This week, BGG received Novel Food approval from the Food Safety Authority of Ireland for its AstaZine astaxanthin products, enabling the Chinese ingredient manufacturer to launch the range into Europe.
The authorisation came in the form of a ‘substantial equivalence opinion’, in which the FSAI ruled that BGG’s astaxanthin oleoresin was permitted for sale in the EU on the basis that it was ‘substantially equivalent’ to existing products on the market.
Dosage vagaries
Following the approval, AstaZine can be used in food supplements “at the current levels of usage”. Asked what this means in terms of specific dosages, Christian Artaria, CEO of BGG Europe and CMO of BGG group, admitted the situation was “slightly unclear”.
“There is no fixed dose level in the EU, which is why we applied for approval at common levels of usage. In the EU, between 2-4mg would usually be considered a normal level of usage, based on risk analysis using EFSA [European Food Safety Authority] statements as a starting point. However, we would advise customers to check with the food authorities in individual member states whether they consider this an acceptable level,” he told NutraIngredients.
He said the usage rules were much more clear cut in the USA, where BGG has successfully petitioned the US FDA (Food and Drug Administration) with two New Dietary Ingredient (NDI) notifications. The most recent was submitted this week, and authorises AstaZine to be used at doses of up to 24 mg/day for a period of 30 days - making it the first astaxanthin product to be notified at high dosage levels.
Heavyweight back-up
BGG has only been present on the European market since February, but although the firm is a new player on the European block, globally, BGG is one of the largest producers of astaxanthin and owner of the second largest farm in the world. It is also the only producer to have organic (National Organic Program) certification for the Haematococcus pluvialis algae produced on its farm and for its spray dried powder.
“We are one of the leading astaxanthin producers worldwide, so we are entering the European market from a strong position. European companies now have the option of sourcing astaxanthin from an established supplier they can count on and with different USPs - including the organic NOP status of our micro-algae,” said Artaria.
However, the certification doesn’t cover the oleoresin production process, which means that at present, companies formulating supplements for sale in Europe cannot claim on-pack that they are ‘organic’, even though they are made from algae that has been organic certified to US standards.
Whilst he couldn’t put specific figures on the size of the astaxanthin market in Europe, Artaria reported that the carotenoid is generating increasing interest from supplement companies looking for alternatives to traditional herbals.
“I believe that astaxanthin is seen as something new - it is an ingredient that many companies and consumers are only just discovering. From a health perspective, research has been wide ranging, focusing on eye health through to skin health. At BGG we are currently focusing our research on its benefits as a sports nutrition ingredient,” he said.
When BGG opened its Swiss office in February, Europe accounted for 15% of its global sales, and
the focus was on three key products: bilberry extracts, liquorice extracts and tocotrienols. In the nine months that have passed, Artaria said sales had “exceeded expections”, as the company had established a broader base of customers, including small and medium sized businesses.
Now that AstaZine is authorised for sale in the region, Artaria said that the “fourth pillar” in BGG’s core portfolio had been added to its European offering, and that his goal was to grow BGG’s European business to over 20% of group sales by 2017.