The products of Mitsubishi Chemical Advanced Materials are commonly used in processing equipment and products which require various types of regulatory compliance, whether it is with respect to specific regulatory requirements or to procedures including:
From the early stages of product development through the industrial manufacture of its stock shapes and finished products, Mitsubishi Chemical Advanced Materials - in close co-operation with its raw material suppliers - routinely checks and works to assure its products meet regulatory requirements as much as possible. In this way, we can offer designers the broadest range of candidate materials.
This table gives the compliance of the raw materials used for the manufacture of the Mitsubishi Chemical Advanced Materials stock shapes with respect to their composition, as set out in the regulations that apply in the United States of America for plastic materials used for the fabrication of finished articles intended to come into contact with foodstuffs.
|Polyolefin Plastic Products||General Engineering Plastic Products||Advanced Engineering Plastic Products||Food Grade Products|
|TIVAR® 1000 natural||Ertalon® 6SA natural||Ketron® 1000 PEEK natural||Acetron® MD Food Grade|
|TIVAR® 1000 blue||Ertalon® 66SA natural||Ketron® 1000 PEEK black||Ertacetal® C Food Grade black 90|
|TIVAR® 1000 yellow||Ertalon® 6PLA natural||Ketron® TX PEEK||Ertacetal® C Food Grade black|
|TIVAR® 1000 red||Ertalon® 6PLA blue||Techtron® HPV PPS||Ertacetal® C Food Grade blue 50|
|TIVAR® Cestidur||Nylatron® MD||Techtron® 1000 PPS||Ertacetal® C Food Grade natural|
|TIVAR® DS yellow||Ertacetal® C natural||SultronTM PPSU black||Ertacetal® C/3WF Food Grade natural|
|TIVAR® H.O.T. white||Ertacetal® C black||Duratron® U1000 PEI natural||Ertalon 6® PLA PA6 Food Grade natural|
|TIVAR® CleanStat black||SultronTM 1000 PSU natural||Ertalon 6® SA PA6 Food Grade natural|
|TIVAR® CleanStat white||Ertacetal® C blue 50||Ketron® 1000 PEEK SP natural||Ertalon® 6 PLA PA6 blue|
|TIVAR® MD blue||Acetron® MD||Fluorosint® 207||Ertalyte® Food Grade black|
|TIVAR® 1000 green||Ertalyte® natural||Fluorosint® HPV||Ertalyte® Food Grade natural|
|Ertalyte® TX||Duratron® U1000 black||Ertalyte® TX Food Grade|
|TIVAR® HPV||AltronTM 1000 PC natural||Ketron® GF30 PEEK||Ketron® 1000 Food Grade black|
|PE 500 natural||Ertacetal® C LQ||Ketron® MD PEEK||Ketron® 1000 Food Grade natural|
|PE 500 blue||Ertalyte® black|
|PE 500 yellow||Nylatron FST|
|PE 500 red||Ketron® MD PEEK Food Grade|
|TIVAR® CleanStat Super||Ketron® TX Food Grade|
|PE 500 green||PE 500 Food Grade blue|
|PE 500 red brown||PE 500 Food Grade green|
|Proteus® H natural||PE 500 Food Grade natural|
|SultronTM PPSU Food Grade black|
|TIVAR® 1000 Food Grade natural|
|TIVAR® 1000 Food Grade blue|
|TIVAR® 1000 Food Grade green|
|TIVAR® MD Food Grade blue|
|TIVAR® Cestidur Food Grade|
|TIVAR® CleanStat Super Food Grade|
|TIVAR® CleanStat Food Grade black|
|TIVAR® DS Food Grade yellow|
|TIVAR® H.O.T. Food Grade white|
|TIVAR® HPV Food Grade|
Statements concerning the European Regulation (EC) No 1907/2006 (REACH)
Safety Data Sheets
Acetron® GP, Black
|808||Acetron® Food Grade Blue 50 POM-C|
|802||Acetron® MD POM-C|
|1706||Altron® GFN3-701 PPO|
|1705||Altron® 780 PPO|
|36||Black Homopolymer Polypropylene|
|1000||Delrin® AF, AF Blend, 588 AF|
|1501||Duratron® U2100, U2200, U2300 PEI Glass Reinforced|
|1500||Duratron® U1000 PEI, Natural + Black|
|2655||Duratron® 7000, 7015G, 7040G PI|
|2700||Duratron® CU60 PBI|
|1800||Duratron® T4203 PAI|
|1802||Duratron® T4275 PAI|
|1801||Duratron® T4301 PAI|
|1811||Duratron® T4435 PAI|
|1810||Duratron® T4501 PAI|
|1808||Duratron® T4503 PAI|
|1807||Duratron® T4540 PAI|
|1803||Duratron® T5030 PAI|
|1804||Duratron® T5530 PAI|
|1806||Duratron® T7130 PAI|
|1809||Duratron® T7530 PAI|
|500||Ertalon® LFX PA|
|1100||Ertalyte® PET-P, Natural and Black|
|1101||Ertalyte® TX PET-P|
|1400||Fluorosint® 207 PTFE|
|1401||Fluorosint® 500 PTFE|
|1407||Fluorosint® HPV PTFE|
|1603||Ketron® CA30 PEEK, Ketron® CM HPV PEEK + Ketron® CM 1030 HT PEEK|
|1655||Ketron® CC LSG PEEK|
|1601||Ketron® CM 1331 HT PEEK|
|1602||Ketron® GF30 PEEK + Ketron® CM GF30 PEEK|
|1604||Ketron® HPV PEEK, Ketron® CM HPV PEEK and Ketron® 1331 PEEK|
|1600||Ketron® 1000 PEEK|
|1606||Ketron® XCRD PEEK|
|702||Nylatron® 6XAU PA|
|101||Nylatron® GF30 PA|
|200||Nylatron® GS PA|
|201||Nylatron® GS-HS (heat stabilized) PA|
|400||Nylatron® GSM and GSM-P PA|
|401||Nylatron® GSM, Blue PA|
|710||Nylatron® LIG PA|
|701||Nylatron® MC 703 XL PA|
|301||Nylatron® MC-903 Blue PA|
|306||Nylatron® MC-907 Black PA|
|307||Nylatron® MC-907 Yellow PA|
|102||Nylatron® MD PA|
|700||Nylatron® NSM PA|
|302||Nylatron® MC 907 Natural and Nylatron LFG PA|
|300||Nylatron® MC-901 Blue PA|
|304||Nylatron® MC-904 Blue & Nylatron MC-904-P Blue PA|
|100||Nylatron® 101, 103, 105 PA66|
|2003||Nylatron® PA11 PA|
|2004||Nylatron® PA12 PA|
|2002||Nylatron® PA6/12 PA|
|23||Proteus® White Homopolymer PP|
|29||Proteus® Co-polymer Polypropylene|
|17||Proteus® and Sanalite® Linear High Density Polyethylene|
|21||Proteus® LF Polypropylene Homopolymer, Semitron® PP Natural|
|2800||Semitron® CMP LL5|
|2801||Semitron® CMP, XL-20|
|1409||Semitron® CNT POM-C|
|804||Semitron® ESd 225 POM-H|
|1103||Semitron® ESd 300 PET|
|1502||Semitron® ESD 410C PEI|
|2150||Semitron® ESd 420 + Semitron® ESd 420V|
|1607||Semitron® ESd 480 PEEK|
|1403||Semitron® ESd 500|
|1805||Semitron® ESd 520HR PAI|
|1410||Semitron® HPV PEEK|
|1404||Semitron® MDS 100|
|1504||Sultron® R5500 XL LSG PPSU|
|2100||Sultron® PSU, Unfilled|
|1701||Techtron® HPV PPS|
|1702||Techtron® PPS SM|
|1703||Techtron® PPS Bearing Grade|
|1605||Techtron® PSGF 40 PPS|
|32||TIVAR® 88 Anti-Static|
|33||TIVAR® 88-2 Anti-Static|
|2||TIVAR® ESD, TIVAR® EC, TIVAR® Black UHMW-PE|
|47||TIVAR® Burnguard UHMW-PE|
|9||TIVAR® Ceram P UHMW-PE|
|12||TIVAR® CleanStat, TIVAR® 1000 FDA Black UHMW-PE|
|10||TIVAR® DrySlide UHMW-PE|
|41||TIVAR® H.O.T. UHMW-PE|
|66||TIVAR® MD UHMW-PE|
|24||TIVAR® Moly-filled UHMW-PE|
|13||TIVAR® Oil Filled UHMW-PE|
|14||TIVAR® Polysteel UHMW-PE|
|42||TIVAR® SuperPlus UHMW-PE|
|4||TIVAR® UV-resistant UHMW-PE|
|34||TIVAR® XL UHMW-PE|
|1||TIVAR® 1000 UHMW-PE|
Declaration of Compliancy
This database includes a copy of the Declarations of Compliance (DOC) for the "Food Grade" engineering plastics marketed by Mitsubishi Chemical Advanced Materials.
Within our portfolio of "Food Grade" engineering plastics, specifically developed for applications in the food processing industries, we offer a wide range of stock shapes for machining with Declaration of Compliance according to Regulations (EC) 1935/2004 and (EU) 10/2011.
Polyolefin Plastic Products
General Engineering Plastic Products
Advanced Engineering Plastic Products
|Ertalon® 6 PLA Food Grade, blue||Ketron® MD Food Grade, PEEK|
|Ertalyte® Food Grade, black|
|Ertalyte® Food Grade, blue 50|
|Ertalyte® TX Food Grade|
Overview of the most common Regulatory Framework
The products of Mitsubishi Chemical Advanced Materials are commonly used in processing equipment and products requiring various types of regulatory agency compliance.
We routinely work with these agencies to assure the widest variety of our products are recognized as being compliant, to give designers the broadest selection of candidate materials.
FDA (Food & Drug Administration) takes responsibility for determining whether and how manufactured materials may be used in contact with food products. Definitions for proper use are found in a series of regulations published annually under Government Regulations CFR 21. The FDA provides certain specifications regarding composition, additives, and properties. A material which meets these standards can then be stated as FDA COMPLIANT. End-users should note that it is their responsibility to use the product in a manner compatible with FDA guidelines. There are also approvals which may comply with the Food Contact Notification (FCN) of the American Food and Drug Administration of effective premarket notifications for Food and Contact Substances (FCS).
USDA (U.S. Department of Agriculture) has jurisdiction over equipment used in federally inspected meat and poultry processing plants, and over packaging materials used for such products. Materials used in this equipment are approved on an individual basis. Determining suitability for use of components and the materials from which they are made is the responsibility of the equipment manufacturer. On request, Mitsubishi Chemical Advanced Materials will supply a "letter of guarantee" for a Mitsubishi Chemical Advanced Materials product listed as USDA compliant. This letter certifies that the material meets applicable FDA criteria. Supporting documentation as may be required by the Food Safety Inspection Service of USDA, is also available.
Food Production and Inspection Branch of the Canadian Government is the Canadian government agency equivalent to the USDA. As with the USDA, plastic materials are approved per material for a group of related applications, such as Acetron® GP acetal (material) for meat and poultry processing (application).
Regulation (EU) 10/2011 enables production safety
Historically, plastics used in food contact applications in the EU were regulated by the Directive 2002/72/EC. To better monitor food production processes for the future, the European Union replaced and revised this directive in May 2011 with the Regulation (EU) 10/2011. These regulations include much stricter conditions for migration testing and apply to all member states of the European Union.
Every order of an MCAM product comes with a Declaration of Compliance
At Mitsubishi Chemical Advanced Materials, we thoroughly test and document each production step. When you order food safe materials from MCAM, every product delivery is accompanied by a Declaration of Compliance (DoC) with EU 10/2011. The DoC ensures the uninterrupted traceability of the plastic product, from the finished stock shape all the way to the unique batch of raw materials.
This traceability is required by law for modern food processing. Each product is marked with the material type, production lot and size. Each DoC is prepared according to material test reporting norms as defined by DIN EN 10204-2.1.
Mitsubishi Chemical advanced Materials produces semifinished stock shapes and manufactures customized finished parts according to the guidelines of Good Manufacturing Practice. The GMP guidelines are part of a quality system covering the manufacture and testing of food products.
Our adherence to GMP guidelines guarantees ensures that our food grade plastics are subject to the highest quality assurance standards. Complete documentation, from the choice of raw material to the finished parts, allows full traceability and supports our customers in their own product control efforts.
3A-Dairy is a voluntary organization that provides standards of construction for milk, cheese, butter and ice cream processing equipment.
The organization covers the requirements of plastic materials for multiple-use as product contact surfaces in equipment for production, processing, and handling of milk and milk products. The criteria for approval of plastic materials are specified in 3A standard 20 latest revision, and include: cleanability, bacterial treatment, repeat use conditions, and FDA compliance. Materials are tested for compliance by the material supplier. Supporting documentation must be available as required by a food inspector.
NSF (National Sanitation Foundation) sets standards for all direct and indirect drinking water additives. Manufacturers who provide equipment displaying the NSF symbol have applied to the NSF for device approval to a specific standard. The approval is issued for the finished product (device) in a specific use (application). To obtain device approval, all components within the device must comply with the Standard. Establishing compliance of the equipment's components can be accomplished in one of two ways:
The NSF maintains numerous standards. Two standards which we frequently encounter and to which some of our products have been tested are:
Very similar to NSF STD 51, although requires more direct support from the raw material supplier.
USP (U.S. Pharmacopoeia) Class VI judges the suitability of plastic material intended for use as containers or accessories for parenteral preparations. Suitability under USP Class VI is typically a base requirement for medical device manufacturers. Mitsubishi Chemical Advanced Materials manufactures a range of materials designed for use in Life Science applications. This range is identified as Mitsubishi Chemical Advanced Materials LSG (Life Science Grade).
ISO 10993 is a set of standards for the evaluation the biocompatibility and biological risk of medical devices.
Mitsubishi Chemical Advanced Materials manufactures a range of materials designed for use in Life Science applications. This range is identified as Mitsubishi Chemical Advanced Materials LSG (Life Science Grade).