Melamine REACH Consortium
The Relevant representative of the melamine business in Europe have joined efforts for their REACH compliance activities and have launched the Melamine REACH consortium in May 2009.
The Relevant representative of the melamine business in Europe have joined efforts for their REACH compliance activities and have launched the Melamine REACH consortium in May 2009.
The Consortium Members agreed to cooperate in the preparation of a REACH Registration dossier for Melamine with the aim to cover major uses of the substance.
The dossier will include information for harmonised classification and labelling. The consortium is managed by ReachCentrum.
The following substances have been registered under the REACH legislation by December 2010:
| Substance | CAS number | EC number |
| Melamine | 108-78-1 | 203-615-4 |
The Melamine REACH consortium structure includes a Steering Committee and a Technical Committee. The consortium is open to manufacturers, importers and only representatives as defined in the REACH regulation and includes their Affiliates.
Current members of the Melamine consortium are:
Please find attached the proposed substance identity profile of Melamine.
Starting from end of May 2020 the substance Melamine has been self-classified by the Consortium as Repro Cat 2 (H361f) (Labelling: H361f according to Regulation (EC) No 1272/2008).
Each registrant will need to comply with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures and therefore the Consortium advises all co-registrants to act on this new information and self-classify the substance accordingly.
A list of supported and unsupported uses of melamine is to be supplied. The Chemical Safety Report (CSR) is available showing the results of the Exposure Assessments.
The final CSR will not be jointly submitted, however all Joint Registrants will receive a core CSR that they can modify as needed before adding to their own registrations. This is to ensure needed flexibility for companies to manage their own CSRs.
The rationale behind the selection of the applicable life cycle stages for the Melamine uses is available here.
In December 2020 the EU adopted the Drinking Water Directive (“DWD”) which entered into force in January 2021. The Directive applies to substances entering in contact with water, intended for drinking, cooking, food preparation or other domestic purposes in both public and private premises, regardless of its origin and whether it is supplied from a distribution network, a tanker or put into bottles or containers, including spring waters. The Directive also applies to water used in any food business for manufacturing, processing, preserving or marketing of products or substances intended for human consumption.
The main pillars of EU drinking water policy are:
The Commission used national notifications to establish the first European Positive Lists (“EUPL”). The European Positive Lists are transitional: entries have expiry dates (2028, 2032, 2036, …) and may need to be reviewed under harmonized criteria. Substances are not organized by chemical identity. They are listed according to material type, technical function and intended use scenario. Therefore, one substance may have more than one EUPL number.
Melamine is, at present, listed under two DWD EUPL numbers: individual starting substances for organic materials (EUPL 0182) and individual organic constituents for cementitious materials (EUPL 1804).
These two EUPL entries for melamine expire on 31 December 2028. In order to keep melamine on the Positive List, the review application dossier must be submitted at least 18 months before the expiry date, i.e., by 30 June 2027.
Prior to the application dossier, applicants must submit a Notification of Intention (“NoI”) to ECHA via IUCLID. The NoI is valid from 30 June 2026 and must be processed prior to the application (deadline 30 June 2027).
If melamine is not kept on the Positive List, melamine containing materials or applications which come in contact with water (see introduction) will not be allowed after expiry date!
ECHA indicates that the applicant may be:
The REACH Consortium will not be the applicant but will provide any support to the DWD applicant(s). In particular, the REACH Consortium can provide hazard information and share owned toxicological data concerning melamine.
The REACH Consortium strongly encourages manufacturers and down-stream users to act timely and inform their value chain about the Drinking Water Directive and the consequences it has towards continuation of the uses of Melamine for both Organic (EUPL 0182) and Cementitious materials (EUPL 1804).
Manufacturers of materials that come into contact with drinking water should check the EUPL to identify the substances used in their production process. If a continued listing is required for melamine they should get in contact with their suppliers to seek for support in the application process. Therefore, manufacturers and any parties with a commercial interest should ideally initiate the application process aware that any necessary supplementary laboratory testing, as well as the preparation of the dossier, are relatively time-consuming.
Only one Notification of Intention and thereafter one application is required to be submitted for maintaining (or adding) a substance to the EUPL for a specific use.
An analytical method has been developed for the detection and quantification of melamine and related substances in aqueous media, including ammeline, ammelide, cyanuric acid, cyromazine, hexamethoxymethylmelamine, and others.
The method depicts a low limit of quantification (LoQ), reaching 0.050 μg/L for cyanuric acid and 0.010 μg/L for melamine and other compounds, enabling assessments that were previously not feasible.
Quantification is performed via calibration with analytical standards in water, and isotope-labelled internal standards are used to correct for intensity variations.
For more details, check the attached Short Method Description and Sampling Protocol.
The LoA is now available. Please use this link to access the LoA e-shop: http://loashop.reachcentrum.eu/
