By Joerg Gruenwald, analyze & realize ag01.26.22
The harmonization of European food regulations is a lengthy process with some famous ups and downs. On the upside, labeling regulations are now harmonized and health claims are regulated at an E.U. level with only minor wiggle room for E.U. member states as they adopt E.U. regulations into country legislation.
On the other hand, maximum intake amounts for vitamins/minerals are still regulated at a country level (although there is movement in this area), and there still is no definitive E.U.-wide list of plant parts or “other substances” (i.e., substances other than vitamins/minerals that are permissible in food).
Hurdles to Harmonization
So each member state is drawing up its own positive list of which plants can or cannot be used as food (supplement) ingredients, sometimes involving cooperation among individual member states, like for the List of Substances jointly developed by Germany, Austria, and Switzerland. The genesis of these plant lists has put a spotlight on one of the hurdles for food business operators that wish to market a botanical food supplement in more than one E.U. country.
Yet another example of dis-harmonization is the definition of what constitutes a pharmacological substance, or at which daily intake amount a substance begins to exert a pharmacological effect. Some member states are stricter in this regard than others. A famous case is melatonin, which has received an authorized health claim for reduction of the time to fall asleep at a daily intake amount of at least 1 mg. This is considered within the pharmaceutical range by Germany, where the claim thus cannot be used. Then there is monacolin from red yeast rice for the maintenance of normal blood LDL concentrations, which in Germany is considered a pharmaceutical and therefore not a food substance, full stop.
Thus, while theoretically all goods can circulate freely within the E.U. single market, there are some obstacles preventing a carefree marketing of food products in more than one E.U. country.
Amino Acids, Mutual Recognition, and Permissions
Another more obscure example is amino acids. They can be used as ingredients in food supplements in most E.U. countries. Germany, again however, up until recently ruled that amino acids are drug substances and are, as such, not permissible in food supplements.
The E.U. has put a process called Mutual Recognition in place, where a product lawfully marketed in one member state must also be marketable in any other. However, member states still retain the right to refuse Mutual Recognition if they decide that a given product is not safe and therefore cannot be marketable after all.
In fact, Germany has put two such mechanisms in place. One is a way to gain an “exceptional permission” to market a specific product following an application to the German authority, which scrutinizes the product for safety issues. Once an exceptional permission is granted, the product can be marketed. However, if the exception is refused, for whatever reason, the product in question is forever illegal to market in Germany.
This is a risk for FBOs, since food supplements that are notified for marketing in Germany in the usual way are not scrutinized by the authority for their marketability. Seeking an exception means unavoidable scrutiny, whereas just quietly notifying the product makes it possible, at least for a while, to let it fly under
the radar.
Another way to grant market access for food supplements containing substances that Germany does not consider permissible is gaining a “general permission.” This permission is given to a single ingredient at a maximum daily intake amount, again following a safety assessment. Once it is granted, the ingredient in question with that intake amount can be used as a food supplement ingredient by all FBOs, in contrast to the exceptional permission, which only applies to a single product.
A number of general permissions have been granted to amino acids over the years, making it possible for these—but certainly not all—amino acids to be used as food supplement ingredients.
Momentum for Harmonization?
However, all this came to an end in July 2021 when, seemingly without much fanfare, the German general food law regulation was amended, and the paragraphs referring to amino acids as “other substances not permissible in food supplements” was quietly removed.
With this step, Germany has aligned with the majority of E.U. member states, where using amino acids as food supplement ingredients has always been possible. Still, intake levels must be kept in mind when formulating food supplements containing amino acids for marketing, since the tenet that foods are not allowed to have pharmaceutical effects still holds true.
FBOs that wish to bring their products to the E.U. market and are uncertain about these finer points of E.U. legislation can eliminate that uncertainty by seeking the advice of experienced consultancies such as analyze & realize GmbH.
Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
On the other hand, maximum intake amounts for vitamins/minerals are still regulated at a country level (although there is movement in this area), and there still is no definitive E.U.-wide list of plant parts or “other substances” (i.e., substances other than vitamins/minerals that are permissible in food).
Hurdles to Harmonization
So each member state is drawing up its own positive list of which plants can or cannot be used as food (supplement) ingredients, sometimes involving cooperation among individual member states, like for the List of Substances jointly developed by Germany, Austria, and Switzerland. The genesis of these plant lists has put a spotlight on one of the hurdles for food business operators that wish to market a botanical food supplement in more than one E.U. country.
Yet another example of dis-harmonization is the definition of what constitutes a pharmacological substance, or at which daily intake amount a substance begins to exert a pharmacological effect. Some member states are stricter in this regard than others. A famous case is melatonin, which has received an authorized health claim for reduction of the time to fall asleep at a daily intake amount of at least 1 mg. This is considered within the pharmaceutical range by Germany, where the claim thus cannot be used. Then there is monacolin from red yeast rice for the maintenance of normal blood LDL concentrations, which in Germany is considered a pharmaceutical and therefore not a food substance, full stop.
Thus, while theoretically all goods can circulate freely within the E.U. single market, there are some obstacles preventing a carefree marketing of food products in more than one E.U. country.
Amino Acids, Mutual Recognition, and Permissions
Another more obscure example is amino acids. They can be used as ingredients in food supplements in most E.U. countries. Germany, again however, up until recently ruled that amino acids are drug substances and are, as such, not permissible in food supplements.
The E.U. has put a process called Mutual Recognition in place, where a product lawfully marketed in one member state must also be marketable in any other. However, member states still retain the right to refuse Mutual Recognition if they decide that a given product is not safe and therefore cannot be marketable after all.
In fact, Germany has put two such mechanisms in place. One is a way to gain an “exceptional permission” to market a specific product following an application to the German authority, which scrutinizes the product for safety issues. Once an exceptional permission is granted, the product can be marketed. However, if the exception is refused, for whatever reason, the product in question is forever illegal to market in Germany.
This is a risk for FBOs, since food supplements that are notified for marketing in Germany in the usual way are not scrutinized by the authority for their marketability. Seeking an exception means unavoidable scrutiny, whereas just quietly notifying the product makes it possible, at least for a while, to let it fly under
the radar.
Another way to grant market access for food supplements containing substances that Germany does not consider permissible is gaining a “general permission.” This permission is given to a single ingredient at a maximum daily intake amount, again following a safety assessment. Once it is granted, the ingredient in question with that intake amount can be used as a food supplement ingredient by all FBOs, in contrast to the exceptional permission, which only applies to a single product.
A number of general permissions have been granted to amino acids over the years, making it possible for these—but certainly not all—amino acids to be used as food supplement ingredients.
Momentum for Harmonization?
However, all this came to an end in July 2021 when, seemingly without much fanfare, the German general food law regulation was amended, and the paragraphs referring to amino acids as “other substances not permissible in food supplements” was quietly removed.
With this step, Germany has aligned with the majority of E.U. member states, where using amino acids as food supplement ingredients has always been possible. Still, intake levels must be kept in mind when formulating food supplements containing amino acids for marketing, since the tenet that foods are not allowed to have pharmaceutical effects still holds true.
FBOs that wish to bring their products to the E.U. market and are uncertain about these finer points of E.U. legislation can eliminate that uncertainty by seeking the advice of experienced consultancies such as analyze & realize GmbH.
Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
