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Food products and nutraceuticals - Novel Food

icone-mainSince January 1, 2018, Novel Foods are regulated by Regulation (EC) 2015/2283. A food or food ingredient is considered Novel Food if its consumption in human food in the EU was negligible before May 15th, 1997.

 

Many changes have occurred with the entry into force of this new regulation, including :

  • A centralized authorization system via the European Commission,
  • A generic authorization system that replaces the individual authorization system,
  • The abolition of the so-called “simplified” procedure, which was based on the principle of substantial equivalence,
  • Facilitated marketing of primary products with 25 years of consumption in the third country,
  • A possibility of data protection for 5 years,
  • As provided for in Article 8 of the Regulation, the Union list of novel foods has been published (Regulation (EU) No. 2017/2470), which includes all novel foods already authorized or notified under the previous regulation (Regulation (EC) No. 258/97).
Only novel foods included in the Union list may be commercialized in the EU, in accordance with conditions of use and requirements laid down in the list, and independently of the company that has obtained the authorization.

 Pharmanager Development assists you with :

  • Realizing the assessment of the Novel Food status with regard to the specifications of the ingredient and its manufacturing process,
  • Realizing the consultation of a Member State in order to decide on the Novel Food status in accordance with the procedure provided for in Article 4 of Regulation (EC) 2015/2283,
  • Realizing Novel Food files, including bibliographic research as well as exposure assessment in the target population,
  • Realizing the e-submission to the European Commission and the follow-up of the dossier during its evaluation process.