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 not subject to any authorisation requirements or any restrictions under REACH.

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.

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 decision of the RAC will be communicated to the European Commission, the only body in the EU with the competency to classify melamine. This is expected to be done via the preparation and adoption of a legislative proposal called “Adaptation to Technical Progress” (ATP). The ATP requires the final approval of the European Parliament and the Council of the European Union in order for the classification to be adopted under CLP. The transition period (usually 18 months) would start before the entry into force of the classification of melamine.