Novel Food Regulation - Fluxograma do Processo de Aplicação

Novel Food Regulation Flow Chart Application Process Application presubmission screening Application submission Administrative Completeness check Risk assessment Risk management EFSA Guideline under Novel Food Regulation 22832015 Risk assessment depends on the New Novel Food or Substantial Modification or New Way of Production EFSA prepares scientific opinion Risk management involves Member States MS and Commission COM Additional risk assessment of food contact materials as needed Decision by MS and EC Granting or refusal of authorization is notified by COM to Member States and applicants Food products can be placed on the market by the applicant Consumer safety assessment and informed decisions throughout the process Data production exchange can occur at any stage EFSA provides guidance documents for applicants and member states EFSA is a member of the EU Food Safety Network Commission regulation EU No 20172469 establishes the application procedure and requirements for authorization of novel foods The process includes a legal framework to ensure consumer safety with transparent and measurable steps Application timelines are defined but can be prolonged by requests for additional information The process depicted is a stepwise flow chart showing decision nodes steps and actions leading from application submission to final authorization