Prepare Products, Materials & Treatment Chemicals for Harmonised EU Drinking Water Requirements

Manufacturers supplying the European drinking water sector are entering a new regulatory environment.

The recast EU Drinking Water Directive introduces harmonised requirements for materials and products that come into contact with drinking water, alongside minimum requirements for treatment chemicals and filter media.

For many businesses, this represents a significant shift away from relying solely on national approval schemes towards demonstrating compliance with a common EU framework.

Blue Frog Scientific can help you determine which requirements apply, assess your existing products and formulations, identify evidence or testing gaps, and develop a proportionate route to compliance.

 

New Regulatory Framework for Drinking Water Contact Materials

Article 11 of Directive (EU) 2020/2184 establishes minimum hygiene requirements for materials that come into contact with water intended for human consumption.

A package of implementing and delegated acts now provides the supporting framework for:

  • European Positive Lists
  • Assessment of Starting Substances, Compositions & Constituents
  • Testing & Acceptance of Final Materials
  • Migration & Microbiological Testing
  • Conformity Assessment
  • EU Declarations of Conformity
  • Harmonised Product Marking

The principal requirements begin to apply from 31 December 2026, although transitional arrangements may apply to some products holding valid national conformity certificates.

Preparing early can help manufacturers identify non-compliant constituents, plan necessary testing, protect strategically important formulations and avoid disruption to European market access.

 

Does the Drinking Water Directive Apply to Your Products?

The requirements may be relevant to manufacturers and suppliers of:

  • Pipes & Fittings
  • Valves & Taps
  • Seals, Gaskets & Elastomers
  • Coatings & Linings
  • Tanks & Storage Systems
  • Pumps & Associated Components
  • Membranes & Filtration Systems
  • Filter Media
  • Water Treatment Chemicals
  • Disinfectants & Process Additives
  • Assembled Products Containing Multiple Water-Contact Components

Applicability depends on the product, its materials, its intended use and how it comes into contact with water intended for human consumption.

Blue Frog can review your product portfolio and establish whether Article 11, Article 12 or other associated regulatory requirements apply.

 

Ensuring Compliance with EU Drinking Water Directive 

Regulatory Applicability & Compliance Strategy

Understanding the applicable pathway is the essential first step.

We can assess your products, materials and intended uses to determine:

  • whether a product falls within Article 11 or Article 12
  • which implementing or delegated acts apply
  • whether European Positive List requirements are relevant
  • which material category and testing requirements apply
  • whether transitional provisions may be available
  • what technical evidence will be required
  • which products should be prioritised

We'll provide you with a practical regulatory strategy, setting out the applicable requirements, identified risks and recommended route to compliance.

 

European Positive List Assessment

Commission Implementing Decision (EU) 2024/367 establishes European Positive Lists of starting substances, compositions and constituents authorised for use in materials and products that come into contact with drinking water.

Blue Frog Scientific can review your formulations and material compositions against the relevant lists, including:

  • preparation of a substance and constituent inventory
  • verification of substance identity
  • identification of non-listed constituents
  • assessment of applicable restrictions and specifications
  • review of migration limits and other acceptance criteria
  • evaluation of impurities and reaction products
  • identification of confidential or unavailable formulation information
  • gap analysis and recommended next steps

This assessment can help determine whether an existing formulation remains suitable, requires additional evidence or may need to be reformulated.

 

Positive List Submission & Substance Eligibility Support

Where a strategically important substance, composition or constituent is not included on the relevant European Positive List, further assessment or submission activity may be required.

  • Substance Eligibility Assessments
  • Dossier & Submission Planning
  • Toxicological Data Evaluation
  • Systematic Literature Reviews
  • Data-Gap Analysis
  • Read-Across & Weight-of-Evidence (WoE) Strategies
  • Assessment of Impurities & Reaction Products
  • Development of Testing Proposals
  • Preparation of Scientific Justifications
  • Compilation of Submission Documentation

Our objective is to develop a scientifically robust and proportionate evidence package while avoiding unnecessary testing wherever suitable existing information can be used.

 

Toxicological Risk Assessment

Compliance decisions may depend on understanding whether substances; migrating from a material or remaining after water treatment, could present a risk to human health.

Our toxicologists can prepare assessments covering:

  • Hazard Identification & Characterisation
  • Evaluation of Repeated-Dose, Genotoxicity, Reproductive & Developmental Endpoints
  • Derivation of Acceptable Exposure Levels
  • Assessment of Impurities & Residual Monomers
  • Evaluation of Degradation & Transformation Products
  • Read-Across & Category Approaches
  • Interpretation of Migration Concentrations
  • Assessment of Unexpected Substances
  • Comparison Against Applicable Migration or Exposure Limits
  • Preparation of Scientific Rationales & Regulatory Conclusions

This combines Blue Frog Scientific’s established toxicology expertise with a detailed understanding of chemical regulatory requirements.

 

Migration, Leaching & Testing Strategies

The harmonised framework introduces procedures for testing and accepting final organic, metallic, cementitious, enamel, ceramic and other inorganic materials.

Depending on the material and product category, the assessment may need to consider migration, unexpected substances, organoleptic effects and enhancement of microbial growth.

Blue Frog can help you develop and interpret testing programmes.

  • Formulation Review
  • Extractables & Leachables
  • Migration Testing
  • Migration Modelling
  • Total Organic Carbon
  • Unexpected Substance Screening
  • Impurity Profiling
  • Odour, Flavour, Colour & Turbidity
  • Enhancement of Microbial Growth
  • Chemical Characterisation
  • Toxicological Testing
  • Analytical Method Requirements

We can help define a proportionate programme, prepare laboratory briefs, liaise with suitably qualified testing organisations and interpret the resulting data within the regulatory framework.

 

Drinking Water Treatment Chemicals & Filter Media

Article 12 establishes minimum requirements for treatment chemicals and filter media that come into contact with drinking water.

They must not compromise human health, adversely affect the colour, odour or taste of the water, unintentionally enhance microbial growth or contaminate the water at levels higher than necessary for their intended purpose. Their purity and quality must also be appropriately assessed and controlled.

Our expert consultants can assess:

  • Active or Functional Constituents
  • Substance Identity & Technical Specifications
  • Manufacturing Impurities
  • Residual Monomers
  • Reaction & Transformation Products
  • Degradation Products
  • Treatment By-Products
  • Residual Concentrations Following Use
  • Proposed Conditions & Levels of Use
  • Toxicological Relevance
  • Alignment with Applicable European Standards
  • Interactions with Biocidal Product Requirements

This support is relevant to manufacturers of disinfectants, coagulants, flocculants, pH-control chemicals, ion-exchange materials, activated media and other products used in drinking water treatment.

 

Conformity Assessment & Technical Documentation

Commission Delegated Regulation (EU) 2024/370 introduces conformity assessment procedures for products that come into contact with drinking water and requirements for the bodies involved in those procedures.

Blue Frog can support manufacturers preparing for conformity assessment.

  • Identification of the Applicable Assessment Procedure
  • Technical Documentation Planning
  • Evidence Compilation
  • Review of Product & Material Specifications
  • Assessment of Formulation & Manufacturing Information
  • Preparation of Scientific Summaries
  • Review of Test Reports & Certificates
  • Gap Analysis Against Conformity Requirements
  • Liaison with Laboratories & Conformity Assessment Bodies
  • Support with EU Declarations of Conformity
  • Review of Marking & Product Information Requirements

By identifying documentation and evidence gaps early, manufacturers can reduce the risk of delays during formal conformity assessment.

 

Regulatory Due Diligence & Portfolio Reviews

The introduction of harmonised requirements may affect individual products, complete product ranges or the regulatory value of an acquisition target.

We provide comprehensive regulatory due-diligence support.

  • Portfolio-Level Applicability Screening
  • Formulation & Material Reviews
  • Assessment of Existing National Approvals
  • European Positive List Checks
  • Review of aAvailable Testing & Technical Evidence
  • Identification of Data Ownership or Access Issues
  • Regulatory Risk Registers
  • Prioritisation of High-Risk or High-Value Products
  • Estimated Compliance Activities & Dependencies
  • Development of a Phased Compliance Roadmap

This service can support acquisitions, product launches, supplier qualification exercises and strategic portfolio decisions.

 

Ongoing Regulatory Stewardship

Drinking water compliance is not necessarily a one-off exercise.

Formulation changes, new suppliers, updated Positive Lists, revised technical specifications and changes to manufacturing processes can all affect the compliance position of a product.

Blue Frog can provide ongoing regulatory support to ensure compliance with the EU Drinking Water Directive.

  • Monitoring of Relevant Regulatory Developments
  • European Positive List Updates
  • Impact Assessments
  • Formulation & Supplier Change Control
  • Review of New Impurities or Analytical Findings
  • Maintenance of Technical Documentation
  • Regulatory Notifications & Submission Support
  • Portfolio Compliance Tracking
  • Strategic Regulatory Advice

Support can be provided for individual projects or through an ongoing regulatory stewardship arrangement.

 

Integrated Regulatory & Scientific Expertise

Drinking water contact compliance sits at the intersection of materials regulation, chemical assessment, toxicology, analytical science and product conformity.

Blue Frog combines deep expertise across a number of regulatory specialisms and scientific disciplines.

This broad range of expertise allows us to look beyond a simple checklist and develop a compliance strategy that reflects the composition, use, risk profile and commercial significance of your products.

 

Proportionate, Commercially Focused Regulatory Support

Our approach is designed to answer the questions that are commercially important.

  • Does the legislation apply?
  • Can the existing formulation remain on the market?
  • Is further testing genuinely necessary?
  • Can existing data or read-across be used?
  • Which products present the greatest regulatory risk?
  • What needs to be completed before the new requirements apply?
  • How can compliance be maintained when products or suppliers change?

The result is a clear, evidence-based route forward rather than an open-ended regulatory exercise.

 

Start Preparing for the EU Drinking Water Requirements

The transition to harmonised EU requirements creates both regulatory risk and an opportunity to establish a stronger, more consistent route to the European market.

Whether you need an initial applicability assessment, a review of your formulations, support with migration testing or a complete compliance programme, Blue Frog are ready to help.

Call or email and speak directly with one of our expert consultants to discuss your products and their Drinking Water Directive compliance requirements.

 

Regulatory Specialisms

Regulatory Specialists

Blue Frog - Damien Carson

Damien Carson

Co-CEO I Chemicals & Biocides