Decision 1606/2013/AN
Purported implementation by ECHA of the first solution
Observations by ECEAE (the complainant)
Summary of ECEAE’s position
1. In ECEAE’s submission, ECHA is failing to implement the first proposal of the friendly settlement in a key respect: it wrongly claims that it does not have the power, still less the duty, to reject a testing proposal on the basis that consideration of alternatives [1] by the registrant is inadequate.
2. ECHA is, in effect, seeking to re-run legal arguments which have been rejected by the Ombudsman. It should not be permitted to do so. Further delay in this long-running dispute should not be tolerated. The Ombudsman may recall that, when responding to ECHA’s response to the Proposal for a Friendly Solution (the proposal), ECEAE expressed serious misgivings as to whether ECHA genuinely intended to implement the individual proposals. Those misgivings have, unfortunately, proved justified with regard to the first proposal.
Background
3. It is worth reminding the Ombudsman where the fault lines were drawn in relation to ECEAE’s complaint about the scope of ECHA’s duties with regard to testing proposals. The position was fairly summarised by the Ombudsman in paragraph 10 of her Proposal:
‘The complainant takes the view that ECHA should reject animal testing proposals when other data about the safety of the substance are available and can be used (“read-across”), or when data could be generated by an alternative method which takes into account the “3R principle” – namely, it does not use animals (replacement), uses fewer animals than proposed (reduction), or causes them less suffering (refinement). The complainant strongly disagrees with ECHA's position that it can reject testing proposals only when the exact information is already available or that information is not required for the tonnage of substance that will be marketed’ (emphasis added).
4. The Ombudsman found in favour of ECEAE’s position. For example, in the Proposal, she said: [2]
‘ … Article 40(3)(c) of the REACH Regulation allows ECHA to reject a testing proposal that does not comply with Annexes IX, X and XI, while requesting the registrant to perform additional tests. Annexes IX, X and XI contain not only the standard information requirements, but also the possible adaptations to them, as well as the general conditions which need to be fulfilled for the standard information requirements to be adapted. This means that a testing proposal might not comply with those Annexes in two ways: the first, if the registrant proposes an alternative testing method that does not fulfil the conditions in the Annexes allowing the standard requirements to be departed from; or the second, if the registrant ignores the possibility of demonstrating the safety of a substance by alternative means (adaptations), even though this would be possible in the given case. In both situations, Article 40(3)(c) enables ECHA to reject the non-compliant proposal and to request that another proposal be submitted; one which, it goes without saying, complies with the relevant Annex’ (emphasis added).
In other words, ECHA’s power to reject a testing proposal under Article 40(3)(c) arises both where a registrant inappropriately proposes an alternative and where a registrant inappropriately fails to propose an alternative. There is no distinction between what ECHA can do in the two situations. This accords with common sense.
5. In Decision 1606/2013/AN (the Decision), the Ombudsman recorded:
‘ECHA has accepted the Ombudsman’s proposals for a solution. However, in order to implement the first proposal, further measures may need to be adopted and the Ombudsman trusts that ECHA will take all the necessary steps to do so. The Ombudsman therefore invites ECHA to inform her, within six months of the date of this decision, of its position on the matter in order to enable her to review the progress made’.
6. The Decision also, in paragraph 26, invited ECEAE to monitor ECHA’s implementation of its commitments. This submission represents acceptance of that invitation.
7. The first proposal was:
‘to systematically require registrants to show that they have considered alternative testing methods [the Three Rs principle] to generate the missing information and have found that the information gap cannot reasonably be filled through such methods’.
8. The second proposal was:
‘to share with the registrant any relevant information concerning the potential availability of alternative testing methods for the registered substance. If a registrant does not adopt the non-animal testing method in question, ECHA should require it to explain to ECHA’s satisfaction why it does not consider it useful or possible to do so’.
The Ombudsman did not require ECHA to report on its implementation of the second proposal.
9. It may also be worth reminding the Ombudsman of the three stages of registration which are relevant to the dispute:
· Completeness (Article 20 of REACH): this is where ECHA checks that a registrant has included information pertaining to the endpoints which are relevant for the tonnage at which the substance is manufactured and imported. There is no assessment of the quality or relevance of information at this point: see Article 20(2)
· Compliance check (Article 41): this is where ECHA can check that the information supplied by a registrant meets the requirements of REACH. Quality and relevance are assessed at this stage
· Testing proposal (Article 40): a registrant must submit a proposal to carry out tests where there is a data gap at Annex IX and X tonnage. There is an opportunity for third parties to provide information relevant to proposals involving live animals (Article 40(2)). Based on its examination of the proposal, ECHA is mandated to accept, vary or reject it (Article 40(3)).
Recent events
10. Implementation of the first proposal has been discussed at the Commission’s Competent Authorities for REACH and CLP committee (CARACAL).
11. On 8 March 2016, the European Commission wrote to ECHA giving is opinion on the measures adopted by ECHA to implement the proposals (attached).
12. On 11 March 2016, ECHA wrote to the Ombudsman to explain how it was implementing the first proposal.
13. On 15 March 2016, ECEAE sent an email to Ms Hirsch-Ziembinska, requesting that the Ombudsman should not make any decision on the adequacy or otherwise of what ECHA was doing in relation to the first proposal until ECEAE had had the opportunity of clarifying some matters with ECHA.
14. On 21 March 2016, ECEAE wrote to ECHA seeking that clarification (attached). It asked ECHA to confirm that it would reject a testing proposal if not satisfied that a registrant had made adequate consideration of alternatives when submitting a testing proposal.
15. On 4 May 2016, ECHA replied, explaining that, in its view, it did not have the legal power to reject a testing proposal for this reason (attached).
ECHA’s position in more detail
16. In its letter to the Ombudsman of 11 March 2016, ECHA explained that:
· A registrant is now required to include in its registration dossier its consideration of alternative methods
· If no consideration is included, the registration is incomplete and liable to be rejected under Article 20 of REACH [3]
· ECHA publishes the consideration along with an animal testing proposal on its website, enabling third parties to comment
· ECHA takes the consideration into account in its evaluation of the testing proposal. A section addressing ECHA’s assessment of the consideration has been developed in its draft testing proposal decision template
· ECHA will reject a testing proposal if it already holds or has access to endpoint compliant data, indicating that the proposed test is not needed for the endpoint in question
· If, however, ECHA believes that it does not have sufficient information on alternatives at its disposal to conclude that animal testing can be avoided, it will require the proposed test to take place
17. ECHA did not, however, state explicitly that it would also reject a testing proposal where there was inadequate consideration of alternatives. ECEAE therefore wrote on 21 March 2016 to ECHA seeking clarification about this:
‘You go on to say that ECHA will reject a testing proposal if it already has endpoint compliant data. Earlier in the letter, you say that a failure to provide considerations will also result in rejection. What you do not say explicitly is that ECHA will also reject a proposal if it is not satisfied that a registrant has given adequate consideration to the availability of alternatives. Logically, that must be ECHA’s position: there is no point in assessing a registrant’s consideration of alternatives unless ECHA will reject a proposal if it concludes that the consideration is inadequate.
I note that you say later that the Commission has confirmed that the friendly solution can be implemented without amending REACH. ECHA had originally argued that REACH in its current form did not permit it to reject a testing proposal on the basis of inadequate consideration of alternatives. It is a key part of the friendly solution that a testing proposal would be rejected for this reason. It appears to follow that ECHA now accepts that it both can and must reject a proposal if there has been inadequate consideration of alternatives.
I would be very grateful if you would confirm that that is indeed the Ombudsman's position’.
18. In its reply of 4 May 2016, ECHA said that, in fact, it could not reject a testing proposal because a registrant had not given adequate consideration to alternatives. It reiterated that a registration dossier which did not contain consideration of alternatives would not be complete within Article 20.
The Commission’s position
19. In its letter of 8 March 2016 to ECHA, the Commission explained its position:
· ECHA has a share in the overall responsibility of avoiding animal testing, a general obligation under REACH (Article 25(1) read together with Articles 1 and 13)
· Registrants may provide the necessary justification for submitting a testing proposal, including taking into consideration alternative methods to the proposed animal test. As a result, ‘considering alternative methods to a requested animal test is an integral part of a testing proposal’
· When conducting a completeness check, ECHA must check that a registrant has included consideration of alternatives. However, the completeness check does not include an assessment or the quality or the adequacy of the data or justifications provided: Article 20(2)
· ECHA can also request this information at any time, on the basis of either Article 36 (read with Articles 13 and 25 and Annexes VI to X but without prejudice to Titles II and VI) or under Article 41 as a result of a compliance check
· There is accordingly no need to amend REACH to enable implementation of the Ombudsman’s decision (as both the Commission and ECHA had earlier suggested)
· With regard to a testing proposal evaluation, ECHA can call on a registrant to remedy deficiencies on the consideration of alternatives. If the registrant fails to provide adequate information on consideration of alternatives, ECHA should launch a compliance check. This may lead to a finding that the registration is not compliant with Article 13. However, this is for enforcement by Member States: a testing proposal cannot be rejected for this reason
· In apparent contradiction to this, the Commission goes on to say that, regardless of the comprehensiveness of a registrant’s documentation demonstrating consideration of alternatives, ECHA has a duty to decide, on the basis of all information at its disposal at the time, on the need to perform, modify or reject the animal test proposed. If there is a data gap, it should be filled either by the proposed animal test or an alternative. If animal testing can, in its opinion, be avoided, ECHA may, under Article 40(3), reject the testing proposal. At the same time, ECHA should require the registrant to update its dossier with data already available or with an adaptation deemed adequate by ECHA to fulfil the information requirement in question
20. The Commission concluded its letter thus:
‘… in the Commission services’ view, under the current REACH framework ECHA has at its disposal the legal and scientific means to implement the [Decision] without any amendment to the Annexes of the REACH Regulation.
On the other hand, it would be advisable to clarify in ECHA Guidance and the relevant IT tools for data submission that registrants have to duly demonstrate having considered alternatives to animal testing in the registration, and failing to do so they will be penalised’.
ECEAE’s submissions
21. In ECEAE’s respectful submission, ECHA, by claiming that it has no power, still less a duty, to reject a testing proposal where a registrant has not given adequate consideration to alternatives, is failing to implement the Decision. It is still maintaining its original position: it can only reject a testing proposal where the information is already available or is not required at the tonnage in question, and cannot reject a proposal because a registrant/proposer has given inadequate consideration to alternatives.
22. It is important background that ECEAE had expressed misgivings, in its Observations in May 2015, about ECHA’s claim, made in its Reply dated 16 April 2015 to the Proposal, that it accepted the first proposal:
‘On page 2 of its Reply, ECHA says that it accepts the proposal. However, it then proceeds to erect a large number of barriers to effective implementation:
i. It says that it “will not be in a position to reject a testing proposal for a standard REACH information requirement on the basis that a registrant has not considered alternative methods”
But that is precisely what the Ombudsman says it must do…
The Ombudsman had noted [4] that Article 40(3)(c) of REACH empowers ECHA to reject a testing proposal which does not comply with Annexes IX, X and XI and explained that a testing proposal could be non-compliant through failing to rely on an available adaptation as much as through proposing an inappropriate adaptation.
ECEAE had complained that ECHA was unlawfully (and contrary to its own guidance) adopting an approach ultra-deferential to registrants by refusing to reject a testing proposal involving animals even where ECHA believed that a non-animal method was available. The Ombudsman evidently agrees that ECHA’s approach is unlawful, reaching the provisional view that ECHA’s interpretation of its obligations in evaluating testing proposals is ‘excessively restrictive’. [5] If a testing proposal contemplates the unnecessary use of animals, it must follow from the Ombudsman’s analysis that ECHA has to reject it. Otherwise, ECHA would be requiring a registrant to do something which is contrary to fundamental REACH principles, as well as the animal experiments directive.