1. 1 Food Additives - EFSA’s Risk Assessment - Prof. Dr. George E.N Kass Deputy Head of the ANS Unit, EFSA

2. 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

3. 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 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

4. 4 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 dossier Administrative data Biological and Toxicological Data Technical data

5. 5 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  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

6. 6 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  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

7. 7 General data requirements (IV) Biological and toxicological data state 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 state 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  Metabolism/Toxicokinetics  Subchronic toxicity  Genotoxicity  Chronic toxicity/carcinogenicity  Reproductive and developmental toxicity  Metabolism/Toxicokinetics  Subchronic toxicity  Genotoxicity  Chronic toxicity/carcinogenicity  Reproductive and developmental toxicity

8. 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, dietary exposure, 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 Managers 8

9. ANS Panel at work 9 Mandate Panel Working Group (WG) Opinion Adopted

10. ANS Panel 2008 - 2011 10

11. ANS Panel 2011 - 2014 11

12. 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 & sweeteners2015, 2016 & 2018 - Sweeteners 2020 - Exception: Aspartame2012 12

13. Overview of the re-evaluation process 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 13

14. Public calls for data Objective: Identify & collect all relevant data Key aspects -Data availability (public call for data) -Interested parties (business operators and others) -Additional information/data -Duration (3-6 months) -Confidentiality (Commission’s decision) -Lack of data: additive might be removed from EU list Information sought (reference to SCF Guidance on food additive applications, 2001) -Technical (specifications, analytical methods, manufacturing, etc.) -Toxicological -Human Exposure -Original dossier (SCF/JECFA) Types - General - Specific 14

15. Specific calls for data Timelines 15 Food additivesLaunching dateStatus Patent blue V (E131) July, 2010Closed Calcium carbonate (E170i) December, 2010Closed Paprika extracts (E160c) March, 2011Closed Indigo Carmine (E132) February, 2011Closed Aspartame (E951) July, 2011Closed

16. 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

17. 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

18. 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

19. 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

20. Thank you very much for your attention !