EU harmonisation not always ‘appropriate’: UK government report

24-Jul-2013 - Last updated on 25-Jul-2013 at 14:04 GMT

"...it is not clear that any initiative to achieve greater harmonisation of Member States’ regulatory approach to herbal medicines would necessarily result in an effective application of better regulation principles and an appropriate level of public health protection within the UK.”

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EU nations could better regulate botanical products and maximum permitted levels (MPLs) for nutrients in food supplements and functional foods than the European Union, a UK government report has suggested.

The report said the herbal products sector represented, “a good example of inconsistent implementation across the EU.”

This is due to the fact that similar herbal products continue to be classified as medicines in some countries, foods or food supplements in others. Adding to the complexity is the EU Traditional Herbal Medicinal Products Directive (THMPD), which is interpreted differently by different member states.

Over to EU?

“In the Government’s view, on the one hand, differences of approach to the regulation of herbal medicines make it challenging for companies wishing to market products across the EU,” states the report which examines how EU membership impacts the UK health sector.

“On the other hand, it is not clear that any initiative to achieve greater harmonisation of Member States’ regulatory approach to herbal medicines would necessarily result in an effective application of better regulation principles and an appropriate level of public health protection within the UK.”

“Classification of products remains a national competency.”

While continuing to support the principle of EU harmonisation as a consumer protection tool and business facilitator, the report finds cases like MPLs may warrant other approaches.

“…each issue needs to be considered carefully to avoid unnecessary burden,” it said.

“Member States can have very different ways of managing some of these issues and achieving harmonisation with strongly held opposing views is problematic.”

“There are barriers to trade where rules are not harmonised, which reduce the opportunity for UK businesses to trade in the EU. Lack of harmonisation may also result in imports from other Member States to the UK market that are of varying quality and have safety implications for consumers.”

The report said the absence of harmonised MPLs had, “led to a fragmentation of the single market, adding significant costs for manufacturers.”

It cited the anti-harmonisation position of the UK groups, Consumers for Health Choice (CHC) and the Health Food Manufacturers’ Association (HFMA) in its deliberations.

“The Government believes that any future decisions on vitamins and mineral food supplements need to be proportionate and based on evidence, so that consumers have confidence in what they buy, while maintaining a wide choice of safe products.”

CHC director of strategy, Chris Whitehouse, said: “CHC is pleased that the detailed concerns it fed into this fundamentally important Government review have been acknowledged and generally sound conclusions drawn.”