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CFR (Code of Federal Regulations) with Colorants

B

BerryBerryGud

#21
#21
Hi Julien,
In my opinion, an approval of a substance in the past for an application that is different than yours can give you a comfort level that it might be good in your application; however I think (just opinion) that you are going to be required to prove that it is safe in your application. There are just too many variables.
I did not investigate alternative black colorants in the project where Carbon Black was used. I was convinced that the colorants we had used were safe. I am aware that other colorants are out there - its just that in my experience Carbon Black is one of the most common colorants for people seeking a black or gray color.
The extraction study was quick (done in a week, once we started) and it wasn't that expensive either. The most time consuming part was planning it, and getting the agency to approve the plan. I also had a board certified toxicologist write a report that assessed the colorant in general, and in light of the extractions. The conclusion (in our case) was that what we expected - that the colorant remained in the polymer and was not extracted.
On the second project, we had used a colorant from a company that specializes in medical grade colorants. They provided a MAF access letter - so then the examiner could look at the master file.
Neither one of my products seem like they are as invasive as yours - they were both surgical devices with brief contact with the body. This is a factor that is also included in the toxicology risk assessment.
If I were in your shoes, I would be inclined to go the extraction + toxicology risk assessment route. I would also find someone who has written several such reports in the past. I used a very well known medical test lab in Northwood, Ohio for both the extraction and the report and was really happy with the results. Note that I am not affiliated with that lab in any way, I was just a customer.
Good luck.
BBG :cfingers:
 
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Ronen E

Ronen E

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#22
#22
BerryBerryGud said:
Hi Julien,
In my opinion, an approval of a substance in the past for an application that is different than yours can give you a comfort level that it might be good in your application; however I think (just opinion) that you are going to be required to prove that it is safe in your application. There are just too many variables.
I did not investigate alternative black colorants in the project where Carbon Black was used. I was convinced that the colorants we had used were safe. I am aware that other colorants are out there - its just that in my experience Carbon Black is one of the most common colorants for people seeking a black or gray color.
The extraction study was quick (done in a week, once we started) and it wasn't that expensive either. The most time consuming part was planning it, and getting the agency to approve the plan. I also had a board certified toxicologist write a report that assessed the colorant in general, and in light of the extractions. The conclusion (in our case) was that what we expected - that the colorant remained in the polymer and was not extracted.
On the second project, we had used a colorant from a company that specializes in medical grade colorants. They provided a MAF access letter - so then the examiner could look at the master file.
Neither one of my products seem like they are as invasive as yours - they were both surgical devices with brief contact with the body. This is a factor that is also included in the toxicology risk assessment.
If I were in your shoes, I would be inclined to go the extraction + toxicology risk assessment route. I would also find someone who has written several such reports in the past. I used a very well known medical test lab in Northwood, Ohio for both the extraction and the report and was really happy with the results. Note that I am not affiliated with that lab in any way, I was just a customer.
Good luck.
BBG :cfingers:
Click to expand...
Thank you BBG for such an informative post!
It also matches my own experience with FDA Master Files.
Have a good one,
Ronen.
 
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