HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products tested represent those commonly sold and/or available nationally in the U.S. and Canada. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, and direct sales or multi-level marketing companies. Products were not accepted directly from manufacturers.
Omega-3 marine oil products were tested in one or more independent laboratories for the following:
- The identity and quantity of total fatty acids including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) by gas chromatography utilizing the AOAC (Association Official Analytical Chemists) Official Method 991.39 or the European Pharmacopoeia method or other appropriate methodology deemed appropriate by CL;
- Total Phospholipid content in krill oil by 31P-NMR, % w/w (FCC-9);
- Percent Phosphatidylcholine in krill oil by 31P-NMR, % of total phospholipid (FCC-9);
- Astaxanthin esters in krill oil by high performance liquid chromatography (HPLC DSC-2015) or spectrophotometric analysis (FCC-9).
- Lead, cadmium, total arsenic (and inorganic arsenic if total arsenic levels exceed 10 mcg per daily serving) by ICP/MS or other appropriate methods determined by CL. Determination of mercury using a cold vapor technique;
- Peroxide (PV) and anisidine (AN) values and calculation of TOTOX value by AOCS method (CD 8-53 & 18-90 respectively) or other methods as appropriate;
- Determination of total PCBs and dioxin like PCBs by High Resolution Gas Chromatography coupled with High Resolution Mass Spectrometry (HRGC/HRMS) (EPA Method 1668A or similar method);
- Optional dioxin testing for PCDDs, PCDF's and Dioxin-like PCBs using isotope dilution HRGC/HRMS (EPA method 1663B).
- Disintegration of enteric coated formulations utilizing USP (United States Pharmacopeia) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements."
Any product not passing any initial testing criteria required for CL Approval was sent to a second independent laboratory for repeat analysis using similar methodologies.
Identities of products were not disclosed to laboratories performing the testing.
To pass, a product must:
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
- Contain 100% and not exceed 150% of the claimed amounts of EPA, DHA and other fatty acids.
- A krill oil product must have a total phospholipid content of: 28 — 52% (w/w) in which the phosphatidylcholine content must be 60 — 90% by 31 P-NMR analyses (FCC 8).
- Contain 100% and not exceed 150% of the claimed amount of astaxanthin esters in krill oil.
- Contain less than 0.1 ppm each of lead, cadmium and mercury (GOED 2012).
- Contain less than 0.1 ppm of inorganic arsenic (GOED 2012 limit for inorganic arsenic). However, inorganic arsenic will only be checked when a product is found to contain more than 10 mcg total arsenic per daily serving (EPA limit for total arsenic).
- Have a peroxide value (PV) of no more than 5 meq/kg, an anisidine value (AV) of no more than 20 for fish oil and 25 for krill oil. and a TOTOX value of no more than 26 (calculated as (2 x PV) + AV) (GOED 2012).
- Contain less than 0.09 mg/kg (90,000 pg/g) of total PCBs (i.e. all 209 polychlorinated biphenyl congeners) (GOED 2012)
- For dioxin-like PCBs (i.e. the sum of 4 individual non-ortho PCBs and 8 mono-ortho PCBs), non-concentrated fish body oils (<80% EPA & DHA (%wt/wt)) must contain no more than 3pg/g (GOED 2012), while fish body oil concentrates (> 80%), fish liver oil, and oil from other marine organisms must contain no more than 6 pg/g (proposed EU).
- If tested for total dioxins (i.e. the sum of 17 individual congeners of dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)), product must contain no more than 3 pg WHO-PCDD/F-TEQ/g defined by the WHO-toxic equivalent factors expressed as TEQ for all marine oils (fish body oils, fish liver oil and oil from other marine organisms) (GOED 2012).
- If applicable to the product, it must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, chewable and time-release products).
- Be in compliance with FDA labeling requirements.
* Passing scores allow for specific margins of technical error associated with each analysis. ConsumerLab.com reserves the right to disqualify a product at any time from passing its testing if it considers such product to present a safety risk or to provide misleading or inaccurate information in its labeling.
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