The focus here at British Sea buckthorn often revolves around the question what is sea buckthorn. There are many websites that provide information on phtyochemical content and potential benefits, but we all know that when it comes to selling product regulations require benefit claims to be substantiated by scientific evidence.
The EU evidence review body has really struggled to provide any positive judgements on botanical sourced claims. The subject becomes clouded by natural biochemical complexity and regulatory requirement to meet highly defined clinical trial results.
It has been an interesting week therefore when it was reported that a court in Italy had thrown out an Italian Competition Authority ruling against a company making claims on fermented extract of papaya. The ruling had followed EU Nutrition and Health Claim directive legislative guidance, but the court ruling is said to effectively voided the Health Claims regs in Italy – at least for a while.
There has also been an interesting turn in the novel food regulations accepting SME’s will not be charged for making bringing a novel food through the regulatory process.. Add to that the statement today that the EU intends to deliver rulings on nutritional profiling and botanicals in 2016, which was supposed to be completed in 2009.
There is then the discussion at the European Food Safety Agency that decision has to be more open. Science is about challenging peers; about scepticism; about finding the nearest approximation of the truth. The new head of EFSA talks of developing a process of structured open data, allowing IP to be released through a patent style fee paid system. Call me an optimist, but coming from an SME perspective when funding R&D is challenging, the potential that regulators may become seen as more transparent and able to work with innovators not obstruct them can only be good news.
Sea buckthorn is a multi functional botanical facilitated by a highly complex soup of biochemicals. There is a wealth of research that pushes and prods at creating an understanding of the methodology and chemical pathways that may be associated with benefits that have been emerged from practical use.
As someone that wants to bring sea buckthorn to market and recognises some of these practical outcomes from years of personal use, it is frustrating not to have definitive clinical trials that have swept that EFSA with accredited claims. It is not surprising however with botanicals remaining in limbo with EFSA that funding clinical trials does not find favour with investors. Again as an optimist, and working within regulations I am sure its wider use will develop as more people try and discover its potential for themselves.
