Version in force , Modified +91 −76§
Amended by Regulation (EU) 2026/1165 32026R1165 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
The second subparagraph of paragraph 1 was reworded: instead of stating that data protected under the Article, or for which the protection period has expired, shall not be protected again, it now states that protection periods under the Article which have expired shall not start to run again, and it adds a cross-reference making this without prejudice to the second subparagraph of Article 95(5).
Cited: Art. 60, v1 (external, EUR-Lex) · Art. 60, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 11 June 2024 02012R0528-20240611 → this version, in force 15 June 2026 02012R0528-20260615
Article 60
Data protection periods
1. Data submitted for the purposes of Directive 98/8/EC or of this Regulation shall benefit from data protection under the conditions laid down in this Article. The protection period for the data shall start when they are submitted for the first time.
Data protected Without prejudice to Article 95(5), second subparagraph, protection periods under this Article or for which the protection period under this Article has have expired shall not be protected start to run again.
2. The protection period for data submitted with a view to the approval of an existing active substance shall end 10 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.
The protection period for data submitted with a view to the approval of a new active substance shall end 15 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.
The protection period for new data submitted with a view to the renewal or review of the approval of an active substance shall end five years from the first day of the month following the date of the adoption of a decision in accordance with Article 14(4) concerning the renewal or the review.
3. The protection period for data submitted with a view to the authorisation of a biocidal product containing only existing active substances shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).
The protection period for data submitted with a view to the authorisation of a biocidal product containing a new active substance shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).
The protection period for new data submitted with a view to the renewal or amendment of the authorisation of a biocidal product shall end five years from the first day of the month following the decision concerning the renewal or amendment of the authorisation.