Member States start compiling health claims lists

In the UK for example, the Food Standards Agency (FSA) yesterday issued instructions to food makers to begin submitting claims for inclusion on the European positive list of health claims based on generally accepted scientific evidence, such as "X is good for your bones"​.

Although Members States have 12 months from the time the regulation enters into force (expected to be January 2007) to compile their lists, the agency said that it wanted to give food businesses optimal time to compile the evidence required for their claims. Under the new legislation, Member States are responsible for compiling a list of initial health claims for consideration. Based on these, the final EU positive list will be drawn up by the Standing Committee within three years.

The lists are to include health claims based on generally accepted science and well understood by the average consumer - not those based on emerging science.

Any such claims, any disease reduction claims (such as "X helps reduce the risk of osteoporosis"​), or any other claims submitted after the 12 month window will have to be assessed by EFSA and approved by the Commission.

Fundamentally, the new European regulation aims to increase consumer protection with regards to nutrition and health claims made on food. It is envisaged to harmonise health claims that can be made on food products throughout the EU.

The legislation has proved incredibly contentious however.

Along with nutrient profiles - that is, whether foods containing high levels of substances detrimental to health like saturated fat, sugar or salt may bear health claims relating to beneficial nutrients - the approvals procedure for claims submitted outside of the initial positive list has been a flashpoint of disagreement.

The Council was in favour of a full authorization procedure, whereas the Parliament preferred notification procedure for the entry of products bearing health claims to market, which would allow the company to make the claims unless objections were raised or evidence requested. This, it was envisaged, would speed up the time to market and compliance would also be less expensive for food companies, and therefore not be such as barrier to innovation.

Under the compromise a registration mechanism that falls between the two. It sets a maximum time frame for assessment by the European Food Standards Agency (EFSA) to review new registration dossiers, possibly of eight months, whereas under the authorisation model no time frame was given.

Once the compromise was given the green light by both the Parliament and Council this summer, adoption was planned for September but subject to a last minute delay over inclusion of the wrong comitology procedure.

However, further months of delay were avoided as the European Commission, Council and Parliament agreed to adopt the text in its current form last Friday, with an immediate amendment. Barring no further problems, the regulation is likely to enter into force in January 2007 and become applicable next July.

In its instructions to food companies making submissions to its list, the FSA said that they must use the required template and be accompanied by references to scientific justification and conditions of use.

"To be eligible for consideration, claims must be based on generally accepted science and relate to the role of a nutrient or other substance in growth, development and functions of the body, psychological and behavioural functions or slimming and weight control,"​ it said.

The FSA went on to point out that the claims listed in the list for consideration do not represent claims approved by the Food Standards Agency and, until adoption of the Community list, food firms must continue to ensure that they comply with current legislation.

"This list is provisional and claims on it will not be guaranteed a place on the final Community list of permitted claims,"​ said the agency.