S.L. 427.108 Art. 5Notification of biocidal products.

(1) Biocidal products which contain active ingredients or active substances which are not included in the approved list specified in Article 9(2) of Regulation (EU) No 528/ 2012 and which are undergoing evaluation, shall be notified by means of an application to the Technical Regulations Division before being placed on the market.

(2) The application referred to in sub-regulation (1) shall at least include the following information:

(a) safety data sheets of all the hazardous ingredients of the product;

(b) original labels of the product;

(c) a copy of the authorisation certificate issued by an EU Member State;

(d) a declaration of the chemical composition of the product;

(e) a letter of access as defined in point (t) of Article 3 of Regulation (EU) No 528/2012.

(3) The applicant shall also provide documented evidence that the supplier is included in the updated version of the list referred to in Article 95 of Regulation (EU) No 528/2012 regarding the product type to which the product belongs.

(4) The Director General shall determine the application within a reasonable period which shall not exceed forty-five (45) working days from the date of receipt of an application:

Provided that such period may be suspended until all relevant information has been submitted.