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April
30, 2008
GELATIN produced in North America is considered to be
safe by Food professionals.
Gelatin, a natural
collagenous protein, is effectively used in a myriad of food and beverage
formulations. In a recent survey conducted by the Gelatin Manufacturers
Institute of America (GMIA) at a national food industry exhibit, a majority
of food formulators, research and development experts and industry
executives concluded that gelatin produced in North America is safe and of
high quality.
The
GMIA conducted this survey to better gauge perceptions about the
versatility, quality and safety of gelatin. Canvassing two hundred sales
and marketing, research and development, operations and purchasing
executives from food manufacturing businesses, the survey yielded favorable
responses for the gelatin industry. These survey results evidenced GMIA’s
position that North America gelatin producers and their gelatin products
are well respected and highly regarded in terms of functionality, quality
and safety.
Although
the food industry has long recognized gelatin as a key ingredient in
desserts and confectionery applications such as marshmallows and gummy
candies, food technologists also appreciate gelatin’s wider
versatility. Survey respondents
rated gelatin’s functionality, taste (or lack thereof) and healthy
attributes as key benefits to using gelatin in food formulations. Its
unique ability to mimic the smooth mouthfeel and texture of fatty
ingredients, gelatin – a fat-free and cholesterol-free protein – offers
product developers and consumers nutritious foods without sacrificing taste
or texture. Gelatin, a hydrocolloid with the ability to bind water, is an
ideal ingredient when gelling, thickening and stabilizing properties are
required. These properties allow formulators to reduce sugars and fats,
replacing them with water and gelatin. Because gelatin is a fully
digestible food that provides amino acids, it can be used in nearly any
food application.
Gelatin
produced by members of the GMIA is tested for quality and gel strength
according to standardized methods. The GMIA developed and adopted these
standards to enhance consistency and reliability among North American
produced gelatin. GMIA’s members also employ Good Manufacturing Practices (GMP)
to foster the purity of gelatin and promote consumer confidence.
Raw
material selections and strict production processes also enhance the safety
of gelatin. From reliable raw material selection to rigorous production
processes to comprehensive physical, chemical and microbiological testing,
the quality, safety and traceabilty of gelatin are of paramount importance
to GMIA manufacturers.
Aside
from use in food applications where gelling, binding, whipping,
stabilizing, foaming and emulsifying agents are required, gelatin is also
used in the pharmaceutical and photographic industries. In the
pharmaceutical health industry, gelatin is used to make the shells of hard
and soft capsules for medicines, dietary supplements, syrups and more. It
is highly digestible and serves as a natural protective coating for
medications. The unique chemical and physical properties of gelatin make it
an important component in the photographic industry. Gelatin serves many
useful purposes in the preparation of silver halide emulsions in the
production of photographic film and inkjet paper.
Founded in 1956, the Gelatin Manufacturers Institute of
America was established to carry on research in the manufacture and usage
of gelatin and to carry on promotional work in its uses. GMIA is comprised
of gelatin manufacturers across North America, including Atlantic Gelatin,
Eastman Gelatine, Gelita, Nitta Gelatin, PB Leiner and Rousselot.
Three cases of BSE have been identified in North America over the past two
years. Two of the diseased cattle originated in Canada and one in the
United States. Both the United States Department of Agriculture
(USDA) and the Canadian Food Inspection Agency (CFIA) are taking
appropriate steps to limit the safety impact on all animal products.
The GMIA assesses that these three isolated and well contained cases have
not compromised the safe source supply chain of any of its members in any
way and is pleased to reconfirm its Affirmation of Gelatin Safety, which is
stated below.
New international research has confirmed that gelatin
manufacturing processes remove and/or inactivate any contamination by BSE
pathogens that might have accidentlly entered into the manufacturing
process in spite of all precautions having been taken with the raw
material. These results once again reaffirm that gelatin is safe for human
consumption in all its varied forms and applications. For a complete
summary of this new international research go to www.gelatine.org and visit
the "Latest News" section.
The Gelatin Manufacturers Institute of America
("GMIA") affirms that gelatin is safe for human consumption in
all of its varied forms and applications. No scientific evidence linking
gelatin with Bovine Spongiform Encephalopathy, commonly known as BSE or
"mad cow disease," exists.
The TSE Advisory committee continues to review and
assess the scientific information on BSE. The GMIA has worked cooperatively
with this Advisory body since its inception with respect to the safety of
gelatin. The TSE Advisory Committee recently assessed results of validation
studies conducted by independent researchers concerning the reduction of
infectivity resulting from various steps of the bovine bone gelatin
manufacturing process. With these new research results, the TSE Advisory
Committee declared "these studies demonstrate a reduction in
infectivity that is sufficient to protect human health." The Committee
urged FDA to reassess the requirements for raw materials used in producing
bovine bone gelatin in light of the very positive research results on
reduction of infectivity resulting from the gelatin manufacturing process.
For a transcript of this TSE Advisory Committee meeting go to: www.fda.gov/ohrms/dockets/ac/03/transcripts/3969t1.htm
The member companies of the GMIA strongly support the
FDA Guidance and they carefully comply with its current provisions. GMIA’s
views can be summarized as follows:
- Source materials used for the manufacture of gelatin,
including bovine hides/bones and porcine skins/bones are safe. According to
the World Health Organization (WHO), these tissues are considered to be
free of any detectable BSE infectivity.
- Gelatin manufactured in the United States for
food,drug and cosmetic uses is made from pig skins or from cattle hides or
bones which are sourced from healthy animals slaughtered in plants
inspected by the U.S. Department of Agriculture (USDA) in this country,
and, to a small extent, from other countries with similar veterinary health
services inspection practices. Gelatin manufactured by GMIA members in
Canada for food, drug and cosmetic uses is made exclusively from pig skins
which are sourced from healthy animals slaughtered in plants inspected by
the Canadian Food Inspection Agency (CFIA) or in plants inspected by the U.
S. Department of Agriculture (USDA). BSE surveillance testing programs are
well-established in the United States and other countries where raw
materials are sourced.
- There have been no cases of BSE-like diseases
observed in pigs anywhere in the world under natural conditions.
- During gelatin processing, raw materials are exposed
to extensive purification procedures including prolonged exposure to either
acid or alkaline conditions, or both, processes that have been demonstrated
to provide a safe gelatin supply for consumption. The raw materials are
also exposed to other processes such as sterilization, filtration, and
demineralization which have also been shown to significantly enhance the
safety of gelatin.
- Gelatin continues to maintain its Generally
Recognized As Safe status.
- The GMIA continues to proactively monitor BSE-related
scientific and regulatory developments worldwide.
Accordingly, the GMIA can confirm that gelatins
manufactured in the United States or by GMIA member company affiliates in
other countries, for import into the United States, are in full compliance
with the current recommendations of the FDA Guidance. We are confident,
based on all currently available scientific data and information, that
gelatin is safe for use in foods, drugs and cosmetics, a position that is
supported by the FDA, World Health Organization ("WHO") and
European Union Scientific Steering Committee (EU S.S.C.).
For additional information, contact any of the
organizations listed here.
International Food Information Council
("IFIC")
Attention: Nick Alexander, Allison Esser, or
Tony Flood
1100 Connecticut Avenue N.W., Suite 430
Washington, DC 20036
Telephone No. (202) 296-6540
Or send e-mail to: Flood@IFIC.org
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-12
Rockville, Maryland 20855
Mailing address:
5600 Fishers Lane
Rockville, Maryland 20857
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