Covance were approached by a client with a synthetic graphite nanotube used in specialized applications who needed to register it in the European Union under REACH (Registration, Evaluation, Authorization and restriction of Chemicals) regulation. Although graphite is already registered under REACH, these tubules were clearly nanomaterials and therefore required a specialized REACH registration.

1. Chemical Services Case Study
Background
Covance was approached by a client with a synthetic graphite nanotube used in specialized applications
who needed to register it in the European Union under REACH (Registration, Evaluation, Authorization
and restriction of Chemicals) regulation. Although graphite is already registered under REACH, these
tubules were clearly nanomaterials and therefore required a specialized REACH registration.
The Challenges
The challenges that confronted Covance were:
▶ Identifying and negotiating to join a SIEF (Substance Information Exchange Forum):
As REACH mandates a one-submission, one-substance approach, registrants of substances must ascertain if their
substance is already registered by submitting a letter of enquiry to ECHA (European Chemicals Agency). If a
substance is already registered, then it is necessary to negotiate with the SIEF to become a joint member to enable
submission under a lead registrant.
▶ Establishing substance identity:
To enable Covance to confirm if the substance was already registered under REACH, a detailed characterization of
the substance was required. For nanomaterials, the analytical approach requires the use of a range of techniques
not usually performed for conventional substances. Identifying the appropriate analytical tests and the subsequent
interpretation of the results can be challenging.
▶ Interpreting complex technical data in the context of the regulations on nanomaterials:
Interpretation of highly technical data in the context of REACH regulation requires scientific and regulatory
expertise. In addition, it can be challenging to present this effectively within the constraints of a REACH dossier
submission.
The Solutions
Covance’s experience with REACH regulations, SIEF engagement and capability in interpreting technical
physicochemical data for nanomaterials ensured successful dossier submission.
Covance’s extensive experience with REACH ensured smooth and timely entry into the appropriate SIEF
With the analytical data available, Covance used their technical know-how and understanding of the REACH system
to conduct a detailed comparison of the characteristics of their client’s nanomaterial against previously registered
carbon nanotubes. This comparison of nanoforms enabled Covance to identify the appropriate SIEF. Covance then
approached and negotiated entry into the SIEF to enable the submission of a joint member dossier.
NAVIGATING NANOMATERIALS
THROUGH REACH

2. Covance’s experience in regulatory submissions and their technical insight enabled the
submission of a highly complex joint member dossier, in line with REACH requirements
for nanomaterials
Joint member dossiers are usually straightforward, but for nanomaterials, specific information,
beyond what is usually required on substance identity and characterization, is needed. For most
substances, spectral analyses e.g., UV-visible and infrared spectroscopy and NMR (nuclear magnetic
resonance) are used to confirm structure with chromatographic analysis being used to assess purity.
For this carbon nanotube, Covance interpreted and summarised an extensive array of
physicochemical characterisation data including, transmission electron microscopy, Raman
spectroscopy, energy dispersive spectroscopy, X-ray diffraction, particle size analysis, pore volume
analysis and gas chromatography-mass spectrometry analysis. This enabled Covance to create a
dossier that described the substance dimensions (both external and internal, as it consisted of a
tube within a tube); crystallinity, particle size, surface area (from gas absorption methodologies),
impurities, carbon content not in the form of tubes (i.e., unreacted carbon), metal and non-
metallic content. Covance were able to take the extensive and highly technical physicochemical and
structural data and present it coherently within the joint member dossier, ensuring that all relevant
interpretation required for regulatory review was provided.
Conclusions
Covance applied its scientific and regulatory insight to create a dossier for a carbon nanotube
aligned with the ECHA legislative requirements for nanomaterials. By keeping pace with regulatory
and scientific innovations, Covance yet again delivered excellent service for clients.
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