By Joerg Gruenwald, analyze & realize GmbH04.14.22
Much has been written and lamented about the situation of botanicals in food/dietary supplements in the EU. Unlike vitamins and minerals, there is very little harmonized legislation for them.
For the most part, they do not have any authorized health claims. Instead, the evaluation of all submitted health claim applications for botanicals is still pending. For the moment, this means that all the submitted health claims, regardless if they have already received an opinion or not—or if that opinion was negative—can currently be used under certain conditions.
It’s not an ideal situation, but food business operators (FBOs) have come to terms with it.
Another problem is the lack of harmonization for the marketability of botanicals. Some botanicals have medicinal properties, some of them may be unsafe, and some of them are not food plants at all and should not be used in foods or supplements. But who decides what is true for which plant?
National Plant Lists
Since there is no top-level legislation such as an EU-wide positive list of plant parts, Member States have, either jointly or individually, drawn up their own national plant lists stating which plants or plant parts are allowed in food or food supplements. Other Member States such as Spain have simply decided that botanicals are not allowed to be used in food supplements at all (unless the products containing them are brought into the Spanish market via Mutual Recognition, a process that can be used if a product is legally marketed in another Member State).
The nice thing about these plant lists is that, for each country that has them, FBOs can reliably inform themselves about the marketability of any given plant or plant part in a given EU country. The downside is that what may be marketable in one country may not be marketable in another, which renders bringing a botanical food supplement to more than one EU country a bit tricky.
Another issue is that any plant that is not on the list—neither the positive list, or (if any) the negative list—then its status is not known. This is often the case for new plants, either novel or not used in food in significant amounts.
“Since there is no top-level legislation such as an EU-wide positive list of plant parts, Member States have, either jointly or individually, drawn up their own national plant lists stating which plants or plant parts are allowed in food or food supplements. Other Member States such as Spain have simply decided that botanicals are not allowed to be used in food supplements at all (unless the products ... are brought into the ... market via Mutual Recognition, a process that can be used if a product is legally marketed in another Member State).”
Algae & Fungi
Algae is an interesting case. They are not considered as plants; instead, they belong to the phylum “protists.” As such, they have no place in a pure plant list.
Also, historically, algae have not been consumed in large amounts in the EU. Still, some of them have recently received attention for being a “superfood” due to their high nutrient content. So far, however, FBOs wishing to use algae in their products will look in vain at the various national plant lists. Therefore, FBOs have no way of knowing if the algae species in question will be marketable.
But now, at least some EU countries are recognizing the situation and are taking steps. Germany, together with Austria and Switzerland, is currently working on changing this situation, at least for these three countries.
The co-authored German-Austrian-Swiss list of plants and substances so far contains plants (both food and medicinal plants) as well as fungi. To help manufacturers bring safe algae to the market, the Working Group Stoffliste in the German Federal Office of Consumer Protection and Food Safety (BVL) has now complemented its lists of botanicals and fungi with a new compilation on algae.
This new addition to the List of Substances, which was last updated in September 2020, is not yet published. Prior to publication, stakeholders are invited to comment on the list until Apr. 13, 2022.
The algae list contains micro and macro algae and lists possible risks and related warning statements for the product label. Like its plant counterpart, the algae list indicates the status of the algae (e.g., novel, food, or medicinal) and lists pharmaceutical dosages and possible adverse events for algae that can have medicinal effects.
This initiative—so far the only one in the EU—will make it possible for FBOs to make informed decisions regarding the marketability of the listed algae. Hopefully, other EU Member States will take this list as a basis for their own lists and thus achieve at least some coherence.
Ideally, of course, EU legislation in cooperation with the Member States will finally agree on an EU-wide list of plants, fungi, and algae. Since that is not yet the case, FBOs wishing to market their botanical (or fungi, or algae) product in more than one EU country are well advised to delve into the various national lists, or to consult an experienced consultancy such as analyze & realize GmbH.
About the Author: 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.
For the most part, they do not have any authorized health claims. Instead, the evaluation of all submitted health claim applications for botanicals is still pending. For the moment, this means that all the submitted health claims, regardless if they have already received an opinion or not—or if that opinion was negative—can currently be used under certain conditions.
It’s not an ideal situation, but food business operators (FBOs) have come to terms with it.
Another problem is the lack of harmonization for the marketability of botanicals. Some botanicals have medicinal properties, some of them may be unsafe, and some of them are not food plants at all and should not be used in foods or supplements. But who decides what is true for which plant?
National Plant Lists
Since there is no top-level legislation such as an EU-wide positive list of plant parts, Member States have, either jointly or individually, drawn up their own national plant lists stating which plants or plant parts are allowed in food or food supplements. Other Member States such as Spain have simply decided that botanicals are not allowed to be used in food supplements at all (unless the products containing them are brought into the Spanish market via Mutual Recognition, a process that can be used if a product is legally marketed in another Member State).
The nice thing about these plant lists is that, for each country that has them, FBOs can reliably inform themselves about the marketability of any given plant or plant part in a given EU country. The downside is that what may be marketable in one country may not be marketable in another, which renders bringing a botanical food supplement to more than one EU country a bit tricky.
Another issue is that any plant that is not on the list—neither the positive list, or (if any) the negative list—then its status is not known. This is often the case for new plants, either novel or not used in food in significant amounts.
“Since there is no top-level legislation such as an EU-wide positive list of plant parts, Member States have, either jointly or individually, drawn up their own national plant lists stating which plants or plant parts are allowed in food or food supplements. Other Member States such as Spain have simply decided that botanicals are not allowed to be used in food supplements at all (unless the products ... are brought into the ... market via Mutual Recognition, a process that can be used if a product is legally marketed in another Member State).”
Algae & Fungi
Algae is an interesting case. They are not considered as plants; instead, they belong to the phylum “protists.” As such, they have no place in a pure plant list.
Also, historically, algae have not been consumed in large amounts in the EU. Still, some of them have recently received attention for being a “superfood” due to their high nutrient content. So far, however, FBOs wishing to use algae in their products will look in vain at the various national plant lists. Therefore, FBOs have no way of knowing if the algae species in question will be marketable.
But now, at least some EU countries are recognizing the situation and are taking steps. Germany, together with Austria and Switzerland, is currently working on changing this situation, at least for these three countries.
The co-authored German-Austrian-Swiss list of plants and substances so far contains plants (both food and medicinal plants) as well as fungi. To help manufacturers bring safe algae to the market, the Working Group Stoffliste in the German Federal Office of Consumer Protection and Food Safety (BVL) has now complemented its lists of botanicals and fungi with a new compilation on algae.
This new addition to the List of Substances, which was last updated in September 2020, is not yet published. Prior to publication, stakeholders are invited to comment on the list until Apr. 13, 2022.
The algae list contains micro and macro algae and lists possible risks and related warning statements for the product label. Like its plant counterpart, the algae list indicates the status of the algae (e.g., novel, food, or medicinal) and lists pharmaceutical dosages and possible adverse events for algae that can have medicinal effects.
This initiative—so far the only one in the EU—will make it possible for FBOs to make informed decisions regarding the marketability of the listed algae. Hopefully, other EU Member States will take this list as a basis for their own lists and thus achieve at least some coherence.
Ideally, of course, EU legislation in cooperation with the Member States will finally agree on an EU-wide list of plants, fungi, and algae. Since that is not yet the case, FBOs wishing to market their botanical (or fungi, or algae) product in more than one EU country are well advised to delve into the various national lists, or to consult an experienced consultancy such as analyze & realize GmbH.
About the Author: 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.
