Color Additives: Current Thoughts on Biological Safety, also titled Colorants: Current Thoughts and Recommendations for Biological Safety, reviews the many concerns around color additives as well as different types of testing that should be used.

1. Color Additives: Current Thoughts on
Biological Safety
Don R. Pohl
Senior Principal Scientist
NAMSA

2. 2
Overview
 Basis for Concern - Why does it appear the FDA
is asking about colorants?
 Significance of listing colorants in CFR
 Role of biocompatibility
 Role of vendor supplied information
 Role of extractables testing and risk assessment

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Basis for Concern

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There are three key items that help answer
why colorants are a present concern
 Information from FDA website
 FDA comments from deficiency statements and discussions with
reviewers
 Draft Guidance released April 23, 2013 regarding replacement for
Blue Book Memorandum #G95-1

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FDA Website
 The following are some of the documents on FDA’s
website that discuss the use of colorants:
 Food, Drug and Cosmetic Act
 Code of Federal Regulations
 FDA Public Health Advisory

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Role of Biocompatibility

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“Complete” biocompatibility testing of
final devices are not enough in all cases

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 Depending on information available, more
biological data may be needed: genotoxicity,
reproductive toxicity and/or carcinogenicity. ADME
mentioned as well
 Vendor biocompatibility data may be useful, but
not enough to answer everything
 Biocompatibility testing alone may not be sensitive
enough to address the issue

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Role of Vendor Supplied
Information

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 Data from vendor of the color additive is
imperative
 Identity of each specific color additive is
needed in the device
 Information allows risk of the color additive to
be initially assessed
 Lack of identity does not allow for assessment
to be performed as risks cannot be established

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Role of Extractables Testing
and Risk Assessment

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 Risk Assessment can play two roles in this process
 Initial evaluation of what is known
 If exposure is possible, can evaluate if 100% is
available what is the risk
 Extractables Testing
 Becomes the source of additional information
 FDA has commented on several approaches to
extractables testing of color additives

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 To view the full series about Color Additives: Current
Thoughts on Biological Safety
 Visit NAMSA Seminars
 For information about the services NAMSA offers
 Check out the pages on our website on Biocompatibility or
Material Characterization & Analytical Chemistry
 Download our Biocompatibility brochure or our
Extractables/Leachables brochure
 If you have any questions or would like to request a quote
 Contact us at clientcare@namsa.com.