FOOD
Novel foods are defined as foods that have not been consumed by people in the UK or EU before May 1997. Each product placed on the market is required to hold its own authorisation.
UK & EU NOVEL FOOD REQUIREMENTS
EUROPEAN UNION (EU)
As of 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods is applicable. A centralised, safety evaluation of the Novel Foods will be carried out by the European Food Safety Authority (EFSA). Novel food products are also subject to the general labelling requirements stated in Regulation (EC) No 1169/2011.
UNITED KINGDOM (UK)
Northern Ireland will continue to follow the EU process of authorisation, although UK legislation will still apply. The UK’s deadline does not apply to products on the NI market, and no lawful sale of such products can take place in NI unless a product has full novel food authorisation from the EU.
The UK has retained the same novel food laws as the EU, but it uses a different application/authorisation system and it is regulated by the Food Standards Agency (FSA) instead of the European Food Standards Agency (EFSA).
THE THREE PARTS TO YOUR NOVEL FOOD APPLICATION
PART ONE
Should contain the administrative data, such as information relating to the applicant
PART TWO
Should include:
- Identity of the novel food
- Production process
- Compositional data
- Specifications
- The history of use of the novel food and/or of its source
- Proposed uses and use levels and anticipated intake
- Absorption, distribution, metabolism and excretion
- Nutritional information
- Toxicological information
- Allergenicity
It should also include a list of all references.
PART THREE
Should include:
- List of references
- Glossary
- Any certificate in support of the dossier
- Full copies of published and unpublished scientific data
- Study reports
- Scientific opinions of international or national regulatory bodies
- Scientific opinions of national/international regulatory bodies.
OUR INTEGRATED REGULATORY AND ANALYTICAL SERVICES
Inter Scientific offers a full service for clients wishing to submit for authorisation under the Novel Foods Regulation. We have developed our integrated services to provide our clients with peace of mind and to ensure product compliance.
Regulatory
- Novel food application for UK and EU
- Risk Management processes
- Technical dossier generation
- Regulatory engagement
- Submission to Food Standards Agency and European Commission
Laboratory
- Product stability studies (temperature, humidity and light controlled)
- Appearance
- pH
- Metals Analysis
- Microbiological evaluation
- Preservative efficacy testing
Let’s talk about your project
Benefit from working with an integrated science-based compliance & regulatory team so you don’t need to outsource to multiple companies – we keep our process smooth and simple.
To discover more about how we can support you to sell your food products safely and legally, fill in the form or call to set up a meeting at
0333 344 2272.
