Comprehensive Analysis of the Scope and Regulatory Framework for Substances of Directive (EU) 2020/2184

Directive (EU) 2020/2184 introduces a major reform of the public health protection framework for water intended for human consumption. Article 11 constitutes the central pillar of the minimum hygiene requirements applicable to materials in contact with water, with the aim of ensuring that such materials do not compromise human health, do not adversely affect the organoleptic properties of water (in particular its taste, odour or colour) and do not promote microbial growth.

1. The technical and geographical scope

The scope of Article 11 is defined very broadly in order to cover the entire supply chain, from water abstraction through to the final consumer.

The Directive applies to materials used in new installations, as well as to those used in the repair or reconstruction of existing installations. It therefore covers all materials involved in the abstraction, treatment, storage and distribution of water up to the point of compliance, namely the user’s tap.

Two major exclusions should, however, be highlighted. First, natural mineral waters and waters classified as medicinal products do not fall within this framework. Second, the substances covered by Article 12, such as treatment chemicals (including coagulants and disinfectants) and filter media (including ion-exchange resins, filtration membranes or sacrificial anodes) are not included in the positive lists of materials, or EUropean Positive Lists, managed by ECHA under Article 11.

2. Typology of regulated substances and compositions

The Directive distinguishes between substances according to the physico-chemical nature of the final material.

Starting substances are any substances intentionally added for the production of organic materials, such as plastics, rubbers, silicones or adhesives, as well as to produce admixtures intended for cementitious materials.

Organic cement constituents refer to the specific organic molecules used in the manufacture of cement-based materials, for example grinding aids or admixtures.

Finally, the term compositions applies to metallic materials, enamels, ceramics and other inorganic materials. In this case, it is not an isolated substance that is included on the positive list, but rather the overall chemical formulation of the material.

3. The hierarchy of technical functions (Level 1 and Level 2)

ECHA requires applicants to define the technical function of their substance at two levels in order to structure the EUPL.

• Level 1 (Generic): This is the category of legal approval. For organic materials, the applicant must choose between: monomer or other reactant, additive, polymer production aid, polymerisation aid, or other. For cement, the functions include admixture, release agent or curing compound. This function will appear on the positive list and constitutes a condition of use.

• Level 2 (Specific): This level describes the precise role of the substance. For example, under “production aid”, one may find solvents, anti-foaming agents or surfactants. This level is crucial for the scientific risk assessment conducted by the Committee for Risk Assessment, RAC, as it makes it possible to anticipate the formation of reaction by-products.

4. The status of additives and process aids

   
   

A frequent source of confusion concerns substances used during manufacturing that are not necessarily intended to remain in the finished product. The Directive clarifies their status by adopting the intentionality of the addition as the main criterion.

• Additives: These are added in order to achieve a physical or chemical effect during processing or in the final material. Examples may include antioxidants, plasticisers or colourants. Since they are intended to be present in the finished product, they must be included on the EUPL.

• Aids to polymerisation: These substances are used to initiate or control the formation of the polymer structure, without themselves becoming structural units of that structure. Catalysts and initiators are typical examples. Although they may be absent from the final product, their intentional addition qualifies them as starting substances subject to approval.

• Polymer production aids: These, in turn, are used to provide an appropriate medium for manufacturing. They are not intended to exert an effect in the final material, but they nevertheless remain within the scope of application insofar as they are intentionally involved in the manufacturing process.

5. The specific case of solvents and volatile agents

Solvents used for evaporation during the processing are classified as polymer production aids. Whether they need to be included on the EUPL depends on the migration threshold rule of 0.1 µg/l.

Accordingly, where a manufacturer can demonstrate that there is no possibility that the solvent, or its reaction products, may be present above 0.1 µg/l at the tap (that is, at the level of Ctap, i.e. the concentration at the tap) inclusion on the positive list is not mandatory for organic and cementitious materials.

However, this exemption is subject to significant limitations. It cannot be relied upon where:

1. the substance is a monomer or a main reactant; 

2. the substance has a toxicity profile that justifies a stricter limit, for example genotoxic substances;

3. the substance is classified as CMR, categories 1A or 1B, as a category 1 endocrine disruptor, or has PBT, vPvB, PMT or vPvM properties. In such cases, inclusion is mandatory even where migration is negligible, and concentration restrictions in the final material apply, often below 0.1% or 0.02%.

6. Impurities and Non-Intentionally Added Species (NIAS)

Although Article 11 focuses primarily on intentionally added substances, the safety assessment must also cover impurities and non-intentionally added species, or NIAS.

Impurities are intrinsic to the starting substance or to the composition. Any impurity present at more than 0.1% in the substance and at more than 0.02% in the final formulation must be identified.

NIAS include products formed during processing, particularly under the effect of high temperatures, as well as products resulting from reactions or degradation, for example through hydrolysis upon contact with water. The applicant must use screening methods, such as GC-MS, in order to identify these substances in migration test waters.

The complex case of UVCBs

UVCBs, which include polymers, are subject to an adapted identification procedure. Due to their intrinsic variability, their identification cannot be based solely on chemical composition.

In this specific case, the detailed description of the manufacturing process therefore becomes the central element of the dossier. The raw materials used, the reaction steps and the control parameters constitute essential information for characterising the substance. Unlike well-defined substances, no distinction is made between constituents and impurities for UVCBs.

7. Governance: submission roles and data sharing

Lead registrant and group submissions

Unlike the REACH Regulation, the DWD does not impose either a lead registrant or a mandatory joint submission. Economic operators are nevertheless strongly encouraged to pool their efforts in order to submit a single application per substance and to avoid redundant testing.

In this context, a group of operators may designate a single entity (for example a consortium or a consultant) to assume responsibility for the dossier.

SIP and data sharing

In order to collaborate effectively, operators must agree on a SIP, or Substance Identity Profile, which defines the boundaries of the substance, including the concentration limits and impurities covered by the common data.

Data and cost sharing are governed exclusively by private agreements between the parties. ECHA has no legal basis to intervene or arbitrate in the event of a financial dispute. Furthermore, the use of a third-party representative may make it possible to protect the actual identity of an operator during public notification.

8. Timeline and obligations of operators

The transition to the harmonised European system imposes critical deadlines:

• 31 December 2026: The first EUPLs will apply from this date. National systems will cease to apply to new products.

• The 18-month rule: In order to renew an existing authorisation, the review dossier must be submitted to ECHA no later than 18 months before the expiry date of the approval for the substance.

• Notification of intention (NoI): This is mandatory within the 12 months preceding submission of the final dossier and is intended to facilitate collaboration between operators, including through consortia, in order to avoid redundant animal testing.

  
  

Conclusion

Directive (EU) 2020/2184 establishes a highly controlled environment in which the distinction between process substance and additive is gradually giving way to two decisive criteria: intentional addition and migration risk.

Each molecule present in the manufacturing cycle, whether a volatile solvent or a catalyst, must be assessed in light of its potential residual Ctap. As from 2027, product compliance will depend on the presence of each starting substance on the EUPL. The management of migration and toxicity data is therefore becoming a major commercial and public health issue for the entire supply chain.

Authors : Floriane Demailly & Loris Mistrulli

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