Authorisation requirements and what you need to submit as part of your application
Food contact materials (FCMs) are materials and articles that come into contact with food during its production, processing, storage, preparation or serving. Examples of FCMs include:
There are four categories of FCMs which are subject to specific regulations:
Regulated FCMs need to be authorised before they can be used and placed on the market in Great Britain (GB). All FCMs must comply with the requirements of Regulation (EC) 1935/2004, which sets out the general framework. The following legislation outlines the authorisation requirements for these substances:
FSS is required to maintain lists of authorised FCMs as determined by the appropriate authority (ministers) in Scotland, England and Wales.
The positive lists for AIMs and recycled plastic processes have not yet been established in legislation. Until the positive lists are in place, responsible parties will need to ensure that they adhere to the relevant legislative requirements set out below.
In the absence of authorisations in GB, AIMs may be placed on the market in GB if they meet:
Local authorities are responsible for enforcing FCM legislation. They have the power to carry out documentary checks and serve enforcement notices in the case of suspected non-compliance with FCM legislation.
Applications will need to be submitted for evaluation and consideration for inclusion on the positive list. There is no requirement to do this immediately for AIMs. We are currently working on a timetable and on further guidance on establishing positive lists for these regulated products.
In the absence of authorisations in GB, recycled plastic processes may continue to operate, and recycled plastic produced from them may be placed on the GB market, if they meet the following:
Local authorities are responsible for enforcing FCM legislation. They have the power to carry out documentary checks and serve enforcement notices in the case of suspected non-compliance with FCM legislation.
Applications will need to be submitted for evaluation and consideration for inclusion on the positive list. There is no requirement to do this immediately for recycled plastic processes. We are currently working on a timetable and on further guidance on establishing positive lists for these regulated products.
There is a separate application process to ensure compliance with the EU requirements under Commission Regulation 2022/1616 and must not be confused with the regulated product market authorisation process or compliance with Regulation (EC) 282/2008 in GB. Commission Regulation 2022/1616 is not applicable in GB but is applicable in Northern Ireland under the Windsor Framework arrangements.
The European Commission has established its Plastic Recycling webpage which provides advice and instructions to plastic recycling operators, whether it is a novel or a suitable technology. The European Commission is also responsible for maintaining its registers.
The FSA is the official competent authority in respect of the requirements set out under Commission Regulation 2022/1616. Please ensure that relevant documents and updates are submitted to recycledplastic-notifications@food.gov.uk.
New additives in plastic and RCF cannot be placed on the market until the authorisation process is complete.
To apply for an authorisation of a FCM, please use the regulated products application portal. This is where you will be asked to upload all the documents to support your application, which will form your dossier. There is no fee for the application.
You will also need to send a sample and accompanying information to the National Reference Laboratory (NRL) as part of the application process for the following FCMs:
Your submission to the NRL should include:
This information will be stored securely by the NRL.
The requested information and sample should be sent to Fera, at the following address:
Fera Science Ltd (Fera)
Food Contact Materials team
York Biotech Campus
Sand Hutton
York YO41 1LZ
United Kingdom
This should be done at the same time as the full application is made to our regulated products application portal.
To avoid any potential delays in UK customs, particularly concerning the submission of physical samples from overseas, please can you pre-notify Fera Science at sales@fera.co.uk or via the FERA website. Please ensure that you refer to the latest guidance on labelling and shipping of parcels to the UK.
EFSA has previously developed technical guidance on the requirements of application dossiers which is also applicable for dossiers submitted in GB. However, you should follow the parts that relate to the development of dossiers only and not the application process. Please also include any supplementary documentation to support your application. For example, this may include additional information/points of clarification previously requested by EFSA.
If you submitted a FCM application to the EU before 1st January 2021 and the assessment process for this application was not completed, for example an EFSA opinion was published but it was not on an authorised (positive) list, you will need to submit your application to us, using the regulated product application portal. When completing the application form, you will be asked to provide your EFSA question number.
If your plastic or regenerated cellulose film additive was authorised by the European Commission before 1 January 2021 and the necessary legislation is in place, that authorisation will remain valid in GB, and you don’t need to apply for a new authorisation.
If you have any questions about the authorisation procedure or application requirements, please contact regulatedproducts@food.gov.uk.
You can now use our online service to make a regulated product application.
