Omega-3 EPA/DHA Softgels

The fill is refined fish body oil (CAS 8016-13-5) pressed from wild-caught pelagic fish, principally Peruvian anchovy (Engraulis ringens), sardine (Sardinops sagax) and mackerel (Scomber spp.), then alkali-refined, bleached, winterised and deodorised. It is a body oil, not a liver oil, so there is no meaningful vitamin A or D3 carry-over to control. The two fatty acids that the buyer is actually paying for are eicosapentaenoic acid (EPA, CAS 10417-94-4, C20H30O2, MW 302.45) and docosahexaenoic acid (DHA, CAS 6217-54-5, C22H32O2, MW 328.5). A 1000 mg fill of standard 18/12 oil delivers 180 mg EPA and 120 mg DHA; a 500 mg fill halves both. Concentrate fills in re-esterified triglyceride or ethyl ester form raise the per-capsule figure, and because the GOED method expresses EPA and DHA as free fatty acid equivalents in mg/g, label figures taken from a supplier COA should be restated on that basis before they are printed. Oxidation is the specification that decides whether a marine softgel is fit to sell. The GOED Voluntary Monograph version 8.1 of 6 January 2022 explicitly covers finished encapsulated oils and applies throughout the stated shelf life, not merely at release: peroxide value maximum 5 meq/kg by AOCS Cd 8b-90 or Ph. Eur. 2.5.5, p-anisidine value maximum 20 by AOCS Cd 18-90 or Ph. Eur. 2.5.36, and TOTOX maximum 26 as the calculation (2 x PV) + pAV. Environmental contaminants follow the same monograph: total PCBs maximum 0.09 mg/kg as the sum of 209 congeners, PCDDs plus PCDFs maximum 1.75 pg WHO-TEQ/g, total dioxins, furans and dioxin-like PCBs maximum 3 pg WHO-TEQ/g, with lead below 0.05 mg/kg and cadmium, mercury and inorganic arsenic each below 0.1 mg/kg. Where the SKU is sold into California, the monograph also flags a working limit of 90 ng PCBs per labelled daily serving for Proposition 65 purposes. Origin and allergen status must be settled before the first batch. The product contains FISH, a declarable allergen under EU Regulation 1169/2011 Annex II, and no shell choice changes that; a vegan shell on a fish-oil fill produces a vegan shell around a marine product, not a vegan product. Standard shells are bovine gelatin, glycerol and purified water, with fish gelatin available to keep the finished unit marine-only for buyers who avoid bovine material, and halal or kosher gelatin on request. The mixed tocopherol antioxidant added to protect the oil is commonly soy-derived, so the finished label may need a soy declaration even though the oil itself carries none. On the regulatory side, the authorised EPA and DHA entry in Commission Regulation (EU) No 432/2012 carries a condition of use of 250 mg EPA plus DHA per day and requires the food to qualify as a source of omega-3 fatty acids under Regulation (EC) No 1924/2006; permitted wording differs by market and remains the brand owner's responsibility.