Implications of the New EU Flavouring Regulations

Paper presented at the IFEAT International Conference in Barcelona, 6 - 10 November 2011 ‘Spain: Bridging Continents and Cultures’ Pages 195-202 in the printed Conference Proceedings.

IMPLICATIONS OF THE NEW EU FLAVOURING REGULATIONS FOR THE FLAVOUR AND FOOD INDUSTRY A. Joy Hardinge OBE BSc FIFST A J H Consulting Tonbridge, Kent UK ajhconsulting@btinternet.com INTRODUCTION

Many provisions of the new EU Flavouring Regulation that came into force at the beginning of 2011 have necessitated important changes in the way flavourings are described. Not only do they affect the flavourings themselves but also they impact upon the foods containing them. The loss of the terms Nature Identical and Artificial has had a big impact and has to be considered carefully when considering possible claims. In addition, for the first time the Regulations will establish a positive list of flavouring substances. What effect will this have on innovation within the industry? One new feature of the Regulations, which is usually seen as a positive step, is the control of materials of toxicological concern through major contributors to the diet; this enables enforcement authorities to concentrate resources on a limited number of foods. Despite the lengthy debates that took place during the drafting of the regulations, both the industry and the regulators perceive many features as unclear and open to interpretation. Both flavour manufacturers and users have worked together to provide guidance, aiming to reduce the areas of uncertainty and ensure a common understanding. The remainder of this presentation aims to provide some greater clarity on these various issues.

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WHAT ARE THE NEW REGULATIONS? The regulations in question were published at the end of 2008 and replace the original 1988 Flavourings Directive. Although they came into force in January 2009 most sections only applied from January 2011 and for those relating to the Union List of flavouring the date is still not finalized although it is expected to be in 2012.

WHAT HAS CHANGED? Although many of the requirements of the old regulation have been taken across into the new ones there are some important differences. In particular the scope of the regulations has been extended, there are new definitions, new labelling requirements and the control of certain undesirable substances is approached in an entirely different manner.

The Regulation now covers “certain food ingredients with flavouring properties” and these are considered to be those that contribute significantly to the presence in food of certain undesirable substances. Some European Union member states already applied this understanding to the old regulations but since this was not universal the regulation was changed in an attempt to ensure uniformity. Herbs and spices are particularly targeted but the exemptions allow the sale of the pure herb/spice without restriction - the local supermarket can still sell dried cinnamon - but its use by the food industry does fall within the restrictions.

DEFINITIONS The definitions have been substantially altered. First, a flavouring is now described as something which imparts or modifies odour and/or taste. The inclusion of “modify” is new and has caused considerable interpretation problems. Some member states have, in particular, expressed concerns over the difference between a flavour enhancer and a flavour modifier and discussions on this are still ongoing. Whilst the definition of flavouring substance is very similar to that in the old directive, the new regulation no longer divides them up into natural, nature identical and artificial, There is a definition for a natural flavouring substance but anything which does not meet this is considered to be just a flavouring substance not, it should be stressed, an artificial one.

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The definition of a natural flavouring substance is more detailed than previously. Annex II contains a list of traditional food preparation processes that may be used and it is made clear that a natural flavouring substance must have been identified in nature. Appropriate physical processes are also defined and the use of substances such as inorganic catalysts is clearly excluded.

In contrast the definition of a flavouring preparation has changed very little although the requirements for traditional preparation processes and appropriate physical processes outlined above also apply. The definition of a smoke flavouring refers to that in the new smoke flavouring Regulation and changes have also been made to the thermal process flavouring definition but both changes are considered to be an improvement on those on the old directive.

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The main difference is the addition of two new categories of flavouring – ‘precursor flavourings’ and ‘other flavourings’. Precursor flavourings are those which may not have flavour themselves but are intended to produce flavour in the food by breaking down or reacting during the food processing.

The category ‘other flavouring’ is the one that has caused the most difficulty. It is basically intended to be a catch all to ensure that if a flavouring material does not fit into one of the previous categories it is still covered by the regulation.

However the allocation of a material to this category does have implications as will be seen from the evaluation requirements.

All flavouring preparations and precursors derived from food do not require evaluation by the EU Food Safety Authority (EFSA). This also applies to all food ingredients with flavouring properties and thermal process flavourings which are made from food and made within the specified guidelines. It should be stressed that this does not mean that no evaluation is undertaken prior to sale as they are covered by the general provisions of the Food Safety Act, it is the responsibility of the producer, seller and/or user to ensure that they are not injurious to health.

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All other materials are required to be evaluated by EFSA after which, if deemed suitable, they will be entered onto the Union List. It can be seen that an understanding of what constitutes food is a key issue and the Regulation takes a very generous interpretation, anything for which there is significant evidence of use to produce flavourings is considered to be food. Some of the more unexpected examples quoted are strawberry leaves and rose wood, yet another area which is very much open to interpretation.

We now come to the most important part of the Regulation and I fear the section which is the most unclear – Labelling.

For business-to-business sales the ingredient listing requirements have only minor changes, that is until you try and use the term “Natural�. As in the original directive, if a flavouring is to be described as natural then the flavouring component can only be made of natural Flavouring Substances and/or Flavouring Preparations.

Just as before, smoke flavourings and thermal process flavourings are not natural even if derived from natural ingredients. The new regulations however then set out a number of additional requirements.

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If your flavouring is made exclusively of natural flavouring substances you may describe it as flavouring substances.

For a flavouring to be described as natural “X” flavouring the flavouring component must be at least 95% from X, the balance must be used for rounding off the flavour and of course it too must also be natural. However, the non-flavouring component does not need to be natural, so for example it could contain propylene glycol as solvent.

If the flavouring component is natural and there is sufficient “X” for it to be recognizable it can be labeled natural “X” flavouring with other natural flavourings.

Only if the flavouring component is from different source materials and a reference to them would not reflect the flavour can the simple label Natural Flavouring without further description be used. An example of this would be BBQ flavour which is not obtained from barbecues, but is often a blend of materials such as spices, tomato and smoke flavourings!

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One important change is that the legislation also directly affects final food labeling. On the ingredient list of the final food the flavouring has to be declared by the word Flavourings or a more specific name. If there is any smoke flavouring present this has to be split out and declared either as Smoke Flavouring or by a more specific name such as Smoke Flavouring from Beech. This is not required however, if the flavouring does not actually impart a smoky flavour. So a small amount of smoke flavouring could be used in a vanilla flavouring without declaration. The requirements for using the term natural are the same as those for the business-to-business requirements. These provisions only affect the declaration of flavourings in the ingredient list of the food, front of pack labelling such as the use of pictures and claims are controlled by different legislation and there is considerable variation between member states.

Annex I of the directive will eventually contain the so-called Union List of Flavouring Substances and other flavouring materials which require evaluation. This is currently under discussion in Brussels and publication is expected in 2012. There will however be transitional measures, which means that it will probably not become 100% effective until 2015.

The final major change is that relating to control of undesirable substances – so called biologically active principles (BAPs). These are materials that are found to be naturally present in some flavouring sources and for which there is believed to be evidence of undesired effects. The list in the old directive has been modified and 4 materials added, capsaicin, estragole, menthofuran and methyl eugenol. It is illegal to add any of the listed materials as such to flavourings but they can be present in foods as a result of the use of natural extracts which contain them. For the majority there are limits set for these in the final food arising from their occurence in flavourings.

However unlike the old directive where there was a limit in all food and beverages the limits are now only set in foods which are considered to be major contributors to the diet. In all other foods there are no numerical limits, the onus is left to the supplier to ensure that he conforms to the general food law and is not selling anything which is injurious to health. For three materials, estragole, methyl eugenol and saffrol the limits set do not apply if the food does not contain flavourings which are sources of these materials.

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There are a number of other restrictions relating to the use of natural extracts – for example, the use of St Johns Wort is restricted to alcoholic beverages.

As we have gone through the regulation it will have become clear that there are a number of areas which are open to interpretation and in order to try and facilitate uniform understanding both the food and the flavour industry have developed guidance documents. These have been discussed with both the Commission and Member States and are of course living documents which need to be updated regularly as understanding and practices change. They are available on the respective Association websites and include guidance on what processes are considered to be suitable for the production of natural products and also give a number of helpful labeling examples.

In conclusion, some aspects of the new regulations are considered to be an improvement on the old regulations but the main problem for both suppliers and users is interpretation. Many areas, particularly those relating to labelling, are extremely unclear and it is important that all parties have the same understanding. Industry has attempted to assist the debate by producing guidance and endorsement of this by the authorities would be helpful for users, producers and enforcement alike. The future publication of the Union List will be another milestone in Flavouring Legislation but I am optimistic that the industry will be able to work with the legislation to continue to provide the consumer with a range of high quality, excellent tasting products.

Joy Hardinge graduated from the University of Nottingham with a zoology degree and joined Quest International (Unilever) in the food legislation department. She worked for Quest for 29 years in a number of roles relating to food safety and legislation. She currently works as an independent consultant on food legislation. Joy has served on numerous Trade Associations dealing with additives and flavourings, and is a past President of the European Flavour Association, and is currently Chairman of the Technical Committee. She is a Past Chairman and Technical Chairman of the British Flavour Association (BEMA) and now acts as a consultant to them. Between 1991 and 1997 she served on the UK Government’s Food Advisory Committee for which she was awarded the OBE. She has published a number of papers relating to food legislation and is a Fellow of the Institute of Food Science and Technology (IFST).

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