Select Committee on Science and Technology Written Evidence


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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