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01 Mar '22
"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.
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.
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).
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.
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.
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".
(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.
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.
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 (email@example.com).
Expertises: Customs,Food safety & product compliance , Transport and Logistics,Customs, Trade & Logistics,Food, Customs and International Trade,Start-up en Scale-up,
Expertises: Food safety & product compliance ,Customs,Transport law, Food,Transport and Logistics,Customs, Trade & Logistics, Customs and International Trade,Enforcement and sanctions,International Sanctions and Export Controls,E-commerce,E-health,
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