Service Finder
Applying for approval of new substances for plastics in food contact materials
Service Description
Materials that come into contact with food are subject to European legislation. In good manufacturing practice and under normal conditions, they must not release components into the food in quantities that
- endanger human health,
- lead to an unacceptable change in the composition of the food or
- cause an adverse effect on the organoleptic properties of the food (e.g. taste or smell).
As a manufacturer of plastic food contact materials, you are responsible for complying with these requirements. You must ensure that the contact materials are harmless to health.
In Germany, there is no obligation to obtain approval for finished plastic products for food contact, such as packaging. However, there is one for the substances and materials that your company uses in the manufacture of individual materials. The basis for this is an EU-wide coordinated and valid procedure.
You can only submit an application for authorization of a new substance for use in food contact plastics via the European Commission's online portal "E-Submission Food Chain Platform" (ESFC).
The Federal Office of Consumer Protection and Food Safety (BVL) is the national contact point in Germany. If you select the BVL as your contact point, the BVL will formally check the application for completeness and relevance of the documents. The BVL then forwards it to the European Food Safety Authority (EFSA).
The EFSA examines your application on the basis of scientific findings. The European Commission decides on the actual approval. Even in the event of non-authorization, the European Commission will inform you and give reasons for its decision.
If the substance meets all food law requirements, it will be added to the so-called Union list of substances permitted in plastics for food contact in accordance with Regulation (EU) No. 10/2011. This means that you and, if applicable, other companies may use the substance for the production of plastic materials with food contact.
You must inform the EU Commission immediately if you have new scientific or technical findings that may affect the assessment of the safety of the substance in relation to human health.
Process flow
You can only apply for the authorization of new substances for food contact plastics online via the European Commission's ESFC portal. The procedure goes through various phases with different parties and responsibilities:
- Upload your application, prepared according to EFSA's specifications, directly to the platform. Follow the procedure described in the platform's UserGuide.
- The application will be forwarded to the BVL if you select it as the national point of contact.
- Once the formal review has been successfully completed, the BVL forwards the application within the platform to EFSA.
- EFSA takes over the scientific review and publishes information on applications received in scientific opinions.
- Via the Open EFSA Portal, you and other interested parties can follow the status of the applications up to the publication of the scientific opinion.
- The European Commission decides on the actual authorization with the involvement of the EU Member States.
Requirements
- The content and form of your application and the accompanying documents must comply with the EFSA guidelines.
Which documents are required?
- You must submit the application documents in accordance with the requirements of the EFSA Guideline document.
What are the fees?
There are no costs.
What deadlines do I have to pay attention to?
There is no deadline for submission.
Processing duration
- You will receive confirmation of receipt within 14 days.
- The BVL usually needs no more than 4 weeks to review your application for the first time. Queries or additional requests as well as your reaction times can influence the duration. Only when the documents are complete will the BVL forward them to EFSA.
Legal basis
Applications / forms
- You file an appeal against a decision directly with the authorizing body, i.e. the European Commission.
What else should I know?
There are no indications or special features.
Further Information
- Information area of the European Commission on food contact materials
- EFSA information section - Application for authorization of food contact materials: rules and guidance
- European Commission guidelines for the application for evaluation of a substance for use in food contact materials
- Instructions for using the ESFC platform on the European Commission website (English)
- Open EFSA - Information platform on applications for scientific opinions received
- Training and support for the use of the E-Submission Food Chain Platform (ESFC)
- Information on the approval procedure for food contact materials on the BVL website
- FAQs from the BVL on the authorization procedure for food contact materials
Author
Federal Office of Consumer Protection and Food Safety (BVL)
The text was automatically translated based on the German content.
- Authorization of new substances for plastics in food contact according to Regulation (EU) No. 10/2011 Issue
Remark: Display of performance in the source portal
Technically approved by
Federal Ministry of Food and Agriculture (BMEL)
Professionally released on
01.09.2022
Source: Zuständigkeitsfinder Thüringen (Linie6PLus)
Start your request directly online:
Competent Authority
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) - Dienststelle Berlin Gerichtstraße (allgemein)
Address
Postal address
10832 Berlin, Stadt