How Products Were Selected:

Products tested represent those commonly sold and/or available nationally in the U.S. purchased products on the open market through retail stores, on-line retailers and direct sales companies. Products were not accepted directly from manufacturers.

Testing Methods:

Omega-3 marine oil products were tested in one or more independent laboratories for the following:
  1. 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, AOCS Ce 1b-89 or the European Pharmacopoeia method or other appropriate methodology deemed appropriate by CL Results expressed by weight (mg/g of oil) and not by area percent (per GOED recommendations).
  2. Total Phospholipid content in krill oil by 31P-NMR, % w/w (FCC-9).
  3. Percent Phosphatidylcholine in krill oil by 31P-NMR, % of total phospholipids (FCC-9).
  4. Astaxanthin esters in krill oil by high performance liquid chromatography (HPLC) (DSC-2015) or spectrophotometric analysis (FCC-9).
  5. 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.
  6. Peroxide (PV) and p-anisidine (pAV) values and calculation of TOTOX value by AOCS method (CD 8-53 & Cd18-90 respectively) or other methods as appropriate.
  7. Disintegration of enteric coated formulations using the United States Pharmacopeia (USP) <2040> methodology.

Any product not passing was sent to another independent laboratory to repeat testing for the criterion on which it did not pass. may modify or use other appropriate test methods if necessary to test special product formulations.

Identities of products were not disclosed to laboratories performing the testing.

Passing Score:*

o achieve a "Pass" in the testing, a product had to:
  1. Contain 100% of the claimed amounts of EPA, DHA, total omega 3 fatty acids, total fatty acids or other fatty acids and not exceed the greater of 150% of any of these amounts or 75 mg per serving above any of these amounts.
  2. 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).
  3. Contain 100% and not exceed 150% of the claimed amount of astaxanthin esters in krill oil.
  4. Contain less than 0.05 ppm of lead (GOED 2019). Pet products in chew or tablet form will have an additional 0.05 ppm (50 ppb) allowance. Contain less than 0.1 ppm each of cadmium and mercury (GOED2019).
  5. Contain less than 0.1 ppm of inorganic arsenic (GOED 2019 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).
  6. Have a peroxide value (PV) of no more than 5 meq/kg, an p-anisidine value (pAV) 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) + pAV) (GOED 2019).
  7. If applicable to the product, it must meet recommended USP <2040> parameters of disintegration for enteric coated formulations.
  8. Be in compliance with FDA labeling requirements.
* Passing scores allow for specific margins of technical error associated with each analysis. reserves the right to disqualify a product at any time from passing its testing if it considers such product to display unacceptable variation in quality, present a safety risk, or to provide misleading or inaccurate information in its labeling.

Back to review