Conformité à des normes strictes
Les industries pharmaceutiques et agroalimentaires, ainsi que les secteurs de la biotechnologie et des sciences de la vie, posent une multitude de challenges en matière d’étanchéité pour les procédés et les composants sensibles.
Ces applications requièrent des produits d’étanchéité fabriqués avec des matériaux conformes à des normes nationales et internationales.
Conformité à toutes les grandes normes
Les matériaux proposés par Trelleborg Sealing Solutions sont conformes à toutes les grandes normes propres à chaque type de mélange, notamment les règles 21 CFR 177.1550 de la FDA concernant les plastiques fluorocarbonés, les règles 21 CFR 177.2600 de la FDA concernant les élastomères, les règles 3-A, USP Classe VI, NSF et celles relatives à la cytotoxicité (USP 87).
Food Contact Regulations and International Standards
European Union
- Framework Regulation on Materials and Articles intended to come into Contact with Food
Regulation (EC) 1935/2004
General safety requirements for all food contact materials and articles
- Regulation on Good Manufacturing Practice for Materials and Articles intended to come in Contact with Food
Regulation (EC) 2023/2006
Requirements for good manufacturing practice for all food contact materials
- Regulation on Plastics Materials and Articles intended to come in Contact with Food
Regulation (EU) 10/2011
Requirements for plastic materials intended for food contact (e.g. PTFE, UHMWPE)
Germany
Recommendations on Food Contact Materials
- BfR XXI
Requirements for commodities based on natural and synthetic rubber (e.g. NBR, EPDM, FKM)
- BfR XV
Requirements for silicones
France
- Arrrêté du 5 août 2020
Order on rubber materials and articles for food contact - Arrrêté du 25 novembre 1992
Order on silicone elastomers for food contact
Netherlands
- Warenwetregeling verpakkingen en gebruiksartikelen (Regulation on consumer articles coming into contact with foodstuffs)
Chapter 0 - Rules applicable to all packagings and cosnumer articles
Chapter III - Rubber products
United States of America
FDA , CFR Title 21
(Food and Drug Administration, Code of Federal Regulations)
- FDA CFR 21 § 177.2600
Rubber article intended for repeated use - FDA CFR 21 § 177.1550
Perfluorocarbon resins - FDA CFR § 177.1520
Olefin polymers
People´s Republic of China
National Food Safety Standards (Regulations)
- GB 4806.1-2016
General safety requirements for food contact materials and articles - GB 4806.6-2016
Food contact plastic resins - GB 4806.7-2016
Food contact plastic materials and articles - GB 4806.11-2016
Food contact rubber materials and articles - GB 9685-2016
Use of additives in food contact materials and articles
Japan
- Positive List for Food Utensils, Containers and Packaging, Notification 196, 2020
Positive List as Amendment of The Specifications and Standards for Food, Food Additives
(Public Notice of the Ministry of Health, Labor and Welfare No.370) (Promulgated on April 28, 2020)
In scope only plastic materials
3-A Sanitary Standards Inc.
- 3-A® Sanitary Standard for multiple-use rubber, Number 18-03
Material and serviceability requirements of rubber materials intended for multiple use as product contact surfaces in the production of milk and milk products - 3-A® Sanitary Standards for multiple-use plastic materials, Number 20-27
For use on voluntary basis
Hygienic requirements for plastic materials for multiple-use as product contact and/or cleaning contact surfaces in equipment for production of milk and milk products
NSF International Standards
- NSF 51 - Food equipment materials
Purpose of the standard: establish minimum food protection and sanitation requirements for the materials used in the construction of commercial food equipment.