NextSDSNeed to manage your chemicals?Discover NextSDS →
Home/BPR/Ch IV/Article 20 / Requirements for applications for ...
CELEX 02012R0528 · v20260819

Article 20 / Requirements for applications for authorisation

Generate AI summary
ChatGPTClaudePerplexityGemini
1.  

The applicant for an authorisation shall submit the following documents together with the application:

(a) 

for biocidal products other than biocidal products meeting the conditions laid down in Article 25:

(i) 

a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;

(ii) 

a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;

(iii) 

a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;

(b) 

for biocidal products that the applicant considers meet the conditions laid down in Article 25:

(i) 

a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;

(ii) 

efficacy data; and

(iii) 

any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.

2.  
The receiving competent authority may require that applications for national authorisation be submitted in one or more of the official languages of the Member State where that competent authority is situated.
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.
Previous
Art 19: Conditions for granting an authorisation
Next
Art 21: Waiving of data requirements

Source: Content sourced from EUR-Lex and licensed under CC BY 4.0. This is an unofficial presentation; only the official EUR-Lex version is legally authentic.