Agencies Regulating Food-Contact Materials

• 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_downFDA

  The Food and Drug Administration of the United States is responsible 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.

  FDA approved food contact materials must meet certain standards regarding composition, additives, and properties. 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

  The United States Department of Agriculture (USDA) has jurisdiction over equipment used in federally inspected meat and poultry processing plants, as well as the packaging materials used for such products.

  Plastic materials used in meat and poultry processing equipment are approved on an individual basis. It is the responsibility of the equipment manufacturer to determine the suitability of each component and the materials from which it is made. On request, Mitsubishi Chemical Advanced Materials will supply a "letter of guarantee" for MCAM products 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

  The Canadian Food Inspection Agency 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. For example, the material Acetron® GP acetal is approved for use in meat and poultry processing applications..

• keyboard_arrow_down3A-Dairy

  3A-Dairy is a voluntary organization that provides standards for the construction of milk, cheese, butter and ice cream processing equipment.

  The organization lays out the requirements for multiple-use, food safe plastic materials used in product contact surfaces in dairy production and processing equipment. The criteria for approval of plastic materials are specified in 3A standard #20. The criteria include cleanability, bacterial treatment, conditions for repeated use, and FDA compliance. Materials are to be tested for compliance by the material supplier. Supporting documentation must be available as required by a food inspector.

• keyboard_arrow_downNSF

  The National Sanitation Foundation (NSF) sets standards for all direct and indirect drinking water additives in the United States. Manufacturers who provide equipment displaying the NSF symbol have applied to the NSF for device approval according to a specific standard. The approval is issued for the finished device in a specific use. To obtain device approval, all components within the device must be compliant. 

  Establishing NSF material compliance for the components of food processing equipment can be accomplished in one of two ways:

  1. The component has been tested to the Standard by the component supplier and is certified as such.
  2. 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 for plastics used in food contact applications. Two NSF standards which we frequently encounter, and with which many of our products are compliant, are:

  1. NSF/ANSI 51 - Plastics in Food Equipment
  2. NSF/ANSI 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 food 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 food grade and medical materials designed for use in Life Science applications. This range is identified as Mitsubishi Chemical Advanced Materials LSG (Life Science Grade). To learn more, download Mitsubishi Chemical Advanced Materials Materials for Life Science Applications.