Health claims for fats

There are three different types of health claims, namely 1) generic health claims, 2) health claims referring to the reduction of a risk factor in the development of a disease and 3) health claims referring to children's development and health. Medical claims are and remain forbidden.

Generic health claims are claims about a foodproduct or a component of this in relation to health, such as ‘linoleic acid can help to maintain a normal cholesterol level in the blood'. Health claims concerning the reduction of a health risk (such as 'reduces the risk of cardiovascular diseases) are classified as health claims referring to the reduction of a risk factor in the development of a disease. An example of a claim referring to children's development and health is ' helps brain development'.

The current situation for the different types of health claims is shown in Table 2. All health claims must be sufficiently scientifically proven before they are permitted. What these scientific criteria are and how they have been arrived at is explained below. The different types of health claims are explained further in the paragraphs following this.

Table 2 Health claims

Health claim	Current rules
Generic health claim (Article 13)	Generic list with proven claims
Health claim referring to the reduction of a risk factor in the development of a disease (Article 14)	Permitted if scientifically proven and approved by the EFSA and member states through the authorisation procedure
Health claim referring to children's development and health (Article 14)	Permitted if scientifically proven and approved by the EFSA and member states through the authorisation procedure

Scientific criteria for health claims

The scientific criteria for assessing health claims have been determined in the PASSCLAIM project. A summary of the important points is given below:

It must be clear what product or ingredient the claim refers to (nutrient, ingredient or product category)
Data about the effectiveness must have been obtained through studies using people (intervention studies and observational research)
Valid biomarkers must have been used (e.g. cholesterol is a valid biomarker for the risk of developing cardiovascular diseases)
Health claims must be based on the total of all available data and evaluation of the evidence. This means that the scientific data may not be used selectively.

A special technical manual is available from the EFSA with information about how to submit a request for approval to use a health claim.

Generic health claims (Article 13 claims)

On 31 January 2008 the member states drew up lists of generic claims that according to those submitting them were already sufficiently scientifically proven. At the end of 2008 the European Commission sent the list with submitted claims to EFSA with the request for a scientific opinion about the various claims. The list of all claims submitted is available for consultation on the EFSA website: http://www.efsa.europa.eu/en/ndaclaims13.htm. Health claims that do not occur on the list and have not been submitted are no longer permitted.

The definitive list with permitted generic health claims was to have been published officially by 31 January 2010. This deadline has not been met. In all probability the EC will now publish part lists with approved generic health claims. Opting for the publication of part lists has as consequence that all generic health claims that were submitted by the member states at the beginning of 2008 and that have not been included in a first part list (in other words that have not yet been definitely approved or rejected by the European Commission) may at least still be used until a definite judgement by the EC is published on one of the following part lists. A transition period of 6 months applies where a claim is rejected.

Health claims referring to the reduction of a risk factor in the development of a disease and claims referring to children (Article 14 claims)

Health claims referring to the reduction of a risk factor in the development of a disease and claims referring to children's development and health (Article 14 claims) are subject to a stricter authorisation procedure. Claims that have not been submitted for this procedure are no longer permitted. A special technical manual is available from the EFSA with information about how to submit a request for approval to use a health claim. A summary of the permitted Article 14 claims about fats is given in Table 3.

Table 3 Permitted claims about fats referring to the reduction of a risk factor in the development of a disease and claims referring to children

Claim referring to the reduction of a risk factor in the development of a disease
It has been proven that vegetable sterols reduce the blood cholesterol level. A high cholesterol level is a risk factor for the development of coronary heart disease.	Information for the consumer that a favourable effect is obtained by the daily intake of at least 1.5 – 2.4 grams. The size of the effect may only be stated for yellow fat spreads, dairy products, mayonnaise and salad dressings. If the size of the effect is stated the full range, “7 to 10%”, and the time required for the effect to be achieved, “after two to three weeks”, must be stated for the consumer.
It has been proven that vegetable stanol esters reduce the blood cholesterol level. A high cholesterol level is a risk factor for the development of coronary heart disease.
Claim concerning children
Essential fatty acids are necessary for a normal growth and development of children.	Information for the consumer that the favourable effect is obtained by a daily intake of 2 grams ALA and a daily intake of 10 g linoleic acid.

Permitted health claims may be used by every foodproducts company in accordance with the conditions applying for this, unless the use is restricted in accordance with the article providing protection for the use of data (Article 21 of the claims legislation).