Product Liability 2009 - Arnold & Porter LLP

REACH and the Consumer Products Sector Freshfields Bruckhaus Deringer LLP
Such substances placed on the market in quantities of between
1 and 100 tonnes must be registered by 1 June 2018.
However, in order to qualify for these deadlines, potential
registrants of phase-in substances had to provide basic “preregistration”
information to ECHA by 1 December 2008. Preregistration
was required by any legal entity that has REACH
registration obligations in respect of most existing substances.
This could include manufacturers and importers of articles (where
a substance present in the article is intended to be released), as well
as of substances on their own or in preparations.
Those that failed to pre-register by 1 December 2008 cannot now
legally manufacture or import the relevant substance until they
submit a full registration to ECHA. There is evidence that many
companies made precautionary pre-registrations with this risk in
mind.
All manufacturers/importers who have pre-registered the same
substance will automatically form a Substance Information
Exchange Forum (SIEF), whose aim is to share data over its
period of operation. Much of the information that ultimately forms
part of the registration dossier for a given substance will come
from other SIEF members.
What information is required in the registration dossier?
The registration dossier must include a technical dossier and, for
substances manufactured or imported in quantities of ten tonnes or
more per year, a chemical safety report (CSR) that records and
summarises a chemical safety assessment (CSA). The CSR
records the hazard classification of a substance and the assessment
as to whether the substance is persistent, bioaccumulative, and
toxic (PBT), or very persistent and very bioaccumulative (vPvB).
The higher the tonnage, the more information on the intrinsic
properties of the substance is required.
The CSR also sets out exposure scenarios for the substance in
question. Exposure scenarios are sets of conditions that describe
how substances should be manufactured or used during their lifecycle.
This includes how the manufacturer or importer controls, or
recommends control of, exposures of humans and the environment
to the substance. The exposure scenarios must include appropriate
risk management measures that, when properly implemented,
ensure the risks from the uses of the substance are adequately
controlled. Exposure scenarios need to be developed to cover all
“identified uses”.
“Identified uses” are the manufacturers’ or importers’ own uses, as
well as uses that are made known to them by their downstream
users. Relevant exposure scenarios will need to be annexed to the
SDS that will be supplied to downstream users and distributors.
Where a customer does not want to make its use of a substance or
preparation known to the supplier, e.g. for reasons of commercial
confidentiality, it may have to assume the burden of preparing its
own CSR for the use in question.
REACH encourages the submission of existing information
wherever possible. New tests are only required when it is not
possible to provide the information in any other permitted way and
testing proposals may have to be pre-approved by ECHA. The aim
is to reduce the amount of testing on animals and avoid
unnecessary costs.
Evaluation
The Agency will evaluate a small proportion of the registration
dossiers received. It will also evaluate testing proposals made by
potential registrants.
Authorisation
Substances classified by the EU authorities as being of very high
concern (SVHC) and placed on Annex XIV of REACH will be
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subject to authorisation under REACH. SVHC include PBT and
vPvB substances, as well as category 1 and 2 CMR (Carcinogenic,
Mutagenic or Reprotoxic) substances. There is no minimum
tonnage threshold for authorisation.
At present, ECHA has published a “candidate list” of SVHC listing
18 potential SVHC, and this will be populated further over time.
Although the publication of the candidate list has triggered certain
obligations for businesses (see below), not all the substances on it
will necessarily be placed on Annex XIV and therefore be subject
to authorisation. Member State authorities are currently evaluating
the substances on the candidate list to determine which of these
substances should be placed on Annex XIV, which identified uses
of such substances should require authorisation and, for each, what
the “sunset date” should be, after which authorisation will be
required before use.
Once this system is fully operational, SVHC that appear on Annex
XIV will have to receive pre-marketing authorisation before they
can be placed on the market on their own, in preparations or in
articles. The burden is on the EU manufacturer or EU importer of
any such substance to convince ECHA, and ultimately the
Commission, that such a substance should receive authorisation.
In the case of CMRs, an authorisation will be granted if the
applicant can demonstrate that the risk from the use of the
substance is adequately controlled. For PBTs and vPvBs, and
CMRs where the applicant is unable to meet the “adequate
control” test, an authorisation may be granted if the applicant can
show that the socio-economic benefits of continued
manufacture/use outweigh the risks and that there are no suitable
alternatives available.
Restriction
This procedure replaces the current regime for banning or
restricting the use of the most hazardous chemicals. REACH
prohibits the manufacture, placing on the market or use of an
exhaustive list of such substances that will be enumerated in its
Annex XVII (which will doubtless be amended over time).
Enforcement
REACH’s legal form - a regulation - means that it took effect
across the EU on 1 June 2007 without the need for its provisions
to be implemented into the law of the Member States (as would be
the case with a directive).
Exemptions
Certain substances will fall outside REACH (e.g. radioactive
substances) or its registration requirements (e.g. substances used
as food additives) or will be deemed to have been registered (e.g.
active substances and co-formulants authorised for use in plant
protection products). Registration is also not required for
substances manufactured or imported at under one tonne/year.
What Regulatory Obligations Will REACH
Impose on Consumer Products Companies?
The direct regulatory impact of REACH on consumer products
companies and other downstream users of chemicals will vary
widely, depending upon the capacity in which any given corporate
entity acts in relation to any given substance or preparation.
EU-based manufacturers and importers of substances and
preparations
Relatively few consumer products companies manufacture
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