EU legislation: It's a minefield out there

EU legislation has created a “minefield” for health food manufacturers says the executive director of the HFMA, Graham Keen. “The good news,” he says, “is we know where the mines are. The bad news is that they keep moving.”

The comments came as Keen introduced last week’s HFMA Spring Seminar on the subject of Managing Change. The one-day event brought together leading industry and regulatory experts from Britain and Europe and produced some lively discussions, particularly on the issue of herbals regulation.

Reality check
Setting the scene on herbals, Penny Viner, chair of the UK Herbal Forum, said: “Wherever you are starting from — if you have herbal medicinal products and/or botanical food supplements — 2011 will be a year of major change.” She urged all companies with herbal products to undertake a “reality check” and plan for changes that would have to be made. “You need to ask yourselves where will you be in 2011 — Marketing under medicines law? Under food law? Or cosmetics law?”

Viner reminded companies that from April 30 2011, when the THMPD transition period ends, all products will need to be registered or authorised to remain legally on the market. After that date, she said, no further stock of unlicensed medicinal products could be put into retail sale — and only products owned by the retailer (not the wholesaler) could be sold through.

Viner said there were some grey areas around marketing herbals without claims under food law. Would the MHRA use ‘medicinal by function’ or dosage levels to classify some products as medicines?

No place to hide
David Carter, of the MHRA’s Borderline Section, warned firms there was “no place to hide” from the new laws on herbal medicines. He said: “This year we will be actively identifying products that will require registration or authorisation and contacting the suppliers to inform them of this. My message to them is that it will not be possible to do nothing and that we will be taking compliance and enforcement action against companies who do not comply with medicines legislation.”

“My message to them (companies) is that it will not be possible to do nothing and that we will be taking compliance and enforcement action against companies who do not comply with medicines legislation.”

Carter hinted that companies who are investing in the registrations process will be strongly incentivised to highlight competitor products being sold illegally. He said: “It’s always been the case that the borderline products area has been policed by people with competitor products”.

Carter also warned that it wouldn’t be possible simply to represent herbal products as food supplements. “Food supplements must look and feel like food supplements — you can’t just change the label.”

A question of claims
Patrick Coppens, secretary-general of the European Botanical Forum, brought delegates up to date on the Nutrition & Health Claims Regulation. He highlighted the high percentage of negative opinions the European Food Safety Authority (EFSA) had delivered in its first 2 batches of Article 13 claims. Two-thirds of the first batch of opinions (delivered in October 2009) were negative, he said, with rejections for probiotics, plant extracts, and soy isoflavones among others. The second batch (February 2010) saw an “overall negative outcome” with claims for “many important ingredients” rejected.

Coppens said that while consumer groups appear to welcome the approach to claims being adopted by the European Commission and EFSA, industry is increasingly concerned at “the inappropriateness of the methodology” and by the serious impacts on innovation and consumer choice the Regulation is creating.

Coppens warned that there was a danger that the Regulation could end up creating almost the opposite of what it set out to achieve. “Just look at attitudes to research investment. You could see this becoming very unattractive to companies when they see that doing five years of good quality research earns you a rejection.”

Taken to the limit
Earlier in the day David Adams, the HFMA’s special projects director, reviewed progress on the Food Supplements Directive. His main focus was on ‘stage 2’ of the Directive, Maximum Permitted Limits (MPLs).

Adams highlighted the two-tier approach to MPLs supported by Britain, in which one tier one would be based on harmonised levels set by EFSA and the second would allow for higher levels to be set at the discretion of national governments (with higher dose products carrying appropriate advisory labels). But he said the two tier system itself would have to be supported by a majority of members states to be legal.

“the key lobbying will be that done before the proposals on MPLs are published”

Adams warned that the future of Britain’s higher potency supplements market remained very uncertain and reminded delegates that the former director general of DG Sanco had said the UK “should expect higher UK levels to be sacrificed in the interest of harmonisation”.

Adams said it was critical that the new UK government, and its regulatory agencies, now pushes very hard on behalf of UK industry. For the industry’s part, he said, “the key lobbying will be that done before the proposals on MPLs are published”. The proposals are due to published thus coming autumn, he added.

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