Biomedical Engineering Reference
In-Depth Information
prompted by the EC's October 3, 2012,
Communication on the Second Regulatory Review on
Nanomaterials
. The Communication describes the REACH program as “the best possible frame-
work for the risk management of nanomaterials when they occur as substances or mixtures” and
notes that “more specific requirements for nanomaterials within the framework have proven neces-
sary.” The CIEL proposal maintains that further regulatory action is necessary, and recommends
a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct
from their nonnanoscale counterparts and substantially lower volume thresholds for registration
of nanoscale substances. It also calls for an EU-wide registry for all nanomaterials and products
on the market.
*
The EC's Environment and Enterprise Directorate-Generals (DG) issued separate
statements in response to the NGOs' proposal. The DG Environment stated: “We regard the NGO
proposal … as a reaction to the Commission's recent regulatory review on nanomaterials. We
are looking forward to discussing our review with all the stakeholders.” DG Enterprise released
a more detailed statement, noting that the EC “does not consider appropriate at present to change
the basic registration rules under REACH and the rules for when a chemical safety assessment is
required under REACH.” In addition, the DG Enterprise stated: “[T]he highest volume substances
such as carbon black and synthetic amorphous silica, as well as the most debated substances such
as titanium dioxide, zinc oxide and carbon nanotubes, have already been registered under REACH.
Together, they represent the vast majority of nanomaterials on the market in terms of tonnage and
sales value.”
ECHA's REACH Technical Guidance Documents, until recently, gave no specific guidance con-
cerning nanomaterials.
†
There was a technical manual on how to include information on nanoma-
terial in an IUCLID dossier, which is an integral part of every REACH registration.
‡
The manual
describes possibilities and best practices to include nanomaterials and to structure the available
nanomaterial information.
§
The latter is particularly important when nanomaterials are additional
forms of a substance rather than substances in their own right.
¶
Further guidance on the clarifica-
tion and elaboration of the REACH information requirements and the Chemical Safety Assessment
in case of nanomaterials is needed as registration dossiers for nanomaterials must be prepared or
updated by companies and reviewed by the ECHA.
**
Work in the scientific community as well as in
international organizations has been ongoing for almost a decade on methodologies for assessing
risks associated with nanomaterials.
††
On this basis the Commission launched a comprehensive REACH Implementation Project
on Nanomaterials (RIPoN) in 2009 to provide advice on key aspects of the implementation of
REACH with regard to nanomaterials concerning Information Requirements and Chemical Safety
Assessment.
‡‡
Based on the scientific and technical state-of-the-art recommendations made in
reports to date, ECHA on April 30, 2012 published three new appendices, updating the
Guidance
on Information Requirements and Chemical Safety Assessment
.
§§
These three new appendices are
recommendations for registering nanomaterials.
¶¶
Another comment of note was issued on October 3, 2012, when the EC announced its adop-
tion of the
Communication on the Second Regulatory Review on Nanomaterials
, that assesses the
*
Center for International Environmental Law (CIEL). 2012. High time to act on nanomaterials: A proposal for a “Nano
Patch” for EU regulation. http://www.ciel.org/Chem/Nano_EU_13Nov2012.html.
†
European Commission—Environment—Nanomaterials. http://ec.europa.eu/environment/chemicals/nanotech/index.htm.
‡
Id.
§
Id.
¶
Id.
**
Id.
††
Id.
‡‡
Id.
§§
Id.
¶¶
Id.
See also
ECHA. 2012.
Updated Guidance on Information Requirements and Chemical Safety Assessment for
Nanomaterials
. http://echa.europa.eu/web/guest/guidance-documents/guidance- on-information-requirements-and-
chemical-safety-assessment.
