Germany: When does food become a pharmaceutical?

For companies exporting to Germany, complying with the different classifications for medicinal products and foodstuffs can be the difference between a hatful of orders and a $30,000 fine. Ina Gerstberger explains

Picture the following nightmare situation: An importer of functional foods and food supplements gets a nasty shock when batches of his products shipped into Germany are immediately seized by customs. He receives an official letter from the food supervisory authority informing him that the products do not comply with the legal requirements as set out in German law. The letter includes a conclusive report specifying the objections, and, because it is a serious breach, the authority slaps a fine of $30,000 on the company. At best, the importer can strike a deal with the authorities to return the goods to their place of origin, rather than be destroyed by customs.

Admittedly, this is a worst-case scenario for functional foods and supplements companies exporting to Germany, but it could happen. A situation like this can result from inaccuracies in the labelling and advertising of foodstuffs, or, as is more likely, in the description of the type and concentration of certain ingredients used in the product.

Objections against the use of certain ingredients usually centre round whether the product itself should be reclassified as medicinal rather than as a foodstuff
Ingredients that have prompted legal disputes in the past include herbal extracts, such as garlic, ginkgo and ginseng; probiotics; amino acids, including L-carnitine and glucosamine sulfate; or secondary plant substances, such as lycopene and lutein. However, it is expected that authorities will focus less on pure multivitamin and multimineral products in the future due to an increasingly regulated and harmonised European legislation on their use in foodstuffs.

Objections against the use of certain ingredients usually centre around whether the product itself should be reclassified as medicinal rather than as a foodstuff, or whether, at the very least, it should be regarded as a novel food or unapproved additive. The first alternative is more often discussed in relation to capsule-type or other dose products like food supplements; the second alternative can apply to all types of food products.

Current classifications
In general, food products are examined in a two-stage process. Firstly, the product is checked for whether it is presented for treating or preventing disease in human beings or is considered a medicinal product due to its specific function. According to prevailing case law, the crucial point is whether the product creates the impression of having a certain ?pharmacological effect.? Despite the existence of an apparently scientific criterion, the decision remains a matter of interpretation based on such clues as:

  • the classification of similar products
  • current scientific opinions
  • the recommended daily dosage of the product
  • the overall advertising of the product

The advertising may become the most decisive factor, if there is no ruling opinion on a product or the ingredients have ambivalent traits. This is most apparent in the case of plants—the line between medicinal and food character is often blurred due to their dual use. If this is the case, statements in the product description or instructions for use are scrutinised to see whether they claim certain medicinal effects or even make use of medicinal terms. On the other hand, statements relating to nutrition and taste can support classification of a product as a foodstuff.

If so, the next obstacle to arise is the classification of the ingredients as either novel foods or as unapproved additives. In the majority of cases, the focus is on additives rather than novel foods because the term ?additive? is very broad under German law. Contrary to European law, all substances designed to be added to a foodstuff in order to influence its quality or obtain specific properties or effects are deemed additives.

The overall advertising of the product may become the most decisive factor, if there is no ruling opinion on a product or the ingredients have ambivalent traits
The only exceptions are for substances of a natural origin or those that are chemically equal to natural substances, which are to be used primarily for their nutrient content, taste or flavour. This means that the manufacturer or importer of a foodstuff needs to check, in particular, whether the ingredients in question serve nutritional purposes or may be justified as flavouring agents in the foodstuff. However, there is no room for interpretation in the case of minerals and trace minerals, amino acids, vitamins A and D, sugar substitutes (except for fructose) and sweeteners, which the legislature treats as equal to additives.

Trading across borders
The classification issue is of vital importance for companies wishing to export and market functional foods or food supplements to Germany. Medicinal products always require authorisation prior to marketing; foodstuffs, with the exception of additives or novel foods, can be marketed without prior authorisation if they comply with legal requirements.

Food additives or novel food ingredients in food manufacturing are generally prohibited and only exceptionally allowed if approved by law or by the authorities.

Due to confusion in the law on foodstuffs between EU member states, diverging decisions on the classification of identical products placed on the market in different member states are common. As a result, trade barriers still remain within the EU and are even accepted if justified by peremptory reasons of health protection. In practice, member states are given a relatively large leeway.

Only recently, Germany?s Federal Court of Justice, the BGH, had to decide on athletes? nutritional products, which were legally marketed as food supplements in the Netherlands and also sold by post to German consumers. The products were considered non-authorised medicinal products by the BGH and are prohibited from being advertised or sold in Germany. The BGH stressed that the prohibition of such products, as well as their advertising via the Internet, may represent quantitative import restrictions within the meaning of the EC?s policy of ?free movement of goods.? But these are justified, said the BGH, because of other EC regulations necessary for the protection of public health.

As the safety and efficacy of the controversial ?food supplements? have not been approved in the Netherlands, the products cannot be considered equivalent to a domestic medicinal product. Therefore, even the direct import of small quantities for ?personal use only? is prohibited. And the otherwise open border remains closed for such products since applying for an authorisation is neither a cost- nor time-effective alternative.

The situation looks much brighter with regard to prohibited additives. Importers can apply to the Federal Office for Consumer Protection and Food Safety, the BVL, for:

  • a ?general administrative order,? according to section 47a German Law on Foodstuffs for food products from other EU member states, or
  • an ?exemption in the particular case,? according to section 37 German Law on Foodstuffs for food products from non-EU member states.

If there are no ?peremptory reasons for health protection,? which would block the use of the substance or its dosage, an order is issued and the product can be placed on the market. However, the duration of this procedure is often unpredictable.

A more favourable option to consider with regard to imports from other EU member states is whether a general administrative order has already been issued that may cover the use of the additive, provided that the form of application is similar. If, for example, a general administrative order has been issued for a food supplement sold as a powder, it cannot be used as a legal basis for the sale of a food supplement sold as capsules or liquids. However, several general administrative orders can be combined to cover the overall formulation of the product.

Ultimately, one could check whether a less-critical alternative formulation is already on the market in other countries, which one could easily switch to. Rather than seeking alternatives, one would hope that German approval procedures will be dramatically shortened in the foreseeable future.

Ina Gerstberger is a lawyer, specialising in food law, at the Life Sciences Group of Taylor Wessing, Munich, Germany.

All correspondence will be forwarded to the author.

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