Nutrition and health claims on labels and in food advertising

"Cholesterol-free", "low-fat", "super light", "sugar-free" or "anti-ageing": all examples of conceivable claims on food labels and advertising. In reality, however, only two of these claims are legally permitted. The Dutch Food and Consumer Product Safety Authority (NVWA) recently published the Handbook of Nutrition and Health Claims as an aid for industry to comply with the legal obligations when using nutrition and/or health claims (hereafter: the "Handbook"). The Handbook deals, among other things, with (non-)permitted claims, the European and Dutch regulations regarding nutrition and health claims and includes several step-by-step plans for the qualification of these claims. Ferah Taptik Salman briefly discusses the contents of the Handbook and the (legal) obligations applicable to businesses.

Nutrition and health claims

Claims are voluntary statements - both direct and indirect - concerning certain characteristics of food. A claim is defined 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 has particular characteristics". Claims can be used on a label, a website or in an advertisement, but also in a blog, a leaflet, direct mailing, etc. Also the name of a website can imply a claim (for example by using the term "flexible joints" in the name) or if a website contains information about flexible joints and a relationship is made with a food or supplement.

In short, a nutrition claim is a voluntary claim that directly or indirectly asserts that a food has certain beneficial nutritional properties due to the fact that it does or does not contain a (food) substance, or that it contains more or less of this substance. It is about the composition of the food. A nutrition claim is defined as follows: "a claim which states, suggests or implies that a food has particular beneficial nutritional properties due to: a) the energy value (calorific value) which it i. provides; ii. provides at 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." Examples: "low fat", "sugar free", "high fibre", "source of magnesium" and "reduced saturated fat content".

A health claim, on the other hand, is a voluntary claim that directly or indirectly refers to the positive effect that a food has on health. A health claim is defined as follows: "a claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health". Health is a broad concept. Health claims often relate to physiological effects, but can also be about psychological and slimming/weight control effects, or relate to disease risk reduction or children. Examples of health claims are: "potassium contributes to normal muscle function" or "magnesium contributes to the reduction of fatigue and tiredness". Most of the permitted health claims relate to a specific ingredient or nutrient; some claims relate to a food, for example "dried plums contribute to normal bowel function" or "sugar-free chewing gum helps maintain the mineralisation of teeth".

In practice, the illustrations, graphics and symbols used are assessed in conjunction with the text used to see whether or not they constitute a nutrition or health claim. For example, an image of a heart in the vicinity of food claims about saturated fat and sodium implies a positive effect on heart health and therefore qualifies as a health claim, while an image of the same heart on a box of chocolates with a bow "for Valentine's Day" implies no health effect and therefore does not qualify as a health claim.

Laws and regulations

The European Regulation (EC) No. 1924/2006 is the basic regulation containing rules on nutrition and health claims. In addition, various EU regulations contain rules for the use of these claims or authorisations of claims and the EFSA has published a number of Guidance documents. The European Claims Register contains all permitted and rejected nutrition and health claims.

The following EU regulations and documents contain rules for the use of claims: Regulation (EC) No. 1924/2006, Regulation (EU) No. 432/2012, Implementing Decision 2013/63/EU, Regulation (EU) 2019/343, a European Claims Register listing the permitted and rejected nutrition and health claims and a Guidance on the Implementation of the Claims Regulation from the European Commission, 14 December 2007 (English only) in which the Commission explains some aspects of the Claims Regulation.

Before a new health claim can be used, it must first be assessed and authorised. The following European regulations and documents relate to applications for authorisation of a new health claim: Regulation (EC) No 353/2008, Regulation (EU) No 907/2013 and EFSA General Scientific Guidance/ EFSA Scientific and Technical Guidance.

Finally, the European regulations with rules on nutrition and health claims have a direct effect in the Netherlands. In article 2, paragraph 4 of the Commodities Act Decree on Foodstuffs Information the penalization of the Claims Regulation (EC) No. 1924/2006 is regulated for the Netherlands. The Ministry of Health, Welfare and Sport is the competent authority insofar as necessary within the framework of the implementation of the Regulation (EC) No. 1924/2006 in the Netherlands (article 13 Commodities Act Decree on Foodstuffs Information). Within the framework of self-regulation, the Inspection Board of Health Product Advertising, in cooperation with various parties (Neprofarm, NPN and FNLI), has drawn up a Guideline Document for the Use of Health Claims with an accompanying Claims Database. This database lists the approved sample wording(s) of a health claim for each nutrient and the permitted and non-permitted alternative sample wording(s).

Step-by-step plan: is this nutrition or health claim permitted?

A company that wishes to make a nutrition or health claim on a food product must first check whether this claim is permitted. The NVWA has included various step-by-step plans in its Handbook for these companies to check whether a certain nutrition or health claim is permitted.

Step-by-step plan: is this nutrition claim allowed?

1. Is the nutrition claim listed in the Annex of the Regulation on Claims (EC) No. 1924/2006? Yes, please go to step 2. No, this nutrition claim is not permitted and may not be used.
   The nutrition claims listed in the Annex of the Claims Regulation are thus the only nutrition claims permitted. Furthermore, for each permitted nutrition claim, the Annex of the Regulation on Claims states that in addition to the described nutrition claim, any other claim is allowed which is likely to have the same meaning for the consumer. Examples: "with iron" has the same meaning as the nutrition claim "source of iron"; "added vitamin D" has the same meaning as the nutrition claim "source of vitamin D; and "packed with vitamin C" has the same meaning as the nutrition claim "rich in vitamin C".
   Nutrition claims that are not included in the Annex of the Claims Regulation or nutrition claims that do not have the same meaning as nutrition claims in the Annex are thus unauthorised nutrition claims. Examples: "contains no trans fatty acids" or "cholesterol free" are not permitted as they are not listed in the Annex; "low in carbohydrates" or "low in protein" are not permitted; nutrition claims are permitted on these nutrients, but not with this wording.
2. Does the product bearing the nutrition claim meet the conditions listed in the Annex of the Regulation on Claims? Yes, go to step 3. No, this nutrition claim may not be used.
   The majority of nutrition claims are subject to conditions, which consist of minimum or maximum values per 100 g, 100 ml or 100 kcal of the food. For example, the claim "fat free" is only allowed if the fat content of the product is maximum 0.5 g/100 g or 0.5 g/100 ml. However, claims such as "X% fat-free", for example, "99% fat-free" are prohibited. Other conditions relate, for example, to the claims "no added sugars", "very low sodium/salt", "source of/rich in [name of vitamin(s)/mineral(s)]" and "naturally/natural".
3. Does the product bearing the nutrition claim comply with the general conditions applicable to all nutrition and health claims? Yes, this nutrition claim may be used. No, this nutrition claim may not be used.  
   Articles 3 and 5 of the Claims Regulation (EC) No 1924/2006 lay down a number of general principles and conditions that must always be complied with for any nutrition and/or health claim. For example, a claim may never be misleading, ambiguous or confusing and thus understandable to the consumer. Furthermore, claims must be scientifically substantiated, operators must be able to justify them and nutrition labelling is mandatory.

Step-by-step plan: is this health claim allowed?

The Regulation on Claims furthermore distinguishes between different types of health claims, including article 13 health claims and article 14 health claims.

Article 13 health claims

Article 13 health claims are claims that refer to a role of a nutrient in growth, development or bodily functions and for which the scientific basis is related to all ages and in any case more widely than only children. These article 13 health claims are claims made to the healthy population (not to patients) about maintaining good health by the use of words such as care, support, help, maintain, etc. of a normal functioning of an organ or body function.

Step-by-step plan:

1. Is the Article 13 health claim included in the consolidated version of Regulation (EU) No 432/2012 containing the list of permitted Article 13 health claims? Yes, please go to step 3. No, please go to step 2.
2. Check whether this article 13 health claim is about a substance for which non-authorised claims are listed in the European Claims Register. Does the Register contain only rejected claims for this substance? Yes, then no health claim can be made about this substance, not even an "on hold" health claim (e.g. "taurine"). No, check whether the claim can be an "on hold" health claim.
3. Does the product bearing the Article 13 health claim comply with the specific conditions for the claim concerned as laid down in Regulation (EU) 432/2012? Yes, please go to step 4. No, this Article 13 health claim may not be used.
4. Does the product bearing the article 13 health claim comply with the general conditions that apply to all food and health claims and the general conditions that apply to all health claims (article 10 and 12 Claims Regulation)? Yes, this article 13 health claim can be used. No, this article 13 health claim is not permitted and may not be used.

Article 14 health claim

An Article 14 health claim is a health claim referring to the reduction of a human disease risk factor. It is a voluntary claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease, for example: "reduces the risk of ...". A health claim regarding the reduction of disease risk is always composed of 2 parts. The first part indicates the effect of a substance or foodstuff on a disease risk factor (e.g. plant sterols on cholesterol levels). The second part describes the role of the disease risk factor in a disease (e.g. the risk of high cholesterol for coronary heart disease). The difference between a health claim about reduction of disease risk and a (prohibited) medical claim is that the latter directly claims something about the prevention or cure of a disease, for example the prohibited medical claim "plant sterols prevent cardiovascular disease".

Step-by-step plan:

1. Is the Article 14 health claim permitted in a European Regulation? Yes, please go to step 2. No, this article 14 health claim is not permitted and may not be used.
2. Does the product bearing the article 14 health claim comply with the specific conditions of the claim as laid down in the European Regulation authorising the claim? Yes, please go to step 3. No, this article 14 health claim may not be used.
3. Does the product bearing the article 14 health claim comply with the general conditions that apply to all food and health claims and with the general conditions that apply to all health claims (article 10 and 12 Claims Regulation)? Yes, this article 14 health claim can be used. Please note: an additional labelling requirement applies to a disease risk reduction claim: a mandatory statement that the disease to which the claim refers has multiple risk factors and that changing one of these factors may or may not have a beneficial effect. No, this article 14 health claim may not be used.

Authorisation procedure for health claims

(Art. 15-21 Regulation (EC) No. 1924/2006 and Regulation (EC) No. 353/2008)

Before a new health claim can be used or before an existing health claim can be amended, a European authorisation procedure has to be completed. A separate application must be submitted for each individual health claim accompanied by a letter of offer. The application for the health claim itself should contain at least the following information: "[wording of the health claim; specification of the type of health claim; a copy of any studies performed and any other scientific studies and data supporting the claim; the target population for the proposed health claim; the quantity of the nutrient or other substance, or food or category of food, and the pattern of consumption required to obtain the claimed beneficial effect; where appropriate, a statement addressed to persons who should avoid using the nutrient or other substance, or food or category of food, for which the claim is made a warning for the nutrient or other substance, or food or category of food, that may present a health risk if consumed to excess; other limitations of use and instructions for preparation and/or use; where applicable, in order to be considered for data protection, the requests for protection of proprietary data must be justified and all data included in a separate part of the application; and a summary of the application."

An application for a health claim must be submitted to a competent authority of a Member State; for the Netherlands this is the NVWA. However, it is not compulsory to submit an application via the Member State where the applicant is established or where the product with the new claim will be marketed after authorisation. It should be noted that the NVWA only acts as an intermediary and forwards the application to EFSA for advice.  EFSA then sends its advice to the European Commission, which prepares a draft decision to be adopted by the Standing Committee on Plants, Animals, Food and Feed. The Commission then informs the applicant of the decision taken and it is published in a Regulation in the Official Journal of the European Union. All approved and rejected claims are entered into the European Claims Register. Up to this stage, the application procedure takes about 8 months. In practice, the total length of the authorisation procedure varies considerably.

Finally, it should be noted that on the basis of self-regulation, the Inspection Board plays an important role in the Netherlands in the area of nutrition and health claims. Companies can have their nutrition or health claims preventively tested by the Inspection Board. Companies can also ask for advice about claims. The Inspection Board monitors compliance with the rules for advertising that have not been submitted for assessment beforehand. The Inspection Board and the NVWA have agreed that the NVWA will not take any action against advertising statements which have been approved in advance by the Inspection Board. Moreover, the NVWA never advises in advance whether the use of a claim on a label or in an advertisement complies with the laws and regulations. Companies that want to have their food or health claims checked beforehand can contact the Inspection Board.

Impact for (food) businesses

Pursuant to the NVWA Handbook, the use of nutrition and health claims entails various obligations for companies. These include qualifying the claim in question as a nutrition or health claim, (substantiating) the claim in question as a legally permitted claim, having to comply with various laws and regulations at European and national level in this respect and possibly having to go through a European approval procedure. If a company does not comply with the aforementioned legislation and regulations, this may have considerable (financial) consequences for the company. For the aforementioned reasons, it is therefore advisable to seek (legal) advice in good time, if necessary, before using the claim in question on labels and in food advertising.

About Ploum's International Trade, Customs and Food Safety & Product Compliance Team

The specialists of our International Trade, Customs and Food Safety & Product Compliance team will be happy to advise you on the laws and regulations as well as the legal steps required when using nutrition and health claims on labels and in food advertising. Thanks to our many years of experience in the food (safety) and commodities practice, we can serve you quickly and effectively. If you have any questions on this topic or on other issues regarding International Trade, Customs or Food Safety law, please contact one of our team members or contact Marijn van Tuijl directly (m.vantuijl@ploum.nl).