The European Chemical Agency announced today that seven new SVHC’s were added to the candidate list, which now brings the list to 151 substances.
What is the Candidate list?
The first step in the authorisation process is to identify those substances that may have serious effects on human health or the environment and, therefore, the risks resulting from their use must be properly controlled and the substances progressively replaced when possible.
A Member State or ECHA at the request of the European Commission, can propose a substance to be identified as a SVHC. If identified, the substance is added to the Candidate List, which includes candidate substances for possible inclusion in the Authorisation List (Annex XIV).
The inclusion of a substance in the Candidate List creates legal obligations to companies manufacturing, importing or using such substances, whether on their own, in preparations or in articles.
What are the legal obligations?
Companies may have legal obligations resulting from the inclusion of substances in the Candidate List. These obligations refer not only to the listed substances on their own or in mixtures but also to their presence in articles.
Substances in Articles:
- From the date of inclusion:
EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
- From 2011:
EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
- For substances included in the Candidate List before 1 December 2010, the notifications have to be submitted not later than 1 June 2011.
- For substances included in the Candidate List on or after 1 December 2010, the notifications have to be submitted no later than 6 months after the inclusion.
Note: A notification is not required when:
- the producer or importer of an article can exclude exposure of humans and the environment during the use and disposal of the article. In such cases, the producer or importer shall however supply appropriate instructions to the recipient of the article.
- The substance has already been registered for that use.
Substances on their own
From the date of inclusion:
EU and EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet.
Substances in Mixtures
From the date of inclusion:
EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).
This is without prejudice to the general obligation, applicable from 1 June 2007, for all EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC to provide the recipients, at their request, with a safety data sheet if the mixture contains a substance with an individual concentration ≥ 1% (w/w) for non-gaseous mixtures and ≥ 0.2% by volume for gaseous mixtures where that substance poses human health or environmental hazards.
The new Seven
Seven new SVHCs were added to the Candidate List. The new entries are listed below. Cadmium sulphide was added as it is carcinogenic and also as it was identified as being of an equivalent concern based on probable serious effects to human health (specifically due to the effects on kidney and bone). The next two substances listed are also identified as being carcinogenic, with the remaining four substances identified as being toxic for reproduction.
The legal obligations that companies may have resulting from the inclusion of substances in the Candidate List may apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles containing any of the seven substances included in the Candidate List on 16 December 2013 have six months to notify ECHA if the SVHC is present in articles in amounts that total more than one tonne per producer or importer per year and above a concentration of 0.1% weight by weight. There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded.
Substances included in the Candidate List for authorisation on 16 December 2013 and their SVHC properties:
|Substance Name||EC No.||CAS No.||SVHC Property|
|1||Cadmium sulphide||215-147-8||1306-23-6||Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f)|
|2||Disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28)||209-358-4||573-58-0||Carcinogenic (Article 57a)|
|3||Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38)||217-710-3||1937-37-7||Carcinogenic (Article 57a)|
|4||Dihexyl phthalate||201-559-5||84-75-3||Toxic for reproduction (Article 57 c)|
|5||Imidazolidine-2-thione (2-imidazoline-2-thiol)||202-506-9||96-45-7||Toxic for reproduction (Article 57 c)|
|6||Lead di(acetate)||206-104-4||301-04-2||Toxic for reproduction (Article 57 c)|
|7||Trixylyl phosphate||246-677-8||25155-23-1||Toxic for reproduction (Article 57 c)|
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