EU Adopts List of Approved Flavoring Substances

The first Regulation provides for a new EU wide list of flavoring substances which can be used in food and will apply from 22 April 2013, giving time for the EU food industry to adapt to the new rules. The second Regulation concerns transitional measures for other flavorings such as flavorings made from non-food sources and will apply from 22 October 2012.

2 Oct 2012 --- Flavoring substances in food will become even safer and more transparent thanks to two pieces of legislation adopted by the European Commission yesterday. Only those flavoring substances featuring on the approved lists will be permitted for use by the food industry.

Used to alter the taste and/or odour of food, flavorings substances have a long history of safe use in a wide variety of foods, such as soft drinks, confectionery, cereals, cakes and yoghurts, and have now been evaluated at EU level.

"Thanks to on-going efforts by the European Food Safety Authority (EFSA) and other scientific bodies, this legislation on flavoring substances will vastly improve the transparency of information to citizens and industry alike. It will be easier for all concerned to know exactly which flavoring substances can be used in food." said John Dalli Health and Consumer Policy Commissioner.

These two new pieces of legislation will clarify and harmonise the use of flavoring substances within the single market:

• The first Regulation provides for a new EU wide list of flavoring substances which can be used in food and will apply from 22 April 2013, giving time for the EU food industry to adapt to the new rules. All flavoring substances not in the list will be prohibited after a phasing out period of 18 months.
• The second Regulation concerns transitional measures for other flavorings such as flavorings made from non-food sources and will apply from 22 October 2012.

The new list includes over 2,100 authorised flavoring substances. A further 400 will remain on the market until EFSA concludes its evaluation. These have been used for a long time and have already been assessed as safe by other scientific bodies.

Transparency and clarity of information is one of the main benefits of the new rules. The authorised uses of flavoring substances will be listed according to the category of food to which they may be added. Transparency will be improved as the list will also be available in an on-line database allowing consumers, food businesses and national food control authorities to easily identify which flavoring substances are authorised in food.

A flavoring substance may only be authorised if its use meets the following conditions:
• it does not, on the basis of the available scientific evidence, pose risks to the health of the consumer at the level of the proposed use;
• its use does not mislead the consumer.
When authorising flavorings other relevant factors may also be considered. These could include amongst others ethical, traditional or environmental factors.

National enforcement authorities have the task to ensure that food containing any unauthorised flavoring substances is withdrawn from the market. They should also inform the European Commission and other Member States on the substance in question through the EU's Rapid Alert System for food and feed (RASFF).

The positive list of approved flavoring substances marks an important milestone in the implementation of the framework Regulation3 on flavoring substances adopted in December 2008. It requires that the use of flavoring substances is safe and does not mislead the consumer.

The legislation divides flavorings into six different categories:
• flavoring substances – these are chemically defined substances with flavoring properties such as citral which gives lemon taste to citrus drinks. They can be natural or non-natural.
• flavoring preparations - these are products other than flavoring substances which meet the definition of flavoring and which are obtained from food or other material of vegetable, animal or microbiological origin such as orange oil or vanilla extract. They are always natural.
• thermal process flavorings – these flavorings are obtained by heating processes of a blend of amino containing ingredients (nitrogen sources) and a reducing sugar. During the process intense flavors develop, as is the case when roasting meat or baking bread. They are used to flavor bouillons, instant soups, gravies and sauces.
• smoke flavorings - these are flavorings obtained by fractionation and purification of a condensed smoke and used mainly to impart a smoky taste to food such as meat or fish as an alternative for traditional smoking processes.
• flavor precursors - are products such as carbohydrates, oligopeptides and amino acids that are intentionally added to food for the purpose of producing flavor by breaking down / reacting with other components during processing of the food,.
• other flavorings – these are flavorings that are added to food to provide odour and/or taste but do not fall under any other flavoring category as mentioned above, for example grill flavor or rum ether.

The safety of around 2100 flavoring substances that will be authorised has been assessed by the Scientific Committee on Food (SCF), the Council of Europe (CoE), the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and/or the European Food Safety Authority (EFSA).

Around 400 flavoring substances which are not authorised because the evaluation by EFSA has not been finalised may remain on the market until the evaluation and approval process are finalised. Many of these substances have been used for long time and have already been evaluated safe by other scientific bodies than EFSA. However, the final view of EFSA is still required. A total of around 2800 flavorings have been on the EU market, of which 2100 have undergone the evaluation and approximately 400 flavorings substances will conclude the approval process by end 2015.

Only flavoring substances that are listed in the EU legislation can be added to food. Most of the flavoring substances may be used in flavored foods in accordance with good manufacturing practice.

For certain flavoring substances which may be used in food for other purposes than flavoring, a use level is laid down which refers to their use as a flavoring substance. These substances are caffeine (FL 16.016), theobromine (FL 16.032), neohesperidin dihydrocalcone (FL 16.061) and rebaudioside A (FL 16.113).

In addition, for certain flavoring substances specific conditions of use are laid down to follow the scientific advice that recommends restrictions of use, for example for d-camphor (FL 07.215), three quinine salts (FL 14.011, FL 14.152 and FL 14.155) and glycyrrhizic acid (FL 16.012) and its ammoniated form (FL 16.060).

Since 2003, the European Food Safety Authority (EFSA) has played an important part in preparing this list by evaluating the safety of thousands of flavoring substances, publishing 170 scientific opinions to date. Currently, over 2,500 flavoring substances have been deemed fit for inclusion in the EU list which enters into force on 22 October 2012. This significant programme of scientific work, which is still ongoing, has played and continues to play a critical role in ensuring that flavoring substances used in foods are of no safety concern for consumers.

Of the substances evaluated to date by EFSA within the “Flavoring Evaluation Programme” some 2,800 were already on the market while around 200 are new. This large number of substances needed to be evaluated under European legislation to ensure that they are safe when used as flavorings in foods.

EFSA’s Scientific Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF) has said that the majority of flavoring substances do not give rise to safety concerns; however, seven flavoring substances for which EFSA, the Scientific Committee on Food and the FAO/WHO Joint Expert Committee on Food Additives (JECFA) raised toxicological concerns have been removed from the EU market. The CEF Panel has asked for further data to allow it to complete the evaluation of over 400 substances included in the Programme. The new EU list, which will apply from 22 April 2013 and will be updated annually, contains deadlines for submission of these new data by industry.

Iona Pratt, Chair of the CEF Panel, said: “The Panel is extremely satisfied that this long-term programme of work is now coming to fruition. However, our job is not completely done yet. Besides the remaining substances for which data are required, EFSA also expects to receive a number of applications related to new flavorings, many of which are likely to be complex mixtures that may require a revised risk assessment approach.”

Looking to the future, the Authority is holding a technical meeting with stakeholders on 14 November, to allow exchanges of views on the future administrative and scientific challenges related to the preparation, submission and risk assessment of applications for flavorings.

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