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 its 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 Member State Committee meeting (MSC-80) held on 13-15 December, 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:

https://echa.europa.eu/candidate-list-obligations

 

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 (The European Chemical Agency) 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.

 

Regulatory next steps

Public consultation: This publication 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. Link to the public consultation:

https://comments.echa.europa.eu/comments_cms/InclusionRecommendation.aspx?SubstanceName=Melamine&ECNumber=203-615-4&CASNumber=108-78-1

At the same time, there is also a parallel call for information by the European Commission on the possible socio-economic consequences of the inclusion of melamine in the Authorisation List. Link to the call for information:

https://comments.echa.europa.eu/comments_cms/CallForInfo.aspx?SubstanceName=Melamine&ECNumber=203-615-4&CASNumber=108-78-1

 

Steps after the public consultation

ECHA recommendation: The opinion of the MSC and the comments received are considered when ECHA finalises its recommendation. The recommendation is then submitted to the European Commission (EC), 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 EC mid-2025.

European Commission Decision: If the EC 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 EC 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 information provided during the public consultation and the final judgement of the EC.

 

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 created a Task Force (EMPA, REACH Consortium, Downstream Users, experts) to work on the Public Consultation submission and will provide a summary document that may be used as a template for other stakeholders when submitting their own responses.
  • EMPA will send out a call for advocacy experts to discuss the next steps in the prioritisation process.
  • EMPA is working with downstream users on a socio-economic 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 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 of melamine (CLH) Carc 2 & STOT RE 2

In November 2019, the German Federal Institute for Occupational Safety and Health (BAuA) submitted a proposal for a Hamonised Classification and Labelling (CLH) for melamine for Carcinogenicicity Category 2 (substance suspected of having carcinogenic potential for humans) and STOT RE 1 (Specific target organ toxicity through prolonged or repeated exposure).

The 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 scrutiny period for the 18th ATP ended on 18 April 2022 and it was published in the Official Journal on 3 May 2022. The ATP entered into force on 23 May 2022. The harmonised classifications of melamine as Carcinogenic Category 2 and Repeated Exposure Specific Target Organ Toxicity 2 (STOT RE 2) are legally in place since December 2023.

 

Self-classification of melamine as REPRO 2

Melamine was self- classified by the Melamine REACH Consortium in May 2020 as 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.

 

Harmonised classification of melamine (CLH) REPRO & PMT

On 6 September 2023, the German Federal Institute for Occupational Safety and Health (BAuA) has 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 of melamine. The proposal is expected to be sent to ECHA mid-2024.