EU regulation 1924/2006 on Nutrition and Health claims made on food was published on 18 January 2007. This is the first piece of scientific legislation to deal with nutrition and health claims and aims to provide a higher level of consumer protection as well as harmonise legislation across the EU to facilitate intra-Community trade.
The regulation will control nutrition and health claims by means of positive lists of authorised claims that can be made on food together with the criteria a product must meet to use them. The annex of the regulation contains the list of permitted nutrition claims and the regulation puts in place processes for the compilation of the list of authorised claims. EU regulations are directly applicable in Member States and this regulation will apply from 1 July 2007.
In order to make a nutrition or health claim now, or in the future, you must comply with the requirements of the new European Regulation (EC) No 1924/2006 on nutrition and health claims made on food. If you make, or plan to make claims, you should consult your Home Authority (FSA for the UK and FSAI for Ireland ). This newsletter is a guide to the regulations and will focus primarily on Article 13.1a which deals with health claims describing or referring to the role of a nutrient or other substance in the growth, development and functions of the body based on generally accepted scientific evidence and well understood by the average consumer. We believe that Article 13.1a is the area dealing with probiotics (BB-12® and LA-5®). In this Article the term ‘approved heath claims' refers to claims which will be included in the community register of approved claims which will be published by January 2010 at the latest. There are various transition periods but this newsletter will deal mainly with transition periods listed in Article 28.5 covering Article 13.1a claims.
After transitional periods set out in Article 28 of the Regulation have expired it will only be possible to make nutrition claims that appear in the Annex to the Regulation and health claims that appear in the lists of authorised claims to be contained in the Community Register which will be published by Jan 2010 at the latest.
Article 4 of the Regulation also puts in place provisions that may restrict the use of claims on certain foods or categories of foods based on their nutritional composition (nutrient profile). Where a product is high in more than two nutrients, for example, fat and sugar, only reduced nutrition claims can be made. However if the product is high in just one nutrient, nutrition claims could be made on the condition that the product also highlights the high content of that nutrient, for example by saying “high fat content”. However it will not be possible to make health claims where any nutrient does not meet the criteria set by the nutrient profile for that food. When establishing nutrient profiles the European Commission will take into account the opinion of the European Food Safety Authority (EFSA) and will also put in place exemptions where these are considered necessary. A position paper by BfR (Germany) has stated that foods which are a major source of ‘qualifying nutrients' but also contain ‘disqualifying nutrients' e.g. full cream milk contains fat and calcium should not be disqualified from making health claims. Nutrient profiles will be established by 19 Jan 2009.
Article 10 of the regulation lists specific conditions including ‘Health claims shall only be permitted if the following information is included in the labeling':
a) a statement indicating the importance of a varied and balanced diet and healthy lifestyle
b) the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect
Also, it is important to note that non specific benefits of a food for overall good health or health related well-being may only be made if accompanied by a specific approved health claim.
In general, only health claims which are listed in the Community Register can be used on food and only if the product meets with any specific conditions of use as well as the general requirements of the Regulation. The Community Register is not yet in existence but will be published by Jan 2010 and national rules will continue to apply until claims are approved.
It is our opinion that Article 13.1a -health claims may continue to be made until the Community Register has been published in Jan 2010 as long as the claims comply with the existing National legislation.
Claims based on generally accepted scientific evidence (Article 13.1a)
Health claims that are based on generally accepted scientific evidence and are well understood by the average consumer will not be required to go through the same approval process as claims which are based on new or emerging science or proprietary data, disease risk reduction claims or claims referring to children's development and health. Instead the Regulation allows the Member States until 31 January 2008 to put together a list of health claims which are based on generally accepted scientific evidence. Once this list has been compiled it will be sent to EFSA for an opinion before a decision is made by the Commission and Member States on inclusion in the Community Register. In our opinion health claims made on products containing our probiotics BB-12® and LA-5® at appropriate levels will be covered by Article 13.
Chr. Hansen intends to apply under article 13 for health claims for BB-12® and LA-5® and will compile a dossier of scientific data to support the application. Chr. Hansen will provide the dossier to customers to aid them in applying for health claims. The dossier is expected to be available by 1st August 2007. Applications must be submitted by 21st September 2007 (Food Standards Agency (FSA in the UK) and 26th September 2007 (Food Safety Authority of Ireland, FSAI).
If you would like further information on getting claims onto this list or how the UK 's list will be compiled please see the following website: www.food.gov.uk .
In Ireland details can be found at: www.fsai.ie .
When do I need to comply with the Regulation?
The requirements of the Regulation will apply from 1st July 2007. After this date all products will need to meet the requirements of the Regulation. As earlier described transition measures will apply until the list of approved claims is published in January 2010.
Article 13.1a health claims referring to the role of a nutrient or other substance in the growth, development and the functions of the body, which are based on generally accepted scientific evidence must be authorised. In our opinion this would apply to probiotic products containing BB-12® and LA-5® but this needs to be confirmed.
We would advise customers wishing to make a probiotic Article 13.1a claim on their products containing BB-12® and/or LA-5® to make an application to the FSA or FSAI by the deadlines set by both organisations. This will ensure that you have the maximum possibility that your product claim will be on the EU Community Register to be published in 2010. Between July 2007 and January 2010 you may continue to make Article 13.1a type health claims. If you do not apply it may be difficult to continue to use Article 13.1a type claims during the transition period.
How to cite this article
Towler, Claire. (2007).
[On-line]. Available from: https://www.dairyscience.info/index.php/packaging/120-nutrition-and-health-claims-eu-leglisation-regulation-no-19242006.html . Accessed: 24 May, 2017.