Additional FILMTEC Membranes Regulatory Information

NSF / ANSI Standard 61

Drinking Water System Components - Health Effects is the nationally recognized health effects standard for all devices, components and materials, which contact drinking water.  It addresses crucial aspects of drinking water system components: whether contaminants that leach or migrate from the product / material into the drinking water are above acceptable levels in finished waters.  Membrane elements are considered mechanical devices under NSF / ANSI Standard 61.  Certification is granted through a testing program developed by NSF consisting of a series of ANSI testing protocols and audits of production facilities.  NSF / ANSI Standard 61 certified FILMTEC™ membrane elements comply with the requirements for the control of potential adverse human health effects from product added to drinking water directly for treatment or indirectly during storage, transmission or treatment. 

A growing number of municipalities are beginning to require a NSF / ANSI Standard 61 Listing as a requirement to sell or build RO membrane systems.  It assures our customers that our membrane elements meet the regulatory requirements.

NSF / ANSI Standard 58

Drinking Water Treatment Product and Related Components and Materials establishes minimum health effects requirements for the chemical contaminants and impurities that are indirectly imparted to drinking water from materials used in drinking water systems.  This standard applies to point-of-use and point-of-entry devices designed to reduce specific contaminants from public or private drinking water.

It provides our customers a sense of assurance that FILMTEC home drinking water elements fully meet the requirements of the NSF / ANSI 58 Standard.

In addition to NSF / ANSI 58 Component Certification, FILMTEC home drinking water elements also have been performance-tested for the reduction of Arsenic, Barium, Cadmium, Chromium (Hexavalent), Chromium (Trivalent), Copper, Cysts, Turbidity, Fluoride, Lead, Radium 226 / 228, Selenium TDS. The test data results may be transferred to third party systems, if the systems meet the requirements contained on the document entitled, "Transfer of Performance Claims for FilmTec Reverse Osmosis Elements", dated 2/20/2003.

FDA 21 CFR 177.2550

It applies to reverse osmosis membranes.  FDA (Food and Drug Administration), located in Washington D.C., is a government regulatory body that regulates food additive components for consumer health. Stated most simply, FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Their work is a blending of law and science aimed at protecting consumers. One reads the 21 CFR 177-2550 as thus: title 21, part 177, section 2550. Section 177 deals with indirect food additives as they relate to polymers. One always states the RO membranes are compliant to this standard and never certified to this standard.

FDA 21 CFR 177-2550 is the FDA standard for reverse osmosis membranes. Extractives testing is required and defined in the code, subsection c. Total extractables must be less than 1 ppm. Time may take 3 to 6 months and costs for compliance testing is minimal. Compliance claims to this standard are self claimed and the liability falls with the company. Compliance is determined by regulatory expertise that resides within Dow. Testing facilities exist in the US and Europe. Regulatory expertise is located in Midland. All material changes may initiate complete or partial re-examination to meeting the standard.

KIWA Certification for Potable Water

The Assessment on Toxicological Aspects (ATA) offers manufacturers active in the potable water sector the possibility to declare that their materials comply with the criteria relevant to this sector. These criteria have been established by the Dutch Chief Inspectorate of Public Health and Evironmental Protection and are binding.

The approval procedure requires complete chemical characterization of the membrane / RO element followed by evaluation by W4 resulting in a set of migration tests to verify if the product meets the requirements. If the chemical characterization and the migration tests are showing that the product meets the requirements, advise by Expert Group to Minister followed by KIWA audit at the production site. Certification issued and yearly inspection at production site with migration tests on random picked element.