Regulatory

Recognised health claims

Favourable regulatory situations for phytosterols exist in many parts of the world. In the EU, phytosterols are an approved ingredient and in the US, PinVita™ Phytosterols (both free and esterified forms) have GRAS status.

Both the FDA and EFSA have endorsed phytosterols for disease risk reduction claims, allowing food and supplement developers to market the link between the cholesterol-lowering benefits of phytosterols and a reduced risk for heart disease.

In addition, there is a pending article 13 claim: “maintenance of normal blood cholesterol levels” in the EU.  Claims are linked to dose per serving (1.5-2.4 g/day for article 14 claim and 0.8 g/day for pending article 13 claim and daily intakes within specified food categories.

Many other countries have approved the use of phytosterols. Our regulatory department would be pleased to assist in your detailed request.