Supplements directive offers bright lights for industry
resulted in a win-win situation for industry, says one of the
groups that took the Commission to court over the laws, reports
Dominique Patton.
It says the ruling has cleared up many elements of the directive that posed a threat to industry, an opinion that could alleviate initial disappointment across trade groups and consumers.
Both supplement makers and consumer organisations had feared that the 2002 directive would reduce the number of vitamin and mineral supplements available in the biggest markets by restricting the nutrient sources to those on a 'positive list'.
Following Tuesday's court decision that the directive was indeed valid, Irish health stores reported panic buying as consumers sought to stock up on threatened products.
However Dr Rob Verkerk, director of the health campaing group Alliance for Natural Health, says the ruling eliminates the possibility of a ban on any natural product, and shifts the burden of proof of an ingredient's safety from the manufacturer to the regulator.
He claims that an 18-page opinion from the organisation's barrister reveals a major let-out clause for natural source products not on the positive list.
"It is to do with the interpretation of paragraph 63 in the context of the directive. This comes in response to a point made in our case that it was disproportionate to look at natural-source products with the same criteria as synthetic ones," Dr Verkerk told NutraIngredients.com.
Essentially, natural source ingredients will be excluded from the directive, he maintains.
He added that the huge number of dossiers submitted to the UK's Food Standards Agency would in any case give most of natural source ingredients derogation from the directive.
The ANH believes that most ingredient makers do not properly understand the process for submission to the positive list, yet it is likely to be considerably simpler and less expensive than previously feared.
"One of the problems is that the derogation process has been very wishy-washy and we need a tight series of guidelines on the amount of data required for dossiers," Dr Verkerk noted.
However entrance to part 1 merely requires the substance to be part of the diet, and for part two the only requirements are safety and bioavailability. There are as yet no clarifications of how much bioavailability is required.
As for safety, the ANH says it is working on a proforma that would help those companies making applications to the positive list.
"Paragraph 73 of the ruling shows that companies can put in a relatively simple dossier. EFSA is really just looking for notification and then the onus is on them to prove whether the ingredient is unsafe or not."
"Once you've made a submission, the only way it can be refused is if it is found to be unsafe by the regulator. This is many ways is similar to the DSHEA in the US," he claims.
While the Health Food Manufacturer's Association (HFMA), which brought a parallel court challenge against the directive, has remained more cautious about the ruling's impact, director David Adams said the dossier process could be made easier.
"There are hints that the judges want the process to be more transparent. The hurdle could well be lower than previously thought," he said.
He pointed to a statement released by the European Commission, in which Markos Kyprianou, Commissioner for Health and Consumer Protection, said that the lawmakers would look to implement the directive in "a transparent and timely manner" so that it is "the least restrictive that science will allow".
