Produtos afetados
Sistema de classificação Código Nome
HS 21 Preparações alimentícias diversas.
ICS 67230 Prepackaged and prepared foods
Detalhes
País Canada
Agência responsável Department of Health
Agency or authority designated to handle comments if different from above Canada’s Notification Authority and Enquiry Point Global Affairs Canada Technical Barriers and Regulations Division 111 Sussex Drive Ottawa (Ontario) K1A 0G2 Canada Telephone: (343)203-4273 Fax: (613)943-0346 Email: enquirypoint@international.gc.ca
Artigos 2.10.1
Covered Products Human milk fortifiers
Cobertura Fortificadores de leite humano
Title, number of pages and language(s) of the notified document Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers) (12 pages, available in English and in French)
Resumo em portugues Propõe Regulamentos Técnicos que alteram os regulamentos de alimentos e medicamentos para fortificadores de leite humano.
Resumo original The proposed regulations would amend the Food and Drug Regulations (FDR) to establish a regulatory framework for the sale of human milk fortifiers (HMFs) in Canada. HMFs are foods which are intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physiological condition exists as a result of a disease, disorder or abnormal physical state. There are currently no provisions in the FDR specific to these products, meaning the general food framework applies. Amendments to the FDR are needed to permit HMFs to have added vitamins, mineral nutrients, and amino acids, and to include provisions to safeguard the health and safety of the vulnerable population using HMFs. The proposed amendments would establish a premarket submission requirement for HMFs new to the market and HMFs that have undergone a major change; permit the addition of vitamins, mineral nutrients, and amino acids to HMFs; set out labelling requirements; and set out conditions of sale. The establishment of clear regulatory requirements would help to ensure continued access to safe and nutritionally adequate HMFs for certain vulnerable infant populations in Canada, enable their use outside of hospitals under medical supervision, and provide greater clarity to manufacturers and importers wishing to sell or advertise for sale these products in Canada.
Objetivos Saúde Humana
Documentos relevantes Draft Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers): Policy Paper – Fall 2020 (11 and 12 pages, available in English and French)
Detalhes do contato The electronic version of the regulations can be downloaded at: Canada’s Notification Authority and Enquiry PointGlobal Affairs CanadaTechnical Barriers and Regulations Division 111 Sussex DriveOttawa (Ontario) K1A 0G2CanadaTelephone: (343)203-4273Fax: (613)943-0346Email: enquirypoint@international.gc.ca

Datas importantes
  • Distribuição
    16/10/20
  • Comentários
    Até 15/11/20
  • Adoção
    On the day of their publication in the Canada Gazette, Part II.
  • Vigência
    These Regulations come into force on the day of their publication in the Canada Gazette, Part II. HMFs which are currently marketed in Canada would have a period of 1 year after this date to come into compliance with the new regulations.
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