BioExx Specialty Proteins Ltd BIXZF

Maybe this is why it takes so long...

[Palmpje]

Found this article via Google, using 'Bioexx Helm' as key words. It gives the outcome of a second opinion regarding consumer safety, in accordance with European Regulation 258/97 concerning novel foods and novel food ingredients. Basically, if my interpretation is correct of this recommendation issued in Decembver 2012, more information regarding food safety is requested first approval by the Food Safety Authority of Ireland (FSAI). This second opinion does not say that it is unsafe, but more information is required to declare it is safe. It is another confirmation of the link between Bioexx and Helm......

 

"The protein preparation in question is produced by a Canadian
company, Bioexx Specialty Proteins Ltd. It is intended for use as an ingredient in a wide
range of composite foods. The application was submitted by a German company, Helm AG,
which wants to place the novel food on the market in the European Union. The dossier was
drawn up by Bioresco, a Swiss company."

 

"Conclusion
The VNV Committee does not agree with the FSAI’s final conclusion that this rapeseed
protein preparation can be safely used as an ingredient in food, as proposed in the dossier.
The VNV Committee takes the view that the product specification should include limit values
for each of the relevant undesirable compounds, which are discussed elsewhere in the
dossier. The Committee also feels that this specification should clearly identify the starting
material (plant species and variety) from which the protein preparation is produced.
Furthermore, according to the Committee, the extent to which consumption of the novel
protein preparation might cause allergic reactions in susceptible individuals has been
insufficiently investigated."

https://www.cbg-meb.nl/NR/rdonlyres/DE4AB6C8-051C-45B6-8D69-079C3AB5C690/0/2ndopinionrapeseedproteinNLENnonconfidential.pdf

Hang in there

Cheers

Palmpje

[Palmpje]

Gadfly - Please repost the link to the report you recently filed. That was done by a Swiss institure, and published in February 2013. What if that was the follow up to this second opinion?CheersPalmpje>

[1320racing]

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[Palmpje]

That's my point... The first 2 recommendations in this second opinion are highly administrative in nature, easy to resolve. No clue how much effort such an additional allergy study addressing the 3rd issue would take. It seems that Helm is heavily partnering up with Bioexx and that they are waiting until they have green light in the EU before making an announcement. That is my take

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[Palmpje]

Check also reference OECD11 in that second opinion report: https://www.oecd.org/science/biosafety-biotrack/49343153.pdf It feels like that the second opinion report is based on checking the items reased in OECD11. Take item 55 as an example related to that allergy recommendation, there is simply not enough information in literature to say that canola does not cause allergy reactions: 55.

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[conscience1]

MIllions of people are allergic to foods that are widely available. The population can't be tested as part of the approval process; it's not feasible. So a label warning will have to suffice. The levels of lead, pesticide, erucic acid etc. can easily be assayed from large scale lots/batches. Concern re: GM or non-GM is irrelevant in terms of the product itself; there's no reason to

[DrAudit]

ha ha ha I hear they roll their own

[gadfly222]

Palmpje - the following report dates were previous to the VNV Committee Report: Received 26 March 2012; accepted 7 November 2012. published online 16 November 2012.   Nutritional evaluation of rapeseed protein compared to soy protein for quality, plasma amino acids, and nitrogen balance – A randomized cross-over intervention study in humans https://www.clinicalnutritionjournal.com/article

[Palmpje]

Gad - Thanks for posting that link. I went back and found your original post earlier today. They are not related. If you take a step back then you see many things happening that were not shared with shareholders. Which makes sense to me, the one announcement we are all waiting for is the only thing that matters. CS said that he expexted a deal by Q3/4 2012; I think the deal with Helm AG is already

[gadfly222]

From a connection that emails BioExx: Responses to VNV findings / conclusion have been provided to the VNV by BioExx (the date of response in unknown). BioExx's regulatory counsel stated issues were not out of the ordinary and reasonable (not a deal breaker?) - whatever that means ...

[Palmpje]

Gad - Interesting data point; question is now whether the position of VNV has changed and whether they have endorsed the FSAI recommendation allowing canola protein to enter the EU market as a novel food ingredient for humans. I do not believe that the VNV conclusions were unreasonable either; timing of that approval, if they get it, is crucial for Bioexx. I am actually getting more and more

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[juanito1]

1320, I understand your concern over their filling, but if you are NOT impressed with  CS and management after two years of a painful ride in the share price..yet he still sticks with it, and Helm...to patiently still be at the table after two years of anticipation of Isolexx to be commercially viable...then your comment of being Not impressed is a silly statement...you just want

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[juanito1]

Bottom line...Helms and Bioexxs so called mis step is completely a mute point if there will be no commercial plant making Isolexx...Once we know there will be a plant making Isolexx....they will have two years to get it approved in all jurisdictions...and guess what...Helm WILL get it approved....

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[juanito1]

Think about your words before you speak...what a mindless comment ....Do you realize how much work needs to go into an agreement of this nature??? Approval is secondary to a whole host of other things...including financing the plant, GEA and their role, Selling price, buyers for the end product etc etc etc....A ton to work out...but when an Agreement comes...it will be iron clad imho....a great