Materiali e Oggetti a Contatto con Alimenti Cerere 12 ottobre Le ispezioni FVO sui MOCA

Transcript

1 Nel mese di ottobre 2010 la FVO ha condotto una missione in Italia per la verifica dello stato di attuazione delle normativa comunitaria in materia di MOCA. La missione ha visitato le regioni Marche e Piemonte. Sono state rilevate alcune Non Conformità (14 ). 1

2 1 Garantire che il personale addetto ad effettuare i controlli ufficiali riceva la formazione adeguata in materia di HACCP, AA, MCA ed etichettatura conformemente all'articolo 6 e all'allegato II del regolamento (CE) n. 882/2004. La DGSAN ha inviato una nota informativa alle Autorità Competenti Regionali (ACR) sulle criticità emerse nel corso dell audit e ha invitato ad intraprendere, ove necessario, le azioni necessarie per superare le carenze riscontrate;in particolare è stata richiamata l importanza della formazione del personale che effettua i controlli per MOCA, additivi e igiene ( all.1). 2

3 4 Garantire che i controlli ufficiali comprendano le attività di ispezione degli operatori MCA e l'esame del materiale scritto conformemente all'articolo 10, paragrafo 2, lettera e), del regolamento (CE) n. 882/2004. Per quanto riguarda le attività di vigilanza sugli operatori il MS sta predisponendo un provvedimento normativo volto a rendere obbligatorio per gli operatori alimentari, compresi i produttori di MOCA, l inserimento dello stabilimento in un anagrafica nazionale. Nell immediato la DGSAN ha richiamato alle ACR (all. 1) l importanza dell attività di ispezione secondo procedure documentate, comprendendo la verifica del materiale scritto; 3

4 5 Garantire che le procedure documentate siano costantemente seguite conformemente all'articolo 8, paragrafo 1, del regolamento (CE) n. 882/2004. Nell ambito del Coordinamento Interregionale per la Sanità animale e la Sicurezza Alimentare è stato istituito un gruppo di lavoro sul Controllo ufficiale sui MOCA che ha lo scopo di individuare modalità condivise di applicazione della normativa e prioritariamente si occuperà di definire delle Linee guida nazionali per il controllo dei MOCA 4

5 6 Garantire che le procedure di verifica siano applicate per consentire la valutazione dell'efficacia dei controlli ufficiali conformemente all'articolo 8 del regolamento (CE) n. 882/2004. Si intendono sviluppare delle modalità per la verifica dell efficacia dei controlli ufficiali..inoltre nella nota informativa DGSAN ha invitato le Autorità Competenti Regionali (ACR).ad attivarsi affinché venga verificata l efficacia dei controlli ufficiali conformemente all'articolo 8 del regolamento (CE) n. 882/

6 9 Garantire che le autorità competenti intervengano in caso di irregolarità conformemente all'articolo 54 del regolamento (CE) n. 882/2004. La DGSAN ha espresso delle precisazioni in merito ad alcuni rilievi formulati durante l ispezione sulle misure adottate dalla ACL e ha richiamato nella nota di cui all allegato 1, rivolta alle Regioni, oltre alla puntuale applicazione dell articolo 54, le misure sanzionatorie esistenti in materia di MOCA e AA, al fine di una applicazione omogenea della normativa. 6

7 12 Garantire che gli ispettori ufficiali siano a conoscenza dei requisiti della dichiarazione di conformità di cui all'allegato VI bis della direttiva 2002/72/CE della Commissione e ne garantiscano la corretta applicazione. L uff. VI della DGSAN invierà, entro marzo 2011, una nota indirizzata alle ACR e agli USMAF che richiami le normative nazionali e comunitarie sui MCA, comprese le plastiche, e descriva le modalità di effettuazione dei controlli relativamente alle dichiarazioni di conformità. 7

8 13 Garantire che i controlli ufficiali comprendano la valutazione delle procedure basate sul sistema HACCP, sulle BPF e sulle BPI conformemente all'articolo 10, paragrafo 2, lettera d), del regolamento (CE) n. 882/2004. Si intende inserire l attività di verifica dell applicazione delle BPF nelle Linee guida per il controllo dei produttori MOCA che saranno definite nel gruppo di lavoro MOCA di cui alla Racc. n. 5. 8

9 14 Garantire che i produttori degli MCA attuino le BPF conformemente al regolamento (CE) n. 2023/2006 della Commissione. E previsto, entro marzo 2011, l invio di una nota alle Associazioni degli operatori del settore MOCA per richiamare gli obblighi di attuazione delle BPF, che peraltro sono oggetto di verifica nell ambito del controllo ufficiale. 9

10 La strategia del controllo ufficiale segue quindi una strada ben delineata dalle raccomandazioni della Missione FVO e delle relative asserzioni del Ministero della Salute. b) Incremento della EFFICACIA del controllo ufficiale dove per EFFICACIA si deve intendere capacità e rapidità della rimozione delle cause che hanno prodotto NC. a) Formazione degli addetti al controllo ufficiale (corsi ISS/MS, corsi RT, corsi Aziendali) c) Verifica della effettiva applicazione di manuali di buone pratiche laddove non sia in essere un sistema di HACCP. 10

11 Gli aspetti connessi alla produzione hanno il netto sopravvento su quelli connessi alla sicurezza alimentare. In alcuni casi è addirittura assente qualunque consapevolezza di essere parte di una filiera. Le corrette modalità di produzione commercializzazione e utilizzo di MOCA devono divenire patrimonio collettivo nell interesse primario di consumatori. 11

12 Filiere lunghee Materiali e Oggetti a Contatto con Alimenti Materie prime Produttore semilavorati O.S.A. es. Acque Scarsa professionalit tà Distributore professional e Converter O.S.A. es. accoppiato Scarsa professionalità Non percezione del problema O.S.A. (es. vetro ) Distributore 12 Consumat ore

13 Vediamo come sono andate le cose negli altri Paesi membri della UE 13

14 France Food additives and food contact materials Overall, a satisfactory system is in place for both FCM and FA although focusing on market controls. Major shortcomings identified are the lack of validation of analytical methods for the majority of FA in the laboratory visited and the limited scope of accreditation. Minor shortcomings have also been identified in the scope of audit system and the limited notifications through the RASFF. 14

15 Denmark Food Additives and Food Contact Materials OVERALL CONCLUSION Overall there is a good control system in place for FA and those FCM that are subject to specific measures. Official controls are carried out on a risk basis with appropriate frequency. Some shortcoming were identified in the range of FCM subject to official controls, in the scope of official controls and audit system, in the inspection procedures observed by the mission team in the establishments visited and in the implementation of RASFF. However, these minor shortcomings do not affect the reliability of the control system in place. 15

16 Germany Specific audit on the official control systems in place for food additives and for food contact materials (parte di general audit) Conclusions The implementation of GMP guides and training of all parties involved is currently ongoing. Official controls do not yet include the assessment of GMP in FCM establishments (Regulation 2023/2006), as required by Article 10(2)(d) of Regulation No 882/

17 Finland import controls, food additives and food contact materials controlli import FCM 6 OVERALL CONCLUSIONS Overall, there is an official control system in place in relation to import controls, FAs and FCMs in Finland which is mainly implemented in accordance with the relevant EC legislation. However, some shortcomings, relating to import procedures, the assessment of FAs and procedures on HACCP principles, and limited GMP implementation in FCM manufacturers, have been identified which might hamper the effective implementation of the official control system. 17

18 Greece Food additives and food contact materials OVERALL CONCLUSION Overall, there is an official control system in place for FA and FCM. Certain organisational difficulties and resource shortages have lead to shortcomings in the application of the Community requirements. Due to the identified significant deficiencies the official control of FA and FCM is not carried out in accordance with the relevant Community legislation. 18

19 Lithuania Food hygiene, food additives, food contact materials OVERALL CONCLUSIONS Overall, there is an official control system in place in relation to food hygiene, FAs and FCMs in Lithuania which is mainly implemented in accordance with the relevant EC legislation. However, some deficiencies, relating to monitoring of FAs consumption, documented procedure(s) for FCM manufacturers' inspection, assessment of the declaration of compliance, NRL laboratory for FCM and limited GMP implementation in FCM manufacturers, have been identified. 19

20 China Food Contact Materials (FCM) OVERALL CONCLUSIONS The control system in place on FCM destined for export to the EU has improved since the previous mission, including the introduction of certain EU requirements on FCM. However, deficiencies regarding laboratory performance, the incomplete investigation of companies notified through the RASFF and the potential risk of non-compliant FCM exported to the EU via Hong Kong mean that equivalence with EU requirements cannot be guaranteed. 20

21 United Kingdom Food Additives and Food Contact Materials OVERALL CONCLUSIONS Overall the official controls on FA and FCM in the UK largely ensure that the relevant legislative requirements are complied with. Official controls are carried out on a risk basis with appropriate frequency, according to documented procedures. Some shortcomings were noted with regard to an analytical method used for testing FA, assessment of DoC for FCM and checks on FA purity criteria. The report makes some recommendations to the competent authorities of the UK to address the shortcomings noted. 21

22 Materiali e Oggetti a Contatto con Alimenti Slovenia Food hygiene, traceability, labelling, bottled water, food additives and food contact materials OVERALL CONCLUSIONS Overall, there is an official control system in place in relation to food hygiene, FAs and FCMs in Slovenia which is mainly implemented in accordance with the relevant EC legislation. However, some deficiencies, relating to monitoring of FAs consumption, NMW recognition, controls of Fas and FCMs is some establishments, have been identified. 22

23 Portugal Food hygiene, traceability, labelling, bottled water, food additives and food contact materials OVERALL CONCLUSIONS The official control system of foodstuffs including FCM and FA are not satisfactory as a number of shortcomings in relation to a lack of monitoring of FA consumption, lack of official controls in FA and FCM, unknown level of HACCP implementation and the failure to report non compliances to the RASFF have been detected. There are procedures in place for the recognition and official control of NMW with some deficiencies identified. 23

24 Latvia Food of plant origin - food hygiene, traceability, labelling, bottled water, food additives and food contact materials OVERALL CONCLUSIONS Overall, there is an official control system in place in relation to food hygiene, natural mineral waters and food additives controls in Latvia which is mainly implemented in accordance with the relevant EC legislation. However, a number of shortcomings, related to official controls of FCM business operators, monitoring for FA consumption, assessment of HACCP principles put in place and controls of FA and FCM in the establishments visited, laboratory analysis for FCM, have been identified 24

25 Romania Food contact materials and food additives OVERALL CONCLUSION Overall, there is an official control system put in place by the CAs in the context of this mission. The system for FA is generally implemented following the relevant EC legislation. Nonetheless, the deficiencies identified regarding coordination, training, audits and laboratory hamper the efficiency of the system. The system for FCM cannot ensure adequate controls on FCM due to the weaknesses identified in terms of training, coordination, risk categorisation, enforcement, audits, inspection and laboratory capability and performance. 25

26 Malta Food hygiene, food contact materials and food additives OVERALL CONCLUSIONS Overall, the CAs have put in place an official control system covering the sectors evaluated during this audit. In the area of food hygiene there is a satisfactory system of official controls, based mainly on the assessment of prerequisites. The assessment of HACCP has not been applied correctly due to the absence of guides and training for the inspectors. The system for FCM and FA cannot ensure adequate controls due to weaknesses identified in terms of training, lack of official guidelines, staffing, laboratory capacity and accreditation. 26

27 Czech Republic Food additives and food contact materials OVERALL CONCLUSION Overall, there is an official control system in place for FA and FCM. The official control of FA is undertaken as part of the official control of foodstuffs. The system for FA controls is mainly carried out following the relevant EC legislation. The FCM chain is subject to official controls. However, some shortcomings have been identified regarding the cooperation between the competent authorities, availability of clear guidelines and instructions, training, inspection procedures, limited knowledge of FCM legislation, assessment of declaration of compliance and good manufacturing practices for FCM, notification through RASFF, which might hamper the effectiveness of these official controls. 27

28 Poland food contact materials and food additives OVERALL CONCLUSIONS It can be concluded that there are procedures established and controls undertaken through all stages of FCM and food production and distribution. However significant deficiencies in coordination of control activities between CAs and lack of clear instructions on FA and FCM reduces the efficiency of the current control system. The monitoring of consumption of FA has not been implemented. 28

29 Bulgaria for food contact materials and food additives OVERALL CONCLUSION The official control of FA and FCM is undertaken as part of the broader official control of foodstuffs. The system for FA is mainly carried out following the relevant EC legislation. However, the shortcomings identified regarding assessment of documentation and the limited scope of laboratory analysis might reduce the efficiency of the system. The official control system for FCM is newly set up and requires legal registration of FCM manufacturers and traders. However, a number of shortcomings have been identified in relation to the very limited scope of analysis, accreditation status and the incomplete assessment of the DoC, which may lead to ineffective controls. 29

30 Italy Food hygiene, traceability, labelling, food contact materials and food additives OVERALL CONCLUSION 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. 30

31 Latvia Food contact materials OVERALL CONCLUSIONS (follow up) Overall, adequate progress has been made since the last mission and all the recommendations concerning FCM have been addressed. Amended legislation will be in force from 2012 which will provide national legal powers for FCM controls, including assessment of Good Manufacturing Practice and improved uniformity towards enforcement measures. A number of shortcomings remain in relation to training and practice in assessing the DoC for FCM and the formal communication to the Commission of the designation status of the NRL. Nevertheless, the NRL had co-operated well with the European Union Reference Laboratory. Good cooperation between the central administration and the territorial offices was also evident. 31

32 Austria Food additives and for food contact materials OVERALL CONCLUSIONS There is a generally good legal framework established for the official control of FA and FCM in Austria. CAs, official laboratories and NRL are clearly designated and sufficiently staffed to undertake their duties. However, shortcomings in the cooperation and coordination between Cas involved in the official controls observed in one visited region reduces the efficiency of official controls. The official controls are generally carried out in accordance with documented procedures. However these procedures are inconsistent and are not yet harmonised between and within Länder and leads to inconsistency in the implementation of controls. A number of shortcomings were noted by the FVO team in the performance of inspectors mainly in one of two visited regions. 32

33 Belgium Food additives and food contact materials OVERALL CONCLUSIONS Overall there is a centralised and consistent approach to official controls which includes the manufacture and distribution of FA but only the distribution of FCM. All relevant legislation is in place and the competent authorities, national reference laboratory and control laboratories are clearly designated and sufficiently staffed to undertake their duties. Official controls of manufacturers of FCM are at a very preliminary stage, however, sampling of FCM at the distribution level is well controlled. The inspectors had not received sufficient training in FCM. The laboratories visited were generally considered satisfactory except for the absence of analytical methods for aniline and saccharin. To date audits did not focus on FA and FCM. There was good cooperation between and within the competent authorities. 33

34 Portugal Food hygiene, traceability, labelling and bottled water and for food additives and food contact materials (follow up) 6 OVERALL CONCLUSION Overall, three out of nine recommendations from mission report DG (SANCO) have been adequately addressed. Positive action has been taken to address the shortcomings relating to the analysis of Sudan dyes and NMWs. The issues relating to the labelling of allergens has been clarified, these are checked as part of the monitoring programme. The policy for reporting RASFF notifications remains non-compliant. Recommendations related to the levels of implementation of HACCP and GMP remain open. There is still an absence of any convincing policy for official controls to be carried out regularly, on a risk basis and with appropriate frequency. This is mainly due to the competent authorities not having access to a reliable source of information of all registered / licensed establishments. Work is in progress to enable all CAs to have access to each others registration / licensing data. The CCA is preparing legislation to clarify the designation of each CA. 34

35 Sweden food additives and for food contact materials OVERALL CONCLUSION The official control system for FAs is mainly carried out following the relevant EU legislation. However, the shortcomings identified regarding assessment of documentation and the limited knowledge and experience of the inspectors regarding official controls of FAs use reduce the efficiency of the system. The official control system for FCMs deals only with the use of FCMs and does not cover the production and import of FCMs. This deficiency together with the lack of laboratory analysis, written control procedures, specific training and the limited knowledge and experience of the inspectors regarding official control of FCMs might hamper the effectiveness of the system. However, the NFA is aware of these shortcomings and has prepared a strategic plan for performing FCMs official controls. Its implementation depends on the availability of the necessary resources staff, knowledge and laboratory capacity. 35

36 Hungary food additives and for food contact materials OVERALL CONCLUSION Overall, the official control system for food additives is carried out following the relevant EU legislation. However, shortcomings were identified regarding the assessment of documentation and use of food additives due to inadequate training of the inspectors and a lack of written procedures and instructions provided. The official control system for food contact materials has been established in It does not cover all FCM manufacturers. This deficiency together with the lack of written control procedures, specific training and the limited knowledge and experience of the inspectors regarding official control of food contact materials limits the effectiveness of the system. 36

37 Danimarca Francia Lituania Grecia Regno Unito Germania Lettonia Portogallo Finlandia Malta Romania Slovenia Rep. Ceca Italia Austria Polonia Bulgaria Belgio Svezia Ungheria

38 Grazie per la vostra attenzione Dr. Ambrogio Pagani UF SAN Azienda Usl 2 Lucca a.pagani@usl2.toscana.it 38