CFR (Code of Federal Regulations) with Colorants help wanted

[NikkiQSM]

Hello All -

Anyone understand what I need to get here:

CFR section to which the color additives comply (with clarification on whether it conforms to CFR for amounts, dye specs, etc)

Certification that additive is from a batch that does not need to be certified in accordance with 706c (they also list 21 CFR 73 part D and 21 CFR 74 part D as references for exemptions)

Wanted to Add: Our company provides compounded plastic pellets which contain types of colorants, and / or fillers.


Any help on clarifying this for me would be greatly appreciated.

[Stijloor]

A Quick Bump!

Can someone help Nikki?

Thank you very much!!

[Ronen E]

In Reply to Parent Post by NikkiQSM

Hello All -

Anyone understand what I need to get here:

CFR section to which the color additives comply (with clarification on whether it conforms to CFR for amounts, dye specs, etc)

Certification that additive is from a batch that does not need to be certified in accordance with 706c (they also list 21 CFR 73 part D and 21 CFR 74 part D as references for exemptions)

Wanted to Add: Our company provides compounded plastic pellets which contain types of colorants, and / or fillers.


Any help on clarifying this for me would be greatly appreciated.

Not sure what exactly you're asking

I'm not an expert on food regulation -- don't those parts refer to food additives?...

If you're in the business of compounding plastic pellets (including any colorants / other additives) for medical devices manufacturers to further mold, I'm not sure that the above (and the like) apply. Maybe if those pellets are used in food packaging... not sure though. For medical use the gold standard would be the ISO 10993 family, and this actually applies in finished product form. If you could explain what are your concerns / goals, maybe more focused help can be provided.

Cheers,
Ronen.

[NikkiQSM]

From what I have been able to find out about this:
Some colorants used in plastics have limitations / maximum allowable amounts. These amounts are stated by the FDA and I need to certify that they do not exceed that maximum.

21 CFR Section C & D both pertain to food & drug, and after a lot of research I was able to some-what find out what I need to do.

Thanks for the help!

[AnaMariaVR2]

What is the ultimate goal of this colorant? would it be inside a patient? as food or outside as polymer in cosmetics? packaging? medical device? it is not quite clear what you are asking...by colorant do you mean a color additive? Just trying to see who has jurisdiction...

Hope this helps:
Colorcon's Regulatory Information Sheets
http://www.colorcon.com/services/reg/General-Info

Colors in Cosmetics: Regulation and Nomenclature in the United States
http://www.ctfa.org/colors-cosmetics-regulation-and-nomenclature-united-states

Good luck

[NikkiQSM]

The customer needs a break down of every additive in the plastic we compound for them. They extrude the compound into medical catheters.

The colorant is used to color the plastic and yes it can and will be inserted into the human body.

[AnaMariaVR2]

May I assume the customer is the sponsor as well?

Color Additives Regulation For Medical Devices:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/ucm142716.htm

The Food, Drug and Cosmetic (FD&C) Act states that devices containing a color additive are considered unsafe, and thereby adulterated, unless a regulation is in effect listing the color additive for such use.

Therefore, the customer needs a complete list of all colorants in the plastic if not, it will be considered adulterated. Whoever manufactures this plastic should provide a complete listing of all colorants used.

Color Additives In Medical Devices:
http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InMedicalDevices/default.htm

More on Color Additives for Industry:
http://www.fda.gov/forindustry/coloradditives/default.htm

Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices:
http://www.fda.gov/forindustry/coloradditives/coloradditiveinventories/ucm115641.htm

[Ronen E]

Great post, AnaMaria! I learned something today


Ronen.