For us humans they are essential, i.e. vital: Omega-3 fatty acids. Besides vitamins and miner-als, Omega-3 fatty acids are the most studied class of substances. Our body cannot produce these itself, which is why we have to regularly include them in our diet. Since they are com-ponents of every single cell in our body, they are also considered to be true all-rounders: in addition to a child’s healthy development, numerous health-promoting effects are also at-tributed to them in adulthood. Two Omega-3 fatty acids are particularly important. This is docosahexaenoic acid, DHA for short, on the one hand and eicosapentaenoic acid, EPA for short, on the other hand. They can be found in high-fat marine cold-water fish (e.g. anchovies, sardines, herrings, mackerel, tuna) as well as in special microalgae in the sea. As a result, there are many dietary supplements that are advertised with health claims for Omega-3 fatty acids. These health claims refer, for example, to heart function, maintaining normal vision or normal brain function, or blood pressure. Similarly, the intake of DHA by the mother may contribute to normal eye development in the foetus and breastfed infant. [1][2]

Health-promoting effects of Omega-3 fatty acids

As already mentioned, Omega-3 fatty acids have numerous health-promoting effects on our bodies. The positive effect of Omega-3 fatty acids on blood vessels and our heart is in turn due to their influence on blood fat levels. They lower the triglyceride level. An increased number of triglycerides in the blood can promote the development of arteriosclerosis and thus increase the risk of cardiovascular disease. They also have the property of lowering elevated blood pressure and thus prevent cardiovascular diseases. In addition, they improve blood cir-culation by firstly increasing the flexibility of erythrocytes so that the blood can flow better and by secondly lowering the blood fat values which also leads to a better flow. Omega-3 fatty acids counteract heart attacks by reducing blood clotting to a limited extent and there-fore the formation of blood clots, which can block small blood vessels, for example in the heart, and trigger a heart attack. A more recent survey deals with the danger of being afflicted by a venous thromboembolism after having already suffered one. The participants in the study were observed for three years. On the one hand, this study confirms the safety of a higher Omega-3 index; on the other hand, it opens up the field for intervention studies on the preven-tion of venous thromboses and thromboembolisms, as Omega-3 fatty acids have so far been studied primarily with regard to arterial diseases. [3] Another characteristic is the positive in-fluence on cardiac arrhythmia. They can weaken the course of chronic inflammations such as rheumatoid arthritis or inflammatory intestinal diseases. The positive influence on eye health is also worth mentioning. DHA in particular is crucial for the development and simultaneous maintenance of visual acuity and visual performance. DHA also provides protection against the development of age-related macular degeneration (AMD). DHA is particularly important for early childhood brain development, which is why it should be guaranteed that the mother has a good supply of Omega-3 fatty acids during pregnancy and while breastfeeding. It is already known that mental illness in children can be associated with a poor supply of EPA and DHA. Omega-3 fatty acids can therefore have a positive effect on depression and attention deficit disorders (e.g. autism). In addition, an improvement in general well-being and mental performance was established in healthy children and adults. [4][5]

EPA and DHA supplements

Unfortunately, marine Omega-3 fatty acids are now disappearing more and more from our diets. The 12th Nutrition Report published by the German Nutrition Society (DGE) in 2012 revealed that, even then, the German population did not eat enough fish and therefore had inadequate amounts of the Omega-3 fatty acids EPA and DHA in their systems. [6] This means that it is not only recommended for vegans to have the status of their Omega-3 fatty acids (Omega-3 index) determined by a doctor from venous blood but also for anyone who does not consume at least 300 mg EPA/DHA a day. Ideally, your Omega-3 index should lie between 8 and 11 %. In this manner, everyone can optimise their personal levels of Omega-3 with additional Omega-3 fatty acid supplements. Since EPA and DHA are mainly found in fatty fish, vegans have to turn to a vegan alternative, EPA and DHA from microalgae. How-ever, these microalgae oils do not contain by far as much EPA as the Omega-3 concentrates obtained from marine fish. [4][7]

High-quality Omega-3 concentrate’s properties

The quality of Omega-3 concentrates varies greatly. Many products are only very low dosed or become rancid after a short time, as the necessary care was not observed already during production leading to an irreversibly high oxidation level.

Therefore, a high-quality Omega-3 concentrate should have the following properties:

the maximum residue limits for peroxide value, anisidine value and toxin value should be kept as low as possible. The peroxide number (POZ) here describes the content of peroxidically bound oxygen in an oil. The peroxide number can therefore be used as a measure for the spoil-age of an oil (primary oxidation), whereby the anisidine number (AnZ) provides information about the concentration of unsaturated aldehydes (secondary oxidation). The Totox value is calculated from the peroxide and anisidine number (AnZ + (2 * POZ)) and describes an oil’s total oxidation value. The higher this value is, the more unpleasant the food supplement’s taste and smell. Experience has also shown that the tendency to suffer fishy belching is significant-ly higher when such an oil is consumed. To neutralise the fishy odour and taste, the product is deodorised with water vapour (e.g. EPAX® TGN concentrate, where N stands for neutral in odour and taste) during production. A very low content of trans-fatty acids, oligomeric frag-ments and environmental pollutants such as heavy metals, organic contaminants like polychlo-rinated biphenyls (PCBs), dioxins and several others is always desirable and should be strived for. Hydrocarbons such as dienes and also oligomeric fragments often occur when high pres-sures, high temperatures and long process times are combined during production. Therefore, it is all the more important to ensure a gentle manufacturing process so the appropriate quality of the oil is also guaranteed. Well-known manufacturers such as the Norwegian manufacturer Epax Norway AS imposed internal limit values on themselves some while ago already; these are significantly stricter than those prescribed by law, e.g. a hundred times lower than the le-gally permitted limit for mercury. Organic contaminants such as PCBs, dioxins etc. can be almost completely removed using a special, upstream ultra-cleaning step. Some manufactur-ers, on the other hand, use so-called triple distillation in their manufacturing process, which can be beneficial for the purity of the concentrate, but leads to high stress on the product and the aforementioned dienes and oligomeric fragments, for example, may arise as a result.

Polychlorinated biphenyls (PCBs) are a class of compounds consisting of 209 individual com-ponents of aromatic organic chlorine compounds that are toxic and carcinogenic. Not just the six indicator PCBs mentioned in the EU Regulation 1259/2011 are removed during the clean-ing step but many other PCB congeners too. The limit for heavy metals is kept far below the legally permissible limit by quality manufacturers of marine Omega-3 concentrates (see Figure).

Likewise, the content of residues of brominated flame retardants resulting from the ubiquitous anthropogenic pollution of the oceans should be kept as low as possible. Brominated flame retardants are mixtures of man-made chemicals commonly used in plastics, textiles and elec-tronic equipment. [8] In addition, it must be ensured that fish oils and marine Omega-3 con-centrates produced from them are also tested for radioactive contaminants. Particular attention has been paid to this issue since the nuclear disaster at Fukushima in 2011. Quality manufac-turers therefore test each batch of crude fish oil for the radioactive isotopes iodine-131 and caesium-137. Another objective is to keep the pollutant limits for phthalates (plasticisers) and 3-MCPD esters (monochloropropanediol) as low as possible. MCPD esters are undesired es-ters from various fatty acids. They are process-related contaminants in foods that occur in re-fined oils or fats. [9] The aim is to avoid the formation of MCPD esters as far as possible by using production methods that that are as gentle as possible. The Norwegian manufacturer EPAX Norway AS has such low values that a person weighing 70 kg, for example, would have to consume approx. 50 grams of Omega-3 concentrate per day (e.g. 50 1,000 mg capsules per day) in order to exceed the limit for 3-MCPD esters. The European Commission’s recom-mendation (2014/661/EU) only stipulates these limits for vegetable oils but not for fish oils; it goes without saying that a quality manufacturer of Omega-3 concentrates observes this for fish oils too. A conscientious manufacturer therefore already deals with any possible contami-nants years before the legislator rises to the occasion. [10]

The sustainability certification of an Omega-3 concentrate is very important. There are two major programmes to promote and certify environmentally friendly fisheries and aquacultures: the independent FOS and the MSC programme. FOS (Friend of the Sea) is the world’s largest organisation dedicated to sustainable and environmentally sound fishing. MSC (Marine Stew-ardship Council), founded in 1997 as a WWF (World Wide Fund for Nature) and the food company Unilever initiative, is a member of the ISEAL Alliance and has 19 regional agencies worldwide. Sustainability certifications are also repeatedly criticised by the press, with the FOS certification regularly faring better than the trade-driven MSC certification. [11]

Molecular distillation – an important process step when manufacturing an Omega-3 concen-trate

The concentrate is manufactured using a very gentle process which operates at very low tem-peratures and is called molecular distillation or short path distillation. This method differs from conventional distillation in that it already runs at low temperatures and operates in the fine vacuum range between 1 and 0.001 mbar. This type of distillation is particularly suitable for thermally sensitive products such as Omega-3 fatty acids. The molecular distillation is pre-ceded by the deacidifying of the crude fish oil. This is followed by a special cleaning step that removes environmental pollutants from the oil. Ethyl esterification is a subsequent step fol-lowed by molecular distillation. The ethyl esters are then re-esterified for the trigylcerides (TG form). It is important that this is done using gentle production methods. The enzymatic re-esterification is extremely gentle here. This is finally followed by the winterization, i.e. the cooling of the oil to produce waxes, sterols etc. Then the oil is bleached using natural bleach-ing earth, mixed and the finished concentrate is filled into barrels. [12] Fish oils intended for human consumption must comply with numerous hygiene regulations in the EU, including Regulation (EC) No. 853/2004, Regulation (EC) No. 2074/2005 and Regulation (EC) No. 2076/2005.

Different dosage forms

There is a great deal of variety in the forms of dosage exist when it comes to dietary supple-ments which contain marine Omega-3 fatty acids. There are soft gelatine capsules in different sizes which allow for different amounts of filling weight and thus different amounts of EPA and DHA at the same time. What’s more, the soft capsules can be coated with an enteric film. This means that the phenomenon which a more sensitive group of people would describe as “belching” can be completely eliminated. A classic method is to take the Omega-3 concentrate in liquid form, e.g. in a bottle. This dosage form is particularly suitable for children and elderly people who have difficulty swallowing. The oil can either be taken directly or eaten after stirring it into yoghurt, muesli or a smoothie.

Legal aspects

There are three health claims for Omega-3 fatty acids, which refer to heart function (EPA & DHA) and maintaining normal vision or brain function (DHA). The respective intake quanti-ties that have to be fulfilled by the respective food supplement must be considered here, as otherwise the claim may not be used. Two other claims refer to the triglyceride level and blood pressure (EPA & DHA). There are also claims regarding the development and health of children that may be used. The statement “The mother’s intake of DHA contributes to the normal development of the brain in the foetus and breastfed infant” may be used if an addi-tional 200 mg of DHA is taken in addition to the recommended daily intake (i.e. 250 mg DHA and EPA). This statement may therefore only be used for dietary supplements whose consumption guarantees a daily intake of at least 200 mg DHA. Any other issuing of addi-tional health claims remains to be seen. [13]

Hassle-free product: A product is only as good as the sum of its accompanying services

It should be noted that it is not only the product’s physical properties that matter. Even if these are excellent, it is important to emphasise the many years of experience and the com-mitment to absolute quality of the accompanying services in practice for a completely hassle-free marine Omega-3 concentrate (hassle-free product). This is exemplified by the Norwegian quality manufacturer Epax Norway AS’s level of service with over 180 years of experience:

A distributor who is very familiar with the specifics of the regional markets and the special legal regulations can also contribute significant added value for the customer. For instance, Goerlich Pharma GmbH has been the exclusive distributor for EPAX® Marine Omega-3 con-centrates in Germany, Austria and Switzerland for more than 10 years. Products with “EPAX® inside” are sold worldwide. Goerlich Pharma itself has over 30 years of experience in the fish oils and marine omega-3 concentrates segment. Goerlich Pharma therefore has a very experienced team from the development and project management divisions at its disposal to implement customised Omega-3 projects.
Author

Christina Spötzl
is Project Development Manager at Goerlich Pharma GmbH. After her successful professional training to become a laboratory assistant in the dairy industry, she completed a Bachelor’s degree in “Food Management and Technology”, with a focus on Healthy Eating, at the Fern-hochschule [distance learning university] Riedlingen. Alongside this, she was employed in the pharmaceuticals industry for six years.

Literature / References:

[1] Arbeitskreis Omega-3 e.V., unter: http://www.ak-omega-3.de/ (Stand: 22.03.2018)
[2] Zentrum der Gesundheit, unter: https://www.zentrum-der-gesundheit.de/tags,omega-3.html (Stand: 22.03.2018)
[3] Reiner MF, Stivala S, Limacher A, Bonetti NR, Méan M, Egloff M, Rodondi N, Aujesky D, von Schacky C, Lüscher TF, Camici GG, Beer JH: Omega-3 fatty acids predict recurrent venous thrombo-embolism or total mortality in elderly patients with acute venous thromboembolism. 2017.
[4] W. Sears, J. Sears: The Omega-3 Effect (2012), Little, Brown and Company, New York
[5] Prof. Dr. C. von Schacky: Omega-3 Fettsäuren und kardiovaskuläre Erkrankungen (2012), UNI-MED Verlag AG, Bremen
[6] 12. Ernährungsbericht der DGE, unter: https://www.dge.de/wissenschaft/ernaehrungsberichte/ernaehrungsbericht-2012/ (Stand: 22.03.2018)
[7] Prof. Dr. C. von Schacky: Warum man einen hohen HS-Omega-3-Index® haben will, 09.11.2017, München
[8] Bromierte Flammschutzmittel, unter: https://www.efsa.europa.eu/de/topics/topic/brominated-flame-retardants (Stand: 04.04.2018)
[9] EFSA: „Revised safe intake for 3-MCPD in vegetable oils and food”, unter: https://www.efsa.europa.eu/en/press/news/180110 (Stand: 04.04.2018)
[10] T. Gulbrandsen: Business Update – EPAX, 09.11.2017, München
[11] D. Lingenhöhl: „Fragwürdiges Ökosiegel“, unter: http://www.zeit.de/wissen/umwelt/2010-09/sd-oekosiegel-fischerei (Stand: 13.04.2018)
[12] EPAX: „Why Epax“, unter: http://www.epax.com/pages/why-epax (Stand: 04.04.2018)
[13] EFSA: “EFSA regulation – Health claims for EPA and DHA”, unter: http://www.1life63.com/en/research-recommended-literature-fish-oil-efsa-health-claims-marine-epa-and-dha/efsa-regulation-health-claims-for-epa-and-dha (Stand: 04.04.2018)