The Drinking Water Directive requires that starting substances, compositions or constituents used in manufacturing materials that come into contact with drinking water, from the water source to the tap, must be listed in one of four European positive lists. Once the water flows from the tap, materials that come into contact with it are managed under food safety regulations.
The European Commission has adopted positive lists for four different types of materials that come into contact with drinking water:
- organic;
- metallic;
- cementitious; and
- enamel, ceramic or other inorganic materials.
The adopted positive lists are based on the national positive lists that the EU Member States notified to ECHA in July 2021. The organic materials positive list incorporates the plastic food contact materials list found in Annex I of the Commission’s Regulation on plastic materials and articles intended to come into contact with food ((EU) No 10/2011).
ECHA will publish the European positive lists in searchable format. However, Commission's implementing decision will remain the only authoritative source for these lists.
Characteristics of the European Positive Lists
There are certain characteristics that apply to all European positive lists.
Each entry has a unique 4-digit European positive list (EUPL) number. It is possible that the same chemical substance may be listed both as a starting substance for organic materials and an organic constituent for cementitious materials. In that case, two different EUPL numbers are assigned, one for each list.
Each entry in a positive list is assigned an expiry date. This date marks the expiration of the permission to use the entry in manufacturing materials in contact with drinking water. For the first European positive lists, each entry has been given one of the following four expiry dates:
- 31 December 2028;
- 31 December 2031;
- 31 December 2034; or
- 31 December 2037.
The expiry dates have been adopted by the European Commission following a recommendation from ECHA. They take into account the hazardous properties of the substances as well as the availability of the underlying risk assessments and how up to date these risk assessments are. Additionally, priority setting for entry reviews has, on a case-by-case basis, considered specific factors, such as chemicals requiring special attention (e.g. PFAS).
Conditions of use of a listed starting substance, composition or constituent
The European positive lists offer the possibility to include specific conditions for using an entry. Such conditions must be respected when using the starting substances, compositions and constituents and the final materials and products.
Alternatively, concentration limits may be set for a substance in the water that comes out of the tap. These are known as Maximum Tolerable Concentrations at the tap (MTCtap) and may apply to the listed substance itself or to another relevant chemical species which migrates into the water. Such relevant chemical species could include a chemical substance which is present as an impurity or is a reaction product of the listed entry.
Reviewing and maintaining the first European positive lists
If an economic operator is interested in keeping a starting substance, composition or constituent on the EU positive lists, they need to send a review application to ECHA by the expiry date. ECHA's Committee for Risk Assessment (RAC) will review and form opinions on those starting substances, compositions and constituents on the first EU positive lists for which a review application has been received.
The Commission will decide, based on the opinion of RAC, if an entry is kept, amended or removed from the first EU positive lists. If no review application is submitted to ECHA by the expiry date, the entry will be removed from the positive lists. The review of all entries in the first EU positive lists needs to be completed within 15 years from the adoption of the lists.
If an economic operator wants to add a new substance to the EU positive lists, they need to submit an application to ECHA. In addition, Member State authorities can submit an application to ECHA to remove an entry from the lists or to update an existing entry, for example proposing new concentration limits based on new information. RAC will form opinions on these applications for the Commission to take a decision.
Timeline for applying the first European positive lists
The first European positive lists will apply from 31 December 2026. Until then, national positive lists and other national provisions will apply.
Additionally, starting substances, compositions and constituents which have been approved by a Member State between 13 July 2021 and 31 December 2026, in line with national provisions, may be used in the manufacture of materials or products that come into contact with drinking water until 31 December 2032.
