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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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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


EFSA meeting 16/04/ 2013 Warsaw, Poland

  • 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


  • limited official control, limited numberofanalyticalmethods + many problems

What is food contact materials?

  • some examples

Industry equipment

Food packaging

Active packaging



Food packaging

Different materials:

plastics, paper, glass….


Printing inks, adhesives…



  • 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

General requirements and definitions

Specific legislation

Declaration of compliance

Supporting documents

Supporting documents


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


↓ ↓

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,..)


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:

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

The first example:Migration of semicarbazide and ESBO or other plasticizers (phtalates, adipates ) from closure gaskets of baby jars




area with food contact

c hain of producing packed food in jars with closures
Chain of producing packed food in jars with closures








The second example: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, …

The third example Releasing of heavy metals (Pb and Cd) from glass and cups /drinking rims/ or from coatings
food crises the need to perform the risk assessment
Food crises – the need to perform the Risk Assessment

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

  • 1. Hazard identification
  • 2. Hazard characterization
  • 3. Exposureassessment
  • 4. Risk characterization

Components in risk assessment

Toxicokinetics (ADME)

Hazard identification

Toxicodynamics (Effects)

Critical effect


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


Toxicokinetics - What the body does to the chemical

      • Absoprption
      • Distribution
      • Metabolism
      • Excretion

Toxicodynamics - What the chemical does to the body


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.
  • 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
  • Concentration in food x Consumption of food for all
  • Consumption for specific groups of consumers
  • (children, eaters, older people, etc.)

Definition of hazard and risk

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


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

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

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

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

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


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 (EU Member States only)

Paper and board

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


(Germany, Slovenia, Spain)

Printing inks(Czech Republic, Rumania, Spain)

Varnish coatings

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


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

national legislation non plastics
National legislation (non plastics)


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


(The Czech Republic, The Netherlands, Slovakia)


(Germany, The Netherlands)

Ion-exchange resins


No national provisions:

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

  • A meeting withstakeholderswasorganised in Milan (Italy) in 2011
  • AlsoEuropeanprofessionalorganisationsactive in thefieldof FCM wereinvitated
european professional organisations
European professional organisations

Paper and board:

ACE (TheAllianceforBeverageCartons and theEnvironment)

CEPI (ConfederationofEuropeanPaperIndustries)

CITPA (International ConfedarationofPaper and BoardConvertors)

FEFCO (EuropeanFederationofCorrugatedBoardManufacturers)


EuPIA (EuropeanPrintingInkAssociation)


FEICA (AssociationofEuropeanAdhesives and SealantsManufacturers)

european professional organisations1
European professional organisations


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
  • 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
  • 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
  • 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
  • - 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 FCMThe 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.
For more detailed information:Please, look at the Final Report of ESCO WG on non-plastic FCM on the website of EFSA