European Food Supplements directive - an industry perspective

The EU food supplements directive has been approved in second reading in the EU Parliament on 13 March 2002, with only one proposed amendment, which is the extension of a time limit contained in the directive for submitting dossiers for the approval of vitamin and mineral sources not yet included in the appendix to the directive. There was heated discussion and opposition by MEPs mainly from the UK, Ireland, the Netherlands and Sweden. The result of the vote however, 139 against the directive, 383 for it, and 19 abstentions was in favour of controlling supplements.

The text that was discussed and passed can be found at http://www.laleva.cc/supplements/c5-0640-01_en.pdf

Vitamin and mineral sources found on the market but not included in the appendix of the directive are about 300 (mainly the more advanced mineral formulations) are posted at http://www.laleva.cc/supplements/forgotten_substances.html

Two are the points most likely to influence industry at this point.

Dosages

The directive mandates that maximum dosages shall be set after consultation of the European Scientific Committee for Foods (SCF). The actual decision however is left to administrative action by the European Commission, which is a kind of rudimentary government for the European Union. There is a large margin of discretion in this setting of dosage limits, as article 5 of the directive states that dosages should be set with regard to safety, but after considering intake of vitamins from other sources than supplements (i.e. from food) and after taking due account of the recommended daily intakes (RDI). So there is really no telling yet where the mood will swing on this, the rules can be interpreted in a variety of different ways.

Ingredients

The directive establishes lists of vitamin and mineral sources that may be utilized in the formulation of supplements. The first draft list, which is an annex to the text of the directive, lists - especially for minerals - the most ineffective forms from a viewpoint of bioavailability, forms which have for years been used in pharmaceutical drugs and in dietetic products. To add a vitamin or mineral source to the list, a scientific dossier needs to be submitted to the Scientific Committee for Foods. There are strict requirements, including toxicological assays, for these dossiers, which were laid down by the SCF. The following is a reference to the published requirements which shows that expensive toxicological assays are needed for the approval of any substance:

The guidelines of the SCF "Guidance on Submissions for Safety Evaluations of Sources of Nutrients or of other ingredients proposed for use in the manufacture of foods" (SCF/CS/ADD/NUT/21 Final) http://www.europa.eu.int/comm/food/fs/sc/scf/out100_en.pdf state in point 3.5:

"3.5 Toxicological Data on the source:

3.5.1 The available data should be submitted in the first instance. The extent of the data needed will depend on safety considerations in relation to the fate of the source in the body. Any deviations from requirements already established for food additives (SCF, 2001b) should be justified."

The guidelines for the evaluation of food additives "Giudance on Submissions for Food Additive Evaluations by the Scientific Committee on Food (SCF/CS/ADD/GEN/26 Final) http://www.europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf state: "In general, this guidance is intended to apply to the evaluation of a proposed new food additive, or to the re-evaluation of an already approved food additive, directly incorporated into food and fulfilling a defined technical purpose".

The Annex of these guidelines (starting on page 22) discusses the detailed considerations underlying the core toxicological studies required by the SCF for food additive submissions to the European Commission.

.........Page 23/24
II. Core Studies (c) Genotoxicity
"Food additives should be evaluated for genotoxicity in order to assess their mutagenic
and carcinogenic potential.....

The basic battery of tests

In general, the SCF requires a battery of three in vitro genotoxicity tests for foodadditives......

For test methods, it is recommended that OECD protocols be used. The OECD has
recently updated six relevant guidelines and introduced a new one. The revised
guidelines provide guidance for the conduct of tests in vitro for the detection of gene
mutations in bacteria (8) and in mammalian cells (9), for the detection of chromosomal
aberrations in mammalian cells (10),...... in rodent bone marrow........ The new guideline
concerns the in vivo/in vitro assay for the detection of UDS in rat liver (14). The same
updated test procedures are proposed for adoption as official test methods by the
European Union."

..........Page 25
"Other test procedures, such as the comet assay, or tissue specific mutations in transgenic
animals may provide additional useful information on the genotoxic and carcinogenicpotential of a food additive."

In conclusion, the required tests are for all intents and purposes the same as those required for potentially toxic additives and will require a major investment on the part of the health food industry for every substance to be kept on the market. Exempted are those substances already on the market for decades in Europe, produced by the larger pharmaceutical manufacturers and used in pharmaceutical drugs, as they are on the "original list" already attached to the directive.

Timing
After having been approved by the European Parliament on 13 March, the directive will now require between two or three months before being ready for final issue by the European Council of Ministers. Member states will then have a time limit within which to issue their own laws to put the directive into effect. This is normally a year. Several member states seem eager however to implement the directive and are preparing national laws for this, to issue in the months following official publication of the directive, during the summer of this year.

Member states have the faculty of leaving the national situation as is, putting into effect only the provisions on labelling, until the (EU) administrative decisions on dosages and allowed substances force changes by eliminating certain higher dosages or disallowing the use of substances in case a dossier is given a negative response.

The changeover will occur gradually from the summer of 2002 for up to seven years, always leaving some leeway to national authorities to be tolerant and keep allowing on the market things that have been allowed so far, or to be restrictive and not allow on the market certain substances and dosages.

There will be a time limit of anywhere between 18 and 36 months (to be determined in negotiations between the EU Parliament and the Council of Ministers) for the submission of scientific dossiers for vitamin and mineral sources now on the market, to be added to the list annexed to the directive.

A substance will have to be taken off the market

- in case no scientific dossier has been filed within the time limit (18/36 months)
- if and when the SCF has given an unfavourable opinion against it's use

Single market
The directive aims to establish a single market for supplements in Europe and it will gradually force member states to accept products sold in other member states that are in compliance with the directive and the successive administrative decisions, as well as to forbid products that are not in compliance. Seven years is the maximum delay for accepting products that comply and for forbidding products that don't.

Uncertainty
There are major uncertainties on dosages to be permitted in the future as well as on the costs for the preparation of scientific dossiers for the approval of substances. But even in the face of these uncertainties it would seem that industry one way or another can adapt, a stance that has been taken by most of the European producers.

But there is more to be considered . . .
There are at least two other legislative proposals already in the works at the European Union which are likely to negatively influence supplements.

The first one is a proposal for the medicinal registration of herbal products. This has been proposed by the European Commission and it appears to be an attempt to extend to the rest of Europe the restrictive German system, where all herbal products are registered medicines (but not restricted to sale in only pharmacies). European industry seems set to oppose that proposal. The time frame is about two years to approval of a directive, if it does advance as planned.

The second legislative proposal is even more insidious. It is a general rivision of the European medicines code and one of the proposed changes is a change in the definition of what constitutes a medicinal product. If the current definition seems all embracing, the proposed changes would seem to incorporate any substance that can be used for purposes of staying or getting healthy, even if not presented in this way. It would also affirm a new principle, that a product can be considered medicinal if it fits the (very extensive) definition, even if it is already subject to other community legislation. Translation: Any health product that turns out to become serious competition to a pharmaceutical product could be picked out and reclassified a medicine, practically without any possibility of legal recourse.

There is also a European directive already in effect, which requires the scientific evaluation (based on a dossier of scientific tests and data) of any food ingredient or food substance that was not already on the market before a certain date (1997 I believe). This novel foods directive was first intended to serve for the evaluation of transgenic foods, but is applied to ANY substance new on the market. Stevia, a plant based sweetener that is in competition with pharmaceutically produced artificial sweeteners, is one example of a novel substance that has been kept off the European market by non approval of a dossier under the novel foods directive.

It would seem that an evaluation of the impact of the food supplements directive should not be done without considering these other pieces of legislation, two in preparation and one already in effect.

Innovation - the noose is tightening
It should be clear that - seen as an organic whole, the recent and ongoing EU legislative changes in the field of supplements, herbs, foods and medicine will hit the supplements industry in its most vulnerable area, reducing the critically important capacity to innovate. If the legislative trend continues in it's present course, innovation of natural and nutritional products will be extremely difficult if not impossible for smaller companies. The costs involved will slow innovation down to the pace of the biggest players, which notoriously have been reluctant to allow any changes in the status quo.

In this context it should be noted that the European directive on supplements mandates that within five years from now, a review should be undertaken with a view to subjecting other categories of ingredients (not only the currently contemplated vitamins and minerals) to the same treatment of requiring scientific dossiers and eliminating any substances that do not pass.

So there seems to be a noose tightening around the collective necks of the health food industry from European regulatory action. It is a very slowly tightening noose, but it is tightening nevertheless and it appears to be inspired by - this is a suspicion not backed by hard evidence - the pharmaceutical producers who are currently "wiggling their way into" the health food business by way of acquisition of companies and by shifting the emphasis from traditional supplements to "functional foods" and "nutraceuticals".

The great unknown - CODEX ALIMENTARIUS
Another ominous development on the horizon is a Codex Alimentarius guideline very similar to the European Union's directive on food supplements. This may, in time, become even more important than the EU directive, which affects commerce only inside the European Union.

Codex guidelines are a reference in international trade disputes have world wide validity. Countries may be forced into compliance with such rules by the mechanism of trade sanctions. The procedure is more or less like this: A country believes its industry is harmed by another country's treatment of its products. It appeals to the WTO (World Trade Organisation) for relief. The WTO hears the case in a Dispute Settlement proceeding, and the losing country is asked to comply to the wishes of the one who complained. If the losing country still refuses to comply, trade sanctions (punitive tariffs) are normally used to force compliance.

Use of such a mechanism to force a change in a country's vitamin laws seems a remote possibility but cannot be completely discounted.

Trans Atlantic Harmonisation
The more likely scenario for harmonisation of rules between the US and Europe however, is industry driven harmonisation as presently discussed in TABD, the Trans Atlantic Business Dialogue. This industry body has much clout with regulators on both sides of the Atlantic. It is made of of the chief executives of multinational companies and some industry associations. TABD has a dietary supplements working group which discusses how to harmonize the laws between the EU and the US, all in the name of trans atlantic trade.

Such harmonisation may bring relief to the beleaguered European health product scene, but it may also bring strictures to the US market, if not by legislation, then by voluntary harmonisation of the market.

Is the health food industry already "sold"?
There certainly is a very active movement of consumers, alternative practitioners and small enterprises opposing the "strategy of a thousand cuts" that is decimating not only our health options but our personal freedoms of choice as well. This movement will continue to grow as awareness of the planned restrictions becomes felt at the personal level. The question that now needs to be answered is, whether this movement will have the support of industry or whether our industry has already been sold. The answer will determine how the fight continues.

14 March 2002Josef Hasslberger
[email protected]