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QSS helps companies prepare and submit food additive applications to EFSA under Regulation EC 1333/2008. If you want to introduce a new food additive to the EU, modify the conditions of use for an existing one, or renew a current authorization, we can help you build a dossier that meets EFSA’s data quality expectations.
Food additives in the EU are regulated under Regulation EC 1333/2008, which establishes the EU list of approved food additives and sets the conditions of use and labelling requirements for each. Any food additive not currently on that list, or any proposed change to the conditions of use of an already-authorized additive, requires an application to the European Commission, which is then evaluated by EFSA.
EFSA assesses the safety of any new food additive before it can be placed on the EU market, and also assesses proposed new uses and modifications of the conditions of use or specification for food additives that have already undergone a full safety assessment and are authorized. The process involves four main phases: pre-submission, submission and completeness check, risk assessment, and post-adoption.
The EFSA review process typically takes 12 to 18 months, depending on the complexity of the additive and the quality of the submitted data. Dossier quality has become an increasingly important factor in processing efficiency, and EFSA’s updated guidance reflects a higher bar for completeness and scientific rigour before submission. QSS helps you understand what is required, build a dossier that meets those standards, and manage the process from initial assessment through to the European Commission’s authorization decision.
We evaluate your food additive’s current status under EU legislation, confirm whether you need a new authorization, a modification, or a renewal, and identify the data requirements that apply to your specific application type.
We review your existing scientific data against EFSA’s published checklists and guidance, identify gaps in toxicology, composition, stability, or exposure data, and advise on what additional studies may be needed before submission.
We compile your full application dossier in line with EFSA’s current scientific and administrative guidance under Regulation EC 1333/2008, including all required sections covering identity, manufacturing process, proposed uses, exposure assessment, and toxicological data.
We manage the submission of your dossier through EFSA’s E-submission Food Chain platform and support follow-up communication with the European Commission and EFSA throughout the review process.
Where your application contains proprietary or commercially sensitive data, we advise on what qualifies for confidentiality protection and support the process of requesting it within EFSA’s framework.
For additives already authorized in the EU, we support renewal applications that must be submitted at least one year before the current authorization expires, as well as applications for modifications to conditions of use.
The EU maintains a positive list of food additives authorized for use under Regulation EC 1333/2008. The list specifies which additives are permitted, in which foods, and at what maximum use levels. Any additive not on this list cannot be legally marketed in the EU until it has been evaluated by EFSA and authorized by the European Commission.
You can apply for authorization of a new food additive, a modification to the conditions of use or specifications of an already-authorized additive, or a renewal of an existing authorization. Each type of application has different scientific and administrative requirements, with new authorizations requiring the most detailed dossiers.
Requirements vary by application type, but typically include information on the additive’s identity and composition, manufacturing process, proposed uses and use levels, dietary exposure assessment, and toxicological data from studies conducted at OECD-compliant GLP laboratories. EFSA has published checklists for each application category that specify the required data elements, and we review your dossier against these before submission.
The review process typically takes 12 to 18 months from submission, depending on the complexity of the additive and the quality and completeness of the submitted data. A well-prepared dossier that meets EFSA’s data quality expectations from the outset is the most reliable way to avoid delays.
GRAS certification can provide relevant safety data, but EFSA requires documentation tailored to EU regulations, including EU-specific exposure analyses and toxicology studies conducted under OECD-compliant conditions. We assess what you already have and identify what needs to be developed or adapted for the EU submission.
Yes. Once authorized by the European Commission following EFSA’s positive scientific opinion, an authorization is valid throughout the European Economic Area. Authorizations are granted for ten years and are renewable for subsequent ten-year periods.
EFSA may request additional data or clarification during its assessment. The public consultation process also allows stakeholders to submit further data. We monitor the review process and support you in responding to any requests from EFSA or the European Commission.