An introduction to EFSA and the panel onAn introduction to EFSA and the panel on

Contaminants in the food chain Contaminants in the food chain

(CONTAM) (CONTAM)

Jean Lou Dorne –Senior Scientific Officer-Toxicology

Unit on Contaminants

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Content

•1. Introduction to EFSA

•2. EFSA ‘s CONTAM Panel

•3.How an EFSA opinion is produced ?

•4.Principles of chemical risk assessment

• 5.Examples of CONTAM risk assessments

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EFSA and EFSA's mission

• EFSA is the European Union's scientific risk assessment body on food and feed safety, nutrition, animal health and welfare, and plant health and protection, tackling issues all along the food chain. Regulation (EC) 178/2002

• Provide science based risk assessments supporting risk management related to food/feed safety.

• Provide scientific and technical advice on all matters within these fields.

• Communicate all findings publicly.

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How does EFSA work?

EFSA

1000 scientific experts

Over 1000 scientific outputs

Networking national agencies and scientific organisations

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Scientific Panels/Scientific Committee

• Max. 21 expert members, not EFSA staff

• Selected on the basis of scientific excellence, area of expertise, gender and geographical

balance

• Appointed by Management Board for 3 years

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Application process

• Scientific Committee & Panel Members

• Open from 23 Oct till 7 Jan 2009

• Experts contacted spring 2009

• New Scientific Committee and Panel members meet and begin work summer 2009

• Scientific experts

• Now open

• No closing date

Fill in an online form on the EFSA website and make a declaration of interests (to ensure their independence)

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Selection of experts

• Scientific Committee & Panel Members• EFSA evaluates

candidates and draws up shortlist

• Management Board assesses shortlists and makes final decision about candidates

• Members are appointed:• for 3 years, renewable

• through an open procedure based on proven scientific excellence

• Scientific experts

• When a scientific need is identified, EFSA selects the most suitable experts to assist it

• Selected experts invited to participate in certain scientific activities of EFSA or Member States

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Organigramme

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Ten Scientific Panels

• Food additives, nutrient sources (ANS)

• Food contact material, enzymes and flavourings (CEF)

• Additives and products in animal feed (FEEDAP)

• Plant Health (PLH)

• Plant Protection Products (PPR)

• Genetically Modified Organisms (GMO)

• Dietetic products, nutrition and allergies (NDA)

• Biological hazards (BIOHAZ)

• Contaminants in the food chain (CONTAM)

• Animal Health and Welfare (AHAW)

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Scientific Committee

Composition:

• Chairs of ten Scientific Panels

• Six scientists not panel members

Role:

• General co-ordination of EFSA’s scientific work, ensure consistency of opinions

• Guidance and scientific advice on multi-sectorialissues, e.g. botanicals, nanotechnology, etc.

• Expert working groups and Advice on risk assessment and policies related to EFSA’s work

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The CONTAM Panel 2006 - 2009

• Chair: Dr. Josef Schlatter (CH)

• Vice-chairs: Prof. Johanna Fink-Gremmels

(NL), Prof. Rolaf van Leeuwen (NL)

Find more information on the CONTAM experts

http://www.efsa.europa.eu/en/science/contam/

contam_members.html

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Mandate of the CONTAM Panel

To deliver scientific opinions on contaminants

in food and feed, associated areas and

undesirable substances i.e. natural toxicants,

mycotoxins and residues of non authorised

substances not covered by another Panel.

F C

F

F

Cx

F

F

S

O

O

R

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3. How an EFSA Opinion is produced (from “question” to “answer”)

European Commission

European Parliament

Member States

EFSA (“self mandate”)

Question?

Risk Assessment

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MandatePanel Working Group

Opinion adopted

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From “question” to “answer”

European Commission

European Parliament

Member States

EFSA (“self mandate”)

Question?

Risk Assessment

Opinion

RiskManagement

Risk Communication

Industry

Media

Consumers

Professionals

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HAZARD IDENTIFICATION

EXPOSURE ASSESSMENTLevels in food, dietary

exposure, groups with higherexposures, relevant food groups, non-food sources, time trends

HAZARD CHARACTERISATIONADME, acute, subchronic & chronic toxicityhuman studies genotox, reprotox,immunotox,dose-response, mode/mechanism of action,selection of critical dataset, ARfD, NOEAL,

TDI, mathematical modelling (BMD)

RISK CHARACTERISATIONMarigin of Exposure (MOE)

Vulnerable groups (children – high level consumers)

4.Principles of chemical risk assessment

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RISK ASSESSMENT METHODS

LOW - DOSEEXTRAPOLATION

Margin of Exposure Approach : risk associated with

intake

QUANTITATIVERISK ASSESSMENT

No Threshold: Cancer endpoint Threshold: Tox other than cancer

NOAEL ANDSAFETY FACTORS

Intake with no appreciable effects

eg ADI

NON - QUANTITATIVERISK ASSESSMENT

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The Margin Of exposure (MOE) developed, by the JECFA and EFSA (2005) Point of reference on the dose-response curve* (based on animal and human data) divided by the estimated human intakes. MOE (animal data) >10,000 as of low concern for public health.

*BMDL: Benchmark Dose

(*NOAEL: No observed-Adverse-Effect-Level)

http://www.efsa.europa.eu/EFSA/Scientific_Opinion/sc_op_ej282_gentox_en3,0.pdf

Margin of exposureMargin of exposure--cancer endpointscancer endpoints

Indicates data point

with confidence bars

NOAELBMDL

BMR0

0

Best-fitting

dose-response

model% A

nim

als

Re

sp

on

din

gDose

100

Lower statistical

limit on dose

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ADI/TDI (mg/kg/day) =

NOAEL or BMDL (mg/kg) / 100

Derivation of the Acceptable and Tolerable Derivation of the Acceptable and Tolerable

Daily Intake (ADI and TDI)Daily Intake (ADI and TDI)

ADI: Intentionally added compounds TDI, PTWI: Contaminants

Indicates data point

with confidence bars

NOAELBMDL

BMR0

0

Best-fitting

dose-response

model% A

nim

als

Re

sp

on

din

g

Dose

100

Lower statistical

limit on dose

NOAEL: No observed-Adverse-Effect-Level BMDL: Benchmark Dose

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5. Examples:

Cross-contamination of non-target feedingstuffs by coccidiostats authorised for use as feed additive

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Cross-contamination of coccidiostats

allowed for broilers

not allowed for laying hens

residues

toxic to some non-target animals

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Terms of reference

The Commission asked EFSA to assess the risks involved for animal health and public health as the consequence of cross-contamination of 11 coccidiostats into feed for non-target animals.

11 opinions have been adopted by CONTAM Panel in 2007 and 2008.

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Overall…

• Depending on active substance, cross-contamination of feeds with coccidiostats can be a health risk to non-target animal species (>2% salinomycin carry over toxic to horses).

• For all coccidiostats, no health risk for consumers caused by cross-contamination was identified. Calculated using the highest residue levels in eggs, liver 10 % cross-contamination level and default values for daily human consumption

• For many coccidiostats, sensitive analytical methods developed for food, should be validated also for feed and used to control cross-contamination.

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• Based on EFSA assessments, European Commission introduced management measures to limit cross-contamination

• The SCFCAH, Animal Nutrition Section will vote on 27.11.2008 on proposal to set maximum levels for these compounds in the frame of the Directive 2002/32/EC:

• Carry-over rate of approx 3 % compared to authorised max concentration for feed for non-sensitive non-target animal species, and

• Carry-over rate of approx 1% compared to authorised max concentration for feed for sensitive non-target animal species and finishing feed has to be achieved.

Follow up…

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Opinion on PAHs in food

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902034842.htm

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Polycyclic aromatic hydrocarbons

� Polycyclic aromatic hydrocarbons (PAHs) form a class of diverse organic compounds, each of them containing two or more aromatic rings

� Hundreds of different such compounds may be formed and released during a variety of combustion and pyrolysis processes. The natural and anthropogenic sources of PAHs in the environment are numerous

� PAH compounds are emitted from the processing of coal, crude oil, petroleum, and natural gas, from production of aluminium, iron and steel, from heating in power plants and homes (oil, gas, charcoal-fired stoves, wood stoves), burning of refuse, wood fires, and from motor vehicle exhausts

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Human exposure to PAHs

� Humans can be exposed to PAHs through different routes. For the general population, the major routes of exposure are from food and inhaled air, while in smokers, the contributions from smoking and food may be of a similar magnitude

� Food can be contaminated by environmental PAHs that are present in air, soil or water, by industrial food processing methods (e.g. heating, drying and smoking processes) and by home food preparation (e.g. grilling, roasting processes)

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Terms of reference,

• Review of the PAHs opinion (SCF, 2002) by taking into account: – New occurrence data from EFSA 2007

– Any new toxicological studies

• Can benzo[a]pyrene be considered as a suitable marker both for occurrence and exposure?– if not: are there other suitable markers?

– can a TEF concept be applied?

– a margin of exposure (MOE) approach should be used, if appropriate

• Which food commodities contribute most to the exposure?

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15 +1 PAHs•15 PAHs identified by the Scientific Committee on Food in 2002

•“Potentially genotoxic and carcinogenic to humans”

•+1 PAH identified by the JECFA in 2006

•Oral carcinogenicity data only available for eight PAHs (PAH8) , (Culp et al., 1998 ): Benzo[a]pyrene, Benzo[k]fluoranthene, Chrysene , Benzo[ghi]perylene, Benz[a]anthracene,Dibenz[a,h]anthracene, Benzo[b]fluoranthene, Indeno[1,2,3-cd]pyrene

•No new toxicological data

benzo[a]pyrene

CH3

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Matching available toxicological data with occurrence data

FACTS:– Oral carcinogenicity data only available for PAH8– PAH8 most often found in food samples

– PAH8 contribute the most to concentrations of PAHs in foods

– In ~50% of samples benzo[a]pyrene was detected

– In ~30% of samples other PAHs were found despite testing negative for benzo[a]pyrene

PAH8:benzo[a]pyrene benzo[k]fluoranthene

chrysene benzo[ghi]perylene

benz[a]anthracene dibenz[a,h]anthracene

benzo[b]fluoranthene indeno[1,2,3-cd]pyrene

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Can sum of PAH8 or sub-groups of PAH8 be good markers foroccurrence and toxicity of PAHs ???

benzo[a]pyrene benzo[k]fluoranthene

chrysene benzo[ghi]perylene

benz[a]anthracene dibenz[a,h]anthracene

benzo[b]fluoranthene indeno[1,2,3-cd]pyrene

The grouping of PAHs:

PAH8

PAH2

PAH4

benzo[a]pyrene

Investigated further

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Dietary exposure to benzo[a]pyrene, PAH2,

PAH4 and PAH8 for different food categories

Consumer exposure to benzo[a]pyrene (BaP), PAH2, PAH4 and PAH8 for each food category for which occurrence data are available. The median value of the mean consumption reported by the Member States for consumers only was calculated.

302012642Cheese

210170842141Fish and fishery products

4212891403627Seafood and seafood products

27919510742132Meat and meat products and substitutes

7425124413Alcoholic beverages

1561065521601Coffee, tea, cocoa (expressed as liquid)

8775405153Fruits

37822112450194Vegetables, nuts and pulses

2391771122638Fats (vegetable and animal)

392513543Sugar and sugar products including chocolate

39325712967257Cereals and cereal products

ng/dayng/dayng/dayng/dayg/day

PAH8PAH4PAH2BaPMedian

ExposureConsumptionCategory

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Total exposure to benzo[a]pyrene, PAH2, PAH4

and PAH8 for average and high consumer in EU

30782068107738917291168641235Median EU

248916618543151415936499188United Kingdom

28761949100336417191168621230Sweden

56013769190570917271158626244Slovakia

42622900147046121361449765252Norway

48863318168753517851197658239Netherlands

43222943150248719621332719255Italy

30092013104937017931188646238Ireland

65684486223269415221039558205Iceland

2410163687731417161168647231Hungary

34392311119442218881258681255Germany

29211966102138018141220655245France

169311556232311422978535185Finland

2300154581829916901135617223Denmark

34492328120742617771196654239Czech Republic

30182027105338515261020560209Bulgaria

31382108110139317321158637232Belgium

PAH8PAH4PAH2BaPPAH8PAH4PAH2BaPCountry

High exposure Sum of P97.5 for cereals and seafood + average exposure for whole population

(ng/day)

Average exposure Whole population

(ng/day)

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Risk characterisation- Margin of exposure (MOE) approach

MOEs at the median of the EU mean estimates of dietary exposure

MOEs at the median of the EU 97.5th percentile estimates of dietary exposure

96000.497.9151.3PAH8

99000.345.3234.5PAH4

95000.172.7718.0PAH2

108000.071.006.5BaP

MOEBMDL10

(mg/kg

b.w. per day)

Exposure ratio to

BaP

Median EU estimated 97.5%ile dietary exposure

(ng/kg b.w. per day)

Marker for the carcinogenic PAH

in food

170000.497.3628.8PAH8

175000.344.9719.5PAH4

159000.172.7310.7PAH2

179000.071.003.9BaP

MOEBMDL10

(mg/kg b.w. per day)

Exposure ratio to

BaP

Median EU estimated mean dietary exposure (ng/kg

b.w. per day)

Marker for the carcinogenic PAH

in food

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What do the MOEs tell us about the risk of PAHs to human health ?

• A low concern for consumer health at the meanestimated dietary exposures

• For high level consumers the MOEs are close to or less than 10,000, which as proposed by the EFSA

Scientific Committee indicates a potential concern for

consumer health and a possible need for risk management action

• Comparison of the MOEs for benzo[a]pyrene, PAH2, PAH4 and PAH8, indicates that PAH2, PAH4 and PAH8can be used as alternatives to benzo[a]pyrene as markers of the carcinogenicity of the genotoxic and

carcinogenic PAHs, and would be equally effective

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Which of the PAH combinations is the best marker ?

1.MOEs indicated that benzo[a]pyrene, PAH2, PAH4 and PAH8 were equally effective as markers of the

carcinogenicity. Occurrence data were more influential

in the overall conclusion.

2. PAH4 and PAH8 were better indicators of the occurrence and toxicity of the genotoxic and

carcinogenic PAHs than benzo[a]pyrene or PAH2.

3. Based on the current pattern of occurrence in different food categories PAH8 did not provide much added

value compared to PAH4.

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Main conclusion

“CONTAM Panel concluded that

benzo[a]pyrene is not a suitable indicator for the occurrence of PAHs in food. Based on the currently available data relating to occurrence and toxicity, the CONTAM Panel concluded that

PAH4 and PAH8 are the most suitable indicators of PAHs in food, with PAH8 not providing much added value compared to PAH4.“

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General EFSA Website :

http://www.efsa.europa.eu

CONTAM activities: http://www.efsa.europa.eu/EFSA/ScientificPanels/efsa_local

e-1178620753812_CONTAM.htm

Register of requested opinions :

http://registerofquestions.efsa.europa.eu/roqFrontend/quest

ionsList.jsf

Join EFSA's Scientific Committee or Panels

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_JoinEFSAScientificCommitteeorPanels.htm

EFSA websites

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Many Thanks you Many Thanks you

for your attentionfor your attention

Köszönöm

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