Official controls of Users (Food Business Operators) - BTSF Workshop on Food Contact Material (FCM) 4-6 June 2019, Grange, Ireland

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Official controls of Users (Food Business Operators) - BTSF Workshop on Food Contact Material (FCM) 4-6 June 2019, Grange, Ireland
BTSF Workshop on Food Contact Material (FCM)

        4-6 June 2019, Grange, Ireland

     Official controls of Users
    (Food Business Operators)
         Alessandra L. Amorena, DVM Regional CA Italy
         alessandra.amorena@regione.veneto.it
Official controls of Users (Food Business Operators) - BTSF Workshop on Food Contact Material (FCM) 4-6 June 2019, Grange, Ireland
Official Controls of FCMs Users (FBOs)

•   Which type of companies are controlled
•   Who is controlling
•   How are controls performed
•   Are the risks of FCM addressed in the HACCP of FBOs? Is this
    verification subject to official controls? Machineries / Equipment are
    part of official controls in the frame of FCM Legislation
•   Evaluation of Declaration of Compliance and Supporting
    Documentation to which extend
•   Non-compliances, Follow-up and Enforcement
•   Challenges and good practices
•   Practical examples
Official controls of Users (Food Business Operators) - BTSF Workshop on Food Contact Material (FCM) 4-6 June 2019, Grange, Ireland
WHICH TYPE OF COMPANIES (FBOs) ARE CONTROLLED

Reg. 882/2004 (→ Reg. 2017/625)

   Reg. 852/2004
                              ●
                                  DB of registered FBO – regional/local level
   Reg. 853/2004
                              ●
                                  DB of approved FBO – central level -
                                  SINTESIS

  Respect to FCM, FBOs can be classified in:

  Only Users: for package and slice/cut and keep food ex. retailes,
  supermarket, restaurants, FCM in processing food (machinary, tools, industry
  equipment)

  Trasforming + Users: es. inflating milk plastic bottle (notification about
  FCMs)

  Criticity

  What can we consider TRANSFORMATION of FCM in a FB establishment?
Official controls of Users (Food Business Operators) - BTSF Workshop on Food Contact Material (FCM) 4-6 June 2019, Grange, Ireland
MASTERLIST OF FB ESTABLISHMENTS

Primary production – REG. 852/2004               Criticity: number of FBOs
                                                 (vegetable or milk or eggs) but the
                                                 control ON fcm is simple

ESTABLISHMENTS ANEX III – REG.
853/2004                                         Criticity: many FCMs in many
                                                 steps of processing food
 Involved in FCM: Re-wrapping, SH, CP, PP, CC,
 meat, milk-dairy, egg, fish,                    (temperature, pression, pH, salt...)
                                                 and than in package food; the
                                                 control in these establishments is
ESTABLISHMENTS registered                        complex
for non-animal-origin food
processing

RETAILER and Annexed                             Criticity: high number of FBOs but the
laboratories                                     control is quite simple/standard
RESTAURANT
...
Official controls of Users (Food Business Operators) - BTSF Workshop on Food Contact Material (FCM) 4-6 June 2019, Grange, Ireland
COMMISSION IMPLEMENTING REGULATION (EU) 2019/723 of 2 May 2019
laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and of the
            Council as regards the standard model form to be used in the annual reports
                                      submitted by Member States
WHO IS CONTROLLING
                        THE COMPETENT AUTHORITY IN ITALY
                              3 levels (Dlgs 193/2008)

●
    CCA – Ministry of Health (National Plan); internal audit on RCA

●
    RCA – Working group (regions and Ministry); regional Plan; internal audit on
    LCA

●
    LCA – Local Health Unit – Prevention dep – Serv. of food hygiene – Local Plan
    and official control on FBO’s

Official Laboratories for analysis (public) (DPR n. 327/1980)

●
    Regional: Istituti Zooprofilattici – ARPA – Labs of local units
●
    Central: ISTITUTO SUPERIORE DI SANITA’ (ISS)
Regional C.A.: Tasks and
                          purposes
      Central            • PROGRAMMI NG,
    Authority
                                                     Local Health
     (Ministry           COORDI NATI NG &
                                                      Authorities
    of Health)
                             CONTROLLI NG

•   REGI ONAL LAW S                 •   MEETI NGS WI TH L.H.U.
•   GUI DELI NES
                                    •   WORKI NG GROUPS
•   CLARI FI CATI ON NOTES
                                    •   TRAI NI NG COURSES

       AUDI TS ON L.H.U.’S DEPARTMENTS AND SERVI CES
WHO IS CONTROLLING

In LCA
a)Inspectors tecnicians
b)Inspectors medicine doctors
c) Inspectors veterinary doctors (in animal origin establishment)

    TRAINING
●
    a,b,c are trained for general official control (ispection) on food hygiene
●
    a are trained for sampling activity
●
    b,c,(a) are trained for auditing FBO on HACCP
●
    some of a,b,c are trained with specific courses on FCM (BTSF, ISS, MoH, IZS,
    regional courses ...)

●
    back office for expertise is available: chemistry doctors in official labs and/or
    officer in regional/central level (ARPA, IZS, ISS)

CRITICITY
Inspectors rarely had specific training to evaluate the contents of the declarations of
conformity and supporting documents
HOW ARE CONTROLS PERFORMED
Reg. 882/2004
Article 10 Control activities, methods and techniques
1. Tasks related to official controls shall, in general, be carried out using appropriate control methods and techniques such as monitoring, surveillance,
verification, audit, inspection, sampling and analysis.
2. Official controls on feed and food shall include, inter alia, the following activities:
…
(iv) materials and articles intended to come into contact with food;
…
(e) examination of written material and other records which may be relevant to the assessment of compliance with
feed or food law;
...

Linee guida CSR n. 212/2016: official controls on FBO’s + Linee guida MdS 2014 FCM SAMPL.

                                                                                              Report of the official control (art.9)
Control activity:                                                                             - check list
- inspection (no notice in advance)                                                           - SCU (scheda controllo ufficiale)
- audit (generally previous information)                                                      - verbale di sopralluogo
- sampling food o FCM for anaysis (no notice)                                                 - verbale di campionamento
 NATIONAL PLANNING → DISTRIBUTION BETWEEN REGIONS OF A NUMBER OF SAMPLING

 Amount of 1.800 analyses/year on FCM; related to the inhabitants number of the Region (21 Regions)

 Criticity

 Specific national official control program in FCM is only for sampling activity
WICH TOOLS ARE USED
Inspection or audit

What we control in a FBO - only user in relation to FCM?

- Correct labelling of FCM and documentation for intended use
- Traceability of FCM (in case of alert)
- Stocking area and transport (clean, sunlight/temperature, pests control...)
- Correct use inside the food process room (temperature, composition of food, pH ...)

What we control in a FBO - trasforming in relation to FCM?
- Correct notification
- see above
- Correct process of transformation (temperature, time, hygiene).
The CA verifies that the risks of FCM is addressed in the HACCP of
  FBOs.

  Machineries / Equipment are part of official controls in the frame of FCM
  Legislation
   Evaluation of Declaration of Compliance and Supporting Documentation to which
   extend

CRITICITY
Inspectors rarely had specific training to evaluate the contents of the declarations of
conformity

CRITICITY
FBOs in the retail, restaurant … can buy FCM in the supermarket without acquire
specific documentation.
EXAMPLE OF
CHECK-LIST
EXAMPLE OF REPORT OF O.C.
EXAMPLE OF CHECK-LIST ACTUALLY IN USE
            ATTIVITA’ DI PRODUZIONE - DISTRIBUZIONE – UTILIZZATORE
                       DOCUMENTAZIONE (rev 0 del 30/08/2017)

DATI ANAGRAFICI IMPIANTO
                    RAGIONE SOCIALE (timbro)                                    Codice aziendale
Data
                    Ditta                                                       CE IT
                          Sede Stabilimento

Sede legale:

Legale Rappresentante
Rappresentante dell’azienda presente al sopralluogo :
Cognome e nome                                              Qualifica

Verifica effettuata da:                                     Qualifica:

Data verifica:

Obbligo di comunicazione ai sensi dell’art. 6 del Decreto Legislativo 10 febbraio 2017 n. 29
relativa agli stabilimenti che eseguono le attività riguardanti i materiali ed oggetti destinati a
venire a contatto con alimenti: SI            NO
Se obbligo inserire la data di comunicazione:

Sanzioni:   SI       NO
DICHIARAZIONE DI CONFORMITA’
Esistono dichiarazioni di conformità dei materiali                                               SI    NO
Dichiarazione di conformità del materiale (descrizione):
È completa di:
· identità-indirizzo produttore/importatore                                                      SI    NO
· identificazione del materiale a cui si riferisce                                               SI    NO
· data della dichiarazione                                                                       SI    NO
· dichiarazione di conformità del materiale per alimenti alla normativa di                       SI    NO
riferimento
· informazioni adeguate circa le sostanze impiegate per le quali sono stabilite                  SI    NO
restrizioni e/o specifiche
· per materie plastiche, banda stagnata/cromata: specifiche di impiego                     SI          NO
(tipi di alimento con cui sono destinati a venire a contatto, i tempi e la temperatura di
trattamento e conservazione a contatto con il prodotto alimentare, il rapporto tra la
superficie di contatto del prodotto ed il volume utilizzato per determinare la conformità del
materiale o dell’oggetto)

· per materie plastiche: in caso di utilizzo di una barriera funzionale in un  SI                      NO
materiale o in un oggetto multistrato la conferma che il materiale o l’oggetto è
conforme alle prescrizioni di cui al Reg. 10/2011

· cognome, nome, firma e funzione aziendale                                                      SI    NO
ETICHETTATURA E RINTRACCIABILITA’
I materiali sono correttamente etichettati (art. 15 Reg. CE 1935/2004)       SI      NO
Esiste una procedura di rintracciabilità                                     SI      NO
Nell’ambito della procedura di rintracciabilità:
· è possibile rintracciare completamente la merce in entrata                 SI      NO
· è possibile rintracciare completamente la merce in uscita                  SI      NO
· esiste una procedura di richiamo                                           SI      NO
· esiste una procedura di comunicazione alla AULSS                           SI      NO

Note_______________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

FIRMA VETERINARIO UFFICIALE/TECNICO PREVENZIONE                          FIRMA OSA
Risk based classification (no FCM)

   Classi di
                       Criteri                                                      Casi
  valutazione

                                                                   Recente
                         Data di costruzione e   Nuova                                 Abbastanza
                  1                                                ristrutturazione                         Datata: 4
Caratteristiche          percorsi                costruzione : 1                       recenti: 3
                                                                   :2
dello
stabilimento:
                         Condizioni di
                                                                                                           Appena
                  2      manutenzione dello      Ottime: 1         Buone: 2                Discrete: 3
                                                                                                           sufficienti: 4
                         stabilimento

                                                                                           Industria        Industria
                  3      Numero di lavoratori    Piccola: 1        Artigianale: 2
                                                                                           media: 3         grande: 4
Entità
produttiva:
                         Ambito di                                                                          Scambi/
                  4                              Provinciale: 1    Regionale: 2            Nazionale: 3
                         commercializzazione                                                                export: 4

                  5      Categoria di alimento   A: 1              B: 2                    C: 3             D: 4
Prodotti:
                                                 Destinato ad
                                                                   Da utilizzare                            Alimenti per
                                                 ulteriore                                 Pronti al
                  6      Destinazione d’uso                        previa                                   categorie
                                                 trasformazione:                           consumo: 4
                                                                   cottura:2                                particolari : 8
                                                 1

                         Igiene delle                                                                      Appena
                  7                              Elevata: 0        Buona: 2                Discreta: 4
                         produzioni                                                                        sufficiente: 8
Igiene delle
produzioni:
                  8      Competenza degli                                                                  Appena
                                                 Elevata: 0        Buona: 2                Discreta: 4
                         addetti e formazione                                                              sufficiente: 8

                         Completezza formale
                  9      del piano di            Completo: 0       Adeguato: 2             Incompleto: 4   Inadeguato: 8
Sistema di               autocontrollo
autocontrollo:
                         Grado di applicazione                                         Carenze             Inadeguato,
                                               Applicato e         Carenze minori:
                  10     del piano di                                                  maggiori:           non
                                               adeguato: 0         2
                         autocontrollo                                                 4                   applicato: 8
                                                                                                           Sostanziali
                         Irregolarità e non                        Formali rilevate    Sostanziali
                  11                          Formali rilevate                                             rilevate dal
Dati storici:            conformità pregresse                      dal controllo       rilevate
                                              dall’azienda: 0                                              controllo
                         riscontrate                               ufficiale: 2        dall’azienda: 4
                                                                                                           ufficiale: 8
SAMPLING ACTIVITY
SAMPLING
 ACTIVITY
SAMPLING ACTIVITY AND ANALYSIS

                                  5 milions
                                 61 milions
SAMPLING-ANALYSIS ON FCM

                   2017              2018
                   ANALYSIS: 2.024   ANALYSIS: 2.848
                   NC: 5             NC: 2

 Migration of
 Ni, Mn, Cr in
kitchen tools;
  NO NC on
  packaging
FOLLOW-UP and ENFORCEMENT
          Reg. 882/2004
      - prescrizioni art. 54
  - Sanzioni art. 55 → Decreto
   Legislativo 193/2007 (FBO)
CHALLENGE

Interregional and Ministry of
Health w.g. is producing a
document for harmonize the
o.c. on FCM in Italy

(in force in 2020?)
GOOD PRACTICIES…

       ...HOPE TO BRING BACK
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