Cholesterol Lowering Spread Endorsed by EU

Unilever PLC/
Unilever NV
27 June 2000


UNILEVER'S CHOLESTEROL LOWERING SPREAD  
FIRST TO BE ENDORSED BY EU MEMBER STATES 
 
The EU Standing Committee for Foodstuffs has voted in favour of a Commission
decision authorising Unilever to market Flora pro.activ, a cholesterol
lowering spread, in the EU. This decision is specific to Unilever's product,
made with natural plant sterols.
 
The EU Standing Committee for Foodstuffs comprises of expert representatives
from 15 Member States. Its positive advice enables the EU Commission to grant
regulatory approval to Unilever's application for Flora pro.activ, and will
allow Unilever to start marketing the product in EU markets. Flora pro-activ
will be available to consumers in various EU markets as soon as preparations
for launch have been completed.
 
On 6 April 2000, the Scientific Committee on Food already issued a positive
assessment on the product. Obtaining approval under the EU Regulations is a
rigorous process intended to review all scientific data supporting the
efficacy and safety aspects.
 
'We are delighted that our cholesterol lowering product is the first in its
category being approved by the EU,' said Lex Kemner, Category Director Foods
at Unilever. 'We are confident that this independent scientific assessment
will contribute substantially to consumers' and health professionals' trust
in Flora pro.activ.'
 
Unilever first launched its Take Control cholesterol-lowering spread in the
U.S. on April 30, 1999, with the assurance of the GRAS (Generally Recognised
as Safe) status reviewed by the FDA. This was followed by successful launches
of pro.activ in Australia, New Zealand, Switzerland and Brazil. Unilever is
also preparing for several launches in major markets outside Europe.
 

Background information: 
 
Too much LDL ('bad') cholesterol is widely accepted to be one of the main
risk factors for coronary heart disease1,2. In Europe, 2 million people die
of coronary heart disease each year3 - cholesterol is one of the major
modifiable risk factors.
 
Flora pro.activ is a spread made with natural plant sterols that are
clinically proven to dramatically reduce cholesterol. Plant sterols, or
phytosterols, are plant extracts which occur naturally in the diet and are
found at low levels in everyday foods such as fruit and vegetables, vegetable
oils, nuts and grains. Around 600 studies have been undertaken since the
1950s showing the cholesterol lowering effect of plant sterols4,5. In
addition Unilever has undertaken 24 studies demonstrating the benefits of the
product.
 
Independent clinical trials show that when moving to a healthy diet including
around 20g of pro.activ per day (current spread intake average in most
European countries) gives average LDL ('bad') cholesterol reductions of
around 10-15 percent within three weeks 6,7,8.
A 10 percent reduction in blood cholesterol reduces the risk of heart disease
in 40-year old males by 50 percent9.
 
Unilever believes regulatory frameworks are the most appropriate systems that
enable:
 
* independent scientific review by experts 
* clear and consistent labelling rules of new foods such as pro.activ before
they come to the market.
________________________________________________________________________
 
For further information please contact: Unilever Press Office 020 7822 6719
 
 
References: 
 
     Assmann G, Schulte H. Relation of high-density lipoprotein cholesterol
and triglycerides to incidence of artherosclerotic coronary artery disease
(the PROCAM experience). American Journal of Cardiology 1992; 70:733-7. 
     Watts GF et al. Effects on coronary artery disease of lipid-lowering
diet, or diet plus cholestyramine, in the St Thomas' Arteriosclerosis
Regression Study (STARS). Lancet 1992; 339: 563-569. 
     European cardiovascular disease statistics, British Heart Foundation,
February 2000. 
     Pollak OJ. Reduction of blood cholesterol in man. Circulation 1953; 7:
702-706. 
     Pollak OJ: Kritchevsky D: Sitosterol. Monographs on arteriosclerosis
1981; 10; 3b: 139. 
     Weststrate JA & Meijer GW. Plant sterol-enriched margarines and
reduction of plasma total- and LDL-cholesterol concentrations in
normocholesterolaemic and mildly hypercholesterolaemic subjects. European
Journal of Clinical Nutrition 1998; 52: 334-343.  
     Hendriks HFJ, Weststrate JA, Van Vliet T, Meijer GM: Spreads enriched
with three different levels of vegetable oil sterols and the degree of
cholesterol lowering in normocholesterolaemic and mildly
hypercholesterolaemic subjects. European Journal of Clinical Nutrition 1999;
53: 319-327. 
     Jones PJH, Raeini-Sarjaz M, Ntanios FY, Vanstone CA, Feng JY, Parsons W.
Modulation of plasma lipid levels and cholesterol kinetics by phytosterol
versus phytostanol esters. Journal of Lipid Research 2000; 41:697-705. 
     M Law et al. By how much and how quickly does reduction in serum
cholesterol concentration lower the risk of ischaemic heart disease? British
Medical Journal 1994; 308: 367-373.