New REACH SVHCs Published Plus Restriction Proposals


17 January 2019

science-1336663_1920The European Chemical Agency announced the addition of six substances to the REACH Candidate List of Substances of Very High Concern on the 15th January 20191. These are:

  • Benzo[k]fluoranthrene (BkFA), fluoranthene, phenanthrene and pyrene. These four substances are polycyclic aromatic hydrocarbons (PAHs). They are not produced intentionally (except pyrene which is used only as an intermediate), but occur as impurities in carbon black, in extender oils and in petrochemical by-products such as pitch. As such they can occur in polymers and rubbers, although usually at less than 0.1% by weight in articles.

BkFA is one of 8 PAHs (4 of which including BkFA are also SVHCs) already restricted from use by REACH (Article XVII, entry 50) in a number of applications including supply to the general public where there is prolonged or short-term repetitive contact with the skin or oral cavity. It is possible that the other 4 restricted PAHs could be put forward as SVHCs. Similarly the other 3 new PAH SVHCs could be proposed for addition to entry 50 of Annex XVII in due course.

Incidence of PAHs as unexpected contaminants in polymers and rubbers has been quite common problem in recent times, but nearly always at <0.1%.

  • 2,2-bis(4'-hydroxyphenyl)-4-methylpentane. This substances is a type of “bisphenol” similar in its chemical structure to bisphenol A and so it may have similar uses such as in adhesives, paints and to make polymers. The ECHA Annex XV report gives two possible uses, one in thermal paper and the other to make polymers although this is only based on patents. Other sources indicate that it may also be used as a bioactive substance.
  • 3-Benzylidenecamphor, (3-BC). This substance is used as a UV filter in cosmetics (where it is subject to concentration limit) such as sunscreen. It is not reported to be used in articles.

All of the new additions, apart from 3-BC, were the subject of a consultation in September 2018 to determine whether they met the criteria for an SVHC (as defined in Article 57). However, one other substance was considered in this consultation - undecafluorohexanoic acid (PFHxA) and its ammonium salt. This was withdrawn by Germany, the Member State which had originally proposed it as an SVHC – but was immediately then put forward for restriction including any of its salts and related substances. The scope of the restriction is not yet defined but there has been widespread concern over the use of PFHxA as the replacement for PFOA in the manufacture of fluorinated products, in particular Teflon. The Annex XV report states that the precursors to undecafluorohexanoic acid and its ammonium salt are also used for photolithography in semiconductor manufacture, in some firefighting foams, and as additives in hard chrome coating processes.

ECHA has also submitted proposals to restrict:

  • microplastics - as intentionally added microplastic particles to consumer or professional use products of any kind.
  • formaldehyde and formaldehyde releasers – in mixtures and articles for consumer uses. Formaldehyde can be released from a variety of polymers and resins (e.g. phenol-formaldehyde is a type of phenolic resin).
  • three siloxanes; octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6). D4 and D5 were already proposed for restriction; D6 has now been added. All three are SVHCs. The proposed restriction covers a number of uses including in consumer and professional dry cleaning, waxes and polishes, washing and cleaning products at above 0.1%.

1 https://echa.europa.eu/candidate-list-table

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Picture of Chris Robertson

Written by Chris Robertson

Head of Product Regulatory Compliance, RINA