Fish Oil Manufacturing Process
November 6, 2011
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GRN No. 193 (Summary)
Company                Peluva Biotech
Substance:             Fish oil (predominantly sardine and anchovy); tuna oil

Intended Use:        Use as direct food ingredients in the food categories listed in 21 CFR 184.1472(a)(3) at levels
                 that are no more than 67 percent of the levels specified in 21 CFR 184.1472(a)(3)

The two substances that have been determined to be Generally Recognized As Safe (GRAS) and are thus the subject of
this GRAS notification are products derived from fish oils, commonly called Eupoly-EPA and Eupoly-DHA. Both products
are manufactured by Puleva Biotech, and are principally composed of triglycerides although may contain small amounts
of mono- and diglycerides. The main differences between Eupoly-EPA and Eupoly-DHA are their contents of the omega-3
fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), being approximately 20% EPA and 10% DHA
for Eupoly-EPA and approximately 10% EPA and 20% DHA for Eupoly-DHA. These differences in EPA:DHA ratios are due
to the different sources of the crude oils used to produce Eupoly-EPA and Eupoly-DHA. Eupoly-EPA is obtained mainly
from the oil of sardine and anchovy and Eupoly-DHA from tuna oil.

Eupoly-EPA and Eupoly-DHA are substantially similar to other fish oils that are already regarded as GRAS for addition to
foods, including menhaden oil (21 CFR 184.1472), small planktivorous pelagic fish body oil (GRAS Notice GRN 102),
salmon oil (GRAS Notice GRN 146), anchovy-sardine 18/12 TG fish oil (GRAS Notice GRN 138), Marinol Omega-3 fish oil
derived from anchovy, sardine and mackerel (GRAS Notice GRN 105), and tuna oil (GRAS Notice GRN 109).

The intended uses of Eupoly-EPA and Eupoly-DHA are to enrich foods in EPA and DHA and replace saturated unhealthy
fats in existing foods (partly) with long chain polyunsaturated fatty acids. Eupoly-EPA and Eupoly-DHA will merely provide
an alternative to menhaden oil or other fish oils as sources of EPA and DHA in the diet. Therefore, no incremental
increase in potential intake of combined EPA and DHA combined will result from the proposed uses of Eupoly-EPA and

Eupoly-EPA and Eupoly-DHA are fish oils suitable for their use in the preparation of (functional) foods because of their
high stability and optimal organoleptic characteristics. Both are liquid oils at room temperature and have a clear and
yellowish appearance.

Fish Oil Manufacturing Process
The manufacturing plant was designed around the principle steps in obtaining edible oils: refination, decolorization,
deodorization, mixing, and stabilizing the final product. Therefore, the fish oil manufacturing process starts with crude fish
oils and consists in a series of chemical and physical operations similar to the ones used commonly in refination of edible
oils (e.g. olive and sunflower oils). As a consequence, fish oils rich in Omega-3 fatty acids are obtained that are suitable
for human consumption and their incorporation into food. The final products are packaged into bag-in-box containers and
sold to other companies within the Ebro-Puleva group as well as to external companies.

Initial steps of manufacturing process
A 1000 L container full of raw fish oil is situated at the beginning of the plant with the help of an electric fork-lift truck. The
oil is passed to a 1500 L container using a volumetric pump. At this point it is possible to mix in the container several
batches of oils with the purpose of obtaining an oil with the right fatty acid profile. This mixing of different oils is sometimes
necessary since the fatty acid profile and the EPA+DHA content of the raw oil is not always the same (sum of EPA+DHA
and their ratio may differ somewhat from batch to batch). By mixing different batches of crude fish oil with different EPA
and DHA contents it is possible to obtain final products with the desired EPA-DHA profile and content. All this is possible
because from each 1000 L container of raw fish oil a fatty acid analysis is performed in the laboratory.

Neutralization and washing
Once all the oil is in the 1500 L container and mixed a series of chemical-physical procedures are performed on the oil in
a fully automatic way. The whole process is controlled from the control room by taking on-line measures (temperature, pH,
pressure,flow rate, etc.) at several points in the process and correcting these to the values
previously determined. The first treatment that is performed is the neutralization of the oil’s free acids. Therefore, the oil is
heated until 60ºC by interchange of heat from hot plates, and a solution sodium hydroxide is added and admixed until the
oil is neutralized.

After neutralization, the mix is pumped to a centrifuge where the oil is separated from the paste. The paste, consisting of
free fatty acids, is passed automatically to a 50 L container. Once a week this container is emptied and the paste is
transported to the byproducts warehouse before it is taken away and processed as industrial waste.
Then, the neutralized oil is pumped into a container from where it is submitted to a washing step. This operation consists
in the mixing of the neutralized oil with warm waterand subsequently the separation of both phases by centrifugation. In
this way small paste particles that may be still present at this point are removed from the oil.

After washing, the oil is passed to a container where it is subjected to a vacuum treatment to remove any remaining
moisture still left in the oil. After the vacuum treatment, the oil is then retained in another container where silica is added
to the oil. This step is necessary to eliminate any remaining paste and/or moisture. After the silica addition the oil and
silica are separated by filtering. The oil is then pumped to the decolorization reactor. In this reactor a mix of decolorizing
earths and active carbon is added to the oil and incubated during 30 min. After the incubation the oil is filtered again to
remove the earths and active carbon. The reason for adding a small amount of active carbon to the decolorization
reaction is to improve the ability of the earths to absorb the color of the oil and thereby improving its
stability. The active carbon also absorbs contaminants like PCB´s, dioxins and heavy metals that might be present in the
crude oil. In this way these contaminants are reduced to a minimum, and are always below the permitted levels.

Deodorization is performed by injecting water vapor into the oil. In this way volatiles that give the fishy smell and taste to a
fish oil are removed by evaporation. These volatiles leave the deodorization container through the vacuum system and
are then condensated and deposited in a stainless steel container. This deposit that contains mainly fatty acids is
emptied periodically and its content stored in the by-products warehouse until it is taken away by a specialized waste

After the deodorization step the oil is cooled, and stabilized by the addition of antioxidants. The antioxidant blend that is
admixed at this point is a mix of natural products consisting of tocopherols and some other food grade antioxidants.

After the addition of the antioxidant, the oil is passed to a stainless steel deposit and from there it is packaged. Packaging
is done manually using a filler machine normally used for nutritional oils and fats. The oil is pushed to the filler by
overpressure in the deposit. The operator holds the mouth of an aluminum bag in the opening of the filler, and this
machine automatically fills the bag with oil, injects nitrogen gas to remove remaining air, and closes the bag. The operator
takes the bag away and stores the bag in a carton box.
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