New Biocidal Products Regulation Expands the Role of the ECHA Board of Appeals
New Biocidal Products Regulation Expands the Role of the ECHA Board of Appeals
Article 37 of the Biocidal Products Regulation (PE-CONS 3/12), adopted on 10 May 2012, grants jurisdiction to the European Chemicals Agency (ECHA) Board of Appeals over appeals against ECHA decisions taken pursuant to Articles 7(2), 13(3), 26(2),43(2), 45(3), 54(3), (4) and (5), 63(3) and 64(1) of the BPR. These ECHA decisions concern:
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Rejection of an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, for failure to timely pay the application fees (Article 7(2)).
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Rejection of an application for renewal of the approval of an active substance for one or more product-types for failure to timely pay the application fees (Article 13(3)).
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Rejection of an application for authorization of a biocidal product under the simplified authorization procedure of Article 25 for failure to timely pay the application fees (Article 26(2)).
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Rejection of an application for Union authorization in accordance with Article 42(1) for failure to timely pay the application fees (Article 43(2)).
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Rejection of an application by or on behalf of an authorization holder for renewal of a Union authorization for failure to timely pay the application fees (Article 45(3)).
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Rejection of an application to establish the technical equivalence of active substances for failure to timely pay the application fees (Article 54(3)).
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Rejection by the ECHA of an application to establish the technical equivalence of active substances on the merits (Article 54(4)).
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Rejection by the ECHA of an application to establish the technical equivalence of active substances for failure to timely submit additional information deemed as necessary to carry out the assessment of technical equivalence (Article 54(5)).
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A decision by the ECHA to allow a Me-Too applicant to refer to animal vertebrate studies owned by the original authorization holder in cases where the parties fail to agree on data sharing (Article 63(3)).
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A decision by the ECHA to allow a Me-Too applicant to refer to existing data after the end of the data protection periods specified in Article 60 BPR (Art 64(1)).
Because an appeal suspends the effect of the ECHA decision (Article 77(2)), it can be a powerful tool in avoiding delays to market in cases where the appropriate fees were inadvertently not paid on time, the applicant seeks to piggy back on existing authorizations, or legitimate data sharing disputes arise.
For assistance in complying with the above obligations, please contact Herbert Estreicher at +1 202.434.4334 or estreicher@khlaw.com.
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The Brussels office of Keller and Heckman LLP has been assisting clients on the Biocidal Products Directive and the National transitional schemes for biocides for a number of years. For further information, please contact Herbert Estreicher (+1 202.434.4334, +32 (0)2 645 50 96, estreicher@khlaw.com).