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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). 2

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) 3

General data requirements (I)

Example for food additive applications General scientific approaches defined in ANS Panel Statement requirements for the evaluation of food additive applications’ ‘Data (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 Biological and Toxicological Data Technical data 4

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 5

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 6

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 7

Chemical Risk Assessment - Principles

EXPOSURE ASSESSMENT

Levels in food, dietary exposure, food consumption, relevant food groups, time trends

HAZARD IDENTIFICATION 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 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 9

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 12

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 Patent blue V

(E131)

Calcium carbonate

(E170i)

Paprika extracts

(E160c)

Indigo Carmine

(E132)

Aspartame

(E951)

Launching date

July, 2010 December, 2010 March, 2011 February, 2011 July, 2011

Status Closed Closed Closed Closed Closed

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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

   Tier 1: Budget method Tier 2: MPLs and consumption data Tier 3: Usage levels and consumption data 16

Colours 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 17

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 19

Thank you very much for your attention !