The comments came as part of a European Parliament workshop in cooperation with the European Federation of Health Products Manufacturers Associations (EHPM) and opened by European Commissioner for health and food safety Vytenis Andriukaitis.
Andriukaitis confirmed the public consultation would be launched by the end of this year, something he hoped would help the Commission make a “fully informed decision” on the 2,000 pending botanical health claims stuck in EU regulatory limbo.
“This will give us a clearer picture to enable the Commission to clarify whether – and to what extent – there is a need to harmonise the use of botanicals in the EU. It will also take into account member states current regulatory activities,” he said in his speech last week.
He said the discrepancy between the clinical studies required for food supplement botanicals under the Nutrition and Health Claims Regulation (NHCR) and the evidence of traditional use accepted for traditional herbal medicinal products posed questions about fairness and coherency.
"[i]t is an issue I believe should be addressed as a matter of priority.”
Yet Andriukaitis, who was appointed in 2014, added: “The evaluation process and the steps that follow are expected to be lengthy. However, I anticipate completing the reflection process on possible changes to the regulatory framework before the end of my mandate.”
The botanical health claim issue in a nutshell
There are about 2,000 botanical health claims on hold, within which 500 received a negative opinion from the European Food Safety Authority (EFSA).
EFSA requires human studies to prove efficacy, but the majority of botanical health claim dossiers rely on 'traditional use' evidence. This kind of evidence is allowed under medicinal laws through a simplified registration procedure under the Traditional Herbal Medicinal Products Directive (THMPD).
Yet under current EU rules, it is possible for the 28 member states to classify a product as food or as medicine on a case-by-case basis depending on its presentation, dosage and claimed effect. This has led to confusion and disparities between countries.
Such a review was promised as part of the Commission’s REFIT (Regulatory Fitness and Performance Programme) mission to cut regulatory red tape, a roadmap for which was published last year.
In his presentation, Andriukaitis said by the end of 2016 the Commission would launch a 12-week closed-question public consultation and an eight-week online survey for member states, stakeholders and SMEs.
A final report would be published by the end of 2017 and “reflections of next steps” would come at the beginning of 2018.
In an open Brussels meeting for the European Food Safety Authority (EFSA) this summer, head of the Commission's DG SANTE food legislation unit Alexandra Nikolakopoulou said concrete measures on the claims would not be seen in the immediate future and they were likely to remain on hold for the foreseeable future.
In his presentation, Andriukaitis cited Euromonitor data showing a return to growth for the botanical supplement sector after a decline between 2010 and 2013.
The data showed the sector was worth €4.7bn in 2015.
601,000 direct and indirect jobs
French market research firm Expansion Consulteam also presented findings of its study of the sector at the workshop.
It estimated the EU botanical supplements market was worth €6.5bn and over 2,000 companies and 601,000 direct and indirect jobs were linked to the sector.
Comparing employment breakdown of the plant food supplement versus non-plant food supplement categories, plant supplements accounted for 63% of revenue and 50% of jobs.
This sector value was largely concentrated in Germany, Italy, France and the UK, which accounted for 62% of botanical supplement revenue in Europe.
This was followed by Spain, Poland, Belgium, the Netherlands and Sweden.
A potential model?
Also presenting at the workshop, Bruno Scarpa, head of the Italian Ministry of Health food safety and nutrition office, highlighted the need for regulatory clarity.
He offered the case study of Italy, which regulates botanicals with a combination of a list of plants safe to use and a permitted list of claims showing efficacy based on traditional use.
In his speech, Commissioner Andriukaitis said the harmonised BELFRIT list between Belgium, France and Italy was a “very interesting example of how voluntary cooperation between member states can be used to address common concerns”.
In its presentation, EHPM urged a pragmatic approach based on best practice already seen in member states.
In September Michel Horn the newly elected chair of the Brussels-based trade group pledged to secure progress on botanicals.
“I take up the role as chair at a crucial point for our industry as the regulatory approach to taken towards botanicals hangs in the balance,” Horn said at the time.
“I will work towards achieving an approach that ensures consumer have access to high quality products that deliver genuine health benefits. Protecting consumers and creating a workable regulatory framework for the SMEs, such as my own, which make up the majority of our sector are not mutually exclusive goals,” said the CEO of Belgian supplements firm Ortis and co-founder of 22-year-old Belgian supplements trade group NAREDI where he remains vice president.