EPA

Assay and chemical form together define the grade. Supplement grade concentrates run from 50 to 70 percent EPA, generally as ethyl ester or re-esterified triglyceride, and are the volume products. High assay material at 90 to 96 percent, made by chromatographic separation, is used in pharmaceutical and clinical applications and is priced an order of magnitude higher. Free acid grades are used where the ester bond would interfere with the formulation.

The second distinction is DHA content. Products positioned specifically on EPA are specified with DHA held low, in some cases below 2 percent, since the point of the material for those buyers is an EPA profile uncontaminated by DHA. Source is declared as marine or algal, the latter carrying a vegan claim and a different contaminant profile. Pharmaceutical grades meeting a pharmacopoeial monograph carry tighter limits on related substances, oxidation and residual solvents than the supplement line. Microencapsulated powders and emulsions are finished formats rather than grades of the acid itself.

In the United States, EPA from marine and algal oils is sold as a dietary ingredient under the dietary supplement framework, and GRAS notifications to which the FDA responded without objection cover specific oil preparations for defined food uses. High assay ethyl ester products used as prescription medicines are separately approved drugs and fall outside the food framework. Fish is a major food allergen requiring declaration where the source is marine. The FDA has issued qualified health claims relating EPA and DHA intake to coronary heart disease and to blood pressure, and the permitted wording follows the relevant enforcement discretion letters.

In the European Union, EPA rich oils are foods rather than additives and carry no E number, but preparations without a history of consumption before May 1997, including several concentrates and algal oils, are authorised individually under the novel food regulation and appear in the Union list with their specifications and conditions of use. Fish is an allergen that must be emphasised in the ingredient list. Maximum levels for dioxins, dioxin-like polychlorinated biphenyls and heavy metals in fish oil are set in the contaminants regulation, and authorised health claims for EPA and DHA at specified intakes are listed in the claims register. Codex has adopted a standard for fish oils that names the oils covered and sets fatty acid composition ranges and quality criteria including acid value, peroxide value and anisidine value.