Foods and Health Claims: the European Approach and Future Perspectives

Posted: Kamis, 01 Januari 2009 by smarters06 in Label:

The new European legislation on health claims has been in force since July 2007. One of the key objectives of the regulation on nutrition and health claims is to “ensure that consumers will be able to rely on the truth and accuracy of information” by making sure that such claims are based on reliable scientific evidence. Thus, the goal is to protect consumers both from misleading information and claims. Another goal has been to focus on central assessment of health claims in Europe.

Interest in the health claims has been high among the industry already for a decade. This has led to the process coordinated by the ILSI Europe with funding from the European Union and collaboration between the industry, regulators and researchers focusing on functional food science in Europe. Along this process, the specific topics and areas of research excellence have been identified. Later, methodologies to ascertain health claims have been clarified through this collaboration resulting in reports and proposals published in the scientific literature.

When the new legislation was finalized, the task of scientific evaluation has been given to the European Food Safety Authority (EFSA) regarding both the scientific assessment of existing claims on foods submitted by all European Union member states and product-specific health claim applications submitted since late 2007 to EFSA. Both tasks are important and specific time lines are enforced. The applications for product specific claims should be handled within 5 months of the submission provided the application can be validated first by EFSA. Assessment of the existing health claims submitted by member states should be concluded by EFSA and submitted to the European Commission. The specific tasks for EFSA include supporting EU decision-makers in implementing the new Regulation by providing scientific advice on:

Setting up nutrient profiles by 2009 – the basic nutritional criteria that will govern the conditions in which claims may be made

Establishing an EU-wide list of permitted health claims by 2010

Assessing on a case-by-case basis whether individual claims are scientifically reliable and justified Providing guidance for applications on the preparation of applications for the authorisation of claims

The evaluation process involves different types of claims as defined in specific articles of the Legislation. These are the following:

Article 13 health claims concern health claims based on generally accepted scientific evidence, the Commission has sent a draft final list to Member States of about 1700 claims. Member States may raise any concerns on any claims not on this list and thereafter EFSA will assess the science base behind the claims.

Article 14 claims relate to children’s health and specific disease risk reduction claims which need to be demonstrated in studies in target populations. Among the first product specific children’s health associated claims was a food supplement made with probiotics and fermented vegetables and fruit and several other are currently evaluated.

Article 18 claims relate to products which are based on new science and proprietary data. These include new application on food and health that may contain new unpublished information.

Over two hundred claim applications have been submitted and are being processed and the abstracts and later also decision will be made public. Advise for applications and checklists are available at the EFSA net-page. Later on, information on the assessment of the existing claims in all member states will become available.

The scientific evaluation is conducted by the NDA Panel (Panel on Nutrition, Dietetic products, and Allergies (NDA)) of the EFSA. This panel currently consists of 17 experts, but there are plans to expand the panel. Additional expertise may also be recruited from outside the panel to assist in preparing health claim assessments for specific areas. Among the first opinions is the scientific opinion on nutrient profiles and how they should be considered in relation to health claims. This part facilitates the target that foods are assessed also for the nutritional quality prior to granting health claims.

The first decisions on health claims include both approvals of applied claims and claims which have not been considered scientifically well documented. The decision can be viewed for example on the EFSA webpage. It is clear, for instance, that health claims for children including diseases risk reduction require more proof, especially clinical intervention trials in the target populations which may include infants after weaning and children of different ages.

This part is also clearly defined in the legislation. It is also clear that the applications have to be prepared in a clear manner and according to the guidelines prepared by the EFSA. This will clearly assist in the assessment and also make it clear for the company preparing the application what is required and how to present and summarize the information.

As we progress, more practical examples become available and also the application summaries can be viewed within the EFSA web-pages. It is likely to be of help to the applicant to check the abstracts and the panel opinions which are public. This will enable the applicant to check the requirements and reasons for either approving or not approving the claims.

Another matter of great interest is the ongoing assessment of health claims that have already been in use in different European Union member states. These have been submitted to the European Commission for assessment by each members state and the procedure is ongoing with expected decisions in 2009. Several thousands of claims were submitted and currently the European Food Safety Authority is assessing the scientific basis of the claims.

The current assessment procedure is especially important for both the consumers and the industry. The target is to provide new and reliable EU-wide claims to consumers to help the consumer in food selection and in understanding the potential scientifically proved health benefits. On the other hand, the target is to allow the companies which have conducted new and scientifically sound research to also state the benefit of the products in their food labels. These targets are designed for the benefit of all of us, and they are likely to lead the food industry to further emphasize health aspects and nutritional benefits in product development thus benefiting all of us.

The interest of the food industry has been significantly high and both small, medium-size and large food companies have focused on this area. The interest is also mirrored in the number of applications submitted in Europe since the legislation was enforced – the number of applications has increased continuously and there was keen interest in the gathering of national lists of existing health claims from member states and providing scientific backing for them.

Thus, the industry is now more prone to guide product development towards increased knowledge of health effects of both food ingredients and products. This focus is within the interest both regulatory authorities, food and nutrition scientists, health professionals and the scientific community as well as the end users. The consideration of health claims also emphasizes the health benefits of foods but it also emphasizes the flavour of healthy or functional foods. It has been experienced and in addition to health claims, the individual foods have to taste good and they have to be desirable to the consumer.

0 komentar: