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 not subject to any authorisation requirements or any restrictions under REACH.
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 the ECHA website on 21 June 2022. BAuA then prepared an SVHC dossier according to REACH Annex XV. The dossier comprises two parts:
- Part 1: Justification for identifying the substance as a substance of very high concern (SVHC)
- Part 2: Further information relevant for the follow-up process (the uses, volumes and possible alternatives to the substance)
The Annex XV dossier was submitted to ECHA for an accordance check on 4 August 2022 and then published on the ECHA website on 2 September 2022.
This triggered a 45-day public consultation which closed on 17 October 2022.
The Annex XV dossier proposes that melamine should be added to the SVHC candidate list based on REACH article 57(f):
- Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health) and
- Equivalent level of concern having probable serious effects to the environment (Article 57(f) – environment)
The focus of the public consultation was on substance identity and hazardous properties detailed in part 1 of the SVHC dossier. Comments related to uses, volumes per use, exposure, alternatives and risks could also be submitted, but they would only be considered later in the authorisation process. Comments are non-confidential and will be published on ECHA’s website shortly after the end of the consultation. BAuA must respond to all comments received. If the scientific basis for inclusion in the SVHC list is not challenged, the substance is automatically added to the Candidate list.
The scientific basis for nominating melamine for identification as a SVHC substance was challenged during the 45-day ECHA public consultation, which closed on 17 October 2022. Therefore, both the proposal and the comments should be referred to the ECHA Member State Committee (MSC) for agreement in December 2022. Should the MSC fail to reach a consensus on whether melamine should be identified as a SVHC, the decision will then be referred to the European Commission.
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.
Obligations for Suppliers of Substances/Mixtures:
- EU and EEA suppliers of substances on the Candidate List (supplied either on their own or in mixtures) have to provide their customers with a safety data sheet (SDS). Section 15 of pre-existing SDS must be updated to reflect the identification of the substance as an SVHC.
- For substances satisfying the PBT and vPvB criteria, manufacturers and importers must use the information in their Chemical Safety Reports (CSR) when implementing on their sites and recommending for downstream users risk management measures (RMMs) which minimise exposures and emissions to humans and the environment. On the basis of that recommendation, downstream users must identify and apply appropriate measures to adequately control the related risks.
Obligations for Article Manufacturers:
- Upon request by a consumer, EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% w/w have to provide sufficient information to allow safe use of the article. This information must be provided within 45 days of the receipt of the request.
- EU and EEA producers or importers of articles are required to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% w/w. Notifications must be submitted no later than 6 months after the inclusion in the Candidate List.
- EU suppliers of articles containing substances on the Candidate List in a concentration above 0.1% w/w when placing them on the EU market have to submit information on these articles to ECHA. This information will be published in the SCIP database established under the Waste Framework Directive (WFD).
EMPA Strategy Workshop 2023
The European Melamine Producers Association (EMPA) organised a two-day strategic workshop, on 30-31 January 2023, in Brussels, following the SVHC identification of melamine.
Given the speed of regulatory developments that could affect melamine (e.g., REACH Authorisation, Restriction, new CLP Hazard classes on Endocrine Disruptors and Persistent, Mobile and Toxic), the value chain gathered to start preparing a strategy to address the upcoming regulatory challenges.
The goal of the workshop was to establish a joint strategy for the long-term defence of melamine by:
- Analysing the upcoming possible regulatory scenarios for melamine;
- Identifying the potential data gaps needed to support the advocacy;
- Defining a value chain advocacy strategy to shape the regulatory pathway of melamine.
The EMPA Secretariat prepared an agenda tailored to satisfy the value chain’s concerns. During the first day, Cefic experts gave presentations on the revision of the CLP regulation, the likely inclusion of new hazard classes – PMT/vPvM and ED, insights on a potential restriction procedure, as well as forecasting of the next steps in melamine’s possible authorisation procedure.
On the second day, Marco Mensink, Cefic Director General, Steven Van De Broeck, Cefic REACH Director, and Aaron McLoughlin, Cefic’s Chief Political Advisor, addressed the value chain on the state of play of EMPA’s regulatory future and reassured them about Cefic’s engagement to safeguard their business interests whilst fully collaborating with the regulating authorities. During the second part of the day, attendees were divided into groups and discussed collectively on the three key challenges melamine could face soon: addressing data gaps for melamine’s presence in the environment (drinking water) and the challenges and opportunities of a potential restriction and/or authorisation procedure.
In the closing session, attendees agreed on:
- Initiating a data collection programme as soon as possible, including the standardisation of testing methodologies, identifying melamine waste streams and identifying improvement waste management methods in melamine plants.
- Producing a socio-economic impact analysis to ensure that industry delivers an overarching approach of the consequences of an authorisation procedure for melamine to the authorities.
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 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.
