Presentation on theme: "1 EU food legislation affecting polyols EPA Technical Meeting – 1 April 2009, Brussels."— Presentation transcript:
1 EU food legislation affecting polyols EPA Technical Meeting – 1 April 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 new polyols The new B2B labelling rules for polyols 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 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
5 Regulation Food Additives – implementation Annex 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
6 Regulation Food Additives – implementation Annex II - Food Categorisation System CAREFULLY MONITOR THE DEVELOPMENT OF ANNEX II !
7 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
8 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)
9 Regulation Food Additives – implementation Annex III - Additives in polyols 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
10 Regulation Food Additives – implementation Revised 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
11 Regulation Food Additives – implementation Revised 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)
12 Regulation Food Additives – implementation Review 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
13 Regulation Food Additives – implementation Review 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
14 Regulation Food Additives – implementation B2B labelling Few changes to B2B labelling rules applying to polyols from 20 January 2010
15 Regulation Food Additives – implementation B2B labelling Sorbitol X OR E 420 OR Sorbitol X E 420 For food OR Restricted use in food Store in a dry and cool place (optional) Lot SBL-385-A – 09-01-16 Instructions 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 weight Best before: January 2011
16 Regulation Food Additives – implementation B2B labelling E 420 For food Lot SBL-385-A – 09-01-16 Not for retail sale 1 000 kg net weight Best before: January 2011 + Additional mandatory information on the accompanying document
18 EFSA re-evaluation of polyols 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
20 Article 13 claims related to polyols 19 January 2009: EFSA publication of pre-screened list of claims SubstanceHealth relationshipCompliance with EFSA criteria Deadline EFSA opinion PolyolsRemineralisation of teethOK31 July 2009 PolyolsLow glycemic propertiesOK31 July 2009 Carbohydrates – non cariogenic e.g. isomaltulose, tagatatose, polyols, polydextrose. Absence of, or low fermentable carbohydrates Dental healthOK30 November 2009
21 Article 13 claims related to polyols EFSA criteria 1. Claims where clarification on scope is needed (e.g. claims referring to risk reduction or referring to childrens development and health, or medicinal claims) 2. General well-being claims where the health relationship is not clear, e.g. Compound X supplementation to sustain vitality while aging 3. Claims which are too vague (claim effect not specified/measurable), e.g. Compound X and energy and vitality. Proposed wording: Compound X is necessary to maintain energy and general vitality 4. Foods which are not sufficiently characterised or conditions of use are not sufficiently specified 5. Combination constituents that are not sufficiently defined 6. Claims in other languages than English (to be returned for translation). If EFSA is asked to carry out the translations, EFSA will send translated claims back to Member States for validation of the translation.
22 Article 13 claims related to polyols 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 deadline 31 January 2010: adoption of the Community list of permitted claims (after scrutiny by the EP)
23 Article 13 claims related to polyols Written 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 March The 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.
24 Article 13 claims related to polyols Art. 14 (1) claim (reduction of a disease risk) wrt chewing gum sweetened with 100 % xylitol Reference to specific risk factor = dental plaque Claim = reduction of dental plaque – dental plaque is a risk factor in the development of caries in children
25 Article 13 claims related to polyols 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 Commissions Regulation Draft proposal Feb 2009: end IS consultation 2 March 3 negative opinions: SG, DG Agri, DG Ent Letter 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 proposal SCFCAH 27 March Vote postponed until 27 April (if not later…)
26 Article 13 claims related to polyols Possible impact of nutrients profile on the use of polyols? In latest drafts (Feb & 17 March), 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.
27 Article 13 claims related to polyols 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?
29 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-, oligosaccharides or polysaccharides and which are listed as permitted sweeteners »
30 Review of labelling legislation 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 Council Council secretariat (for distribution to MS) EP Rapporteur ENVI COM: R. Sommer EP: ca 10 MEPs interested in food topics February 2009 Czech Presidency in the Council
31 Review of labelling legislation Results: 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