If a flange is installed in a North American drinking water system, the spec sheet is almost certain to reference NSF®/ANSI/CAN 61 before any other standard. NSF/ANSI/CAN 61 determines whether a flange, gasket, or coating is permitted to contact potable water at all. This guide covers what the standard actually regulates, where it originated, what a manufacturer must do to earn certification, how it intersects with lead-content requirements and newer PFAS testing rules, and why it is rarely referenced in isolation.
What NSF/ANSI/CAN 61 Covers
NSF/ANSI/CAN 61: Drinking Water System Components – Health Effects is an American National Standard establishing minimum health-effects requirements for the chemical contaminants and impurities that products, components, and materials might indirectly impart to drinking water. It does not set performance, taste, odor, or microbial growth requirements. focuses specifically on the chemicals and contaminants a material might leach into potable (drinking) water.
Category | Examples |
Protective barrier materials | Cements, paints, coatings |
Joining and sealing materials | Gaskets, adhesives, lubricants |
Mechanical devices | Water meters, valves, filters |
Pipes and related products | Pipes, hoses, fittings, and flanges |
Plumbing devices | Faucets, drinking fountains |
Process media | Filter media, ion exchange resins, nonmetallic potable water materials |
A Brief History of NSF/ANSI/CAN 60 and 61
Before the Standard Existed
Through the 1970s and into the early 1980s, the EPA ran a review program for manufacturers seeking approval for drinking water contact products. That program evaluated material formulations strictly on paper, omitting laboratory product testing and facility inspections. The EPA recognized the gap and, in 1984, issued a request for proposals asking independent nonprofits to build something more rigorous.
First Publication and Accreditation
The Lead-Free Era
Since then, lead reduction has driven much of the standard’s evolution. In December 2008, Annex G was added to NSF-61, establishing a 0.25% weighted-average lead-content methodology. That methodology was spun into its own standard, NSF/ANSI 372, in 2010. The following year, the federal Safe Drinking Water Act formally redefined “lead-free” nationwide using that same 0.25% threshold, with a compliance deadline of January 2014. NSF-61’s own Section 3.5 was updated to mirror that deadline.
Recognition and Recent Updates
In 2019, both standards were recognized as National Standards of Canada, becoming NSF/ANSI/CAN 60 and NSF/ANSI/CAN 61. This is the naming convention still used today. In January 2022, Section 3.6 took effect, requiring lead-content verification testing on nearly every certified product. Most recently, the 2024 edition expanded PFAS testing requirements for fluoropolymer materials, with a compliance deadline running to 2028. Nearly 40 years after its initial publication, the standard continues to evolve as new contaminant risks come into focus.
What Actually Goes Into Certification
- Full disclosure — The manufacturer discloses all product formulations, raw materials, manufacturing aids (such as coolants, lubricants, and wash chemicals), and intended end uses before evaluation begins
- Technical review — NSF’s technical team reviews the submitted formulations, parts list, and process aids to determine the required laboratory testing scope
- Laboratory testing — extensive product testing and material analysis under simulated drinking-water contact conditions
- On-site facility audit — NSF auditor visits/inspects the actual production facility to confirm that shop-floor manufacturing processes, materials, and quality controls are consistent with the submitted documentation
- Ongoing surveillance — certification is maintained through continued audits, not granted once and left alone
How NSF-61 Intersects With EPA PFAS Rules
In April 2024, the EPA finalized its first National Primary Drinking Water Regulation covering six PFAS compounds. NSF-61 was updated the same year with an expanded test battery covering seven compounds: the six regulated by the EPA, plus one additional compound. This testing applies to a specific group of materials, including PTFE, ETFE, PVDF, and fluoroelastomers. Because these fluoropolymers are widely used in gaskets and seals, they often require PFAS evaluation for use in flanged assemblies. PFAS testing applies to the assembly even if the flange bodies used are made of forgings or plate in stainless or carbon steel.
The Certification Process for Flanges
Step | Name | What Happens for a Flange |
1 | Application | The manufacturer applies, identifying the specific flange series, size range, and material grade |
2 | Submission | Alloy composition, manufacturing method, and any gasket or seal materials in the assembly are disclosed in full |
3 | Review | NSF’s technical team reviews the formulation and parts list line by line, confirming alloy grades and identifying what needs testing |
4 | On-Site Audit | An auditor visits the actual foundry, forge, or machine shop and collects or requests representative samples |
5 | Testing | Samples undergo laboratory extraction testing, simulating drinking-water contact under controlled conditions |
6 | Technical Evaluation | Review findings, audit results, and lab data are combined into a single pass/fail determination |
7 | Certification | The NSF mark is granted — then maintained annually through continued audits, not a one-time approval |
Documentation Requirements for Manufacturers
Compliance vs. Certification
NSF-61 and NSF-372: Two Standards, One Certification Path
Why This Matters for API International's CleanLine
API International’s CleanLine covers both the ANSI/ASME and AWWA flange families and are manufactured with 304/304L & 316/316L stainless steel which is sourced domestically to meet AIS/BABA requirements. Every part is evaluated and certified to both NSF-61 and NSF-372 standards. See our official certification listing page for a list of our NSF-61-372 certified products. For a buyer specifying flanges for municipal water systems, a treatment plants, or any potable or clean water application, that means the certification on the spec sheet reflects the full picture: health effects and lead content are both verified by an independent third party, not a manufacturer’s own claim.
Conclusion
NSF/ANSI/CAN 61 is the standard that determines which materials are permitted to contact drinking water. It rarely applies in isolation. Lead content testing under NSF-372, and increasingly PFAS testing on fluoropolymer components, apply alongside it on nearly every certified flange. The standard has been revised and expanded in scope repeatedly since 1988, and that continuity is a primary reason it still carries significant regulatory weight today. Every flange in API International’s CleanLine is built to meet all of these requirements. Explore the comprehensive range of flanges in our online product catalog, or contact us for custom machining on nonstandard sizes and configurations. Get connected with a dedicated sales representative today, or call us at 503.692.3800.



