Commentaries: Art. 28

For data submitted to the Notification Authority in accordance with this Ordinance, the following protection periods apply:
1. for data submitted with a view to the approval of an existing active substance: 10 years from the first day of the month following the date of the approval of the relevant active substance for the particular product type by the European Commission in accordance with Article 9 of Regulation (EU) No 528/2012¹;
2. for data submitted with a view to the approval of a new active substance: 15 years from the first day of the month following the date of the approval of the relevant active substance for the particular product type by the European Commission in accordance with Article 9 of Regulation (EU) No 528/2012;
3. for data submitted with a view to the renewal or review of the approval of a new active substance : 5 years from the first day of the month following the date of the renewal or review of the approval by the European Commission in accordance with Article 14 paragraph 4 of Regulation (EU) No 528/2012;
4. for data submitted with a view to the authorisation of a biocidal product containing only existing active substances: 10 years from the first day of the month following the date of the authorisation by the Notification Authority or by the competent authority in accordance with Regulation (EU) No 528/2012;
5. for data submitted with a view to the authorisation of a biocidal product containing a new active substance: 15 years from the first day of the month following the date of the authorisation by the Notification Authority or by the competent authority in accordance with Regulation (EU) No 528/2012;
6. for data submitted with a view to the renewal or amendment of the authorisation of a biocidal product: 5 years from the first day of the month following the date of the authorisation by the Notification Authority or the date of the decision concerning the renewal or amendment of the authorisation by the competent authority in accordance with Regulation (EU) No 528/2012.
The protection period shall start when data is submitted for the first time.
It cannot be renewed.
By way of derogation from paragraph 1, the data protection periods for existing active substances listed in combination with a product type in Annex II to Regulation (EU) No 1062/2014²– including data not involving tests on vertebrates – but for which a decision on inclusion in Annex I to Directive 98/8/EC³was not taken before 1 September 2013 shall expire no later than 31 December 2025.⁴

See footnote to Art. 1b para. 3. ↩
See footnote to Art. 7 para. 1 let. b. ↩
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market, OJ L 123 of 24 April 1998, p. 1; last amended by Directive 2013/44/EU, OJ L 204 of 31 July 2013, p. 49. ↩
Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). ↩

Art. 28

Footnotes