responsibility finder
Schleswig-Holstein

Apply for approval of new substances for cellophane films in food contact

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)

Service Description

Do you want to use new substances for the production of regenerated cellulose films in contact with food? To do so, you must submit an application for authorization on the European Commission's online portal E-Submission Food Chain Platform.

Materials that come into contact with food are subject to European legislation.

In good manufacturing practice and under normal conditions, they must not release ingredients into the food in quantities that

  • endanger human health,
  • lead to an unacceptable change in the composition of the food or
  • cause an impairment of the organoleptic properties of the food (e.g. taste or smell).

As a manufacturer of plastic food contact materials, you are responsible for compliance with these requirements. You must ensure that the contact materials are harmless to health.

Food contact materials are materials and articles that

  • are intended to come into contact with food
  • are already in contact with food and are intended to come into contact with food or
  • can reasonably be expected to come into contact with food or to transfer their constituents to food during normal or foreseeable use.

In the European Union, and therefore also in Germany, no authorization is required for the finished food contact material, i.e. the finished product.

However, this does not apply to new substances that are to be used for the manufacture of food contact plastics. So if your company wants to use new substances for the production of corresponding regenerated cellulose films, you need an authorization.

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).

If the Federal Office of Consumer Protection and Food Safety (BVL), as the national contact point in Germany, has been selected by the applicant as the point of contact, the BVL will check the application formally, i.e. for completeness and relevance of the documents. The BVL then forwards the application to the European Food Safety Authority (EFSA).

EFSA publishes detailed specifications on the required documents and content requirements in guidelines on its website.

The EFSA examines your application on the basis of scientific findings. The European Commission decides on the actual authorization.

Even in the event of non-authorization, the European Commission will inform you and you will receive a justification.

If the substance meets all food law requirements, it is placed on the so-called Union list of authorized substances of the European Union (EU). 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 with regard to human health.


Process flow

You must submit the application via the European Commission's online portal ESFC:

  • Upload your application prepared according to EFSA's specifications directly to the ESFC platform. Details on the procedure are described in the platform manual (user guide).
  • The application will be forwarded to the BVL if you select it as the national point of contact.
  • The BVL formally checks the application. The BVL then forwards the application within the platform to EFSA.
  • EFSA carries out the scientific review. 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. Details can be found on the EFSA website.

Which documents are required?
  • You must submit your application documents in accordance with the EFSA guidance document. Details can be found on the EFSA website.
What are the fees?

There are no costs.

What deadlines do I have to pay attention to?

There is no deadline.

Processing duration

The BVL usually needs no more than 4 weeks to review your application for the first time. However, queries or additional requests as well as your reaction times can influence the duration. Only when the documents are complete will the BVL forward the application to EFSA.

Legal basis
Appeal
  • There are no legal remedies against the BVL.
  • An appeal against a decision must be submitted directly to the European Commission.
Applications / forms

Forms available: No

Written form required: No

Informal application possible: No

Personal appearance necessary: No

Online services available: Yes

What else should I know?

There are no indications or special features.

Weiterführende Informationen
Author
Forwarding service: Deep link to the portal of origin

Federal Office of Consumer Protection and Food Safety (BVL)

The text was automatically translated based on the German content.

Teaser

Do you want to use new substances for the production of regenerated cellulose films in contact with food? To do so, you must submit an application for authorization on the European Commission's online portal E-Submission Food Chain Platform.

Process flow

You must submit the application via the European Commission's online portal ESFC:

  • Upload your application prepared according to EFSA's specifications directly to the ESFC platform. Details on the procedure are described in the platform manual (user guide).
  • The application will be forwarded to the BVL if you select it as the national point of contact.
  • The BVL formally checks the application. The BVL then forwards the application within the platform to EFSA.
  • EFSA carries out the scientific review. 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. Details can be found on the EFSA website.

Which documents are required?

  • You must submit your application documents in accordance with the EFSA guidance document. Details can be found on the EFSA website.

What are the fees?

There are no costs.

What deadlines do I have to pay attention to?

There is no deadline.

Processing duration

The BVL usually needs no more than 4 weeks to review your application for the first time. However, queries or additional requests as well as your reaction times can influence the duration. Only when the documents are complete will the BVL forward the application to EFSA.

Legal basis

Appeal

  • There are no legal remedies against the BVL.
  • An appeal against a decision must be submitted directly to the European Commission.

Applications / forms

Forms available: No

Written form required: No

Informal application possible: No

Personal appearance necessary: No

Online services available: Yes

What else should I know?

There are no indications or special features.

Weiterführende Informationen

Author

Forwarding service: Deep link to the portal of origin

Federal Office of Consumer Protection and Food Safety (BVL)

The text was automatically translated based on the German content.

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