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Food safety,
               EU rules
                 Ankara, 13 May 2009
                         BSP
                     ©2009 Dario Dongo
      CIAA, Food Safety Management Task Force, v.chairman
Global Food Safety Initiative Tech. Committee, CIAA representative
        Federalimentare, Regulative Policies, responsible




                                                             1
EU Rules,        the   A-B-C
  Food & feed traded in the Single market
             shall comply with the
    EU requirements of food law, or
conditions recognized by the EC as equivalent



                               C) CONTROLS
  A)   SAFETY
                              (public/private)



             B)   HYGIENE
                                             2
A)    SAFETY


• RESPONSABILITY. All operators must
 monitor the safety of products and
 processes under their responsibility
 Self-checks -> Safety assessment

• TRACEABILITY
• INCIDENT MANAGEMENT

(EC) Reg. No. 178/02, General Food Law   3
R
E
S                               tion
                            c
P
                          du
O
                    p   ro
N
S             ary                         “FROM

           rim
                                          FARM
I
B
       P                                   TO

I
                ring                 t     FORK”
L          tu                    or
         ac                   sp
I
       uf                  an
T
     an                 Tr                on
I   M                                 u ti
E                                 rib
S                             ist
                            D               4
Safe food
               i.e. heavy metals in fish


• Food cannot be placed on the EU market
     if:                                ie. aflatoxins in pistachio nuts


1)   harmful           short-mid-long term
                   (in the                                                 /
     cumulative effects / sensitivities of
     specific categories of consumers)
            i.e. undeclared allergens

2)   unfit to human consumption                               (ie.
     physical contamination, deterioration,
     putrefaction, deacay)                                             5
Safe food - allergens


     Food labels must indicate
the presence - even if just in traces - of
     allergenic substances, and/or
      materials derived thereof
     (except those mentioned in Dir. 2007/68/EC)

                          ER
                    D ANG

Clear impact on the management of the
whole process
Self checks against X-contamination                6
Safe feed

• Feed cannot be placed on the EU market
  nor fed to any food-producing animal, if
  they

1) have an adverse effect to animal health,
  or
                                         i.e. melamine

2) make  the food derived from food-
  producing animals unsafe for human
  consumption
                  i.e. (carry over) dioxins

                                                         7
Safety assessment



• Safety is evaluated regarding the
 normal intended use of the product,   and
 the
 information given on its label

• The entire batch/consignment
    risky product is
 of a
 presumed by law to be unsafe           8
Traceability


All operators must
be able to identify their suppliers – who
supplied what (food & feed, food contact materials)
be able to identify the business operators to
whom they have delivered their products - who
has received which product

inform the competent authorities on what
above, whenever requested                       9
T
R
A
C
E         …
A    GOING
B   FURTHER!
I
L
I
T
Y

     10
Incident management
            Operators duties (1)

• In case of a food/feed safety risk:

 immediate withdrawal of the product, so
 as to stop the distribution and to prevent its
 placement on the shelves

 inform the competent authorities.
 Immediately, specifying the adopted measures, when
 there is a danger for the human health
                                                11
Incident management
             Operators duties (2)

where the product may have reached consumers, give
effective    and   detailed    information      to
consumers, explaining its reasons                 (ie. physical
contamination with …, food non suitable for consumption, yes/no
health danger)

“when other measures aren’t enough to achieve an
high health level”, public recall of products from
the market
cooperate with competent authorities and the
other operators involved
                                                        12
Incident management   (3)




  Information to
consumer, example




                         13
B)   HYGIENE
               General obligations

• All business operators have to be registered
  or approved (foods of animal origin) by the
 competent authorities

• It is due to implement measures   and conditions
  aimed to control hazards          and ensure
  safety of the product


          ->   HACCP-based procedures
                                             14
Hazard Analysis                         and     Critical Control Points

1.     HAZARD ANALYSIS             (multidisciplinary team; product      description,   its
       intended use; flow diagram; hazard & control measures list )

2.     IDENTIFICATION OF CRITICAL CONTROL POINTS (decision tree)

3.     CRITICAL LIMITS               AT   CRITICAL CONTROL POINTS (ie. temp., pH,
       sensory parameters         target levels)

4.     MONITORING PROCEDURES                          AT CRITICAL CONTROL POINTS
       (continuously or on a set frequency)

5.     CORRECTIVE ACTIONS

6.     VERIFICATION PROCEDURES (ie. random analysis, tests)

7.     DOCUMENTATION AND RECORD KEEPING

(Ref. FAO/WHO Codex Alimentarius document CAC/RCP 1-1996, rev. 4-2003)          15
H
A
      A
C   GLOBAL
    ISSUE
C
P

      16
Hygiene
              Detailed requirements

 Primary production:                 After primary production:
    EC Reg. 852/04                         EC Reg. 852/04
    Art. 4.1, Annex I                     Art. 4.2, Annex II


Food of Animal Origin:                 Feed:
                                   EC Reg. 183/05
     EC Reg. 853/04


                                 For certain products:
      Where applicable:         microbiological criteria
Contaminants & residues, food      EC Reg. 2073/05
  contact materials, GMOs,
       irradiation, …                                       17
Guides to Good Practice
                        To be
developed by Industry associations (National and European)
                                and
               implemented on a voluntary basis
                                 do
• advise on plants, equipments, training (ie. cleaning and
  disinfection procedures)

• define how to reach the safety targets
• adapt HACCP principles to the sector
• define what is necessary, appropriate, adequate, sufficient

-> From CIAA, see GMP’s (PAS 220), Acrylamide toolbox
                                                                18
Export to the EU
                 Foods of animal origin
•   Consignments must be presented at EU Border
    Inspection Posts - accompanied by all certificates
    required in EU veterinary legislation - for import control

•   Prior notice of the arrival in the BIP must be given
    (in accordance with National rules of the Member State in which the
    border inspection post is situated)

•   Products must derive from approved countries,
    regions and establishments (as appropriate)

-> for certifications and certificates, see TR@CE (TRade
    Control & Expert System, EC), www.traces-cbt.net
                                                                19
Export to the EU
          Foods of non-animal origin

•   In general, these foods
    can enter the EU without certification by the
    competent authorities   of    the   third   country   of
    dispatch, and
    are not subjected        to     a    pre-notification
    procedure on arrival

• High risk foods           of   non-animal origin:
    designation of    points of entry, prior
    notification of the arrival (EC Reg. 669/09)
                                                     20
C)   CONTROLS, public



The   EU-Member States network implies

Information flow        (RASFF,      Border Inspection Posts)

Contact points      (European Commission-DG Sanco, Ministries
of Health)

Methods      (sampling & analysis)

Scientific cooperation        (European Food Safety Authority,
EFSA)
                                                          21
Rapid Alert System on Food & Feed

 Annual report 2007: 2976 notifications




                                     22
RASFF – weekly overview
                        Abstract from Week 18, 2009:
Date     Notified    Ref:    Reason for notifying:           Notification   Status:
         by:                                                 basis:
27/04/   Germany     2009.                                   official       product (to be)
2009                 0526
                             oxamyl (0.31 mg/kg - ppm) in
                             green peppers from Turkey       control on     withdrawn from
                                                             the market     the market
29/04/   Italy       2009.                                   border         information on
                             too high count of Escherichia
2009                 0556                                    control -      distribution
                             coli (700 MPN/100g) in clams
                                                             consignment    not (yet) available
                             (Donax trunculus) from Turkey
                                                             released
27/04/   Germany     2009.                                   Border         Product (to be)
2009                 AVH
                             aflatoxins (B1 = 3.20; Tot. =
                                                             rejection      re-dispatched
                             7.45 µg/kg - ppb) in roasted
                             diced hazelnut from Turkey
27/04/   Germany     2009.                                   Border         Product (to be)
2009                 AVQ
                             aflatoxins (B1 = 12.3; Tot. =
                                                             rejection      re-dispatched
                             14.1 µg/kg - ppb) in roasted
                             pistachio nuts from Turkey


                    http://ec.europa.eu/food/food/rapidalert/index_en.htm            23
RASFF – weekly overview
                       Abstract from Week 18, 2009:
Date     Notified   Ref:    Reason for notifying:            Notification   Status:
         by:                                                 basis:
28/04/   Germany    2009.                                    Border         Product (to be)
2009                AVR
                            aflatoxins (B1 = 3.74; Tot. =
                                                             rejection      re-dispatched
                            12.9 µg/kg - ppb) in diced
                            hazelnuts from Turkey
28/04/   France     2009.                                    Border         product under
2009                AVX
                            aflatoxins (B1=20.9;
                            Tot=28.9; B1=0.9; Tot=9.6        rejection      customs seals
                            µg/kg - ppb) in dried figs
                            from Turkey
28/04/   France     2009.   aflatoxins (B1 = 2.6; Tot. =     Border         product under
2009                AVG                                      rejection
                            7.9 µg/kg - ppb) in dried figs                  customs seals
                            Lerida from Turkey
28/04/   France     2009.                                    Border         product under
2009                AVG
                            aflatoxins (B1 = 3.5; Tot. =
                                                             rejection      customs seals
                            10.7 µg/kg - ppb) in natural
                            dry figs from Turkey
                                                                                    24

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Food Safaty, EU Rules. May09

  • 1. Food safety, EU rules Ankara, 13 May 2009 BSP ©2009 Dario Dongo CIAA, Food Safety Management Task Force, v.chairman Global Food Safety Initiative Tech. Committee, CIAA representative Federalimentare, Regulative Policies, responsible 1
  • 2. EU Rules, the A-B-C Food & feed traded in the Single market shall comply with the EU requirements of food law, or conditions recognized by the EC as equivalent C) CONTROLS A) SAFETY (public/private) B) HYGIENE 2
  • 3. A) SAFETY • RESPONSABILITY. All operators must monitor the safety of products and processes under their responsibility Self-checks -> Safety assessment • TRACEABILITY • INCIDENT MANAGEMENT (EC) Reg. No. 178/02, General Food Law 3
  • 4. R E S tion c P du O p ro N S ary “FROM rim FARM I B P TO I ring t FORK” L tu or ac sp I uf an T an Tr on I M u ti E rib S ist D 4
  • 5. Safe food i.e. heavy metals in fish • Food cannot be placed on the EU market if: ie. aflatoxins in pistachio nuts 1) harmful short-mid-long term (in the / cumulative effects / sensitivities of specific categories of consumers) i.e. undeclared allergens 2) unfit to human consumption (ie. physical contamination, deterioration, putrefaction, deacay) 5
  • 6. Safe food - allergens Food labels must indicate the presence - even if just in traces - of allergenic substances, and/or materials derived thereof (except those mentioned in Dir. 2007/68/EC) ER D ANG Clear impact on the management of the whole process Self checks against X-contamination 6
  • 7. Safe feed • Feed cannot be placed on the EU market nor fed to any food-producing animal, if they 1) have an adverse effect to animal health, or i.e. melamine 2) make the food derived from food- producing animals unsafe for human consumption i.e. (carry over) dioxins 7
  • 8. Safety assessment • Safety is evaluated regarding the normal intended use of the product, and the information given on its label • The entire batch/consignment risky product is of a presumed by law to be unsafe 8
  • 9. Traceability All operators must be able to identify their suppliers – who supplied what (food & feed, food contact materials) be able to identify the business operators to whom they have delivered their products - who has received which product inform the competent authorities on what above, whenever requested 9
  • 10. T R A C E … A GOING B FURTHER! I L I T Y 10
  • 11. Incident management Operators duties (1) • In case of a food/feed safety risk: immediate withdrawal of the product, so as to stop the distribution and to prevent its placement on the shelves inform the competent authorities. Immediately, specifying the adopted measures, when there is a danger for the human health 11
  • 12. Incident management Operators duties (2) where the product may have reached consumers, give effective and detailed information to consumers, explaining its reasons (ie. physical contamination with …, food non suitable for consumption, yes/no health danger) “when other measures aren’t enough to achieve an high health level”, public recall of products from the market cooperate with competent authorities and the other operators involved 12
  • 13. Incident management (3) Information to consumer, example 13
  • 14. B) HYGIENE General obligations • All business operators have to be registered or approved (foods of animal origin) by the competent authorities • It is due to implement measures and conditions aimed to control hazards and ensure safety of the product -> HACCP-based procedures 14
  • 15. Hazard Analysis and Critical Control Points 1. HAZARD ANALYSIS (multidisciplinary team; product description, its intended use; flow diagram; hazard & control measures list ) 2. IDENTIFICATION OF CRITICAL CONTROL POINTS (decision tree) 3. CRITICAL LIMITS AT CRITICAL CONTROL POINTS (ie. temp., pH, sensory parameters target levels) 4. MONITORING PROCEDURES AT CRITICAL CONTROL POINTS (continuously or on a set frequency) 5. CORRECTIVE ACTIONS 6. VERIFICATION PROCEDURES (ie. random analysis, tests) 7. DOCUMENTATION AND RECORD KEEPING (Ref. FAO/WHO Codex Alimentarius document CAC/RCP 1-1996, rev. 4-2003) 15
  • 16. H A A C GLOBAL ISSUE C P 16
  • 17. Hygiene Detailed requirements Primary production: After primary production: EC Reg. 852/04 EC Reg. 852/04 Art. 4.1, Annex I Art. 4.2, Annex II Food of Animal Origin: Feed: EC Reg. 183/05 EC Reg. 853/04 For certain products: Where applicable: microbiological criteria Contaminants & residues, food EC Reg. 2073/05 contact materials, GMOs, irradiation, … 17
  • 18. Guides to Good Practice To be developed by Industry associations (National and European) and implemented on a voluntary basis do • advise on plants, equipments, training (ie. cleaning and disinfection procedures) • define how to reach the safety targets • adapt HACCP principles to the sector • define what is necessary, appropriate, adequate, sufficient -> From CIAA, see GMP’s (PAS 220), Acrylamide toolbox 18
  • 19. Export to the EU Foods of animal origin • Consignments must be presented at EU Border Inspection Posts - accompanied by all certificates required in EU veterinary legislation - for import control • Prior notice of the arrival in the BIP must be given (in accordance with National rules of the Member State in which the border inspection post is situated) • Products must derive from approved countries, regions and establishments (as appropriate) -> for certifications and certificates, see TR@CE (TRade Control & Expert System, EC), www.traces-cbt.net 19
  • 20. Export to the EU Foods of non-animal origin • In general, these foods can enter the EU without certification by the competent authorities of the third country of dispatch, and are not subjected to a pre-notification procedure on arrival • High risk foods of non-animal origin: designation of points of entry, prior notification of the arrival (EC Reg. 669/09) 20
  • 21. C) CONTROLS, public The EU-Member States network implies Information flow (RASFF, Border Inspection Posts) Contact points (European Commission-DG Sanco, Ministries of Health) Methods (sampling & analysis) Scientific cooperation (European Food Safety Authority, EFSA) 21
  • 22. Rapid Alert System on Food & Feed Annual report 2007: 2976 notifications 22
  • 23. RASFF – weekly overview Abstract from Week 18, 2009: Date Notified Ref: Reason for notifying: Notification Status: by: basis: 27/04/ Germany 2009. official product (to be) 2009 0526 oxamyl (0.31 mg/kg - ppm) in green peppers from Turkey control on withdrawn from the market the market 29/04/ Italy 2009. border information on too high count of Escherichia 2009 0556 control - distribution coli (700 MPN/100g) in clams consignment not (yet) available (Donax trunculus) from Turkey released 27/04/ Germany 2009. Border Product (to be) 2009 AVH aflatoxins (B1 = 3.20; Tot. = rejection re-dispatched 7.45 µg/kg - ppb) in roasted diced hazelnut from Turkey 27/04/ Germany 2009. Border Product (to be) 2009 AVQ aflatoxins (B1 = 12.3; Tot. = rejection re-dispatched 14.1 µg/kg - ppb) in roasted pistachio nuts from Turkey http://ec.europa.eu/food/food/rapidalert/index_en.htm 23
  • 24. RASFF – weekly overview Abstract from Week 18, 2009: Date Notified Ref: Reason for notifying: Notification Status: by: basis: 28/04/ Germany 2009. Border Product (to be) 2009 AVR aflatoxins (B1 = 3.74; Tot. = rejection re-dispatched 12.9 µg/kg - ppb) in diced hazelnuts from Turkey 28/04/ France 2009. Border product under 2009 AVX aflatoxins (B1=20.9; Tot=28.9; B1=0.9; Tot=9.6 rejection customs seals µg/kg - ppb) in dried figs from Turkey 28/04/ France 2009. aflatoxins (B1 = 2.6; Tot. = Border product under 2009 AVG rejection 7.9 µg/kg - ppb) in dried figs customs seals Lerida from Turkey 28/04/ France 2009. Border product under 2009 AVG aflatoxins (B1 = 3.5; Tot. = rejection customs seals 10.7 µg/kg - ppb) in natural dry figs from Turkey 24