BAKGRUNN (fra fra kommisjonsforordningen)

(1) Article 25(1) of Regulation (EC) No 1107/2009 provides that safeners and synergists are to be approved when the criteria for the approval of active substances, laid down in Article 4 of that Regulation, are fulfilled. Furthermore, Article 25(2) of that Regulation provides that the general rules applicable to the procedure for the approval of active substances, or the renewal thereof, set out in Articles 5 to 21 of that Regulation apply to safeners and synergists as well. In addition, Article 25(3) of that Regulation provides that similar data requirements to those applicable for the approval of active substances should be defined for the approval of safeners and synergists. 

(2) In addition, and as required by Article 26 of Regulation (EC) No 1107/2009, a work programme for the gradual review of safeners and synergists already on the market should be established. To ensure alignment with the derogation provided for in Article 81(1) of Regulation (EC) No 1107/2009, these procedures should allow these safeners and synergists to be reviewed within five years of the adoption of that work programme. 

(3) In order to ensure that all safeners and synergists already on the market can be reviewed, it is appropriate to first establish a list of the safeners and synergists already on the market, procedures for potential applicants to notify their interest in submitting applications for the approval of these safeners and synergists, the deadline for submitting such applications and the procedures for the evaluation of the admissibility of applications. 

(4) To ensure coherence with the specific conditions for scientific assessments established under Regulation (EC) No 178/2002 of the European Parliament and of the Council, it is appropriate to envisage similar provisions for safeners and synergists. Consequently, rules detailing the process of submitting joint applications and specifying the procedures for pre-submission consultations with the European Food Safety Authority ('the Authority') regarding planned tests and studies aimed at securing approval for safeners and synergists, along with the required notifications about studies initiated or conducted by prospective applicants to substantiate their applications, should be established. 

(5) In order to minimise animal testing, applicants should, where possible, take measures to avoid animal testing and inform the Authority, as part of its notification of studies commissioned or carried out, if any conducted or commissioned study incorporates the utilisation of alternative testing methods. 

(6) In order to ensure the appropriate handling of data sharing and to safeguard the rights and interests of applicants and other stakeholders regarding public access to information, it is essential to apply the data protection and confidentiality rules established in Regulation (EC) No 1107/2009 to the work programme. Consistent with the principles of data protection and confidentiality outlined in that Regulation, measures should be taken to protect the information submitted by applicants during the establishment and implementation of the work programme. 

(7) Similar data requirements to those applicable for the approval of active substances should be defined for the approval of safeners and synergists. In addition to the data requirements applicable to the approval of active substances, certain supplementary data should be required, in particular in relation to the demonstration of efficacy of the safeners and synergists. 

(8) In view of the substantive links between the empowerments in Article 25(3) of Regulation (EC) No 1107/2009 concerning the definition of data requirements for the approval of safeners and synergists and in Article 26 of that Regulation concerning the establishment of a work programme for the gradual review of safeners and synergists already on the market, in particular the applicability of the same data requirements, it is appropriate to lay down those rules jointly in the same act. 

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,