EU Says No to New Health Claims


Posted By: Selerant RSA

On July 1, 2015, European Commission issued Commission Regulation (EU) 2015/1052 by which it refused to authorise certain health claims made on foods, referring to the reduction of disease risk.

Which Ones Got a No-No?

Two companies had previously applied for authorisation of health claims for two of their products.

The first is a food supplement in powder sachets containing plant sterol esters for which the company requested to be assigned the health claim of “lowering/reducing blood cholesterol”, knowing that “high cholesterol is a risk factor in the development of coronary heart disease”. The Commission had previously authorized the usage of health claims stating that plant sterols/plant stanol esters ‘have been shown to lower/reduce blood cholesterol’ when added in products such as fat spreads, dairy products, mayonnaise and salad dressings. Of course, this includes a prescribed minimal daily intake of 1.5 - 3 g of plant sterols over a certain period of time.

The second health claim refused is for a cranberry concentrate (CranMax®), a product used in nutritional supplements and functional foods. The company applied for and was refused the right to use the health claim of “preventing bacterial adhesion to urinary tract, which is a risk factor for developing urinary tract infections”. In the past, other products have been refused authorisation of similar claims, on the basis of insufficient scientific evidence that could not substantiate the claim.

What is EU Health Claims Authorisation?

European Union has very strict rules on using nutrition and health claims in the labelling, presentation and advertising of foods placed on the EU market.   

According to Regulation (EC) 1924/2006 health claims made on foods are prohibited, unless they get an authorisation from the Commission.

If they want a new health claim to be authorized, companies can apply to national competent authorities (EU Member State level). National authorities will then forward valid applications to the European Food Safety Authority (EFSA) for scientific assessment. Following the opinion issued by EFSA (in other words, the result of the scientific assessment), European Commission then decides on authorization or refusal of a new health claim.

A list of all permitted nutrition claims and all authorized and non-authorized health claims can be found in the public EU Register of Nutrition and Health Claims.

The Product vs the Legislation

The idea behind this strict process is, of course, the protection of the consumer. The companies are increasingly investing in producing functional foods with (hopefully) beneficial health effects. This may not be enough. Following closely the legislation changes at target markets and knowing how to add value to your good products through adequate (and legal!) food communication is paramount in today’s food business. Make sure the information you have is up-to-date, by using RegData database. Feel free to contact Selerant for any additional information or guidance you may need.