Presentation on theme: "1 EU food legislation affecting polyols EPA Technical Meeting – 13 October 2009, Brussels."— Presentation transcript:
1 EU food legislation affecting polyols EPA Technical Meeting – 13 October 2009, Brussels
2 New Regulation on food additives – implementing measures Annex II - Food Categorisation System & transfer of polyols Annex III - Additives in polyols Revision of purity criteria for polyols Review of EFSA guidelines for R.A. of additives EFSA re-evaluation of polyols Article 13 claims related to polyols Review of labelling legislation – definition of polyols
3 New Regulation on food additives Implementing measures
4 Regulation Food Additives – implementation Annex II - Food Categorisation System Finalisation of review of the FCS & transfer of existing authorisations now in the hands of MS (WP additives) EPA updated position sent to Commission in April June-Dec 09: population Annex II by Sanco with help of MS – finalisation first draft Sept - Oct. 09: ELC/CIAA informal consultation on several categories Corrections needed wrt polyols Still possibility to obtain inclusion of polyols used for properties other than sweetening in Group I (QS additives) Formal consultation: first half 2010
5 Regulation Food Additives – implementation Annex II - Food Categorisation System Sancos provisional calendar: Sept 2010: final draft Annex II Oct-Nov 2010: Interservice consultation – Representation DG Enterprise? Nov-Dec 2010: translations Jan 2011: presentation SCFCAH – vote EP scrutiny (2 months) May 2011: adoption by Commission June 2011: publication in OJEU of a Regulation amending Regulation (EC) 1333/2008
6 Regulation Food Additives – implementation Annex III - Additives in polyols Aim: population of Annex III – Part 2 additives in additives Additives in polyols – request for extension of use sent to DG Sanco on 6 November 2008 Additives other than carriers in the following polyols: E 420 (i) sorbitol E 421 mannitol E 965 (i) maltitol E 967 xylitol E 968 erythritol E N°NameUse asMaximum level of use (g/kg) E 341 (iii)Tricalcium phosphateAnti-caking agent10 E 551Silicon dioxideAnticaking agent10 E 552Calcium silicateAnticaking agent10 E 553a (i)Magnesium silicateAnticaking agent10 E 553 a (ii)Magnesium trisilicateAnticaking agent10 E 553 bTalcAnticaking agent10
7 Regulation Food Additives – implementation Annex III - Additives in polyols First feedback from Sanco: EPA submission receivable Generalisation of the approach to all polyols possible: to be in line with the polyols group of Annex II to future proof the entry, should a brand new polyol (powder) be authorised: PolyolsE341 iii, E551, E552, E553a, E553b @ 10 g/kg (as anticaking agents)
8 Regulation Food Additives – implementation Annex III - Additives in polyols Next steps: Summer: theoretical end of collection by Sanco of submissions for extension of use for all additives Discussion with MS on Annex III: likely not before Dec. 09 Adoption by SCFCAH EP scrutiny (2 months) Adoption by Commission Regulation amending Regulation (EC) 1333/2008 - Date of application: 1 January 2011
9 Regulation Food Additives – implementation Revised purity criteria Mid-December 08: EPA required changes were included in the ELC consolidation document sent to Sanco June 09: EPA conf call with Sanco to explain the rationale behind the required changes, which are found reasonable by Sanco Next step: presentation of draft revised purity criteria by Sanco to MS for endorsement Impact of Nanotechs discussion wrt size? ELC paper to oppose inclusion of size in specs of non-nano additives Adoption of Regulation by June 2011 (along with Annex II)
10 Regulation Food Additives – implementation Review of EFSA guidelines for R.A. of additives As all food additives, polyols developed in future may have to comply with safety criteria different from the safety criteria in place today (assessment according to 2001 SCF guidelines) July 2009: publication of EFSA general data requirements for risk assessment of food additives (consultation of ELC in March 09) Inclusion of these data requirements in the Commission guidelines for authorisations of additives, to be available by 16 Dec.2010 at the latest EFSA in depth review of the guidelines for R.A. of additives (genotoxicity, toxicokinetics, nanotechs…): by July 2011 - public consultation organised in 2010
12 EFSA re-evaluation of polyols July 2009: draft re-evaluation programme for targeted consultation polyols re-evaluated by 31 December 2020 Unknown: IS & consumer organisations Still time for EPA to collect available data – undertake gap analysis – carry out studies (e.g. intake assessment) Template for review of existing studies EPA 31/09 Next on the list: preservatives /antioxydants: 2009-2013 Publication of the final Re-evaluation Programme by 20 January 2010
14 Article 13 claims related to polyols SubstanceHealth relationshipCompliance with EFSA pre- screening (19 Jan. 09) EFSA opinion ID 618/2907 - PolyolsRemineralisation of teethOK Proposed for withdrawal from Art. 13.1 claims with no assessment ID 619 - PolyolsLow glycemic propertiesOK Not proposed for withdrawal, but not yet assessed ID 463 - Carbohydrates – non cariogenic e.g. isomaltulose, tagatatose, polyols, polydextrose. Absence of, or low fermentable carbohydrates Dental healthOK Proposed for withdrawal from Art. 13.1 claims with no assessment
15 Article 13 claims related to polyols June 2009: Sanco ad hoc WG on Art. 13 claims Non cariogenic claims generally not sufficiently characterised to allow an assessment of the claimed effect Low GI carbohydrate claims: lack of internationally recognised methods for characterising GI index Dental health/non cariogenic claims are comparative claims Eligibility to EFSA evaluation was questioned Withdrawal of these claims from the list of claims to be evaluated by EFSA was considered Request to MS to confirm eligibility of these claims
16 Article 13 claims related to polyols August 2009: development of EPA position paper Early Sept. 09: use of the paper towards Commission, MS & sister associations 14 Sept. 09: Commission WG on claims agreement to have a follow-up meeting with MS to review additional clarification and adjust EFSA list accordingly: 16 October 2 Oct. 09: Additional EPA clarification to Commission, MS & sister associations 6 Oct. 09: EFSA/EC/MS meeting
17 Article 13 claims related to polyols General overview of the process 14 July 09: despite industrys lobby, confirmation of publications of EFSA opinions by batches 1 October 2009: publication first batch: 94 opinions covering 523 claims Adoption of Community list of permitted Article 13 claims: progressive, statement re interim list. First publication AFTER 31 Jan. 2010 (incl. EP scrutiny). In the meantime, claims may be made under the responsibility of the business operator provided that they comply with Regulation (EC)1924/2006 – non misleading
18 Article 13 claims related to polyols 2010: if my polyol-related claim is accepted, what are the products that are allowed to bear it? Nutrients profile (for nutrition (?) and health claims) Draft proposal Feb 2009: end IS consultation 2 March 3 negative opinions: SG, DG Agri, DG Ent Autumn: still under IS consultation – highly political – when (if) will it be published? Application to nutrition claims: subject to legal interpretation (industry/EC). Not submitted for decision by SCOFCAH
19 Article 13 claims related to polyols Possible impact of nutrients profile on the use of polyols In latest drafts (Feb & 17 March 09), confectionery falls under other foods: 10 g/100 g sugars 2g /100 g saturated fatty acids 300 mg/100 g sodium Polyol-related health claims & chocolate re. SFAs Double labelling: Protect teeth & High SFAs content Interest for cocoa manufacturers??? Polyol-related nutrition claims (Annex I) With no added sugars Sugars-free OK interpretation that no need to mention SFAs content in this case. This is industrys interpretation, not necessarily all MS interpretation.
21 Review of labelling legislation Proposed Regulation for the provision of food information to consumers Definition of polyols What is in: »Polyols means alcohols containing more than two hydroxyl groups » What EPA wants to be in: « Polyols are defined as carbohydrates which are reduced mono-, di-, oligo- or poly-saccharides and which are listed as permitted sweeteners »
22 Review of labelling legislation What was done by EPA: Development of substantiation (wrt glycerol & reference to alcohols) Sending: November 2008 DG Sanco (E4 & E3) French Presidency in the Council Council secretariat (for distribution to MS) EP Rapporteur ENVI COM: R. Sommer EP: ca 10 MEPs interested in food topics – EPA amendment tabled by MEP Doyle February 2009 Czech Presidency in the Council July 2009 Swedish Presidency in the Council: ELC meeting 1 st October 09 New EP: Sommer confirmed Rapporteur – A. Doyle not MEP anymore At national level?
23 Review of labelling legislation EP calendar – 1st reading Mid-October: Ms Sommer's draft report ready for translation: EPA amdt still in? Early November: consideration draft report in ENVI Cte Mid-November: deadline for amendments End-January 2010: consideration amendments in ENVI Cte 16 March 2010: Vote ENVI Cte 19 April 2010: Plenary vote Shadowrapporteurs in ENVI Cte –Gerben-Jan Gerbrandy (ALDE, NL) –Glenis Willmott (S&D, UK) –Stuan Stevenson (ECR, UK)
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