questions on nutrition and health claims. 19. There is a Food Supplements Control Plan (PCSA), dealing with the controls in establishments that produce or import food supplements. FBOs are required to notify DGAV of all new food supplements entering the Portuguese market and all changes made to products. A notification table is completed electronically and it includes information on the product itself, claims on the label and legal references. Controls are carried out by DRAP using a specific checklist for food supplements. 20. DGAV has established a risk management system to assess the risk level for each FBO. As a result of this assessment, the FBOs are classified in five risk categories. Based on the risk category, the PACE information system (named SIPACE) automatically calculates for each FBO its inspection frequencies. 21. Sanctions in case of non-compliance range from an official notification in case of a minor non-compliance to fines or restrictions on marketing in case of a major noncompliance. 5

10 22. ASAE has proactive actions as part of its control plans based on: the results of controls; complaints; and, notifications from the Rapid Alert System for Food and Feed. The basis for the annual control planning is the National Inspection Plan (PNFA) and the National Sampling Plan (PNCA). 23. PNFA is implemented throughout the whole food chain. Controls include, amongst other actions, checks on nutrition and health claims. PNCA includes in total 1,800 samples and 24,000 analyses carried out annually. The samples are taken at retail level. ASAE informed the audit team that the samples are checked for nutrition and health claims by specialised staff, however, only about 1% of these samples contains nutrition and health claims. 24. Implementation of official controls is coordinated through operation orders issued by the central level of ASAE. These orders determine timeframes, procedures, legal references, main topics to be covered and sometimes specific lists of FBOs and/or foods to be controlled, actions in case of non-compliance, contact details of experts within ASAE and other CAs involved. 25. Controls on FBO advertising activities, especially websites, were the responsibility of DGC until The audit team was informed that this task is now within ASAE. While drafting operation orders, websites may be checked beforehand to collect information. 26. In case of non-compliances, ASAE, as part of its administrative procedure, issues a notification to the FBO to correct the non-compliance within a set deadline. In case of a severe non-compliance, ASAE has ten days to forward the case to a prosecutor for criminal proceedings. Conclusions on Organisation and Scope of Official Controls 27. The organisation of official controls meets the requirements of Regulation (EC) No 882/2004. These controls are carried out regularly, on a risk basis and include controls to verify FBO compliance with nutrition and health claims made on foods at all stages of production, processing and distribution Implementation of Official Controls Legal requirements Article 10(2)(b)(vi) of Regulation (EC) No 882/2004, Article 18 of Regulation (EC) No 178/2002, Regulation (EC) No 1924/2006 and Commission Regulation (EU) No 432/2012 Findings 28. The audit team observed inspections in seven different FBOs. Three inspections were carried out by ASAE, three by DRAP and one by DSAVR. In accordance with the procedures, nutrition and health claims were checked in those establishments which make such claims for their products. Five of the FBOs visited use nutrition and /or health claims. Where claims were made, the labels were checked for the mandatory information to verify that any nutrition claims were permitted and any health claims 6

11 were authorised. More information on these inspections is provided in the audit report DG (SANTE) , in chapter The audit team observed an unannounced inspection of a health shop. ASAE inspectors performed the inspection based on a general operation order on labelling and nutrition and health claims. Inspectors used two checklists, one for food supplements and one for food information and nutrition and health claims. The inspectors selected at random ten items focussing on new and promoted products in the shop. Due to time constraints, only four products could be checked on-the-spot. 30. The four products were all food supplements and were checked for the mandatory information required under Directive 2002/46/EC of the European Parliament and of the Council. They all complied with these requirements. 31. The first product was a food supplement with relaxing related health claims. Amongst other ingredients, melatonin and Vitamin B6 were present. The inspectors checked the health claims related to these substances, as authorised in Commission Regulation (EU) No 432/2012. They concluded that the health claims were compliant. They also concluded that the conditions for use were met, which means that 50% of the Nutrient Reference Value of vitamin B6, as regulated in Annex XIII of Regulation (EU) No 1169/2011 of the European Parliament and of the Council, and 1 mg melatonin per portion should be present. The product also contained a health claim related to a herbal ingredient passiflora. The inspectors contacted the expert at the central office of ASAE to check the status of the health claim and to translate the wording in the EU register from English to Portuguese. DGAV was consulted to check the notification status and was asked to issue an opinion regarding the status of passiflora. The inspectors also discussed the novel food status of passiflora. An official sample from the product was taken for a more detailed examination in the laboratory. 32. The second product was a food supplement for eye health. It contained vitamin A and E and the mineral zinc. There were nutrition claims on the label: high in vitamin A, E and zinc. These claims are only allowed when the product contains twice the value of source of (Annex of Regulation (EC) No 1924/2006). The values were found to be compliant by the inspectors. On the package of the product was a picture of an eye and the text: vitamin A, E and lutein. The inspectors assessed that this picture is a health claim suggesting a relation between eye health and these ingredients. For vitamin A this claim is permitted. For vitamin E and lutein, the health claim in relation to eye health, is in the EU register listed as a non-authorised claim. A sample was taken for more detailed examination in the laboratory. The product was seized and the remaining packages were put in a bag, sealed and kept at the shop until the investigation will be finalised. The inspectors stated that they will take actions to withdraw this product from the market, depending on the results of the final investigation. 33. The third product for joint health had a picture of a human joint and the product name suggesting joint health. The ingredient concerned was glucosamine. The inspectors noted that there is no authorised health claim for glucosamine in relation to joints. This product was also seized and the inspectors will carry out further investigations thereon. The inspectors stated that they will withdraw this product from the market based on the precautionary principle, health risks and unfair commercial practices. 7

12 34. The fourth product checked by the inspectors was vitamin D3. The inspectors concluded that the health claim was compliant as the required amount of vitamin D3 was present. 35. The audit team observed an inspection at a food supplement producer using their own labels and labels of customers for whom they were producing product under the customers brand e.g. supermarket chains. This FBO produces around 400 different products and had notified around 1,000 products. The inspection was carried out by DRAP, based on PCSA and PCAI selections of products to be controlled. The inspectors used checklists provided by DGAV. The audit team saw evidence of a previous inspection carried out in July 2016 and of official sampling in 2016 for heavy metals analyses. A non-compliance detected was the inadequate monitoring of the metal detector. The samples were all compliant. 36. The inspectors checked the facilities and took a sample from a product at the end of the production line. The main ingredient in the chosen product was artichoke and the health claim contributes to normal working of the liver function" was checked by the inspectors and noted to be an authorised health claim. 37. The inspectors checked the additives mentioned on the label for compliance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council. According to this Regulation, 240 mg/l of sucralose is allowed in a liquid formula, while 660 mg/l was present, according to the recipe. This issue has to be further investigated in the office and the results will be forwarded to the FBO. In the meantime the FBO has to suspend the marketing of the product. 38. The audit team observed an inspection of a dairy establishment by DSAVR. The FBO produces yoghurt and yoghurt drinks only for clients, using the customers' own-brand labels. In most cases, the labels were developed by the producer and validated by the customers. 39. The inspectors checked three labels using the checklist containing detailed questions regarding nutrition and health claims. One yoghurt product with fruit had nutrition claims, 0 % fat, 0 % sugar added and no gluten. Based on the technical sheets and own-checks for the presence of gluten, the inspectors concluded that the claims were compliant with EU requirements. 40. The second product, a yoghurt product for children, contained the nutrition claim with calcium and vitamin D. The inspectors concluded that the required amounts of calcium and vitamin D were present and that the obligatory information in relation to claims was present. 41. The last label checked, was drinkable yoghurt with the claims without lactose and source of calcium and phosphate. Also in this case, the claims were compliant in relation to the composition of the product. The FBO provided evidence that the lactose content was checked from every batch. 42. The audit team was informed by DGAV that in 2015 and 2016 a total of 4,006 inspections were carried out in relation to, amongst other issues, food information to consumers and nutrition and health claims made on foods. In total 192 non-compliances regarding food information and claims were detected. 43. ASAE informed the audit team that 1,167 inspections including food information to consumers and nutrition and health claims were carried out between 2014 and 2016, and 8

13 identified 250 non-compliances. ASAE took in total 3,639 samples in 2015 and 2016 concerning food information to consumers and nutrition and health claims. All samples were taken in retail establishments. There were 86 non-compliances regarding food information and none related to nutrition and health claims (see paragraph 23). Conclusions on Implementation of Official Controls 44. The official controls cover verification of FBO compliance with EU requirements concerning nutrition and health claims made on foods in order to guarantee that relevant requirements are met. These controls include checks on misleading, illicit and nonauthorised claims whereby pictures/images and conditions for use are also taken into account. 6 OVERALL CONCLUSIONS The official control system in place meets the requirements of EU legislation. The system includes documented, regular and risk-based controls covering nutrition and health claims made on foods at all stages of production and placing on the market. Official controls can provide guarantees that food businesses meet the main EU requirements as regards nutrition and health claims made on foods and that in cases of non-compliance, enforcement measures are taken. 7 CLOSING MEETING A closing meeting was held on 18 May 2017 with representatives of the CAs. At this meeting the audit team presented the preliminary findings of the audit. The authorities made some minor textual comments on the preliminary findings. 9

14 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Dec. 2013/63/EU OJ L 22, , p /63/EU: Commission Implementing Decision of 24 January 2013 adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council Dir. 2002/46/EC OJ L 183, , p 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. 1924/2006 OJ L 404, , p Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements 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 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods

15 Reg. 1169/2011 OJ L 304, , p Reg. 432/2012 OJ L 136, , p Reg. 1333/2008 OJ L 354, , p 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 Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children s development and health Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives