EU Directive Called Necessary But Imperfect

BRUSSELS, Belgium—The recently adopted EU Food Supplements Directive has won guarded approval from most European ingredients suppliers, supplements manufacturers and industry groups.

Those companies that spoke with FFN agreed it was a necessary step for the good of the industry to bring about a long-awaited harmonisation of the European regulatory framework, but stressed lobbying would continue with the aim of amending aspects of the legislation they considered either ambiguous or inappropriate.

Pim Dekker, technical director at vitamin and herb manufacturer Solgar Vitamins Holland, welcomed the impending legislation despite reservations about its workability.

"It is a great opportunity for many countries that have no food supplements because they are considered medicines," he said. "We are, however, concerned about the Scientific Committee on Food (SCF) and how it will interpret upper safety levels as well as those ingredients that may or may not make it to the approved Annexes. Some ingredients that have been used safely by millions of people for more than 20 years are not on the list."

It has been alleged that up to 300 supplement ingredients currently available in liberal European constituencies such as the UK, the Netherlands and Sweden will be banned from use under the Directive. These include iron, selenium, boron, ascorbate, vanadian, calcium, chromium, copper and magnesium.

The European Federation of Health Product Manufacturers (EHPM) regulatory affairs director, Pedro Vicente Azua, said its members, generally are larger dietary supplements manufacturers, unanimously supported the legislation.

"Although we recognise the Directive is not perfect, we knew that it was now or never for it to progress and so we supported it," he said. The extension from 18 to 36 months for the submission of scientific dossiers to the SCF for ingredient approval was a significant concession, he said, pointing out that lobbying would continue.

"We will be doing everything to ensure as many ingredients as possible make it onto the Annexes and that upper safety limits are set as high as possible."

Rose Schraitle, regulatory affairs manager of the German Medicines Manufacturers Association, highlighted the potential economic benefits of the legislation. "At the moment every country has its own rules, and this means manufacturers have to produce different products for different countries. In the future it will be possible for a company to produce and market a product throughout a unified Europe."

Dr John Hathcock, vice president of nutritional and regulatory science at the Trans-Atlantic Business Dialogue (TABD), a group set up to foster trade between the US and Europe, said American ex-porters were split on the Directive's probable effects.

"Those primarily focused on the UK market are somewhat dismayed with the Directive because it is more restrictive than the regulatory environment to which they have become accustomed and therefore it is going to become harder for them to do business," he said. "Those that have been exporting to the Nordic countries, Spain, Germany and so forth find it to be liberating." It was unlikely to influence the dietary supplements regulatory structure in the US, he said.

The New Legislation: What Will It Mean For Companies Entering Europe?

  • The Directive is likely to become law by the middle of the year. It needs to be rubber-stamped by the EU Council of Ministers, at which point it is published in the Official Journal. Twenty days later it will become law. Member States must then introduce it into their national legislatures within a year.

  • The Directive currently covers only vitamins and minerals. Amino acids and fatty acids may be added at a later date.

  • Companies have three years to submit scientific dossiers to the SCF, which will review them over the next seven years. National authorities can use this seven-year period to allow the continued sale of ingredients not on the approved list, unless the SCF delivers a verdict against an ingredient within that time.

  • The SCF is likely to deliver its verdicts on upper safe levels within a year.

  • The definition of food supplements includes those with a nutritional or physiological effect. It includes a host of herbal products that can gain approval under the legislation, though herbs will likely be more difficult to gain passage than conventional vitamins and minerals.

  • Currently, 13 vitamins, 15 basic minerals and some of the forms in which they are used are exempted from the regulations.

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