Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
In 21 CFR Part 117, FDA established a CGMP regulation as part of the “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food” rule.
Part 117 establishes requirements for CGMPs and for hazard analysis and risk-based preventive controls for human food (PCHF) and related requirements.
Generally, domestic and foreign food facilities that are required to register with FDA by Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must comply with the requirements for risk-based preventive controls in Part 117 (unless an exemption applies). The modernized CGMPs generally apply to establishments that manufacture, process, pack, or hold food and apply to some activities that are exempt from the preventive controls requirements, such as juice and seafood processing.
Title 21 - Chapter I - Subchapter B - Part 117 - § 117.40 Equipment and utensils.
(a)
(1) All plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact and contamination.
(2) Equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
(3) Equipment must be installed so as to facilitate the cleaning and maintenance of the equipment and of adjacent spaces.
(4) Food-contact surfaces must be corrosion-resistant when in contact with food.
(5) Food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds, sanitizing agents, and cleaning procedures.
(6) Food-contact surfaces must be maintained to protect food from allergen cross-contact and from being contaminated by any source, including unlawful indirect food additives.
(b) Seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and allergen cross-contact.
(c) Equipment that is in areas where food is manufactured, processed, packed, or held and that does not come into contact with food must be so constructed that it can be kept in a clean and sanitary condition.
(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, must be of a design and construction that enables them to be maintained in an appropriate clean and sanitary condition.
(e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment.
(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food must be accurate and precise and adequately maintained, and adequate in number for their designated uses.
(g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives.
FDA Food Safety Modernization Act (FSMA) - Content:
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS
Sec. 101. Inspections of records.
Sec. 102. Registration of food facilities.
Sec. 103. Hazard analysis and risk-based preventive controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce safety.
Sec. 106. Protection against intentional adulteration.
Sec. 107. Authority to collect fees.
Sec. 108. National agriculture and food defense strategy.
Sec. 109. Food and Agriculture Coordinating Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of food.
Sec. 112. Food allergy and anaphylaxis management.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance relating to post harvest processing of raw oysters.
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS
TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD
TITLE IV--MISCELLANEOUS PROVISIONS
The United States of America doesn’t have an official language on the federal level. They do use English as the primary language for official documents and publications, legislation, orders, regulations and rulings.
The states with English as the only official language are:
Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Massachusetts, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, South Carolina, South Dakota, Tennessee, Utah, Virginia and Wyoming.
Puerto Rico has declared Spanish the principal language, but both English and Spanish are official languages.
In the US Virgin Islands, only English is official, while American Samoa has English and Samoan.
Guam has English and Chamorro has official languages and in the Northern Mariana Islands, English, Chamorro and Carolinian are official.