Brussels, 1 October 2012
FAQ: Food: EU adopts list of approved flavouring substances
What are flavourings and what are they used for?
Flavourings are not intended to be consumed as stand-alone products but rather are products added to food in order to impart or modify odour and/or taste of food. Flavourings are normally used to give taste to food and have a long history of safe use in a wide variety of foods, such as confectionery, soft drinks, cereals, cakes and yoghurts. They are used in small amounts so that consumer exposure is relatively low.
The legislation divides flavourings into six different categories:
What flavourings are authorised in food?
Flavourings may be derived from a food or non-food source. The general approach is that if a flavouring is derived from food, it does not require an evaluation and approval. If a flavouring is derived from a non-food source, it would require an evaluation and approval. However, all flavouring substances, whether naturally-occurring or not, smoke flavourings and other flavourings must be evaluated and authorised.
What are the changes introduced by the new rules on flavourings?
The new legislation provides for a list of flavouring substances that may be used in food in the European Union. All flavouring substances not in the list will be prohibited after a phasing out period.
The legislation also allows flavouring substances for which the evaluation still has to be completed to remain on the market until the evaluation and authorisation processes have been finalised.
It also provides time for applicants to submit applications on flavourings other than flavouring substances which have to be evaluated and authorised in accordance with the new rules in the framework regulation.
Are flavouring substances safe?
The safety of around 2100 flavouring 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 flavouring 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 flavourings have been on the EU market, of which 2100 have undergone the evaluation and approximately 400 flavourings substances will conclude the approval process by end 2015.
How is the safety of flavouring substances evaluated?
EFSA assesses the safety of the flavourings substances. Flavouring substances are evaluated based on a dossier, usually provided by an applicant (normally the producer). Flavouring substances are allocated to chemical groups with common chemical structure. EFSA adopts opinions on each chemical group, known as flavouring group evaluations. To assess the safety of flavourings substances, EFSA scientists look at intake levels, absorption, metabolism and toxicity of individual substances within the group. Where EFSA identifies data gaps – for instance on toxicity or exposure – it notifies the need for further data to the applicant and to the European Commission. In the course of its work, EFSA asked manufacturers to provide further data on around 400 flavouring substances. EFSA will re-assess those substances once the requested data are received. The same approach has been used by other scientific bodies.
What are the conditions to authorise flavouring substances?
A flavouring substance may only be authorised if its use meets the following conditions:
When authorising flavourings other relevant factors may also be considered. These could include amongst others ethical, traditional or environmental factors.
Can any substance be used as flavouring substance?
Only flavouring substances that are listed in the EU legislation can be added to food. Most of the flavouring substances may be used in flavoured foods in accordance with good manufacturing practice.
For certain flavouring substances which may be used in food for other purposes than flavouring, a use level is laid down which refers to their use as a flavouring 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 flavouring 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).
What is an FL-number?
When EFSA evaluates flavouring substances, it allocates them a unique identification number called an FL-number. FL comes from the word "FLAVIS" which means the EU flavouring information system. An FL-number is not used for labelling purposes.
Is there a list of authorised flavouring substances?
The flavouring substances that are authorised in food and their conditions of use are listed in Part A of Annex I of Regulation (EC) No 1334/2008 on flavourings. Only flavouring substances that are in that list are authorised under specific conditions.
The Commission's flavourings database will be available on the internet once the list is adopted. The EU list of authorised flavourings substances will be adopted on 1 October 2012 and published the following day.
Through this database the consumers and business operators can find out what flavouring substances are authorised and which substances may remain on the European Union market.
When does the Commission authorise flavourings other than flavouring substances?
The first EU list of flavourings substances will form the first part of Annex I of Regulation (EC) No 1334/2008. Once the list is in application, only those flavouring substances which are in the list may be used in or on food in the EU. In the future, this list will also include other flavourings for which evaluation and authorisation are required. To this effect, a transitional period will be set for the flavourings currently placed on the market so that interested parties will have time to submit applications for evaluation and authorisation to the Commission.
What is the procedure for the authorisation of flavourings?
The authorisation procedure for flavourings is laid down in Regulation (EC) No 1331/2008.
A flavouring is usually authorised following an application to the European Commission by an interested party such as the producer or the use of the flavouring. For new flavourings, the Commission will request EFSA to assess the safety of the substance. After EFSA has given its opinion (within nine months following the request), the Commission, together with Member States flavourings experts will consider the authorisation request.
If considered appropriate, the Commission will prepare a proposal for possible authorisation of the flavouring and present it for vote at the Standing Committee on the Food Chain and Animal Health (SCoFCAH) which is comprised of Member State competent authorities. If SCoFCAH supports the proposal, it will be presented to the Council and the European Parliament for opinion. They can still reject it in case they consider that the authorisation does not comply with the conditions of use set out in the EU legislation. This authorisation procedure may take up to a total of 18 months.
How is the consumer informed about the use of flavourings?
Flavourings in food are labelled according the rules set out in Directive 2000/13/EC. In general, if ingredient labelling is required, flavourings may be labelled under category name flavourings or using the specific name, such as vanillin. However, caffeine and quinine used as flavourings must always be labelled with the specific name. A new requirement to label smoke flavourings was also introduced, but only in the case where the smoke flavouring imparts a smoky taste to the food.
To complement these rules on labelling, Regulation 1334/2008 sets out the specific requirements for use of the term "natural". These apply when a flavouring substance or a flavouring preparation is used in food and the food business operator wishes to label these as natural flavourings. The general principle is that when labelling a flavouring as natural, the source of the flavouring should be revealed, for example "natural strawberry flavouring".
What happens if a flavouring substance is found to be on the EU market which is not authorised?
The enforcement authorities of the concerned Member State would have to ensure that food containing the unauthorised flavouring substance is withdrawn from the market. The concerned Member State has a possibility to inform the Commission and other Member States on the substance in question through the Rapid Alert System (RASFF).