Risk assessment on non-harmonized FCM at
the national 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
Website: www.szu.cz
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 Contact Materials – a huge area
• FCM made of different types of materials
(plastic and non-plastic) + many chemicals
• FCM may release chemicals into food products
and beverages which are in contact with them
Critical issue:
• limited official control, limited number of
analytical methods + many problems
What is food contact
materials?
- some examples
Food
packaging
Industry equipment
Active packaging
?
Food packaging
Different materials:
plastics, paper, glass….
Multilayer
Printing inks, adhesives…
Machinery – utensils equipment
DIFFERENT TYPE OF MATERIALS
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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, texiles etc
Combinations and active and intelligent packaging
Recycled materials
Existing EU legislation
EU FRAMEWORK REGULATION (1935/2004)
General requirements and definitions
Specific legislation
Existing EU legislation
Regulation EC No.1935/2004 is the framework EU legislation
that covers all food contact materials and articles
It defines FCM and sets basic requirements:
• FCM shall not be endanger human health
• FCM shall not bring about an unacceptable changes in the
composition of the food
• FCM shall not bring about deterioration in the organoleptic
characteristics
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


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All others materials as are:
Elastomers, Silicons
Paper and Board
Rubber, Coatings,
Metals and Aloys
Printing inks, Colorants
Regenerated cellulose film
Plastics
Ceramics
Recycled plastics
Active and intelligent FCM
Individual chemical substances
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:
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
Semicarbazide
Semi
H2N-NH-CO-NH2
area with food contact
Chain of producing packed food in jars with closures
PVC
food
packaging
lid
gasket
plasticizers
Plasticizers found in lids
Substance nr. Plasticizer
Reg. 10/2011
532
Epoxidized soybean oil
73, 797
Polyesters of hexanedioic acid with polyols,
polyadipates
138
Acetyl tributyl citrate
242
Di-n-butyl sebacate
8
Acetylated mono- & di-glycerides
783
Acetylated and hydrogenated castor oil monoglyceride (Danisco Grindsted Soft-N-Safe)
775
Diisononyl cyclohexane-1,2-dicarboxylate
798
Bis(2-ethylhexyl) terephthalate
283
Bis(2-ethylhexyl) phthalate
207
Bis(2-ethylhexyl) adipate
not listed
Ester of C16:0 and C18:0 (1:1) fatty acids with
2-ethylhexylalcohol
728 + 729
Diisononyl + Diisodecyl phthalate
497
2,2,4-trimethyl-1,3-pentanediol diisobutyrate
884
Alkyl(C10-C21)sulphonic acid, esters with
phenol (Mesamoll)
Abbreviation
ESBO
PA
Nr. of
lids
226
203
% of
lids
73
66
Average
conc. (%)
17
18
ATBC
DBS
acPG
ARMG
169
147
142
49
55
48
46
16
12
1.4
nq
8.5
DINCH
DEHT
DEHP
DEHA
Ehol
31
6
4
4
3
10
2
1.3
1.3
1.0
12
22
21
12
nq
DIDP/DINP
TXIB
1
1
1
0.3
0.3
0.3
32
9.5
nq
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, 1hydroxycyclohexyl-1phenylketone, …
The third example
Releasing of heavy metals (Pb and Cd) from glass and
cups /drinking rims/ or from coatings
Risk analysis
Food crises – the need to perform the Risk Assessment
We have to follow principles and methods for the Risk
Assessment of Chemicals in Food as a scientifically based
process consisting of the following four steps:
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1. Hazard identification
2. Hazard characterization
3. Exposure assessment
4. Risk characterization
Components in risk assessment
Toxicokinetics (ADME)
Hazard identification
Toxicodynamics (Effects)
Hazard characterisation
Critical effect
Dose x response relationship
Health based intake threshold
Concentration in food
Exposure assessment
Intake of food
Risk characterization
Conclusion on
hazard characterisation
and exposure assessment
Toxicokinetics - 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 system etc.
Toxicodynamics
• 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
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
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 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 FCM
General approach and methodology

to collect information available in Member States on the
evaluation of substances for FCM other than plastics

to prepare inventory lists of evaluated substances for different
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 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 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)
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)
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
ESCO WORKING GROUP ON NON PLASTIC FOOD
CONTACT MATERIALS MEETING WITH THE
STAKEHOLDERS
A meeting with stakeholders was organised in Milan
(Italy) in 2011
Also European professional organisations active in the
field of FCM were invitated
European professional organisations
Paper and board:
ACE (The Alliance for Beverage Cartons and the Environment)
CEPI (Confederation of European Paper Industries)
CITPA (International Confedaration of Paper and Board Convertors)
FEFCO (European Federation of Corrugated Board Manufacturers)
Printing inks:
EuPIA (European Printing Ink Association)
Adhesives:
FEICA (Association of European Adhesives and Sealants
Manufacturers)
European professional organisations
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
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
• Collect information available 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
• 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 FCM
• - Inventory list with 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 FCM
The lists contain the following columns:
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•
•
•
•
•
•
•
•
•
•
•
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),
B means 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 nonplastic FCM on the website of EFSA
tHANK YOU VERY MUCH FOR your KIND ATTENTION !