ELC Annual General Meeting 16 May 2006, Brussels

The FIA package Purity criteria – draft amendments Re-evaluation of food additives Amendment to Directives 95/2 and 94/35 REACH New Regulation on organic products GM legislation Food additives used in feed CCFAC 2006

17 February 2005: new working document-Revision February 2005: WP on food additives – presentation of the new document 31 March 2005: ELCs specific comments 15 July 2005: ELCs additional data on economic impact of change of PA definition July 2005: informal interservice consultation Autumn 2005: formal interservice consultation Commission proposals Package food improvement agents released mid-June??? Later??? Draft proposal on food additives

Commission WP 15 May Translation of the FIA completed – but still one technical problem Commission meeting on 18 May to discuss an acceptable solution to that problem If problem solved: the related text section will have to be translated Proposal published by mid-June If no agreement: ????? Indication that Sanco would seriously think to a 7th amendment to MAD Draft proposal on food additives

Package on food improvement agents Draft proposal on food additives Regulation Common Authorisation Procedure Regulation Food Additives Regulation Food Enzymes Regulation Food Flavourings

Structure 4 Chapters I – General provisions II – Placing on the market of foodstuffs containing a food additive III – Labelling IV – Other provisions 4 Annexes I - List of functional classes of food additives II – List of existing additives III – List of additives in additives and enzymes IV – List of foodstuffs considered as traditional where certain categories of additives are prohibited Draft proposal on food additives

Pros COMITOLOGY! Streamlining the authorisation procedure Centralised legislative reference for additives Possible remaining general problems Conflicts in timing? Additives in additives Need to extend authorisation of non QS additives for their use in additives and enzymes Transfer of existing lists not so clear: working group Draft proposal on food additives

Commission WP 15 May – presentation of the WG Aims Developing a suitable Food Category System Ensuring a correct transfer in the positive list Reviewing the uses – remove if not used Members Belgium – Norway – Denmark – Greece? – Germany? ELC CIAA Draft proposal on food additives

Commission WP 15 May – presentation of the WG Timing To be finalised in about 4 years max. (2 years adoption + 2 years to transfer the list) 1st meeting: autumn – e-meetings + physical meetings Frequency: every 3-4 months Draft proposal on food additives

Lobbying strategy EP: support the Commission proposals COMITOLOGY! Coordination with AMFEP-EFFA-CIAA (CIAA meeting on 15 June – even if FIA package not published) Council: ask for specific/technical amendments Active involvement of ELC members is paramount SHARING THE INFORMATION IS ESSENTIAL! Draft proposal on food additives

Calendar Assuming publication Commission proposal: June EP 1st reading: first discussions in autumn 1st reading mid-2006? Council: first discussions in July ??? Draft proposal on food additives

Commission WP 15 May Draft amendment to Dir. 96/77/EC (Misc. additives) Draft amendment to Dir. 95/31/EC (Sweeteners) Results Almost 100 % finalised on 15 May (remaining: minor technical points + sucralose) Almost all ELC comments included Will be proposed for voting at the SCFCAH in September (too late for the SC on 23 June) Amendments to purity criteria

Re-evaluation of food additives EFSA – AFC panel December 2004: call for tender for a service contract concerning the preparation of reports on existing data for colours 24 Feb 2006: Contract signature (2)! Award: Centre for Substances and Integrated Risk Assessment (NL) February 2006: Commission provided EFSA with 10 natural colors + 10 synthetic colors for review 2006 EFSA: good willingness to discuss with industry? REQUEST FOR INTAKE DATA

Re-evaluation of food additives Exposure assessment – Possible impact of the intake assessment of feed additives FEFANA project on intake assessment of feed additives explained at the ELC GA November 2005 ELC meeting with FEFANA on 27 January Impact limited to food additives with ADIs, which are used in feed: « sharing ADIs » develop a close cooperation between FEFANA and the food additive sectors that are indirectly involved in the feed additive intake assessment, to make sure that it will end up with realistic data rather than with an overestimation that might be detrimental both for food and feed applications.

Re-evaluation of food additives Exposure assessment – Possible impact of the intake assessment of feed additives Proposals for common action with FEFANA urge the EFSA Scientific Committee to be more ambitious in the development of a complete EU food consumption database: already supported by ELC. alternatively, ask EFSA to assess the uncertainty linked to the use of the UK food consumption data as a European model (i.e. weighting of the UK data by a uncertainty factor when they are considered as EU representative) ??? fight the principle that the consumption of the additive should be well below ADI, with no definition of what well below actually means ???

Calendar 6th amendment adopted in 1st reading: 26 Oct 2005 No 2 nd reading Council adoption in June (Health Council – point B) Final adoption:????? Expected entry into force: 18 months after publication in OJEC 6th Amendment to Directive 95/2 (Miscellaneous additives)

Position ELC Support CIAA : exclusion of food and feed from general scope (Title I) Exclusion of food additives from general scope (Title I) REACH

1st reading EP Food and food additives excluded from scope of REACH in ENVI Cte vote on 4th October 2005 Compromise amendment voted in plenary on 17 November 2005 – food additives in the scope but excluded from registration and other major titles REACH

Council 1st reading Council political agreement 13 December 2005 – essentially in line with EP plenary vote Common position still to be adopted – Competitiveness Council May? REACH

2 nd reading - future Position of the Commission: support for Council compromise DG Environment: food out of scope DG Enterprise: supports Council EP 2 nd reading: PES (Mr Sacconi) reluctant to amend the scope, other issues have priority The institutions aim at adopting REACH in 2 nd reading REACH

ELC – new position? Limited political interest in scope in 2 nd reading: Food likely to remain in scope (Title 1), but exempt from all major titles Lobby still useful? Ask Commission for clarification/ interpretation of current wording? REACH

Calendar Commission 21 Dec 2005: adoption of the Comm. proposal for a Council Regulation on organic production and labelling of organic products 23 March 2006: DG Agri Standing Committee on organic farming draft Regulation amending Annex VI to Council Regulation 2092/91 New Regulation on organic products

Council March: Council WP on organic farming 20 April: Council WP on organic farming EP 30 May: EP AGRI COM – discussion on draft opinion (consultative) 13 June: adoption in EP plenary 19 June: Council political agreement? New rules proposed to apply from 1 January 2009 New Regulation on organic products

Content An answer to the conclusions of the Council of October 2004 on the European Action Plan for organic food and farming of June 2004 Concerns for ELC 1. Definition products produced by GMOs 2. Future of Annex VI of the current Regulation (EEC) 2092/91 3. The bio labelling New Regulation on organic products

Definition products produced by GMOs means food and feed additives, flavourings, vitamins, enzymes, processing aids, […] produced by nourishing an organism with materials that are in whole or in part GMOs. No comment on it at this stage, in line with CIAA. Nevertheless, creates a dangerous precedent in the legislation! New Regulation on organic products

Future of - to date – authorised ingredients of non-agricultural origin and PA in the future Regulation (Annex VI of Reg. 2092/91) Maintaining the current practices (certain additives, micro-organism preparations…) Take the opportunity to put an effective EU harmonisation, since it has not been completed yet (the use of certain additives still governed by MS) March: supported CIAA draft position accordingly New Regulation on organic products

The bio labelling Restriction to the use of the term bio in labelling of non-organic products Bio = of biological origin versus Bio = organic Pb for existing registered brands Potential source of confusion since this restriction does not apply to products that clearly cannot be associated with agricultural production March: asked CIAA to revise its draft position accordingly – but not taken on board New Regulation on organic products

Importance of the lobby at national level – Council representatives New Regulation on organic products

Status of fermentation products – GMMs Regulations 1829/2003 & 1830/2003- before 7 November 2005, the Commission shall forward to the EP and the Council a report on the implementation of these Regulations 2005: ELC comments on Commission Questionnaires re. Implementation of Reg. 1829/2003 and 1830/2003 May 2006: report 1830/2003 – just published report 1829/ still expected Status of fermentation products (GMMs kept under contained use / nutrients) to be clarified??? Doubtful: SCFCAH 24 Sept GM legislation

Reg. 1831/2003 – notification 7 Nov. 2005: publication of the Commission Register of existing feed additives, further to their notification by manufacturers before Nov still legally present on the market vs informative list? Format of the list Before 7 Nov : submission of an application for authorisation of the notified additive to Commission and EFSA, on the basis of detailed guidelines/guidances Notification of feed additives

Calendar Guidelines from the Commission: mid-summer? Guidances from EFSA: already worked on certain documents Food additives used as feed additives: EFSA more strict than the Commission? Notification of feed additives

In preparation of this 2006 meeting, ELC member of : e-WG on revision of the principles of GSFA Key issue for ELC: defend possibility of exceptions to the general principle that additives with ADI specified should have numerical limits. PRINCIPLE INCLUDED in the proposed procedures for consideration of the entry and review of food additive provisions in the GSFA. Will be forwarded to the CAC, through the CCGP, for inclusion in the Procedural Manual. e-WG on GSFA Quality Control Priority Additives: ELC channelled comments for several members. CCFAC 2006

Additionally, written comments provided on: Revision of class names and INS (CL 2005/32-FAC) Additional revisions to INS (CL 2005/38-FAC) Now different INS for Tagetes extract (E161 b i) and lutein from Tagetes extract (E161 b ii) CCFAC 2006

In preparation to CCFAC 2007, ELC is member of: e-WG for consideration on relevant amendments to the Procedural Manual For monitoring purposes mainly. eWG on GSFA Quality Control (priority additives) Possibility to channel comments from ELC members CCFAC 2006

Commission WP 15 May Future strategy – priority additives Pay attention to WTO rules Not enter too much into details – give some flexibility whenever possible WG to support Sancos work: F – UK – SP? CCFAC 2006

The new Committee CCFAC to be split in 2 parts from 2007: contaminants / additives. Hosting country for additives from 2007? China??? Name of the new Committee? CCFA??? More information at CAC meeting in July 2006 CCFAC 2006