ECHA finalises recommendation for 8 more substances to become subject to authorisation under REACH

April 18, 2023

The European Chemicals Agency (ECHA) has formally recommended that the European Commission add a further eight substances of very high concern (SVHCs) to the REACH authorisation list. If the Commission implements the recommendation, it would mark the first time that substances become subject to authorisation due to their respiratory sensitisation properties. It would also create a significant new headache for the diverse industries and professions that rely on use of lead metal.

Authorisation is a REACH process that aims to manage the risks associated with use of high-hazard substances by driving their replacement with safer alternatives. Substances that are subject to authorisation must not be used (or supplied for a use) after their ‘sunset date’ unless that use has been authorised or an exemption applies.

Annex XIV of REACH contains the list of substances that are subject to authorisation. This list is periodically updated following recommendations by ECHA on substances that should become subject to authorisation. The Commission has the final say on including the substances in Annex XIV and does not always adopt every recommendation in full.

On 12 April 2023, ECHA recommended that the following eight substances should be added to Annex XIV of REACH:

NameAlternative / trade nameReason for inclusionUses
Lead -  EC no. 231-100-4,  CAS no. 7439-92-1-Toxic for reproductionUsed in the production of lead batteries, lead articles or alloys, lead solder, in galvanisation, as heat transfer fluid or in formulation and use of lubricants.
Glutaraldehyde -  EC no. 203-856-5,  CAS no. 111-30-8Glutaral, Cidex, Sonacide, HospexRespiratory sensitiserUsed as a disinfectant, medication, preservative, corrosion inhibitor, fixative, hardener in X-ray film developers, in leather tanning, as a cleaning agent, and in polymerisation reactions.
Ethylenediamine -  EC no. 203-468-6,  CAS no. 107-15-31,2-diaminoethane, Edamine, EDA, Algicode 106L, Amerstat 274, Bruggolen P22Respiratory sensitiserUsed as an intermediate, process additive, corrosion inhibitor, for the control of odour emission, in medicines, and as a monomer in epoxy, polyurethane and other polymers for adhesives and coatings.
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers - EC no. 201-289-8 and others,  CAS no. 80-54-6 and othersLilial, Lilyal, Lilyall, Lilestralis, Lysmeral, Lily aldehyde, Monastral Red B, QuinacridoneToxic for reproductionUsed as fragrances in a wide range of scented articles and mixtures, such as cosmetics, laundry powders, polishing, car care products, air cleaners etc, and use as an intermediate to make biocidal active substances.
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone -  EC no. 404-360-3,  CAS no. 119313-12-1Chivacure 169, Genocure BDMM, Irgacure 369, Omnirad 369, Speedcure BDMB, CG 25-369, TK 11-319Toxic for reproductionUsed as a photo-initiator in polymer production, in UV-curable coatings, inks, adhesives, putties, plasters, modelling clay and similar applications.
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one -  EC no. 400-600-6,  CAS no. 71868-10-5Genocure PMP, IHT-PI 907, Irgacure 907, Speedcure 97, UV 907Toxic for reproductionUsed as a photo-initiator in polymer production, in UV-curable coatings, paints, thinners, printing inks and toner.
Diisohexyl phthalate -  EC no. 276-090-2,  CAS no. 71850-09-4-Toxic for reproductionPlasticiser. May be used as a substitute for other comparable phthalates already subject to authorisation or recommended for inclusion in Annex XIV.
Orthoboric acid, sodium salt - EC no. 237-560-2,  CAS no. 13840-56-7Boric acid (H3BO3), sodium saltToxic for reproductionMay be used as a substitute for other borates already recommended for authorisation.

The Commission will now decide which of these substances to add to the authorisation list and what conditions apply, although this process can take several years.

The impact of authorisation can be very significant to companies and supply chains, from breaching the regulation to unplanned obsolescence. Some Annex XIV substances have limited use or can be readily replaced, but this isn’t always the case - the uncertainty and upheaval following inclusion of chromium trioxide on Annex XIV in 2013 is still playing out across companies and sectors. The use of very small quantities of Annex XIV substances in niche uses or formulations can be far more difficult to unearth and just as costly to resolve.

The inclusion of lead metal to Annex XIV REACH is expected to be particularly challenging. While the effects of lead on neural development are well known, lead is still used in safety critical applications such as radiation shielding. The International Lead Association (ILA) is also concerned about consequences for carbon reduction goals under the EU’s Green Deal initiative, given lead’s use in batteries for electric vehicles and renewable energy storage. A wave of new applications for authorisation will be triggered for uses that cannot be readily replaced or avoided.

TSG Consulting can help

Businesses need to understand and act where they or others in their supply chain rely on substances in Annex XIV to avoid business interruption.

Led by Sue Bullock, TSG’s Head of Chemical Compliance, Stewardship and Sustainability, our industry and regulatory experts can support you in understanding what implications the proposals might have for your business and supply chain.

  • We provide advice and strategy development for businesses concerned that the substances they use will be impacted by proposed developments under REACH
  • We have deep understanding of regulatory policy development and provide regulatory insight, technical support and advocacy services to affected businesses. We can help you build and make your case to public authorities as they progress proposals to control and limit the use of substances of very high concern
  • We help businesses identify and assess the feasibility of potential alternative substances or technologies. Our team of scientists and engineers help define the technical function and requirements relevant to the use and assess the implications of reduced performance from substitution
  • We help businesses develop practical roadmaps for REACH compliance. We work with you to assess potential options and identify the preferred strategy, based on available regulatory, technical and commercial considerations, minimising business risks in the event of authorisation listing

If you’d like to speak with our team, please get in touch at [email protected]

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