MEPs pass strict herbals legislation
legislation on traditional herbal products which will require all
herbal medicines on sale in the European Union to be registered.
European members of parliament have adopted a resolution for new laws which will require all herbal medicines on sale in the European Union to be registered.
Under the new rules, traditional herbal medicines will be subject to standards on the quantity and quality of their ingredients. And in what has been the most controversial point, products will also have to prove their safety through "traditional use" with presence on the market for at least 30 years - 15 years of which must have been in Europe.
The herbal industry has been on the whole opposed to the length of the time period. But Erkki Liikanen, European Commissioner for Enterprise and the Information Society, said in a speech before yesterday's vote that 30 years was an 'appropriate' time frame.
"Such a period should enable us to decide whether the product can be considered safe and efficacious. The assessment has to be done for the use in the EU. I stress this since the effects of a medicine do not only depend on the product itself but also on the setting in which it is used."
"At the same time, we recognise that there are important medicinal traditions outside the EU. For this reason, we propose that up to 15 years can have taken place outside the Community," he continued.
The legislation will also bring in a new labelling regime. At present, unlicensed remedies cannot state on the label what they are intended for and what conditions they can treat or cure.
Amendments to the proposal requested a new Committee on Herbal Medicinal Products to take over from the Committee for Human Medicinal Products. The committee will oversee what is likely to be a time-consuming evaluation process of all herbal products.
Products will also have to give information describing the nature and main priorities of the ingredients and informing the consumer about possible adverse reactions or interactions with food and/or other drugs administered.
The MEPs adopted a further amendment which will see the new Committee set up a classification of herbal medicinal products, taking into account their composition and their pharmacological and toxicological effects. Therapeutic indications, routes of administration, daily doses, possible adverse reactions and any risk of interactions with drugs, alcohol and foods will be included in the classification, as well as any other information required for safe use, especially by children, pregnant women and elderly people.
While MEPs described the measures as a bid to set basic safety and quality standards, there has been vociferous opposition from some consumer and trade groups.
In the UK, where both food supplements and herbal remedies enjoy a liberal environment, some groups are worried that the directive will remove several hundreds of products from sale and also threaten jobs and some small health retailers.
British organisation Consumers for Health Choice (CHC) this week presented a petition, with more than 1 million signatures, to the British government asking them to fight the European legislation. In an interview with NutraIngredients.com, CHC director Sue Croft said: "The herbal market is a very responsible one. The problems come from traditional herbalists making up their own concoctions at home, but this directive does not touch them. There is no further consumer protection offered by this."
The directive also fails to address the problem of legalising products containing both herbal ingredients and other nutrients.
The Commission claims, however, that the main objectives of the directive are first and foremost to guarantee a high level of health protection for European patients. Liikanen also said the directive would create "a clear and favourable environment for the mainly small and medium-sized companies working in this sector. "
"In today's environment, for new medicines, providing fresh scientific data is indispensable to ensure that the patient is treated with safe and efficacious medicines," he said. "To protect the patient's health it is essential that the information on the product's traditional use must be so reliable that it allows us to conclude on the product's safety."
The proposal still has to be passed by European health ministers before entering into law.
