This is a Pan European Union war!

1. IRISH HEALTH TRADE ASSOCIATIONWorking together towards a healthier IrelandAnnual General Meeting18 May 2011Presentation by: Alan Ruth, Chief Executive Officer

2. This is a Pan European Union war!

3. LOBBYING ACTIVITY WITH MEPs Liam Aylward, Brian Crowley and Pat the Cope Gallagher (all FF/ALDE) Marian Harkin (Independent/EPP) and Mairead McGuinness (FG/EPP) Gay Mitchell and Sean Kelly (both FG/EPP) Nessa Childers and Parliamentary Assistant (Lab/S&D) and Proinsias De Rossa (Lab/S&D) Paul Murphy (Socialist Party/GUE/NGL) Jim Higgins (FG/EPP)

4. Parliamentary Question for written answer 19 April 2011 (Mairead McGuinness) Subject: Full implementation of Directive 2002/46/EC • The Commission has recently responded to numerous parliamentary questions on the implementation ofArticle5 of Directive 2002/46/EC, relating to the failure of the Commission to produce a proposal on maximum amounts to be included per daily portion of vitamin and mineral food supplements. • This failure of implementation leads to confusion among consumers and increased costs for food supplement manufacturers faced with different rules in different Member States. This is contrary both to the intention of the directive and the spirit of the Single Market. The criteria for setting maximum amounts are set out in Article 5 of the directive: ‘Upper safe levels of vitamins and minerals established by scientific risk assessment’ and ‘Intake of vitamins and minerals from other dietary sources’. • Independent scientific safety evaluations of vitamins and minerals were completed several years ago by the European Food Safety Authority and other international scientific bodies. The Commission should therefore be in a position to fulfill its obligations under the directive. • Are there any specific issues delaying a proposal, relating to disagreement on the upper safe levels set for specific vitamins or minerals or the risk management methodology for setting maximum amounts? If so, can the Commission clearly indicate what these issues are and what is being done to resolve them? • Can the Commission provide a clear indication of when it will put forward the proposal required to secure the full implementation of a directive that was adopted in 2002?

5. Parliamentary Question for Written Answer (5 April 2011) Liam Aylward (ALDE), Pat the Cope Gallagher (ALDE) and Brian Crowley (ALDE) Subject: Regulation (EC) No 1924/2006 on nutrition and health claims made on foods • The implementation of Regulation (EC) No 1924/2006 on nutrition and health claims made on food is causing significant problems for producers working in the natural products industry. There are concerns that the European Food Safety Authority (EFSA) is applying an unsuitable pharmaceutical assessment model for the assessment of generic health maintenance claims. Can the Commission outline the methodology used by the EFSA to evaluate Article 13.1 health claims under this Regulation? • In the absence of a Commission conducted impact assessment on the consequences of the model applied, sectors of the industry (European Health Claims Alliance) have conducted their own pan-EU impact assessment on the economic consequences of the current EFSA approach to the assessment of Article 13 health claims. This study concluded that the non-vitamins and minerals section of the EU market for food supplements may decrease in size by about 25% threatening the viability of many EU businesses. Customers would also loose out because of reduced choice and potentially higher prices. • What is the response of the Commission to this industry impact assessment? What measures does the Commission have in place to ensure that this Regulation does not result in the closure of businesses and the loss of jobs in this sector? Furthermore, how can the Commission ensure that this Regulation does not result in consumers having less choice?

6. LOBBYING NORTHERN IRISH MEPs • Jim NicholsonUUP/EPP • Bairbre de Brun (SF/GUE/NGL) • Diane Dodds (DUP/NA)

7. IRELAND PUNCHES WELL ABOVE ITS WEIGHT European Health Claims Workshop for MEPs and their Parliamentary Assistants on 20 April 2011 Co-chaired by: Marian Harkin MEP (Ireland) and Boguslaw Sonik (Poland) MEPs and PAs attendance league table: Joint 1st: Ireland = 4 UK (including N. Ireland) = 4 Italy = 4 Joint 4th France = 3 Poland = 3 6th Czech Republic = 2 Joint 7th Finland = 1 Bulgaria = 1 Netherlands = 1 All other Member States = 0 MEP/PA attendees

8. THERE ARE MORE QUESTIONS THAN ANSWERS!What do you want me to do? – Gay MitchellWhat do you want me to do? – Sean KellyWhat should I do? – Nessa Childers to her Parliamentary AsstWhat do you want us to do? – Mairead McGuinness & Marian HarkinFor example, would you like me to make an appointment to see Commissioner Dalli?- Marian Harkin John Dalli – Commissioner for Health & Consumer Policy Máire Geoghegan-Quinn – Commissioner for Research, Innovation & Science Antonio Tajani – Commissioner for Industry & Entrepreneurship (former President of the EPP)

9. EVOLUTION OF KEY IHTA ACTIVITIES • Greater focus (input from SIT) for CEO >>>>>>>>>>>> • Further relationship building & influencing MEPs, IMB, FSAI , DoHC >>>> • Influencing & pushing EHPM >>>>>>>> • Sharing information internationally >>>> >>>>>Raising the IHTA profile & impact • Informing members >>>>

10. SOME THINGS I’VE PUSHED EHPM ON • Becoming more goal and objective oriented in relation to ‘key issues’ • Getting inactive national association EHPM members to take action on key issues • Developing and agreeing an EHPM European Strategy • Being more forceful in communications with the Commission and EFSA officials • Ensuring that the Health Claims Impact Assessment was carried out using a sound methodology • Getting IASDA to alert member associations to both + ve and - ve research news and issue rebuttals, much more quickly. • Getting eminent scientists to challenge EFSA’s approach to evaluating health claims • Encouraging the sharing of information between the national associations which constitute EHPM • Development of an EHPM botanical supplements strategy

11. AFTER ABOUT 3 YEARS OF PUSHING From: Elodie Lebastard E-mail dated 17 December 2010 To: All Members EHPM Subject: EHPM Strategic Plan 2011-2014 Dear Members, Earlier this year, the EHPM Board decided that it was necessary to develop a Strategic Programme for the organisation. This was subsequently developed by the Board and presented for comments at the EHPM Council of Presidents meeting in September in Brussels. Further to that discussion, amendments were made and the programme was adopted this week by the Board.

12. EHPM COMPLAINT TO EUROPEAN OMBUDSMAN (EO) • In July 2010 EHPM issued a complaint to the EO against the Commission & EFSA • The complaint challenged the decision of the EC and EFSA in relation to a batch-wise approach to the Community list of permitted Article 13.1 claims. • The complaint called upon the EO to issue a formal recommendation that the Commission should wait for EFSA to deliver all of its evaluations on the Article 13.1 claims, on grounds that the batch-wise approach being used was ‘maladministration’. • In late September the EC announced that it had revised the way it will adopt rulings on Article 13 health claims into law. • EHPM decided to withdraw its complaint because the goal of remedying batch-wise adoption of claims by the EC had been achieved >>>>>>> Avoidance of the distortion of the market that would have followed a batch-wise approach >>>>>>> New time-line provided a significant amount of time for industry to continue discussions with EC & MSs • About a year before EHPM issued its complaint to the Ombudsman, I proposed such action at an EHPM Board meeting. My proposal was rejected. It was also thought not to be a good idea by Jean Savigny (EHPM’s main legal advisor)!

13. Raising the IHTA profile in Europe

14. Raised IHTA profile within Europe • IHTA’s CEO re-elected to second term on EHPM Board • Proposal/discussion document for EHPM botanical supplements strategy • Complaint to European Ombudsman eventually made & was successful • In April 2010, the EP Petitions Committee agreed to keep open, the IHTA’s petition questioning the Commission’s proposal to limit maximum levels. • Leading scientists (from Europe & U.S.) now “challenging” EFSA ‘s approach to evaluating Article 13.1 claims. I pushed EHPM to use U.S. scientists over a year previously. • More strategic thinking by EHPM – “strategy’ is now in the “inner circle’s” vocabulary • Invitation to dinner from Marjan Willaert (President, NAREDI, Belgium) to discuss common concerns • Request from Massimiliano Carnassalle, Secretary General, FEDERSALUS to place IHTA Briefing Notes on their website • Request from Camil Rodino (Secretary General, Afepadi, Spain) to visit Ireland to meet with me • Regular communication and assistance from: a Spanish Professor of Food Law, a Spanish Food Law Consultant, and other European colleagues.

15. ACTIVITIES WITH THE IMB

16. ACTIVITIES WITH THE IMB 2 IHTA Herbal sub-committee meetings (August & September) 2010 - To formulate an IHTA ‘consolidated’ response to 3 documents published on IMB website i.e. (1) List of plant substances not permitted in foods or food supplements (draft guide) (2) List of herbal substances which may be acceptable for inclusion in food supplements (draft guideline) (3) Herbal medicines on the Irish market 2010 • IHTA submission presented to IMB on 29/9/10 requested 49 substances be added to “positive” list • IMB revised “positive” list had 99 substances added • IMB revised “negative” list had 54 substances added

17. ACTIVITIES WITH THE IMB • On 28 March – sent request/submission to IMB to add 21 herbal/plant substances to IMB revised list dated 1 March of Herbal substances which may be acceptable in FSs • Cited ‘Homeostasis Model’ and dosage • Cited Belgian Royal Decree of 29 August 1997 • Cited Hungary as going the dosage route • Cited & provided link to ‘It’s the Dosage, Stupid …..’ article • Provided evidence for the food/culinary use of the 21 substances

18. Dr. Mike Morris’s reply • I have had a look at your proposals and would not necessarily disagree with them. I intend to seek opinion of our expert sub-committee in this regard. • I cannot see a problem with substances that are clearly culinary herbs. • However, I do have a problem with the whole concept at this stage. The lists were established to try to distinguish medicinal from food herbs, and as you say, there is often not a clear separation because the outcome is product specific. • Furthermore, the positive list is very much open ended, since there are potentially thousands of herbal substances which can be, and are, used in foods. • My biggest concern is that the IMB does not regulate foods, and it becomes the responsibility of the FSAI. I would like to see them take over this list and will be suggesting this to them. • The IMB list does not delineate what the FSAI could accept as a food supplement. • Consequently, my preferred option is not to extend the positive list further since it cannot cover everything, but rather to identify a list of herbal substances which might be acceptable for THMPs, as opposed to those that would not. I would welcome your thoughts on this approach.

19. IHTA Submission to IMB re vitamin B12 • In Summer 2010, FSAI wrote to several IHTA companies re products containing ingredients “considered medicinal substances in Ireland” • Vitamin B12, at a daily dose of above 25 mcg, was one of these • IHTA made a very detailed written submission to IMB requesting that food supplements containing a very much higher daily dose be permitted without prescription • Submission highlighted a number of international comparisons, to strongly make the point that 25 mcg is a very low dose of B12 to act as a prescription threshold. Response from Dr. Mike Morris: Dear Alan, Thank you for your e-mail, received also in hard copy. I have sympathy with the points you raise but fundamentally the hands of IMB are tied by the prescription legislation – this is the property of DoHC not IMB. I will revert to you as soon as I can with a more substantial response to the points you make in your very helpful letter. Yours sincerely, Mike

20. IMB Sell-through period for unregistered products (THMPs) come 1 May? • Proved to be a bit of a saga beginning mid-December, when I first raised the question • Over the following months, I persevered for an answer • Mike Morris provided information bit by bit • I shared this with members and the IAHS as and when it became available • Eventually the IMB decided to host a meeting on 31 March – to clarify the IMB’s approach to THMPs when the transition period ends on 30 April. • The IHTA learned about this meeting on 28 March (3 days in advance) and informed members immediately. • Notes on the meeting were made available to IHTA members

21. ACTIVITIES WITH THE FSAI

22. ACTIVITIES WITH THE FSAI 25 May 2010 – FSAI Health Claims Seminar Speakers (regulators): - Prof. Albert Flynn (EFSA), Dr. Mike Morris (IMB) Dr. Mary Flynn (FSAI), Dr. Sarah Burke (FSAI) Speakers (industry): - Dr. Judith Bryans (The Dairy Council, UK) - John Redman (Group MD, Merck Consumer Healthcare, UK) & Vice-Chair HFMA) Booklets: • Information on Nutrition & Health Claims (April 2010) • Guidance Notes: Food Supplements Regulations and Notifications (Revision 1)

23. ACTIVITIES WITH THE FSAI • In February 2011, requested that the list of food supplements notified to FSAI be placed on FSAI website Initial response from Dr. Mary Flynn: - expressed concern re protecting information confidentiality for FBOs - need to consider products notified as FSs which the FSAI referred to IMB - need to explore if any downsides for FBOs by sharing list of names & products notified • Mary phoned me end March to say that FSAI would act on our request • E-mailed me on 8 April – FSAI had become aware of legal issues which may prevent compliance with our request

24. Position paper on to Food Information to Consumers • Last month I sent Dr. Mary Flynn and Anne Marie Boland the IHTA’s position statement regarding the future Regulation on food information to consumers. • The minimum font size of respectively 1.2 mm and 0.9 mm for packages of less than 60 square cms, proposed by the Council under article 13.2 and 13.s is impractical and a disproportionate burden for manufacturers, in the case of FSs and other specialist health products. • Strongly support the amendment , already introduced by the EP at 1st reading, regarding the exemption from providing all mandatory particulars in article 16.2 for packages/containers with the largest printable surface of < 80 square cms • Should the EP adopt an approach requiring a mandatory font size, we believe that any such requirement would have to be proportionate and take due account of a number of points made in the IHTA position. • Support was expressed for 2 proposed amendments i.e. (1) No mandatory font size labelling, (2) Mandatory font size of 1 mm or less • Opposition to any amendment requiring a mandatory font size of more than 1 mm

25. TARGETED IRISH GOVERNMENT MINISTERS • Minister Roisin Shortall TD (Minister for Primary Care, Department of Health) • Minister John Perry (Minister for Small Business)

26. THANK YOU FOR YOUR ONGOING SUPPORT