Quality
and Safety of Omega-3 Products
by
Morten Bryhn, MD, Ph D
2/11/2003
Omega-3 fatty acids are important
for maintaining good health and prevention of diseases.
This claim has been reinforced by statements from the American
Heart Association and the World Health Organisation. Pronova
Biocare is striving to produce the best quality products
to the nutritional supplement market.
Omega-3
fatty acids are generally regarded as important for maintaining
good health and prevention of diseases. Prestigious national
and international bodies such as the American Heart Association
and the World Health Organisation recommend regular intake
of omega-3 fatty acids. It is therefore anticipated that
omega-3 fatty acids will be one of the fastest growing dietary
supplements in the years ahead. Previously the consumers
were mainly interested in low prices but now quality and
safety are the most important issues driving the choice
of the consumer. This will lead to a preference for suppliers
capable of meeting this challenge. Producers of cheap, inferior
products are leaving the arena to a few serious players
that will dominate the market. Pronova Biocare is one of
these and our brand on the product label will guarantee
that the customer is getting the best product available.
The
raw material for Pronova Biocare’s omega-3 products
is fish oil from fisheries on the west coast of South America,
where nutrient rich cold water from the Antarctic region
runs northwards in the Humboldt Current. The fish oil produced
in this region is a co-product of fishmeal production. It
is used both for making fish feed for the salmon farming
industry and for companies like Pronova Biocare using the
oil for production of food supplements. The oil from the
Humboldt Current fisheries is high in omega-3 fatty acids
and low in industrial pollutants.
Many
industrial pollutants are fat-soluble and will therefore
end up in fatty fish. At the Pronova Biocare factories the
crude fish oil is purified in several steps, some of which
are patented process unique to our products. Even if fish
oil products containing about 30% omega-3 fatty acids are
also purified, the concentrates typically containing 60%
are by far the most pollutant free omega-3 products on the
market. The environmental toxins in focus are PCBs, heavy
metals like mercury and lead, dioxins and polybrominated
flame retardants (the recent industrial pollutant coming
from PC- and TV-waste). Our concentrates are usually lower
in these pollutants than the fish sold in the region where
the products are marketed.
Exposure
to oxygen makes omega-3 fatty acids rancid. Prevention of
oxidation is therefore, the second most important quality
issue, next to removal of pollutants. At an early stage
of production the crude fish oil is prepared according to
a patented technology removing oxidative components. Later
oil tanks and processing equipment are flooded with nitrogen
in order to prevent the oil getting in contact with oxygen.
The end product is kept in specialised containers covered
with a nitrogen blanket. Well inside the capsules, the oils
are not exposed to air, so there is no need for having nitrogen
in the capsules. The final product contains a small amount
of natural vitamin E for stabilisation of the product.
Pronova
Biocare is one of two producers in the world qualified by
the US Food and Drug Agency for producing omega-3 pharmaceuticals.
The fish oil, intermediate products and the end product
are controlled according to predefined quality standards
using state of art analytical methods. Routine audits by
health authorities are done on a regular basis to ensure
that the products are produced in accordance with Good Manufacturing
Practice (GMP), the highest quality standard.
Pronova
Biocare is continuously engaged in developing new processes
for better handling of the omega-3 fatty acids. Working
with polyunsaturated oils is very challenging and costly.
New and patented concentration techniques using special
enzymes have been implemented. These methods will allow
us to process the oils at low temperatures, which will further
improve the careful processing we use today. Being a supplier
of products targeting human health needs, quality is always
our top priority.
The omega-3 concentrates are capsulated in soft-gel capsules
by industrial partners with a long experience in this field.
About 15% of all pharmaceuticals on the market are capsulated
using similar encapsulation technology and the materials
and processes used in the production of Pronova Biocare’s
products meets pharmaceutical standards.
Holding the market authorisation for an omega-3 pharmaceutical,
the Pronova Biocare organisation is well prepared for the
challenge of producing good quality documentation for our
products. More than 70 controlled clinical studies in patients
and healthy individuals have been published on the omega-3
concentrates used in our food supplements. Pronova Biocare
therefore has, without comparison, the best-documented omega-3
concentrates on the market. Several thousand patients and
healthy people have used the product since mid-80’s
meaning that the concentrates are very well documented regarding
safety. A special issue on safety has been published in
a medical journal (1)
Soon
omega-3 food supplements are expected to be as common as
multivitamins. New omega-3 fortified food products may appear
in the supermarkets and some beverages will contain a certain
amount of omega-3. Most of the products will be based on
concentrates, since these are the best-documented omega-3
products regarding quality and safety. Omega-3 will increase
the daily intake of an essential nutrient that may significantly
reduce the risk of getting cardio-vascular disease and maintain
mental health and vitality.
REFERENCE:
1) Schmidt
EB, et al. Safety aspects of Fish Oils. Experiences with
an omega-3 concentrate of re-esterified triglycerides. Drug
Invest. 1994;7(4):215-220
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