UA – Same biocidal product SPC translation review

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Presentation transcript:

UA – Same biocidal product SPC translation review CA-March18-Doc.4.5c UA – Same biocidal product SPC translation review Biocides Assessment Unit European Chemicals Agency

Legal requirements according to BPR Article 20(3) For applications for Union authorisations submitted under Article 43, the applicant shall submit the summary of the biocidal product characteristics referred to in point (ii) of paragraph (1)(a) of this Article in one of the official languages of the Union accepted by the evaluating competent authority at the time of application and in all official languages of the Union before the authorisation of the biocidal product. Art 44(4) Within 30 days of submitting its opinion to the Commission, the Agency shall transmit to the Commission, in all the official languages of the Union, the draft summary of the biocidal product characteristics, as referred to in Article 22(2), where applicable.

Implications of legal requirements The BPR does not make any distinctions between UA-APP and UA-BBP. It is the responsibility of the applicant to provide the translations of the SPC. The BPR does not establish a process for the review of the SPC translations. ECHA has a coordinating role “transmitting” the translations to the Commission.

Review process of SPC translations Even though not specified in the BPR, it is in the benefit of everyone to have high quality translations. A procedure for the review of SPC translations by MSs was agreed during the CG-23 meeting, where no distinction was made on UA-APP and UA-BBP applications.

Review process of UA-BBP translations The SPC will be an annex to the Implementing Regulation (IR) granting the UA. As such, MSs will have to check the SPC in their official languages as part of the consultation of the SCBP. Checking the translation prior to the submission of the SPCs in all EU languages to the Commission will allow more time for MSs to complete this task.

Proposal: Request applicants for UA-BBP to submit SPC translations identical to those of the related reference product already reviewed by MSs (for the sections not affected by the administrative changes). ECHA will check whether the translations of the sections not affected by the administrative changes are identical to those of the final SPC of the related reference product. MSs will only need to review the translations for the modified sections compared to the related reference product.

https://echa.europa.eu/contact/bpr Thank you!