Food Additives
- EFSA’s Risk Assessment Prof. Dr. George E.N Kass
Deputy Head of the ANS Unit, EFSA
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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).
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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
- Other than food colours & sweeteners
- Sweeteners
(94/36/EC)
(95/2/EC)
(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)
Example for food additive applications
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.
Application dossier
Administrative
data
Technical
data
Biological and
Toxicological Data
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General data requirements (II)
Administrative data
 Applicant’s, Manufacturer’s and Contact
person’s contact details

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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)
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
Other substances with
nutritional and/or
physiological effects
Any possible effect of
instability on biological
properties including
nutrient value
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General data requirements (IV)
Biological and toxicological data


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

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
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Chemical Risk Assessment - Principles
HAZARD
IDENTIFICATION
EXPOSURE ASSESSMENT
HAZARD CHARACTERISATION
Levels in food, dietary
exposure, food consumption, relevant
food groups, time trends
ADME, acute/sub-chronic/chronic toxicity,
human data, genotox, reprotox, etc.
Derivation of a health based guidance value
(e.g. ADI, MOS)
RISK CHARACTERIZATION
Relate exposure to Health Based Guidance Value or Margin of Exposure (MOE)
Risk Managers
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ANS Panel at work
Panel
Mandate
Working Group (WG)
Opinion Adopted
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ANS Panel 2008 - 2011
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ANS Panel 2011 - 2014
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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
- FA other than food colours & sweeteners
- Sweeteners
- Exception: Aspartame
2015
2015, 2016 & 2018
2020
2012
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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
Preparatory
document
Additional call
for data
Discussion of DO by Panel
Adoption of opinion by
Panel
Publication
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Specific calls for data
Timelines
Food additives
Launching date
Status
Patent blue V (E131)
July, 2010
Closed
Calcium carbonate
December, 2010
Closed
March, 2011
Closed
Indigo Carmine (E132)
February, 2011
Closed
Aspartame (E951)
July, 2011
Closed
(E170i)
Paprika extracts
(E160c)
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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
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
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Tier 1: Budget method
Tier 2: MPLs and consumption data
Tier 3: Usage levels and consumption data
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Colours already re-evaluated
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•
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•
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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
•
•
•
•
•
•
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Lycopene
Lutein
Curcumin
Canthaxanthin
Caramel colours
Erythrosine
Brilliant blue
Green S
Calcium carbonate
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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)
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)
• 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 !