ANH pledges scrutiny and pressure over EC positive list

Under the 2002 supplements directive, the European Food Standards Agency has the responsibility of assessing applications to be added to the positive list of permitted vitamins and minerals.

But ANH's bugbear centres around the transparency of the European Commission and EFSA's procedures for doing so and the time-line.

ANH brought a legal challenge to the directive in 2005 saying that it infringes EU constitutional law and basic principles of free trade - and a parallel case was brought by two trade associations (the Health Food Manufacturers Association and the National Association of Health Stores).

In April 2005 the European Court of Justice (ECJ) Advocate General Geelhoed said that the procedures "had the transparency of a black box" and recommended that the directive be invalidated.

In the event three months later, however, the court ruled that the directive was valid - but 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.

But Dr Robert Verkerk, executive & scientific director of the ANH, said on Friday: "The EC and EFSA appear to be ignoring the ECJ's ruling and continue to be operating within their black box."

Verkerk came to this conclusion since the ANH has been corresponding with various authorities, including the EC, EFSA and the UK's Food Standards Agency regarding the procedure and time lines for applications.

It says has yet to receive adequate, clear responses.

"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."

EFSA had not provided NutraIngredients.com with a comment in time for publication of this article.

The ANH is now testing the procedures with the submission of 15 applications of its own.

It is confident that its submissions have sufficient scientific backing, and it has indicated that it will launch legal action.

Verkerk told NutraIngredients.com that the alliance's lawyers have said six months is a reasonable time frame for the receipt of a decision.

While annex I of the 2002 supplements directive, which gives the groups for vitamins and minerals that can be included in food supplements, is fairly complete in terms of vitamins, it presently lists only 15 minerals - although ANH says science has shown many more are needed for optimum health at levels above those found in modern diets.

ANH's 15 applications include nine additional minerals that it would see added to annex I of the positive list, including sulphur, strontium, vanadium, boron and lithium.

The EJC said that the only criterion for a vitamin or mineral to be added to this annex is that it be normally found in and consumed as part of the diet.

Annex II, meanwhile, gives the specific forms of vitamins and minerals permitted, and the criteria for inclusion are safety and bioavailability.

Verkurk said that the omission of sulphur from annex one is a particularly concerning anomaly, since annex II contains several sulphur-containing mineral forms.

The six applications ANH has made to annex II include mixed carotenoids, wheatgerm oil containing natural forms of vitamin E (mixed tocopherols and tocotrienols) and palm fruit vitamin E tocotrienols.

The current list contains only 114 forms, while according to ANH more than 400 forms have been used safely for decades.

Those forms not on the list have not been banned to date, however, since derogation dossiers were submitted to EFSA prior to July 12 2005 - yet only two of these have so far been evaluated and approved.

ANH expects that the fate of the remaining vitamins and minerals is unlikely to be known until closer to the end of the derogation phase, in December 2009.

The rejection of any dossier will make the sale of any products containing the relevant ingredient immediately illegal.

Verkerk said that one of the concerns is that many of the derogations did not meet bioavailability criteria, and on this basis EFSA would be justified in rejecting them.

He said: "We believe that under proper procedures, any dossier should have been rejected by now so that the company can re-submit it."

ANH hopes that, by keeping up the pressure on the EC and EFSA, it can "pave the way towards a more rational and transparent approach towards regulation of all categories of food supplements over the coming years".

It also hopes to set a precedent for the selling of other groups of nutrients like botanicals, essential fatty acids and probiotics further down the line.

Robert Collins, Legal Director of the ANH said: " 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."