11 April 2013
Two Rulon® Materials from Saint-Gobain Performance Plastics, Seals Group, Have Been Regulation (EU) No. 10/2011 Certified
Saint-Gobain Seals Group recently certified two material grades, Rulon® 123 and Rulon® 641, for applications with direct food contact. Specific inertia chemical testing was performed according to NF EN 1186-1 test procedure, which meets the requirements of the European Commission Regulation (EU) No. 10/2011 [in regards to Regulation (EC) No 1935/2004] on “plastic materials and articles intended to come into contact with food.”
The Seals Group was also able to confirm that all material components of the substances are identified and listed in the Regulation (EU) No. 10/2011, Appendix 1. Under the conditions of the test (to determine the quantity of components that would migrate and contaminate food), the values obtained for overall migrations met the overall migration limit as specified in the above regulation.
As part of the Seals Group’s polymers product line, the Rulon® brand consists of a family of proprietary, homogeneous materials that are mostly composed of PTFE based resins. Primarily used in mechanical, electrical and chemical applications, Rulon® material withstands a variety of harsh environments such as extreme dryness, cryogenic temperatures, water, steam and hydrocarbon fuel. An example of one of these harsh environments is Mars where Rulon® ball bearings were installed on the NASA rover Curiosity that was launched to Mars in November 2011.
In addition to the recent certification, Rulon® 641 and Rulon® 123 have proven to be compliant for repeated contact with food or drugs for oral consumption under Title 21CFR §177.1550 of the United States Food and Drug Administration (FDA). Two other grades, Rulon® 1439 and Rulon® 1337, complete the FDA compliant materials family for this brand. Furthermore, Rulon® 641 was granted full USP Class VI Certification that complies with stringent disposable and reusable medical device requirements.
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