Meaning
Safety standards established by the German Federal Institute for Risk Assessment for plastic commodities in contact with food provide the specific criteria for elastomers and rubbers. This regulatory framework, commonly known as BfR Recommendation XXI, defines the permitted starter substances and additives used in the manufacture of food-contact rubber articles. It divides these commodities into categories based on the duration and surface area of contact, setting distinct limits for each group.
The document excludes thermoplastic elastomers from its scope, governing only vulcanized rubbers and cross-linked silicone materials.
Material Category
Rubber articles intended for repeated contact with foodstuffs must comply with differing migration limits. The recommendation specifies that category one comprises long-term contact articles such as storage tank seals, whereas category four applies to short-term contact objects like conveyor belts. Each group must undergo rigorous extraction tests using food simulants to ensure that total volatile substances do not exceed the permitted weight percentages.
This categorization determines the maximum level of plasticizers allowed in the compound.
Migration Threshold
Chemical migration testing is conducted using simulated solvent environments to replicate the behavior of food contact over time. The migration of primary aromatic amines must remain below detection limits, ensuring that carcinogenic compounds do not leach into food. Transition metal catalysts and vulcanizing residues are also restricted to prevent potential toxicity in consumer products.
These extraction protocols ensure that the rubber matrix maintains its chemical integrity under normal operating conditions.
Compliance Documentation
Manufacturers of rubber seals and gaskets must provide a declaration of compliance demonstrating adherence to these specific composition lists. The document verifies that each raw material utilized in the elastomer compound is approved under the German regulatory framework. Processing plants must maintain batch traceability to confirm that the vulcanization process has been completed to the required specification.
Finished components must be accompanied by this certification to be integrated into food processing equipment.
