Substances used in plastic food contact materials application procedure
How to submit a dossier for scientific evaluation
At EFSA we assess the safety of any new substance to be used in plastic food contact materials before it can be placed on the EU market.
We also assess proposed modifications of the conditions of use for substances that have already undergone a full safety assessment and are authorised for use.
The administrative and scientific requirements of your application differ depending which of these procedures you need to apply for. In short, an application for a new substance is more detailed while an application for a modification requires less scientific information.
Below you can follow our step-by-step guide to the application process. It includes four main phases: pre-submission, submission and completeness check, risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation, and post-adoption. You need to use different documents and tools during each phase to move the process forward.
A useful overview of the application process
Getting started
EU legislation explains the overall process, the steps in the authorisation procedure, and subsequent marketing of the product.
Legislation
- Regulation EC 1935/2004 on materials and articles intended to come into contact with food – provides a harmonised legal EU framework and sets out the general principles of safety for all food contact materials
- Regulation EU 10/2011 on plastic materials and articles intended to come into contact with food
- EC overview of the authorisation process for food contact materials
For any question on the authorisation and the legislation, please contact the SANTE-fcm [at] ec.europa.eu (European Commission).
Please be aware that we are required by law to make the non-confidential version of your application publicly available in the course of the application process and to hold a public consultation. Consult this page for information on how to request confidentiality for specific information in your application.
Administrative guidance
EFSA’s administrative guidance documents describe in detail all the different phases of the application life-cycle, from pre-submission to the conclusion of the evaluation. They specify the administrative requirements for preparing and submitting an application and provide practical tips and tools to support this process.
There is one administrative guidance document to check when preparing your application.
- Administrative guidance for the preparation of applications on substances to be used in plastic food contact materials (updated on 27 November 2025)
N.B. We regularly update our administrative guidance documents to take account of new working practices. Please check that you use the latest version of these documents before applying!
Scientific guidance documents tell you what scientific data and other information you need to include in your recycling process application dossier.
Scientific guidance
There is one scientific guidance document for substances used in plastic food contact materials applications. You need to consult it when preparing a dossier for your substance. In brief, an application dossier for substances used in plastic materials needs to contain information on the identity of the substance, its characterisation and conditions of use, information on the potential of the substance to migrate in the food, and its safety.
- Note for Guidance for the Preparation of an Application for the Safety Assessment of a Substance to be used in Plastic Food Contact Materials (last republication on 16 March 2021)
N.B. We sometimes update our scientific guidance documents to take account of new science, tools and working practices. Please check that you use the latest version of these documents before applying!
We strive for a customer-oriented approach and provide a range of support services, which are available to you throughout the application process – from pre-submission to post-adoption:
- Services to applicants – from pre-submission advice and responses to queries and clarification teleconferences at various stages of the application process.
- SME support services – in addition to the services for all applicants, we offer a range of services dedicated to Small and Medium-sized Enterprises (SMEs) preparing and submitting applications, including fast-tracking of advice, support using IT tools, and teleconferences at various stages of the application process.
- Frequently Asked Questions – to clarify any doubts about the applicable procedure.
1. Pre-submission
What do I need to do first? Register in our systems, request advice and notify studies.
You need to register on our platform to access our support and start getting ready to submit your application.
- Connect.EFSA – this platform is where you obtain a pre-application identification number, notify the studies you plan to include in your submission, and access pre-submission advice along with tailored information. It also offers opportunities for further engagement in later phases. You can register by following this quick guide.
Notifying studies to EFSA - before they start
Studies submitted in support of an application that were commissioned or carried out after 27/03/2021 must be notified to EFSA using the Connect.EFSA portal, before the study starts.
- Information for creating, submitting and managing study notifications is available in the EFSA Toolkit (see the user guide on pre-application ID and the user guide on notification of studies).
- Clarification on what studies to notify is available here.
Request general pre-submission advice
From the early stages of your application, we strongly recommend requesting pre-submission advice to clarify any doubts you may have regarding the requirements and content of your future application.
2. Submission and completeness check
You need to register on another platform to prepare your application for submission.
- E-submission Food Chain platform (ESFC) – this platform is where you submit your application dossier with all the required scientific evidence. It also allows you to interact with us as needed – for example to request deadline extensions or withdraw an application or monitor progress once the risk assessment starts. You can register by creating an EU login.
- Follow the steps described in the administrative guidance and ensure you provide scientific information in line with the requirements described in the scientific guidance.
The submission process takes place entirely online. Once you have created your application and uploaded all the required information and documents in the ESFC e-submission system, your application is ready for submission.
Once you’ve submitted your application, at EFSA we do a completeness check. We may contact you via the ESFC to request further information if anything is missing or incorrectly submitted. This may also include additional information needed in relation to confidentiality and sanitisation.
When the completeness check is over, we proceed with the validation of the application.
3. Risk assessment
What happens after I’ve submitted a valid application? Monitor progress & provide additional information if requested.
After the application is validated, our scientists assess your application. During this phase, we hold a public consultation on the non-confidential version of the application dossier through Connect.EFSA.
You can monitor the progress of your application using the ESFC. It is also visible on our Open.EFSA Portal, a publicly available platform where users can follow the life cycle of all our ongoing and completed risk assessments.
If your application has all the necessary information, the assessment should take 6 months.
Important: Sometimes during an assessment we may require additional information from you. This can happen for different reasons, for example, the studies provided did not allow a clear-cut conclusion about a possible health effect, or the quality of the studies may not have been high enough for the results to be considered reliable. When this happens, we stop the clock to allow you time to provide the additional information.
The scientific assessment of your plastic material application is complete when EFSA’s expert Panel on Food Contact Materials adopts a scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment which describes their assessment and conclusions.
4. Post-adoption
What happens following adoption? Publication of a scientific opinion & possible authorisation by risk managers.
Publication follows adoption but usually takes a few weeks as we carry out editorial checks and adapt the document to the scientific publishing platform used for the EFSA Journal.
Once the scientific opinion is adopted, responsibility for your application switches from EFSA to the European Commission. The Commission, together with EU Member States, decides whether to authorise your substance for use in plastic food contact material Any material, typically packaging or kitchen equipment, designed to come into contact with foodstuffs and for what purpose.
How to follow post-adoption
You can continue follow your application on the ESFC.
If your substance is authorised for use in plastic materials, it will be included in the list of authorised substances, which also specifies the authorised conditions of its use.
- The EU Rules – European Commission
- List of authorised substances – Annex 1 to Regulation EU 10/2011 – European Commission
Application jargon explained
When you submit an application, you will find it useful to understand the jargon used to explain certain procedural aspects. These are explained in our administrative guidance. Some common examples follow:
“Notification of study”: the process of submitting a notification of the studies which will support your application. Studies must be notified in Connect.EFSA before they are conducted.
“Request for information”: when checking the completeness of your application, EFSA might request missing information to complete your submission.
“Additional data request”: during the risk assessment phase, EFSA may request additional information to complete the assessment of your application.
“Clock-stop”: term used when EFSA requests additional information during the risk assessment phase. The deadline for delivering EFSA’s opinion is put on hold until you submit the requested information.