What is the minimum EPA and DHA for the heart health claim?

The daily number, 250mg combined, and what the claim's condition of use actually says

What is the minimum EPA and DHA for the heart health claim is a question with two numbers for an answer rather than one, because the claim has a condition on the day and a condition on the label, and the honest page gives both, with the wording, since the wording is what a reader is entitled to see on a tub. The daily number: the register authorises the sentence EPA and DHA contribute to the normal function of the heart, and attaches a condition of use to it, which reads that the claim may be used only for food which is at least a source of EPA and DHA, and that in order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 250mg of EPA and DHA, the heart claim's authorisation, so the minimum intake for the claim's effect is 250mg of EPA and DHA combined per day, and a product carrying the claim must tell the reader that number somewhere on the label, usually in small print near the claim. Three things about the daily number worth reading carefully: it is combined, EPA and DHA together in any ratio, so a product high in one and low in the other meets it on the total; it is per day and per person, not per capsule, so a product whose serving carries less than 250mg may still carry the claim as long as it states the daily intake, with the reader doing the arithmetic; and it is a maintenance claim about the normal function of a well person's heart, written by the regulator as a nutrition claim and not as a prevention claim, the outcome trials at four times the dose having found no reduction in events and the guideline saying do not offer omega-3 for prevention, so the 250mg is the minimum for the claim's sentence and nothing else.

The label number, 40mg per 100g and per 100kcal, what each softgel size means, the reader's arithmetic, and the numbers filed

The label number: the claim may be used only on a food that is at least a source of omega-3 fatty acids, and the nutrition claim rules define a source of omega-3 as a food containing at least 0.3g of alpha-linolenic acid per 100g and per 100kcal, or at least 40mg of EPA and DHA combined per 100g and per 100kcal, the nutrition claim conditions' definition, so the label number for a fish oil product is 40mg of EPA and DHA per 100g of product and per 100kcal, the threshold the product must clear before it may carry the heart claim at all regardless of the daily intake. Any fish oil softgel clears it many times over, a 1000mg softgel carrying 300mg of EPA and DHA being 30 percent EPA and DHA by weight against a threshold of 0.04 percent, so the label number is a threshold for fortified foods, an omega-3 bread or an enriched spread, rather than a hurdle for a supplement, and its presence on the page is for the reader who wants to know why a cereal can carry the claim and a chip cannot. What each softgel size means against the daily number: a standard 1000mg softgel carrying 180mg of EPA and 120mg of DHA, 300mg combined, meets 250mg on its own, one a day, and is the reason this site's audit sends a low-fish reader to one softgel; a 500mg softgel carrying 150mg needs two a day; a concentrate capsule carrying 600mg to a gram meets it on one with room to spare; and a cod liver oil softgel carrying 200mg needs two, along with the vitamin A that comes with it. The reader's arithmetic, then, is the label's EPA plus DHA per capsule divided into 250, rounded up, which is the number of capsules the claim's condition requires, and a product that carries the claim with a serving below 250mg has stated the daily intake as the rules require and left the reader to reach it. The register's other omega-3 numbers sit alongside for reference, 250mg of DHA for the brain function and vision claims, 200mg of DHA extra for the maternal claim, two grams for the triglyceride claim and three for the blood pressure claim, and a five-gram safe level above them all. The numbers filed: 250mg combined per day as the claim's condition of use that the consumer must be told, 40mg per 100g and per 100kcal as the source-of-omega-3 threshold to carry the claim, one standard 300mg softgel meeting the daily number alone and two 150mg softgels needed, with the worked example being one softgel that meets the daily number on its own, £14.99 for 90 at 17p.

The verdict, 250mg a day for the effect and 40mg per 100g and 100kcal for the label, with one standard softgel meeting the first alone

What is the minimum EPA and DHA for the heart health claim: two numbers, the daily number of 250mg of EPA and DHA combined per day, the condition of use under which the authorised claim that EPA and DHA contribute to the normal function of the heart obtains its beneficial effect and which a product carrying the claim must tell the consumer, combined in any ratio, per person and per day, and as a maintenance claim rather than a prevention one, and the label number of 40mg of EPA and DHA combined per 100g and per 100kcal, the source-of-omega-3 threshold a food or supplement must clear before it may carry the claim at all and which any fish oil clears many times over, so that a standard 1000mg softgel carrying 300mg meets the daily number on its own, a 150mg softgel needs two, and the reader's arithmetic is the label's EPA plus DHA per capsule divided into 250. One softgel that meets the daily number alone: Futuro Labs Omega 3 Fish Oil, one with food, 180mg EPA and 120mg DHA, 300mg combined, 90 for £14.99 at 17p a day.

What to check on the label

Questions people also ask

What is the exact wording of the EPA and DHA heart claim?

EPA and DHA contribute to the normal function of the heart, with the condition that the claim may be used only for a food that is at least a source of EPA and DHA and that the consumer must be informed that the beneficial effect is obtained with a daily intake of 250mg of EPA and DHA, which is the sentence and the small print a reader is entitled to see together on a tub.

Does the 250mg need to be EPA or DHA specifically?

Combined, in any ratio: the heart claim's condition is 250mg of EPA and DHA together, so a product high in one and low in the other meets it on the total, while the separate brain function and vision claims are for DHA alone at 250mg and the maternal claim for 200mg of DHA extra.

Can a fish oil with less than 250mg per capsule carry the heart claim?

Yes, if it states the daily intake: the rules require the consumer to be told that the beneficial effect is obtained with a daily intake of 250mg, so a 150mg softgel may carry the claim with that information and the reader takes two a day to reach it, the arithmetic being EPA plus DHA per capsule divided into 250 and rounded up.

What does a source of omega-3 mean on a label?

At least 0.3g of alpha-linolenic acid per 100g and per 100kcal, or at least 40mg of EPA and DHA combined per 100g and per 100kcal, the nutrition claim threshold a food must clear to say source of omega-3 and to carry the heart claim at all, which any fish oil softgel clears many times over and which matters for fortified breads, spreads and cereals.

Is 250mg of EPA and DHA enough to protect the heart?

It is enough for the claim, which is a maintenance claim about the normal function of a well person's heart and not a prevention claim: the outcome trials at four times that dose found no reduction in heart attacks or strokes, and the guideline says do not offer omega-3 for prevention, so 250mg meets the sentence on the tub and heart protection belongs to training, weight, blood pressure, not smoking and a GP's numbers.

Sources

1. EFSA Panel on Dietetic Products. Scientific opinion on the substantiation of health claims related to EPA and DHA and normal function of the heart (250mg daily condition of use). EFSA Journal 2010;8(10):1796. https://www.efsa.europa.eu/en/efsajournal/pub/1796
2. The nutrition claim conditions in the annex to Regulation (EC) 1924/2006 as amended: a food may be labelled a source of omega-3 fatty acids if it contains at least 0.3g of alpha-linolenic acid per 100g and per 100kcal, or at least 40mg of EPA and DHA combined per 100g and per 100kcal, and the authorised EPA and DHA heart claim may be used only on a food that is at least such a source, with the consumer informed that the beneficial effect is obtained with a daily intake of 250mg. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1924-20141213
3. Retained Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, and the Great Britain nutrition and health claims register. https://www.gov.uk/government/publications/great-britain-nutrition-and-health-claims-nhc-register
4. The large cardiovascular outcome trials of omega-3: around a gram a day of EPA and DHA in primary-prevention populations produced no meaningful reduction in major cardiovascular events, while four grams of purified EPA in people with raised triglycerides on statins reduced events in one large trial, so the supplement-dose story is maintenance and the treatment-dose story is a prescription. PubMed record

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