* Fish Oil Quality Standards and Toxins August 28 2012

Human activity has led to the pervasive contamination of the planet ecosystem, including its even most remote parts. Oceans and rivers and fish that live in them are not an exception. Consumers should be aware of two types of contaminants are frequently present in fish and in fish oil:

  • Heavy metals. Heavy metals that may be present in fish are Arsenic (Arsenicum), Lead (Plumbum), Mercury (Hydragyrum), and Cadmium (Cadmium)
  • Environmental toxins. Toxins that may be present in fish are the families of related in structure compounds called polychlorinated dibenzo p-dioxins (aka dioxins or PCDDs) and polychlorinated dibenzo furans (aka furans or PCDFs), and polychlorinated biphenyls (aka PCBs), including dioxin-like PCBs. PCBs used to be intentionally created in the industrial process; dioxins and furans are by-products of the industrial activity. In their impact on human health, dioxin like PCBs from the PCBs family are similar to dioxins and furans and are therefore particularly hazardous.

When consumed in quantities above safe limits, these heavy metals and toxins may lead to cancer, reproductive issues and create other health complications.

 

A number of regulatory bodies around the world set the limits on the acceptable levels of those contaminants in food items, water, and nutritional/dietary supplements. Below is the list of authoritative bodies that set widely recognized standards:

  • Food and Drug Administration (FDA) - USA, 
  • World Health Organization (WHO) - International,
  • California Safe Drinking Water and Toxic Enforcement Act of 1986, mostly known as Proposition 65 - California, USA. The Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program and maintains and updates a list of toxins that are known to cause either reproductive problems or cancer. The list currently has over 900 known toxins. The Act does not prohibit selling food or supplement items with those dangerous compounds, but requires placing a warning on the label if any such compounds are present. The exception is if the compound is present within the limits that pose "no significant risk".  

 

Professional organizations and trade associations dealing with fish, fish oil, and dietary supplements also establish acceptable limits that they either recommend or mandate to their members. The standards are either based on or closely match those set by the regulatory bodies. Among such professional organizations are:

  • Global Organization for EPA and DHA Omega-3 (GOED) - a not-for-profit Trade Association that establishes standards for its members,
  • Council for Responsible Nutrition (CRN) - Dietary Supplement Industry Trade Association, USA/International,  
  • European Pharmacopeia (EP) defined by the Council of Europe - an official Pharmacopeia of the European Union, a compendium that contains directions for the identification of samples and the preparation of compound medicines,
  • United States Pharmacopeia (USP) defined by United States Pharmacopeial Convention - an official US compendium that contains directions for the identification of samples and the preparation of compound medicines,
  • International Fish Oil Standards (IFOS) is a voluntary testing and reporting program by Nutrasource Diagnostics, a Canadian contract research organization and testing laboratory. The program tests samples of the fish oil supplements and assigns a star rating to a product.

In addition to the limits on heavy metals and environmental toxins, some organizations established standards for oxidation, which is used to measure freshness of the oil. High oxidation of the fish oil leads to strong fishy odor and to what is known as "fish burps", and consumes anti-oxidants within the body, particularly vitamin E.

We compiled the strictest and the most comprehensive standards in the table below. The cells with the strictest limit for a compound are colored in blue; those strictest limits were used as a baseline for setting BlueMedNet standards for Omega3HealthEliteTM

 

 

 

Legend:

  • mg -    miligram
  • mcg -  microgram = 1/1000 of a mg
  • ng -    nanogarm  = 1/1000 of a mcg 
  • pg -    picogram = 1/1000 of a ng 
  • TEQ -   toxic equivalent 
  • ppm - parts per million = 1 mg/kg  = 1 mcg/g
  • ppb - parts per billion  = 1 mcg/kg = 1 ng/g
  • ppt - parts per trillion  = 1 ng/ kg   = 1 pg/g
  • bw - body weight
  • KOH - potassium (latin: Kalium - K) hydroxite, KOH/g is used to measures acidity 

Note: calculated standards as described below are italicized in the table 

Note on the California Proposition 65 standards:

No significant Risk Level (NSRL) is defined by the Act for carcinogens (e.g., lead, arsenic, cadmium, dioxins, furans) as the level calculated to cause no more than 1 case of cancer in 100,000 individuals exposed to that level on a daily basis for 70 years.

No significant risk for the compounds classified as reproductive toxins is called “no observable effect level” (NOEL). Maximum Allowable Dose Level (MADL) is established as 1/1000 of the NOEL level. It is an exposure level, which even when multiplied by 1,000 will not produce birth defects or other reproductive harm.

Where no limits were set to date in parts per unit (e.g. 1 ppm) of a dietary supplement or fish oil, we recalculated the available NSRL and MADL to allow meaningful comparison. The recalculated California Prop65 levels shown in the table are A) the strictest one from NSRL and MADL, then B) divided by 20 to limit the maximum daily exposure from 2 softgels of the dietary supplement to 10% of the total maximum exposure (or 5% per softgel).  

Note on the WHO standards: Certain standards of WHO and European Union are set in acceptable exposure per kg of body weight per day or per week. The recalculated WHO levels shown in the table are A) the WHO number B) multiplied by 50 kg (a theoretical person of 50 kg body weight ~ 118 lb), C) divided by 7 if the WHO number is per week, D) divided by 20 to limit the maximum exposure from the 2 softgels of the dietary supplement to 10% a day (or 5% per 1 softgel). 

Where no calculation is shown, it is the limits set in the WHO Monograph for certain medicinal plants.

Note on the FDA standards: Some FDA standards that were only defined for a certain item are marked as such (e.g., the strictest available for Mercury is that for Menhanden oil). We chose to include these standards to provide an idea of the FDA standards that might be applicable to the dietary supplements. Certain standards of FDA are set in provisional total tolerable intake levels (PTTILs) per day. The recalculated FDA levels shown in the table are A) the strictest FDA number (e.g. 6 mcg of lead PTTIL is that for infants) B) divided by 20 to limit the maximum exposure from the 2 softgels of the dietary supplement to 10% a day (or 5% per 1 softgel).

You can find more information about the heavy metals and environmental toxins here:

  • California OEHHA:                               http://www.oehha.ca.gov/prop65/p65faq.html
  • California Attorney General’s Office:     http://caag.state.ca.us/prop65/index.htm
  • Proposition 65 news:                           http:/www.prop65news.com
  • Environmental Law Foundation:            http:/www.envirolaw.org 
  • FDA:                                                 http://vm.cfsan.fda.gov/~dms/qa-top.html
  • USP:                                                 http://www.usp.org/aboutUSP/contactUs.html?h
  • CRN about Omega-3:                          http://www.crnusa.org/pdfs/O3FINALMONOGRAPHdoc.pdf