Last week the Alliance for Natural Health (ANH) said that it has made 15 'test' submissions to the positive list for vitamins and minerals in the annexes of the 2002 food supplements directive.
Since the alliance is confident that it has met all the criteria and demonstrated the safety of the proposed uses, legal director Robert Collins said that it "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."
But EFSA spokesperson Dr Carola Sondermann told NutraIngredient.com: "We are surprised that AHN even tries to threaten the European Commission and EFSA with taking them to court if a negative opinion will be issued by EFSA "EFSA's role is to undertake risk assessments and, in this case, to consider the evidence base for the safety of food supplements and in particular the nutrients contained within them.
EFSA will do this work on an independent basis irrespective of any threats or pressure from industry or other sources."
Moreover, Sondermann said that EFSA was copied on a letter sent by ANH to the UK's Food Standards Agency at the end of February, which included proposed dossiers.
However under the directive, it is for the European Commission, a member state or the European Parliament to task EFSA with carrying out a risk assessment and providing an opinion.
Since it has yet to receive an official request for the assessment of ANH's 15 submissions, to date EFSA has been unable to begin working on them.
Dr Robert Verkerk, executive & scientific director of the ANH, told NutraIngredients.com earlier this week that the alliance's lawyers have said six months is a reasonable time frame for the receipt of a decision.
When EFSA does receive official requests for food supplements, they are dealt with by its scientific panel on food additives, flavourings, processing aids and materials in contact with foods.
To date, EFSA has received around 400 applications - but about half of these did not contain any documentation on the safety of the substance.
Pending the receipt of further data, the incomplete applications have not yet been forwarded to the panel.
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It is indeed EFSA 's task to provide independent scientific advice.
But it should be pointed out that it is always within the responsibility of the applicant to demonstrate that a product/substance is safe, whilst it is EFSA's role to evaluate this data provided," said Sondermann.
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.
"We believe that under proper procedures, any dossier should have been rejected by now so that the company can re-submit it."
ANH said that it expects that the fate of many vitamins and minerals is unlikely to be known until closer to the end of the derogation phase, in December 2009.
Moreover, Verkerk said that there is still too little transparency surrounding the EC and EFSA's assessment procedures - despite the European Court of Justice ruling in 2005 that they be made fully transparent and carried out within a reasonable time frame.
But EFSA says it pays much attention to vitamin and mineral assessments, but due to the high number of applications the panel has to set priorities.
"It takes time to carry out a proper risk-assessment," stressed Sondermann.
The panel has set up a working group to cluster the 200 complete applications where appropriate, and for most of the substances rapporteurs have already been nominated.