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September 1, 2005
The European Court of Justice?s rejection of the challenges brought against the Food Supplements Directive has drawn varying reactions from the groups that mounted them and other industry bodies.
The UK-based Health Food Manufacturers Association (HFMA) claimed the July 12 ruling would decimate the UK supplements industry by banning hundreds of nutrients and thousands of supplements if it could not be invalidated or amended. Its challenge, as did that of the Alliance for Natural Health (ANH), sought and failed to annul the Directive in the UK.
In a statement, the HFMA called on the UK government to pressure Brussels into altering the Directive. ?We are calling for ? a simple amendment to the FSD, whereby an individual member state can allow the sale of supplements outside the restrictions of the FSD in its own territory … which do not need to be regulated communitywide,? HFMA stated.
But the ANH claimed the detail in the court?s ruling was actually a victory. It highlighted the court?s opinion that the process for adding nutrients to the Directive?s positive lists should be simplified and made more transparent. ANH said this would greatly increase the likelihood of nutrient additions to the lists once the European Commission?s risk assessment body, the European Food Safety Authority (EFSA), begins assessing nutrient dossiers.
More than 500 dossiers have been received in the UK by the UK Food Standards Agency, thereby granting them a stay of execution until the EFSA begins delivering safety verdicts, a process which must be wrapped up by Dec 31, 2009.
ANH executive director Dr Robert Verkerk said the court?s ruling also implied that the burden of proof on the safety of nutrients had shifted away from industry toward the regulators. ?Our lawyers have analysed the ruling and believe the regulators will have to prove a nutrient is unsafe. This is a significant victory for industry.?
The HFMA said: ?The judgement does not go so far as to place any explicit obligation on the commission/EFSA to conduct their own research to prove or disprove safety.?
Peter van Doorn, president of the Natural and Health Products Association of the Netherlands and chairman of the European Health Product Manufacturers Association, welcomed the verdict. He said many of the dossiers received by the UK?s Food Standards Agency would not meet EFSA criteria. No derogations would be granted in the Netherlands on the basis of these submissions until each had been scrutinized by Dutch authorities, he said.
The UK authority, which put up funds to assist in the compilation of some of the 505 dossiers it received, was uncertain how EFSA would treat them.
?We recognize only basic information has been provided in a number of the derogation submissions we have received, and we hope EFSA will provide these companies with the opportunity to provide more information,? a spokesperson said.
Asked why it had funded some of the dossiers, the spokesperson said: ?We are trying to maintain consumer choice. We wanted as many dossiers to be produced as possible. Companies will still be required to provide safety data, and we have no plans to provide further funding for the collection and compilation of that kind of data.?
The US Council for Responsible Nutrition?s vice president for scientific and international affairs, John Hathcock, welcomed the verdict but said the court did not give clear enough instruction to the court/EFSA. ?There are no specific instructions to the court about how to improve its processes for the admission of ingredients onto its positive lists. So it?s a wait-and-see game as to what the court and EFSA will do.?
He expressed concerns about the UK dossiers, some of which have been submitted by US companies. ?There is no doubt some of the derogations are well-deserved. With others, the evidence is so sparse it is almost nonexistent, which may create a situation where EFSA begins rejecting these minimal ?dossiers? en masse. If this occurs the negative publicity could be very damaging for industry. I fear a situation may be arising where the industry is giving itself enough rope to hang itself.? Ric Hobby, chairman of the UK Council for Responsible Nutrition (CRN), questioned the relevance of some of the nutrient dossiers received by the EFSA.
?CRN is pleased the EFSA has granted derogations for all the key substances widely used?in the market, in response to the dossiers submitted to support them,? he said. ?However, we do not understand why a significant number of substances are on the list, where clearly these?substances do not meet the criteria for derogation under the Directive because they don?t provide sources of either vitamins or minerals.
?In addition, some?substances listed?have significant safety issues, while other substances cannot even exist chemically,?bringing into question what is actually being sold in the UK market today.? He added: ?CRN is very concerned that when EFSA reviews these substances and subsequently?rejects them, this will bring the whole?industry into disrepute.?
A list of the derogations granted in the UK can be found at www.food.gov.uk/foodindustry/vitmin/supptable
A summary of the judgement can be found at: curia.eu.int/en/actu/communiques/index.htm
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