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 April 12, 2023, ECHA recommended that the following eight substances should be added to Annex XIV of REACH:
| Name | Alternative / Trade Name | Reason for Inclusion | Uses |
|---|---|---|---|
| Lead | EC no. 231-100-4, CAS no. 7439-92-1 | Toxic for reproduction | Used 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 | Glutaral, Cidex, Sonacide, Hospex | Respiratory sensitiser | Used 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 | 1,2-diaminoethane, Edamine, EDA, Algicode 106L, Amerstat 274, Bruggolen P22 | Respiratory sensitiser | Used 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 | Lilial, Lilyal, Lilyall, Lilestralis, Lysmeral, Lily aldehyde, Monastral Red B, Quinacridone | Toxic for reproduction | Used 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 | Chivacure 169, Genocure BDMM, Irgacure 369, Omnirad 369, Speedcure BDMB, CG 25-369, TK 11-319 | Toxic for reproduction | Used 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 | Genocure PMP, IHT-PI 907, Irgacure 907, Speedcure 97, UV 907 | Toxic for reproduction | Used 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 reproduction | Plasticiser. 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 | Boric acid (H3BO3), sodium salt | Toxic for reproduction | May 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.
