Novel foods & regulatory submissions

Our experienced team are here to support you at every stage of your regulatory journey from complex EU and UK novel food regulations to US FDA GRAS processes, we have the expertise to give your submission the best chance of success.

 

The novel food space is dynamic and diverse, with organisations of all sizes, each facing unique regulatory and technical challenges.  Whether you’re a start-up in need of an expert scientific and regulatory partner or a multinational looking to validate a method for your novel product, RSSL has the expertise to help.  

 

Our end-to-end service is designed to support you on this journey, from initial gap assessment through to final novel food application submission and beyond. Most importantly, our approach is always bespoke and driven by your priorities, timeframe and budget.  

Your novel food regulatory journey to success with RSSL

Your journey to regulatory success starts with RSSL. You may need our strategic novel food regulatory consultancy to set you on the right path, or proven method development and validation expertise to generate reliable data for your submission. You may also benefit from our wider R&D/product development capabilities, especially in the early stages when time and resources are limited. Additionally we have extensive experience generating compositional data and we can perform stability studies for a wide range of ingredients and product applications.

 

However you choose to partner with RSSL, our comprehensive approach and technical rigour means we can provide exactly what you need to get your novel food submission over the line. And because we know that no two enquiries are ever the same, you can be sure our response will be as unique as your innovation.

 

 

Get your free 20 minute consultation with one of our experts

 

Our highly qualified novel food experts are here to help with a wealth of knowledge and experience that will get you started on your journey to market.

 

 

 

Partnering with you to bring your product to market

1. Free consultation - take the first step with our experts!

Kickstart your journey to market with a free 20-minute consultation with our team of experts. Contact us to schedule in your call. 

 

2. Is your product Novel or not*?

We start by understanding your product’s regulatory status through a comprehensive gap assessment. This will help determine if your product is considered ‘novel’ by regulatory bodies. If your product is not Novel – we can still help! If your product isn’t classified as novel, you may still require regulatory approval for ingredients such as food additives including enzymes and food colours. RSSL provides comprehensive regulatory and R&D support to ensure compliance with safety laws and marketing

 

3. Tailored testing and submission strategy for success

We will develop a tailored testing and submission strategy covering relevant scientific studies such as compositional data, stability studies and toxicological assessments

 

4. Seamless dossier submission and follow-up

Our team can take care of the entire process, from preparing and submitting the complete dossier to the relevant regulatory body as well as managing queries and following up with authorities to ensure your submission progresses smoothly.  If you already have a regulatory consultant, we're happy to collaborate to support your submission effectively. 

 

5. Post-approval continued partnership

With over 35 years of expertise in award-winning product development, regulatory compliance and analytical excellence – our team will help you navigate the scientific, technical and regulatory challenges, to ensure your successful product launch and growth in local and global markets.

 

 

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Our end-to-end novel food and regulatory service includes:

  • Gap assessment 
  • Expert consultancy to interpret complex novel food dossier requirements
  • Development of submission strategy
  • Evaluation of ingredients in relevant model food systems or novel food products
  • Development and validation of analytical methods for specific chemical compounds including low level impurities
  • Studies to demonstrate the stability of the ingredient itself, as well as in a variety of finished products 
  • Unique internal process to evaluate the sensory characteristics of unapproved novel ingredients
  •  Particle size for nano-material characterisation (solubility)
  • Novel food dossier submission and clarification to scientific committees and regulatory bodies including EFSA, FSA, GRAS data for FDA
  • Toxicology strategy and consultancy
  • Post approval support through scale-up and commercialisation
  • Dedicated project manager to ensure efficient communication and progress tracking for your novel food application

Frequently asked questions

  • According to EU novel food regulation, a novel food is defined as any food that has not been consumed to a significant degree by humans in the EU before May 15, 1997. Examples include new types of food ingredients, novel food products, or those derived from unconventional sources such as nano-materials, algae, or insects.

  • RSSL offers comprehensive regulatory and technical support services, from early-stage strategic guidance to dossier submission and monitoring.  With expertise across scientific testing, regulatory requirements and method validation, we provide tailored support at set you up for success with your regulatory submission. Please contact us to discuss your needs.

  • Yes but this is complex. The regulatory authorities will evaluate the technical rigour of your dossier, part of it includes whether or not you’ve used standard methods widely accepted in the industry or validated methods. RSSL has extensive experience in bespoke method development and validation if required, and can also work to validate a client method if needed. Please contact us to discuss your needs.

  • The regulatory authorities will expect a combination of chemical and physical testing  to define the novel food and its safety. RSSL offers a wide range of analytical methods, from standard methods to bespoke as well as access to state of the art analytical equipment.

    Our stability cabinets allow us to assess your product's stability under real-world conditions. Our expert team will advise you on the potential deterioration mechanisms that could occur and what analyses we would recommend performing.

  • Yes. We have extensive experience working with start-ups and well versed in working with limited sample amounts. While regulatory submissions typically require scaling-up your ingredient/product, many of our methods allow us to use a minimal amount of sample.

    Please get in touch with us so we can discuss what analyses we would recommend to prioritise at this stage and what efficiencies we are able to build into the workflow to use as little sample as needed, as well as clarify how much sample will be required for future tests.  

Meet our experts

  • Daniele Leonarduzzi 2

    Daniele Leonarduzzi

    With extensive experience in analysing the physical properties of products and a specialisation in novel food regulation, Daniele offers technical guidance to clients, assisting in the preparation of scientific dossiers for regulatory submissions and ensuring compliance with current requirements.

  • Alice FHI Smaller

    Alice Joubran

    Extensive experience in food research and product development, with a special interest in the link between product formulation, processing and the resulting techno-functionality and digestibility. Alice partners with clients offering both technical consultancy and project management to support their end to end innovation.

  • Ben Price 1 (1)

    Ben Price

    Ben has been a key member of the RSSL Team since 2014, working as a Business Development Manager.  His focus on supporting clients with their R&D projects and regulatory submissions has been instrumental in driving the food industry forward. With a strong background in analytical chemistry, Ben brings extensive experience across a range of sectors. His strong project management skills, coupled with his technical knowledge and comprehensive knowledge of the food and ingredient industry, ensures clients receive the highest quality scientific solutions tailored to their specific needs. Ben is a valuable partner for companies seeking innovative solutions.

Resources

White Paper
RSSL Whitepaper Thumbnail Novel Foods Designing A Winning Strategy For Successful EFSA Applicants
Food & Consumer Goods
Novel Foods: Designing a strategy for successful EFSA applications
Flyer
Regulatory Support & Novel Foods
Food & Consumer Goods
Regulatory support & novel foods
Brochure
Food R&D Brochure
Food & Consumer Goods
Food services brochure

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