Smoke flavourings authorisation guidance

This page is part of the Regulated products application guidance

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.

Register of smoke flavourings

The register of smoke flavourings sets out a list of smoke flavouring primary products permitted for use in Great Britain. The register does not replace retained EU Regulation No. 1321/2013 or retained EU Regulation No. 2065/2013 which are the legal basis for the placing on the market and use of primary products.

New authorisations

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

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

Renewals

Deadline for applications for renewals

The current authorisations will expire on 1 January 2024. Renewal 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.

Studies required for renewals

We would like the original dossier and any other additional information submitted as part of the original approval. However, we appreciate that some organisations may no longer hold this information. 

Detailed information on what studies are required for renewal applications can be found in the EFSA guidance.

A complete dataset for the characterisation of the smoke flavouring primary product, exposure data and genotoxicity data must be included. Alternative toxicological studies to those outlined in the guidance may be submitted. Should authorisation holders choose to submit alternative toxicological studies, they must contain a justifiable strategy and the data must address all the safety concerns as outlined in the guidance so to enable the assessment of the safety of the smoke flavouring in relation to the proposed conditions of use.

The UK’s Committee on Toxicity encourages applicants to utilise existing data from the original dossier, read-across and non-animal methodologies (NAMs) as a first tier approach to the safety assessment of the smoke flavourings.  

Should this not provide enough information, and the relevant Scientific Advisory Committee considers more evidence is required for the risk assessment, then, in line with the EFSA guidance, the following additional studies may be required: 

-    An extended One Generation reproductive Toxicity Study (EORGT) (OECD TG 443) or the two following studies:

a)    An enhanced 90-day oral toxicity study comprising OECD TG 408 and including assessments of neurotoxicity, effects on the endocrine system (annex B of OECD TG 408) and effects on the immune system based on investigation of the following parameters.

At term (at sacrifice):

• Histopathology, including bone marrow cellularity
• Weighing lymphoid organs

In blood:

• Immunoglobulin isotypes
• Complement assays: total serum haemolytic activity or individual components;
• C-reactive protein (CRP)
• Total and differential white blood cell count 

In spleen:

• Phenotypic analysis of spleen cells (CD4 and CD8 T cells, regulatory T cells, B cells, natural killer (NK) cells, macrophages)
• Natural killer cell functional analysis
• Phagocytic activity
• Mitogen stimulation assays for B and T cells

b)    A developmental toxicity test in rats according to OECD TG 414

Further details on the requirements for these studies can be found in Section 3.3.3 of the EFSA Guidance.

However, acknowledging the time constraints with regards to the timelines for the renewal of the smoke flavouring applications, applicants who choose not to utilise a NAMs strategy should alternatively provide evidence in their application that an EOGRT, or new 90-day study and developmental toxicity study in rats, has been commissioned and will be submitted once the study results are available.

Handling of applications for renewals

We understand that some studies requested for the EU renewal process may not have been completed prior to the end of June 2022. We expect submissions for renewal to include complete dataset for the characterisation of the smoke flavouring primary product, exposure data and genotoxicity data. In addition, the dossier must contain a statement from the applicant detailing why the NAMs, EOGRTs or the alternative toxicological studies are not included and a declaration that the studies have been commissioned. Please indicate clearly in your submission what studies are ongoing and will be submitted at a later date. 

Ongoing applications

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.

Existing authorisations

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. 

Getting help

If you have any questions about the authorisation procedure or application requirements, you can contact us at regulatedproducts@food.gov.uk

Apply for authorisation

Apply for a smoke flavouring authorisation using our regulated products application service.