Germany’s BfR Revises Recommendations for Rubber Commodities

SafeGuardSHardgoods, Toys and Juvenile ProductsSeptember 17, 2024

SG 143/24

The German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) has amended three recommendations for natural and synthetic rubber commodities. These recommendations can be regarded as effective immediately.

In September 2024, Germany’s BfR issued three revised recommendations for natural and synthetic rubber commodities, including those that are intended to come into contact with food.

The three amended guidelines (in German or English) are:

Recommendation XXI ‘Commodities based on natural and synthetic rubber’
Recommendation XXI/1 ‘Commodities based on natural and synthetic rubber in contact with food’
Recommendation XXI/2 ‘Special consumer goods made of natural and synthetic rubber and of lattices made of natural and synthetic rubber (formerly special category)’

Highlights of these recommendations are summarized in Table 1.

Recommendation (as of September 1, 2024)	Highlights
XXI ‘Commodities based on natural and synthetic rubber’	When compared to its February 2023 version: Clarifies the deadlines apply to the deletion of substances from Table 2 in Recommendations XXI/1 and XXI/2 Amends Annex Table 1 ‘Evaluated starting materials, additives and production aids’ in relation to emulsifiers and dispersants (for lattices only)
XXI/1 ‘Commodities based on natural and synthetic rubber in contact with food’	When compared to its February 2023 version: Clarifies that membranes are within the scope of section 2.8 ‘Migration values for closures’ Details the assumptions for surface-to-volume ratio if the intended use of the item is not known (section 2.8b) Updates sections and/or entries in Table 1 ‘Rubber/lattices and Table 2 ‘Not conclusively evaluated raw materials, additives and processing aids’ ≤ 10 mg/dm² for overall migration (OM) from commodities in categories 1 to 3* of this Recommendation, but: ≤ 60 mg/dm² for OM for caps, seals, stoppers and similar closures as well as membranes (section 4.1) ≤ 30 mg/dm² when tested in 3% acetic acid, of which a maximum of 10 mg/dm² is organic content, for latex disposable gloves (section 4.1) ≤ 6 mg/kg for total transfer of formaldehyde from finished products under categories 1 to 3* (section 4.8)
XX1/2 ‘Special consumer goods made of natural and synthetic rubber and of lattices made of synthetic and natural rubber (formerly special category’	When compared to its July 2021 version: Updates sections and entries in Table 2 ‘Additives and manufacturing aids not conclusively evaluated’ ≤ 6 mg/kg for total transfer of formaldehyde from finished products (section 4.5)

Table 1

*Category 1: Long-term contact – commodities that come into contact with food for longer than 24 hours and up to several months when used as intended

Category 2: Medium contact time – commodities that come into contact with food for up to 24 hours when used as intended

Category 3: Short-term contact – consumer articles that come into contact with food for up to 10 minutes during intended use

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