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horak.
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Food law - horak Attorneys at law, Germany

What does the Act on Foodstuffs and Goods in Daily Use comprise?

Articles of Food: substances which are intended to be consumed by human beings in an unprocessed, processed or prepared condition.

Additives: substances which are added to articles of food in order to change its nature or to achieve particular properties or effects.

Tobacco products: products obtained exclusively or partly from raw tobacco which are intended to be smoked, chewn or otherwise used orally or sniffed.

Cosmetic preparations: substances intended be applied externally on human beings or in their oral cavity for hygiene, care or to influence appearance or body odour.

Goods in daily use: goods that are used when producing, processing, distributing or consuming articles of food and which come into contact with articles of food.

What role does the Medical Preparations Act or the Law on the Advertising of Medicaments play?

As far as communication (advertising, packaging, etc.) is concerned, articles of food, especially dietary supplements are often advertised “in a boundary area”, namely by means of statements which could rather be attributed to medical preparations. The latter would, however, significantly reduce the marketability, and can, moreover, lead to the application of the Law on the Advertising of Medicaments.

Under § 2 (3) Nr. 1 Medical Preparations Act connected with § 1 of the Act on Foodstuffs and Goods in Daily Use, the question has to be answered first if we are concerned here with an article of food as defined by of § 1 of the Act on Foodstuffs and Goods in Daily Use. In accordance with this regulation, articles of food are defined as substances which are intended to be consumed by human beings, which excludes substances which are consumed „predominantly” for purposes other than nourishment or pleasure. Considering the purpose of a substance and its actual role on the market, the possible ways it can be used are decisive as objective characteristics. Thus, dietary supplements can be regarded such articles of food, only if their consumption can be put down to nutrition grounds, i.e. if insufficient nutrition leads to consuming such dietary supplements.

What is directly prohibited under the Act on Foodstuffs and Goods in Daily Use?

Under § 8 of the Act on Foodstuffs and Goods in Daily Use it is prohibited to produce or distribute articles of food which are suitable to damage the health of a human being. Moreover, it is prohibited to use goods of daily use in articles of food in such a way that their consumption might injure health. Further, it is prohibited to produce, process or distribute products that can be mistaken for articles of food for third parties, when they constitute a risk to the health of human beings.

What should be taken into consideration as far as advertising or the product packaging are concerned?

It is forbidden to use advertising statements which ascribe effects to articles of food they do not have according to scientific research or are not secured enough scientifically. Critical indications such as “natural”, “naturally pure”, “residue-free”, etc, are legally admissible only in the narrow area of § 17 (1) Nr. 4 of the Act on Foodstuffs and Goods in Daily Use.

Moreover, there are advertising bans defined in § 18 of the Act on Foodstuffs and Goods in Daily Use which apply to advertising referring to health. Apart from a few exceptions, it is forbidden to advertise articles of food by promising prevention, alleviation or elimination of illnesses.

§ 18 of the Act on Foodstuffs and Goods in Daily Use contains several appropriations of the above and – contrary to § 17 of the Act on Foodstuffs and Goods in Daily Use – can be represented in the following way (complete wording of the law):

(1) “Notwithstanding the regulation of § 17 (1) Nr. 5, in transactions involving articles of food or in advertising of articles of food, it is generally or in a particular case forbidden to use

  • statements which refer to prevention, alleviation or elimination of illnesses,
  • references to doctors’ recommendations or medical opinions,
  • medical records or references to such,
  • statements of third parties, especially addresses of thanks, letters of acknowledgement or letters of recommendation, if they refer to elimination or alleviation of illnesses, as well as references to them,
  • illustrations of persons in working clothes or of members of medicals profession, therapeutic vocation or pharmacology at work,
  • statements which are suited to cause or take advantage of fear,
  • publications or written data which encourage treatment of illnesses by means of articles of food.

(2) The prohibitions listed under Paragraph 1 do not apply to practitioners of medical, auxiliary medical or therapeutic professions. The prohibitions under Paragraph 1 Nr. 1 and 7 do not apply to dietetic articles of food, as long as the Federal Ministry by means of an executive order with consent of the Federal Council provides otherwise.”

There is a range of court decisions in actual cases regarding each of the above statements, which should be taken into consideration.

What do we offer you?

We check the marketability of your new foodstuffs and their ingredients, as well as the delimitation from medical preparations which is particularly important. Of course, we also advise you on the matter of the admissibility of a packaging under the law on competition. Moreover, we assist you in your official proceedings relating to the foodstuffs law. We offer our services for all branches, typically including:

  • advice and assistance relating to additional foodstuffs
  • examination of the packaging (especially texts/pictures)
  • advice on foodstuffs and medicine advertising
  • advice, protection and defence of geographical indications of origin and trademarks
  • advice and representation when applying for a permit
  • representation and trial conduct at the enforcement of claims or at the defence against claims under foodstuffs/medical preparations law.

At your wish, we offer you assistance from designated experts on matters relating to microbiology, medical preparations or food chemistry.

What do we need to handle your legal questions relating to foodstuffs/medical preparations?

Usually we need exact data concerning your product, including its ingredients, information on the way of distribution of your product and/or – depending on your legal question – the packaging and all relevant documents which are to be agreed upon individually..

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© German lawyer Michael Horak 2002-2017

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