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Food AdditivesFood Additives- EFSA’s Risk Assessment - - EFSA’s Risk Assessment -

Prof. Dr. George E.N Kass

Deputy Head of the ANS Unit, EFSA

Remit of the ANS Panel and UnitRemit of the ANS Panel and Unit

Food additives (safety) re-evaluation of food additives that were permitted before 20

January 2009new applications

Nutrient sources (safety and bioavailability)Sources of vitamins and minerals for food supplementsSources of vitamins and minerals for dietetic products and

fortification of foodOther substances added for nutritional or functional purposes

Other substances deliberately added to food (excluding flavourings and enzymes).

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Evaluation of Food additives Evaluation of Food additives Legal framework Legal framework

Regulation (EC) No 1333/2008 (food additives)

Regulation (EU) No 257/2010 (re-evaluation programme)- Re-evaluation finalised by 2020- Priority criteria- Functional class

Directives- Food colours (94/36/EC)- Other than food colours & sweeteners (95/2/EC)- Sweeteners (94/35/EC)

SCF Guidance on Food Additives (2001) - Info on metabolites

- Technical part (specifications, manufacturing, etc.)- Exposure- Biological/Toxicological data (ADME, toxicity, genotoxicity, repro, etc.)

New Guidance on submission for food additives evaluations (to be published 2012)

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General data requirements (I) General data requirements (I)

General scientific approaches defined in ANS Panel Statement ‘Data requirements for the evaluation of food additive applications’ (2009) in relation to the current state of the art of risk assessment, science and technology.

Specific scientific approaches suggested in the guidance applicable at the time of application.

Example for food additive applications

Application dossierApplication dossier

Administrative Administrative datadata

Biological and Biological and Toxicological DataToxicological Data

Technical Technical datadata

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General data requirements (II)General data requirements (II)

Administrative dataAdministrative data

Applicant’s, Manufacturer’s and Contact person’s contact details Type of application Date of submission of the dossier Table of contents of the dossier List of documents and other particulars. List of parts of the dossiers requested to be treated as confidential

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General data requirements (III) General data requirements (III)

Technical dataTechnical data

identity and characterisation of the substance (including the proposed specifications and analytical method) manufacturing process stability, reaction and fate in foods to which the substance is added case of need and proposed uses existing authorisations and evaluations exposure assessment

Any possible effect of Any possible effect of instability on biological instability on biological

properties including properties including nutrient valuenutrient value

Other substancesOther substances with with nutritional and/or nutritional and/or

physiological effectsphysiological effects

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General data requirements (IV) General data requirements (IV)

Biological and toxicological dataBiological and toxicological data

To statestate whether the test material in the studies performed conforms to the proposed or existing specifications

if not,if not,

the relevance of these data to thesubstance under consideration should be demonstrated

Metabolism/Toxicokinetics Subchronic toxicity Genotoxicity Chronic toxicity/carcinogenicity Reproductive and developmental toxicity

RISK CHARACTERIZATION Relate exposure to Health Based Guidance Value or Margin of Exposure (MOE)

Chemical Risk Assessment - Principles

EXPOSURE ASSESSMENT

HAZARD IDENTIFICATION

Levels in food, dietaryexposure, food consumption, relevant

food groups, time trends

HAZARD CHARACTERISATION

ADME, acute/sub-chronic/chronic toxicity, human data, genotox, reprotox, etc.

Derivation of a health based guidance value (e.g. ADI, MOS)

Risk ManagersRisk Managers8

ANS Panel at work

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MandatePanel Working Group (WG)

Opinion Adopted

ANS Panel 2008 - 2011ANS Panel 2008 - 2011

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ANS Panel 2011 - 2014ANS Panel 2011 - 2014

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Re-evaluation of Food additives Re-evaluation of Food additives Legal frameworkLegal framework

Priority criteria- Last evaluation (SCF)- New scientific evidence- Extend of use/human exposure- Commission request- Emerging concern

Procedure- Mandate from Commission- Data availability (public call for data)- Additional information/data

Timelines (Regulation 257/2010)- Food colours 2015

- FA other than food colours & sweeteners 2015, 2016 & 2018

- Sweeteners 2020- Exception: Aspartame 2012

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Overview of the re-evaluation Overview of the re-evaluation processprocess

Preparation of Draft opinion (DO) by rapporteur

Discussion of DO by WG

Adoption of opinion by Panel

Discussion of DO by Panel

Preparatory document

Objective - evaluation of each additive

Data from public call

Publication

Additional call for data

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Specific calls for data Specific calls for data TimelinesTimelines

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Food additives Launching date

Status

Patent blue V (E131)

July, 2010 Closed

Calcium carbonate (E170i)

December, 2010 Closed

Paprika extracts (E160c)

March, 2011 Closed

Indigo Carmine (E132)

February, 2011 Closed

Aspartame (E951) July, 2011 Closed

Risk assessment approachRisk assessment approach

Intake/Exposure data Maximum Permitted Levels (MPLs) Usage levels: Typical and maximum levels (Occurrence data)

Additional (but relevant) sources

Calculations/Assessment Tiered approach (SCOOP task report 4.2) on

adults & children Tier 1: Budget method Tier 2: MPLs and consumption data Tier 3: Usage levels and consumption data

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Colours already re-evaluatedColours already re-evaluated

• Red 2G• Tartrazine• Sunset Yellow FCF• Azorubine

(Carmoisine)• Ponceau 4R• Allura Red AC• Brown HT• Brown FK• Amaranth• Brilliant Black BN• Litholrubine BK• Quinoline Yellow

• Lycopene• Lutein• Curcumin• Canthaxanthin• Caramel colours• Erythrosine• Brilliant blue• Green S• Calcium carbonate

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Outcome of the re-evaluation of colours: Outcome of the re-evaluation of colours: Example of Azo dyesExample of Azo dyes

Azo dyes recently re-evaluated by EFSA– Tartrazine (E102)– Azorubine/Carmoisine (E122)– Allura Red AC (E129) Conclusions: 1. The Panel concluded that there was no need to change the previously

established Acceptable Daily Intakes (ADIs)2. Some children who consume large amounts of food and drink containing

Azorubine/Carmoisine or Allura Red AC could exceed the ADIs for these colours

– Quinoline Yellow (E104)– Sunset Yellow FCF (E110)– Ponceau 4R (E124)Conclusions: 1. The ANS Panel has lowered the ADIs (e.g. from 4 mg to 0.7 mg/kg bw/day

for Ponceau 4R)2. The Panel concluded that exposure to these colours could exceed the new

ADIs for both adults and children

The Next Steps (for colours)The Next Steps (for colours)

• 2011:– Indigotine

• 2012:– Patent blue

• 2015:– Riboflavin– Cochineal, carminic acid,

carmines– Chorophyls and chlorophyllins– Copper complexes of

chlorophyls and chlorophyllins– Vegetable carbon– Carotenes– Annatto extracts, bixin, norbixin– Paprika extract

– Beta-apo-8’-carotenal– Ethyl ester of beta-apo-8’-

carotenoic acid– Beetroot red– Anthocyanins– Titanium dioxide– Iron oxides and hydroxides– Silver– Gold

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Thank you very much for your attention !