Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
A registrant may identify certain information listed in Article 119 (2) as confidential in
his registration dossier for reasons of commercial interests (Article 10(a)(xi)). If the
justification is accepted as valid by ECHA, such information will not be made publicly
available. The information listed in Article 119 (2) will be published on the ECHA
website if no valid confidentiality claim is submitted by the registrant and is accepted as
valid by ECHA.
Access to such pieces of information and other pieces of information may be granted by
ECHA on request on a case-by-case basis whenever this is foreseen in Regulation (EC)
No 1049/2001. This Regulation also defines cases in which public access to documents,
whatever its medium, has to be denied, for instance for reasons related to commercial
interests. Where it is not clear whether a document may or may not be disclosed, the
regulation requires ECHA to consult the owner of the document with a view to assessing
whether it should or should not be disclosed.
According to Article 119(2) the following pieces of information can be claimed confidential for
reasons relating to commercial interests of the registrant or any other party, if justified:
If essential to classification and labelling, the degree of purity of the substance and the
identity of impurities and/or additives which are known to be dangerous;
the total tonnage band (i.e. 1-10 tonnes, 10-100 tonnes, 100-1000 tonnes or over
1000 tonnes) within which a particular substance has been registered;
the study summaries or robust study summaries of the information on physicochemical
data concerning the substance, on pathways and environmental fate as well as on
toxicological and ecotoxicological studies;
certain information contained in the safety data sheet as defined in Article 119(2);
the trade name(s) of the substance;
the name in the IUPAC Nomenclature for non-phase-in substances which fulfil the
criteria for any of the hazard classes set out in Article 58 (1) of Reg (EC) No 1272/2008
for a period of six years;
the name in the IUPAC Nomenclature for substances which fulfil the criteria for any of
the hazard classes set out in Article 58 (1) of the CLP Regulation that are only used as
one or more of the following:
(i) as an intermediate;
(ii) in scientific research and development;
(iii) in product and process orientated research and development.
Disclosure of the following information shall normally be deemed to undermine the protection
of the commercial interests of the concerned person, and therefore according to Article 118
this information must not be published on the ECHA website or disclosed otherwise, with an
exception when urgent action is essential to protect human health, safety or the environment:
details of the full composition of a mixture;
without prejudice to Article 7(6) and Article 64(2), the precise use, function or
application of a substance or mixture, including information about its precise use as an
intermediate;
the precise tonnage of the substance or mixture manufactured or placed on the market;
the links between a manufacturer or importer and his distributors or downstream users.
In contrast, the following information submitted in the registration dossier and held by ECHA
on substances whether on their own, in mixtures or in articles, shall be made publicly
available, free of charge on the ECHA website:
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu