MANDATORY LABELLING
Producers of food products on the packaging of which they wish to make a health claim are obliged to label them appropriately and to label their products in a specific manner.
Health claims made on a product are only permitted if the relevant information is included on the labelling and, if the product does not have a label, on the presentation and advertising of the product.
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LABELLING A PRODUCT WITH A HEALTH CLAIM
What information to put on the product?
Indicate:
- a statement indicating the importance of a balanced diet and a healthy lifestyle;
- the quantity of the food and the level of consumption required to obtain the beneficial effect claimed;
- a statement addressed to persons who should avoid the food (if appropriate);
- an appropriate warning for products that are likely to present a health risk if consumed to excess.
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RESTRICTIONS ON THE USE OF HEALTH CLAIMS
It is illegal to use health claims that:
- suggest that health could be affected by not consuming the food;
- refer to the rate or amount of weight loss;
- refer to the recommendations of individual doctors or health professionals and other associations.
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HEALTH CLAIM VS TRADEMARK
A trade mark, brand name or marketing name appearing on the label, presentation or advertising of a food which may be perceived [which may be perceived] as a nutrition or health claim may be used without being subject to the authorisation procedure which is indicated in Regulation 1924/2006 provided that it is accompanied by a nutrition or health claim on the same label, presentation or advertising which complies with the requirements of the aforementioned Regulation.
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WHEN A HEALTH CLAIM IS NOT NEEDED
Neither is permission needed for information relating to general references to health, fitness, well-being, the benefits of a healthy diet.
However, it is important that such information does not fall under the category of health claims. In such cases, their use requires registration in a competent register and authorisation from the relevant authority.
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HEALTH CLAIMS IN PRACTICE
Foodstuff vs. medicinal product
- Judgment of the WSA, VII SA.Wa/1062/20 - The Court in Warsaw rejected a complaint against a decision of the GIS to impose a fine for an unauthorised health claim.
- The product labelling used the claims: "can be an invaluable aid in supporting the treatment of phobias or depression"; "plant used in medicine for thousands of years"; "acts as a sedative and calming agent".
- The Chief Sanitary Inspector, followed by the WSA in Warsaw, stated that a foodstuff cannot have claims equivalent to a medicinal product - a medicine - which has much stricter regulations and restrictions than a foodstuff.
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HEALTH CLAIMS IN PRACTICE
Must every substance be labelled with a health claim?
- There is a dispute before the Court of Justice of the European Union as to whether plant or herbal substances, so-called botanical substances, can be advertised with health claims under Article 10(1) of Regulation 1924/2006.
- Currently, botanical substances are not included in the official list of health claims and the European Commission has not yet decided on their inclusion in the list.
- The issue, therefore, breaks down as to whether health claims indicating botanical - plant or herbal - substances can be used on the market if they are not on the official list of the European Commission.
- The Court's ruling could result in an outright ban on advertising, communication, labelling and other commercial activities in relation to botanical substances, if the Court subscribes to the view that if such substances are not listed, they cannot be used on the market.
- As of the end of January 2024, a ruling on this matter had not yet been reached.
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FOOTNOTES
- Article 10 of Regulation 1924/2006.
- Article 12 of Regulation 1924/2006.
- Commission Regulation (EU) No 175/2014 of 25 February 2014 refusing to authorize certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health (OJ EU. L. 2014 No 56, p. 7).
- Commission Regulation (EU) No 1170/2011 of 16 November 2011 refusing to authorize certain health claims made on foods and referring to the reduction of disease risk (OJ EU. L. 2011 No 299, p. 1).
- Commission Regulation (EU) No 383/2010 of 5 May 2010 refusing to authorize a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health (OJ 2010. EU. L. No 113, p. 4).
- The applicant failed to provide adequate scientific studies demonstrating a causal link between the substance and the effect claimed in the application.
- The EFSA Panel concluded that water as a food ingredient is sufficiently characterized.
- The applicant did not provide adequate scientific studies showing a causal link between the substance (product) and the effect indicated in the application.
- This judgment was confirmed by the judgment of the Supreme Administrative Court of 23.09.2021, II GSK 919/21, LEX No 3258344.
- Medicinal products are mainly regulated by the Act of 6 September 2001. Pharmaceutical Law (i.e. Journal of Laws of 2022, item 2301, as amended).