10 Things You Should Know About REACH
-
REACH
is expected to affect some 30,000 chemical substances on the EU market.
- Manufacturers
or importers are prohibited from placing such substances on the EU market in
quantities greater than 1 tonne per year unless that substance, and its
particular use, is pre-registered with the European Chemicals Agency within
stipulated deadlines and, if a substance of high concern, has secured
authorisation (the 'no data, no market' principle).
- The
'no data, no market' principle applies to chemical substances themselves,
preparations of such and articles incorporating these substances where those
substances are intended to be released during reasonably foreseeable conditions of use of the article.
- Companies
must identify all their substances (including in finished products) subject to
the REACH registration requirements in order to prepare for the initial
pre-registration stage.
- A
non-EU manufacturer producing a substance and exporting it to the European
Union is directly affected by REACH, but it is unable to register. Registration, and all other REACH obligations
will be carried out by the importer of
the non-EU manufactuer’s substance. Alternatively, the non-EU
manufactuer may choose to appoint an “only representative” (OR) within the EU
to fulfil REACH obligations, in order to safeguard sensitive data, rather than
the importer assuming this responsibility.
- Comprehensive
and detailed information on the properties of such substances must be gathered
to demonstrate safe use, identify related risks and provide guidance on safe
use. This imposes major administrative
responsibilities on EU producers and importers, the costs of which are
estimated to amount to billions of euros.
- Downstream
users, including producers of finished articles incorporating these substances,
will be significantly affected. They
must apply the risk management measures for dangerous substances identified on
the chemical substance supplier's Safety Data Sheet (SDS). They can also insist that the manufacturer of
a substance which it uses lists its particular use as an 'identified' use.
- Manufacturers
and importers will be required either to include any 'identified' downstream
uses reported to them in their chemical safety assessments or pass the request
up the supply chain.
- Restrictions
may be imposed on the use of registered substances (whether on own, in a
preparation or in an article) in certain products or their use may be totally
banned.
- REACH
requires cooperation between undertakings in data sharing and new data
development regarding dossier development and for joint registration. Undertakings will likely form consortia to
manage data, benefit from cost sharing and protect confidential business
information. Significant legal and
technical resources will be required to set these up.