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

By Lynn L. Bergeson & Carla N. Hutton on May 16, 2023
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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.

Photo of Lynn L. Bergeson Lynn L. Bergeson

President of The Acta Group (Acta®), Ms. Bergeson counsels clients on issues pertaining to chemical hazard, exposure and risk assessment, and risk communication. She has earned an international reputation in the legal and regulatory aspects of conventional and nanoscale chemical regulatory…

President of The Acta Group (Acta®), Ms. Bergeson counsels clients on issues pertaining to chemical hazard, exposure and risk assessment, and risk communication. She has earned an international reputation in the legal and regulatory aspects of conventional and nanoscale chemical regulatory programs under the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and on issues pertinent to nanotechnology and other emerging transformative technologies. Specialties include chemical product approval and regulation under TSCA, FIFRA, and REACH, as well as nanoscale substances and nanomaterials law, policy, and regulation.

Today, Ms. Bergeson works with corporations and a wide range of trade associations on evolving regulatory and policy matters pertinent to products of conventional, biotechnology, biobased chemicals, nanotechnologies, and other emerging technologies particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

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Photo of Carla N. Hutton Carla N. Hutton

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C’s clients, as…

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C’s clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    REACHblog™
  • Organization:
    The Acta Group

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