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horak.
Attorneys at Law Hannover
Lawyers
Patent Attorneys
Georgstr. 48
30159 Hannover (Headquarter)
Germany
Fon +49 511.35 73 56-0
Fax +49 511.35 73 56-29
info@healthlawyer.de   
hannover@healthlawyer.de
 
horak.
Attorneys at Law Berlin
Lawyers
Patent Attorneys
Wittestraße 30 K
13509 Berlin
Germany
Fon +49 30.403 66 69-00
Fax +49 30.403 66 69-09
berlin@healthlawyer.de
 
horak.
Attorneys at Law Bielefeld
Lawyers
Patent Attorneys
Herforder Str. 69
33602 Bielefeld
Germany
Fon +49 521.43 06 06-60
Fax +49 521.43 06 06-69
bielefeld@healthlawyer.de
 
horak.
Attorneys at Law Bremen
Lawyers
Patent Attorneys
Parkallee 117
28209 Bremen
Germany
Fon +49 421.33 11 12-90
Fax +49 421.33 11 12-99
bremen@healthlawyer.de
 
horak.
Attorneys at Law Düsseldorf
Lawyers
Patent Attorneys
Grafenberger Allee 293
40237 Düsseldorf
Germany
Fon +49 211.97 26 95-00
Fax +49 211.97 26 95-09
duesseldorf@healthlawyer.de
 
horak.
Attorneys at Law Frankfurt/ Main
Lawyers
Patent Attorneys
Alfred-Herrhausen-Allee 3-5
65760 Frankfurt-Eschborn
Germany
Fon +49 69.380 79 74-20
Fax +49 69.380 79 74-29
frankfurt@healthlawyer.de
 
horak.
Attorneys at Law Hamburg
Lawyers
Patent Attorneys
Colonnaden 5
20354 Hamburg
Germany
Fon +49 40.882 15 83-10
Fax +49 40.882 15 83-19
hamburg@healthlawyer.de
 
horak. 
Attorneys at Law Munich
Lawyers
Patent Attorneys
Landsberger Str. 155
80687 Munich
Germany

Fon +49 89.250 07 90-50
Fax +49 89.250 07 90-59
munich@healthlawyer.de 
 
horak.
Attorneys at Law Stuttgart
Lawyers
Patent Attorneys
Königstraße 80
70173 Stuttgart
Germany
Fon +49 711.99 58 55-90
Fax +49 711.99 58 55-99
stuttgart@healthlawyer.de
 
horak. 
Patent Attorneys Vienna
 
Trauttmansdorffgasse 8
1130 Vienna
Austria
Fon +43 1.876 15 17
Fax +49 511.35 73 56-29
vienna@healthlawyer.de

Foodstuffs

What does the Food and Commodity Goods Law 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 their nature or to achieve particular properties or effects.

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

Cosmetic preparations: substances intended to 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 Pharmaceutical Act or the Law on Advertising in the Healthcare System 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 Advertising in the Healthcare System.

Under § 2 (3) Nr. 1 Pharmaceutical Act connected with § 1 of the Food and Commodity Goods Law, the question has to be answered first, if we are concerned here with an article of food as defined by § 1 of the Food and Commodity Goods Law. 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 as 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 Food and Commodity Goods Law?

Under § 8 of the Food and Commodity Goods Law 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 for third parties products that can be mistaken for articles of food, 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 which they do not have according to scientific research or which 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 Food and Commodity Goods Law.

Moreover, there are advertising bans defined in § 18 of the Food and Commodity Goods Law 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 Food and Commodity Goods Law contains details on this and – contrary to § 17 of the Food and Commodity Goods Law – can be represented in the following way (complete version of the act):

(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 a medical 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 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 an authorisation,
  • representation and trial conduct during the enforcement of claims or in the defence against claims under foodstuffs/medical preparations law.

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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