Risk Assessment of Manufactured Nanomaterials - Environmental and Human Health Impacts of Nanotechnology - page 406

Appendix 10.A

Chemicals Risk Assessment Under REACH and TSCA

10.A.1 REACH

The European Commission (EC) regulates industrial chemicals under the
Registration, Evaluation, Authorisation and restriction of CHemical substances
regulation (REACH) (EC No 1907/2006), which came into force on 1 June 2007.
The REACH regulation applies to chemicals that are manufactured or imported
in amounts greater than 1 tonne/year. Substances that are excluded from REACH
are covered by more specifi c legislation (e.g. human medicines, radioactive sub-
stances, non-isolated intermediates and waste). Although this regulation is specifi c
to the EC, similar regulation of industrial chemicals occurs world wide (e.g.
Morgenstern et al. , 2000 ; Thanawalla, 2002 ; NICNAS, 2004 ; ECHA, 2008 ).
REACH provides an over-arching legislation applying to the manufacture,
placing on the market and use of substances on their own, in preparations or in
articles. REACH is based on the principle that manufacturers, importers and down-
stream users have to ensure that they manufacture, place on the market or use such
substances that do not adversely affect human health or the environment. There
are no specifi c provisions in REACH referring to nanomaterials, but REACH
applies to manufactured nanomaterials on their own, in preparations or in articles
when they are considered as chemical substances.
Under REACH, manufacturers and importers have to submit a registration
dossier for substances manufactured at or above 1 tonne/year. If substances are
imported or manufactured at levels greater than 10 tonnes/year, the registrant will
have to perform a chemicals safety assessment (CSA) and produce a chemical
safety report (CSR; as shown in Figure 10.A.1). The CSA will have to cover the
risks of the nanomaterials including the properties of the nanomaterials, its clas-
sifi cation and labelling of hazardous properties, its risks and risk management
measures. The risk management measures have to be communicated to the supply
chain. Data generated under REACH serves as input to other regulations, for
example worker protection, cosmetics and environmental protection.
Regulation of chemical substances under REACH is based on the (precaution-
ary) principle 'that industry should manufacture, import or use substances or place
them on the market in a way that, under reasonably foreseeable conditions, human
health and the environment are not adversely affected' (ECC, 2000 ; ILGRA, 2001 ;
ECHA, 2007). Therefore, the emphasis is on the manufacturer or importer to collect
or generate the data on substances and to assess the risks involved.
Within REACH, there are several triggers (pieces of information which
force the regulator or manufacturer to supply further information) for specifi c
information requirements (Figure 10.A.1). The CSA, for substances imported
or manufactured in amounts over 1 tonne/year, contains information about the
physicochemical properties of the chemical and some toxicological information.
Further information triggers at 10, 100 and 1000 tonnes/annum require a CSR
to be submitted with more detailed information on toxicological, ecotoxicological
and carcinogenicity required as well as the physico-chemical properties of the
substance.