REFIT – the EC’s rolling programme intended to review and simplify regulation governing nutrition profiles, plants and their preparations last saw the light back in June 2017.
Here, small and medium enterprises (SMEs), including micro-enterprises, were asked for their input and experiences in complying with legislation. The consultation was supposed to run for eight weeks.
Like most of the nutrition industry, Luca Bucchini, managing director for Hylobates Consulting, a firm specialising in regulatory consulting in the food sector, does not know where the Commission is on this.
“The Commission should propose a regulatory solution to the health claims regarding the botanicals conundrum, which either recognise tradition or the processing of claims via current procedures, which run the high risk of rejection.
“Regulation also has to be determined on quality of plants, with a positive list of plants that can be used across the EU.
Bucchini comments on the difficulty in predicting the Commission’s next move made more difficult by competing stakeholders from different Member States; the interests of consumers, both in safety and product availability; and the European economy's growth.
“There are also legal issues, as there are limitations in how you can modify existing legislation,” he adds.
“I can only predict what is less likely to happen – that is an outcome in which all claims for botanicals are banned, and very restrictive measures are put in place for botanicals are enacted.
“This is likely to face defiance in some Member States, as in the case of botanicals. In addition, there is no scientific or consumer protection case for going down that route.
“On the other hand, the status quo, with the Court of Justice ever more likely to weigh in, and the fragmentation of the EU market, is not sustainable.”
Recent EFSA opinion of hydroxyanthracenes additionally demonstrates how difficult it is to define botanical’s role in food supplements and traditional herbal medicine.
While the European Medicines Agency (EMA) gave a cautious nod, EFSA came back with a negative opinion on the same plant.
“I think EMA started from the tradition, and the fact that these products have been on the market for a long time; so, given uncertainty in the data, experts were hesitant to take a major negative decision against tradition,” Bucchini said.
“EMA's panellists are generally selected by Member States, so they may be more aware of the impacts of their decision. They felt they needed more evidence for a negative outcome.
“EFSA's experts had no such concerns at all. But of course this is not acceptable, also under EU law (regulation 178/2002): the opinions must be reconciled.”
Vitamins and minerals
Along with hydroxyanthracenes, the other notable example of dividing opinion are those for vitamins and minerals.
Scientific assessment by the Member States has resulted in very different maximum levels. For example, EFSA has found betaine safe at 400 milligrams per day (mg/day).
However, the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) were proposing a safe level of 1500 mg/day – a figure already authorised in Italy for food supplements since 2013.
“In general, given the different regulatory contexts, authorities have tended to ignore each other's assessments,” said Bucchini.
“EFSA has decided on novel foods; Member States have kept their views for substances which were not novel.
“Germany's BFR has been more insistent in a dialogue with EFSA, but this has happened more in fields other than nutrients.”
While the Refit consultation remains mired in regulatory limbo, the delay in proceedings begs the question as to the role of Belgium, Italy and France’s BELFRIT project – the countries’ regulatory answer to a botanical common standard.
The project now totals approximately 1000 herbal substances, all assessed and approved by a scientific committee.
While France follows a comparable list of approved botanicals, Italy and Belgium refer and adhere to the list.
It’s important to note that while the outcomes of the project are not legal in any EU country, any decision the Commission makes in the future will have to contend with the weight and influence the BELFRIT project carries.
“It is hard not to see BELFRIT as the basis of any future EU legislation, with perhaps some of the plants expunged for safety concerns,” said Bucchini.
“BELFRIT is alive, but it is not fully successful on two counts: first, to include further countries; second, to gain legal acceptance throughout the EU through mutual recognition as the de facto standard.
“It has almost created almost a single market in France, Italy and Belgium. If the REFIT ends with few results, BELFRIT will continue to work for some Member States.”