Understanding the European Flavor Community List
Luke Grocholl, Head of Food Regulatory Experts, Merck
A Regional Regulation with a Global Impact
Finalized at the end of 2008 and effective January 2009, the EU regulation number 1334/2008 on flavoring and certain food ingredients with flavoring products codifies the requirements of flavors for food in the EU. This regulation is also accepted by many non-EU, European countries such as Switzerland and Great Britain and can be used as the basis for flavors in other countries such as Australia and New Zealand. The JECFA international guidance for the use of flavors1 is closely aligned with the definitions of guidance on flavors found in EU 1334/2008. With such a large acceptance across many countries it is important to understand clearly the how to meet the stipulations in this regulation in order to do business in Europe and other regions.
The EU Flavor Regulation, a Brief Overview
Flavoring is defined as the product added to food to impart a taste and/or smell and consisting of one or more the defined flavoring ingredients in the regulation. There are eight different types of flavoring ingredients defined in the regulation: flavoring substances, natural flavoring substances, flavoring preparation, thermal process flavoring, flavor precursors, and other flavorings. Flavorings may also include food additives such as carriers or preservatives. The flavor ingredients defined in this regulation are as follows:
- Flavoring substances are defined chemical entities, sometimes called aroma chemicals.
- Natural flavoring are flavoring substances that must meet all of the regulation’s requirements for flavoring substances and, in addition they must meet the following criteria:
- They are derived from natural sources (animal, botanical, or microbiological),
- They have been identified in nature,
- And made they are produced using “traditional” food preparation methods. Understanding what the EU considers a traditional food preparation method can be complicated, but in summary only physical or microbiological manufacturing methods that use, where necessary, natural reagents are allowed. For more information on natural flavor regulations, see our publication, Navigating Natural Flavor Regulations. There is also an excellent guidance offered by the European Flavor and Fragrance Association (EFSA).
- Flavoring preparations are typically oils or related materials extracted or isolated from botanicals, animals, microbiological or enzymatic processes or form food. Manufacturing methods and extraction solvents are limited to ensure the preparations always meet the EU’s natural definition.
- Thermal process flavors are mixtures of reducing sugars and amino acids that, when heated react to form a flavor. They are sometimes called reaction flavors.
- Smoke flavors are condensed smoke meant to convey a smokey flavor. Regulations on smoke flavors are detailed under the EU regulation number 2065/2003.
- Flavor precursors are not them themselves flavor but added to food to impart a flavor, either by reacting with the food or breaking down to form flavors.
- Other flavors are those ingredients with flavoring properties but do not fall under any of the categories above.
Flavor labeling requirements are also included in the regulation. For business-to-business transactions, for example, not only must the flavor be clearly described, but the label must declare the flavor is intended for use in food. Furthermore, the manufacturer/packer business contact information must be printed on the label as well as batch identification and any special requirements for storage or use (such as storage temperature). All flavors sold in the EU must also indicate the net quantity and use-by date on the label. If the flavor consists of different categories of flavor ingredients, each type of ingredient used must be indicated along with any other components (e.g., carriers, preservatives/stabilizers) in the flavoring.
The EU Community List
EU regulation 1334/2008 calls for the creation of a “community list” of flavor ingredients and source materials approved for use in foods. The community list, also called the union list, includes all the approved flavors for each of the flavor categories described above except for smoke flavors which are listed in EU regulation 265/2003. In addition to indicating the approved flavor ingredients, the union lists also stipulate other requirements those ingredients must meet. It is a restrictive list, so only those materials on the community list can be used in flavorings in the EU.
The union list of flavoring substances lists ~2500 aroma chemicals approved for use in the EU. Natural flavoring substances do not require a separate community list since they are considered a subset of flavoring substances that in addition to meeting the substances community list requirement must also meet all the stipulations in the community. The EU has not yet established a community list for flavor preparations, thermal process flavors, flavor precursors, or flavor source materials. For these categories of flavors only those materials with an established safety for use in food are allowed. There is a community list for “other flavors” but only a single ingredient is on this list, pyroligneous distillate, a flavor ingredient used to impart a rum-like flavor in some alcoholic beverages. This is the only “other flavors” approved for use as a flavor in the EU.
Flavoring Substances
With so many materials on the community list of flavoring substances, it is important to fully understand this list in order to market flavors in the EU. Firstly, the list identifies aroma chemicals in several ways. It includes a “Flavis Number” the indexing number used by the EU. The material’s CAS number and, where appropriate, the JECFA number are also used. JECFA is the Joint FAO/WHO Expert Committee on Food Additives. These three numbers, along with the substance name, are used to identify the approved material. Establishing the identity of the material is not always straight-forward, however. If the substance has different stereoisomers allowed in the EU, then only the CAS number for the racemate is listed. For example, Flavis number 02.013, linalool is listed as CAS number 78-70-6. This is the CAS number for the non-stereospecific material, so (+)-linalool (CAS# 126-90-9), (-)-linalool (CAS# 126-91-0) as well as mixtures of the stereoisomers are considered to be represented on the list as Flavis number 02.013. On the other hand, Flavis number 09.644 specifies in both the name, (S)-methyl lactate, and the CAS number (27871-49-4) that only the S isomer is allowed. Neither the R isomer (CAS# 17392-83-5) nor the racemic mixture (CAS# 547-64-8) are allowed. In addition to stereoisomers, common salts of substances on the community list are also allowed in the EU, as long as the salt has flavoring properties. Ammonium, calcium, potassium, and sodium salts are allowed, as well as carbonates, chlorides, and sulfates of the approved substance.
Most of the flavoring substances must be 95% pure, but the community list does provide for other specified purities for some substances. For example, Flavis number 01.019, a-terpinene has a purity requirement of at least 89% (a-terpinene) and 6-7% 1,4 and 1,8-cineole. The combined components thus have a total purity of 95% or higher. It is important to review the list and determine if a specified purity (including accepted levels of minor components) is allowed.
Although most flavoring substances are allowed for use without restriction, the community does place some restrictions on specified applications. Thoebromine (Flavis number 16.032) for example is restricted to ≤70 ppm in dairy products and ≤100 ppm in non-alcoholic substances when used as a flavor.
Updates and Changes to the Community List
The community list was initially published in 2012. Since then, there have been periodic calls for additionally safety information and reviews for different classes of materials on the community list. The European Food Safety Authority (EFSA) then has an open call for safety data. If the toxicity information is considered insufficient, such as when industry does not provide data because there is no longer a market need determined for the ingredient, the flavor is removed from the community list. This is typically accompanied by a transition period after which food with those flavor ingredients can no longer be sold in the EU. Additionally, the scientific studies on flavoring substance may result in changes to the purity requirements or the restrictions on use. New substances could be introduced to the community list. Before marking a flavor in the EU, it is important to check the most current version of the community list to ensure that up-to-date information is used ensure compliance.
The EU offers an attractive and diverse marketplace for flavors. In order to market flavors in the EU or those regions that adhere to EU requirements, the flavor must meet all the EU regulatory requirements. Some elements of the EU regulation, such as the community list, may seem daunting, but when reviewed carefully and each requirement considered, the requirements become clear.
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