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Risk assessment on non- harmonized FCM at the n ational level - experience and conclusions from the ESCO Working Group of CEF Panel Jitka Sosnovcová , M.Sc , MPH National Institute of Public Health , Prague NRL for FCM EFSA meeting 16/04/ 2013 Warsaw , Poland.

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Website szu cz

Risk assessment on non-harmonized FCM atthenationallevel - experience and conclusionsfromthe ESCO Working Group of CEF Panel

Jitka Sosnovcová, M.Sc, MPH

National Institute of Public Health, Prague

NRL for FCM

EFSA meeting 16/04/ 2013 Warsaw, Poland



Introduction
Introduction

  • Food Contact Materials (FCM)

  • Regulatory background, harmonized and non-harmonized area

  • Examples of „food crises“ caused by FCM

  • Risk assessment of FCM

  • Creation and mandate of ESCO Working Group on non-plastic FCM

  • Main aims, general approach and methodology of its work

  • Final Report, findigs and outcomes of ESCO Working Group on non-plastic FCM

  • Conclusion


Food c ontact materials a huge area
Food Contact Materials – a huge area

  • FCM made ofdifferenttypesof materials (plastic and non-plastic) + many chemicals

  • FCM mayreleasechemicalsinto food products and beverageswhich are in contactwiththem

    Criticalissue:

  • limited official control, limited numberofanalyticalmethods + many problems


Website szu cz

Industry equipment

Food packaging

Active packaging

?


Website szu cz

Food packaging

Different materials:

plastics, paper, glass….

Multilayer

Printing inks, adhesives…



Website szu cz

DIFFERENT TYPE OF MATERIALS

  • Glass,

  • Ceramics

  • Laquers

  • Metals/alloys

  • Paper/board

  • Plastics (PE, PP, PVC, PA, PS, PET, ABS, SAN, copolymers….)

  • Printing inks

  • Rubber

  • Silicone

  • Surface coatings

  • Woods, cork, stones, texilesetc

  • Combinations and active and intelligent packaging

  • Recycledmaterials



Eu framework regulation 1935 2004
EU FRAMEWORK REGULATION (1935/2004)

General requirements and definitions

Specific legislation

Declaration of compliance

Supporting documents

Supporting documents

Supporting

Supporting documents


Existing eu legislation1
Existing EU legislation

Regulation EC No.1935/2004istheframework EU legislationthatcoversall food contactmaterials and articles

Itdefines FCM and sets basic requirements:

  • FCM shall not beendangerhumanhealth

  • FCM shall not bringaboutanunacceptablechanges in thecompositionofthe food

  • FCM shall not bringaboutdeterioration in theorganolepticcharacteristics


Structure of existing legislation on fcm
Structure of existing legislation on FCM

For all type FCM

REGULATION EU No. 1935/2004

REGULATION EC No. 2023/2008 on GMP

SPECIFIC LEGISLATION on materials or individual substances (REGULATIONS, DIRECTIVES, NATIONAL PROVISIONS AND REGULATIONS OR RECOMMENDATIONS)

↓ ↓

Harmonised at the EU level National provisions

  • Regenerated cellulose film All others materials as are:

  • Plastics Elastomers, Silicons

  • Ceramics Paper and Board

  • Recycled plastics Rubber, Coatings,

  • Active and intelligent FCM Metals and Aloys

    Individual chemical substances Printing inks, Colorants

    or groups (e.g. BADGE, BFDGE, NOGE,..)


Website szu cz

In recent years, Competent Authorities of MSs and the European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.


Safety of food contact materials depends on
Safety of Food Contact Materials depends on: European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

Selection of suitable raw materials (chemicals), additives, colorants…

Compliance with good manufacture practice

Comliance with proper use of a product for the corresponding conditions for application of FCM according to the type of materials, (temperature, time, type of foodstuffs )

transportation, storage

Safe and complient food contact material or final article means = reduced risk of migration or transition of harmful substances into foods


Website szu cz
The first example: European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. Migration of semicarbazide and ESBO or other plasticizers (phtalates, adipates ) from closure gaskets of baby jars

Semicarbazide

H2N-NH-CO-NH2

Semi

area with food contact


C hain of producing packed food in jars with closures
C European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. hain of producing packed food in jars with closures

PVC

lid

gasket

food

packaging

plasticizers


P lasticizers found in lids
P European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. lasticizers found in lids


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The second example: European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. The need for urgent actions on ink components/mainly photoinitiators/ used for printing paperboard and for multilayer packaging found in food( ITX isopropylthioxanthone, benzophenone, 4-methylbenzophenone, alkylbenzenes, 1-hydroxycyclohexyl-1phenylketone, …


Website szu cz
The third example European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. Releasing of heavy metals (Pb and Cd) from glass and cups /drinking rims/ or from coatings


Risk analysis
Risk analysis European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.


Food crises the need to perform the risk assessment
Food crises – the need to perform the Risk Assessment European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

Wehave to followprinciples and methodsforthe Risk AssessmentofChemicals in Food as a scientificallybasedprocessconsistingofthefollowingfoursteps:

  • 1. Hazard identification

  • 2. Hazard characterization

  • 3. Exposureassessment

  • 4. Risk characterization


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Components in risk assessment European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

Toxicokinetics (ADME)

Hazard identification

Toxicodynamics (Effects)

Critical effect

Hazardcharacterisation

Dose x response relationship

Health based intake threshold

Concentration in food

Exposure assessment

Intake of food

Conclusion on

hazard characterisation

and exposure assessment

Risk characterization


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Toxicokinetics European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. - What the body does to the chemical

  • Absoprption

  • Distribution

  • Metabolism

  • Excretion

    Toxicodynamics - What the chemical does to the body

    Effects:

    Change in the morphology, physiology, growth, development, reproduction or life span of an organism

    Adverse effects:

  • Cancer

  • Damage on organs (liver, kidney, lung, heart....etc)

  • Damage on the central nervous system (neurotoxicity)

  • Damage on the reproductive systemetc.


  • Toxicodynamics
    Toxicodynamics European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    • Studies in experimental animals

    • In vitro studies (on bacteria and cells)

    • Human data (Epidemiolgical studies)

    • Non-testing data ( based on structural data e.g. QSAR


    Exposure
    Exposure European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    • Concentration in food x Consumption of food for all

    • Consumption for specific groups of consumers

    • (children, eaters, older people, etc.)


    Website szu cz

    Definition of hazard and risk European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    Hazard is the inherent property of an agent having the potential to cause adverse effects in an organism exposed to the agent.

    Risk is the probability of an adverse effect in an organism caused under specified circumstances by exposure to an agent.


    Esco working group on non plastic fcm
    ESCO Working Group on non-plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    2009

    Internal Mandate proposed by EFSA to the CEF Panel

    for the creation and management of an EFSA Scientific

    Cooperation (ESCO) Working Group

    The initiative for the establishment of the ESCO WG has been given by

    the Advisory Forum of the EFSA in 2009 with the aim to collect relevant

    information on the evaluation status of non plastic substances of FCM

    and articles.


    Esco working group on non plastic fcm1
    ESCO Working Group on non-plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    The main aims:

    • to collect the relevant information on the evaluation status of non plastic parts of Food Contact Materials

    • to highlight gaps and propose priorities for future actions


    Esco working group on non plastic fcm2
    ESCO Working Group on non-plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    General approach and methodology

    • to collectinformationavailable in MemberStates on theevaluationofsubstancesfor FCM otherthanplastics

    • to prepare inventorylistsofevaluatedsubstancesfordifferent FCMs including information of date used and type of evaluation

    • to classify the substances according to the way they were evaluated

      (risk assessment background)


    Esco working group on non plastic fcm3
    ESCO Working Group on non-plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    General approach and methodology

    • to identify the gaps and strengths in different approaches

    • to establish the principles of setting the priorities for further evaluations

    • to organize a workshop with stakeholders to discuss findings, outcomes and the draft ESCO report


    Esco working group on non plastic fcm4
    ESCO Working Group on non-plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    Work activities started by comparing the various legislative requirements and recommendations in Member States

    Findings:

    The scope and structure of the national requirements are usually different:

    Positive lists of substances, requirements on impurities, requirements on final products (migration limits, concentration in mass of products,.. )

    Also safety evaluations (risk assessment background) differs


    National legislation on non plastic fcm eu member states only
    National legislation on non plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. (EU Member States only)

    Paper and board

    (Belgium, Czech Republic, France, Germany, Greece, Italy, Latvia, Lithuania,Netherlands, Poland, Slovakia, Slovenia)

    Adhesives

    (Germany, Slovenia, Spain)

    Printing inks(Czech Republic, Rumania, Spain)

    Varnish coatings

    (Belgium, Czech Republic, France, Greece,Italy, Netherlands, Slovakia, Slovenia, Spain

    Silicone

    (Czech Republic, Germany, Hungary, Italy, Netherlands, Spain


    National legislation non plastics
    National legislation (non plastics) European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    Rubber

    (The Czech Republic, France, Germany, Hungary, Italy, The Netherlands, Romania, Slovakia, Slovenia, Spain

    Cork

    (The Czech Republic, The Netherlands, Slovakia)

    Wax

    (Germany, The Netherlands)

    Ion-exchange resins

    (Spain)

    No national provisions:

    Austria, Bulgaria, Cyprus, UK, Denmark, Estonia, Finland, Ireland, Luxembourg, Malta, Portugal, Sweden


    Website szu cz

    ESCO WORKING GROUP ON NON PLASTIC FOOD European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. CONTACT MATERIALS MEETING WITH THE STAKEHOLDERS

    • A meeting withstakeholderswasorganised in Milan (Italy) in 2011

    • AlsoEuropeanprofessionalorganisationsactive in thefieldof FCM wereinvitated


    European professional organisations
    European professional organisations European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    Paper and board:

    ACE (TheAllianceforBeverageCartons and theEnvironment)

    CEPI (ConfederationofEuropeanPaperIndustries)

    CITPA (International ConfedarationofPaper and BoardConvertors)

    FEFCO (EuropeanFederationofCorrugatedBoardManufacturers)

    Printinginks:

    EuPIA (EuropeanPrintingInkAssociation)

    Adhesives:

    FEICA (AssociationofEuropeanAdhesives and SealantsManufacturers)


    European professional organisations1
    European professional organisations European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    Rubber:

    ETRMA (European Tyre & Rubber Manufactuters Association)

    IISRP (International Institute of Synthetic Rubber Producers European Section Secretary

    Varnishes and coatings:

    CEPE: (European Council of Paint, Printing Ink and Artists´colours Industry)

    Metals and alloys:

    APEL (Association of European Producers of Steel for Packaging)

    EMPAC (Empac Food Contact Commission)

    Food contact additives:

    CEFIC-FCA (CEFIC . Food Contact Additives)


    Topics for discussion
    Topics for discussion European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    • Subjects of discussion:

    • crisis prevention,

    • increase the consumer confidence into packaged foods, positive lists for non plastic materials,

    • if migration data of substances used in non plastic FCM are available /analytical methods,

    • identification of gaps……

    • Discussion the draft ESCO final report

    • Expected results (outputs) collection of the information about

    • Follow up activities in the future


    What we did
    What we did European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    • Collect informationavailable in Member States on the evaluation of substances for FCM other than plastics:

    • - Collecting the evaluations available in Member States

    • - Preparing inventory lists of evaluated substances including information of the data used and the outcome of the evaluation

    • - Identifying the most knowledgeable experts in the field, who could be mobilized in case of further need

    • Analyze the information collected:

    • - Classifying the substances according to the way they were evaluated (guidelines, risk assessment background).

    • - Identifying the gaps and strengths in different approaches and underlying guidelines.

    • - Establish the principles of setting the priorities for further evaluations


    Report of esco wg on non plastic fcm
    Report of ESCO WG on non-plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    • Final Report was issued

    • This external report is not produced by EFSA. It is published here to help keep the public informed of developments related to EFSA's scientific work. EFSA reserves its rights, view and position as regards the issues addressed and conclusions reached in the present document, without prejudice to the rights of the authors.

    • Report

    • Annex I


    Report of esco wg on non plastic fcm1
    Report of ESCO WG on non-plastic FCM European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.

    • - Inventory listwith 2800 entries*:

      substances used for manufacture of non-plastic FCM

      (*list A: 230 substances evaluated according

      SCF Guidelines)

    • - Other evaluations for prioritization:

      Threshold of Toxicological Concern (TTC)

    • - Dietary exposure:

    • based on uses and concentration in FCM


    Annex i of esco wg on non plastic fc m the lists contain the following columns
    Annex I of ESCO WG on non-plastic FC European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. MThe lists contain the following columns:

    • A. PM/REF N°:Commission PM reference number;

    • B. CAS RN: CAS Registry Number;

    • C. NAME: name of the substance ( and C.I. name, only for pigments and dyes);

    • D. SCF list: the classification into an SCF list, if available;

    • E. Regulation/Recommendation: the national Regulation or Recommendations where the substance is listed, if available;

    • F. Restriction: the restrictions contained in the national Regulations or Recommendations;

    • G. Substance in positive list(y/n): if the substance is included in the MS positive list or not;

    • H. MS: Member State;

    • I. Safety Evaluation by MS: this column contains A or B,

    • A means that the evaluation was done after 1991 (when the first version of the SCF guidelines was published),

    • Bmeans that the evaluation was done before 1991;

    • J. Remarks: any other relevant information related to the substance, e.g. technological function, reaction products etc.


    Website szu cz
    For more detailed information: European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM. Please, look at the Final Report of ESCO WG on non-plastic FCM on the website of EFSA


    Thank you very much for your kind attention
    tHANK YOU VERY MUCH FOR your KIND ATTENTION ! European Commission as well had to solve urgent actions (called „food crises“) due to finding of chemicals in food migrating or releasing from different FCM.