Smoke flavourings are added to foods, such as meat or cheese, to give them a ‘smoked’ flavour, as an alternative to traditional smoking. They can also be added to foods which are not traditionally smoked, such as soups, sauces or confectionery. In some cases, smoke flavourings are used at very low levels to add an undertone of a particular flavour only and not the full smoky taste.
Smoke flavourings need to be authorised before they can be placed on the market in Great Britain (GB). Retained EU law on smoke flavourings outlines the authorisation procedure for these types of flavouring. There is a separate authorisation process for flavourings such as flavouring substances.
Smoke flavouring primary product authorisations are applicant specific and are given for 10 years. They can be renewed after this period. Smoke flavourings are controlled under different legislation to other flavourings and so have different timings for the risk analysis process and data requirements for the applications.
You can find a list of authorised smoke flavourings in retained EU Regulation 1321/2013.
To apply for an authorisation of a smoke flavouring in GB, use our regulated products application service. After completing an application form, you’ll be sent a link where you can upload application documents which will form your dossier. There is no fee for the application.
Your application should consist of:
- an overall summary of the application
- administrative data (part 1)
- technical data (part 2)
- toxicological data (part 3)
- references and reports (part 4)
Detailed guidance has previously been developed by EFSA and remains relevant as our approach is based on EU processes. You should follow the parts that relate to the development of dossiers only and not the application process:
- EFSA guidance on the submission of a dossier on smoke flavouring primary product
- retained EU Regulation 627/2006 – smoke products covers the quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products
The current authorisations will expire on 1 January 2024. Re-authorisation applications must be submitted 18 months before the authorisation expires. This means that you need to submit your dossier by the end of June 2022. You can send your application before this date, however we will not consider it beforehand.
Full testing data for any studies carried out since the original authorisation should be included in the dossier. We would also like the original dossier and any other additional information submitted as part of the original approval. We may also ask for further information if we require it to complete our assessment.
If you submitted a smoke flavouring application to the EU before 1 January 2021 and the assessment process for this application has not been completed, you will need to submit your application to us, using our regulated products application service. When completing the application form, you will be asked to provide your EFSA question number.
If your smoke flavouring has been authorised by the European Commission before 1 January 2021 and the necessary legislation applies, that authorisation will remain valid in Great Britain until its expiry date.
How long will my application take?
The law includes deadlines for key steps in the process:
- 6 months for the risk assessment
- 3 months for the development of risk management decisions
This could be longer if the clock is stopped as new information is requested.
The quality of the dossier, and the information provided, will significantly affect the time needed for assessment and authorisation. We encourage applicants to follow the guidance and provide as much information as possible to ensure we can process your request as efficiently as possible.
If you have any questions about the authorisation procedure or application requirements, you can contact us at firstname.lastname@example.org
Apply for authorisation