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Food Additives - EFSA’s Risk Assessment - . Prof. Dr. George E.N Kass Deputy Head of the ANS Unit, EFSA. Remit of the ANS Panel and Unit. Food additives (safety) re-evaluation of food additives that were permitted before 20 January 2009 new applications

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food additives efsa s risk assessment

Food Additives- EFSA’s Risk Assessment -

Prof. Dr. George E.N Kass

Deputy Head of the ANS Unit, EFSA

remit of the ans panel and unit
Remit of the ANS Panel and Unit
  • Food additives (safety)
      • re-evaluation of food additives that were permitted before 20 January 2009
      • new applications
  • Nutrient sources (safety and bioavailability)
      • Sources of vitamins and minerals for food supplements
      • Sources of vitamins and minerals for dietetic products and fortification of food
      • Other substances added for nutritional or functional purposes
  • Other substances deliberately added to food (excluding flavourings and enzymes).
evaluation of food additives legal framework
Evaluation of Food additives 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 Guidanceon 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)
general data requirements i
General data requirements (I)

Example for food additive applications

Generalscientific 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.

Application dossier

Administrative data

Technical data

Biological and Toxicological Data

general data requirements ii
General data requirements (II)

Administrative 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
general data requirements iii
General data requirements (III)

Technical 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 instability on biological properties including nutrient value

Other substances with nutritional and/or physiological effects

general data requirements iv
General data requirements (IV)

Biological and toxicological data

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

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

if not,

the relevance of these data to the

substance under consideration should be demonstrated


Chemical Risk Assessment - Principles




ADME, acute/sub-chronic/chronic toxicity,

human data, genotox, reprotox, etc.

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

Levels in food, dietary

exposure, food consumption, relevant food groups, time trends


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

Risk Managers


ans panel at work
ANS Panel at work



Working Group (WG)

Opinion Adopted

re evaluation of food additives legal framework
Re-evaluation of Food additives Legal 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

overview of the re evaluation process
Overview of the re-evaluation process

Objective - evaluation of each additive

Data from public call

Preparation of Draft opinion (DO) by rapporteur

Discussion of DO by WG

Additional call for data

Preparatory document

Discussion of DO by Panel

Adoption of opinion by Panel


risk assessment approach
Risk 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
colours already re evaluated
  • Lycopene
  • Lutein
  • Curcumin
  • Canthaxanthin
  • Caramel colours
  • Erythrosine
  • Brilliant blue
  • Green S
    • Calcium carbonate
  • 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
outcome of the re evaluation of colours example of azo dyes
Outcome of the re-evaluation of colours: Example of Azo dyes

Azo dyes recently re-evaluated by EFSA

  • Tartrazine (E102)
  • Azorubine/Carmoisine (E122)
  • Allura Red AC (E129)


  • The Panel concluded that there was no need to change the previously established Acceptable Daily Intakes (ADIs)
  • 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)


  • The ANS Panel has lowered the ADIs (e.g. from 4 mg to 0.7 mg/kg bw/day for Ponceau 4R)
  • The Panel concluded that exposure to these colours could exceed the new ADIs for both adults and children
the next steps for colours
The NextSteps (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