18/02/2022 – Le prossime Linee guida della U.S. FDA al programma alimentare
Sul sito ufficiale della U.S. Food & Drug Administration (FDA) il 31/01/2022 è stata pubblicata una comunicazione dal titolo Foods Program Guidance Under Development che contiene un elenco di argomenti che FDA ha intenzione di sviluppare tramite documenti di orientamento o revisioni di documenti già esistenti. Questa specifica attività non precluderà il rilascio di documenti di orientamento su argomenti non presenti nell’elenco. Nella comunicazione si precisa che il proposito è di pubblicare un documento guida per ogni argomento presente nell’elenco ma che diversi fattori, quali nuove priorità, problemi di salute pubblica emergenti o altre circostanze potranno influire sulla capacità di FDA di emettere le linee guida elencate.
Di seguito si riportano i titoli degli argomenti presentati in relazione alla categoria di appartenenza definita nella comunicazione:
Categoria Allergens
- Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders;
- Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Draft Guidance for Industry.
Categoria Cosmetics
- Testing Methods for Asbestos in Cosmetic Products Containing Talc; Draft Guidance for Industry.
Categoria Dietary Supplements
- Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry;
- New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry;
- Best Practices for Convening a GRAS Panel; Guidance for Industry
Categoria Food Additives
- Best Practices for Convening a GRAS Panel; Guidance for Industry
- Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
Categoria Food Safety
- Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
- Action Levels for Lead in Juice; Draft Guidance for Industry
- Inorganic Arsenic in Apple Juice: Action Level; Guidance for Industry
- Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry
- Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
- Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule; Guidance for Industry
- Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting; Guidance for Industry
- Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
- Reconditioning of Fish and Fishery Products by Segregation; Guidance for Industry
Categoria FSMA
- Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
- Questions and Answers Regarding the Accredited Third-Party Certification Program: Draft Guidance for Industry
- Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Guidance for Industry
- Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry
Categoria Labeling
- Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry
- Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
- Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
Categoria Nutrition
- Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Draft Guidance for Industry
La comunicazione, in lingua inglese, è visionabile al seguente link: Foods Program Guidance Under Development
