RE: RE: RE: RE: RE: Money No one (!) can give a guarantee for a positive outcome of this authorisation procedure in Europe whatever an applicant has spent in money and efforts. The system in the EU is very much different and significantly mor stringent than in the USA. The GRAS (US) procedure is basically a notification process of a self-confirmed safety assessment. The FDA can object or accept this self-assessment. Finished.
Since the early 2000s when the EFSA was established in Europe, the stadards became the highes in the world. Whatever new substance, may it be a flavouring, an enzyme in food production, a new packaging material, a pesticide, a GMO, a novel food, a colour agent, a new feed ingredient....all these undergo a tough procedure.
Read about Danone, Unilever, Nestle... they all failed in the last years to get approval for propiotic health claims made on food... Helm is a nobody compared to these companies.
IF it was that easy to get green light at the EFSA as you or CS suggest than the procedure would have already stopped positively in Ireland. But it did not.
Ireland issued a positive view on BXI/Helm rapeseed protein, but apparently the Netherlands objected:
https://www.cbg-meb.nl/NR/rdonlyres/DE4AB6C8-051C-45B6-8D69-079C3AB5C690/0/2ndopinionrapeseedproteinNLENnonconfidential.pdf see page 7:
"Findings of the VNV Committee
The VNV Committee objects to the authorization of this rapeseed protein preparation as a
novel food ingredient, as there is insufficient data to conduct a safety assessment....."
Apparently also The United Kingdom has expressed concerns against this application:
https://acnfp.food.gov.uk/meetings/acnfpmeet13/acnfpmeet13feb/acnfpagpa13feb
"5. Rapeseed Protein: The Committee will consider the applicant’s response to its questions and concerns about this novel ingredient ACNFP/109/2"
This is only The Netherland and the United Kingdom, both "heavy weights" in food safety in Europe. As far as I am aware, Irland, UK and the Netherlands are the only EU Member States who publish their statements on Novel Food applications. Two of them (Netherlands, UK) expressed objections and concerns. How many of the other 24 EU Member States? Germany, Austria, Sweden, Finland have very similar standards as Netherands and the UK. We don't know about the content (and kind of concerns) of their statements sent to the EU Commission. Isolexx is not 100 % pure protein, but it certainly contains also undesirable substances - which may have been of concerns for some EU Member States in addition to allergenicity. This EU procedure is very intransparant, because the very most of the EU States do not publish their statements.
If it was that clear, then no EU Member State would have objected. But they did.
The fact that at least 2 Member States objected lead to the involvement of the EFSA which can overrule the EU Member State views. I still believe that Isolexx finally will get green light in the EU, but I also see the uncertainties including the timing and the permitted applications (uses) of rapeseed protein. Have a look on the EFSA Webpage
https://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoader?panel=ALL
Filter the "food sector area" for novel foods and enter "search".
Some novel food applications have been submitted in 2011 - but still not finished yet (!) e.g. "Astaxanthin" or "Arracacia Xanthorrhiza"
Fortunately, the EFSA has to publish its assessment and provide the reasoning for the approval/approval under certain conditions/refusal.