One of the largest growing markets of supplements in Europe could be in crisis as the EU Commission keeps a list of botanical health claims on hold – some for as long as seven years already.
The backed up list of claims has led experts to say the Nutrition and Health Claims Regulation (EC) no.1924/2006 (NHCR) “does not encourage the innovation in the EU food sector”.
In a recent study on the NHCR published in the International Journal of Food Science and Nutrition, experts from the University of Bonn and the University of Perugia said that the NHCR does not provide an incentive for product innovation and differentiation.
The on-hold claim evaluations are due to the REFIT initiative which is aiming to make EU regulation more efficient and effective while reducing burden and without undermining policy objectives.
“The Commission decided to temporarily suspend the further processing of health claims on botanical substances due to major concerns that were raised in relation to these health claims. In that context, a total of 2078 claim IDs on plants and their preparations were identified as claims made on plants and their preparations and were put ‘on hold’,” said an EU parliament spokesperson.
As part of the initiative, a meeting has been held at European parliament, questionnaires have been sent out and stakeholders have put forward their own views, with a report said to be published at the end of the year.
However, some experts believe, despite this, focus on quality has been dropped by industry players in order to just scrape by the legal requirements.
“Some stakeholders and national policymakers seem to have given up on the idea of harmonisation on quality, on claims or a shared positive list, and rather try to carve –more or less in line with EU law – national regulatory niches which meet the needs of the local industry,” said Luca Bucchini, food risk scientist and managing director at Hylobates.
“Needless to say, this is very short-sighted and created increasing challenges for businesses that wish to go beyond their national markets –not to speak of consumer information,” Bucchini added.
Published on February 10, Belgium’s 1000 plus list in BELFRIT has many more mandatory warnings and restrictions compared to the Italian list of botanicals.
However, Bucchini says the list has lost impetus.
“Regulators who were at the core of the project have either left their posts or lost enthusiasm; there is no established mechanism for others to provide input or joining. It shoes that without the support of a structure like the Commission, intergovernmental projects may face serious issues,” he added.
The Italian market of food supplements containing botanicals was worth just under €1 bn from May 2015- May 2016, making it the most prosperous in Europe, according to FederSalus.
Italy is also known for having the most permissive legislation on botanicals, approving health claims concerning prevention, maintenance of homeostasis and the normalisation of biological parameters.
Whereas the European Food Safety Authority (EFSA) recognises very few health claims attributed to botanicals and instead only recognises health claims attributed to active ingredients.
“The European Commission seems to have given up on defending the single market in this area, not intervening in cases of mutual recognition and not promoting harmonisation; this becomes a negative feedback circle, because businesses need to focus on their local markets and do not push for harmonisation, as the sector weakens. Moreover, national courts, in Sweden for example, have been ignoring EU law. On a whole, in this context, I would be surprised to see positive developments in the future,” said Bucchini.
While the Commission works through the claims on-hold, it is likely that member states will be granted permission to regulate botanical claims on a national level. However this could be detrimental to brands who sell across the whole EU, as well as for ingredient producers.
Botanicals is one of the largest growing markets in Europe, with food supplements made from plants, algae, fungi and lichens becoming widely available, according to EFSA.
Most botanical supplements can be purchased without a prescription, in pharmacies, supermarkets and online.
This ease of purchase has prompted safety concerns over the quality of the botanicals being sold.
“Whatever legislative decisions are taken must address in practical and pragmatic terms the dogged issue of the quality of some botanicals which unfortunately blights the whole industry and does the consumer a disservice,” said Dick Middleton, Chairman of British Herbal Medicine Association (BHMA).
Despite the challenges facing the botanicals market, Luca Bucchini says it’s not all doom and gloom, the industry is still alive and the true forecast will not be revealed until the study is completed.
“Consumers continue to like botanicals… many still think that protected national markets may work some incumbents, but are bad for most. So, we may still see positive developments – good regulations promoting quality, positive lists and a reasonable approach to claims – in 2017 or more likely in 2018, if the EU survives this moment of uncertainty.”
“However, stakeholders have a huge responsibility in telling their national regulator – and the Commission – that Europe can’t afford to give up on a single market for botanicals.”
Agreeing with Bucchini that there is light at the end of the tunnel is Patrick Coppens, director of regulatory and scientific affairs at Food Supplements Europe.
He said: “member states want to try and solve this issue, and try to prevent barriers to trade. Now with BELFRIT, and Belgium and Italy already publishing their lists, this is a step forward. If that would be taken as the best practice by the EU Commission then I think there can be a quick movement, but there are also member states, of course, who are more resistant to a change in the system. You still need majority of member states to agree on a policy.”
Coppens said the Commission needs to respect the existing market but needs to change the approach to legislation for botanicals in order for it to be successful.