1 EU food legislation affecting polyols EPA Technical Meeting – 9 March 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 Claims related to polyols Article 13.1 claims Nutrition claims Review of labelling legislation – definition of polyols Falsified medicines & pharmaceutical excipients

3 New Regulation on food additives Implementing measures

4 Regulation Food Additives – implementation Annex II - Food Categorisation System Timeframe October & November 09: EPA comments on draft populations sent to Sanco End March 2010: first consolidated draft – for informal consultation until end April June 2010: presentation to Advisory Group – Formal public consultation September 2010: finalisation Community List October 2010: final consultation with MS in WP November 2010: EC Interservice consultation January 2011: presentation & possible vote at SCFCAH EP scrutiny (2 months) May 2011: adoption by Commission June 2011: publication in OJEU of a Regulation amending Regulation (EC) 1333/2008 Consideration of polyols Sanco is affirmative that polyols used for their non-sweetening properties are included in Group I additives (i.e. QS additives)

5 Regulation Food Additives – implementation Annex III - Additives in polyols PRO MEMORIA 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

6 Regulation Food Additives – implementation Annex III - Additives in polyols PRO MEMORIA First feedback from Sanco in November 2008: 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, 10 g/kg (as anticaking agents)

7 Regulation Food Additives – implementation Annex III - Additives in polyols 1 December 09: first Sanco Ad hoc WG meeting Additives in Annex I of Dir 95/2/EC are authorised in additives and in enzymes List of questions on the use of certain conditionally permitted additives EPA submission (with indication maximum levels) slipped out of the review further to Sanco turnover – Re-sending in December 2009 – seems now to be OK, except maybe for E 341 because estimated high intake. Potential contribution to the total dietary intake of E 341 through polyols may be expected. Silicates (E ): The WG agreed to maintain silicates as carriers and to introduce them as well in the list of additives in additives 28 Jan 10: 2 nd Sanco Ad hoc WG meeting No specific question related to polyols

8 Regulation Food Additives – implementation Annex III - Additives in polyols PRO MEMORIA Next steps: Adoption by SCFCAH EP scrutiny (2 months) Adoption by Commission Regulation amending Regulation (EC) 1333/ Date of application: 1 January 2011

9 Regulation Food Additives – implementation Revised purity criteria PRO MEMORIA 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 WG Sanco/MS 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 public consultation organised in 2010 PRO MEMORIA

11 EFSA re-evaluation of polyols

12 EFSA re-evaluation of polyols SCFCAH 8 Feb 2010: adoption of Regulation on re-evaluation programme of food additives All sweeteners (polyols & IS) re-evaluated by 31 December 2020 BUT…

13 EFSA re-evaluation of polyols 23 Nov. 2009: EFSA calls for information data on: Preservatives & anti-oxidants Re-evaluation programme: shall be evaluated by Deadline for preliminary information to EFSA: 23 Feb 10, + 2 months (exceptionally) Deadline for EFSA to receive additional info: Dec Emulsifiers, stabilisers and gelling agents Re-evaluation programme: shall be evaluated by Deadline for preliminary information to EFSA: 23 Feb 10, + 3 months (exceptionally) Deadline for EFSA to receive additional info: Dec Waxes (re-evaluation programme: shall be evaluated by )

14 EFSA re-evaluation of polyols Format of the EFSA calls for information - Two-step approach: First step 3 months to register the contact details of the interested party and to provide a description of the information available (using a pre-defined template) Second step 20 working days to provide hard and/or electronic copies of the data selected by EFSA + additional EFSA/applicant exchanges on the information provided.

15 EFSA re-evaluation of polyols Area of Information (as far as possible the areas of information covered should be defined with reference to the applicable guidance document on food additives: SCF 2001 guidance document) Type of information please choose from drop down menu in each cell (Published or unpublished data - previously evaluated or not) Confidential information please choose from drop down menu in each cell (Yes or No) Description of informationComments Chemistry & Specifications (e.g. JECFA specifications, analytical results, etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated NO Published data/Previously evaluated NO Manufacturing process (e.g. description of manufacturing process, raw materials etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated No Published data/Previously evaluated No

16 EFSA re-evaluation of polyols Area of Information (as far as possible the areas of information covered should be defined with reference to the applicable guidance document on food additives: SCF 2001 guidance document) Type of information please choose from drop down menu in each cell (Published or unpublished data - previously evaluated or not) Confidential information please choose from drop down menu in each cell (Yes or No) Description of informationComments Determination in food (e.g. analytical method etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated NO Published data/Previously evaluated NO Reaction and fate in food (e.g. stability studies etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated No Published data/Previously evaluated No

17 EFSA re-evaluation of polyols Area of Information (as far as possible the areas of information covered should be defined with reference to the applicable guidance document on food additives: SCF 2001 guidance document) Type of information please choose from drop down menu in each cell (Published or unpublished data - previously evaluated or not) Confidential information please choose from drop down menu in each cell (Yes or No) Description of informationComments Present Usage (e.g. typical use levels per food category, maximum use levels etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated NO Published data/Previously evaluated NO Exposure ( e.g. exposure assessment report, scientific publications, etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated No Published data/Previously evaluated No

18 EFSA re-evaluation of polyols Area of Information (as far as possible the areas of information covered should be defined with reference to the applicable guidance document on food additives: SCF 2001 guidance document) Type of information please choose from drop down menu in each cell (Published or unpublished data - previously evaluated or not) Confidential information please choose from drop down menu in each cell (Yes or No) Description of informationComments ADME (Metabolism – Toxicokinetics) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated NO Published data/Previously evaluated NO Subchronic toxicity at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated No Published data/Previously evaluated No Genotoxicity (e.g. chromosomal aberrations etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated No

19 EFSA re-evaluation of polyols Area of Information (as far as possible the areas of information covered should be defined with reference to the applicable guidance document on food additives: SCF 2001 guidance document) Type of information please choose from drop down menu in each cell (Published or unpublished data - previously evaluated or not) Confidential information please choose from drop down menu in each cell (Yes or No) Description of informationComments Chronic toxicity & carcinogenicity (e.g. long- term toxicity, carcinogenicity etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated NO Published data/Previously evaluated NO Reproduction & Developmental toxicity at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated No Published data/Previously evaluated No Other studies (e.g. immunotoxicity, allergenicity etc) at least a summarised description of the studies/reports/data and, if possible, also the corresponding references Published data/Previously evaluated No

20 EFSA re-evaluation of polyols Article 6 - Regulation on re-evaluation programme: In the framework of the re-evaluation of a food additive, the interested business operator(s) or any other interested party shall inform EFSA and the Commission of any information relevant to any environment risks from the production, use or waste of that food additive.

21 EFSA re-evaluation of polyols The most difficult info for EFSA to retrieve is the original study reports: SCF archives not available anymore JECFA archives: 5 years back max WHO: some original dossiers may be available but not easy to obtain MS? FDA? Lot of BIBRA information lost during the transfer to TNO

22 EFSA re-evaluation of polyols Time to start at EPA? Collect information - review of existing studies, use REACH data EPA 31/09 Undertake gap analysis Continue intake assessment study Shall we set up a WG to start working on it?

23 Claims related to polyols - Article 13.1 claims - Nutrition claims

24 Article 13.1 claims related to polyols SubstanceHealth relationshipCompliance with EFSA pre- screening (19 Jan. 09) EFSA opinion ID 618/ PolyolsRemineralisation of teethOK In progress ID PolyolsLow glycemic propertiesOK In progress ID Carbohydrates – non cariogenic e.g. isomaltulose, tagatatose, polyols, polydextrose. Absence of, or low fermentable carbohydrates Dental healthOK In progress

25 Article 13.1 claims related to polyols PRO MEMORIA 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

26 Article 13.1 claims related to polyols August – Oct 2009: EPA position papers & lobby 10 Nov. 09: EC confirmed eligibility of comparative claims to EFSA assessment FSA report Feb.10: « MS have been unable to submit further clarification in support of the comparative claims so the additional information submitters sent to the Agency (i.e. FSA) to define the comparator for these claims has not been passed to EFSA. EFSA will assess these claims based on the information of the original application. » Subsequent EPAs request to MS and Sanco to send to EFSA the additional information provided by EPA on 1 Sept & 2 Oct 09 1 March 10: Sanco refuses to forward EPA clarification responsibility of MS

27 Article 13.1 claims related to polyols General overview of the process 1 October 2009: publication first batch: 94 opinions covering 523 claims adopted on 2 July January 2010: publication by EFSA of list of 621 claims for which MS have not provided by June 2009 the clarification required by EFSA (EPA entries not in because eligibility of assessment was still questioned at that time) entries withdrawn upon MS request 25 February 2010: publication 2 nd batch July 2010: publication 3rd batch? 2011: completion of work? (additional claims expected from MS) Community Register of (rejected/permitted) health & nutrition claims up and running on Sancos website but does NOT include Article 13.1 claims (Sanco is working on Regulation for permitted claims as a priority for the new Commissioner: first draft in April/May?) 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

28 Article 13.1 claims related to polyols Towards some opening of the process? EC proposed that applicants may have the possibility in certain cases (e.g. emerging evidence/conflicting evidence/insufficient characterisation of microorganisms…) to present additional data via the EC. Such option was presented to MS on 22 Feb and most of them were in principle in agreement on the possibility to allow for missing evidence or data to be provided by the operators Still under discussion.

29 Article 13.1 claims related to polyols PRO MEMORIA 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 09: 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 SCFCAH Discussion due to resume now that the new Commission is up and running

30 Article 13.1 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 chocolate 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. PRO MEMORIA

31 Nutrition claims related to polyols Proposed amendments to Annex on nutrition claims of Regulation (EC) 1924/2006: With no added sugars: « A claim stating that sugars have not been added to a food, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties except sweeteners as defined by Directive 94/35/EC. If sugars are naturally present in the food at a concentration higher than 0.5/100g or 100 ml, the following indication (should) shall also appear on the label: « contains naturally occuring sugars » Reduced [name of the nutrient] & energy-reduced claims : 25 instead of 30 %

32 Nutrition claims related to polyols Adoption procedure: comitology with scrutiny (3 months) Discussion started in autumn st amendment wrt omega 3 and unsaturated fats claims published in Feb 2010 Regulation updating the Annex : SCFCAH in March 2010 or later ( pbs in IS consultation wrt legal aspects of « comparative claims » e.g. « now 10 % sugars less » in framework of Regulation (EC) 1924/2006.) Both nutrition & health claims shall enter the Community Register:

33 Review of labelling legislation

34 Review of labelling legislation First reading (co-decision procedure) EC « Poyols means alcohols containing more than two hydroxyl groups » EP ENVI Committee Amdt 533 in draft report (H. Schnellhardt): definition of polyols « Polyols are defined as carbohydrates which are reduced mono-, di-, oligosaccharides or polysaccharides and which are listed as permitted sweeteners » EP AGRI Committee (adopted opinion) Amdt 94: « natural sugars » means monosaccharides and disaccharides naturally present in the food Amdt 95: « added sugars » mans monosaccharides and disaccharides used as sweeteners Council (on-going discussion) Polyols « covered by legislation » means alcohols containing more than two hydroxyl groups (footnote - stbc)

35 Review of labelling legislation Lobby: EPA voting recommendations sent via + post mail (with brochure on polyols) to 38 MEPs of ENVI Cttee in February, including to: Rapporteur (R. Sommer) Shadowrapporteurs Gerben-Jan Gerbrandy (ALDE, NL) Glenis Willmott (S&D, UK) Stuan Stevenson (ECR, UK) Inclusion in ELC voting recommendation to ENVI MEPs Addressed by ELC in meetings with MEPs: Sommer, Gerbrandy, Schnellhardt ELC voting recommendation sent to CIAA for information Support to revision of definition included in ELC (final) letter to Spanish Presidency

36 Review of labelling legislation Timetable – 1st reading 16 March 2010: ENVI vote 14 June 2010: Plenary vote First reading agreement with Council is unlikely 2 nd reading

37 Falsified medicine & excipients

38 Falsified medicines & excipients Proposed Directive amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products Draft Report ENVI (Matias amendt Jan 09) Pharma excipients shall be subject to the same conditions of GMP and GDP than APIs /medicinal products IPEC Europe GMP and GDP requirements for excipients should not be more demanding on the industry than the current widely-accepted IPEC-PQG GMP and IPEC GDP guidelines ELC GMP and GDP shall not be required for food grade excipients because their safety is already guaranteed by EU legislation and food certification systems CEFIC GMP and GDP shall not be required: for food grade excipients (food safety system already in place) for cosmetic ingredients (GMP guidelines already in place) for any other excipient that comply with IPEC- PQG GMP and IPEC GDP guidelines

39 Falsified medicines & excipients Additional amendments to Draft Report ENVI – 3 March: ????? Not yet available Timetable EP: 6 April: adoption of ENVI report June: adoption in EP Plenary (indicative) Council: proposed a definition for excipients (Sp. Pdcy) – not opposed to extension of the scope to excipients