Federation of EU Specialty Food Ingredients Industries

Transcription

1 Federation of EU Specialty Food Ingredients Industries Additives: - Discovering the new EU positive lists of food additives and preparing for EFSA s re-evaluation system - Getting ready for a changing environment Maryse Hervé Secretary General ELC Fi Masterclass Legislation & Regulation in F&B Paris 28 November 2011

2 ELC at a glance The ELC is the voice of the Specialty Food Ingredients Industries in Europe. We aim to create a safe and suitable regulatory environment and represent the industry with EU-decision-makers. It is our objective to ensure that all stakeholders from manufacturers and retailers to regulatory authorities and consumers are correctly informed of the use and safety of specialty food ingredients and their advantages.

3 ELC at a glance (cont d) More than 200 EU companies represented either by direct membership or through a member association ELC membership (2011) ECU Association members Corporate members INEC

4 ELC at a glance (cont d) Specialty ingredients are valuable not just for the food industry but for everybody who enjoys tasty, safe, affordable food and choice. Manufactured food has a place in today s health balanced diet. The ingredients used are there for a reason. With their technological, nutritional and health related functions, they help deliver tasty, safe, affordable food and food choices, hence they are an integral part of our food supply. To name but a few: vitamins, minerals, enzymes, specific proteins, fibres, additives, specific carbohydrates, cultures etc.

5 ELC at a glance (cont d) 3-8 % of EU specialty food ingredients manufacturers turnover is dedicated to R&D, depending on the sectors. Overall the average investment is between 4-5 % of revenue. The specialty food ingredients industry represents around 35 billion of the global food ingredients market of which 40 % (around 15 billion) is in Europe.

6 Today s agenda I - Setting the scene: the new EU legislative framework for FA II - From the lab to the Community lists of FA Risk assessment Risk management Authorisation III - Re-evaluation of FA

7 I - Setting the scene: the new EU legislative framework for FA

8 The new EU legislative framework for FA (cont d) Directive 89/107/EEC Framework Directive Directive 94/35/EC Sweeteners Directive Specifications Dir 2008/60/EC Directive 94/36/EC Colours Directive Specifications Dir 2008/128/EC Directive 95/2/EC MAD Directive Regulation (EC) 1331/2008 Common authorisation procedure for FA, FE & FF Regulation (EC) 1333/2008 Food Additives Regulation (EC) /2011 Specifications Specifications Dir 2008/84/EC

9 The new EU legislative framework for FA (cont d) Application Common authorisation procedure (simplified chart) Commission 9 months EFSA Opinion 9 months 3 months Commission Draft Regulation SCFCAH Council EP Not adopted Adopted or no opinion 2 months scrutiny Publication Community list = Total minimum 24 months

10 The new EU legislative framework for FA (cont d) EC General guidance EC Practical Guidance Sept 2011 Common Authorisation Procedure EFSA General guidance directly inspired from the 2001 SCF guidelines Reg. (EU) 234/2011 implementing Reg. (EC) 1331/ EFSA guidelines on data requirements for the evaluation of FA applications EC guidance for applicants on the submission of applications for FA, FE and FF EFSA guidance to explain the technical, exposure and toxicological data required to establish the safety of food additives EFSA Technical guidance Early 2012

11 The new EU legislative framework for FA (cont d) Food Additives Regulation Community list of FA permitted per food category Application from 1 June 2013 (Annex II) How manufacturers of TTS shall make available information to allow the safe use by consumers 2012? Regulation (EU) 1129/2011 on Annex II TTS guidance Regulation (EU) 1130/2011 on Annex III Regulation on specification s Additives in additives, enzymes, flavourings & nutrients Application 2 December 2011 Adoption Feb 2012 Application from 1 December 2012 (Reg.)

12 Annex II The new EU legislative framework for FA (cont d) Consolidation in a single Community list of all current authorisations spread over the 3 former vertical Directives (no mechanical transfer a few new authorisations included minimal cleaning exercise) Composed of 5 parts: A: general provisions B: list of all permitted food additives C: definitions of groups of food additives D: food categories E: authorised food additives and conditions of use in food categories Express authorisations in a more transparent, clear and coherent manner, i.e. list of additives permitted per category/subcategory

13 Annex II (cont d) The new EU legislative framework for FA (cont d) New food additives/extensions of use of permitted food additives will be permitted via amendments to the Regulation establishing Annex II (1 st : steviol glycosides Reg. (EU) 1131/2011) New applications shall take into account the new FCS A list of descriptors of main food categories will be available to facilitate interpretation BUT it is not part of the Regulation (i.e. not legally binding) In principle a specific Regulation for each new FA authorisation Speed up the procedure comparing to former «omnibus» approach Confine potential EP rejection However unclear how the pending authorisations will be treated

14 Annex III The new EU legislative framework for FA (cont d) Composed of 6 parts: Carriers in food additives Food additives other than carriers in food additives (NEW) Food additives including carriers in food enzymes (NEW) Food additives including carriers in food flavourings Food additives in nutrients Section A : FA in nutrients except nutrients for use in foodstuffs for infants and young children (NEW) Section B: FA in nutrients for use in foodstuffs for infants and young children Definitions of groups of FA for the purpose of the 5 other parts

15 Conditions for inclusion and use of FA in Community lists (Art. 6 & 7 of Reg. (EC) 1333/2008) The new EU legislative framework for FA (cont d) Only if it meets the following conditions and, where relevant, other legitimate factors, including environmental factors: (a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed (b) there is a reasonable technological need that cannot be achieved by other economically practicable means; and (c ) its use does not mislead the consumer In addition, it must have advantages and benefits for the consumer Additional specific conditions are laid down for sweeteners and colours

16 The new EU legislative framework for FA (cont d) Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product, including its fruit and vegetable content. Other legitimate factors include societal, economic, traditional, ethical and environmental factors, the precautionery principle and the feasibility of controls. Whereas (7) Reg. (EC) 1333/2008

17 II - From the lab to the Community list of food additives 06.5 Noodles group I Additives group II Colours at quantum satis quantum satis Source: La Provence? E E Batters Phosphoric acid - phosphates - di - triand polyphosphates Soybean hemicellulose 2000 (1) (4) only pre-packaged ready to eat oriental noodles intended for retail sale (1): The additives may be added individually or in combination (4): The maximum level is expressed as P 2 O 5 Group I Additives Group II Group III E 160b Colours at quantum satis Food colours with combined maximum limit Annatto, Bixin, Norbixin quantum satis 500 only batters for coating 20 only batters for coating

18 From the lab to the Community list of FA Risk assessment Risk management Authorisation

19 Risk assessment Application prepared according to EFSA & EC (new) guidances «Light» application in case of requests for extension of use of a permitted FA If numerical ADI calculation of impact on intake exposure is essential R.A. by EFSA (ANS Panel + other Panels as relevant) Focus: safety of the food additive Outcome of Risk Assessment: EFSA opinion

20 From the lab to the Community list of FA Risk assessment Risk management Authorisation

21 Risk management EC/MS Working Party of Governmental Experts SCFCAH Basis: EFSA opinion Focus: Safety at the levels of use considered (below ADI) Technological need Not misleading the consumer Benefits for the consumers Other legitimate factors

22 Risk management (cont d) Outcome of Risk Management: Draft Regulation amending Annex II It defines the food categories where the additive is permitted, and the permitted levels of use.

23 From the lab to the Community list of FA Risk assessment Risk management Authorisation

24 Authorisation Proposed Regulation submitted to scrutiny of EP/Council Favourable opinion of EC and MS may not be enough to guarantee the authorisation - role of the EP is important The thrombin case

25 Authorisation (cont d) Outcome of scrutiny: Publication of Regulation amending Annex II in the OJEU BUT

26 Authorisation (cont d) Even if a food additive authorisation is not time-limited: The authorisation may be withdrawn/restricted on the basis of new scientific or technical information that might affect the assessment of the safety of the food additive The food additive is submitted to a re-evaluation according to a programme set in Regulation (EU) 257/2010

27 III - Re-evaluation «Learning by doing» process for EFSA, EC & industry

28 Re-evaluation Re-evaluation programme set in Regulation (EU) 257/2010 Applies to all FA permitted in the EU before 20 Jan Ambitious deadlines total completion by Risk assessment by EFSA Risk management measures by EC

29 Re-evaluation ? Start colours End colours Start MAD End certain priority MAD End certain priority MAD End all MAD End Asparta me Start Sweeteners? Anticipated in 2011 End sweeteners

30 Re-evaluation Risk assessment EFSA calls for data published on EFSA s website Procedure to provide the requested information is defined in the calls for data Currently a two-steps procedure Registration of the contact details of the interested party and description of the information available [Within (3-6) months after call for data is issued] Submission to EFSA of the data selected by EFSA [20 working days to provide hard and/or electronic copies of data upon request]

31 Re-evaluation Risk assessment (cont d) Information sought Use patterns (intake, actual levels of use (typical & maximum), exposure assessments if available) Purity, including particle size and particle size distribution if relevant Production method Analytical methods available for determination in foods Toxicokinetics and toxicity (subchronic toxicity, genotoxicity and carcinogenicity, reproduction and environmental toxicity, allergenicity etc) and any information relevant to their safety assessment

32 Re-evaluation Risk assessment (cont d) Learning from the re-evaluation of colours Progressive improvement A certain standardisation of the procedure Some interaction with the interested parties, in particular in step 2 of the procedure Some dialogue with industry in the framework of general meetings (i.e. on the procedure in general, not on a given FA) Some flexibility If data gathered is insufficient new call If request for new tox study that the industry commits to perform in a certain timeframe Still room for improvement (coordinated input from IP, limitation of conservative approach to intake assessments etc)

33 Re-evaluation Risk management (on the basis of EFSA opinion) Withdrawal of authorisation Restrictions of use Maintenance of the same authorisation Possible impact on specifications

34 To conclude: The EU Food Additives legislation is complex It has far-reaching consequences since FA are used in almost all processed foods & beverages To apply for a new FA authorisation/extension of use of a permitted FA new rules shall be taken into account (new guidances, new FCS, new Annex III etc) To maintain a FA on the market robust dossier for the re-evaluation

35 Federation of European Specialty Food Ingredients Industries Thank you for your attention