Loader
Home »   ...  » Support » Regulatory Information

Regulatory Information

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:

  • Handling or working with the materials in a safe manner
  • Contact with Food
    (Regulations (EC) 1935/2004 and (EU) 10/2011, FDA)
  • Restrictions on the use of hazardous substances (RoHS, REACH)
  • Biocompatibility (USP, ISO 10993)

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.
 

E-mail our Regulatory Experts for more Details

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.

Polyethylene Plastic ProductsGeneral Engineering Plastic ProductsAdvanced Engineering Plastic ProductsLife Science GradesFood Grade Products
TIVAR® 1000 naturalErtalon® 6SA naturalKetron® 1000 PEEK natural Acetron® MD Food Grade
TIVAR® 1000 blueErtalon® 66SA naturalKetron® 1000 PEEK black Ertacetal® C Food Grade black 90
TIVAR® 1000 yellowErtalon® 6PLA naturalKetron® TX PEEKDuratron® LSG naturalErtacetal® C Food Grade black
TIVAR® 1000 redErtalon® 6PLA blueTechtron® HPV PPSKetron® CLASSIXTM LSG PEEKErtacetal® C Food Grade blue 50
TIVAR® CestidurNylatron® MDTechtron® 1000 PPSKetron® LSG PEEK blackErtacetal® C Food Grade natural
TIVAR® DS yellowErtacetal® C naturalSultronTM PPSU blackKetron® LSG PEEK Food Grade blackErtacetal® C/3WF Food Grade natural
TIVAR® H.O.T. whiteErtacetal® C blackDuratron® U1000 PEI naturalKetron® LSG PEEK Food Grade naturalErtalon 6® PLA PA6 Food Grade natural
TIVAR® CleanStat blackErtacetal® C black 90SultronTM 1000 PSU naturalKetron® LSG PEEK naturalErtalon 6® SA PA6 Food Grade natural
TIVAR® CleanStat whiteErtacetal® C blue 50Ketron® 1000 PEEK SP naturalAltronTM LSG PC naturalErtalon® 6 PLA PA6 blue
TIVAR® MD blueAcetron® MDFluorosint® 207SultronTM LSG PPSU R5100 black BK937Ertalyte® Food Grade black
TIVAR® 1000 greenErtalyte® naturalFluorosint® HPVSultronTM LSG PPSU R5100 natural NT15Ertalyte® Food Grade natural
TIVAR® Ceram PErtalyte® TXDuratron® U1000 blackSultronTM LSG PPSU R5500 grey GY1037Ertalyte® TX Food Grade
TIVAR® HPVAltronTM 1000 PC naturalKetron® GF30 PEEKProteus® LSG H naturalKetron® 1000 Food Grade black
PE 500 naturalErtacetal® C LQKetron® MD PEEKProteus® LSG HS blackKetron® 1000 Food Grade natural
PE 500 blueErtalyte® black Proteus® LSG HS whiteKetron® LSG PEEK Food Grade black
PE 500 yellowNylatron FST SultronTM LSG PSU naturalKetron® LSG PEEK Food Grade natural
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
    Techtron® HPV Food Grade
    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 Directive 2011/65/EU (RoHS), including Directive (EU) 2015/863

  • RoHS (Restriction of the Use of Certain Hazardous Substances in Electrical or Electronic Equipment)

Polyolefin Products

General Engineering Plastic Products

Advanced Engineering Plastic Products

Mitsubishi Chemical Advanced Materials Products for the Food Contact Market (Food Grade)

Advanced Engineering Plastic SP Products 

 Safety Data Sheets

SDS Number

Product Identification

800Acetron® GP
807

Acetron® GP, Black

808Acetron® Food Grade Blue 50 POM-C
802Acetron® MD POM-C
801Acetron® POM-H
1900Altron® PC
1704Altron® PPO
1706Altron® GFN3-701 PPO
1705Altron® 780 PPO
60Armor-X
36Black Homopolymer Polypropylene
1000Delrin® AF, AF Blend, 588 AF
900Delrin® Products
62Durapro®
1854Duraspin®
1501Duratron® U2100, U2200, U2300 PEI Glass Reinforced
1500Duratron® U1000 PEI, Natural + Black
2655Duratron® 7000, 7015G, 7040G PI
2700Duratron® CU60 PBI
2101Duratron® PPSU
1800Duratron® T4203 PAI 
1802Duratron® T4275 PAI 
1801Duratron® T4301 PAI 
1811Duratron® T4435 PAI 
1810Duratron® T4501 PAI 
1808Duratron® T4503 PAI 
1807Duratron® T4540 PAI 
1803Duratron® T5030 PAI 
1804Duratron® T5530 PAI 
1806Duratron® T7130 PAI 
1809Duratron® T7530 PAI 
500Ertalon® LFX PA
1100Ertalyte® PET-P, Natural and Black
1101Ertalyte® TX PET-P
1400Fluorosint® 207 PTFE
1401Fluorosint® 500 PTFE
1407Fluorosint® HPV PTFE
1603Ketron® CA30 PEEK, Ketron® CM HPV PEEK + Ketron® CM 1030 HT PEEK
1655Ketron® CC LSG PEEK
1601Ketron® CM 1331 HT PEEK
1602Ketron® GF30 PEEK + Ketron® CM GF30 PEEK
1604Ketron® HPV PEEK, Ketron® CM HPV PEEK and Ketron® 1331 PEEK
1600Ketron® 1000 PEEK
1652Ketron® CA30 LSG PEEK
1651Ketron® GF30 LSG PEEK
1653Ketron® LSG PEEK
1654Ketron® CLASSIX LSG PEEK
1606Ketron® XCRD PEEK
19LDPE
702Nylatron® 6XAU PA
101Nylatron® GF30 PA
200Nylatron® GS PA
201Nylatron® GS-HS (heat stabilized) PA
400Nylatron® GSM and GSM-P PA
401Nylatron® GSM, Blue PA
710Nylatron® LIG PA
701Nylatron® MC 703 XL PA
301Nylatron® MC-903 Blue PA
306Nylatron® MC-907 Black PA
307Nylatron® MC-907 Yellow PA
102Nylatron® MD PA
700Nylatron® NSM PA
302Nylatron® MC 907 Natural and Nylatron LFG PA
300Nylatron® MC-901 Blue PA
304Nylatron® MC-904 Blue & Nylatron MC-904-P Blue PA
100Nylatron® 101, 103, 105 PA66
2003Nylatron® PA11 PA
2004Nylatron® PA12 PA
2002Nylatron® PA6/12 PA
23Proteus® White Homopolymer PP
29Proteus® Co-polymer Polypropylene
17Proteus® and Sanalite® Linear High Density Polyethylene 
21Proteus® LF Polypropylene Homopolymer, Semitron® PP Natural 
2800Semitron® CMP LL5
2801Semitron® CMP, XL-20
1409Semitron® CNT POM-C
804Semitron® ESd 225 POM-H
1103Semitron® ESd 300 PET
1502Semitron® ESD 410C PEI
2150Semitron® ESd 420 + Semitron® ESd 420V
1607Semitron® ESd 480 PEEK
1403Semitron® ESd 500
1805Semitron® ESd 520HR PAI
1410Semitron® HPV PEEK
1404Semitron® MDS 100
1405Semitron® MP370
1504Sultron® R5500 XL LSG PPSU
2100Sultron® PSU, Unfilled
1701Techtron® HPV PPS
1700Techtron® PPS
1702Techtron® PPS SM
1703Techtron® PPS Bearing Grade
1605Techtron® PSGF 40 PPS
6TIVAR® 88
32TIVAR® 88 Anti-Static
5TIVAR® 88-2
33TIVAR® 88-2 Anti-Static
2TIVAR® ESD, TIVAR® EC, TIVAR® Black UHMW-PE
47TIVAR® Burnguard UHMW-PE
9TIVAR® Ceram P UHMW-PE
12TIVAR® CleanStat, TIVAR® 1000 FDA Black UHMW-PE
10TIVAR® DrySlide UHMW-PE
41TIVAR® H.O.T. UHMW-PE
66TIVAR® MD UHMW-PE
24TIVAR® Moly-filled UHMW-PE
13TIVAR® Oil Filled UHMW-PE
14TIVAR® Polysteel UHMW-PE
15TIVAR® QuickSilver
42TIVAR® SuperPlus UHMW-PE
4TIVAR® UV-resistant UHMW-PE
34TIVAR® XL UHMW-PE
1TIVAR® 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.

"Food Grade" 

Polyolefin Plastic Products

"Food Grade" 

General Engineering Plastic Products

"Food Grade"

Advanced Engineering Plastic Products

"Food Grade"

Life Science Grade Products

TIVAR® 1000 Food Grade, natural

Ertalon® 6 SA Food Grade, natural

Ketron® 1000 Food Grade PEEK, natural

Ketron® LSG Food Grade PEEK, natural

TIVAR® 1000 Food Grade, blue

Ertalon® 66 SA Food Grade, natural

Ketron® 1000 Food Grade PEEK, black

Ketron® LSG Food Grade PEEK, black

TIVAR® 1000 Food Grade, green

Ertalon® 6 PLA Food Grade, natural

Ketron® TX Food Grade, PEEK

SultronTM LSG Food Grade PPSU, black BK937

TIVAR® 1000 antistatic Food Grade

Ertalon® 6 PLA Food Grade, blueKetron® MD Food Grade, PEEK

TIVAR® Cestidur Food Grade

Nylatron® MD Food Grade

Techtron® HPV PPS Food Grade

 

TIVAR® DS Food Grade, yellow

Ertacetal® C Food Grade, natural

 

 

TIVAR® H.O.T. Food Grade

Ertacetal® C Food Grade, blue 50

 

 

TIVAR® CleanStat Food Grade, black

Ertacetal® C Food Grade, black 90

                         

 

TIVAR® 1000 ASTL Food Grade

Ertacetal® C Food Grade, black

                         

 

TIVAR® 1000 EC Food Grade

Ertacetal® C/3WF Food Grade, natural

                

TIVAR® MD Food Grade

Acetron® MD Food Grade

  

TIVAR® HPV Food Grade

Ertalyte® Food Grade, natural

                        

 

 

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.

  • keyboard_arrow_downFDA

    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).

  • keyboard_arrow_downUSDA

    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.

  • keyboard_arrow_downCanada AG

    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).

  • keyboard_arrow_downEU 10/2011

    Plastic Materials in Compliance with EU Food Regulations

    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.

    Download MCAM's Food Grade Brochure for free!

  • keyboard_arrow_downGMP

    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.

  • keyboard_arrow_down3A-Dairy

    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.

  • keyboard_arrow_downNSF

    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 component has been tested to the Standard by the component supplier and is certified as such.
    • The equipment manufacturer must supply documentation that the component meets the Standard, If any testing is required, it must be completed by the equipment manufacturer.

    The NSF maintains numerous standards. Two standards which we frequently encounter and to which some of our products have been tested are:

    • 51 Plastics in Food Equipment
    • 61 Drinking Water System Components-Health Effects
  • keyboard_arrow_downUL Form 0

    Very similar to NSF STD 51, although requires more direct support from the raw material supplier.

  • keyboard_arrow_downUSP Class VI

    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). 

    LEARN MORE

  • keyboard_arrow_downISO 10993

    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).

Contact