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Regulatory Information

The products of Mitsubishi Chemical Advanced Materials are commonly used in processing equipment and products requiring various types of regulatory compliance, whether it is with respect to specific regulatory requirements or to procedures for

  • handling or working with the materials in a safe manner (Product Handling Information Sheets)
  • contact with food or drinking water (Regulations (EC) 1935/2004 and (EU) 10/2011, FDA, WRAS, KTW, ACS, ...)
  • restrictions on the use of hazardous substances (RoHS, REACH, GADSL, customer lists, ...)
  • 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.

Polyolefin Plastic ProductsGeneral Engineering Plastic ProductsAdvanced Engineering Plastic ProductsFood Grade Products
TIVAR® 1000 naturalErtalon® 6SA naturalKetron® 1000 PEEK naturalAcetron® MD Food Grade
TIVAR® 1000 blueErtalon® 66SA naturalKetron® 1000 PEEK blackErtacetal® C Food Grade black 90
TIVAR® 1000 yellowErtalon® 6PLA naturalKetron® TX PEEKErtacetal® C Food Grade black
TIVAR® 1000 redErtalon® 6PLA blueTechtron® HPV PPSErtacetal® C Food Grade blue 50
TIVAR® CestidurNylatron® MDTechtron® 1000 PPSErtacetal® C Food Grade natural
TIVAR® DS yellowErtacetal® C naturalSultronTM PPSU blackErtacetal® C/3WF Food Grade natural
TIVAR® H.O.T. whiteErtacetal® C blackDuratron® U1000 PEI naturalErtalon 6® PLA PA6 Food Grade natural
TIVAR® CleanStat black SultronTM 1000 PSU naturalErtalon 6® SA PA6 Food Grade natural
TIVAR® CleanStat whiteErtacetal® C blue 50Ketron® 1000 PEEK SP naturalErtalon® 6 PLA PA6 blue
TIVAR® MD blueAcetron® MDFluorosint® 207Ertalyte® Food Grade black
TIVAR® 1000 greenErtalyte® naturalFluorosint® HPVErtalyte® Food Grade natural
TIVAR® Ceram PErtalyte® TXDuratron® U1000 blackErtalyte® TX Food Grade
TIVAR® HPVAltronTM 1000 PC naturalKetron® MD PEEKKetron® 1000 Food Grade black
PE 500 naturalErtacetal® C LQKetron® GF30 PEEKKetron® 1000 Food Grade natural
PE 500 blueErtalyte® black  
PE 500 yellowNylatron FST  
Proteus® H natural  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
   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)

Polyethylene 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 

Statements concerning the European Regulation (EC) No 1907/2006 (REACH)

  • In the view of the latest update of the ECHA Candidate List of Substances of Very High Concern (SVHC)

Borotron® Products

Polyethylene Products

General Engineering Plastic Products

Advanced Engineering Plastic Products

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

MediTECH® Products

Product Handling Information Sheet

This database includes the Product Handling Information Sheets (PHIS) for the engineering plastics marketed by Mitsubishi Chemical Advanced Materials EPP.

According to the “REACH” Regulation (EC) No 1907/2006 of the European Parliament and of the Council dated 18 December 2006, a Safety Data Sheet shall be provided by the supplier of a substance or a preparation to the recipient of the substance or preparation (as stipulated in article 31 of the said regulation). Our semi-finished and finished products, however, are under REACH not considered as substances or preparations but as “articles” for which a Safety Data Sheet is not required. However, as a basic rule we want to continue supplying our customers with adequate information on the handling of our semi-finished and finished products and have therefore developed ‘Product Handling Information Sheets’ (PHIS) for our different materials.

Polyethylene Plastic ProductsGeneral Engineering Plastic ProductsAdvanced Engineering Plastic Products

TIVAR® DrySlide

Ertalon® 6 SA

Duratron® CU60 PBI

TIVAR® TECH

Ertalon® 66 SA

Duratron® D7000 PI

TIVAR® Cestidur

Ertalon® 4.6

Duratron® D7015G PI

TIVAR® DS

Ertalon® 66 GF30

Duratron® T4203 PAI

TIVAR® Ceram P

Ertalon® 6 PLA

Duratron® T4301 PAI

TIVAR® SuperPlus

Ertalon® 6 XAU+

Duratron® T4501 PAI

TIVAR® H.O.T.

Ertalon® LFX

Duratron® T4503 PAI

TIVAR® Burnguard

Nylatron® MC 901

Duratron® T5530 PAI

TIVAR® CleanStat black

Nylatron® GSM

Ketron® 1000 PEEK

TIVAR® 1000 ASTL

Nylatron® GS

Ketron® HPV PEEK

TIVAR® 1000 EC

Nylatron® SLG PA6

Ketron® GF30 PEEK

TIVAR® MD

Nylatron® NSM

Ketron® CA30 PEEK

TIVAR® Oil Filled

Nylatron® 703 XL

Ketron® TX PEEK

TIVAR® SurfaceProtect

Ertacetal® C

Techtron® PPS

TIVAR® ChainLine

Ertacetal® H

Techtron® HPV PPS

TIVAR® Cestigreen

Ertacetal® H-TF

 SultronTM PPSU

TIVAR® XtendedWear

Ertacetal® C ELS

Duratron® U1000 PEI

TIVAR® HPV

Acetron MD®

SultronTM PSU 1000

Borotron® UH015

Ertalyte®

Fluorosint® 207

Borotron® UH030

Ertalyte® TX

Fluorosint® 500

Borotron® UH050

AltronTM PC 1000

Fluorosint® HPV

Borotron® HM015

 

Ertacetal® C LQ

Fluorosint® MT-01

Borotron® HM030

Ertalyte® SLP

Semitron® ESd 225

Borotron® HM050

Nylatron® 66 SA FR

Semitron® ESd 410C

TIVAR® 1000

 

Nylatron® 66 SA FST

Semitron® ESd 500HR

TIVAR® 1000 antistatic

Nylatron® MD light blue

Semitron® ESd 520HR

TIVAR® ECO greenNylatron® GSM 30PKetron® HT PEEK
TIVAR® ECO black antistaticFlexxtronTM TPE 1055Ketron® MD PEEK

PE 500

 Techtron® 1000 PPS

TIVAR® 88

 Semitron® ESd 420
TIVAR® BlueLine Semitron® HPV

QuickSilver®

  

DURAPRO™

  

RCH 500

  

RCH 1000

  

TIVAR® Cleanstat white

  

TIVAR® ICE


TIVAR® 88 ESd


Proteus® H


TIVAR® VisiLiner

Please consult us for more information.

  

Declarations of Compliance

This database includes a copy of the Declarations of Compliance (DOC) for the "Food Grade" engineering plastics marketed by Mitsubishi Chemical Advanced Materials EPP.

Within its portfolio of "Food Grade" engineering plastics, specifically developed for applications in the food processing industries, Mitsubishi Chemical Advanced Materials offers 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

TIVAR® 1000 Food Grade natural

Ertalon® 6 SA Food Grade natural

Ketron® 1000 Food Grade PEEK natural

TIVAR® 1000 Food Grade blue

Ertalon® 66 SA Food Grade natural

Ketron® 1000 Food Grade PEEK black

TIVAR® 1000 Food Grade green

Ertalon® 6 PLA Food Grade natural

Ketron® TX Food Grade PEEK

TIVAR® 1000 Food Grade antistatic

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

TIVAR® Cestidur Food Grade 

Nylatron® MD Food Grade

Techtron® HPV
Food Grade PPS

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® Food Grade C/3WF natural

               

TIVAR® MD Food Grade 

Acetron® MD Food Grade

 

TIVAR® HPV Food Grade

Ertalyte® Food Grade natural

                        

PE 500 Food Grade natural

Ertalyte® Food Grade black

                       

PE 500 Food Grade blue

Ertalyte® Food Grade blue 50 

PE 500 Food Grade green

Ertalyte® TX Food Grade

                           

TIVAR® Ceram P UHMW-PE Food Grade, green  
TIVAR® 1000 UHMW-PE Food Grade, black  
PE 500 HMW-PE Food Grade, black  

 

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).

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