Apply for approval of active and intelligent substances in food contact materials
Do you want to use active and intelligent substances for materials that come into contact with food? Then you need to apply for approval on the European Commission's online portal E-Submission Food Chain Platform.
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 constituents into the food in quantities which
- endanger human health
- lead to an unacceptable change in the composition of the food, or
- cause a deterioration in the organoleptic properties of the food, such as taste or odor.
As a manufacturer of food contact materials, you are responsible for compliance with the legal requirements. You must ensure that the contact materials are safe for human health.
What are active and intelligent food contact substances?
Active materials absorb or release substances to improve the quality of packaged food or extend its shelf life.
Smart materials monitor the condition of packaged food or the environment surrounding it. For example, they provide information about the freshness of the food.
Applications for approval of active and intelligent substances in food contact can only be submitted 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 point of contact in Germany. If you select the BVL as your point of contact, the BVL formally checks the application for completeness and relevance of the documents. The BVL then forwards it to the European Food Safety Authority (EFSA).
EFSA reviews and evaluates your application based on scientific evidence. The European Commission decides on the actual approval. Even in the event of non-approval, the European Commission will inform you and give reasons for its decision.
If the active and intelligent materials or articles meet the legal and scientific requirements, they will be added to the corresponding EU list of permitted substances. They may then be used as food contact materials.
If you have new scientific or technical knowledge that may affect the evaluation of the safety of the substance in relation to human health, you must immediately inform the EU Commission.
Online service
E-Submission Food Chain Platform (ESFC) der Europäischen Kommission
Description
Use this service online
Trust level
You need an account with password to use this online service (trust level: low).
further information on the level of trust for online services
Identification
- electronic identification using national eID means – user name/password
Contact person
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) - Dienststelle Berlin Gerichtstraße, Referat 113
Address
PO box address
Post office box 11 02 60
10832 Berlin
address
Contact
Internet
Payment methods
The following payment methods are possible:
- Bill
- Transfer
Bank account
Bundeskasse Trier
Recipient: Bundeskasse Trier
IBAN: DE81 5900 0000 0059 0010 20
BIC: MARKDEF1590
Bank institution:Deutsche Bundesbank Filiale Saarbrücken
Required documents
- You have to submit the application documents according to the requirements of the so-called Guideline document of EFSA.
Forms
Forms available: No
Written form required: No
Informal application possible: No
Personal appearance required: No
Online services available: Yes
Prerequisites
- The content and form of your application and the accompanying documents must comply with the requirements of EFSA's guidance.
Basis for legal action
Legal remedy
- You file an appeal against a decision directly with the authorizing body, i.e. the European Commission.
Procedure
You can apply for the approval of active and intelligent substances in food contact exclusively online via the ESFC portal of the European Commission. The process goes through different phases with different stakeholders and responsibilities:
- Upload your application, prepared according to EFSA's specifications, directly to the platform. Follow the procedure described in the so-called user guide of the platform.
- The BVL will receive the application if you select it as the national contact point.
- After successful completion of the formal review, the BVL forwards the application within the platform to the responsibility of EFSA.
- EFSA takes over the scientific review and publishes information on received applications in scientific opinions.
- Via the Open EFSA Portal, you and other interested parties can follow the status of applications up to the publication of the scientific opinion.
- The European Commission, with the involvement of the EU member states, decides on the actual authorization.
Deadlines
There are no deadlines for submission.
Processing time
0 to 4 weeks (- You will receive a confirmation of receipt within 14 days. - The BVL usually needs no more than 4 weeks for the initial review of your application. Queries or additional requests as well as your reaction times may influence the duration. Only when the documents are complete, the BVL forwards them to EFSA.)
Costs
There are no costs involved.
Further Information
- Informationsportal der Europäischen Kommission zu Lebensmittelkontaktmaterialien (Englisch)
- Leitlinien der Europäischen Kommission für den Antrag auf Evaluierung von aktiven und intelligenten Substanzen in Lebensmittelkontaktmaterialien (Englisch)
- Anleitung zur Nutzung der ESFC-Plattform auf der Internetseite der Europäischen Kommission (Englisch)
- EFSA-Portal - Antrag auf Zulassung von Lebensmittelkontaktmaterialien: Vorschriften und Leitlinien (Englisch)
- Open EFSA Portal - Informationsplattform zu eingegangen Anträgen auf wissenschaftliche Stellungnahme (Englisch)
- Training und Unterstützung zur Nutzung der E-Submission Food Chain Platform (ESFC) (Englisch)
- Information zum Zulassungsverfahren für Lebensmittelkontaktmaterialien auf der Internetseite des BVL
- FAQs des BVL zum Zulassungsverfahren für Kontaktmaterialien in deutscher Sprache
Area of validity
Germany-wide
Official approval
Officially approved by Federal Ministry of Food and Agriculture (BMEL) on 20.07.2022
Keywords
FCM, Lebensmittel-Kontaktmaterial, Verpackung, Verpackungsmaterial, Intelligentes Material, EFSA, Aktives Material, E-Submission Food Chain Platform, Bundesamt Verbraucherschutz Lebensmittelsicherheit, Europäische Behörde für Lebensmittelsicherheit, Verpackungsmaterial für Lebensmittel, ESFC-Plattform, Smart packaging, food contact material, Lebensmittelkontaktmaterial, ESFC, BVL, Kontaktmaterial für Lebensmittel, Lebensmittelsicherheit, Kunststoff, Lebensmittelverpackung, Zulassung, Lebensmittelbedarfsgegenstand, European Food Safety Authority