Is the Romanian botanical decree a step toward or away from harmonisation?

By Annie Harrison-Dunn

- Last updated on GMT

Romanian issues new botanical decree

Related tags European union

Romania has a new law on botanicals – but the jury is out on whether this will help or hinder the case for a pan-EU list.

It notified the European Commission of the new law​ at the end of March, around the same time Belgium made a similar move​ to replace its former list of botanicals with those approved under Belgium, France and Italy’s unified list BELFRIT.

The decree has been described as similar in structure to the Belgian law – with the first annex containing a list of 473 genera and species of plants whose parts or derivatives were prohibited in food supplements, a second annex containing 109 algae, 26 lichens and 322 fungi permitted in food supplements and a final annex of 2647 plants allowed for use in food supplements under certain conditions.

Yet, Luca Bucchini, managing director of Hylobates Consulting, said there were significant differences between Romania’s lists and that just passed by Belgium and earlier by Italy.

It differed from BELFRIT too in its use of a ‘negative’ list. Romania’s ‘positive’ list also had about two and a half times more botanicals.

He said it could be questioned whether the Romanian authorities had evidence for all the novel food statuses of the plants and said within Romania there had been disagreement over whether this list or BELFRIT was more appropriate.

“Will the decree go through the notification process? It would be a pity if it did, and other member states were to refuse products on the Romanian list as they doubt their novel food status. If they have such doubts, they should stop the decree now,” ​he told us.

EU member states are obliged to notify the European Commission of new technical rules to ensure compatibility with EU law and internal market principles. The draft was now open to comments, only after which it could pass into national law.

Commenting on the development, Christian Artaria, marketing director for Italian botanical firm Indena, said for his firm clarity of any kind was always positive.

“We welcome rules, we welcome clear rules and if these are applied at a pan-European level, this is even better,”​ he told us.

He said this was vital for a company if it wanted to plan investments with confidents.

While Bucchini said Romania’s decree was not in itself a positive development for BELFRIT and those seeking harmonisation of botanicals, it may help convince the Commission that the matter could not be left to member states if the principles of single market and mutual recognition were to work.

Instead a combination of national lists at EU-level was needed.

The Romanian decree was prepared by the the Ministry of Agriculture and Rural Development and the Ministry of Health.

Products outside of this new law will be given until the stocks are depleted, but no longer than 12 months from when the order comes into force.

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1 comment


Posted by David Whitley,

We do not know what plants were considered but not listed by BELFRIT and the Romanians. A major issue is the practicality of the mechanisms (if any) for getting consideration of plants that have not previously been considered.
While harmonisation is valuable it would be a great pity if in the process there was a net loss of access to plants that can be and currently are used safely and usefully as food supplements.
It is clear that the ideal would be a system that takes account of the way a plant is used including the dose. Without consideration of dose these lists are either unduly restrictive or not giving adequate safety.

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