ECHA has added the substance PFHxS to the Candidate List. Entries for bisphenol A and four phthalates have been updated to include endocrine-disrupting properties for human health. The Candidate List of substances of very high concern (SVHCs) for authorisation now contains 174 substances.
PFHxS belongs to the group of per- and polyfluoroalkyl substances (PFASs). This identification is part of a regulatory activity, targeting this large substance group with the aim to clarify the concerns and regulate the substances, as necessary. The aim is also to avoid undesired substitution with other PFASs. Several PFASs have already been identified as SVHCs, one group (PFOA and related substances) is now restricted, one restriction is under preparation and many assessments are underway.
Besides, the entry for bisphenol A (BPA) has also been updated to include endocrine-disrupting properties for human health, based on a proposal from France, following the SVHC identification process with the involvement of the Member State Committee (MSC). The BPA entry was updated to reflect an additional reason for inclusion due to its endocrine-disrupting properties causing adverse effects to human health. BPA was included in the Candidate List due to its toxicity to reproduction in January.
Four existing entries for benzyl butyl phthalate (BBP), bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) were also updated, due to the fact that the European Commission has decided on the endocrine-disrupting properties of the phthalates above, following MSC opinions on these substances.
Substances included/updated in the Candidate List for authorisation on 7 July 2017 and their SVHC properties:
|#||Substance name||EC number||CAS number||SVHC property||Examples of use(s)|
|1||Perfluorohexane-1-sulfonic acid and its salts (PFHxS)||–||–||vPvB (Article 57e)||Not yet registered under REACH. May be used as a plasticiser, lubricant, surfactant, wetting agent, corrosion inhibitor and in fire-fighting foams.|
|2||4,4′-isopropylidenediphenol (bisphenol A; BPA)||201-245-8||80-05-7||Endocrine disrupting properties (Article 57(f) – human health)||Manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing PVC and in thermal paper production.|
|3||Benzyl butyl phthalate (BBP)||201-622-7||85-68-7||Endocrine disrupting properties (Article 57(f) – human health)||Adhesives, sealants and coating products.|
|4||Bis(2-ethylhexyl) phthalate (DEHP)||204-211-0||117-81-7||Endocrine disrupting properties (Article 57(f) – human health)||Used as a plasticiser in polymers, such as PVC.|
|5||Dibutyl phthalate (DBP)||201-557-4||84-74-2||Endocrine disrupting properties (Article 57(f) – human health)||Used as a plasticiser in polymers, such as PVC.|
|6||Diisobutyl phthalate (DIBP)||201-553-2||84-69-5||Endocrine disrupting properties (Article 57(f) – human health)||Coating product, fillers, putties, plasters, modelling clay and polymers.|
To increase clarity and transparency, the terminology used in the Candidate List, regarding the reason for inclusion for substances identified as SVHCs under Article 57(f) is replaced with a description of the properties causing the adverse effects. Therefore, the previous text concerning â€œequivalent level of concernâ€ is replaced by a statement of the intrinsic properties relevant for identification under Article 57(f) in each of the applicable entries.
The Candidate List is a list of substances that may have serious effects on human health or the environment. Substances on the Candidate List are also known as “substances of very high concern”. The aim of publishing such a list is to inform the general public and industry that these substances are candidates for possible inclusion in the Authorisation List. Once they are on the Authorisation List, industry will need to apply for permission to continue using the substance after the sunset date.
Companies may have legal obligations resulting from the inclusion of the substance in the Candidate List. These obligations may apply to the listed substance on its own, in mixtures or in articles. In particular, any supplier of articles containing a Candidate List substance above a concentration of 0.1% (weight by weight) has communication obligations towards customers down the supply chain and consumers.
In addition, importers and producers of articles containing the substance have six months from the date of its inclusion in the Candidate List (7 July 2017) to notify ECHA. Information on these obligations and related tools are available on ECHA’s website.