09/21/2021 | Press release | Archived content
In mid-2021, Germany's Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) published three interrelated Recommendations for natural and synthetic rubber commodities, including those that are intended to come into contact with food. These three Recommendations supersede BfR Recommendation XXI 'Commodities based on natural and Synthetic Rubber' of 2011.
According to the latest Recommendation XXI, a separate Recommendation XXI/3 'Consumer goods made of cross-linked thermoplastic elastomer' is planned for food contact thermoplastic elastomers (TPEs).
Highlights of Recommendations XXI, XXI/1 and XX/2 are summarized below.
In addition to the recommendations indicated above, this guideline contains, inter alia, several important provisions:
Federal Institute for Risk Assessment |
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Food contact consumer goods made of natural and synthetic rubber (when used as intended)* |
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Category |
Category 1 (Long-term contact) |
Category 2 (Medium-term contact) |
Category 3 (Short-term contact) |
Time in contact with food |
More than 24 hours and up to several months |
24 hours maximum |
10 minutes maximum |
Example of commodity |
- Storage containers - Container linings - Sealing rings for cans, jars, bottles and similar items - Bottle stoppers and caps |
- Sealing rings for pressure cookers, hoses for coffee machines - Lid seals e.g. for milk cans - Valve balls |
- Gloves and aprons worn during processing of food - Roller covers for fatty food |
Simulants |
1) deionized water, 2) 10% ethanol, 3) 20% ethanol, 4) 3% acetic acid, 5) 50% ethanol, 6) poly(2,6-diphneyl-p-phenylene oxide) particle size 60-80 mesh, pore size 200 nm and 7) vegetable oil with less than 1% unsaponifiable matter |
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Test conditions** for migration |
40 °C, 10 days*** |
40 °C, 24 hours |
40 °C, 10 mins |
*The extracts from categories 1, 2 and 3 commodities (articles and materials) must also comply, among other things, with the following:
**Practical use test conditions must be adapted if actual conditions of use differ significantly from test conditions |
Table 1
Examples of the aforementioned goods include toys intended to be placed in the mouth or intended for children under 36 months, balloons, bottle teats, soothers (dummies), breast caps, teething rings and denture protection products.
This Recommendation contains, among other things, provisions for migration testing (see Table 2 below), substances for the manufacture of consumer goods from natural and synthetic rubber, starting materials, as well as additives and production aids. In addition to meeting the testing requirements in Table 2 below, finished goods must, inter alia, comply with the following:
Click here to view the Federal Institute for Risk Assessment, Table 2
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