We are asking European citizens to respond as soon as possible to this. Exercise your democratic rights. Write to your MEP - now (at least before end-March 2004)!

The Commission's proposed Nutrition and Health Claims Regulation constitutes, we believe,at least as much of a threat to the availability and supply of leading-edge food supplements as the EU Food Supplements Directive.

However, if many of you write to your MEP, the legislation could be blocked, or at least slowed in its progress through the judicial system, so that ANH and others can work to ensure more amendments are made to the legislation.

This release is divided into two sections; the first is Issues Identification (which includes a section of suggested issues to include in our letter writing campaign to Members of the European Parliament [MEPs]), the second is a Briefing Document, providing further background to the Nutrition and Health Claims Regulation.

ISSUES IDENTIFICATION: HEALTH CLAIMS REGULATION

To read the full Regulations, please click here and then click on the link to the right of the section entitled 'Initial Proposal', given as COM(2003)0424.

1. Who does this Regulation affect?

This Regulation does not just affect supplement manufacturers, but all business' that are in any way involved in the passage of products or supply of promotional information to the final consumer. Therefore this includes any marketing or distribution activities of wholesalers, retailers, and practitioners where specific products are recommended to clients.

2. Definition of a Health Claim Requiring EFSA approval

Whilst no product will be forced to withdraw from sale, no statement may be made on either the product label, any advertising, promotional or educational material that in any way links a nutrient or food component with normal body processes or physiology without first being approved by the European Food Safety Authority. This approval must be of the exact word form and context, both written and visual, that is intended to be used. In other words, EFSA must approve even simple statements of fact such as ‘Vitamin C is an essential nutrient in supporting Immune System Health'. The context of such a statement in any promotional piece, advertising or packaging must also be approved and may not be altered in any way without re-approval.

We believe that this aspect of the regulation serves no positive purpose towards either EU harmonisation or consumer safety, and will only serve to limit consumer education and understanding of the role of nutrition in health. That all statements used in labelling and promotion should be honest, truthful and fully substantiated is not at issue. Evidence should be available to the authorities on demand, but the proposed approval requirements for this level of claim and the costs proposed are excessive and produce no discernible benefit to either the consumer or businesses.

3. Positive list of nutrient/ normal function claims

A UK positive list is being developed for approximately 200 basic nutrient/physiology claims whilst many thousands of such interactions are already accepted and proven nutritional facts. Industry must pay for further additions to the positive list at an estimated cost of £20,000 per claim. The financial implications of this degree of beurocracy are vast, and beyond the means of most business' operating in this sector. This provision means that much valuable information will be withheld from the consumer and will limit the ability of consumers to make informed and reasoned choices about their nutrition, health and well-being.

4. Enhanced Function & Disease Risk Reduction Claims

Enhanced function claims & disease risk reduction claims will be required to go through a costly and complex process with a degree of substantiation similar in many aspects to that required of medicines approvals. Existing study data in population groups that are not representative of populations as a whole may be deemed inadequate and too short term in duration to be accepted. This is a significant threat not only to many claims for existing products but especially to innovation and new product development. We wish to ensure that such evidence can be used in substantiation.

5. Some claims are to be banned even if they are scientifically proven beyond doubt

Some claims which are believed ‘not to be easily understood by the average consumer' or ‘vague and meaningless' will be specifically banned even though they are true. Provision of additional material to facilitate understanding is also prohibited.

A specific example quoted in the Regulation of such a banned claim is that of the role of folate supplementation in the ‘normalisation of homocysteine levels'. Many 1000's of studies now show that homocysteine is an important risk factor and marker in Cardiovascular Disease. How can such restrictions of information benefit Consumers or add to the health and well-being of our populations? How does communication of such benefits and explanation of their importance in nutrition and health in any way cause harm to consumers?

This provision is nonsensical and any claim that can be proven should be allowed.

5. So we may not be able to make any claims for products - why is this such a problem for supplement supply and consumer choice?

Few companies will be able to meet the requirements of this Regulation for financial reasons alone rather than a lack of evidence or a scientific basis to support claims. The consequences to every business in the alternative and complimentary health sector are enormous.

Who will place advertisements if you cannot say what a product is for, nor what role a food component has in normal physiology? Who will buy products if Consumers do not understand their use or benefit and no materials exist to allow them to find out? How many small and medium companies can survive and continue if they may no longer promote their products effectively? How will companies continue to educate health practitioners and update them on the latest scientific developments and any safety or other issues?

In view of the increased costs facing manufacturers from FSD and THMPD, many suppliers will simply go out of business. In effect this will remove large numbers of products from the market and reduce consumer choice, as well as removing a valuable channel of consumer health education. The knock on effects of all these factors are a threat to retailers, distributors, media companies, and practitioners alike especially if a significant part of their income relates to sales or recommendations of health food products and supplements.

The time to act is now!

European citizens, please write to your MEP immediately!

Click here if you are a UK citizen, to find your MEP.

Non UK citizens, click here to find your MEP.

Objectives of this letter-writing campaign

• To prevent MEPs merely ‘rubber stamping' the Environment Committee recommendations and, at the very least, force the Regulation to a second reading to give added time for the campaign to lobby MEPs and get substantial alterations made to this Regulation.
• To delay the passage of this Regulation so that it is returned to the Committee Stage for proper consultation and a review of the financial impacts on Small and Medium sized enterprises. Affected businesses include the Health Food and Supplement Sector, as well as retailers, media, distributors & marketers and practitioners. If this delay can be achieved, the Regulation must return to consultation after the elections to include the views of the Accession countries. This will allow further amendments to be tabled and considered.

MEP letter writing campaign

It would be extremely helpful if you can make your opinions known via the written word to your MEPs.

You can find your MEP by clicking on the followinglinks:

Click here if you are a UK citizen.

Non UK citizens, click here to find your MEP.

In your letters you may wish to:

• Highlight the lack of proper consultation - if like many people you have only just become aware of this Regulation and its full impacts to your business or practice, please state this.
• Ask your MEP to request further information from the Commission of the Regulatory and Financial Impact on small and medium sized business' to demonstrate that this has not been properly carried out; highlight how you feel the Regulation will affect you.
• Ask your MEP to query the ability of the European Food Safety Authority (EFSA) to cope with the approvals this Regulation will demand, and,

- highlight the added workload and costs of complying with this Regulation for your business or practice

- State if the claim/ promotional materials requirements set out are achievable for your business. If not, what will the financial implications be for yourselves if you cannot promote/ market products (your own or other suppliers if you are a distributor).

- If a supplier, what are the anticipated costs of re-branding (product names are included in the Regulation) and re-labelling, and are these achievable? What will the loss be to your business from removing existing Brand Names that imply a health claim or indication for use?

• Express your views on how you think consumer choice and health education will be adversely affected by the Regulation.
• Ask your MEP to vote against this Regulation and return it to the committee stage for further consultation and amendments. This will allow ANH and other organisations working to modify this Regulation to find workable solutions that address parliamentary concerns whilst ensuring that the field of health and nutrition does not become the sole preserve of multinational corporations and pharmaceutical companies.

Other Guidance

We recommend that letters are hand-written for maximum impact, and directed to your MEP,preferably copiedto your MP. We would be grateful if you would also send ANH a copy (preferably by email, to [email protected]) so the size of the response across Europe can be gauged.

BRIEFING DOCUMENT: HEALTH CLAIMS REGULATIONS

Who does this Regulation affect?

This Regulation does not just affect supplement manufacturers, but all business' that are in any way involved in the passage of products or supply of promotional information to the final consumer. Therefore this includes any marketing or distribution activities of wholesalers, retailers, and practitioners where specific products are recommended to clients.

Definition of a Health Claim Requiring EFSA approval

Whilst no product will be forced to withdraw from sale, no statement may be made on either the product label, any advertising, promotional or educational material that in any way links a nutrient or food component with normal body processes or physiology without first being approved by the European Food Safety Authority. This approval must be of the exact word form and context, both written and visual, that is intended to be used. In other words, EFSA must approve even simple statements of fact such as ‘Vitamin C is an essential nutrient in supporting Immune System Health'. The context of such a statement in any promotional piece, advertising or packaging must also be approved and may not be altered in any way without re-approval.

We believe that this aspect of the regulation serves no positive purpose towards either EU harmonisation or consumer safety, and will only serve to limit consumer education and understanding of the role of nutrition in health. That all statements used in labelling and promotion should be honest, truthful and fully substantiated is not at issue. Evidence should be available to the authorities on demand, but the proposed approval requirements for this level of claim and the costs proposed are excessive and produce no discernible benefit to either the consumer or businesses.

Positive list of nutrient/ normal function claims

A UK positive list is being developed for approximately 200 basic nutrient/physiology claims whilst many thousands of such interactions are already accepted and proven nutritional facts. Industry must pay for further additions to the positive list at an estimated cost of £20,000 per claim. The financial implications of this degree of beurocracy are vast, and beyond the means of most business' operating in this sector. This provision means that much valuable information will be withheld from the consumer and will limit the ability of consumers to make informed and reasoned choices about their nutrition, health and well-being.

Enhanced Function & Disease Risk Reduction Claims

Enhanced function claims & disease risk reduction claims will be required to go through a costly and complex process with a degree of substantiation similar in many aspects to that required of medicines approvals. Existing study data in population groups that are not representative of populations as a whole may be deemed inadequate and too short term in duration to be accepted. This is a significant threat not only to many claims for existing products but especially to innovation and new product development. We wish to ensure that such evidence can be used in substantiation.

Some claims are to be banned even if they are scientifically proven beyond doubt.

Some claims which are believed ‘not to be easily understood by the average consumer' or ‘vague and meaningless' will be specifically banned even though they are true. Provision of additional material to facilitate understanding is also prohibited.

A specific example quoted in the Regulation of such a banned claim is that of the role of folate supplementation in the ‘normalisation of homocysteine levels'. Many 1000's of studies now show that homocysteine is an important risk factor and marker in Cardiovascular Disease. How can such restrictions of information benefit Consumers or add to the health and well-being of our populations? How does communication of such benefits and explanation of their importance in nutrition and health in any way cause harm to consumers?

This provision is nonsensical and any claim that can be proven should be allowed.

So we may not be able to make any claims for products - why is this such a problem for Supplement Supply and Consumer Choice?

Few companies will be able to meet the requirements of this Regulation for financial reasons alone rather than a lack of evidence or a scientific basis to support claims. The consequences to every business in the alternative and complimentary health sector are enormous.

Who will place advertisements if you cannot say what a product is for, nor what role a food component has in normal physiology? Who will buy products if Consumers do not understand their use or benefit and no materials exist to allow them to find out? How many small and medium companies can survive and continue if they may no longer promote their products effectively? How will companies continue to educate health practitioners and update them on the latest scientific developments and any safety or other issues?

In view of the increased costs facing manufacturers from FSD and THMPD, many suppliers will simply go out of business. In effect this will remove large numbers of products from the market and reduce consumer choice, as well as removing a valuable channel of consumer health education. The knock on effects of all these factors are a threat to retailers, distributors, media companies, and practitioners alike especially if a significant part of their income relates to sales or recommendations of health food products and supplements.

Conclusion

With your help, we can get this Regulation returned to consultation and gain amendments and modifications that will both provide the degree of consumer protection sought by the Commission, and ensure that new product developments capitalising on developing scientific knowledge are protected.

Please act NOW!