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22. August 2019

Europur: Regulatory update on melamine, flame retardants and formaldehyde

As the European association of flexible polyurethane foam blocks manufacturers Europur  has previously reported, it is expected that Germany will submit a proposal to the European Chemicals Agency (ECHA) to classify melamine as a Class 2 Carcinogen in combination with Specific Target Organ Toxicity with Repeated Exposure (STOT RE) Class 1.

The proposal was first expected at the end of 2018 but was delayed due to a process of alignment amongst German government agencies. Latest information received from the European Melamine Producers Association (EMPA) indicates that the proposal should be tabled during summer 2019. Europur said it is preparing a note for its member companies to explain what the consequences of this classification mean for the flexible PU foam industry and its customers.

At the time of drafting this article, the website of the ECHA still mentions that a proposal for a restriction of TCEP, TDCP and TCPP in childcare articles, residential furniture and possibly adult mattresses is scheduled for publication on 19 July 2019. According to Europur, of real relevance for the industry is only TCPP as TCEP is not used in Europe anymore and TDCP is used in automotive application. So the association's activities on this matter have always focused on TCPP.

Information received informally indicates that the ECHA would prefer to wait for the conclusions of a study on the chronic carcinogenicity of TCPP in rats and mice currently performed by the US National Toxicology Program before submitting a proposal for a restriction, said Europur. This is why the proposal for a restriction, initially anticipated for April 2019, was already delayed. The US NTP has not yet released the results of the study, which will give definitive answers on whether the substance is a class 1b, 2, or no carcinogen. Latest intelligence suggests that the results should become available at the end of 2019/beginning of 2020.

Earlier this year, Europur performed a migration test on TCPP out of commercial foams provided by member companies. The study showed no detectable migration of TCPP over a mattress cover. The results were subject to a risk assessment by Arche Consulting, which concluded that there is no risk for consumers under realistic worst-case conditions of use. The study was communicated to ECHA and is being reviewed by them, said Europur.

Should a restriction proposal be formulated, it will follow the decision-making procedure foreseen by the REACH Regulation. This includes reports by the ECHA Socio-Economic Assessment Committee (SEAC) and Risk Assessment Committee (RAC), which have twelve months to formulate their opinions. After ECHA Committees provided their opinions, the European Commission has to draft a legislative proposal and put this forward for a vote in the REACH Committee, consisting of representatives of EU Member States, where voting takes place on the basis of a qualified majority. Therefore, a possible restriction would at the earliest come into force around the summer of 2021, and it would probably include a transition period to leave time to industry to adapt.

Furthermore, the ECHA has prepared and submitted a Restriction Proposal for formaldehyde and formaldehyde releasers. The proposed restriction text states that articles shall not be placed on the market or used if formaldehyde released from them exceeds a concentration of 0.124 mg/m³ in the air of a chamber used under conditions prescribed in EN 717-1. The main issue for the PU industry and many others is that EN 717-1 is a standard designed for wood panels. When compared to CertiPUR, the standard specifies a higher loading (1 vs 0.4 m²/m³), a higher air change rate (1 vs 0.5 ACH), and a longer preconditioning (10 – 28 vs 3 days). Within a sample of more than 100 CertiPUR tests, formaldehyde was detected in 45 % of test reports (LoD 1 µg/m³) with an average of 0.005 mg/m³ and a maximum of 0.019 mg/m³.

Europur said it is therefore not concerned about the limit for emissions set by the restriction but much more about how companies can demonstrate compliance, which is unclear at the moment. If companies need to demonstrate compliance for all foams according to EN 717-1 they produce they would incur significant testing costs. Considering the number of standards and specifications already covering formaldehyde in the PU industry, Europur and Euro-Moulders requested an exemption for PU flexible foam during the public consultation.

There also, like for other restrictions, ECHA's Risk Assessment Committee and Socio-Economic Assessment Committee will formulate an opinion on the proposal based on the proposal itself and input received during the public consultation by March 2020. Thereafter the European Commission will draft a legislative proposal for a vote in the REACH Committee.

www.europur.org

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