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ECHA Accepting Comment on Draft SEAC Opinion on Proposed MCCP Restriction Proposal

By Lynn L. Bergeson & Carla N. Hutton on June 30, 2023
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The European Chemicals Agency (ECHA) is seeking comment on the draft opinion of its Committee for Socio-Economic Analysis (SEAC) concerning the restriction proposal for medium-chain chlorinated paraffins (MCCP) and other substances that contain chloroalkanes with carbon chain lengths within the range of C14 to C17. According to the Information Note on SEAC’s draft opinion, substances containing chloroalkanes with carbon chain lengths from C14 to C17 are used in various sectors and in a broad range of applications, such as polyvinyl chloride (PVC), adhesives and sealants, rubber, metalworking fluids, paints, and coatings. The Information Note states that they are mainly used as plasticizers, flame retardants, or extreme pressure additives. Comments on SEAC’s draft opinion are due August 14, 2023. Comments received will be taken into account before the adoption of the SEAC final opinion in September 2023. ECHA will send the Committee for Risk Assessment (RAC) and SEAC final opinions to the European Commission (EC), which will make the decision whether to include the proposed restriction in Annex XVII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.

The Information Note states that the consultation includes four specific questions intended to obtain information considered to be particularly relevant to the evaluation of the proposal:

  1. SEAC’s view is that a transition period of seven years for the entry into force of the ban on the use of the substances in metalworking fluids is required since alternatives may not be readily available for all extreme pressure metalworking fluid applications. SEAC also notes that several respondents who contributed to the third-party consultation of the Annex XV restriction report requested a transition period longer than seven years. SEAC’s view is that these requests were not sufficiently substantiated, however.

    SEAC is therefore looking for additional information on the use of the substances in metalworking fluids that would allow SEAC to assess further whether a longer transition period for these applications is needed. In the absence of concrete and well-substantiated comments, SEAC will consider that the conclusion reached on the transition period required for the use in metalworking fluids is adequate.
  2. The third-party consultation of the Annex XV restriction report confirmed that substances containing chloroalkanes with carbon chain lengths from C14 to C17 that are used as extreme pressure additives in metalworking fluids for heavy-duty metalworking operations (such as fine blanking, broaching, and deep drawing) are challenging to replace with alternatives and that it seems that the type of fluids concerned are oil-based fluids. Based on this, the Dossier Submitter has refined the wording of the derogation for metalworking fluids under restriction option B in the Background Document to specify the type of fluids that should be covered by MCCP and other substances that contain chloroalkanes with carbon chain lengths within the range from C14 to C17 derogation, namely oil-based metalworking fluids as defined under the German Institute for Standardization (DIN) 51385 standard.

    SEAC is concerned that the wording of the scope may be too narrow, however, as other categories of metalworking fluids (not covered by the definition of oil-based fluids under this DIN standard) might also be relevant and should be included under paragraph 8 of the restriction entry text.

    Please provide detailed information on whether other categories of metalworking fluids used for heavy-duty applications and not covered by DIN 51385 would also require a longer transition period than two years. Please refer to any relevant industry standards applicable to the type of metalworking fluids concerned.
  3. According to the SEAC draft opinion, a ban on the manufacture of the substances within the scope of the restriction proposal should enter into force after the seven-year transition period for metalworking fluids has ended. Please provide further information on the potential impacts of a ban on manufacturing once the ban on the placing on the market and use of the substance in the European Union (EU) has entered into force.
  4. During the third-party consultation on the Annex XV report, some stakeholders have indicated the presence of substances containing chloroalkanes with carbon chain lengths from C14 to C17 in concentrations above 0.1 percent (and up to 15 percent) in PVC recyclates (e.g., from PVC cables) and PVC articles made of these PVC recyclates. According to the recently published restriction on lead (Pb) in PVC, flexible PVC containing Pb above 0.1 percent by weight will no longer be allowed to be recycled in Europe by May 28, 2025. In this context, SEAC would like to understand how the restriction on Pb in PVC would affect the recycling of PVC containing chloroalkanes with carbon chain lengths from C14 to C17. Please estimate the quantity/volume of recycled PVC that would not contain Pb but could still contain chloroalkanes in the scope of the restriction proposal.
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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