1 EU food legislation affecting polyols EPA Technical Meeting – 1 April 2009, Brussels.

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EU food legislation affecting polyols

EPA Technical Meeting – 1 April 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 new polyolsThe new B2B labelling rules for polyols

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

Aim of the review of the FCS: to prepare for the transfer of permitted additives in the Annex II of the future Regulation

Polyols: appear as a separate group, i.e. not included in the list of QS additives

Consequence: use of polyols in certain food categories is questioned on a case-by-case basis

Risk of phasing out of certain existing authorisations if case of need not demonstrated by the users/producers

Unvoluntary omissions also possible

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Regulation Food Additives – implementationAnnex II - Food Categorisation System

Adoption of Annex II (info from Sanco dated end March):- Significant work before the FCS is fully reviewed and the transfer finalised: first draft by end 2009- Presentation of the draft Annex to the WP additives: June 2009- Consultation with MS and SH: 2010- Interservice consultation: Oct/Nov 2010- Presentation to SCFCAH: Jan 2011 (review to be completed by 20 January 2011)

- EP scrutiny- Adoption by the Commission: May 2011- Publication in OJEU: June 2011

Regulation amending Regulation (EC) 1333/2008

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Regulation Food Additives – implementationAnnex II - Food Categorisation System

CAREFULLY MONITOR THE DEVELOPMENT OF ANNEX II !

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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: Sanco is still in the process of collecting submissions for extension

of use for other additives Discussion with MS on Annex III unlikely to start before the summer 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

Aim: • consolidation in a single act of purity criteria for all food

additives• correction of any errors and inconsistencies• adjust, where necessary, with the production and extraction

processes currently in use• origin of the food additive• + additional specific questions

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Regulation Food Additives – implementationRevised purity criteria

EPA required changes were included in the ELC consolidation document sent to Sanco mid-December 08.

Sanco has not started to review the (huge) document yet

Requests for additional clarification on certain changes to be expected as soon as Sanco will resume the work

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 new polyols

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)

20 July 2009: completion of EFSA (light) review of 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

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Regulation Food Additives – implementationReview of EFSA guidelines for R.A. of new polyols

EFSA in depth review of the guidelines for R.A. of additives (genotoxicity, toxicokinetics…): by end 2010 - public consultation organised in spring 2010

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Regulation Food Additives – implementationB2B labelling

Few changes to B2B labelling rules applying to polyols from 20 January 2010

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Sorbitol X OR E 420 OR Sorbitol X E 420For food OR Restricted use in foodStore in a dry and cool place (optional)Lot SBL-385-A – 09-01-16Instructions for use (optional) OR Not for retail sale (if optional instructions for use are on accompanying documents related to the consignment)

Bestpolyolsintheworld Ltd OR Not for retail sale (name and address on accompanying document)

Millbank 1132 London

Use according to Regulation (EC) 1333/2008 OR Not for retail sale (information on compliance with legislation on accompanying document)

1 000 kg net weightBest before: January 2011

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E 420For food Lot SBL-385-A – 09-01-16Not for retail sale 1 000 kg net weightBest before: January 2011

+ Additional mandatory information on the accompanying document

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Re-evaluation of colours: completed by end 2010

Next on the list: preservatives /antioxydants: 2009-2012 (?)

Publication of the full Re-evaluation Programme by 20 January 2010

(criteria for prioritisation – indication of immediate priorities)

Unknowns: against which criteria are the additives re-evaluated?

Still time for EPA to collect available data – undertake gap analysis

Template for review of existing studies EPA 31/09

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19 January 2009: EFSA publication of pre-screened list of claims

Substance Health relationship Compliance with EFSA criteria

Deadline EFSA opinion

Polyols Remineralisation of teeth OK 31 July 2009

Polyols Low glycemic properties OK 31 July 2009

Carbohydrates – non cariogenic e.g. isomaltulose, tagatatose, polyols, polydextrose. Absence of, or low fermentable carbohydrates

Dental health OK 30 November 2009

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EFSA criteria1. Claims where clarification on scope is needed (e.g. claims referring to risk reduction orreferring to children’s development and health, or medicinal claims)2. General well-being claims where the health relationship is not clear, e.g. “Compound Xsupplementation to sustain vitality while aging”3. Claims which are too vague (claim effect not specified/measurable), e.g. Compound Xand “energy and vitality”. Proposed wording: Compound X is “necessary to maintainenergy and general vitality”4. Foods which are not sufficiently characterised or conditions of use are not sufficientlyspecified 5. Combination constituents that are not sufficiently defined 6. Claims in other languages than English (to be returned for translation). If EFSA is askedto carry out the translations, EFSA will send translated claims back to Member States forvalidation of the translation.

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EFSA deadline July 2009: claims that were included in the draft list received by EFSA in July 2008 (no

changes made in the Nov. or Dec. 08 lists)November 2009: claims that were included in the list received by EFSA in November

2008 which were not included in the draft list received in July, or that were included in the draft list in July but were subsequently changed in the list received in November

Commission deadline31 January 2010: adoption of the Community list of permitted claims (after scrutiny by

the EP)

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Article 13 claims related to polyolsWritten question MEP Bowis – 18 Feb

What steps is the Commission taking to ensure that EFSA properly distinguishes between the processes and criteria for assessment of claims submitted between (a) Articles 14 and 13.5 which cover specific health claims, and (b) Article 13.1 , which cover more generic claims based upon generally accepted scientific evidence and understood by average consumers?

Response Commissionner Vassiliou – 13 MarchThe different procedure for assessing the Art.13 health claims does not imply that the

nature, amount and quality of the evidence required to substantiate such claims should be different than for the reduction of Art. 14 claims.

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Art. 14 (1) claim (reduction of a disease risk) wrt chewing gum sweetened with 100 % xylitolReference to specific risk factor = dental plaqueClaim = reduction of dental plaque – dental plaque is a risk factor in the development of

caries in children

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31 January 2010: my polyol-related claim is accepted. Which products are allowed to bear it?

Nutrients profile (for nutrition and health claims)Delayed adoption of Commission’s Regulation Draft proposal Feb 2009: end IS consultation 2 March 3 negative opinions: SG, DG

Agri, DG EntLetter from J. Daul (Pdt EPP-DE in EP) to Barroso (Pdt Commission): “scope of the

proposal will focus on processed products that offer opportunities for innovation and reformulation for the food industry” (5 March 09)

WP 20 March: discussion continues – new proposalSCFCAH 27 March Vote postponed until 27 April (if not later…)

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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), 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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An EFSA stakeholder meeting including all key players is foreseen for 15 June 2009 to discuss recent development with respect to health claims

try to have a seat for EPA?

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Review of labelling legislation

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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-, oligosaccharides or polysaccharides and which are listed as permitted sweeteners »

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What was done by EPA:Development of substantiation (wrt glycerol & reference to alcohols)Sent in November 2008 to:

DG Sanco (E4 & E3) French Presidency in the CouncilCouncil secretariat (for distribution to MS)EP Rapporteur ENVI COM: R. SommerEP: ca 10 MEPs interested in food topics

February 2009Czech Presidency in the Council

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Review of labelling legislationResults:

Council small comment by France (footnote)Belgium: a priori prefer the definition in their law:Polyols: edible substances that may

replace sugars and that contain two or more hydroxyle groups but that do not contain functional groups other than hydroxyle groups.

Sanco: E4 aware of the issue

EP: amendment tabled by Ms Doyle - Supported in ELC voting list

BUT: vote in ENVI Committee (planned end March) is postponed until new EP is running to enable the Rapporteur to deal with approx. 1 200 amendments

1 EU food legislation affecting polyols EPA Technical Meeting – 1 April 2009, Brussels.

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Transcript of 1 EU food legislation affecting polyols EPA Technical Meeting – 1 April 2009, Brussels.