Regulatory information

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.

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 a Food Grade product from Mitsubishi Chemical Group - Advanced Materials Division comes with a Declaration of Compliance

At Mitsubishi Chemical Group, 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 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

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).