Re: The no preservative preservative Biovert

[Guest guest]

>It contains potassium thiocyanate. The manufacturer claims this is not

>a major component of the system therefore is not required to be

>included in the INCI nomenclature (is this true?).

Good question.

This is what the regulations say:

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21 CFR 701.3(l) The provisions of this section do not require the

declaration of incidental ingredients that are present in a cosmetic at

insignificant levels and that have no technical or functional effect in

the cosmetic.

For the purpose of this paragraph, incidental ingredients are:

(1) Substances that have no technical or functional effect in the

cosmetic but are present by reason of having been incorporated into the

cosmetic as an ingredient of another cosmetic ingredient.

(2) Processing aids, which are as follows:

(i) Substances that are added to a cosmetic during the processing of

such cosmetic but are removed from the cosmetic in accordance with good

manufacturing practices before it is packaged in its finished form.

(ii) Substances that are added to a cosmetic during processing for

their technical or functional effect in the processing, are converted

to substances the same as constituents of declared ingredients, and do

not significantly increase the concentration of those constituents.

(iii) Substances that are added to a cosmetic during the processing of

such cosmetic for their technical and functional effect in the

processing but are present in the finished cosmetic at insignificant

levels and do not have any technical or functional effect in that

cosmetic.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=701.3

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and this is what the Biovert FAQ says:

http://www.archpersonalcare.com/ProductDocumentation/Technical%20Data%20Sheet/Bi\

overt%20FAQ%20v%201.1.pdf

---------------------------------------------

The Biovert enzyme solution contains glucose oxidase and

lactoperoxidase

The Biovert substrate solution contains glucose along with two

ESSENTIAL ingredients, potassium thiocyanate and potassium iodide, at

very low concentrations. As these formulating aids are used at

concentrations of less than 1% and do not contribute efficacy to the

substrate solution alone they do not need to appear in the INCI

nomenclature. Upon addition of the Biovert enzyme solution into the

final formulation, these aids are ACTIVATED.

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I added the capitalization for emphasis.

Personally, I don't see how two ESSENTIAL ingredients that are

ACTIVATED in the final formula can be considered to be incidental

ingredients.

Looks like abuse of the FDA's regulations.

>A quick google of

>potassium thiocyanate produces an MSDS that reads like a horror story

>and it's general use as a pesticide and fungicide (is this true?). Is it a

>concern to have this chemical in skincare? Does it accumulate in the

>body's tissues or organs?

I am not familiar with the uses of potassium thiocyanate.

>It's effectiveness drops when temperatures reach over 35C. I am

>thinking of hot Australian summers and postal conditions.... for

>effectivity to drop does it need to only be exposed to that temperature

>once or does it need to be maintained constantly at that temperature to

>comprise the system?

A Biovert brochure says that:

" Biovert should not be exposed to process temperatures in excess of 40ø

C. In elevated storage trials, typical emulsion based products

containing

Biovert are able to withstand BP challenge testing after more than two

months storage below 40ø C, three months at 37ø C, six months at 35ø C

and over two years at 25ø C.

This robust enzyme based system is being utilized by manufacturers of

consumer products the world over. Sales have been made to extremely hot

equatorial countries such as Ecuador right through to freezing cold

climates like Iceland. "

>They claim that high levels of cationic surfactants can compromise the

>system, forgive my ignorance of chemical basics, but are cationic

>emulsifiers like BTMS grouped in this category?

Yes.

>The above are all questions that are not addressed by the company's

>FAQ on the Biovert system, so any clarification on the above points

>would be gratefully received.

, you should compare the cost of using a Biovert preservative

system to other preservative systems.

Biovert (aka Myavert C) has been around for about 10 years. You should

ask yourself why don't more cosmetic companies use Biovert. I know of

one large " natural " company that tried Myavert C and had to do a

product recall because of contamination. They don't use Myavert C or

Biovert any more.

Maurice

--------------------------------------------------------

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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[Guest guest]

I have a question that is somewhat unrelated. The highlighted paragraph would

indicate to me that in the case of soap (labelled in the US as a cosmetic) would

not require sodium hydroxide to be listed in the ingredient list.

Would you agree Maurice?

cathy Sutton.

Good question.

This is what the regulations say:

---------------------------------------------

21 CFR 701.3(l) The provisions of this section do not require the

declaration of incidental ingredients that are present in a cosmetic at

insignificant levels and that have no technical or functional effect in

the cosmetic.

For the purpose of this paragraph, incidental ingredients are:

(1) Substances that have no technical or functional effect in the

cosmetic but are present by reason of having been incorporated into the

cosmetic as an ingredient of another cosmetic ingredient.

(2) Processing aids, which are as follows:

(i) Substances that are added to a cosmetic during the processing of

such cosmetic but are removed from the cosmetic in accordance with good

manufacturing practices before it is packaged in its finished form.

(ii) Substances that are added to a cosmetic during processing for

their technical or functional effect in the processing, are converted

to substances the same as constituents of declared ingredients, and do

not significantly increase the concentration of those constituents.

(iii) Substances that are added to a cosmetic during the processing of

such cosmetic for their technical and functional effect in the

processing but are present in the finished cosmetic at insignificant

levels and do not have any technical or functional effect in that

cosmetic.