European positive lists
European positive lists
The revised Drinking Water Directive requires starting substances, compositions or constituents that are used to manufacture a material that comes into contact with drinking water between the water source and the tap to be included in one of four European positive lists. After the tap, materials that come into contact with the water are managed under food safety regulations.
There will be separate positive lists for different types of materials that come into contact with drinking water:
- metallic; and
- enamel, ceramic or other inorganic materials.
The use of starting substances, compositions and constituents included in the lists may be limited by specific conditions. Alternatively, limits may be set on the concentration of a substance in the water that leaves the tap.
Establishing the first European positive lists
Member States notified ECHA of their existing national positive lists, other national provisions and related documents, such as risk assessment reports, by 12 July 2021.
ECHA compiled the draft European positive lists based on these notifications and the Union list of authorised substances of Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. ECHA is currently verifying the list entries before sending them to the European Commission. The European Commission then decides on the adoption of the lists by 12 January 2025.
Setting review priorities for the first European positive lists
All entries in the first European positive lists will be reviewed. Each entry will receive an expiry date based on a recommendation from ECHA. The expiry dates will consider the hazardous properties of the substances, the availability of the underlying risk assessments, and the extent to which those risk assessments are up to date.
ECHA has proposed a set of standard expiry dates of 3, 6, 9 and 12 years from 2025 (the assumed entry into force of the European positive lists) and has developed a methodology for prioritising the positive list entries, based on the following considerations:
The starting point for assigning an expiry date to an EU positive list is its origin:
- Entries that are approved at EU level under an accepted assessment methodology have the lowest priority for review and are proposed to have the longest expiry date of 12 years. This applies to entries in the EU positive list for organic materials which originate from the Union list of Commission Regulation (EU) No 10/2011.
- Entries that are approved on a national level under a documented assessment methodology with recognised reliability are of low priority for review and will be proposed to have a relatively long expiry date of 9 years. This applies to entries in the EU positive lists that originate from positive lists of the ‘4MS Initiative’ (an initiative of Germany, France, the Netherlands and Denmark together with the United Kingdom) and which have been subject to review under the methodologies established by the initiative. Relevant entries are those coming from the 4MS Core positive list of starting substances for organic materials and the 4MS positive list of metallic compositions.
- Entries that are approved on a national level but have not been subject to a systematic review under a documented assessment methodology are of medium priority for review and will be proposed to have a relatively short expiry date of 6 years. This applies to any other entry notified by a Member State to ECHA.
Once this initial allocation of expiry dates takes place, the criteria below are used to prioritise specific entries.
Substances for which there is limited, or no, knowledge of their human health hazards are given a higher priority for review. ECHA considers the availability of a registration under REACH as an appropriate proxy for hazard data availability:
- Substances on an EU positive list without a REACH registration that do not benefit from an exemption from the REACH registration obligation will be given the highest priority for review and will be proposed to have an expiry date of 3 years.
- Group entries (i.e. entries in the EU positive lists which appear to cover more than one specific substance within their boundaries of identity or for which their boundaries are uncertain) for which their REACH registration status is unclear, will be given the second highest priority and will be proposed to have an expiry date of 6 years.
These substances are considered to be the highest priority for review and will be proposed to have an expiry date of 3 years:
- Substances that have a harmonised classification as CMR Cat. 1A or 1B according to Annex VI to the CLP Regulation; or
- Substances that have been identified as persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) or as endocrine disruptors (ED) according to Article 57 (d, e, f) of the REACH Regulation and appear as such in the REACH Candidate List.
This criterion applies to entries in the EU positive list for organic materials which originate from the Union list of Commission Regulation (EU) No 10/2011. Those entries that have been assessed by the European Food Safety Authority (EFSA) before 2010 are deemed to have a higher priority for review compared to other entries from the Union list. As such, an expiry date of 9 years is considered appropriate.
The expiry date for each entry will be adopted by the European Commission. The Commission’s decision may also include transitional provisions for certain substances.
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 is received.
The Commission will decide based on RAC’s opinion if an entry is kept, amended or removed from the first EU positive lists. If no review application is sent to ECHA by the set 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, e.g. propose new concentration limits based on new information. RAC will form opinions on these applications for the European Commission to take a decision to regularly update the positive lists.