Germany BfR Issued New Recommendations for Commodities Based on Natural and Synthetic Rubber

Oct. 25 2021

Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) of Germany published three New Recommendations superseding previous version of BfR Recommendation XXI ‘Commodities based on Natural and Synthetic Rubber’.

The new BfR Recommendations on natural and synthetic rubbers are three interrelated parts, including those that are intended to come into contact with food. They are:

XXI. Commodities based on natural and synthetic rubber;
XXI/1. Commodities based on natural and synthetic rubber in contact with food; and
XXI/2. Special consumer goods made of natural and synthetic rubber and of latices made of natural and synthetic rubber (formerly special category).

Note: The latest XXI also mentioned a separate Recommendation XXI/3 ‘Consumer goods made of cross-linked thermoplastic’ is in preparation, for food contact thermoplastic elastomers (TPEs) but not published yet.

The significant area of the Recommendations XXI, XXI/1 and XXI/2 are summarized as follow:

1. Recommendations XXI ‘Commodities based on natural and synthetic rubber’
This Recommendation explained the structure and procedures for the inclusion of new substances and the clarification of the related terms on natural and synthetic rubber, as well as giving an Annex of lists the evaluated substances for the manufacture of the products according to Recommendations XXI/1 and XXI/2.

No objections are made from the Recommendation concerning the use of natural and synthetic rubber and their latices for manufacturing of goods, in the sense of German Food and Feed Code (LFGB), provided that the products are suitable for the intended purpose and the requirements in Recommendation XXI/1 and XXI/2 are met.

2. Recommendations XXI/1 ‘Commodities based on natural and synthetic rubber in contact with food’
This recommendation classified commodities made of the natural and synthetic rubber into four categories subject to their contact time (see categories 1 to 3) (refer to Table 1 in Appendix). Category 4 commodities can be waived from migration testing due to their limited contact with the food only at temperatures up to room temperature and only for a very short time and/or only with a very small surface area and cannot be classified in categories 1 to 3.

Addition to the above guidelines, this Recommendation contains several important provisions:
• Testing migration from repeated use commodities
• Migration benchmark "not detectable”
• Migration values for closures (in mg/kg, unless the intended use of item is not known)
• Substances for the manufacture of commodities from natural and synthetic rubber or from the corresponding latices
o Starting materials, solid rubbers, rubber dispersions (lattices) as well as monomers, additives and production aids

The extract from commodities (Categories 1 to 3) must also comply, among all other requirements and specifications, with the following:
• = 10 mg/dm²   - Overall migration
• = 25 mg/kg   - Zinc migration
• = 1 mg/kg   - Aluminum migration
• = 0.01 mg/kg   - Lead migration
• = 1.0 µg/dm²   - N-nitrosamines release in elastomers
• = 0.002 mg/L   - primary aromatic amines (PAAs) classified as carcinogenic
categories 1A and 1B under the Regulation (EC) No 1272/2008
• = 0.01 mg/L   - PAAs (others)
• = 3 mg/L   - Formaldehyde
(Remarks: Antimicrobial effect substances must not be used)

3. Recommendations XXI/2 ‘Special consumer goods made of natural and synthetic rubber and of latices made of natural and synthetic rubber (formerly special category)’
This Recommendation has scope applies to three types of consumer products which come into contact with:
• the human mucous membrane,
• the human mucous membrane and additionally into contact with food,
• come into contact with the human mucosa and are intended as toys for children under 36 months.

Examples of goods include toys intended to be put into mouth or intended for children of age under 36 months, balloons, bottle teats, soothers (dummies), breast caps, teething rings and denture protection products.

This Recommendation includes provisions for migration testing (see Table 2 in Appendix), substances for the manufacture of consumer goods from natural and synthetic rubber (i.e. Starting materials, additives, and production aids). The articles shall also comply, among all other requirements and specifications, with the requirements of commodities (Categories 1 to 3) of XXI/1 with differences of the following:

• = 60 mg/dm²   - Overall migration
• = 10.0 µg/kg   - N-nitrosamines (not detected) for articles other than bottle teats, soothers, balloons and toys for children under 36 months which are intended or foreseeably placed in the mouth
• = 0.1 mg/kg   - N-nitrosatable substances (not detected) for articles
• The release of N-nitrosamines and N-nitrosatable substances from teats is to be tested using DIN EN 12868
• The release of N-nitrosamines and N-nitrosatable substances from toys and balloons is to be tested using DIN EN 71-12 by taking the deviation in Annex C into account
(Remarks: Antimicrobial effect substances must not be used)

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