Agency Approvals

At Ticona we are aware  that the compliance of our engineering resins with regulations is fundamental for our customers  . Many of our products and product grades comply with a wide variety of regulations and standards in both Europe and North America. These include requirements for food, drug and potable water contact, medical device applications, automotive and electrical uses, heavy metals content and other criteria. For specific compliance information on any product or grade, please contact Ticona's Product Safety Department. Please find the following list of standards the various grades of our materials comply with. In addition, we provide some links containing further information.

USA

Food and Drug Administration (FDA) - Food, Drug and Medical Devices

• Food contact (including packaging) either under 21 CFR 177 or Food Contact Notifications
• Drug Contact (including packaging) - USP class VI testing; Cytotoxicity, Sensitization, ISO 10993.  Formulation information is stored in Drug Master Files
• Medical Devices - USP class VI testing; Cytotoxicity, Sensitization, ISO 10993; Formulation information is stored in Device Master Files

United States Department of Agriculture (USDA)

• Plastics approved for contact in meat and poultry applications

National Sanitary Foundation (NSF) - Drinking Water and Food Processing Equipment (industrial food production machines)

• Standard 42: Drinking Water Treatment Units - Aesthetic Effects
• Standard 61: Drinking Water Systems Components - Health Effects
• Standard 51: Plastic Material and Components used in Food Equipment

NSF International is an independent, not-for-profit organization committed to public health, safety and protection of the environment by developing standards, by providing education and by providing third-party conformity assessment services while representing the interest of all stakeholders. NSF/ANSI Standard 61 testing can be carried out either by NSF, by Underwriters Laboratories (UL) or IAPMO (International Association of Plumbing and Mechanical Codes).

Assessment of flammability , Electrical data and Temperature Ratings

UL is an independent not-for-profit organization that develops standards, investigates performance, audits ongoing production of materials, devices, products, and equipment, In addition UL inspects construction methods and systems with respect to hazards affecting life and property.

Ticona has obtained "UL Component Recognition" for many product grades. Detailed information on flammability classes of the different grades can be found at UL website.

3A Sanitary Standards

• Standard developed by the Dairy Industry Committee of the US Public Health Service for dairy applications

Military Specifications

• Military Specification MIL-M-24519.

ISO/TS 16949:2002

• ISO/TS 16949 (formerly QS-9000) is an international automotive industry standard harmonizing the quality requirements of Ford, Daimler-Chrysler and General Motors. It includes the total ISO 9001 standard.

CONEG (Coalition of Northeastern Governors = EU Directive 94/62/EG)

This directive requires that total heavy metal (Lead, Cadmium, Mercury and Chromium-VI) concentration does not exceed 100 ppm by weight of the polymer (100 mg / kg polymer).

Canada

Canadian Standards Association (CSA)

• The CSA maintains a full line of standards calling for testing and listing of products sold in Canada.

Europe

Drinking water approvals

• UK: WRAS listing
• Germany: Microbiological testing according to DVGW-standard W 270, KTW testing of major products at standard plates; End-product testing has to be conducted by customer
• France: ACS testing   
• Netherlands: KIWA – Testing

Food contact

• 2004/1935 (Framework Regulation -> replaces EU directive 89/109/EC): European framework regulation for materials in food contact.
• 2002/72/EC. European Directive for plastic materials, positive list of monomers and additives - requires testing of migration at the end product (GM = global migration limit, SML = specific migration limit)
• Germany: BfR (=German Federal Institute for Risk Assessment = formerly known as BgVV and BGA) Recommendations and BGVO: German Implementation of EU Directive 2002/72/EC
• EU-Member states: other national legislation

Pharmaceutical applications and medical devices

Development of special polymer grades – MT-grades (e.g. Hostaform MT8U01), to fulfill the requirements of the pharmaceutical and medical device segment:

• European Pharmacopoeia monographs: GUR complies to respective monographs for polyolefins. For all other Ticona products, no monographs are applicable so far. The monographs can solely be generated by the European pharmacopoeia commission, thus there is no influence to the establishment of further monographs.
• BSE: The product family for medical and pharmaceutical applications are produced using just additives of non-animal origine.
• Biocompatibility has been tested according to ISO 10993 (ISO 10993-5; ISO 10993-6; ISO 10993-10; ISO 10993-12) for selected MT grades.

94/62/EG (=CONEG)

• Same as in the US

Automotive

• ELV- Directive 2000/53/EC (End of Life Vehicle) and its first Amendment 2002/525/EC is regulating heavy metals content
• Listing in IMDS-Database

Electronic and Electrical Applications

• WEEE: EU-Directive 2002/96/EC (WEEE = Waste on Electrical and Electronic Equipment): Regulates recycling quotes and waste stream (e.g. for brominated compounds)
• RoHS : EU-Directive 2002/95/EC (Restriction of Hazardous Substances in electrical and electronic equipment) : heavy metal (lead, cadmium, mercury and chromium), defined polybrominated diphenylethers
• EU-Directive 2003/11/EC: Restriction (ban) of pentabromodiphenylether and octabromodiphenylether (Amendmend of EU directive 76/769/EC)

Toys

• EN 71-3: Restricts heavy metals content.