SME concerns raised at European Parliament botanicals workshop

By Shane STARLING contact

- Last updated on GMT

Belgian, Italian and French authorities shared their experience of botanical regulation at a time when 1500+ botanical EU health claim submissions are on-hold across the bloc...
Belgian, Italian and French authorities shared their experience of botanical regulation at a time when 1500+ botanical EU health claim submissions are on-hold across the bloc...

Related tags: Herbal medicinal products, European union

More than 70 stakeholders attended a botanicals workshop in the European Parliament’s Brussels offices last week as the heat increases to resolve regulatory ambiguity across the EU for herbal products - especially that ambiguity's impact on SMEs.

Key botanical industry facts and the importance of small-to medium sized enterprises (SMEs) to the sector were also discussed, including a presentation from Belgian firm, ORTIS.

Irish MEP Marian Harkin also emphasised the need for SMEs to be considered in any changes in regulatory structures.

The event was organised by Belgian MEP Marc Tarabella who said: “My objective in organising this workshop was to highlight existing best practice and the fact that asystem that is workable for SMEs and provides adequate protection for consumers is possible. I hopethe event has been useful for all participants.”

Attendees included MEPs, European Commission officials, national authorities and industry stakeholders.

Belgian, Italian and French authorities shared their experience of botanical regulation at a time when 1500+ botanical EU health claim submissions are on-hold across the bloc as debate continues about the right kind of scientific criteria to verify them.

At the same time the EU Traditional Herbal Medicinal Products Directive (THMPD) has been in operation since May, 2011, creating in theory a class of products between foods and medicines.

“…the basis for a workable EU system already exists…”

European Federation of Associations of Health Food Products Manufacturers (EHPM) chairman Alban Maggiar presented data that showed the importance of the botanical sector to the EU economy.

“It is very clear that through sharing the expertise from national authorities in Member States that have a long history of using botanicals in foods and foods supplements, the basis for a workable EU system already exists,” ​Maggiar said.

“The European Commission and Member States continue to reflect on the most appropriate approach to take to the regulation of botanicals.”

UK debate

A debate on botanicals regulation will be held in the UK parliament on July 9.

The debate, initiated by David Tredinnick MP, has been welcomed by liberal market backers, Consumers for Health Choice (CHC).

“Well done to David Tredinnick for arranging this debate,”​ said CHC director of strategy, Chris Whitehouse.

“It will be an invaluable opportunity to press Government Ministers not to renege on their previous commitments to introduce statutory regulation for herbal practitioners.”

He added: “Statutory regulation would boost the reputation of the profession, it would boost consumer safety and confidence, and it would enable consumers to continue to have access through the practitioner prescribing route to those very specialist products, often produced by very small manufacturers, who cannot afford the significant cost of applying for registrations under the provisions of the Traditional Herbal Medicinal Products Regulation.”

“For over two years statutory regulation has been promised for herbalists, but we now hear that civil servants are trying to persuade Ministers to drop the whole plan. That would be unacceptable.”

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