認可について

規格に準拠した幅広い材料

重要な製造システムに適用される規制
製薬、食品、飲料業界、あるいはバイオテクノロジー、ライフサイエンス分野は、 重要なプロセスや構成部品で多くの高機能シールを必要としており、様々な国内・ 国際認可や規格に準拠した様々な材料から製造されたシール製品が求められます。

すべての主要規格に適合
トレルボルグ シーリング ソリューションズの材料は、 あらゆる種類のコンパウンドに利用でき、 かつすべての主要規格｛フッ素樹脂に関するFDA 21 CFR 177.1550 エラストマーに関する FDA 21 CFR 177.2600 , 3-A, USP クラスVI, NSF, 細胞毒性規制(USP 87)など｝に適しています。

動物由来成分を含まない
動物由来成分（Animal Derived Ingredients、ADI)は、BSEなどの発祥原因 になる危険があるため、人間が摂取する製品の生産用途では使用できません。 シール材料の成分や加工助剤にADIが含まれる場合がありますが、 トレルボルグ シーリング ソリューションズでは、幅広い材料ラインアップ全てを調査し、 現在では、ADIゼロ製品・材料を提供する事ができます。

In the groove

Read the latest news on FoodPro® materials compliant with food contact regulations

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 

BfR (Federal Institute for Risk Assessment)
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.