Four new substances have been added on the Candidate List of substances of very high concern for Authorisation on the 16th of July, 2019. These substances now identified as SVHC substances are:
- Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)
- Endocrine disrupting properties, used as a stabilizer for the production of plastic and rubber products
- 4-tert-butylphenol (CAS 98-54-4)
- Endocrine disrupting properties, used as a monomer in e.g. the production of resins
- 2-methoxyethyl acetate (CAS 110-49-6)
- Toxic for reproduction, used as an industrial solvent in e.g. resins, paints and lacquers
- 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides covering any of their individual isomers and combinations thereof; HFPO-DA
- Equivalent level of concern having probable serious effects to human health and the environment, used as a processing aid in the production of fluorinated polymers.
The Candidate List is a restriction mechanism under the EU REACH Regulation. One of the main aims of the REACH Regulation is to substitute chemicals of concern with safer options and processes. The substances on the Candidate List have been picked as candidates for further authorisation. The use of an authorised substance requires a permit.
The abbreviation SVHC stands for substances of very high concern. In order for a substance to be added on the Candidate List, it must have one or more of the following properties:
- Carcinogenic, mutagenic or toxic for reproduction (category 1A or 1B)
- Persistent, bioaccumulative and toxic (PBT)
- Very persistent and very bioaccumulative (vPvB)
- Endocrine disrupting properties
- Substances that cause an equivalent level of concern, such as respiratory sensitizers
Immediate obligations follow upon the identification of substances as SVHC substances, for article manufacturers and suppliers, especially. The following obligations enter into force:
- A Safety Data Sheet must be available for substances and mixtures with > 0,1 w-% of SVHC substances
- The supplier of an article containing > 0,1 w-% of SVHC substances must provide its customers sufficient information to allow safe use
- Upon request, consumers need to be informed of SVHC substances in articles in > 0,1 w-% concentrations within 45 days
- Article manufacturers and suppliers need to inform the European Chemicals Agency (ECHA), if their articles contain > 0,1 w-% of an SVHC substance and the total amount of that SVHC substance is > 1 tonne/year per manufacturer or supplier.
Article manufacturers, importers and suppliers should also be aware of the different SVHC consumer interfaces that are under development. ECHA is setting up a database that would require each of the suppliers along an article’s supply chain to make a notification of the SVHC substances in the article, starting from 5.1.2021. The EU-funded project LIFE AskREACH is also developing an app for mobile phones that consumers could use to check the SVHC substances in articles directly using the bar code.
Currently there are a total of 201 substances on the Candidate List. The list is updated twice a year, in January and July. Substances that might eventually end up as SVHCs based on their properties have been identified by ChemSec on their SIN List, with impressive accuracy.