Controlling Quality in Fish Oil Production

Popularity comes with a price. Omega-3 fatty acids have achieved star status among dietary nutrients, thanks to widespread health benefits research and a growing number of ways consumers can purchase and take omega-3s. Fish oil has dominated this spotlight, as it continues to rack up positive results on major health issues such as inflammation, heart disease and mental development. However, meeting the higher demand in both volume and innovative delivery forms, fish oil products have faced specific quality control challenges. The key to the longevity of this market is in how fish oil producers address these issues.

Fish oil product quality focuses on two main issues: the health of the fish and the health of the humans consuming the fish oil. As a byproduct of fishing, crude fish oil production is affected by the health of the fish population. Different species have battled over-fishing, heavy metal contamination and varying omega-3 levels. On the other end, the health benefits linked to fish and fish oil consumption have indicated health benefits at specific doses, sometimes ratios, of the primary fish oil omega-3s, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Thus, it is important for fish oil products, like other dietary supplements, to contain what their labels promise.

Certain fish are rich in DHA and EPA due to the algae in their diets. This may be direct, or fish may eat other marine animals that have fed on omega-rich algae. The food chain is important in fish health and quality, as contamination can also work its way up the food chain. However, pollution around the world is also responsible for contaminated oceans and rivers. Methylmercury is the big, bad wolf of fish toxins, though fish can contain any number of heavy metals (cadmium, lead), PCBs, chloridane, DDT and dioxins. These toxins have greatly affected the seafood industry, as contamination levels in certain fish have risen dramatically over the past few decades.

Oceans Alive, an arm of the Environmental Defense watch group, maintains a list of fish differentiated by species known to contain high levels of mercury and other contaminants versus species thought to be low in toxins. Another resource is Natural Resources Defense Council (NRDC), which maintains a number of resources on tracking marine mercury, which can have debilitating effects on brain and nervous system health in humans, especially children and pregnant women.

Despite any environmental laws, there is little way for anyone to clear the fish populations of contaminants, which can start as air pollution (or result from natural processes such as forest fires) and settle into the world's waterways, eventually seeping into marine life. Thus, fish oil producers must accept this issue of contamination and deal with it via technology, such as distillation.

However, this was not a widespread practice years ago. According to Adam Ismail, executive director of the Global Organization for EPA and DHA (GOED), the fish oil industry got together seven years ago, recognizing quality issues such as contamination could become a concern for their market in the future. The international band of fish oil companies helped create a Voluntary Omega-3 Monograph, under the auspices of a Council for Responsible Nutrition (CRN) omega-3 working group. In 2006, they created GOED as an official trade association, replacing the working group, with a charge of furthering the quality of the fish oil market via expansion of the voluntary monograph. The list of founding members reads like a who's who of omegas—including DSM, Croda, Ocean Nutrition Canada (ONC), EPAX, Lipid Nutrition, Marine Nutraceuticals, Martek Biosciences and OmegaPure.

Ismail gives credit to these companies and others that have joined the pursuit of fish oil quality for virtually ridding the market of contaminants. William Rowe of Nutrasource, which provides third-party lab testing across the entire fish oil product chain, agreed the industry stepped up when it came under pressure years ago. "The processing and technology in use now for fish and marine oils are so sophisticated," he said. "There are fantastic technical methods companies employ to remove contaminants, if [toxins] are even in there to begin with."

As evidence of this progress, ConsumerLab.com recently conducted its biggest test on fish oils to date, finding all 50 of the tested supplements, foods and beverages containing fish oil ingredients were found safely free from heavy metal and other contamination. Moreover, the products, which contained between 16 mg to over 1,000 mg per serving, all met label claims for EPA and DHA, without any signs of spoilage.

"We've seen multiple times in the natural products industry how one negative media report can have a great affect on the market," Ismail said. "The way the fish oil industry has handled the contamination quality issue should be a case study for segments of the natural products industry."

For fish oil industry's efforts in ridding the market of contaminants, there are many factors working in their favor. For one, contaminants tend to collect in the meat of the fish, not as much in the oil. Then, the fish used for fish oil are generally species not on the lists of highly contaminated fish. Rowe noted most fish oil is produced from small fish that have short life spans and are lower on the predatory food chain; therefore, they don't bioaccumulate. "Shark, King Mackerel, albacore tuna and other big fish atop the predatory chain are at higher risk of bioaccumulating dioxins and PCBs," Rowe said.

Also helping with the contamination issue is the fact that the bulk of fish oil supply—a byproduct of fishmeal production—comes from fisheries in a select few locations in the world, which are keenly monitored. Almost all of the world's fish oil supply comes from fisheries in Peru, with additional supplies from Morocco and the United States.

"The Peruvian upwelling region, where the cold Antarctic waters meet the steep, continental shelf off the west coast of South America, is one of the richest marine environments in the world," said Lori Covert, VP of marketing & communications at Ocean Nutrition Canada. "This fishery is highly regulated and protected by the Peruvian government to ensure that it remains biodiverse, environmentally responsible, and entirely sustainable."

"Governments in Peru, Chile and Morocco heavily regulate this fishing," Ismail assured. "They go out and take regular sonar readings of fish populations, and every fishing boat utilizes a GPS system for tracking. They figure out how much they can catch, and they'll shorten the season as necessary. They have a good understand of what the reproduction rates are and other parameters of the population size and health."

Solveig Hellebust, vice president of human relations and communications at Pronova BioPharma ASA, said IMARPE (Instituto del Mar del Per) monitors fishing very thoroughly. IMARPE, established in 1963 by the Peruvian government, has verified the anchovy population used for fishmeal and fish oil is in good biological shape.

Andrew Jackson, technical director if the International Fishmeal and Fish Oil Organisation (IFFO), conceded the whole sustainability issue is of growing importance, but agreed increasing efforts are being made to demonstrate this. "The two biggest fisheries for fish oil are the South American anchovy fishery, principally in Peru, and the menhaden fishery in the United States," he echoed. "Both these fisheries are very tightly managed and the fish stocks are currently in very good shape."

The fish commonly used for fish oil production include species such as anchovies, sardine and mackerel. Oceans Alive and ED rank anchovy, mackerel and sardine among its eco-best. Fish in danger of over-fishing include species more commonly served at restaurants, such as certain types of wild salmon, sea bass and tuna. However, salmon oil supplements tend to be sourced from farmed salmon, which can be more easily controlled for eco-factors including sustainability and even contaminants.

"In farming, we have a high focus on traceability and contaminant analyses of both feed and salmon produced in the whole value change from egg to harvest salmon," noted Knut Erik Gulbrandsen, Marine Harvest Ingredients. "For industrial fish, you have no traceability and must build up records from batch to batch of contaminants."

Gulbrandsen stressed traceability is a big factor in markets where there are many hands in the proverbial pot, including fisheries, refiners, importers, exporters and other manufacturing partners. One of the issues is degradation, which is most often due to oxidation. The nature of DHA and EPA is their long-chain structure, which is both good and bad. The long, polyunsaturated chain is key to the health benefits of EPA and DHA, but this structure also renders it susceptible to oxidation. As Gulbrandsen puts it, "No product, in my understanding, will be better than the starting point." This is why he touts traceability and control over all steps in the process of a finished product.

Given degradation can happen over time, the period of time between catch and finished fish oil supplement rollout increases the risk of oxidation and degradation of the omega chains. However, here again, the better part of the industry is in good shape. "When we pass finished fish oil supplement products, they've already been through molecular or steam distillation, so by the time it hits us, it is on spec," Rowe said. "Even in the case of raw materials, the oil has already gone through the clean-up by the time we get it, and we don’t see any degradation of the DHA and EPA content at all."

Jackson said IFFO has seen this positive trend in the market. "The raw fish oil is purchased by the manufacturers following a tight specification on fatty acid content, oxidation and contaminants," he explained. "They then take the raw oil and refine it, and they can then blend different oils to get the exact EPA/DHA level they want for their application. In the United States and Europe, there are very tight rules on the acceptable contamination levels and on the labeling of products, as well as on the health claims that can be made."

The European Union (EU) is still sorting out its regulations on fish oil, but the United States has established guidelines. The EPA sets limits for heavy metals, as well as methods for detection. The World Health Organization (WHO) also has established models for contaminant detection that overlap EPA guidelines on toxins such as PCBs.

In Europe, the food regulations going into effect in November 2008 will change the status of fish oil supply imports from "feed quality" to "human food grade," according to Gulbrandsen. He noted it is not normally possible to upgrade from feed to food grade, but the new hygienic rule will change this.

"The pending hygienic rule means that fishing boats and fish oil factories shall satisfy hygienic rules according to food standards, not feed," he said. "This is a big battle going on at the moment." He said the biggest problem in Europe is opposition to increased quality requirements for fish oil headed to the EU human market. "There are a lot of cowboys looking for good deals," he said, referring to importers buying low-grade fish oil for cheap and selling to the human market for greatly increased prices. These "cowboys" are resisting the hygienic rule and other changes.

For salmon oil, in particular, Gulbrandsen reported some importers of fish oil argue that crude fish oil quality does not matter, as they are refining the products. "It's only half of the story," he argued. "The analytical quality (free fatty acids, peroxides, etc.) can be low shortly after refining, but you don't get rid of core aldehydes, free radicals will soon start oxidation, giving rancidity. In a fresh, high-quality raw material you have low levels of core aldehydes, and oxidation starts much later."

As Rowe pointed out, there are two primary issues with fish oil quality: safety (presence of heavy metals and other contaminants) and efficacy (presence of DHA and EPA in the right amounts for health benefits). With contamination control in the fish oil market mostly solved—it comes down to process control and, now, GMP adherence, the prevailing issue is omega content. This certainly is affected by oxidation and degradation, which changes the chemistry of the long-chain fats, but there are other factors involved.

Given the manner in which fish acquire and build-up DHA and EPA levels (diet of algae or of other fish that eat algae), the levels of these omega-3 fatty acids can vary. In fact, there is some concern the DHA levels of fish used for crude fish oil are getting lower. While Jackson said IFFO has seen no evidence of such DHA waning in fish used for fish oil, Ismail said it is occurring, at least in some areas.

"Fewer fish in South America are producing high DHA levels," he contended. "The reason why some companies don't talk about it is because the impact isn't that big." There is no danger of DHA levels disappearing, he noted, but the lower levels still need to be addressed by manufacturers, especially if it affects the content of their finished product with specific label content claims. "It's a natural fluctuation, so it may go back the other way in the next few years or even by the next fall catch.”

"The content of EPA/DHA is very close to 30 percent of the fatty acids in the oil," Covert reported, noting the ratio can shift relative to the latitude and other factors. "This is related to the temperature of the water and the amount of sunlight (the microalgae makes the EPA and DHA). Surely, El Nino is one of the many factors."

Hellebust recognized the changing DHA levels in fish, but he couldn't put his finger on the cause. "No one has a clear explanation why," he said. "It is most likely related to what the fish is eating."

Gulbrandsen combined both sentiments. "I expect natural seasonal effects of fatty acids composition; fish composition before and after spawning is a good example," he said, adding he doesn't exactly see why fatty acid changes in some years. "It could be based on the composition of feed sources lower down in the pyramid, as in who is eating whom."

Ismail suggested it is possible such fluctuation could have happened in the past but the fish oil market was smaller, so the impact would have been lighter. In fact, GOED reported the fish oil market today is about 18 times bigger than it was in 2001, when the voluntary monograph was conceived. This expanding market is now taking a greater share of the crude oil supply. At 1 million metric tons, the fish oil human market is still only 6 percent of the global crude fish oil supply (the remainder goes to aquaculture and agriculture); but, now that the human segment is taking more oil than in the past, Ismail speculated there could just be more demand for a small amount of existing high-DHA oil.

Lower DHA content might affect the ratio of EPA:DHA in resultant fish oil supplements and other products. If this affects finished product content, any label content claims, such as specific ratios, would have to be changed or risk misbranding.

Covert explained omega-3 manufacturers buy fish oils with different ratios of EPA and DHA, and blend them in different proportions to obtain an 18:12 ratio. "Few companies still follow this old practice and still use 18:12 oil," she said. "Today, most of the Omega-3 market (by volume) use fish oil with 30 percent content of EPA and DHA ... [which] is almost constant in the Peruvian fishery."

Testing a large portion of the fish oil products in the U.S. and Canadian market, Rowe said Nutrasource primarily sees the 18:12 and 40:20 ratios, although other ratios are becoming more prevalent. "We do see ratios like 70:10 or 60:10, most commonly for products catering to depression and mood applications," he said. "We also see 10:30, 10:40 and 10:50, as the DHA-heavy products are tailored more for paternal health or other DHA benefits, such as in ocular health." He noted in last 18 to 24 months there have been more customized ratios for specific health conditions, in addition to more combination products such as omega-3 and coenzyme Q10 (CoQ10) for cardiovascular health.

While varying DHA levels in fish is one oft-debated influence on omega content, Rowe reiterated DHA and EPA levels are very tied to oxidation/degradation. Oxidation is big part of what labs test in fish oil products. This includes stability studies and finished product oxidation testing. These tests help establish shelf life and expiration dates. "Oxidation and EPA/DHA levels go hand-in-hand," he said, declaring oxidation is the single most challenging issue facing the fish oil supplement industry. "The answer is in both technology and process controls."

Still, whether oxidation or decreasing omega levels in fish, the end goal is a quality fish oil product that contains what it promises on the label. The ConsumerLab test results showed great compliance with label claim among a huge list of finished fish oil products. Some insiders like Gulbrandsen and Jackson don't see why fish oil products need be in 18:20 ratio. As with other standardized natural products, the 18:20 ratio was simply a formula used by one of the first quality fish oil products on the market.

As is normally the case, the subsequent fish oil products followed this lead, to keep pace with the product on the market. Soon, it became a standard. However, it is not a definitive standard based on research. In fact, the levels of DHA and/or DHA required for health benefits varies greatly depending on the health condition. This means the types and amounts shown in research to benefits cardiovascular health are different from the levels used in eye health or joint inflammation studies. If fish oil product formulation is, as reported, becoming more customized to specific health benefits, it is likely the 18:12 ratio will become less and less the standard.

The present and future quality of the fish oil market depends on many links in the product chain, from fisheries and raw material importers to testing labs and manufacturers. The industry cannot rest on its gains in the areas of contamination, but must continue to improve purification technologies, tweak testing methods, fight oxidation and tie products (i.e. ratios/levels) to researched benefits. The other trick is dealing with those companies ignoring the testing requirements and existing resources like the Voluntary Fish Oil Monograph and innovative technologies. The good news is the trade associations represent almost all of the world's fish oil companies, meaning nearly the entire industry segment has committed to quality control.

"We work closely with the value-chain as well as the regulatory authorities to ensure that the products are safe and sustainable," Jackson said. "However, our members just produce the raw fish oil; how this is refined and converted into its final form is carried out by others."

Many of these others are GOED members. "There are not a lot of companies in our membership, which covers 90-percent of the world's production, that are not following the monograph," Ismail touted. "I think that's part of why [quality improvements] been successful."

Covert added achieving the highest quality is achieved by producing, testing, warehousing and transporting fish oil supply and product according to cGMPs and HACCP guidelines.

In fact, many in the fish oil industry suggested fish oil segment's handling of quality issues should serve as a model for other parts of the natural products industry, especially botanicals, as herbal supplements and other plant-based products and foods have been the subject of many recalls and quality gaffes in recent years. Fish oil has not had the same frequency of problems recently, but is still under suspicion in a media apparently undereducated on the fish supply and processed used to make fish oil products. There's something fishy about that, given the strides the fish oil companies have made.

The Quality Control section is sponsored by Ethical Naturals; however, the company does not review or approve editorial content.