EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office Ares(2011)379458 DG(SANCO) 2010-8591 - MR FINAL FINAL REPORT OF A SPECIFIC AUDIT CARRIED OUT IN ITALY FROM 04 TO 12 OCTOBER 2010 IN ORDER TO ASSESS THE OFFICIAL CONTROL SYSTEMS IN PLACE FOR FOOD HYGIENE, TRACEABILITY, LABELLING, FOOD CONTACT MATERIALS AND FOOD ADDITIVES IN THE CONTEXT OF A GENERAL AUDIT In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.
Executive Summary This report describes the outcome of a Food and Veterinary Office (FVO) specific audit in Italy, which took place between 4 12 October 2010, as part of the general audit of Italy carried out under the provisions of Regulation (EC) No 882/2004 on official food and feed controls. The objective of the specific audit was to check that official controls are carried out in accordance with the principles of that Regulation and in line with the multi-annual national control plan (MANCP) as specified in Article 41 of the above Regulation. In order to achieve the overall objective the specific audit evaluated the implementation of the Community legislation in the area of food additives (FA) food contact materials (FCM) and food hygiene (FH). At the central level the Ministry of Health (MoH) is the central competent authority (CCA) which has over all responsibility for official controls in the context of this mission. At the regional level the Regional Public Health Services (RPHS) co-ordinates and undertakes detailed planning of the instructions received from the central level. The operational work is carried out by the Local Health Units (AUSL). In respect of inspections of food businesses operators (FBO) and FCM manufacturers there were a number of shortcomings noted: inadequate assessment of declaration of compliance (DoC), dosage of FA in final products not being checked, and incomplete assessment of procedures based on HACCP. There is little information on the level of implementation of Good Manufacturing Practice (GMP) as the registration of FCM manufacturers and traders is not obligatory and efforts to collect data have only started. Training for inspectors in HACCP, FCM, FA and labelling requirements is inadequate. In the context of this mission, official control laboratories for testing FA and FCM have been clearly designated, including the National Reference Laboratory (NRL) for FCM. Laboratories are well equipped and adequately staffed. The range of accredited methods and participation in proficiency tests for FA and FCM is inadequate. Considerable progress has been made since the last mission on food hygiene. However, assessment of HACCP systems by inspectors was inadequate. The specific controls of FA / FCM are at a very early stage. The laboratories, although well equipped and well staffed are constrained by their lack of accredited methods and non- participation in proficiency tests. These shortcomings hamper the full implementation of relevant EU legislation. The report makes a number of recommendations to the Italian CAs, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place. I
Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES OF THE MISSION...1 3 LEGAL BASIS FOR THE MISSION...2 4 BACKGROUND...2 4.1 CONTRIBUTION TO THE GENERAL AUDIT...2 4.2 BACKGROUND TO THE SERIES OF MISSIONS ON FOOD HYGIENE...3 4.3 BACKGROUND TO THE SERIES OF MISSIONS ON FOOD ADDITIVES AND FOOD CONTACT MATERIALS...3 5 FINDINGS AND CONCLUSIONS RELATED TO IMPLEMENTATION OF REGULATION (EC) NO 882/2004.4 5.1 COMPETENT AUTHORITIES...4 5.1.1 DESIGNATION OF COMPETENT AUTHORITIES...4 5.1.2 CO-OPERATION BETWEEN COMPETENT AUTHORITIES...5 5.1.3 CO-OPERATION WITHIN COMPETENT AUTHORITIES...5 5.1.4 DELEGATION OF SPECIFIC TASKS RELATED TO OFFICIAL CONTROLS...5 5.1.5 CONTINGENCY PLANNING...6 5.2 RESOURCES FOR PERFORMANCE OF CONTROLS...6 5.2.1 LEGAL BASIS FOR CONTROLS...6 5.2.2 STAFFING PROVISION AND FACILITIES...7 5.2.3 STAFF QUALIFICATIONS AND TRAINING...7 5.3 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS...8 5.3.1 REGISTRATION / APPROVAL OF FOOD BUSINESS OPERATORS...8 5.3.2 PRIORITISATION OF OFFICIAL CONTROLS...8 5.3.3 CONTROL ACTIVITIES, METHODS AND TECHNIQUES...9 5.3.4 SAMPLING AND LABORATORY ANALYSIS...9 5.3.5 PROCEDURES FOR PERFORMANCE AND REPORTING OF CONTROL ACTIVITIES...10 5.3.6 TRANSPARENCY AND CONFIDENTIALLY...11 5.4 ENFORCEMENT MEASURES...12 5.4.1 MEASURES IN THE CASE OF NON-COMPLIANCE...12 5.4.2 SANCTIONS...12 5.5 VERIFICATION AND REVIEW OF OFFICIAL CONTROLS AND PROCEDURES...13 5.5.1 VERIFICATION PROCEDURES...13 5.5.2 AUDIT...13 5.6 MULTI ANNUAL NATIONAL CONTROL PLAN...14 6 SECTOR SPECIFIC FINDINGS AND CONCLUSIONS...14 6.1 LEGISLATION...14 6.2 REQUIREMENTS ALONG THE FOOD CHAIN FOR FOOD ADDITIVES AND FOOD CONTRACT MATERIALS...15 6.2.1 DECLARATION OF COMPLIANCE...15 6.2.2 CONTROL AT VISITED PREMISES INCLUDING TRACEABILITY AND HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)...16 6.3 GOOD MANUFACTURING PRACTICE FOR FCM...17 6.4 MONITORING SYSTEMS FOR THE CONSUMPTION AND USE OF ADDITIVES...18 6.5 LABORATORIES CARRYING OUT OFFICIAL CONTROL ANALYSIS...18 6.5.1 MICROBIOLOGICAL LABORATORY ANALYSES...19 6.5.2 FA LABORATORY ANALYSES...19 6.5.3 FCM LABORATORY ANALYSES...20 6.6 RAPID ALERT SYSTEM FOR FOOD AND FEED...21 6.7 FOLLOW UP TO THE REPORT DG(SANCO)2007-7193...22 7 OVERALL CONCLUSION...23 II
8 CLOSING MEETING...23 9 RECOMMENDATIONS...23 ANNEX 1 - LEGAL REFERENCES...25 III
ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation ARPA MT AUSL BHA BHT BIP BTSF CA CCA CCP CP DEHA DGAHVM DGFSN DG(SANCO) DoC EC EN ISO EU EURL FA FAO FBO FCM FH FNAO FVO GA GHP GMP HACCP HPLC ITX Explanation Agencia Regionale per la Protezione Ambientale Mission Team Local Health Units Butylated hydroxyanisole Butylated hydroxytoluene Border Inspection Point Better Training For Safer Food Competent Authority Central Competent Authority Critical Control Point Country Profile Di(2-ethylhexyl) adipate Directorate General for Animal Health & Veterinary Medical Products Directorate General for Food Safety and Nutrition Health and Consumers Directorate-General Declaration of Compliance European Community European Norm International Organisation for Standartisation European Union European Union Reference Laboratory Food Additive Food of Animal Origin Food Business Operator Food Contact Material Food Hygiene Food of Non Animal Origin Food and Veterinary Office General Audit Good Hygiene Practice Good Manufacturing Practice Hazard Analysis Critical Control Points High Performance Liquid Chromatography Isopropyl Thioxantone IV
ISS IZS LOD LC/MS LVS MANCP MIPAAF MoH MS NAS NRL OML PAA PRISA PT RASFF RPHS SML USMAF SA SEM SIAN SOP TC National Institute for Health Instituto Zooprofilattico Sperimentale Limit of Detection Liquid Chromatography / Mass Spectrometry Local Veterinary Services Single Integrated Multi-Annual National Control Plan Ministry of Agriculture Food and Forest Policies Ministry of Health Member State Police for Health National Reference Laboratory Overall Migration Limit Primary Aromatic Amines Three Year Integrated Regional Plan Proficiency Tests Rapid Alert System for Food and Feed Regional Public Health Services Specific Migration Limit Air and Sea Health Offices Specific Audit Semicarbazide Hygiene and Nutrition Services Standard Operating Procedure Third Country V
1 INTRODUCTION The Specific Audit formed part of the FVO's planned mission programme. It took place in Italy from 4 th October to 12 th October 2010. The mission team (MT) comprised two inspectors from the Food and Veterinary Office (FVO) and two laboratory experts from two different European Union (EU) countries. The MT was joined by a representative of DG(SANCO) Directorate E for part of the mission. Representatives from the central competent authority (CCA) namely the Ministry of Health (MoH) accompanied the MT for the duration of the audit. An opening meeting was held on 4 of October 2010 with the CCAs. At this meeting, the objectives of, and itinerary for, the specific audit were confirmed by the MT and the control systems were described by the authorities. 2 OBJECTIVES OF THE MISSION The objectives of the specific audit were to: verify that official controls are organised and carried out in accordance with relevant provisions of Regulation (EC) No 882/2004, and the multi-annual national control plan (MANCP) prepared by Italy in the sectors currently being evaluated; to evaluate the implementation of the Community legislation in the area of food additives (FA), in particular Regulation (EC) No 1333/2008 and transposition and implementation of Annexes to Commission Directives 94/35/EC, 94/36/EC, 95/2/EC and related legislation concerning the purity of food colours, sweeteners and FAs other than colours and sweeteners; to evaluate the implementation of the Community legislation in the area of food contact materials (FCM), in particular implementation of Regulation (EC) No 1935/2004 and related legislation with regard to regenerated cellulose film, plastic materials, ceramic articles and active and intelligent food contact materials and articles. concerning food of non-animal origin (FNAO) and composite products at all stages of processing and distribution, as well as food of animal origin at retail level, to evaluate the implementation of: Regulation (EC) No 852/2004 on the hygiene of foodstuffs (FH) and Regulation (EC) No 882/2004 on official controls; Community legislation regarding the general principles and requirements of Article 18 of Regulation (EC) No 178/2002 regarding traceability; national provisions based on Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs, in particular the implementation of provisions addressing the labelling of allergens. In terms of scope, the audit concentrated primarily on: Regulation (EC) No 882/2004, the organisation of official controls (Artt. 3-7,) control and verification procedures and methods (Artt. 8-10), enforcement (Artt. 54-55), and MANCP (Artt. 41-42); 1
The implementation of Community legislation regarding FA, FCM and FH. The table below lists sites visited and meetings held in order to achieve that objective: MEETINGS/VISITS n COMMENTS COMPETENT AUTHORITIES Central 2 Opening and closing meeting with MoH, National Institute for Health (ISS), Ministry of Agriculture Food and Forest Policies (MIPAAF) Regional 2 Regional CAs in Piemonte and Marche including Air and Sea Health Offices (USMAF) LABORATORIES 2 Instituto Zooprofilattico Sperimentale (IZS) and Agencia Regionale per la Protezione Ambientale (ARPA) in Piemonte ESTABLISHMENTS 4 One meat producer using FA and FCM Two non animal food producer using FA and FCM One producer and importer of FCM RETAIL 1 One supermarket in Marche region 3 LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community legislation, and in particular: Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules; A full list of the legal instruments referred to in this report is provided in the Annex and refers, where applicable, to the last amended version. 4 BACKGROUND 4.1 CONTRIBUTION TO THE GENERAL AUDIT Article 45 of Regulation (EC) No 882/2004 requires the Commission to carry out general and specific audits in Member States (MS). The main purpose of such audits is to verify that, overall, official controls take place in MS in accordance with the multi-national control plans referred to in Article 41 and in compliance with Community law. This Specific Audit was carried out as a component of a General Audit to Italy and it is the first FA / FCM audit undertaken to this MS. It forms part of a series of audits to MS with similar objectives concerning the evaluation of the implementation of Community legislation on official controls for FA and FCM. Section 5 contains findings and conclusions relating to the implementation of Regulation (EC) No 882/2004; section 6 contains findings and conclusions relating to sector specific issues. 2
4.2 BACKGROUND TO THE SERIES OF MISSIONS ON FOOD HYGIENE A previous series of missions was carried out to all MS from June 2004 to October 2005 with the objective of evaluating EU legislation on controls on the hygiene of foodstuffs. These missions also evaluated aspects of the veterinary legislation, in so far as they were applicable to butchers shops. The overview report of this series of missions is available on the DG (SANCO) Internet site at: http://ec.europa.eu/food/fvo/specialreports/index_en.htm The report DG(SANCO) / 2007-7193 of the last mission on food hygiene carried out by the FVO in Italy from 11-15 June 2007 can be found at: http://ec.europa.eu/food/fvo/ir_search_en.cfm This is the second food hygiene mission undertaken to Italy under the above legal basis. It forms part of a series of missions to MS with similar objectives concerning the evaluation of the implementation of Community legislation on official controls for food hygiene, traceability, labelling and to follow up on the action taken in response to the recommendations made in the previous report. 4.3 BACKGROUND TO THE SERIES OF MISSIONS ON FOOD ADDITIVES AND FOOD CONTACT MATERIALS Article 50 of Regulation (EC) No 178/2002 requires that information on foodstuffs and feedingstuffs found to have public health implications is disseminated as notifications through the Rapid Alert System for Food and Feed (RASFF) to all MS and to the exporting country. As regards FCM, 767 notifications concerning mainly products originating from Third Countries (TC) and to a lesser extent from MS, have been notified through RASFF in the last four years. These break down as follows: 192 alerts in 2006, 172 in 2007, 206 in 2008 and 197 in 2009. The following hazards were reported: primary aromatic amines (PAA), semicarbazide (SEM), di(2- ethylhexyl) adipate (DEHA), formaldehyde, heavy metals (lead, cadmium, chromium, nickel, iron, manganese or zinc), excessive total migration, organoleptic properties, isopropyl thioxantone (ITX), benzophenone, 4-methylbenzophenone and phthalates (e.g. DEHP, DBP). As regards FA, around 600 notifications concerning foodstuffs originating from TC and MS, have been notified through RASFF in the last four years. The use of illegal dyes (e.g. Sudan) as well as the high content or unauthorised use of sulphites in foodstuffs have been notified frequently. Other FA notified were benzoic acid, sorbic acid and artificial sweeteners (e.g. Aspartame). "Food additive" is defined as a substance not normally consumed as food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the internal addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods. Community legislation establishes a "positive list" of additives authorised for use in foodstuffs, usually specifying the maximum content thereof allowed in food or setting the permitted limit at a level necessary to achieve the technological purpose without misleading the consumer. Before authorisation, FA have to undergo appropriate toxicological testing and evaluation, leading to approval or rejection and to establishment of the maximum permitted levels in foodstuffs. This evaluation takes into account 3
any cumulative, synergistic or potentiating effect of use thereof and the phenomenon of human intolerance to substances foreign to the body. It is illegal to use unauthorised additives in foodstuffs and to apply additives to foodstuffs without authorisation for each specific application. 5 FINDINGS AND CONCLUSIONS RELATED TO IMPLEMENTATION OF REGULATION (EC) NO 882/2004 5.1 COMPETENT AUTHORITIES 5.1.1 Designation of Competent Authorities Article 4(1) of Regulation (EC) No 882/2004 requires Member States to designate the competent authorities responsible for official controls. At the central level the MoH has overall responsibility for official controls in the context of this mission. Within the Directorate General for Food Safety and Nutrition (DGFSN) several offices carry out different actions. Office II is responsible for General Food Hygiene which includes official controls in the area of FNAO. Although USMAF are under the supervision of Office III of the Directorate General For Sanitary Prevention, for activities related to FA and FCM instructions are provided by Office II. Office VI is responsible for Food Technology and Hygiene which includes activities in the field of of FCM and FA. Office VIII is responsible for food chain control systems plans and management of RASFF. Within the Directorate General for Animal Health & Veterinary Medical Products (DGAHVM) Office IX deals with audit. At the regional level the Region Public Health Services (RPHS) co-ordinates and undertakes detailed planning of the instructions received from the central level. The 19 regions and two autonomous Provinces have responsibility within their territories, for planning, co-ordination, guidance, authorisation and verification of controls. The operational work is carried out by the Local Health Units (AUSL) which are public bodies responsible for the organisation and management of all public health services at the local level. They have a high degree of managerial, administrative, financial and technical autonomy. There are 195 AUSL in total in Italy. There are two units dealing with Food Safety: the Hygiene and Nutrition Services (SIAN) which is responsible for FNAO and the Local Veterinary Service (LVS) which is responsible for food of animal origin (FAO). The Police for Health (NAS) are a special branch of the Carabinieri which operate under the supervision and direction of the MoH. The NAS are responsible for investigations and controls on tainting of foodstuffs, fraud and illegal trafficking of medicines. Their food safety inspection activities are generally triggered by a suspicion of fraud or other criminal activity and account for 50% of their work. There are twelve USMAF along with 37 territorial units which are located at the main ports and airports. They are responsible for controls on imported FNAO and FCM. 4
5.1.2 Co-operation between Competent Authorities Article 4(3) of Regulation (EC) No 882/2004 provides for efficient and effective co-ordination and co-operation between competent authorities. Relations between the State and Regions are managed through the State-Region Conference. The State-Region conference is composed of the Presidents of all Regions and deals with the political, technical and co-ordination aspects of food safety. It meets 15-20 times per year. In addition there is an Inter-Regional committee on Food Safety in which MoH's DGFSN takes part by invitation. This committee is assisted by technical working groups. These meetings occur approximately ten times per year. The topic of FA was discussed at the April 2010 meeting, however FCM has not been discussed recently. The outcome of the Inter Regional Committee is formally adopted by the State / Region Conference. The MT was provided with evidence of co-ordination between the USMAF and the AUSLs in the Marche region, when a consignment of FCM passes from the port (USMAF authority) to the AUSL. 5.1.3 Co-operation within Competent Authorities Article 4(5) of Regulation (EC) No 882/2004 requires that, when, within a competent authority, more than one unit is competent to carry out official controls, efficient and effective co-ordination and co-operation shall be ensured between the different units. In the Piemonte region the MT was informed that at least once a year a general meeting between the directors of the AUSLs and the regional authorities takes place. The objectives of this meeting include the preparation of the annual work programme. Subsequently sector specific meetings and working groups (comprising the laboratories and AUSLs) deal with the details of a wide range of topics from registration issues, alerts, primary production and procedures for official controls. In the Piemonte region the MT was informed that the LVS and the SIAN performed joint inspections in supermarkets. In the Marche region a joint inspection of LVS and SIAN took place in a supermarket where responsibility was divided according to the origin of the products. 5.1.4 Delegation of specific tasks related to official controls Article 5 of Regulation (EC) No 882/2004 sets out the scope of possible delegation to control bodies, the criteria for delegation, and the minimum criteria which must be met by control bodies. Where such delegation takes place, the delegating competent authority must organise audits or 5
inspections of the control bodies as necessary. The Commission must be notified about any intended delegation. The MoH stated that no tasks relating to official controls within the scope of this audit are delegated. 5.1.5 Contingency planning Article 4 of Regulation (EC) No 882/2004 also requires that competent authorities have contingency plans in place, and are prepared to operate such plans in the event of an emergency. Article 13 of Regulation (EC) No 882/2004 requires Member States to draw up operational contingency plans setting out measures to be implemented without delay when feed or food is found to present a serious risk. The MoH confirmed that there is a contingency plan in existence in Italy within the meaning of Article 4.2 of Regulation (EC) No 882/2004. In January 2008 a decision of the State / Region Conference was taken to implement a contingency plan for food and feed. In May 2009 the first meeting with the regions took place and a national crisis unit was established. In November 2009 a simulation exercise took place which included testing all relevant contacts via teleconference. In May 2010, a three day training exercise entitled 'Food Safety Emergency: Procedures and Management' took place. An expert working group, which includes the ISS had recently been established with responsibility for defining operational procedures and a set of guidelines are in preparation. Conclusions on Competent Authorities The CAs in the context of this mission have been designated. Horizontal communication between the CAs is in general ensured. Cooperation within the CAs is adequate. There is no delegation of tasks related to the official controls in the context of this mission. There is a contingency plan in place that could be used in the event of an emergency as required by Articles 4 and 13 of Regulation (EC) No 882/2004. 5.2 RESOURCES FOR PERFORMANCE OF CONTROLS 5.2.1 Legal basis for controls Article 4 of Regulation (EC) No 882/2004 requires that the necessary legal powers to carry out controls are in place and that there is an obligation on food business operators to undergo inspection by the competent authorities. Article 8 of the above Regulation requires that CAs have the necessary powers of access to food business premises and documentation. 6
The Legislative Decree 193/2007 nominates the MoH, the Regions / Autonomous Provinces of Trento and Bolzano and the AUSLs as competent authorities for food safety in order to implement Regulation (EC) No 882/2004 and Regulation (EC) No 852/2004. In the Piemonte region the MT was informed that two pieces of regional legislation LR 2610 1982 No 30 provides the legal basis for the RPHS to take action in issues relating to hygiene and public health and LR 28 July 2008 no 23 enabling the reorganisation changes at regional level. During the audit the MT observed that CAs have the necessary powers of access to food business premises and documentation. 5.2.2 Staffing provision and facilities Article 4 of Regulation (EC) No 882/2004 requires the competent authority to ensure that they have access to a sufficient number of suitably qualified and experienced staff; that appropriate and properly maintained facilities and equipment are available; and that staff performing controls are free of any conflict of interest. The Country Profile (CP) Annex III provides a detailed breakdown of the staffing at central, regional and local levels as well as laboratory staffing levels. The MT was informed that staffing levels at the central level and in the Piemonte and Marche region were sufficient. Staff were properly equipped. All inspectors have the equivalent status of the judicial police and it is a criminal offence to be found in a conflict of interest situation. 5.2.3 Staff qualifications and training Article 6 of Regulation (EC) No 882/2004 requires competent authorities to ensure that staff receive appropriate training, and are kept up-to-date in their competencies. The CP states on page 13 that the SIAN staff are composed of medical doctors, chemists and technicians with a second level diploma. The majority of inspectors in the LVS are veterinarians. In the Piemonte region there had been two training sessions in FCM in 2009 in which a total of 163 staff had attended and in 2010 there were training sessions on FA planned. One member of the administrative staff attended the DG (SANCO) Better Training for Safer Food (BTSF) on FCM and two people from the LVS had attended BTSF training on Hazard Analysis and Critical Control Points (HACCP). In the Marche region there were a total of 395 staff: 175 medical, veterinary and chemical 7
personnel, 180 technical staff and 40 administrative staff. One inspector met by the MT, had a civil engineering background with a chemistry qualification. One member of staff had attended the BTSF training on FCM in 2010 and this information has been made available to all staff in the region. In addition this knowledge is being transferred to other members of staff through a cascade system of training. Conclusions on Resources for Performance of Controls The CAs have adequate legal powers to carry out official controls and legal procedures are in place to give them access to the premises of and documentation kept by the FBOs as required by Articles 4 and 8 of Regulation (EC) No 882/2004. The CA has a sufficient number of qualified and trained staff available. Although training in FCM and HACCP has commenced some inspectors met during the site visits were not yet fully competent in these subjects. No training in FA has taken place. 5.3 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS 5.3.1 Registration / approval of food business operators Article 31 of Regulation (EC) No 882/2004 requires Member States to establish procedures for the registration/approval of food and feed business operators, for reviewing compliance with conditions of registration and for the withdrawal of approvals. According to the CP (page 38) the administrative acts and authorisations which requires FBO to notify starting up a business are also used for the purpose of registration. Registration is undertaken by the AUSL. In both regions the MT saw the register of businesses. There is no legal requirement for FCM manufacturers to register in Italy and there are no plans to change this situation. 5.3.2 Prioritisation of official controls Article 3 of Regulation (EC) No 882/2004 requires that official controls are carried out regularly, on a risk basis and with appropriate frequency. Controls shall be carried out at any of the stages of the production and processing chain and, in general, are to be carried out without prior warning. Controls shall be applied with the same care to exports from the Community, imports into the Community and to product placed on the Community market. : The national legislation, Presidential Decree of 14 July 1995 as amended by Ministerial Decree 8 8
October 1998 prescribes the minimum inspection frequency which is once per year. All inspections are carried out without prior warning. In the Piemonte region a three year integrated regional plan (PRISA) is approved by D.D 373 of 4 June 2010. On the basis of PRISA each AUSL develops a detailed annual plan which is subsequently assessed and approved at the regional level. In the Marche region, the three year regional health plan is not yet fully approved at the regional political level but a draft version is being discussed. However, the Marche region had approved a food safety official control and sampling plan for 2010. This plan does not include FCM manufacturers, importers and distributors. The CA confirmed that much of the work associated with FCM to-date was in response to alerts. Both the Piemonte and Marche region have an information technology (IT) system that has been developed for categorisation of FBOs based on the risk associated with their size, industrial activities and previous inspection history. A scoring system identifies a risk category of low, medium or high. Both IT systems will be used to provide a risk rating of FCM business organisations in the future. In Piemonte for high risk establishments an inspection frequency of at least once a year is required, but in reality such facilities are inspected twice a year. For medium and low risk establishments an inspection frequency of once every two years is required. The USMAF in Marche undertakes a 100% documentary check, and 50% physical check on the imported FCM and 5% sampling of such goods. 5.3.3 Control activities, methods and techniques Article 10 of Regulation (EC) No 882/2004 specifies the control activities, methods and techniques that should be deployed. Tasks relating to official controls are in general carried out using appropriate control methods and techniques such as monitoring, verification, audits, inspection, sampling and analysis. 5.3.4 Sampling and Laboratory analysis Article 4 of Regulation (EC) No 882/2004 requires competent authorities to have, or to have access to, adequate laboratory capacity. Article 11 of the Regulation establishes requirements for sampling and analysis and Article 12 requires the competent authority to designate laboratories that may carry out analysis of samples taken during official controls. It also lays down accreditation criteria for laboratories so designated. 9
The IZS is a network which covers the whole national territory and is composed of 10 head offices located in the cities of Brescia, Foggia, Padua, Palermo, Perugia, Portici (Naples), Rome, Sassari, Teramo and Turin and over 90 diagnostic sections present in almost all Italian provinces. The network of IZS laboratories has generic accreditation since 1998 by SINAL (now merged into one accreditation body for Italy, ACCREDIA). The MT visited the IZS in Piemonte which is the designated official laboratory for chemical analysis of FAO and the microbiological analysis for all types of food. The ARPA is a network of regional laboratories coordinated by the regions and by 'Istituto Superiore per la Protezione e la Ricerca Ambientale' (the National Institute for Environmental Protection and Research). It belongs to a network system known as the Environmental Agency System. In Italy, there are currently 21 ARPAs. In the ARPA Polo Alimenti laboratory in Piemonte, both FCM and FA official controls for FNAO were conducted. The laboratory is also accredited to EN ISO 17025 since 1998. There were no accredited methods for FCM and for FA there is one for preservatives. Participation in Proficiency Tests (PT) was not undertaken for FCM and was limited to preservatives for FA. The samples are taken by AUSL inspectors according to the plan. The AUSLs are obliged to use the analytical services of IZS and ARPA. No sampling was observed during this audit. 5.3.5 Procedures for performance and reporting of control activities Article 8 of Regulation (EC) No 882/2004 requires that competent authorities carry out their official controls in accordance with documented procedures, containing information and instructions for staff performing official controls. Article 9 of the above Regulation requires competent authorities to draw up reports on the official controls carried out, including a description of the purpose of official controls, the methods applied, the results obtained and any action to be taken by the business operator concerned. All CAs generally have written instructions and check-lists covering the areas to be controlled. The MT saw two different guidelines developed by the Regional CA. The one which was used by the LVS incorrectly stated that Regulation (EC) No 852/2004 was the legal basis for FCM official control. The second guideline which is used by SIAN correctly stated that Regulation (EC) No 1935/2004 was the legal basis for FCM official controls. There are no guidelines available to inspectors for the assessment of HACCP in FA producers and users. All inspections are unannounced and are undertaken by a minimum of two inspectors, a report is written up at the end of the inspection and a copy given to the FBO. The copy retained by the RPHS is verified and filed. 10
5.3.6 Transparency and confidentially Article 7 of Regulation (EC) No 882/2004 requires that competent authorities carry out their activities with a high degree of transparency, in particular by giving relevant information to the public as soon as possible. However, information covered by professional secrecy and personal data protection is not to be disclosed. The web page of the MoH publishes the MANCP and other policy documents and alerts the public to potential food safety issues. The DGFSN (Office VIII) produces an annual report on the results of monitoring and controls on foodstuffs in Italy which is also published on the MoH website. In both regions visited the MT was informed that the plan for official controls and the report was published on its web site. It does not publish the names of FBOs who are involved in administrative procedures. Conclusions on Organisation and Implementation of Official Controls There are adequate procedures for registration of FBOs and there is no legal requirement for the registration of FCM business organisations. Official controls for FH in both regions visited are carried out at predefined regular intervals and on a risk basis. The official controls of FA / FCM are at an early stage and are being integrated into food hygiene controls. There are no guidelines available to inspectors for the assessment of HACCP in FA users and producers. Although there are instructions available for inspectors on the official controls of FCM and FA there are different versions for FCM based on different legal basis. The range of FA / FCM accredited methods of analysis in the laboratories is inadequate. Participation in PT is limited to preservatives for FA and not undertaken for FCM. In each region the inspectors draw up reports on the official controls that they have carried out and a copy is provided to the FBO concerned as required by Article 9 of Regulation (EC) No 882/2004. Information on the control activities of the CAs are publicly available. 5.4 ENFORCEMENT MEASURES 5.4.1 Measures in the case of non-compliance Article 54 of Regulation (EC) No 882/2004 requires a competent authority which identifies a noncompliance to take appropriate action to ensure that the operator remedies the situation. 11
At the central level and the Marche region, the MT was informed that Article 5 of Decree 283/1962 provides the legal basis for the relevant CAs to recall, withdraw suspect products including FCM and FA. In Marche the MT saw examples of measures being taken on the basis of Article 54 Regulation (EC) 882/2004. In Piemonte the MT was informed that in relation to FCM, measures can be imposed on the basis of Regulation (EC) No 882/2004 and an example was provided which dealt with implementation of good manufacturing practice (GMP) in the FCM business operator. In both regions visited the Criminal code can additionally be invoked to initiate criminal proceedings for serious breaches of legislation. 5.4.2 Sanctions Article 55 of Regulation (EC) No 882/2004 states that Member States shall lay down the rules on sanctions applicable to infringements of feed and food law and other Community provisions relating to the protection of animal health and welfare and shall take all measures necessary to ensure that they are implemented. The sanctions provided for must be effective, proportionate and dissuasive. The basic law for administrative sanctions is Decree 689/1981. Most infringements are covered by administrative sanctions except those covered by Law 283/1962 (Article 5, 6 and 12). In the Piemonte region the MT was informed that fines for infringement in connection with FCM are imposed according to Article 2, 3,4,5 of DPR 777/82 which was modified by Article 1, 2,3,4, 5, of DL No 108/82. Conclusions on Enforcement Measures The legal provisions are in place and provide for a range of measures in the event of non compliance. 5.5 VERIFICATION AND REVIEW OF OFFICIAL CONTROLS AND PROCEDURES 5.5.1 Verification procedures Article 4 of Regulation (EC) No 882/2004 requires the CAs to ensure the impartiality, consistency and quality of official controls at all levels and to guarantee the effectiveness and appropriateness of official controls. Article 8 states that they must have procedures in place to verify the effectiveness 12
of official controls, to ensure effectiveness of corrective action and to update documentation where needed. The MoH carries out planned on the spot observations on different topics. In the context of this mission no such on the spot observations have taken place. The CA stated that there are six inspections of the RPHS in the catering sector planned for 2010. The Piemonte region has an exchange programme in place whereby inspectors from one AUSL can perform inspections with staff from another AUSL. Its aim is to encourage dialogue and to ensure a uniform approach to inspections within the region. The results of such observations are reported to the regional level. 5.5.2 Audit Under Article 4 of Regulation (EC) No 882/2004 competent authorities are required to carry out internal audits, or have external audits carried out. These must be subject to independent scrutiny and carried out in a transparent manner. The MoH (Office IX) confirmed that there is a national plan for undertaking 50 audits in 2010. Of these four were system audits which are the responsibility of Office IX and the remaining specific audits are undertaken by other offices within the CCA. However of the six audits carried out in the regions to date there were none in the context of this mission. In 2009, training was undertaken by 64 staff in audit techniques and 96 staff were given similar training in 2010. In Piemonte, an audit plan had been prepared which has been approved by the regional government. However training for auditors was still ongoing and no audit was expected to be performed until training had been completed at the end of 2010. No audit from the central level has been performed in Piemonte in the context of this mission. Conclusions on Verification Procedures There are adequate procedures in place for verification but they have not been applied to-date. Audits within the meaning of Article 4.6 of Regulation (EC) 882/2004 have commenced however none have been carried out in the context of this mission. 13
5.6 MULTI ANNUAL NATIONAL CONTROL PLAN Article 41 of Regulation (EC) No 882/2004 requires that each Member State prepares a single integrated multi-annual national control plan (MANCP). According to Article 42 it should be implemented for the first time no later than 1 January 2007 and be regularly updated in light of developments. Details on the type of general information on the structure and organisation of the systems of feed and food control and of animal health and welfare control in the Member State concerned are provided. The annual report for 2008 and the MANCP for 2007-2010 has been received by the Commission from the Italian authorities. The control systems applied to FA and FCM are not described. Conclusions on Multi-Annual National Control Plan The MANCP does not contain the information on FCM/FA required in Article 42(2)(e) of Regulation (EC) No 882/2004. 6 SECTOR SPECIFIC FINDINGS AND CONCLUSIONS 6.1 LEGISLATION The MoH is responsible for drafting legislation in relation to food safety and transposing EU legislation. All legislation is available on the MoH website. Each region has the power to draw up its own legislation. The CAs stated that all EC Directives in the context of this mission have been transposed into the national legislation. There is additional legislation in place for FCM relating to plastic, rubber, paper and cardboard, glass, stainless steel, tin, chromium plate and aluminium and these have been reported to the European Commission. Conclusions Responsibilities for drafting and transposing legislation in the scope of this audit are clearly defined. Legislation is well defined and publicly available. The EC Directives relevant to this audit have been transposed into Italian law. 14
6.2 REQUIREMENTS ALONG THE FOOD CHAIN FOR FOOD ADDITIVES AND FOOD CONTRACT MATERIALS 6.2.1 Declaration of Compliance Article 16 of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food requires that FCM shall be accompanied by a written declaration stating that they comply with the rules applicable to them. Article 9 of Commission Directive 2002/72/EC as amended relating to plastic materials and articles intended to come into contact with foodstuffs requires that at the marketing stages other than the retail stage, plastic materials and articles as well as the substances intended for the manufacturing of those materials and articles, shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004. Article 2(a) of Council Directive 84/500/EEC as amended relating to ceramic articles intended to come into contact with foodstuffs requires that at the marketing stages up to and including the retail stage, ceramic articles which are not yet in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004. In the meat producer visited the inspector assessed the declaration of compliance (DoC) on the basis of Regulation EC No 852/2004. The inspector did not check if the plastic buckets used for FA were of food grade and accompanied by a DoC. In the FA / FCM user visited in the Piemonte region the DoC was adequately assessed, however it was noted that a reference to compliance with specific migration limits (SML) was absent although the table of results was given in the DoC. In the FA / FCM user in the Marche region the assessment of the DoC by the inspector was restricted to checking for the presence of a DoC and the existence of a compliance statement. No details were reviewed. In the FCM producer / importer the inspector adequately assessed the DoC. A detailed check list was used by the inspector. Conclusions The assessment of the DoC in the companies visited did not always follow the requirements of Annex VI a of Commission Directive 2002/72/EC. 6.2.2 Control at visited premises including traceability and hazard analysis and critical control points (HACCP) Article 10 of Regulation (EC) No 882/2004 lays down that official controls shall, in general, be carried out using appropriate control methods and techniques. 15
Article 5(1) of Regulation (EC) No 852/2004 requires that FBO shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles. Article 5(2)(g) of Regulation (EC) No 852/2004 requires that the HACCP principles shall consist, among other things, of establishing documents and records commensurate with the nature and size of the food business. Article 5(5) of Regulation (EC) No 852/2004 allows the adoption of arrangements to facilitate the implementation of the HACCP requirement by certain FBO. These include the use of guides for the application of HACCP principles. Article 18 of Regulation (EC) No 178/2002 establishes traceability requirements in food and feed. Article 17 of Regulation (EC) No 1935/2004 establishes traceability requirements in FCM. The MT focussed on controls of FCM / FA in Piemonte and incorporated official controls in FH in the Marche region. The MT was informed by the MoH that Guides to Good Hygiene Practice (GHP) were drafted by the relevant Trade Associations and once validated by the MoH were published on their web site. The MT was provided with a list of the current twelve guides to GHP which were approved. In both regions visited it was confirmed that although these GHP guides existed they were not used by FBOs. In all establishments visited, the inspectors stated that official controls of FA / FCM were relatively new activities and were mostly undertaken in the context of general hygiene missions. In the Piemonte region the MT visited two establishments; a meat processing facility and a vegetable processing facility, both users of FA and FCM. The LVS inspector in the meat processing establishment had detected a problem with FA (nitrites) dosage records during an on site visit in 2008. A staff member in the establishment had failed to adequately complete the written records, however, the problem was detected rapidly by the inspector who was on site at the time and all necessary corrective actions were implemented. The use of FA was adequately assessed. The assessment of FCM was incomplete as the inspector failed to check if buckets used in the FA weighing area were food grade 1. The SIAN inspector in the visited vegetable processing establishment stated that to date controls on FA and FCM focussed on the retail level rather than the processing establishments. However, in 2003 there had been a general potential problem relating to Sudan dyes. A RASFF alert had been initiated and there was concern that FBOs might have bought some product that had been tainted. The suspected batches were quarantined and samples sent for analysis to ARPA and no non compliances were detected. The inspector correctly assessed traceability and labelling however the assessment of FA did not cover the assessment of the dosage to ensure that it was in line with the maximum limits in the legislation. In the Marche region, in the establishment using FA / FCM the assessment of critical control points 1 In their response to the draft report the Competent Authority noted that the FBO was informed of this non compliance and a subsequent inspection confirmed that it had been recified. 16
(CCP) and FA controls were not adequately covered. The SIAN inspector failed to identify any of the important parameters relating to the inspection of the premises. A list of temperatures reviewed was considered acceptable without any reference to the temperature limits established by the FBO in the HACCP plan. There were no questions asked relating to corrective actions that would be taken in the event of an incorrect reading being obtained. In the supermarket, a joint inspection with LVS and SIAN inspectors was observed. Inspectors were equipped with a calibrated thermometer and temperature checks were adequately performed at the meat counter. Inspectors assessed the single CCP which was established by the FBO in the HACCP plan. Temperature records were reviewed without knowing the limits established by the FBO in the HACCP plan. In addition corrective actions were not discussed. The assessment of labelling was incorrect as the inspector failed to recognise that the absence of storage conditions and best before date was a breach of EU legislation. The assessment of labelling of allergens was adequate. In the FCM producer / importer the inspector confirmed that this was the first official control of FCM undertaken at the establishment. Although a detailed check list was used the inspector did not request the appropriate documentation to demonstrate compliance with the legislation, he accepted that it existed on the word of the FBO. Conclusions Examination of written documentation relating to dosage of FA and activities of FCM manufacturer was not adequately assessed in all sites visited as required by Article 10.2(e) of Regulation (EC) No 882/2004. In the Marche region there was an incomplete assessment of the procedures based on HACCP which is contrary to Article 10.2(d) of Regulation (EC) No 882/2004. In the supermarket there was incomplete assessment of the labelling requirements of foodstuffs which is contrary to Article 3 of Directive 2000/13/EC. 6.3 GOOD MANUFACTURING PRACTICE FOR FCM Article 3 of Regulation (EC) No 1935/2004 requires that FCM shall be manufactured in compliance with GMP. Commission Regulation (EC) No 2023/2006 on GMP for materials and articles intended to come into contact with food. In the absence of a legal requirement for registration of FCM businesses, the RPHS in the Piemonte region was in the process of collecting data. The most recent data lists 333 FCM manufacturing businesses and it is estimated by the RPHS that 40% of these have implemented GMP. In the Marche region no data was currently available on the number of FCM operators, however, the one FCM operator / importer that was visited had implemented GMP. 17
Conclusions There is only limited information on the level of GMP implementation in Piemonte region and none available for the Marche region. 6.4 MONITORING SYSTEMS FOR THE CONSUMPTION AND USE OF ADDITIVES Article 27 of Regulation (EC) No 1333/2008/EC requires MS shall maintain systems to monitor the consumption and use of FA on a risk-based approach and report their findings with appropriate frequency to the Commission. The MoH is responsible for the monitoring of the use and consumption of FA in Italy and the ISS is charged with undertaking the task. The MT reviewed a number of documents from this monitoring activity which included the use and consumption of sulphates (2000), the use of Benzoic acid (2001) and intake of sweeteners by Italian teenagers (1999). The studies were considered adequate. Conclusions The MoH has undertaken a number of studies to monitor the use and consumption of FA. 6.5 LABORATORIES CARRYING OUT OFFICIAL CONTROL ANALYSIS Article 11 of Regulation (EC) No 882/2004 requires that sampling and analysis methods used in the scope of official controls shall comply with relevant Community rules. Article 12 of Regulation (EC) No 882/2004 requires CAs to designate laboratories that may carry out the analysis of samples taken during official controls. Article 33 of Regulation (EC) No 882/2004 requires MS to designate NRL for each Community reference laboratory (CRL) referred to in Article 32. The NRL shall collaborate with the CRL, coordinate activities, organise comparative tests, ensure dissemination of information, and provide scientific and technical assistance. Article 24 of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food requires the CRL for FCM and NRL established as laid down in Regulation (EC) No 882/2004 to assist MS with a high quality and uniformity of analytical results. The mission visited visited two laboratories in Piemonte region: the IZS Turin for foodstuffs and ARPA laboratory for FA and FCM. 18