Regulatory Update: 04/2012
Issued: 17th February 2012
Introduction and background
Regulation (EC) No 1107/2009 applied from 14 June 2011, and put in place new rules for the avoidance of duplicate testing and sharing of tests and studies involving vertebrate data. The purpose of this Regulatory Update is to provide updates of CRD policy in this area.
Vertebrate data sharing provisions – a reminder
Article 62 of Regulation (EC) 1107/2009 introduced new vertebrate data sharing provisions allowing Member States to use vertebrate studies on behalf of prospective applicants even if an agreement with the holder(s) of the authorisation could not be reached.
Article 62(3) states that the prospective applicant and authorisation holder(s) must make ‘every effort’ to ensure that they share vertebrate tests and studies and the costs must be determined in a ‘fair, transparent and non-discriminatory way’. What constitutes ‘every effort’ has been discussed between Member States and the European Commission. It has been agreed that the prospective applicant should submit an official letter to the Member State demonstrating that they have made an attempt to gain access and have allowed sufficient time for the authorisation holder(s) to respond. It was also agreed to be good administrative practice that Member States contact the original notifier to confirm contact has been made. If no agreement can be reached and we are satisfied that the prospective applicant has made ‘every effort’ with the authorisation holder(s) then the studies will be used to support authorisations.
CRD is not in a position to adjudicate in commercial disputes. However, where companies are unable to reach agreement voluntarily, Regulation (EC) 1107/2009 allows the competent authorities to introduce national measures obliging the companies involved to share data using procedures specified by the authorities. Details of the current UK arbitration scheme can be found in the Applicant Guide. It should be noted that such arbitration decisions are only valid in the UK.
These vertebrate data sharing arrangements apply to all applications received after 14 June 2011.
Acceptance of duplicate studies
Article 62 (2) states that MS shall not accept the duplication of tests and studies on vertebrate animals or those initiated where conventional (calculation) methods could have been used. If vertebrate studies are submitted, they must be justified fully (see Article 8 (1) (d)). CRD will not accept studies without such justification from the applicant.
We will accept vertebrate studies generated prior to 14 June 2011, providing justification is submitted that demonstrates that the studies were generated in good faith and on the basis that no alternative approaches were available (for example following previous failed attempts to negotiate access under the previous legislation). We may also accept arguments for the submission of studies generated to support other regulatory regimes.
Vertebrate data sharing provisions – scope of studies
Recital 40 of Regulation 1107/09 refers to Council Directive 86/609/EEC, which in turn defines the type of experiments that are covered by the vertebrate data sharing arrangements. On this basis, CRD consider that field monitoring data (e.g. such as that conducted for higher tier bird and mammal assessments) are not within the scope of the vertebrate data sharing arrangements.
The data protection guidance in the Applicant Guide has been updated to reflect this Regulatory Update.
Contact information
If you have any questions relating to this Regulatory Update, please contact CRD Pesticides Branch.
Email: applicant-enquiries@hse.gsi.gov.uk
Postal address: Pesticides Branch, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK
