Health Alliance To Test European Supplements Directive
CategoriesMarch 2007 - The Alliance for Natural Health (ANH) has filed fifteen applications to add natural forms of vitamins and some minerals to the lists of ingredients that may be used in the manufacture of supplements according to the European Union's Food Supplements Directive. The applications, to be evaluated by the European Food Safety Authority, are seen as a test of the European Commission's procedures for extending the "allowed ingredients" lists appended to the directive, which sharply limit the compounds that may serve as sources of vitamins and minerals in supplements.
Previously, the ANH had challenged, in a legal action before the European court of justice, the restrictive nature of the directive and in particular the onerous requirements for providing data on nutrient sources that have traditionally been used in food supplements. Although the European court confirmed the validity of the supplements directive, in a decision of July 2005, it made some important clarifying statements which, according to the ANH, will bind the Commission and simplify procedures for keeping food supplements on the market despite what to many observers seemed an unnecessarily restrictive directive.The fate of the recently filed applications will show whether the court decision's directions and clarifications are being taken seriously by the European Commission and the Food Safety Authority.
Here is the ANH's public statement ...
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ANH puts spotlight on European Commission over food supplement procedures
16 March 2007, Dorking, United Kingdom
ANH PUTS SPOTLIGHT ON EU PROCEDURES FOR FOOD SUPPLEMENTS FOLLOWING EUROPEAN COURT JUDGMENT
The Alliance for Natural Health has today informed the European Commission that it will scrutinise its procedures and those of the European Food Safety Authority on food supplements, in accordance with a European Court of Justice (ECJ) judgment.
On 12 July 2005 the European Court of Justice (ECJ) in Luxembourg delivered its judgment on a case brought by the EU-wide Alliance for Natural Health (ANH), along with two UK health food associations. The case challenged the EU Food Supplements Directive potential ban on thousands of food supplement products on the EU market that contain nutrient forms not listed on the ‘positive list’ of the Directive.
ANH files applications to create legal precedent
The ANH has filed 15 applications to the Directive’s positive list as a means of testing the European Commission and European Food Safety Authority’s procedures, which were referred to as having the “transparency of a black box” by the ECJ’s Advocate General Geelhoed in April 2005. This flaw was regarded as being of such a profound nature that the Advocate General made a recommendation to the ECJ that the Directive be invalidated.
When the ECJ delivered its ruling some three months later, the Directive was upheld – but on the condition that the procedures for adding vitamin and mineral ingredients to the Directive’s limited positive lists were made fully transparent and carried out within a reasonable time frame.
The ANH has been engaged in correspondence with the relevant authorities, including the UK Food Standards Agency, the European Commission and the European Food Safety Authority, on all aspects of the procedure and time lines for applications to the positive list and has yet to receive adequate, clear responses.
“The European Commission and European Food Safety Authority appear to be ignoring the ECJ’s ruling and continue to be operating within their black box,” says Dr Robert Verkerk, Executive & Scientific Director of the ANH. “It’s critically important now that we establish proper procedures for permanently adding vitamins and minerals to the Directive’s positive list, using the clarified procedures set up by the European Court, especially as derogation dossiers, some of which were very brief, could be rejected at any stage.”
The Directive only lists 15 minerals, when scientific research has shown that many more are needed for optimum health, at dosages greater than those found in most contemporary diets. Among the ANH’s 15 applications, nine are applications to have additional minerals, including sulphur, strontium, vanadium, boron and lithium added to Annex I of the positive list.
The European Court clarifies the criteria required for positive list applications
The ECJ also spelled out the criteria required for applications to the positive list. The ECJ made it clear that the only criterion required to have a vitamin or mineral added to the positive list (Annex I) was that it be normally found in and consumed as part of the diet. In its nine test applications to Annex I of the Directive, the ANH has demonstrated, using peer reviewed, published scientific research or government nutrient intake statistics, that all these substances are normally found in the diet. However, scientific research shows that their concentration is often insufficient for optimum health, hence the value of supplements containing these substances.
The ECJ also stipulated that two criteria were required for applications to Annex II of the positive list, which contains the vitamin and mineral forms which may be used in the manufacture of food supplements. The current list contains only 114 forms, while more than 400 forms have been used safely for decades. A ban has yet to occur since the fate of the additional 400 or so vitamin and mineral forms has yet to be decided following the submission of derogation dossiers to the European Food Safety Authority prior to 12 July 2005. In fact, only two of these submissions have been evaluated and approved since this time. The fate of the vast majority may not be known until closer to the end of the derogation phase in December 2009. Any dossier that is rejected will immediately make illegal any sale of products containing the relevant ingredient.
ANH applications prioritise natural forms of vitamins and minerals
The ANH has filed six applications to Annex II including generic and proprietary forms of mixed carotenoids, wheatgerm oil containing natural forms of vitamin E (mixed tocopherols and tocotrienols) and palm fruit vitamin E tocotrienols. These sorts of natural complexes are conspicuously absent from the Directive’s positive lists and, at the proposed dosages, are considered to be free of harmful effects sometimes associated with isolated, synthetic vitamin forms. Scientific studies also suggest that these natural forms of vitamins are of greater benefit to health.
ANH intends to challenge any refused applications in the courts
Robert Collins, Legal Director of the ANH said, “With so much uncertainty about, it is essential that clear, workable and transparent procedures are established – and of course the European Court has made this abundantly clear. The European Food Safety Authority can only reject applications if the criteria they have given are not met or they can prove that the proposed use is unsafe. Moreover, the Court has indicated that if the procedure results in a refusal, the refusal must be open to challenge through the courts. Since, in our test applications, we believe we have met the required criteria and have demonstrated the safety of the proposed uses, we will be taking any refusals to the courts so that proper precedents can be developed according to the procedure made law by the European Court.”
The ANH will continue to maintain very close scrutiny over the European Commission and European Food Safety Authority procedures. It is hoped, assuming the ECJ’s ruling is taken into account, that this will pave the way towards a more rational and transparent approach towards regulation of all categories of food supplements over the coming years.
See also:
Judgment of the ECJ on the ANH case (12 July 2005)More information on this action - ANH website
ANH pledges scrutiny and pressure over EC positive list
EFSA surprised at legal threat over dossier assessment
The European Food Safety Authority (EFSA) has said that it will not bow to industry pressure over scientific assessment of vitamins and minerals submitted for the positive list of the 2002 food supplements directive.ANH responds to EFSA accusation of legal threat
Since the ANH put the spotlight on the European Food Safety Authority and the European Commission over applications to the Food Supplements Directive positive list, it appears that certain cages have been rattled. The ANH now responds...
posted by Sepp Hasslberger on Wednesday March 21 2007
updated on Tuesday July 29 2008
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