bosley
- 20 Feb 2004 09:34
garyble
- 06 Dec 2006 11:19
- 22830 of 27111
Jim/Oblo,
FSA should read FDA I think.
Also, I recall the statement being typically vague:
"Starpol 3000 is expected to be confirmed as fully compliant under the same regulation and we expect approval in turn for this within weeks"
Does not state that they have applied for FDA approval but does imply that they assume approval to be a formality as Starpol 2000 was already approved.
We all know that "weeks" could mean any number of them, similar to the "several hundred GS conversions".
jimward9
- 06 Dec 2006 11:28
- 22831 of 27111
sorry my mistake Gary but you knew what i ment.
Huhtami, Klkner Pentaplast, both use plastic films and supply bio products supplied by Naturworks USA.
RPC Group use plastic and bio films supplied by a co in bristol uk (BEBO)
garyble
- 06 Dec 2006 11:43
- 22832 of 27111
Yep, I did Jim.
Re: FDA approval:
"Under the PMN process, a notification becomes effective 120 days after the date of receipt by FDA, unless FDA determines that, based on the data and information before the agency, the use of the substance is not safe and FDA objects to such notification within the 120 day period. If FDA does not object within 120 days to the use of a food contact substance that is the subject of a PMN, the substance may be legally marketed for the notified use".
greekman
- 06 Dec 2006 11:48
- 22833 of 27111
The 3 mentioned all supply food containers, film coverings to such containers, but can't find anything on their web sites to put them into competition with SEO re SEO having a far better, cost effective, produce keeping product.
Before anyone mentions the obvious, all these 3 companies products are up and running, whereas SEO's are not.
Innovations in every manufacturing field are always just around the proverbial corner.
Todays innovation is tomorrows old hat.
It is often said the most modern up to date product is the next one.
Let's hope the next one it SEO.
I am sure that the likes of Walmart/Asda will have compared ALL packaging products against SEO's.
We all know the SEO packaging package is a good product and presumably if it was not, Walmart/Asda would have been out of the SEO game long ago.
But as often been stated. If you can't sell it, it's not earning money sitting on the shelf.
Tonyrelaxes
- 06 Dec 2006 11:58
- 22834 of 27111
Gary - yep! There is no formal "approval" - it occurs by default. ie. if the FDA do not say no within 120 days it is OK.
So when (if?) did SEO submit their application/data?
The Chief Executive's statement dated 31 July 2006 said "Starpol 3000 .... food contact approvals are being sought".
That statement was 128 days ago.
Why no news?
greekman
- 06 Dec 2006 12:29
- 22835 of 27111
Tony,
The statement dated 128 days ago say's,Starpol 3000 .... food contact approvals are being sought".
That could mean being sort in the future, so the date of submission may have been later.
Just nit picking perhaps.
Don't have time at the mo to delve deeper.
Will look later, unless someone posts the submission date.
garyble
- 06 Dec 2006 12:35
- 22836 of 27111
I got the impression from the prospectus that they were still playing around with the formulation of Starpol 3000.
oblomov
- 06 Dec 2006 13:02
- 22837 of 27111
Sorry, FDA approval.
Tony, I'm sure there was something in May which suggested the approval application was in - I'll have a look after lunch!
Mad Pad
- 06 Dec 2006 13:03
- 22838 of 27111
Why then did the AGM statement say that approval was expected within weeks?That was in May of this year.
oblomov
- 06 Dec 2006 13:46
- 22839 of 27111
Just about to say the same, Pad.
From the AGM Statement, dated 2nd. May:-
'As announced on 14 February 2006, Starpol 2000 now has the
relevant US FDA approval, along with its European equivalent. Starpol 3000 is
expected to be confirmed as fully compliant under the same regulation and we
expect approval in turn for this within weeks'
This implies the application was already in. Of course, within weeks if taken literally doesn't mean much - it could mean 200 weeks.
May 2nd was about 30 weeks ago, or 210 days. Given the 120 day rule, there are are two possibilities.
1) The application didn't go in before about the 10th August (i.e. approx 120 days ago), which doesn't tie in with the AGM statement.
2) Approval wasn't given.
I'm afraid I have to go for 2) - I think Starpol 3000 has suffered the same fate as Greenseal and they've gone back to the drawing board.
oblomov
- 06 Dec 2006 13:49
- 22840 of 27111
Sorry, I've missed a 3rd possibility.
3) Starpol 3000 has gained approval but SEO haven't told anyone.
I still go for 2), as it seems unlikely SEO wouldn't have told us - I'm sure they would have grabbed at any reasonably positive news to put out over the past couple of months.
garyble
- 06 Dec 2006 14:23
- 22841 of 27111
From the open offer prospectus:
"Starpol 3000 - a family of multilayered thermoplastic materials with up to 100 per cent. biodegradability and sustainability. Starpol 3000 materials can combine the properties of different biodegradable materials to give higher functionality and competitive overall cost. Formulations of Starpol 3000 materials also provide gas and moisture barriers required for MAP matching industry standards. The product has completed initial stages of development and food contact approval is being sought"
garyble
- 06 Dec 2006 14:27
- 22842 of 27111
Also:
"Starpol 3000 is the next product from Biotec and is nearing completion. The material is expected to provide barrier properties that are equal or better than traditional non-biodegradable plastics"
Prospectus is dated 9th October 2006.
Can an incomplete product be submitted for approval?
Mad Pad
- 06 Dec 2006 14:52
- 22843 of 27111
Well spotted Garbyle,then how could it have been submitted for approval early this year if it had not been fully developed or have I missed something?Infact strictly speaking you could say that as at 9/10/06 Starpol 3000 did not exist as it was "nearing completion"!
greekman
- 06 Dec 2006 15:30
- 22844 of 27111
An Environment assessment on Starpol was approved by the FDA on 11th October 2005.
There is no FDA record of Starpol 2000 or Starpol 3000 being either submitted or assessed. Although the approval on 11th Oct 2005 includes Starpol 2000, although this (the approval of Starpol 2000 is not separately mentioned).
This leads me to believe that Starpol is the initial product name requiring assessment, with Starpol 3000 being assessed, without a separate FDA record as it is initially and fundamentally the same product with an added ingredient that by itself is not required to be tested. It it did require a full approval testing, why is there no FDA record of either submission or/and approval.
Are there any chemist, chemical type brains out there who can clarify, when a product improvement does or does not require an FDA full assesment.
oblomov
- 06 Dec 2006 16:01
- 22845 of 27111
The AGM statement said 3000 is expected to be confirmed as fully compliant under the same regulation and we expect approval in turn for this within weeks'
Would/should it have used the word 'approval' if it didn't need approval? And why the 'within' weeks if approval wasn't needed?
garyble
- 06 Dec 2006 16:24
- 22846 of 27111
Greek,
FCN 558 is I think the approval of Starpol 2000:
Food Contact Substance {FCS}:
"1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol, adipic acid, hexamethylene diisocyanate and not more than 1 percent by weight of a polyhydric alcohol, as described in FCN 372."
Notifier/Manufacturer of the FCS:
Stanelco Plc
Intended Use:
For use in blends with food-contact polylactide polymers used to produce single use food-contact trays
Effective Date:
February 10, 2006
garyble
- 06 Dec 2006 16:27
- 22847 of 27111
I also believe that each product in the range has to be approved due to varying chemical composition and possibly impacting of safe daily intake.
greekman
- 06 Dec 2006 16:35
- 22848 of 27111
Oblomov,
Not saying it does not need approval, just asking if when a product that has been approved (Starpol 2000) and an improvement is made (Starpol 3000) is FULL testing required and approval required for the product as a whole or just for the added ingredient. The statement 'under the same regulation' ,could that mean it is only any none adverse effect of any additional substance. Just asking.
There is no record on the FDA site re submission or approval for Starpol 3000, which I find confusing.
Garyble,
Just read your post. It is strange that Starpol 2000 is still not mentioned on the FDA site.
Did you find your info via the SEO site as I did re Starpol 2000.
FCN 558 relates to Starpol on the FDA site (2000) is not mentioned.
I will stay confused.
oblomov
- 06 Dec 2006 16:53
- 22849 of 27111
You're not the only confused, greek.
My last few emails to SEO have gone unanswered or I'd ask if they could clear up the confusion. Does anyone have any more success than me communicating with them?