APPENDIX 21
Supplementary memorandum from the Department
for Environment, Food and Rural Affairs
During the evidence session held by the House
of Commons Science and Technology Committee on 9 February on the
new EU Chemicals Strategy (REACH), the Committee asked for further
information regarding the Commission's proposal for sharing of
test data and how this links with the Government's proposal of
"one substance, one registration".
We welcome the Commission's efforts to minimise
animal testing and we recognise that several provisions have been
included in the legislative proposal to encourage maximum use
of existing data and to minimise duplication of testing. However,
we have outstanding concerns about some of the mechanisms included
in the proposal for data sharing and consider that a system of
"one substance, one registration" would further improve
on the current draft text. In addition to the benefits in terms
of reduction of animal testing, we believe that our proposal of
"one substance, one registration" will have several
other benefits. It will lead to a reduction in the administrative
burden of REACH by reducing the number of individual registrations,
ensure that the information has been agreed by all manufacturers
and importers of the substance, lead to more accurate information
in the market, quicker processing of registration packages and
easier access to the information on any one substance by downstream
users. Set up correctly, it is also likely to be less open to
exploitation by unscrupulous companies as a barrier to market
entry by EU or external competitors.
There are three main areas where we consider
there is, on our current reading of the Commission proposal, scope
for duplicate animal testing. In addition, there is a fourth area
where broader data (and thus cost) sharing is not as strong as
we would like:
1. For phase-in substances (broadly speaking
those that are currently on the market), there is an obligation
for all potential registrants of the same substance to pre-register
(in two phases depending largely on supply tonnage) and join a
Substance Information Exchange Forum (SIEF). Before testing on
vertebrate animals is carried out, a potential registrant must
find out if that test is available within the Forum. If a relevant
study is available, the potential registrant and the study owner
shall take steps to reach agreement on cost-sharing. If, however,
the owner of the test refuses to provide either the cost of the
test or the test itself, the potential registrant shall proceed
as if the test did not exist unless the summary of the study is
already available in another registration. If our reading is correct,
this effectively means repeating the test to fulfil the registration
requirements.
2. The potential for duplicate testing may
be greater where a relevant test does not exist in the Forum.
In this case, the proposal states that members of the Forum who
require the same test "shall take all reasonable steps to
reach agreement as to who is to carry it out on behalf of the
other participants". The proposal does not, however, explicitly
prevent duplicate testing nor does it provide a mechanism for
ensuring that this does not happen. Additionally, where a test
result is not available within the SIEF, but exists, there is
no real mechanism for ensuring no duplication. One potential scenario
for this is where a substance is produced both at high volumes
(above 1,000 tonnes per year) and at medium or low volume (below
1,000 tonnes per year) and where the latter manufacturer/importer
has relevant data that is not available at the time of pre-registration/registration
by the former.
3. For non-phase-in substances (broadly
speaking a substance that is not currently on the market), we
consider that there are two occasions where tests may be repeated:
— In this context, the proposal does
state that "vertebrate animal tests will not be repeated"
where these are already available. If cost sharing cannot be agreed
between registrants, the Agency, on request, will hand over study
summaries for all the tests needed by the subsequent registrant.
However, the previous registrant will have a claim for 50% of
the test costs. Our reading of "on request" leaves open
the possibility that a subsequent registrant will repeat the test.
— In addition, only the study summary
will be provided, not the whole study. Study summaries may not
be sufficient if the registrant wishes to use the data in another
context (eg for complying with legislation in other jurisdictions).
This too could lead to repeat testing in order to acquire this
information.
4. Although not an issue of animal testing,
the Commission's proposal to our reading is that the main elements
of the data sharing requirements (detailed in Title III of the
proposal) refer only to vertebrate animal tests unless a registrant
indicates that information from tests not involving vertebrate
animals may be shared (against payment) with subsequent registrants.
This does not, therefore, guarantee that test data not involving
vertebrate animals must be shared. In this context it is worth
noting that the proposed information package for substances in
the 1-10 tonnes per year band contains no vertebrate animal tests,
so the Commission's approach would not provide much benefit for
the registrants of the majority of chemicals.
March 2004
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