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May 16, 2023

ECHA Calls for Evidence on Analytical Methods to Measure CMR Substances in Childcare Articles

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The European Chemicals Agency (ECHA) has begun a call for evidence on analytical methods to measure carcinogenic, mutagenic, or reprotoxic substances (CMR) in childcare articles. ECHA states that the European Commission (EC) has requested that ECHA prepare a report on CMRs in childcare articles. According to ECHA, this work will support the EC in the preparation of a restriction proposal for CMR 1A or 1B substances in childcare articles on the basis of Article 68(2) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Responses are due June 7, 2023.

According to the EC’s mandate, the scope of ECHA’s report should cover:

  • Articles under the definitions in entry 51 of Annex XVII of REACH: Any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children; and/or
  • Articles within the remit of European Committee for Standardization (CEN) Technical Committee (TC) 252: Any product “designed or obviously intended to safely ensure and facilitate seating, bathing, changing and general body care, feeding, sleeping, transportation and protection of young children.”

The substances within the scope are all CMRs with harmonized classification category 1A or 1B under Regulation 1272/2008 on the classification, labeling, and packaging of substances and mixtures (CLP). The mandate notes that consideration should also be given to future updates of the restriction when additional substances will get harmonized classifications. For enforcement purposes and to help with implementation of the restriction, the mandate states that ECHA’s report “should gather data on whether the substances are present in childcare articles, to establish a list of most relevant substances per group of articles, and the materials typically used in the articles and where possible, if they either can be released from articles or lead to exposure of children.”

The mandate states that the deliverable is a report that should include:

  • A list of CMRs with harmonized classification 1A or 1B that may be present in childcare articles (grouped per article types/material types, intentional vs unintentional if possible);
  • Where available, information on tonnage, concentration ranges, frequency of finding in articles to be used as estimation of likelihood of exposure for further prioritization;
  • Where available, information on release/exposure potential;
  • An inventory of existing Generic Concentration Limits (GCL)/Specific Concentration Limits (SCL) per substance or per groups of substances and further existing regulatory measures;
  • Identification if deviation from GCL/SCL (content) limits is needed;
  • Summary of information on availability of analytical methods; and
  • An overview and summary of the stakeholder consultations.

ECHA states that the call for evidence is intended for testing laboratories (e.g., enforcement, customs, independent, and industry laboratories). ECHA encourages both European Union (EU)/European Economic Area (EEA) and non-EU stakeholders to participate. ECHA notes that information can be submitted confidentially.