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.
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.
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 not subject to any authorisation requirements or any restrictions under REACH.
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.
Self-classification of melamine
ECHA published its decision in November 2017 to re-investigate the reprotoxic effects of melamine. To that extent, the Melamine REACH Consortium, a separate entity from EMPA which includes manufacturers of melamine joining efforts for REACH compliance activities, coordinated all the necessary steps to perform the reprotoxicity animal testing together with a qualified service provider, and following ECHA guidance.
While melamine did not cause developmental toxicity or have an adverse effect on reproductive performance in the Extended One-Generation Reproductive Toxicity Study (EOGRTS) performed with rats, some adverse findings led the Consortium to commonly agree on a self-classification for melamine as Reproductive Toxicant Category 2 (substance suspected of being toxic for human reproduction).
Manufacturers and importers will provide all the relevant information to downstream users, who in turn are expected to use the same classification and label their products consistently, in order to ensure full compliance with the self-classification.
Procedure for harmonised classification of melamine (CLH)
In November 2019, the German Federal Institute for Occupational Safety and Health (BAuA) submitted a proposal for classification and labelling (CLH) of melamine as 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 launched a public consultation which concluded in February 2020, to which EMPA provided its scientific input. The dossier was discussed during the Risk Assessment Committee (RAC)-55 meeting in December 2020.
The RAC opinion was published on the ECHA website on 3 March 2021, recommending 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 European Commission adopted the 18th ATP under CLP in February 2022 and sent the legislative proposal to the European Parliament and the Council of the European Union, as part of the Delegated Act Procedure.
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 is entering into force on 23 May 2022. Taking into account the usual 18-month transition period, the harmonised classifications of melamine as Carcinogenic Category 2 and Repeated Exposure Specific Target Organ Toxicity 2 (STOT RE 2) are expected to be legally in place in December 2023.
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.
Additionally, the RMOA proposes to address the reproductive toxicity of melamine through a harmonised classification for Reprotoxicity 2 under CLP.
Finally, the RMOA also proposes to establish an Indicative Occupational Exposure Limit Value (IOELV) for the workplace.