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Proposal and Justification Committee for Risk Assessment RAC Annex 2 Response to comments document (RCOM) to the Opinion proposing harmonised classification and labelling at EU level of Melamine EC Number: 203-615-4 CAS Number: 108-78-1 CLH-O-0000006932-69-01/F Adopted 10 December 2020 P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu [04.01-ML-020.02] ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON MELAMINE COMMENTS AND RESPONSE TO COMMENTS ON CLH: PROPOSAL AND JUSTIFICATION Comments provided during consultation are made available in the table below as submitted through the web form. Any attachments received are referred to in this table and listed underneath, or have been copied directly into the table. All comments and attachments including confidential information received during the consultation have been provided in full to the dossier submitter (Member State Competent Authority), the Committees and to the European Commission. Non-confidential attachments that have not been copied into the table directly are published after the consultation and are also published together with the opinion (after adoption) on ECHA’s website. Dossier submitters who are manufacturers, importers or downstream users, will only receive the comments and non-confidential attachments, and not the confidential information received from other parties. Journal articles are not confidential; however they are not published on the website due to Intellectual Property Rights. ECHA accepts no responsibility or liability for the content of this table. Substance name: 1,3,5-triazine-2,4,6-triamine; melamine EC number: 203-615-4 CAS number: 108-78-1 Dossier submitter: Germany GENERAL COMMENTS Date Country Organisation Type of Organisation Comment number 06.02.2020 Germany Pfleiderer Company-Downstream 1 Deutschland GmbH user Comment received Melamine is one of the most important substances which are necessary for the production of wood based panels (WBP). Beside formaldehyde and urea it is one of the essential substanc-es to produce glues or resins for the production of raw boards as well as decorative boards. Normally for the production of raw boards the glues are consisting of urea-formaldehyde poly-condensates but in the meantime polycondensates also using melamine are getting more and more important (MUF glues). The reason is that melamine is a very reactive molecule, building very easily polymers with formaldehyde which are much more stable against hydrolysis than polymers consisting only of urea and formaldehyde. So by adding melamine very low emitting boards can be produced. This is exactly the reason why for decorative laminates only melamine-formaldehyde resins are used at least in the last impregnation step because of course such decorative laminates have to be very hygienic and resistant against the requirements of daily life (e.g. coming into contact with food). Because of the fact that melamine is very reactive, the concentration of free melamine which is completely unbounded is very low in the final articles and if unbounded melamine is present in traces it can be regarded as impurity. In our company we have two glue/resin plants where we are using pure melamine since dec-ades of years. Melamine is handled in closed systems so there is no direct contact between the worker and melamine. Measurement of worker exposure with respect to dust/melamine are therefore showing results close to the detection limit. Also the reactors in which melamine is mixed together with urea and formaldehyde or only with formaldehyde are closed systems. Only for some procedures regarding quality assurance the worker can come into direct contact with the resin. In this moment the worker is 1 (71) ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON MELAMINE obliged to wear gloves, so no contact to skin is possible. After this production process of glues/resins the free melamine is bounded and so in the further processing steps (impregnation/gluing) a completely new chemical substance (MF/MUF res-in/glue) is used. In our company we never had health effects of the workers in our plants regarding melamine. So the conclusion is that free melamine can only be found in a very small part of the whole production process of WBP and this part is at the very first beginning (the production of res-in/glue). All further steps of the process (impregnation of paper with resin, gluing of wood, production of raw boards in continuous presses or decorative laminated boards in short cycle presses) are using melamine which is completely polycondensated and no more unbounded. It is very difficult to say how much unbounded melamine is included in the matrix even if it is clear that, if at all, it must be in very small traces. The reason for the problem with the analysis of unbounded melamine is that it is insoluble in water and other liquids so if you want to analyse it you must treat it with acids or something else with the consequence that the matrix will be destroyed and therefore the analysis is result-ing in higher amounts of free melamine and so overestimating the real concentration. Regarding the final article there is a European law which is applicable for plastics coming into contact with food and so it is also applicable for decorative WBP. In this European law it is de-scribed how you have to measure the migration of certain substances out of the matrix and there are limit values which have to be fulfilled. We have uploaded such a certificate of compli-ance regarding our products showing that this European law is fulfilled. You can also find the test report showing that no melamine can be found in this migration test. So the conclusion is that in the WBP industry melamine is used not as unbounded melamine but in a resin and so it is handled in a safe manner regarding workers and consumers. The CHL proposal for melamine would not result in more safety for the health of workers and consumers but it would result in perhaps dramatic unintended consequences. According European law there would be the consequence that if melamine is exceeding 1 % in a mixture (not an article) this mixture would have to be labelled in a complete different way. What would it mean concretely for the WBP Industry? During the production of WBP along the described process steps we have different mixtures containing melamine which are generated as waste in the production process. We have waste of resin, impregnated paper and the waste from processing steps of the final product (dust from cutting, sawing, broken boards, cutting the edges in the short cycle presses …) which would have to be classified as dangerous waste it the content of melamine would exceed 1 %. As described above the analysis of unbounded melamine is very complicated and if analyses are made the result would probably overestimate the content. So all this waste would have to be classified as dangerous waste and would have to be 2 (71) ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON MELAMINE dis-posed with additional enormous costs compared to today. At the moment this waste can be burned in the own incinerators but this would be no more possible if the waste would be classified as dangerous waste. Further consequences would be that the furniture industry cannot burn the waste from processing the boards in their own incin-erators. Biomass as a fuel would have to be substituted by fossil energy. Additionally the recycling of decorative boards or low emitting raw boards would be no more possible because probably the content of free melamine can exceed 1 %. This is completely in contradiction to the European principle of cascade. Another unintended consequence would be the image of the WBP industry. Customers are not willing to distinguish between melamine and melamine in a polymer. Customers do not want to have carcinogenic substances in the product and therefore there is a huge risk for loss of mar-ket. Of course it can be shown by the mentioned test reports that there is no problem at all for the consumer, but nevertheless the consumer is understanding that a WBP is using a carcino-genic substance in the top of the decorative board which is coming in close contact with food, children … We have to conclude that the risks of unintended negative consequences of the CHL proposal are much higher than any benefits. ECHA note – An attachment was submitted with the comment above. Refer to confidential attachment ISEGA Unbedenklichkeitserklärung Pfleiderer.pdf Dossier Submitter’s Response RESPONSE #1 The DS appreciates the comments and acknowledges that it may be difficult for consumers to distinguish between pure melamine and melamine in a polymer. The DS also acknowledges the concern of unintended negative consequences. However, as the protection of human health is a priority, an assessment of potentially harmful substances is important to draw conclusions regarding safe use of chemicals and to provide hazard communication information to those who handle the substance/mixture or those who are exposed to it. As a first step, an evaluation of potential hazardous properties needs to be done. It is important to stress, however, that CLP is hazard-based and does not take exposure into consideration in arriving at a classification as stated in ECHA’s Guidance on the Application of the CLP Criteria (1.1.3). Hence, classification under CLP is exclusively based on hazardous properties of a given substance. Exposure considerations are important elements, which, however, come into play in a
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