Regulation
Food products and nutraceuticals
Food products and nutraceuticals
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Pharmaceutical products
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Cosmetics
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Animal nutrition
Biocides
Biocides
Novel food

Food products and nutraceuticals - Novel Food

Novel foods are governed by Regulation (EC) No 258/97. A food or food ingredient is considered a novel food if it has no history of “significant” human consumption in the European Union prior to 15th May 1997. 

 

icone-mainFrom 1st January 2018, Regulation (EC) N° 258/97 will be repealed in favour of the new Regulation (EU) N° 2015/2283. A number of changes are to be expected, including:

 

  • A single centralised procedure for the assessment and authorization of novel foods (article 10)
  • Facilitated access to market for mrimary products consumed in at least one third country for at least 25 years (article 14)
  • Possibility of data protection provisions for 5 years (article 26)
  • Engineered nanomaterials require a Novel Food authorization
  • Insects are covered bu the new Regulation

 

 Pharmanager Development assists you with:

  • Assessing regulatory status.
  • Finding information to prove significant human consumption within the European Union prior to 15th May 1997.
  • Preparing Novel Food applications:
    • – According to the full procedure (if necessary, we can help you choose or carry out the toxicology studies required for the application).
    • – According to the substantial equivalence procedure.