Phytosterols are approved for use in margarines and yoghurt and milk drinks, salad dressings, milk-based fruit drinks, soy drinks, cheeses, spicy sauces and rye bread across the European Union’s 27 member states.
Some of these of these feature in Unilever’s pro.activ range and that of main sector rival, Raisio-owned Benecol, a portfolio that employs phytostanols which do not require novel foods approval as the ingredient was already on the market before May 1997, when novel foods rules kicked into play.
Plant stanol-based products designed for home cooking and baking are already on-market.
Both can make EU-backed, cholesterol-reduction claims under the nutrition and health claims regulation (NHCR), but the market for the products has been flat for several years, despite the claim validation.
In its submission, Unilever said surveys indicated plant sterol and stanol intakes in the EU ranged from 0.4 g to 2.5 g per day – below the 1.5 g to 3 g level established by the European Food Safety Authority (EFSA) for cholesterol-lowering effects to be achieved.
Conversely an earlier opinion from Europe's central science agency also sets the safe upper daily consumption limit at 3 g.
“To provide consumers that need to lower their blood cholesterol with more consumption opportunities to reach the desirable intake, Unilever is applying for an extension to its current novel foods authorisations…” the Dutch-Anglo firm wrote.
“These products will be placed on the market under the pro.activproduct range which is part of the heart health brands Becel, Flora and Fruit d’Or and will be targeted at consumers that need to lower their blood cholesterol.”
In regard to the safe upper limit being exceeded due to a potential expansion of phytosterol use in home cooking, Unilever pointed to clinical data showing safe use up to daily consumption of 9 g per day.
“Whilst acknowledging that the 3 g/day upper consumption advice should clearly be maintained, is there a basis for toxicological concern for consumption over this level?” the firm said.
“The products will contain comprehensive labelling to prevent over-consumption of plant sterols among target consumers, and to avoid consumption among non-target consumers of children under 5 years and pregnant and lactating women.”
It said a worst-case scenario showed phytosterol intakes of 5.4 g per day among 19-30 year olds if they replaced all margarine used in spreads and cooking and baking products with phytosterol products.
Baking and cooking trials indicated only biologically insignificant amounts of plant sterol oxides were produced.
Unilever said it possessed data showed home cooking and baking with phytosterol products could increase intakes by 0.4 g per day.
The UK Food Standards Agency’s Advisory Committee on Novel Foods and Processes (ACNFP) has published the Unilever submission and called for public comment until July 10 this year.