Nutrition and Health Claims Legislation

General Information

Q. When does this legislation come into force?

Regulation 1924/2006/EC on nutrition and health claims made on foods came into force on 19th January 2007 and will apply from 1st July 2007.

Q. What foods are covered by this legislation?

All foods, including foods for particular nutritional uses (PARNUTS), natural mineral waters, water intended for human consumption and food supplements are covered by this Regulation. It applies to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer, including foods which are placed on the market unpacked or supplied in bulk.

It also applies to foods intended for supply to restaurants, hospitals, schools, canteens and similar mass caterers.

Q. Are there any claims to which the legislation does not apply?

A. The Regulation does not apply to claims made in non-commercial communications, such as dietary guidelines or advice issued by public health authorities and bodies, or non-commercial communications and information in the press and in scientific publications.

Q. Does the legislation only apply to nutrition and health claims made on the food labelling?

No. This legislation applies to nutrition and health claims made in the labelling, presentation or advertising of foods. The legislation defines a ‘claim’ as any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food had particular characteristics. Trademarks and other brand names which may be considered as nutrition or health claims are also regulated by this legislation.

Q. What conditions must be fulfilled for a nutrition and/or health claim to be made?

Nutrition and health claims are only permitted where the following conditions are fulfilled:

the presence, absence or reduced content in a food or category of food of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific evidence;
the nutrient or other substance for which the claim is made:
is contained in the final product in a significant quantity as defined in Community legislation or, where such rules do not exist, in a quantity that will produce the nutritional or physiological effect claimed, as established by generally accepted scientific evidence; or
is not present or is present in reduced quantity that will produce the nutritional or physiological effect claimed, as established by generally accepted scientific evidence;
where applicable, the nutrient or other substance for which the claim is made is in a form that is available to be used in the body;
the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient or other substance to which the claim relates, as defined by Community legislation, or where such rues do not exist, a significant quantity that will produce the nutritional or physiological effect claimed, as established by generally accepted scientific evidence;
compliance with the specific conditions set out in Chapter III (Nutrition claims) and Chapter IV (Health claims) as the case may be.

In addition, nutrition and health claims are only permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim, and they must refer to the food ready for consumption in accordance with the manufacturer’s instructions.

Q. What are nutrient profiles?

Foods, or certain categories of foods, must comply with specific nutrient profiles in order to bear nutrition and health claims. These nutrient profiles are to be established by the Commission by 19th January 2009 at the latest. Note: Nutrient profiles have not been established to date and are still being worked on by the Commission.

Q. How will these nutrient profiles be devised?

The nutrient profiles will be established by taking into account:

(i) the quantities of certain nutrients and other substances in foods, such as fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium;

(ii) the role and importance of food and the contribution to the diet of the population; and

(iii) the overall nutritional composition of the food and the presence of nutrients that have been scientifically recognized as having an effect on health.

The European Food Safety Authority (EFSA) will provide the Commission with relevant scientific advice and the Commission will also carry out consultations with interested parties, in particular food business operators and consumer groups.

Q. If a nutrition or health claim is made, is nutrition labelling required?

Yes. When a nutrition or health claim is made nutrition labelling is required, but must appear in Group 2 format as set out in Article 4(1) of Directive 90/496/EEC on nutrition labelling of foodstuffs.

In addition, the amounts of substances to which a nutrition or health claim relates, that do not appear in the nutrition labelling, must also be stated in the same field of vision as the nutrition information and expressed according to Article 6 of Directive 90/496/EEC.

For food supplements where a nutrition or health claim is made, the nutrition information must be provided in accordance with Article 8 of Directive 2002/46/EC on food supplements.

Q. How long can foods labelled prior to the new legislation coming into force remain on the market?

Foods placed on the market or labelled prior to 1st July 2007 which do not comply with the requirements of this Regulation may be marketed until their expiry date but not later than 31st July 2009 . With regard to nutrient profiles, foods may be marketed until 12 months following the adoption of the relevant nutrient profiles and their conditions of use.

In addition, health claims describing or referring to the role of a nutrient or other substance in the growth, development and the functions of the body may be made from 19th January 2007 until the adoption of the list of health claims referred to in Article 13(3), under the responsibility of the food business operator, provided that they comply with this Regulation.

See more detailed information on transitional arrangements

Q. Are there any conditions set out in the legislation for comparative claims?

Yes, there are two conditions for the use of comparative claims:

A comparison may only be made between foods of the same category, taking into consideration a range of foods in that category. The difference in the quantity of a nutrient and/or the energy value must be stated and the comparison must relate to the same quantity of food.
Comparative nutrition claims must compare the composition of the food in question with a range of foods of the same category, which do not have a composition which allows them to bear a claim, including foods of other brands.

Please refer to pages 6-9 of the following guidance note for further information:

Guidance on the implementation of Regulation 1924/2006 on nutrition and health claims made on foods

Q. Are there any provisions for products bearing brand names or trade marks which could be considered as making a claim?

A trade mark, brand name or fancy name appearing in the labelling, presentation or advertising of a food which may be construed as a nutrition or health claim may be used without undergoing the authorisation procedures provided for in the Regulation, provided that it is accompanied by a related nutrition or health claim in that labelling, presentation or advertising which complies with the provisions of the Regulation.

Products bearing trade marks or brand names existing before 1st January 2005 which do not comply with this Regulation may continue to be marketed until 19th January 2022 after which time the provisions of the Regulation will apply.

Q. Can any claims be made on alcoholic beverages?

Health claims are not allowed on beverages containing more than 1.2% by volume of alcohol.

However, nutrition claims referring to low alcohol levels, or the reduction of the alcohol content, or the reduction of the energy content for beverages containing more than 1.2% by volume of alcohol are permitted.

Q. What is the Community Register?

The Commission will establish and maintain a Community Register of nutrition and health claims made on foods. It will include:

(a) the nutrition claims and conditions applying to them as set out in the Annex;

(b) any foods or categories of foods for which nutrition or health claims are to be restricted or prohibited;

(d) the list of rejected health claims and the reason for their rejection.

Health claims authorized on the basis of proprietary data will be recorded in a separate Annex to the Register together with the following information:

(1) the date the Commission authorized the health claim and the name of the original applicant that was granted authorization;

(2) the fact that the Commission authorized the health claim on the basis of proprietary data;

(3) the fact that the health claim is restricted for use unless a subsequent applicant obtains authorization for the claim without reference to the proprietary data of the original applicant.

The Register has now been established.

Q. Is a general statement such as ‘for a healthy diet’ or ‘good for you’ considered a health claim?

Under Article 10 (3) reference to general non-specific benefits of the nutrient or food for overall good health or health related well-being may only be made if accompanied by a specific health claim. Therefore these general claims are not required to be present on the list of approved claims on the condition that they are accompanied by an approved health claim.

Q. If I have questions relating to the new legislation or the submission process who can I contact?

You can contact the Food Safety Authority of Ireland Advice Line on 1890 33 66 77 with any queries or questions you may have.

Nutrition claims

Q. What is a nutrition claim?

A nutrition claim is any claim which states, suggests or implies that a food has particular nutritional properties due to:

(a) the energy (calorific value) it (i) provides, (ii) provides at a reduced or increased rate, or (iii) does not provide, and/or

(b) the nutrients or other substances it (i) contains, (ii) contains in reduced or increased proportions, or (iii) does not contain.

Q. What nutrition claims will be permitted under this new Regulation?

Only those nutrition claims listed in the Annex to the Regulation and which comply with the conditions set out in the Regulation will be permitted. The most up to date list of nutrition claims is available on the Community register

Q. Are there any derogations for nutrition claims on products which do not meet the nutrient profiles?

Yes. A nutrition claim can still be used where a single nutrient exceeds the nutrient profile. However, a statement in relation to this nutrient must appear on the label in close proximity to, on the same side and with the same prominence, as the claim. This statement must read as follows: ‘High […(*)] content’. (Note: Since nutrient profiles have not yet been established nutrition claims can be used as long as the conditions for use of the claim are met.)

Q. Are there any nutrition claims which can be made without reference to the nutrition profiles?

Yes. Nutrition claims referring to the reduction of fat, saturated fatty acids, trans fatty acids, sugars and salt/sodium will be allowed without reference to a profile for the specific nutrient, provided they comply with the conditions laid down in the Regulation. (Note: Since nutrient profiles have not yet been established nutrition claims can be used as long as the conditions for use of the claim are met.)

Q. Can I use the nutrition claim ‘with no added sugars’ if my product contains artificial sweeteners?

Yes. According to the Annex of Regulation 1924/2006 the claim ‘With no Added Sugars’ can be used if the ‘product does not contain any added mono- or disaccharides or any other food used for sweetening purposes’. It is the opinion of the FSAI that ‘foodstuffs with sweetening properties’ refers to foods such as honey, sugars glucose syrups but not refer to artificial sweeteners.

Q. Can I use the claim ‘High in omega-3’?

Yes. The Annex to Regulation 1924/2006/EC was amended by Regulation 116/2010/EC to include the claims 'Source of Omega-3 fatty acids' and 'High Omega-3 fatty acids' as well as claims for 'High monounsaturated fat', 'High polyunsaturated fat' and 'High unsaturated fat'. Conditions for the use of these claims can be found on the Community Register

Q. Can I use the nutrition claim ‘free from trans-fat’?

No. The Annex of permitted nutrition claims does not include this claim.

Health Claims

Q. Under what circumstances do I need to make a submission for authorisation for use of a health claim?

Authorisation is required for claims which fall under the scope of Article 14 and Article 13(5) of Regulation (EC) 1924/2006.

Article 14 claims include reduction of disease risk claims and claims referring to children’s development and health. These claims require a detailed submission to be made to the FSAI for assessment by EFSA, as outlined in Article 15 of the Regulation.

The FSAI is now accepting Article 14 applications. See more information on Article 14 health claims submission process.Submission of health claims under Article 13(5) of Regulation 1924/2006/EC. These are health claims based on newly developed scientific evidence and/or applications which include a request for the protection of proprietary data.

Q. Is there a closing date for the receipt of Article 14 dossiers?

A. On June 28 2007 the Commission published an amendment to Regulation (EC) 1924/2006 to allow for a transition period for claims relating to children’s development and health. This proposed amendment was agreed upon on by European Parliament in December 2007. Under the amendment, food business operators with claims related to children’s development and health which have been on the market before 19 January 2007 were required to submit an application pursuant to the Regulation to the FSAI by 19 January 2008. FBOs wishing to put claims relating to children's development and health on the market after 19 January 2007 can only do so provided an application is made pursuant to the regulation and the health claim is authorised.

No transitional measure is in place for disease risk reduction claims. Due to the prohibition of claims referring to the prevention, the treatment and the cure of a disease by Directive 2000/13/EC, and the introduction of the new category of claims referring to the reduction of disease risk by the Regulation (EC) No 1924/2006, products carrying such claims should not have been on the Community market.

Q. Who compiled the List of Article 13 Health Claims for Ireland?

In Ireland the FSAI, with support and input from the Department of Health and Children, compiled the list of Article 13 health claims submissions for Ireland. The List was collated using an on-line process. All claims submitted via the FSAI Article 13 online submissions process between June and December 2007 were included in the List. The claims on the List of Article 13 Health Claims Submissions for Ireland do not represent claims that are in any way endorsed or approved by the FSAI or the Department of Health and Children.

Q. Can I still put an Article 13(1)(a) claim on my product eventhough I did not submit the claim to the FSAI or another Member State Authority before 31 January 2008?

Yes. Article 28(5) states that health claims may be made from the 19 th of January 2007 until the adoption of the Community list of health claims on 31 st January 2010 provided that they comply with the Regulation.

Q. When will the list of health claims be adopted by the Commission?

The Commission had intended to adopt the list of health claims, along with conditions for their use, by 31st January 2010 at the latest. However, due to the number of health claims submitted (over 44,000) it will be at least the end of 2011 before the list of permitted health claims is complete.

Health claims which have been approved can be viewed on the Community Register

Q. Can any food business operator use the health claims from the Community list of health claims to be adopted by the Commission?

A. Yes, any FBO can use a health claim from the approved list provided they meet the conditions for the use of such a claim.

Q. What do I do if my health claim is not on the final list adopted by the Commission?

A. If you have not already made a submission in relation to this health claim and wish to have it added to the list, you must make a submission to the Commission, through the FSAI, for approval and authorisation. If you have already made a submission and the claim has been rejected, then you must remove the claim from your products as it is not authorised.

Q. Is there any additional information that must appear on a label along with a health claim?

Yes. Health claims are only permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising:

a statement indicating the importance of a varied and balanced diet and a healthy lifestyle
the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect
where appropriate, a statement addressed to persons who should avoid using the food, and
an appropriate warning for products that are likely to present a health risk if consumed to excess.

Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.

Q. Are there any health claims which will be prohibited?

Yes. The following health claims are not allowed:

claims which suggest that health could be affected by not consuming the food;
claims which make reference to the rate or amount of weight loss;
claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11 of the Regulation.

Q. Is ‘contains antioxidants’ a health claim?

Yes. If in the naming of the 'substance' or 'category of substances' there is a description or indication of a functionality or effect on health the 'contain claim' is a health claim. In other words if the function is mentioned - even in the naming of a substance or substances - this relates to a health claim.

Q. Does the claim ‘gluten free’ fall under the scope of the Regulation?

No. Recitals, paragraph 22 states that claims addressed to a group of consumers with specific disorders are not intended to be covered by the claims Regulation i.e. claims such as 'lactose-free' or 'gluten-free'.

Q. Does the claim ‘no artificial colours or preservatives’ fall under the scope of the Regulation?

No. Labelling of additives is mandatory under appropriate EU legislation and would not therefore be classed as a nutrition and/or health claim.