Keeping pace with the constant stream of new and updated regulatory requirements issued by EFSA, FDA and other scientific bodies is a constant challenge. Complex dossier requirements need to be interpreted correctly to ensure the right analysis is carried out and your ingredient submission has the best chance of success. Get it wrong and valuable time is lost in terms of bringing your product to market. And this is where RSSL can provide valuable support.

Our combined internal/external expert team of regulatory consultants, food technologists and analytical experts offers a seamless service. Right from the start, you benefit from authoritative advice and guidance on the data that is needed for your application. This is then translated into action by our laboratory teams who have the proven capabilities to carry out specified testing and validation to the required standards. An approach designed to give you the confidence that your application is in safe hands.



Meet our scientific & regulatory consultant


Nigel Baldwin, BSc, CSci

During his distinguished career, he has worked on more than 80 food ingredient approvals globally and advised on multiple “start-to-finish” new product introductions.

Best known for his work on novel food ingredient approvals, food additives and enzymes, he is also recognised as a global expert in the successful introduction of new infant formula ingredients.
A regular speaker at industry events, Nigel has authored and co-authored numerous well-respected articles, presentations and scientific publications.



Our experienced team can work with you on the following applications:
  • Novel foods
  • Food additives / feed additives
  • Food enzymes
  • Food flavourings
  • Extraction solvents
  • Generally Recognised as Safe (GRAS)
  • Nutrition and health claims


SUPPORTING YOU WITH YOUR REGULATORY SUBMISSION

RSSL work with external parties to provide an integrated regulatory support services, including:

  • Regulatory strategy consultancy (External)

    The experienced team will carry out a robust assessment of your regulatory status. This includes:

    • Confirmation on what submissions are required for each ingredient, providing you with an indication of timescales
    • Undertaking a review of the analytical data already available as part of a gap analysis in order to define the scientific data required to obtain a positive outcome
    • Providing an interpretation of scientific guidance documents, such as EFSA, FDA, etc.
    • Defining likely areas of concern and develop appropriate analytical testing strategies
    • Providing risk assessment analytical testing data for hazard analysis assessments
    • Delivering risk management data for case of need, where applicable
  • Product characterisation

    To assess the product characteristics of an ingredient, we will draw on a broad range of techniques - including NMR, FT-IR, HPCC, GC, LC-MS and wet chemistry - with the precise methodology designed according to the specifics of the product under review.
    For example:

    • Structure identity may be used for chemical entities
    • Comparative assessments may be relevant for natural identical ingredients
    • Fingerprinting and an assessment against reference actives may be required for botanicals

    • In all cases, representative batch analysis will be conducted to confirm characterisation against specification.

  • Evaluation in product applications

    Our product development team will evaluate different aspects of an ingredient’s performance in basic but representative food formulations by:

    • Selecting food applications which reflect the desired end use and relevant processing conditions, such as pasteurisation and UHT, as well as different pH and solids content
    • Undertaking an informal sensory assessment to provide you with an understanding of these important characteristics
    • Conducting stability studies to demonstrate the in-use stability of the ingredient through relevant processing conditions and in the in finished food products over the appropriate shelf-life period
  • Analytical Method development & validation

    For new ingredients, there are often no existing analytical methods to quantify the purity of the material which means a tailored approach is required. RSSL’s analytical team has the proven capabilities to:

    • Develop analytical methods: Although the precise technique depends on the nature of the material in question, it is often an HPLC or LC-MS method
    • Conduct subsequent validation: To ensure the analysis method is fit for purpose and quantify the ingredient within food matrices
    • Prepare validation protocols: The scope of which is aligned with the ingredient under review
    Learn more
  • Stability studies

    We provide the mandatory data you need to demonstrate the stability of your ingredient; both on its own and when used in food formulations. This involves conducting:

    • Appropriate studies on the ingredient, as if from multiple batches; to demonstrate consistency of production
    • Informal and sensory analytical assessments on relevant food applications; to confirm in-use stability
    Learn more
  • Particle size safety assessment

    RSSL is able to provide support with EFSA’s particle size safety assessment, which requires you to confirm if your material has a significant amount of nano-particles present.

    We can not only help you interpret EFSA’s highly complex guidance document, including the various stages and tiers, but also use a wide range of techniques to assess the material.
    These include:

    • Volume specific surface area (BET)
    • Dynamic light scattering (DLS) particle size
    • Electron microscopy techniques
  • Document preparation & ongoing support

    We have a strong partnership with external experts who can assist with the toxicological aspects of regulatory submissions as well as completing the dossier submission. If you would like help with these aspects, please contact us and we would be delighted to assist you with finding the right partner to support you.

    Our external parties will assist you with the preparation and presentation of the technical section of the documentation required for ingredient and novel foods submissions. Proven expertise in this area will help you overcome the regulatory challenges and maximise your chance of success.

    Our team also knows that the work does not stop once your submission is made. We continue to support your application by helping you to manage complex requests from scientific and regulatory committees for analytical additional information.

If you would like to find out more about how RSSL can help you with the analytical aspects for your regulatory submission, please complete the enquiry form below or contact us.

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