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Whitepaper: The New Compliance Map for Water-Contact Products

This whitepaper provides an overview of global frameworks and what they mean for water contact product manufacturers seeking to commercialize their products in multiple regions.

Introduction

Global regulations for products and materials in contact with drinking water are in a period of significant change. Compliance roadmaps, supply chains, and product portfolios are all affected. In this white paper we provide a global overview of the regulatory frameworks and market access requirements.

We open with the EU’s updated Drinking Water Directive (DWD 2020/2184) and the introduction of EU-wide minimum hygiene requirements (EU-MHR) and examine what it means for compliance managers.

Section 2 surveys and compares the major regulatory frameworks in force today across North America, the UK, Germany, France, and Asia-Pacific.

We close with key takeaways in section 3, and FAQs for quick reference in section 4.

EU-MHR: What’s changing

In April 2024, the EU updated Directive 2020/2184 on drinking water quality (DWD) with six legal acts (three Implementing Decisions and three Delegated Regulations) that translate Article 11 on minimum hygiene requirements (EU-MHR) for materials and products in contact with water into concrete requirements.

These acts define a common EU-wide framework that includes:

  • A European positive list of authorized starting substances, compositions, and constituents.
  • Recommended early gap analysis using guidance from the European Chemicals Agency (ECHA).
  • Testing plan aligned with the requirements of the directive, which covers ingredients, final materials, ingredient migration, non-intentionally added substances (NIAS) screening, and flavor impact.
  • EU-wide certification with a conformity assessment body.
  • New and generally stricter MHRs including tighter limits on leaching, microbial growth, and sensory impacts.

This change will put an end to decades of fragmentation, with manufacturers needing national approvals (ACS for France, KTW-BWGL for Germany, etc.) for different EU markets.

For new products, the unified standards will apply from January 1, 2027. For existing products that already have national approvals, there will be a six-year transition period until the end of 2032. During this time, these products can continue to be sold and used, unless they undergo significant change (e.g., formulation change, redesign).

Legacy national approvals continue to be valid only in the countries that issued them.

Other frameworks at a glance

Regulatory requirements for water-contact products can vary significantly by market. Here is an overview of the major frameworks across North America, Europe, and Asia-Pacific.

United States and Canada

NSF/ANSI/CAN 61 defines minimum health effects requirements for leachables from materials and products in contact with potable water, such as coatings, joining/sealing materials, pipes/fittings, mechanical devices, and process media. It’s required in nearly all US states and Canadian provinces.

NSF/ANSI/CAN 372 addresses maximum product lead content for “lead-free” (≤0.25% weighted average) established under the US Safe Drinking Water Act. Together, NSF/ANSI/CAN 61 and 372 provide complementary protection: NSF-372 controls what goes into the material, NSF-61 controls what comes out of it into the water.

The Lead and Copper Rule Improvements (LCRI) operate on a parallel track, mandating that utilities replace lead service lines within approximately ten years and lower the action level to 10 ppb by November 2027. As utilities execute these replacement programs, these standards become the specification of choice.

United Kingdom

Regulation 31 of the Water Supply (Water Quality) Regulations establishes the requirements for all chemicals, construction products, and materials used in the treatment and distribution of public drinking water. The regulation applies specifically to the treatment and distribution network owned by water utility companies, covering products such as treatment chemicals, coatings, pipes, linings, sealants, and process technologies. Point-of-use fittings at the delivery point are regulated separately.

The Drinking Water Inspectorate (DWI) operates the approval system on behalf of the national authorities.

This is not to be confused with UK’s Regulation 4, which covers products inside the property boundary.

Germany

The Drinking Water Ordinance (TrinkwV) establishes the legal obligation that materials in contact with drinking water must be safe and delegates to UBA (German Environment Agency) the authority to define what “safe” means in practice.

The technical requirements are established by national regulation KTW-BWGL. It includes positive lists for plastics and organic materials, migration limits, and testing methodologies. In March 2022 it was expanded to include elastomers and thermoplastic elastomers (TPEs), with a transitional compliance period extended until July 1, 2026.

UBA explicitly notes that these national requirements will be replaced in the future by the EU framework.

France

In France, the Attestation de Conformité Sanitaire (ACS) is required for materials and assembled products in contact with drinking water. Unlike Germany’s positive list system, ACS works through laboratory testing and sanitary conformity assessment, conducted by qualified laboratories accredited under the Ministry of Health. Certificates are typically valid for five years.

Comparing frameworks

The three main frameworks share the same goal—ensuring that materials in contact with drinking water do not harm public health—but differ in how they pursue it. Below is a comparison table for quick reference:

DimensionEU-MHRNSF/ANSI/CAN 61KTW-BWGL
Positive Lists and Chemistry Control

Single positive lists for starting substances, compositions, and constituents.

Unified processes to add/amend wentries, detailing testing methodologies, acceptance criteria, scope, and notification requirements.

No positive list system.

Relies on toxicological review and leachate testing against health-based limits.

The leachate testing methodologies are different from EU-MHR.

Maintains positive lists for organic materials, including organoleptic, migration, and microbiological growth considerations.
Scope of Products and Materials

Applies across the full water supply chain.

EU-wide conformity mark and declaration required from January 1, 2027, for new products.

Applies across the full water supply chain.

Evaluates the health effects of unintentionally added chemicals leaching into water.

Covers plastics and organic materials, elastomers and TPEs, including valves, meters, and fittings.
Conformity Assessment and MarkingEU-MHR is an EU law with a prescribed conformity process. Annual audits and surveillance testing through third-party accredited certification bodies are mandatory.

NSF/ANSI/CAN 61 is a consensus standard and certification scheme that many jurisdictions can adopt and require. Annual audits and surveillance testing through third-party accredited certification bodies are mandatory to claim compliance.

Recognized by state/provincial regulators across US and Canada.

Assessment tiered by product risk: for high-contact products (pipes, valves), third-party audit and annual surveillance are required; for lower-risk products, simplified type testing, or self-declaration.
Microbial Growth Control

Explicit hygiene standards aimed at minimizing biofilm support and leachables.

EU-level microbiological requirements, adding a materials chemistry control layer absent from other frameworks.

Does not consider microbial growth or control with the leaching tests.References EN 16421 for microbial growth assessments on organic materials.

Asia-Pacific

In the Asia-Pacific region, each country maintains independent national standards built around its own public-health risk models, testing protocols, and certification schemes.

EU-MHR does not apply directly to any APAC market. However, many APAC regulators respond well to EU-MHR’s level of transparency and data completeness and rely in part on the WHO Guidelines (also a reference for EU-MHR) for national standards. For these reasons, manufacturers are increasingly using EU-MHR as a reference in their global portfolio management and EU-MHR-level documentation (ingredient listings, migration studies, risk assessments) tends to reduce friction in APAC submissions.

Australia and New Zealand

The WaterMark Certification Scheme requires mandatory testing against AS/NZS 4020. From May 1, 2026, all products in contact with drinking water must contain ≤0.25% lead by weight.

Certifications from other jurisdictions (e.g., NSF/ANSI/CAN 372) may be accepted as supporting evidence during WaterMark assessments, but the final determination remains with Australian conformity-assessment bodies.

Japan

Governed by the Waterworks Act, with voluntary material specifications maintained by the Japan Water Works Association (JWWA) and periodically strengthened based on WHO guidance and independent Japanese toxicological reviews. PFOS/PFOA limits were added to statutory standards effective April 2026.

Singapore

PUB (Public Utilities Board) enforces some of the most detailed water-fittings compliance requirements in APAC. No fitting may be supplied or installed without meeting PUB’s Stipulation of Standards and Requirements, with testing by SAC-accredited laboratories.

Hong Kong

Adopts the Hong Kong Drinking Water Standards (HKDWS), based directly on EU and WHO parameters, meaning EU-MHR developments may indirectly influence future HKDWS revisions.

ASEAN (Southeast Asia)

No harmonized regional framework currently exists for this region. Most jurisdictions rely on food-contact-material legislation rather than water-contact-specific rules. Regulatory modernization is underway in several member states, but no direct EU-MHR recognition is anticipated.

Key takeaways

  • The transition window is shorter than it looks. From January 1, 2027, new products in 27 EU Member States must meet EU-MHR requirements. While the transition to 2032 gives manufacturers time to convert their existing portfolios, EU procurement specs will increasingly require EU-MHR conformity and EU marking for post-2026 tenders, making early conversion of high-volume products a commercial priority.
  • Act before the bottleneck. As more manufacturers work on their new EU certifications, laboratories and certification bodies are expected to face significant capacity constraints in 2026-2028. Acting early will make the difference between who gets certified on time and who gets left behind.
  • EU-MHR raises the bar. While EU-MHR promises “test once, sell across the EU,” it also elevates expectations around audits, labeling, documentation, and ingredient control—particularly for elastomers, coatings, and complex assemblies—beyond most current national schemes.
  • NSF/ANSI/CAN 61 and 372 remain non-negotiable in North America. As utilities accelerate the replacement of lead service lines under LCRI, products with strong low-lead credentials and robust NSF certification will increasingly be the specification of choice.
  • Regulation 31, too, is non-negotiable. Regulation in England and Wales requires Regulation 31 approval – and at the time of publishing of this whitepaper, it carries no automatic recognition under EU-MHR.
  • EU-MHR is increasingly relevant in APAC. For manufacturers operating in Asia-Pacific markets, EU-MHR does not apply directly but is increasingly relevant as a reference framework.

Conclusion

The shift to EU-level hygiene rules is the most far-reaching regulatory change for water-contact products in decades.

For global manufacturers, the winners will be those who treat EU-MHR, NSF/ANSI/CAN 61, and UK Regulation 31 as an integrated compliance ecosystem—harmonizing formulations where possible, planning test capacity early, and building documentation that travels across jurisdictions.

The reward goes beyond compliance: speed to market, supply-chain resilience, and sustained confidence from utilities and end users that the materials touching their drinking water are safe by design.

FAQ

Is “EU-MHR” just another name for the EU Drinking Water Directive?

Not exactly. EU-MHR colloquially refers to the minimum hygiene requirements established under Article 11 of the actual EU Drinking Water Directive (DWD) 2020/2184. The DWD is the umbrella law; EU-MHR is the hygiene pillar that affects products and materials.

When will it be mandatory to comply with EU-MHR?

January 1, 2027 for new products placed on the EU market. December 31, 2032 for existing products with national approval (but the latter can only be sold in the country the specification was required for in that timeframe).

Can NSF/ANSI/CAN 61 certification substitute for EU-MHR?

No. It remains vital for North America, but EU-MHR has EU-specific positive lists, test methods, and marking. However, data packages (e.g., leachate analytics) can be leveraged to expedite EU submissions if aligned with EU methods.

How do UK approvals fit?

The UK enforces Regulation 31 as approval for municipal treatment and distribution products. At the time of publishing this whitepaper, there is no known mutual recognition with EU-MHR. For dual-market products, plan for separate product files and documentation.

What role do WHO Guidelines play?

The WHO Guidelines for Drinking-Water Quality provide the scientific foundation that underpins most national standards globally, including the DWD. They establish the risk-based approach to water safety that explains why material hygiene—what products leach into water—matters within the broader picture of safe drinking water supply.

Learn more about municipal water systems and products

Have your municipal water products and systems thoroughly tested and certified. This includes everything from water storage tanks and reservoirs to water meters and individual components.

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