Regulatory status
REACH Regulation
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation is the European Union’s main framework for chemical legislation, which entered into force on 1 June 2007. REACH aims to ensure a high level of protection for human health and the environment through the improved and earlier identification of the risks that can be posed by chemical substances.
The European Chemicals Agency (ECHA) has a coordination role and supports the European Commission by managing the technical and administrative aspects of the implementation of REACH as well as providing information to consumers and professionals.
Registration
According to the REACH Regulation (Art. 5), “substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered [..]”. This requires manufacturers and importers to gather information on their substances for safe management and to register the information in the ECHA database. In compliance with this provision, melamine (EC number 203-615-4; CAS number 108-78-1) has been registered under the REACH Regulation since December 2010.
Evaluation
Melamine underwent several registration dossier evaluations, carried out by ECHA. All processes launched at the request of ECHA have been concluded.
Authorisation and Restriction
Melamine is currently not subject to any authorisation requirements or any restrictions under REACH.
Risk Management Option Analysis on melamine
On 15 June 2022, the German Federal Institute for Occupational Safety and Health (BAuA) published the conclusion of its Risk Management Option Analysis (RMOA). The RMOA concluded that melamine meets the criteria to be identified as Substance of Very High Concern (SVHC) under REACH due to its Persistent, Mobile, Toxic (PMT) properties in the environment.
SVHC Identification
The German Federal Institute for Occupational Safety and Health (BAuA) published their intention to identify melamine as a Substance of Very High Concern (SVHC) on 21 June 2022.
Following the ECHA Member State Committee meeting held on 13-15 December 2022, melamine was identified as a Substance of Very High Concern (SVHC) for inclusion in the REACH Candidate List due to scientific evidence of probable serious effects to human health and the environment which give rise to an equivalent level of concern to PMT.
The inclusion in the Candidate List brings immediate obligations. These obligations, which are effective from the date of inclusion, refer not only to the listed substances on their own or in mixtures but also to their presence in articles. Further information on the obligations resulting from inclusion of SVHCs in the Candidate List can be found here.
Prioritisation for Authorisation
The 12th draft recommendation for inclusion in Annex XIV to the REACH Regulation was published on the ECHA website on 7 February 2024. Melamine was included among the substances recommended for inclusion in Annex XIV (Authorisation List).
This is an automatic process done by ECHA that gives priority to substances with PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent, very Bioaccumulative) properties, wide-dispersive use or high volumes. Melamine received a total score of 40 by ECHA, with a split of 13 for inherent properties, 15 for volumes and 12 for wide-dispersive use. EMPA does not agree with this score.
The publication of the 12th draft recommendation initiated a 90-day public consultation, in which interested parties are invited to comment on the prioritisation results and general issues, which include the uses that should be exempted.
At the same time, the European Commission also launched a parallel call for information on the possible socio-economic consequences of the inclusion of melamine in the Authorisation List.
Regulatory next steps
ECHA’s Member State Committee (MSC) is currently in the process of forming its opinion on the 12th draft recommendation for inclusion in Annex XIV. The opinion of the MSC and the comments received during the public consultation are considered when ECHA finalises its recommendation. The recommendation is then submitted to the European Commission, who makes the final decision on which substances to include (or not) in the Authorisation List. We expect the final recommendation to be submitted to the Commission by end-2025.
If the European Commission decides not to include melamine in the Authorisation List, the process ends. In case melamine is included in the Authorisation List, ECHA typically proposes a period of 18, 21 or 24 months between the decision of the Commission and the Latest Application Date. After the Sunset Date (Latest Application Date + 18 months), the placing of melamine on the market and its use is generally prohibited in Europe unless, companies are granted authorisation to continue using and placing substances on the market.
The regulatory process is well defined. However, the outcome of this process, i.e. a possible inclusion of melamine in the Authorisation List, is open and will depend on the final judgement of the European Commission.
What is EMPA doing
- The Melamine REACH Consortium has updated the Registration Dossier with the latest data.
- EMPA is closely working with Downstream Users and others who could be affected.
- EMPA has submitted a comprehensive joint industry response to the ECHA public consultation. EMPA has also conducted a socio-economic assessment and submitted a comprehensive joint industry response to the European Commission call for information based on this assessment.
- EMPA will seek meetings with relevant EU Member State Competent Authorities and Commission to clarify the industry position and share new data findings.
- EMPA will support stakeholders by providing regular updates on progress via the Melamine Technical Steering Committee, newsletters and the EMPA website.
CLP Regulation
The Classification, Labelling and Packaging (CLP) Regulation aims to ensure a high level of protection of human health and the environment, as well as the free movement of substances, mixtures and articles. It entered into force on 20 January 2009, based on the United Nations’ Globally Harmonised System (GHS) in order to provide alignment with classification, labelling and packaging of chemical substances and mixtures.
Harmonised classification in place – Carc. 2 & STOT RE 2
In November 2019, the German Federal Institute for Occupational Safety and Health (BAuA) submitted a proposal for a Harmonised Classification and Labelling (CLH) for melamine for Carcinogenic Category 2 (substance suspected of having carcinogenic potential for humans) and STOT RE 1 (Specific target organ toxicity through prolonged or repeated exposure).
ECHA’s Committee for Risk Assessment (RAC) recommended the classification of melamine as Carcinogenic Category 2 and STOT RE 2.
The final decision was adopted by the European Commission, the only body in the EU with the competency to classify melamine. This was done via the preparation and adoption of a legislative proposal called “Adaptation to Technical Progress” (ATP). The 18th ATP, including melamine, was published in the Official Journal of the EU on 3 May 2022 and entered into force on 23 May 2022. The harmonised classification of melamine as Carcinogenic Category 2 and Repeated Exposure Specific Target Organ Toxicity 2 (STOT RE 2) has been legally applicable since 23 November 2023.
Self-classification of melamine as REPRO 2
Melamine was self-classified by the Melamine REACH Consortium in May 2020 as a Reproductive Toxicant Category 2 (substance suspected of being toxic for human reproduction), following the execution of the Extended One-Generation Reproductive Toxicity Study (EOGRTS) performed with rats, which showed some adverse effects.
Proposed harmonised classification of melamine – REPRO & PMT
On 6 September 2023, the German Federal Institute for Occupational Safety and Health (BAuA) announced its intention to submit a Harmonised Classification and Labelling (CLH) proposal for melamine for Reproductive Toxicity and Persistent, Mobile, Toxic/ very Persistent, very Mobile properties. The proposal is expected to be sent to ECHA in the first half of 2025.
Regulatory next steps
Once submitted to ECHA, the melamine CLH dossier undergoes a check to assess whether it is in accordance with the legal requirements of the CLP Regulation. If accepted, the dossier is then published on the ECHA website.
This publication initiates a 60-day public consultation, in which interested parties are invited to comment on those hazard classes for which data has been provided in the CLH dossier. During the consultation, any comments received are published on the ECHA website. Once the consultation closes, all the comments and attachments received are compiled and forwarded to the dossier submitter German authority, inviting them to provide their response to the comments. The compiled comments and non-confidential attachments are also published on the website at this stage.
The CLH dossier, the comments received and the response of the dossier submitter Competent Authority are then forwarded to RAC for the opinion development. The opinion must be adopted by RAC within 18 months of receipt of the CLH dossier. The RAC opinion and its annexes are published on the ECHA website once the opinion is adopted.
ECHA sends the RAC opinion along with its annexes to the European Commission for its decision and publishes it on the ECHA website. The Commission, assisted by the expert group CARACAL (the Competent Authorities for the REACH and CLP Regulations), prepares then the legislative act.
What is EMPA doing
- EMPA will be working together with the Melamine REACH Consortium to prepare a comprehensive technical/scientific response to the public consultation.
- EMPA will provide a summary document that may be used as a template for other stakeholders when submitting their own responses.
- EMPA will seek meetings with relevant EU Member State Competent Authorities to clarify the industry position and share new data findings.
- EMPA will support stakeholders by providing regular updates on progress via newsletters and the EMPA website.
- EMPA will organise meetings with Downstream User associations once additional information is available.
Analytical Method for Melamine Detection and Quantification in Water
EMPA is eager to provide scientific data based on robust methods to assist authorities with informed, science-based regulatory action. Therefore, we are pleased to announce the development of an analytical method for detecting and quantifying melamine and related substances in water.
This method, developed as a joint project by the Melamine Technical Steering Committee, can determine melamine (MEL), ammeline (AMN), ammelide (AMD), cyanuric acid (CYA), cyromazine (CYRO), and hexamethoxymethylmelamine (HMMM) in various water samples. The method key characteristic is the low LoQ (limit of quantification) reaching 0.050 µg/L for CYA and 0.010 µg/L for melamine as well as for the other mentioned substances. This enables environmental assessments that were previously not possible.
Quantification is achieved through calibration with analytical standards in water. For all substances except HMMM, isotope-labelled internal standards are used to correct for intensity variations.
This new method is now available upon request. EMPA encourages stakeholders to utilise this advanced tool to enhance their analytical capabilities and ensure accurate detection and quantitation of melamine and related substances in your water samples. To request access to this method, please contact the EMPA Secretariat via empa@cefic.be.