Service Finder
Application for inclusion of a smoke flavoring primary product in the Community list of authorized primary products
Service Description
Smoking is one of the oldest methods of treating food. It is used for both preservation and seasoning. However, if the main aim is to take advantage of the taste benefits of smoking, smoke flavorings can also be used to process food nowadays. However, smoke flavourings are used exclusively for flavouring foods such as meat, soups and snacks. According to current knowledge, it is not possible to extend the shelf life by spraying smoke flavorings or dipping food in smoke flavorings.
If you use smoke flavorings, you should first check which smoke flavorings are approved in the European Union. The approved smoke flavorings are on a Community list of the European Community. As smoke flavorings are made from smoke that is fractionated and purified, the use of smoke flavorings is generally considered to be less harmful to health than the traditional smoking process. However, if you wish to use a smoke flavoring that has not yet been approved, you must first apply for approval from the Federal Office of Consumer Protection and Food Safety (BVL).
What are smoke flavorings
As with conventional smoking, smoke is used to produce smoke flavorings. Hardwoods are smouldered under controlled conditions. The smoke is then used and processed to create the so-called primary products. If these primary products are supplemented with carriers, smoke flavorings are created that can be incorporated directly into the food or applied to its surface.
Why approval is required
As smoke flavorings are complex mixtures of many chemical substances, special regulations apply to their use as food flavorings. A smoke flavoring therefore requires approval to prove that it does not pose a risk to human health.
Legal basis
In principle, only smoke flavorings on the EU list of approved smoke flavorings and primary products can be used for processing in or on food. It is specified how primary products are
- evaluated,
- authorized,
- and used
should be used. All approved primary products and smoke flavorings in the European Community are listed in this Community list. This ensures a high level of consumer safety.
Applying for authorization
If you would like another smoke flavoring or its primary product to be approved and thus added to the EU Community list, you must submit an application to the Federal Office of Consumer Protection and Food Safety. The European Food Safety Authority (EFSA) will then assess the safety of the product on the basis of the data submitted. It will check whether there are any risks to human health or the environment from the use proposed in the application.
Please note that smoke flavorings are generally only approved for 10 years. If you have already received approval for a smoke flavoring in the past, you must submit a new application at least 18 months before the existing approval expires.
Process flow
You can apply for the approval of smoke flavorings electronically via the E-Submission Food Chain (ESFC) platform of the European Commission. Proceed as follows:
- Go to the E-Submission Food Chain (ESFC) platform of the European Commission.
- Use the user manual and other training documents to help you.
- Create a user account and log in to the portal.
- Select "Food Improvement Agents" from the "Food" domain list. Then select the domain type "Smoke Flavorings", the application type, the recipient member state and the relevant competent authority and then click on "Start process".
-
Then create your dossier. Your application must contain the following information, among others:
- The species of wood used to manufacture the primary product;
- detailed information on the production processes of the primary products and further processing in the production of derived smoke flavorings;
- the qualitative and quantitative chemical composition of the primary product and the characterization of the unidentified part. Of particular importance are the chemical specifications of the primary product and information on the stability and degree of variability of the chemical composition. The unidentified fraction, i.e. the fraction of substances whose chemical structure is not known, should be as small as possible and characterized by appropriate analytical methods, such as chromatographic or spectrometric methods;
- a validated analytical method for sampling, identification and characterization of the primary product;
- information on the intended use levels in or on specific foods or food categories;
- toxicological data in accordance with the opinion of the Scientific Committee on Food in its report on smoke flavorings of June 25, 1993 or its latest update. EFSA suggests that the application dossier be written in English in order to avoid delays in the evaluation of the application due to the translation to be arranged there.
- Attach any other required documents to the application.
- Submit the application online.
If you have applied for authorization of a primary product, your application will be received by the Federal Office of Consumer Protection and Food Safety (BVL) as follows:
The BVL
-
confirms receipt of your application in writing within 14 days of its receipt.
- The date of receipt of the application will be noted in the confirmation.
- will inform EFSA without delay,
- may request you, as the applicant, to complete the application documents within a specified period.
- The European Food Safety Authority immediately informs the other Member States and the Commission of the application and makes all application documents available to them.
- The European Food Safety Authority examines the application and publishes its opinion.
-
Within 3 months of publication of the opinion, the European Commission shall prepare a draft regulation to include the primary product applied for in the list of authorized primary products or a draft decision addressed to the applicant refusing authorization.
Requirements
The use of smoke flavorings in or on foods is only permitted if the applicant company can prove that this does not pose a risk to human health and that consumers are not misled.
Which documents are required?
If you wish to submit an application for approval of smoke flavorings, you must submit the following documents in accordance with Article 7(3) of Regulation (EC) No 2065/2003:
- Name and address of the applicant;
- the information listed in Annex II to Regulation (EC) No 2065/2003;
- a reasoned statement that the product complies with the first indent of Article 4(1) (that the use does not present a risk to human health);
- a summary of the dossier;
- where applicable, a request for confidentiality of certain information in accordance with Article 15 of Regulation (EC) 2065/2003.
The application must be prepared in accordance with the "Scientific Guidance for the preparation of applications on smoke flavoring primary products" (EFSA Journal 2021;19(3):6435).
What are the fees?
There are no costs.
What deadlines do I have to pay attention to?
There is no time limit for applying for a new smoke flavoring. The validity of an existing authorization is 10 years. An application to extend an authorization must be submitted at least 18 months before the existing authorization expires.
Processing duration
Duration: 9 months to several years.
Subsequent requests for documents with a deadline of up to one year can lead to a considerable extension of the processing time
Legal basis
- Article 6(1) of Regulation (EC) No 2065/2003
- Article 7 of Regulation (EC) No 2065/2003
- Implementing Regulation (EU) No 1321/2013 establishing the Union list of authorized primary products for the production of smoke flavourings for use as such in or on foods and/or for the production of derived smoke flavourings
- § Section 1 no. 5 of the Ordinance on the Transfer of Tasks to the Federal Office of Consumer Protection and Food Safety (BVL Task Transfer Ordinance - BVLAÜV)
Appeal
Forms available: No
Written form required: No
Informal application possible: No
Personal appearance required: No
Online services available: Yes
What else should I know?
The following notes apply:
Approval is granted for 10 years. An extension for a further 10 years is possible. For this purpose, the authorization holder must submit a corresponding application to the European Commission at least 18 months before the authorization expires.
Previously authorized primary products are authorized until January 1, 2024. Applications to extend the authorization must be submitted by June 30, 2022.
Further Information
- General information and a summary of the legal resolutions and their explanations can be found on the website of the German Association of the Aroma Industry (Deutscher Verband der Aromaindustrie e. V.).
- Questions and answers on the subject of smoke flavorings on the website of the Federal Institute for Risk Assessment
- Summary of the history and legal framework by the European Food Safety Authority (EFSA)
- Scientific Guidance for the preparation of applications on smoke flavouring primary products on the website of the European Food Safety Authority
- User manual and other training documents for the EU Commission's E-Submission Food Chain Platform
- Information on renewal applications to the EU Commission
Author
Federal Office of Consumer Protection and Food Safety (BVL)
Forwarding service: Deep link to the portal of origin
The text was automatically translated based on the German content.
Technically approved by
Federal Ministry of Food and Agriculture (BMEL)
Professionally released on
02.03.2022
Source: Zuständigkeitsfinder Thüringen (Linie6PLus)
Start your request directly online:
Competent Authority
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL), Abteilung 1 Referat 111
Address
13347 Berlin, Stadt
Remark: Department 1 of the BVL (food, feed, consumer goods)
Link to the directions:
BVL-Dienststelle Berlin Gerichtstraße
