Regulation (EC) No. 1924/2006 (Health Claims)

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Regulation (EC) No. 1924/2006

Title: Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of December 20, 2006 on nutrition and health claims made on foods
Designation:
(not official) 		Health Claims Regulation
Scope: EU
Legal matter: Food law
Basis: EGV , especially Art. 95
Procedure overview: European Commission
European Parliament
IPEX Wiki
To be used from: January 1, 2007
Reference: OJ L 404 of 30.12.2006, pp. 9-25
Full text Consolidated version (not official)
basic version
Regulation has entered into force and is applicable.
Please note the information on the current version of legal acts of the European Union !

The Health Claims Regulation (in German about "Health Claims Regulation") refers to Regulation (EC) No. 1924/2006 of the European Parliament and the Council of December 20, 2006 on nutrition and health claims made about foods .

General

The Health Claims Regulation (HCVO) came into force on July 1, 2007 in all member states of the European Union. As a regulation, it has since been observed by all courts and authorities in the EU as directly applicable law.

The purpose of the Health Claims Regulation is in particular to protect health. According to the regulation, advertising with health and nutritional information is only permitted if the information has been scientifically recognized by the European Union in a procedure prescribed by the HCR. The European Food Safety Authority (EFSA) is responsible for scientific recognition . The final decision on the admissibility or inadmissibility of certain health or nutrition claims is made by the European Commission.

According to the HCR - apart from transitional provisions and exceptions - food may only be advertised with health or nutritional information that has been expressly approved. Health and nutritional information about food is therefore subject to a prohibition with reservation of permission. In addition, the HCR makes further additional requirements for advertising with health and nutritional information that must be taken into account in individual cases.

Scope and definitions

a) The health claim regulation applies in accordance with their Art. 1 Para. 2 for nutrition and health claims that are made in commercial communications for the labeling and presentation of or in advertising for foodstuffs that are to be given as such to the end consumer, including insofar as they are for Restaurants, hospitals, schools, canteens and similar facilities are intended for communal catering.

b) The term "commercial communication" within the meaning of Art. 1 Para. 2 HCR is to be understood as meaning that a. Notices in the form of a food advertising recorded, which serve to directly or indirectly promote the sale of this food. The message must be intended for the end user, but not addressed to the end user. This also includes advertising to a doctor that he should distribute to patients.

c) According to Art. 2 Clause 1 of Regulation (EC) No. 178/2002, foods are all substances or products which are intended for this purpose or which can reasonably be expected to be in a processed, partially processed or unprocessed state People are included. According to Art. 2 Para. 1 b) HCR in conjunction with Art. 2 of Directive 2002/46 / EC, this also includes food supplements .

The scope of application of the HCR is opened up by the fact that information is given in a commercial communication about certain foods, i.e. statements are made or representations are made which, in the case of a normally informed and appropriately attentive and sensible average consumer, can give the impression that a food has special properties .

d) The HCR covers all information relating to the health or nutritional value of a food. Other information can be recorded by other sets of regulations, for example Regulation (EU) No. 1169/2011 on informing consumers about food (Food Information Regulation (LMIV) or Regulation (EC) No. 258/97 on novel foods and novel food ingredients ( Novel Food Regulation, see also Novel Food ).

e) The term “health-related claim” is defined in Art. 2 Para. 2 No. 6 HCR as any information that explains, suggests or even indirectly expresses that the consumption of a food category, a food or a food component significantly lowers a risk factor for developing a disease in humans. It is sufficient that, according to the understanding of the average consumer, a connection between the food or a component of a food and the health status of the consumer is suggested. Information is also recorded which suggests that the consumption of a food is less harmful than other foods of the same kind. The concept of health also includes information on mental equilibrium.

aa) Health-related information must be differentiated from statements relating to general well-being. Advertising messages related to general well-being are not covered by the regulations of the HCR. The question of whether a claim relates to health or general well-being is judged from the point of view of the advertising addressees.

bb) On the other hand, the concept of health claims must be distinguished from the concept of nutrition claims. According to Art. 2 Para. 2 No. 4 HCR, a “nutritional value claim” is any claim that explains, suggests or even indirectly expresses that a food has particularly positive nutritional properties because it has a certain energy (calorific value ) or not, or contains nutrients or other substances or not. While nutrition claims refer to the amount of nutrients, other substances or energy contained in a food and thus provide (only) factual information with regard to a certain nutrient, health claims establish a connection between a food or one of its components and health . An indication that arouses certain associations in this direction among advertising recipients can also be related to nutrition.

Admissibility of health-related claims

a) When assessing the admissibility of health-related claims, a distinction must first be made between specific and non-specific health-related claims. The admissibility of specific health-related claims is based on Art. 10 para. 1 HCR, the admissibility of non-specific health-related claims according to Art. 10 para. 3 HCR.

b) Specific health-related claims are accessible to evidence and can be the subject of an authorization procedure. Non-specific health claims are also health claims that explain, suggest or indirectly express that there is a connection between a food category, a food or one of its components on the one hand and health on the other. However, they cannot be proven and therefore cannot be approved.

In the case of specific health-related information, a distinction must be made between information on so-called botanicals, which are natural herbal substances, and other foods. While the EU Commission has meanwhile decided on all health-related claims registered for approval beginning in May 2012, whether they are permissible or not, this is not the case with botanicals.

The use of a health-related claim for a food (apart from a botanical) is only permitted according to Art. 10 Para. 1 HCR if the claim has been expressly permitted and (cumulatively) also the general requirements of Chapter II and the special requirements in Chapter IV of the regulation. The health-related claims made by the EU can be researched in the EU register using nutritional and health-related claims on foods.

Examples

Possible health claims can be:

Nutrient / substance / food Information (VO 432/2012) Conditions for use (VO 432/2012)
Rye - fiber "Contribute to normal bowel function" High fiber content (= at least 6 g fiber per 100 g)
Wheat bran "Contributes to increasing the volume of stool " High fiber content (= at least 6 g fiber per 100 g)
Wheat bran "Contributes to the acceleration of the intestinal transit" High fiber content (= at least 6 g fiber per 100 g) and a daily intake of at least 10 g wheat bran

The health claim must also relate to the ingredient for which it has been approved and not to the food as a whole. Permissible is e.g. For example, the claims "The vitamin C in a glass of orange juice helps reduce tiredness and fatigue", while the claims "A glass of orange juice helps reduce tiredness and fatigue" or "High C helps reduce tiredness and fatigue." “Are inadmissible because the approved health claim refers to vitamin C and not to orange juice or even the Hohes C brand. On the other hand, formulations that differ from the approval are permitted. In terms of content, however, they must be identical to the permitted information. In this respect, case law applies a strict standard.

For botanicals, the transitional provision of Art. 28 (5) HCR applies in conjunction with Art. 5 HCR. Health-related claims about botanicals are permissible if it is ensured on the basis of generally recognized scientific evidence that the presence or absence or reduced content of a substance to which the claim relates has a positive nutritional or physiological effect in a food (Art . 5 para. 1 lit. a and b) HCR). This generally recognized scientific proof must be provided by the company making the health claim about a food. Evidence based on randomized and placebo-controlled double-blind studies, as required in case law for health-related claims for products such as drugs, medical devices, cosmetics, etc., is not required. The Court of Appeal relies on Article 16a of Directive 2001/83 / EC on the creation of a Community code for medicinal products for human use. According to this, the information on the effects or the effectiveness of the substance must be plausible based on bibliographical information or reports from experts after many years of use and experience.

c) References to general, non-specific advantages of the food or a substance in the food for general health or health-related well-being are permissible according to Art. 10 Para. 3 of the HCR if they contain a special one in one of the lists under Article 13 or 14 health-related information is attached (so-called "coupling requirement"). It is disputed in case law whether this coupling requirement also applies to botanicals for which there are no approved health claims that could be added to the non-specific information. The court case law does not follow the opinion of the BGH, according to which the coupling requirement for botanicals does not apply.

d) For both specific and non-specific health claims, Article 10 (2) HCR must be observed in advertising. According to this, health-related information according to Art. 10 Para. 1 and Art. 10 Para. 3 HCR may only be given if the labeling or, if this labeling is missing, the presentation of the food and the food advertising provide the following information:

  • an indication of the importance of a varied and balanced diet and a healthy lifestyle,
  • Information on the amount of the food and consumption pattern required to achieve the claimed beneficial effect,
  • if applicable, a notice to people who should avoid consuming this food, and
  • a suitable warning label for products which, if consumed in excess, could pose a health risk.

The reference to the importance of a varied and balanced diet and a healthy lifestyle is mandatory in any case. The further information only has to be given if the corresponding requirements are met.

e) The Health Claims Ordinance contains further bans on health-related claims that must also be observed in advertising. According to Art. 3 Para. 2 HCR, the nutrition and health claims used may be used

  • not be false, ambiguous, or misleading;
  • do not raise doubts about the safety and / or nutritional suitability of other foods;
  • do not encourage excessive consumption of any food or display it benevolently;
  • do not explain, suggest or even indirectly express that a balanced and varied diet generally cannot provide the necessary amounts of nutrients. In the case of nutrients for which a balanced and varied diet cannot provide sufficient quantities, different rules, including the conditions for their use, may be approved in accordance with the procedure referred to in Article 24 (2), taking into account the special circumstances in the Member States;
  • not - through a textual statement or through representations in the form of pictures, graphic elements or symbolic representations - refer to changes in body functions that could trigger fears in the consumer or benefit from them.

For drinks with an alcohol content of more than 1.2 percent by volume, no health-related information at all may be made in accordance with Art. 4 Para. 3 HCR.

According to Art. 12 HCR, the following health-related claims are still not permitted:

  • Claims giving the impression that health could be impaired by not consuming the food;
  • Information on duration and extent of weight loss;
  • Information referring to recommendations by individual doctors or representatives of the medical professions and by associations not mentioned in Article 11.

Admissibility of nutrition claims

A "nutrition-related claim" is any claim that explains, suggests or even indirectly expresses that a food has particularly positive nutritional properties, based on a) the energy (calorific value) it provides, in reduced or reduced form supplies or iii) does not supply, and / or b) contains or does not contain nutrients or other substances which it contains in reduced or increased quantities.

According to Art. 8 (1) HCR, nutritional information may only be made if it is expressly listed in the annex to the HCR and if it complies with the conditions set out in this ordinance. This appendix is ​​updated regularly. It is also permissible to use information that is "likely to have the same meaning" for the targeted traffic.

The general prohibitions of Art. 3 HCR also belong to the conditions for the use of nutritional information. Beverages with an alcohol content of more than 1.2 percent by volume may not bear any nutritional value claims, with the exception of those that refer to a reduction in alcohol content or calorific value.

literature

  • Christina Rempe: Consumer protection through the Health Claims Regulation. Nomos Verlagsgesellschaft, Baden-Baden, 2009, ISBN 978-3-8329-4284-7 .
  • Kai Purnhagen, Erica van Herpen, Ellen van Kleef: The Potential Use of Visual Packaging Elements as Nudges - an Analysis on the Example of the EU Health Claims Regime. Wageningen Working Papers in Law and Governance 5/2015, available at on the website of the Social Science Research Network: Abstract and download option (forthcoming in Klaus Mathis / Avishalom Tor (eds.), Nudging - Possibilities, Limitations and Applications in European Law and Economics , Cham / Heidelberg / New York / Dordrecht / London 2016)
  • Hermann-Josef Omsels, online commentary on the Health Claims Regulation

Web links

Individual evidence

  1. ↑ Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of December 20, 2006 on nutrition and health claims made on foods , accessed on June 3, 2017
  2. ↑ ECJ, judgment of July 14, 2016 - C-19/15, Item 39 - VSW / Innova Vital
  3. ↑ ECJ, judgment of July 14, 2016 - C-19/15, Item 29 ff - VSW / Innova Vital
  4. ↑ Directive 2002/46 / EC
  5. ↑ BGH, ruling v. July 24, 2014 - I ZR 221/12, Item 22 - Original Bach flowers with reference to ECJ, ruling v. July 18, 2013 - C-299/12, Item 24 - Green - Swan Pharmaceuticals
  6. ↑ ECJ, judgment of September 6, 2012 - C-544/10, Item 34 ff - Wholesome wine; BGH, ruling v. February 26, 2014 - I ZR 178/12, item 18 - prebiotics
  7. ↑ ECJ, judgment of September 6, 2012 - C-544/10, Item 34 ff - Wholesome wine; OLG Stuttgart, ruling v. November 3, 2016 - 2 U 37/16, Item 29 - Digestible beer
  8. ↑ BGH, ruling v. July 24, 2014 - I ZR 221/12, Item 23 - Original Bach flowers
  9. ↑ BGH, ruling v. July 24, 2014 - I ZR 221/12 - Original Bach flowers; Ruling v. January 17, 2013 - I ZR 5/12 - medicinal mushrooms; Acceleration from January 13, 2011 - I ZR 22/09 - Gurktaler herbal liqueur
  10. ↑ BGH, ruling v. February 26, 2014 - I ZR 178/12, Item 17 - Praebiotics
  11. ↑ BGH, ruling v. February 12, 2015 - I ZR 36/11, Item 28 f - Monsterbacke II
  12. ↑ BGH, ruling v. February 12, 2015 - I ZR 36/11, Item 36 - Monsterbacke II
  13. ↑ BGH, ruling v. April 7, 2016 - I ZR 81/15, Rn. 14 - repair capsules; BGH, decision of December 5, 2012 - I ZR 36/11, Rn. 10 - monster cheek
  14. ↑ EU register on nutrition and health claims about food
  15. ↑ BGH, ruling v. April 7, 2016 - I ZR 81/15, Item 34ff - Repair capsules
  16. ↑ BGH, ruling v. April 7, 2016 - I ZR 81/15, Item 30 - Repair capsules; BGH, ruling v. October 10, 2015 - I ZR 222/13, Item 51 f - Learner
  17. ↑ BGH, ruling v. January 17, 2013 - I ZR 5/12, Item 21 - Medicinal mushrooms
  18. ↑ BGH, ruling v. January 17, 2013 - I ZR 5/12, Item 20 - Medicinal mushrooms
  19. ↑ KG, judgment of July 10, 2015 - 5 U 24/15 (= MD 2015, 847)
  20. ↑ BGH, ruling v. October 10, 2015 - I ZR 222/13, Item 13 - Learner
  21. ↑ BGH, ruling v. January 17, 2013 - I ZR 5/12, Item 15f - Medicinal mushrooms
  22. ↑ OLG Hamm, ruling from October 7, 2014 - 4 U 138/13, Item 71; KG, ruling v. November 27, 2015 - 5 U 96/14, Item 32
  23. ↑ OLG Cologne, judgment of February 15, 2012 - 6 U 169/11, Item 18; Hamburg Higher Regional Court, decision of April 24, 2014 - 3 W 27/1, II.3.a
  24. ↑ Hamburg Higher Regional Court, decision of April 24, 2014 - 3 W 27/1, II.3
  25. ↑ OLG Celle, judgment of May 26, 2016 - 13 U 76/15, II.2.b.bb.1.c