Petfood Industry - January 2018 - 44

44 | www.PetfoodIndustry.com

PETFOOD INSIGHTS

David A. Dzanis, DVM, PhD, DACVN

How to convene a GRAS panel
for novel pet food ingredients
Regardless of whether notification to FDA is made,
convening a panel of experts to review and opine on the
available data to support safe use of an ingredient is perhaps
the best means of confirming GRAS status. To that end, pet
food and ingredient companies considering this approach
should take heed of FDA's advice in forming and convening
a panel. The 30-page document offers significant detail in
this regard. Considerations should include:

1

Appropriate and balanced expertise of
panelists

Convening a panel of experts
to determine the GRAS status
of a pet food ingredient has
advantages, regardless of
whether you intend to notify
FDA of the outcome.

The US Food and
Drug Administration
(FDA) has recently
provided draft guidance on best practices
for convening a GRAS
endostock, Fotolia.com
(Generally Recognized
As Safe) expert panel
(see sidebar, "Relevant FDA links"). The determination of a
substance as GRAS is one means to allow for use of a novel
ingredient in pet foods distributed in the United States.
This method of documenting safety has its advantages and
disadvantages over other processes (e.g., filing a Food Additive Petition or an AAFCO Feed Ingredient Definition), but
is best reserved for substances where the vast bulk of the
available supportive data is in the public domain. Formal
notification of FDA as to a determination of a substance as
GRAS is not legally required, but for practical purposes is
usually prudent in the case of animal feed ingredients. 

The experts comprising a GRAS panel are essentially
serving as proxies for the scientific community at large. No
one person can be an expert on everything, so diversity
in training and perspective among panelists is critical in
ensuring that all aspects of safety are addressed. While the
number of panelists needed to attain this wide range of
expertise may vary, I have found in my experience serving
on quite a few panels that at least three experts are usually
needed. 
„ Much of a GRAS dossier includes data to address not only
acute and chronic toxicity, but also factors such as mutagenicity and carcinogenicity. In my opinion, presence of a
toxicologist on the panel is paramount.
„ Obviously, the expertise of a nutritionist is critical to
any evaluation of a substance intended for its nutritive
value. However, even for a non-nutritive substance, such
as a preservative or anticaking agent, the fact that it is
intended to be in the food and/or drinking water requires
a careful assessment of anticipated intake of food/water
by the animal so that the estimated exposure to the
substance can be reliably determined.

Dr. Dzanis is CEO of Regulatory Discretion Inc. and a writer and consultant on nutrition, labeling and regulation. He is also the
author of Petfood Industry magazine's monthly column, "Petfood Insights."

January 2018

Industry


http://www.PetfoodIndustry.com http://www.Fotolia.com

Table of Contents for the Digital Edition of Petfood Industry - January 2018

Petfood Industry - January 2018
Contents
Top 2018 pet food trends: clean label, full transparency
Industry News
New Products
WellPet: focus on freeze-dried, raw meat premium pet food
3 pet food trends that continue to redefine the industry
Top pet health trends impacting pet nutrition research
Addressing health issues in older dogs with pet food
What to expect from FSMA pet food safety inspections
Petfood Forum Asia: innovation for rising pet food markets
How to convene a GRAS panel for novel pet food ingredients
Agar-agar: Gelling agent option for canned dog and cat foods
US pet food market to reach US$27 billion in 2018
Marketplace
Advertiser’s Index
Petfood Industry - January 2018 - CT1
Petfood Industry - January 2018 - CT2
Petfood Industry - January 2018 - Petfood Industry - January 2018
Petfood Industry - January 2018 - Cover2
Petfood Industry - January 2018 - 1
Petfood Industry - January 2018 - Contents
Petfood Industry - January 2018 - 3
Petfood Industry - January 2018 - Top 2018 pet food trends: clean label, full transparency
Petfood Industry - January 2018 - 5
Petfood Industry - January 2018 - Industry News
Petfood Industry - January 2018 - 7
Petfood Industry - January 2018 - 8
Petfood Industry - January 2018 - 9
Petfood Industry - January 2018 - New Products
Petfood Industry - January 2018 - 11
Petfood Industry - January 2018 - 12
Petfood Industry - January 2018 - 13
Petfood Industry - January 2018 - 14
Petfood Industry - January 2018 - 15
Petfood Industry - January 2018 - 16
Petfood Industry - January 2018 - 17
Petfood Industry - January 2018 - WellPet: focus on freeze-dried, raw meat premium pet food
Petfood Industry - January 2018 - BB1
Petfood Industry - January 2018 - BB2
Petfood Industry - January 2018 - 19
Petfood Industry - January 2018 - 20
Petfood Industry - January 2018 - 21
Petfood Industry - January 2018 - 3 pet food trends that continue to redefine the industry
Petfood Industry - January 2018 - 23
Petfood Industry - January 2018 - 24
Petfood Industry - January 2018 - 25
Petfood Industry - January 2018 - 26
Petfood Industry - January 2018 - 27
Petfood Industry - January 2018 - 28
Petfood Industry - January 2018 - 29
Petfood Industry - January 2018 - Top pet health trends impacting pet nutrition research
Petfood Industry - January 2018 - 31
Petfood Industry - January 2018 - Addressing health issues in older dogs with pet food
Petfood Industry - January 2018 - 33
Petfood Industry - January 2018 - 34
Petfood Industry - January 2018 - 35
Petfood Industry - January 2018 - What to expect from FSMA pet food safety inspections
Petfood Industry - January 2018 - 37
Petfood Industry - January 2018 - 38
Petfood Industry - January 2018 - 39
Petfood Industry - January 2018 - 40
Petfood Industry - January 2018 - 41
Petfood Industry - January 2018 - Petfood Forum Asia: innovation for rising pet food markets
Petfood Industry - January 2018 - 43
Petfood Industry - January 2018 - How to convene a GRAS panel for novel pet food ingredients
Petfood Industry - January 2018 - 45
Petfood Industry - January 2018 - 46
Petfood Industry - January 2018 - 47
Petfood Industry - January 2018 - Agar-agar: Gelling agent option for canned dog and cat foods
Petfood Industry - January 2018 - 49
Petfood Industry - January 2018 - US pet food market to reach US$27 billion in 2018
Petfood Industry - January 2018 - 51
Petfood Industry - January 2018 - 52
Petfood Industry - January 2018 - 53
Petfood Industry - January 2018 - Marketplace
Petfood Industry - January 2018 - 55
Petfood Industry - January 2018 - Advertiser’s Index
Petfood Industry - January 2018 - Cover3
Petfood Industry - January 2018 - Cover4
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