The requirement you are referring to, 21 CFR 177.2600, is a regulation established by the U.S. Food and Drug Administration (FDA) related to food contact substances. Specifically, it addresses the use of rubber articles intended for repeated use in contact with food.
Key Points of 21 CFR 177.2600:
1. Scope:
- The regulation applies to rubber articles that are intended for repeated use in contact with food.
2. Authorization for Use:
- It provides authorization for the use of certain rubber materials in the manufacturing of articles that come in contact with food.
3. Permitted Rubber Materials:
- Specifies the types of rubber materials that are permitted for use, including certain elastomers such as ethylene-propylene rubber, styrene-butadiene rubber, and others.
4. Conditions of Use:
- Outlines the conditions under which these rubber materials are allowed to be used, ensuring that they do not pose a risk to human health when in contact with food.
5. Extractables Limitations:
- Sets limitations on the amount of extractable substances from the rubber material into food, ensuring that the migration of potentially harmful substances is within safe limits.
6. Compliance with Good Manufacturing Practices (GMP):
- Requires compliance with Good Manufacturing Practices to ensure that the manufacturing process meets the necessary hygiene and safety standards.
7. Temperature Limits:
- Specifies temperature limits for the use of rubber materials, ensuring that they remain stable and do not transfer harmful substances to food under normal and foreseeable conditions of use.
8. Specific Use Cases:
- Provides specifications for specific types of rubber articles, such as gaskets, seals, and other components used in food processing equipment.
9. Labeling Requirements:
- May include requirements for labeling to ensure that end-users are informed about the intended use and compliance with FDA regulations.
10. Risk Assessment:
- It's crucial for manufacturers and those involved in the production of rubber articles intended for use in contact with food to carefully adhere to the specifications outlined in 21 CFR 177.2600. Compliance with these regulations helps ensure the safety of food products and protects the health of consumers. Manufacturers should stay informed about any updates or amendments to these regulations to maintain compliance with the latest standards.