Title 21 of the Code of Federal Regulations (CFR) contains regulations promulgated by the Food and Drug Administration (FDA) in the United States. Section 177.2600 of Title 21 CFR specifically pertains to rubber articles intended for repeated use in contact with food.
Key Points from 21 CFR 177.2600:
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Scope:
- The regulation covers rubber articles that come into contact with food and are intended for repeated use. This includes items such as gaskets, seals, grommets, and other rubber components used in food handling equipment.
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Permitted Ingredients:
- The regulation specifies the types of rubber and permissible ingredients that can be used in the manufacture of these articles. It establishes conditions under which rubber materials are considered safe for repeated contact with food.
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Extraction Limits:
- Limits are set on the amount of extractable substances from rubber articles. The regulation defines the acceptable levels of substances that may migrate from rubber into food.
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Conditions of Use:
- Conditions under which rubber articles are intended to be used are outlined. Compliance with these conditions ensures that the rubber materials do not pose a risk of contamination to the food they come into contact with.
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Specific Use Cases:
- The regulation provides specific requirements for various rubber articles and their use in food handling equipment. This includes considerations for different types of food and intended applications.
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Overall Safety:
- The primary objective of 21 CFR 177.2600 is to ensure that rubber materials used in contact with food are safe for repeated use and do not introduce harmful substances into the food.
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Compliance and Certification:
- Manufacturers of rubber articles intended for food contact must ensure compliance with the specified requirements. Compliance is often demonstrated through testing, and manufacturers may provide certifications to affirm that their products meet FDA standards.
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Documentation and Recordkeeping:
- The regulation may require manufacturers to maintain records and documentation demonstrating compliance with the standards. This includes information on the formulation of rubber materials, testing procedures, and results.
It's important for manufacturers, food handlers, and regulatory professionals to be familiar with the specific requirements outlined in 21 CFR 177.2600 to ensure the safety and compliance of rubber articles used in contact with food. Regular updates to regulations should also be considered, as the FDA may revise or amend standards over time.