“Novel Food” Regulations For Botanical Products In Europe

The world is constantly changing, and when it comes to food, sometimes the government needs to work hard to keep up. In the European Union, this is exemplified by the Novel Foods regulations that oversee the marketing and safety of foods that are not traditionally part of European cuisines. Since the first novel food laws were passed in 1997, more than 125 foods received this distinction. [1] After 2017, when the statutes were upgraded, more than 80 additional foods have applied to be included on the novel foods list.

As these laws change, they become increasingly more complicated. Combining this fact with increased interest, it is worth exploring the process of how novel foods are classified within the European Union. The most straightforward way to do this is to focus on botanical products, which not only represent a significant portion of novel foods but a growing source for food stocks in general.

What are Novel Foods?

The term “Novel Foods” was first legally defined in 1997 when the European Commission passed Regulation No. 258/97, entitled “Concerning Novel Foods and Food Ingredients.”[2] The Commission felt that foods considered to be “novel,” or foods not commonly consumed in European markets prior to May 15, 1997, fell into two distinct categories. 

• new foods developed using innovative techniques or technologies;
• foods not traditionally consumed in European markets.

Aside from this initial start date, novel foods in Europe are also defined by a few basic criteria. [3] For starters, the foods in question must be safe for human consumption, and they must also be properly labeled. In certain cases, novel foods are marketed as a replacement for an existing food source already available in Europe.

If this is the case, the novel food must demonstrate improved nutritional value beyond the food that it is replacing, creating a nutritional net positive in the overall market. Finally, any novel foods that plan to be sold in the EU must receive authorization from the European Commission prior to their release for mass consumption. This authorization is based on how accurate the data is for the preceding factors, and consists of three basic steps:

• food producers must prove the food is novel;
• food producers must establish a history of consumption;
• food producers have to prove their foods are safe for human consumption.

This application process and evaluation method for novel foods was the standard European practice for 20 years, but it changed on December 31 2017, when the EU released an amended version of these statutes in the form of Regulation no. 1852/2001. [4] These updated policies helped to open the application process further by accounting for new techniques, additional food categories, and exceptions for new food products. While the application process remains the same, the European Commission saw a need to clarify and expand their policies as new applications continued to increase.

This is especially true for botanical products, as they can come in increasingly varied forms and rely on new production methods, making them novel foods by European standards.

Determining if the Food is Novel

The responsibility of identifying whether a new food is in fact novel falls to the food producers themselves. This is not so easily done for several reasons. First, in order for said food to receive the novel distinction, the manufacturer must check each ingredient to determine that it was not being consumed in significant amounts within Europe prior to May 15, 1997. In some instances, this may require providing data on consumption patterns either within the EU or from external regions to establish the food’s ubiquity.

The reason this evaluation process is so complicated has to do with the fact that the EU is made up of 27 countries, many of which have unique regional culinary traditions that could only be common to certain pockets of Europe. As a result, it may be the case that certain foods are consumed in one small part of Europe, but not more readily available throughout the EU.

Beyond ingredients, another way to evaluate whether a food source is novel relates to its preparation method. It may be the case that the plant materials being utilized are common in Europe, but if they are prepared in a new way it may classify the product as novel. This can be an arduous process, requiring the filtering through data from each country. This is a necessary step owing to the fact that the European Union does not maintain an exhaustive database of novel food ingredients or production methods. 

Instead, the EU central government only keeps a basic list mostly encompassing broad categories.[5] With this in mind, food producers must sift through different sources of data to prove their food source is novel within Europe. It may sound counterintuitive to prove a negative, but to be considered a novel food, food producers must establish a history of dietary consumption or that their preparation techniques do not exist. 

This often requires the work of food experts who can help food manufacturers work through sources from each country, like Italy’s Ministry of Agriculture list of “Traditional agri-food products” or the European Food Safety authority Compendium of Botanicals. [6][7] These lists are updated annually and include traditional recipes and processes that often go back to ancient times. Without the experts’ help, this process is nearly impossible, due to the amount of possible data sources and the potential to overlook something.

Establishing a Safe Use History

If food producers determine that a history of dietary consumption or preparation method do not exist in Europe, they may move on to the next stage of the application process. This portion focuses on the safety of their products for human consumption. The safety of novel botanical products depends on several variables, and each product must be evaluated on a case by case basis. One of the easiest ways to prove a product’s safety is to supply data of human consumption, even if that data is sourced from outside the EU. This is recognized by the EU by establishing a traditional use of the plant.[8] 

The European Union considers food to be traditional if it has been used for at least one generation, which typically constitutes a period of 25 years. Considering the fact that plant materials can serve a pharmacological purpose as well as a culinary one, food producers may need to expand the scope of their data on traditional use. If the botanical material produces a physiological response, it may also be necessary to provide evidence that the physiological response of the novel food products do not produce adverse reactions.

Botanical materials that may serve as medicinal supplements are only recognized as traditional if they have been used for a minimum period of 30 years, with at least 15 years of those years being in the EU. Of course, the longer the plant material has been utilized, the more likely the EU will accept the safe use data. 

This means that the approval process is simple for products if there are multiple generations having safely consumed the botanical material. Beyond intended use, food producers must also explain the safety of their preparation methods.[9] This also includes several aspects, including factors related to the plant like species, region of origin, harvest period, parts of the plant used, and drying method. This is only the beginning, as the EU also evaluates how the botanical material is extracted, including what kind of solvent is used. 

Currently, in the EU, the only solvents that are approved for human consumption are propane, butane, ethyl acetate, ethanol, carbon dioxide, acetone, and nitrous oxide.[10] Going past these basic details, in order to prove their preparation method is safe, food producer must also prove that the finished product is at least comparable to the original plant material.

Basically, if the botanical food extracts go through any changes, they must not negatively affect the nutrition of the final product. This may mean accounting for chemical changes that could occur during the production phases, including the amount of solvent used, the changes in temperature, or the duration of the extraction process. When evaluating a finished product, it is also worthwhile to compare the concentration of the desired plant’s compound in the extract to the original botanical material.

Meaning that a novel food may choose to increase the concentration of the extract, but the EU wants proof that the higher concentrations won’t hurt consumers. This is relative, though, and food manufacturers can avoid this problem by more shrewdly choosing which plant material they choose to compare their products to. It may be the case that they decide to use a cheaper, but lower concentration botanical material, for the extraction but compare it to a different variation of the same plant to illustrate the differing concentrations have negligible risks.

Depending on data and what materials are sourced for comparison methods, the European commission will either rule that the differences from the manufacturing process are negligible, and thus safe for consumption, or that this may constitute a novel food based on a new production technique. Of course, if it is a novel food based on technique, the food producers may need to provide data that their production method still produces a safe product as well. These small details may constitute the difference between approval and rejection for food producers’ novel foods. 

Nanomaterials

One final aspect of novel food regulations that the European Union updated in 2017 is their regulation of nanomaterial engineering. [11] This is an acknowledgement that food technology is advancing, and that regulations need to balance these improvements with the need to protect consumers. Nanomaterial engineering is the manipulation of the food particles within the botanical materials to produce specific results.

This could be in the form of increased nutritional value, lowered fat content, or improved tastes. The regulation of nanomaterials is an ongoing discussion.[12] Recognizing the potential benefits, the European Commission doesn’t want to pass defining legislation, and prefers to evaluate the foods containing nanomaterials on individual bases. Doing so helps to indicate to food producers that they are welcome to experiment, but they must be cautious of any risks that may affect individual consumers or present environmental hazards.

References:

1. Ververis, Ermolaos, et al. “Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority.” Food Research International 137 (2020): 109515.
2. European Commission. (1997, January 27). REGULATION (EC) No 258/97 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 1991 concerning novel foods and novel food ingredients. Retrieved April 23, 2024, from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31997R0258
3. Vapnek, Jessica, Kai Purnhagen, and Ben Hillel. “Regulatory and legislative framework for novel foods.” Food formulation: Novel ingredients and processing techniques (2021): 285-308.
4. REGULATION (EU) 2015/2283 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. (2017, November 25). European Commission. Retrieved April 24, 2024, from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015R2283&qid=1713947078073
5. Establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. (2017, December 20). Official Journal of the European Union. Retrieved April 24, 2024, from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R2470
6. Ministero della Salute. 2022. Circolare ministeriale “Indicazioni sull’uso delle piante e delle loro parti negli integratori alimentari per garantire la sicurezza e tutela dei cittadini”. 27 Maggio 2022.
7. European Food Safety Authority. “Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements.” EFSA Journal 10.5 (2012): 2663.
8. Hermann, Michael. “The impact of the European Novel Food Regulation on trade and food innovation based on traditional plant foods from developing countries.” Food policy 34.6 (2009): 499-507.
9. Bleve, Gianluca, et al. “Identification of safety and quality parameters for preparation of jellyfish based novel food products.” Foods 8.7 (2019): 263.
10. Gulati, Om P., and Peter Berry Ottaway. “Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products.” Toxicology 221.1 (2006): 75-87.
11. Gulati, Om P., and Peter Berry Ottaway. “Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products.” Toxicology 221.1 (2006): 75-87.
12. European Commission. (2022, June 10). Commission Recommendations on the Definition of Nanomaterials. Official Journal of the European Union. Retrieved April 24, 2024, from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022H0614(01)