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ECHA reporting on nanomaterials to the European Commission
ECHA has analysed the extent to which companies included information about nanomaterials in their REACH registration dossiers and classification and labelling notifications. A report of the analysis has been sent to the Commission, which will use it in reply to the European Parliament.
In April 2009, the European Parliament asked the Commission to compile information on how nanomaterials are covered in all legislation across the European Union. In 2010, the Commission made an official request to ECHA for assistance in gathering information on nanomaterials reported by chemical companies either in their REACH registration dossiers or in notifications to the classification and labelling inventory under the CLP Regulation.
Challenge with nanomaterials
ECHA has a very large repository of REACH registration and C&L notification dossiers that could in principle provide information on nanomaterials registered or notified and therefore on the market. However, the REACH and CLP Regulations do not have any specific requirements for registrants and notifiers of substances that are nanomaterials or nanoforms of a substance. There is also no definition for nanomaterial  within REACH and CLP legislations. The European Commission has, however, addressed nanomaterials in a series of papers endorsed by the REACH and CLP competent authorities (CARACAL).
For REACH registrations, the position of the Commission2 is that nanomaterials are covered by the definition of substance under Article 3(2) of the REACH Regulation, and that REACH requirements are applicable to nanomaterials. It has also been agreed that nanomaterials could be considered as substances in their own right and thus registered as such, or as forms of a substance and included in the registration dossiers of corresponding bulk substances. For C&L notifications, the Commission considers that the classification and labelling of nanomaterials should follow the rules set in the CLP Regulation.
Therefore, it was expected that nanomaterials would be reported in the dossiers as any other substance or form together with their hazardous properties and the appropriate risk management measures. Registrants and notifiers were encouraged to make explicit in their dossiers if they believed their substance was a nanomaterial or a nanoform of a substance.
Retrieving information from ECHA databases
The databases holding the REACH registrations and C&L notifications were screened at the end of June 2011 for retrieving information on nanomaterials. The screening strategy included retrieving those registrations and notifications that had reported "nanomaterial" as the form of the substance in the appropriate fields of the dossier, as well as those that contained the word "nano" in any part of the dossier. The retrieved dossiers were further assessed to verify whether they were likely to contain relevant information on nanomaterials.
The term "nano" was chosen as the search criterion because without a definition for nanomaterial in REACH or CLP, information on particle size could not be used as a clear-cut criterion. The use of "nano" by a registrant or a notifier in a relevant context was considered to be an indication that the dossier may include nanomaterials or nanoforms within the scope of the substance.
Conclusions of the analysis
The screening retrieved dossiers for 78 registered substances which contained some information on nanomaterials. Of these, five substances clearly included nanoforms within the scope of the substance. For most of the dossiers, however, "nano" was found in the context of read-across from studies carried out on nanomaterials, but the company did not specify whether the registered substance included nanoforms or not. The C&L database search yielded 18 notifications with nanomaterial selected as the form of the notified substance. One substance was common to both lists.
The retrieved substances included many of those that are on the list of manufactured nanomaterials compiled by the OECD Working Party on Manufactured Nanomaterials (WPMN). In some cases though, when a registered substance was on the WPMN list, the registration clearly excluded nanoforms from the scope of the registration. In addition, it is possible that some of the substances on the WPMN list are not manufactured at a level that would already require registration; e.g. no registrations or notifications were found for fullerenes. It may have been also unclear to companies whether to treat their substances as nanomaterials due to the lack of consensus on the definitions for particulate nanomaterials at the time of registration or notification. Nevertheless, the analysis was able to retrieve from the registration and C&L databases the substances which companies had explicitly identified as nanomaterials.
- European Parliament resolution of 24 April 2009 on regulatory aspects of nanomaterials
- Second Commission communication on the Regulatory aspects of nanomaterials
- Nanomaterials in REACH.
Document endorsed by the REACH and CLP Competent Authorities in December 2008
- Classification, labelling and packaging of nanomaterials in REACH and CLP.
Document reflecting the discussions within the REACH and CLP Competent Authorities in December 2009
- List of manufactured nanomaterials and list of endpoints for phase one of the sponsorship programme for the testing of manufactured nanomaterials: revision
 In October 2011, the European Commission adopted the recommentation on the definition of a nanomaterial and published the reports from the REACH Implementation Projects on Nanomaterials (RIPoNs). The screening reported here was carried out at the end of June 2011. Therefore, the screened registrations and notifications were submitted before the official recommendation was adopted.
Text by Sanna Airaksinen and Hanna-Kaisa Torkkeli
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