1 EU food legislation affecting polyols EPA Technical Meeting – 13 October 2009, Brussels

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EU food legislation affecting polyols

EPA Technical Meeting – 13 October 2009, Brussels

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New Regulation on food additives – implementing measuresAnnex II - Food Categorisation System & transfer of polyolsAnnex III - Additives in polyolsRevision of purity criteria for polyolsReview 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

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New Regulation on food additivesImplementing measures

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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 categoriesCorrections 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

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Regulation Food Additives – implementationAnnex II - Food Categorisation System

Sanco’s 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

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Regulation Food Additives – implementationAnnex 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 mannitolE 965 (i) maltitolE 967 xylitolE 968 erythritol

E N° Name Use as Maximum level of use (g/kg)

E 341 (iii) Tricalcium phosphate Anti-caking agent

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E 551 Silicon dioxide Anticaking agent

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E 552 Calcium silicate Anticaking agent

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E 553a (i) Magnesium silicate Anticaking agent

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E 553 a (ii) Magnesium trisilicate Anticaking agent

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E 553 b Talc Anticaking agent

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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:

Polyols E341 iii, E551, E552, E553a, E553b @ 10 g/kg (as anticaking agents)

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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

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Regulation Food Additives – implementationRevised 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)

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Regulation Food Additives – implementationReview 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

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July 2009: draft re-evaluation programme for targeted consultation polyols re-evaluated by 31 December 2020Unknown: IS & consumer organisationsStill 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

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Article 13 claims related to polyolsSubstance Health relationship Compliance

with EFSA pre- screening (19 Jan. 09)

EFSA opinion

ID 618/2907 - Polyols Remineralisation of teeth OK Proposed for withdrawal from Art. 13.1 claims with no assessment

ID 619 - Polyols Low glycemic properties OK 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 health OK Proposed for withdrawal from Art. 13.1 claims with no assessment

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June 2009: Sanco ad hoc WG on Art. 13 claimsNon cariogenic claims generally not sufficiently characterised to allow an assessment of

the claimed effectLow GI carbohydrate claims: lack of internationally recognised methods for characterising

GI indexDental 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

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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

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General overview of the process14 July 09: despite industry’s 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

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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 EntAutumn: 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

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Article 13 claims related to polyolsPossible 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 sugars2g /100 g saturated fatty acids300 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 industry’s

interpretation, not necessarily all MS interpretation.

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Review of labelling legislation

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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 »

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Review of labelling legislation What was done by EPA:

Development of substantiation (wrt glycerol & reference to alcohols) Sending:

November 2008DG Sanco (E4 & E3) French Presidency in the CouncilCouncil 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 2009Czech Presidency in the Council

July 2009Swedish Presidency in the Council: ELC meeting 1st October 09 New EP: Sommer confirmed Rapporteur – A. Doyle not MEP anymore

At national level?

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Review of labelling legislationEP 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)

Documents

1 EU food legislation affecting polyols EPA Technical Meeting – 13 October 2009, Brussels