Commentaries: Art. 17

The assessment authorities shall evaluate the documents within their area of responsibility as follows:
1. documents for ALand AnLauthorisations and simplified authorisations, and for recognitions: according to the principles specified in Annex VI to Regulation (EU) No 528/2012¹;
2. documents for the evaluation of Union authorisations that are submitted to the Notification Authority on the basis of international agreement: under the provisions of Articles 43–46 of Regulation (EU) No 528/2012 and Implementing Regulation (EU) No 354/2013²; this also applies to the evaluation of amendments and extensions to Union authorisations;
3. ³ documents for the evaluation of an active substance that are submitted to the Notification Authority on the basis of international agreement: under the provisions of Chapters II and III of Regulation (EU) No 528/2012 and Chapter II of Delegated Regulation (EU) No 1062/2014⁴; the foregoing also applies when evaluating the extension of the approval of an active substance;
4. ⁵ documents for ZNauthorisations: from the point of view of whether the active substance is suitable for the use and product type applied for; in the event of increased risk or in other justified cases, an assessment shall be carried out in accordance with letter d;
5. other documents: according to the latest scientific and technical knowledge.⁶
.⁷
For biocidal products containing an active substance which is a candidate for substitution, the assessment authorities shall perform a comparative assessment as specified in Article 11g.
The assessment authorities shall inform the Notification Authority of the results of their evaluation.
In the case of applications for authorisation AL, AnLand simplified authorisation, the Notification Authority, after validation, shall, in consultation with the assessment authorities, within the set time limit (Art. 19 para. 1 let. d–j), prepare an assessment report summarising the conclusions of the evaluation and the reasons for granting or refusing to grant authorisation.
Where it appears that additional information is necessary to carry out the evaluation, the Notification Authority shall ask the applicant to submit such information within a specified time limit. The Notification Authority may ask the applicant to provide samples, if this is necessary for the evaluation.
The Notification Authority shall send the draft assessment report to the applicant and provide him with the opportunity to submit comments within 30 days.

See footnote to Art. 1b para. 3. ↩
Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council, Amended by OJ L 109 of 19.4.2013, p. 4. ↩
Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). ↩
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council, OJ L 294 of 10.10.2014, p. 1. ↩
Inserted by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125). ↩
Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩
Repealed by No I of the O of 31 Jan. 2018, with effect from 1 March 2018 (AS 2018 817). ↩

Art. 17

Footnotes