Mr. Michael Sabisch, Senior Quality Assurance Specialist and Mr. David Smith, International Sales Coordinator, Sigma-Aldrich Flavors & Fragrances
Introduction
The Regulatory Landscape
US and EU Definitions of Natural
Regional Regulatory Variations
The Example of Vanillin
The Case for Standardization
What comes to mind when you see a food and beverage ingredient labeled natural? It seems like the simple answer would be that natural ingredients come from nature. However, with so many new technologies in place, the way ingredients are produced is more multi-faceted than ever before; and this has started to blur the lines on what qualifies an ingredient to be labeled as natural. Adding to the complexity, the definition of a natural ingredient varies from country to country, and the industry accepts a wide range of categories in which ingredients can be classified as appropriate for food applications (Figure 1).
These categories cross the boundaries of what is defined as a natural or synthetic ingredient, making the standardization process more complicated. Navigating this complex regulatory landscape is proving to be a growing challenge for the Flavor industry. The solution may lie in the creation of a globally accepted set of food and beverage ingredient regulations for both suppliers and buyers.
Figure 1. The Flavor industry accepts a wide array of ingredient categories as appropriate for food and beverage application. Within this complex landscape, synthetics or natural aroma materials can fall within multiple additional regulatory classifications.
Consumer demands for natural products have placed a spotlight on the issue of consistent regulatory standards across the global food and beverage ingredients industry. The issue is not a result of a lack of regulatory bodies. Rather, it is the result of these bodies having different levels of classifications that can lead to further confusion for both suppliers and buyers.
The Food and Drug Administration (FDA) is the main regulatory body for the United States and the European Food Safety Authority (EFSA) for Europe. There are also many other industry and governmental bodies that work on the creation of regulations for food safety and quality standards, such as the Flavors and Extract Manufacturers Association (FEMA), the Food Chemical Codex (FCC), the Joint FAO/WHO Expert Committee on Food Additives (JEFCA), and the Council of Europe’s Index System. Even with all of these bodies working to ensure food and beverage ingredient safety and quality, authorities have yet to come together to create universal regulations for food and beverage ingredients.
Most global bodies follow the lead of either the US or EU when determining if a flavor is natural. Although US and EU regulatory requirements are similar, they do have distinct differences:
| US | EU |
| Production methods are not as well-defined | Must be produced via approved production method |
| Specific biologic sources defined in 21CFR regulations | Source material definition is vauge |
| No corresponding US requirement | Natural flavoring substances correspond to substances that are naturally present and have been identified in nature |
| Natural flavoring substance - Typically a single chemical entity and corresponds to a naturally present material. | |
| Natural flavoring preparation - Typically a “preparation” has several flavor chemicals found in the natural source. | |
In the US, a material is deemed natural when it is derived from a product such as a spice, fruit, extract, oleoresin, or from a group of materials that the FDA recognizes as natural starting materials. There is a long list of processes that can be applied to derive the flavor with a natural claim still being permitted, such as distillation, extraction, roasting, heating, enzymolysis, hydrolysis and fermentation. The real weight in the US definition of natural is given to how the flavor is derived from the natural source, and not the process used.
Regulations are slightly stricter in the EU because EFSA is more restrictive with the permitted processes. EU directive 1334/2008 contains a list of processes that are acceptable for producing a natural item which is limited in comparison to the lengthy US permissions list. Additionally, the EU requires a natural substance be identical to that found in nature and not altered in any way. This may be as specific as ensuring that the ratio of different chiral forms in the final product is identical to the chiral forms found in nature. For instance, a fermentation process may result in a material that has a different mix of enantiomers than that found in nature. In this case, the flavor is produced with acceptable methods for either US or EU natural, however, since the enantomeric ratio differs from that found in nature, the material could not be considered EU natural.
The discrepancies also carry over into labeling requirements. On labels in the US, a natural ingredient is either described as a ‘natural’ or ‘natural flavor’, where in the EU the description tends to be broader. Other EU definitions include ‘natural flavoring substance’ which signifies a single, high-purity molecule that may have been processed in some way or a ’natural flavoring preparation’ which indicates that several different compounds are present in the ingredient.
To make the regulatory complexities more tangible, let us apply the US and EU regulatory variations to vanillin, the molecule that gives vanilla its flavor. This flavor ingredient can be produced in a number of different ways, and the method used to produce it determines whether a natural claim will or will not be allowed.
When vanillin is extracted directly from vanilla beans, both the US and EU regulatory authorities allow a natural claim. When vanilla extract is subjected to fractional distillation to isolate the vanillin component, the labeling on the consumer product may be indicated as ‘natural vanilla flavor’ in the US and Europe.
Vanillin can also be made through different fermentation processes. Fermentation from a starting material such as ferulic acid, allows for the extraction of the vanillin from a variety of natural sources including coffee beans, apple and orange pips, and wheat bran. If vanillin is made using the ferulic acid fermentation process, a ‘natural flavor’ claim can still be made in both the US and Europe. If the vanillin is produced through fermentation from another source, for example guaiacol, the labeling of the products begin to differ. In the US, if the process is not approved the material is labeled as both ‘artificial’ or ‘synthetic,’ whereas in the EU the material may still be labeled as ‘natural’.
Other starting materials can also be converted to vanillin by chemical processes – for example, lignin can be heated with an alkali and an oxidation agent to create a synthetic (or artificial) version of vanillin. In this case, the product would be labeled in both the US and Europe as ‘artificial’ or ‘synthetic’ vanillin.
Finally, there is the molecule ethyl vanillin that is not found in nature and is typically produced using synthetic chemistry. The US label claim would be ‘artificial vanilla flavor’ but in Europe, the label claim is ‘vanilla flavoring’. The absence of the word natural in Europe implies that it is an artificial flavor.
A defined set of global ingredients standards is needed for the industry in order to help flavor houses and food and beverage manufacturers streamline their ingredient sourcing processes. It would also help ingredients suppliers guide customers through the complex regulatory maze so they can source exactly the right ingredient required to support their product claims.
A universal set of ingredients standards would enable suppliers to simplify the buying process and improve the quality of the buying experience through:
Additionally, a universal standard for flavor production would allow supplier audit standards to be unified and consistently enforced.
The value of a global set of ingredients standards has been clearly established and now the roadblock is finding a way to take action. Now is the time for the industry to come together and develop a global solution to these regulatory discrepancies.
As a trusted supplier globally to the Flavors & Fragrances industry, Sigma-Aldrich understands the complexity of the regulatory landscape and strives to provide the best regulatory services to its customers. Sigma-Aldrich’s natural products are clearly tagged as EU or US naturals, supplied with a natural certificate showing which specific regulations are met, and all natural products are validated by an independent testing by a trusted third party, the University of Georgia. By offering our customers access to our dedicated Quality Assurance experts, we mitigate risk and supply chain complexity until an improved food ingredient regulation emerges.
For more information on Sigma-Aldrich’s natural ingredients offer view our product listings at:http://www.sigmaaldrich.com/chemistry/chemistry-products.html?TablePage=12916829
