Placing biocidal products on market

 

Biocidal products are regulated in the EU by the EU Biocides Regulation (BPR).

Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation or registered on transitional period in accordance with Estonian Biocides Act.

Before  placing a biocidal product on the Estonian market for a particular type of product you will need to ensure that the active substance is either approved or under review in that Product Type. The status of the active substance can be checked form ECHA webpage.

 

Transitional measures for biocides


In case the active substance is still under the BPR review program the national requirements on transitional period apply to the biocidal product and the biocide needs to be registered or the change requested.

To register your biocide or to request the change of already registered biocide, please send the e-mail to the BPR Helpdesk bpr@terviseamet.ee with the following documents:

  • filled and signed application form (DOC).  NB! CHANGED SINCE 15.09.2020
  • in case the applicant is not the producer of the biocidal product, the document certifying the right of representation, where the producer of the biocidal product gives permission to the applicant for registering the biocidal product;
  • document proving the use of the active substance(s) from the manufacturer/supplier who is included in the BPR Art 95 list, e.g. purchase document, filled in and signed self-declaration or confirmation (DOC) ;
  • safety data sheet of each active substance;
  • copy of the receipt of fee payment.

The fee for the registration is 345 EUR per biocidal product or per family.

The fee for the change of the registration is 150 euros per registration certificate.

All Bank Transfer Charges to Appliers Account.

Beneficiary customer: RAHANDUSMINISTEERIUM

Beneficiary's account: IBAN EE89 1010220034796011

Beneficiary's Bank: AS SEB PANK (Address: Tornimäe 2; City: Tallinn; Postcode: 15010; Country: Estonia)

BIC: EEUHEE2X

Details of payment: Terviseamet - 2900082304, name of biocide.

Health Board will respond to your application within 30 calendar days.

The registration certificate issued during the transitional period is valid until the approval of the active substance(s) or until the 31 of December 2024 (BPR Art. 89(1)).

Please be informed that for biocidal products Article 45 to CLP regulation applies. In case you have additional questions related to Article 45 notification please turn to CLP Helpdesk clp@terviseamet.ee.

For the biocidal product added to the list of the registered biocidal products, the producer is responsible for controlling and ensuring the efficacy of the product and for labelling the product according to the requirements. Listing the product shows that the required information have been submitted to Health Board and that the product can be made available and used in Estonia.

List of the registered biocidal products (XLS)

 

Active substance is approved for your product type
 

Applications for authorisation shall be submitted no later than the date of approval of the last active substance for that product type. 

For further information about authorisation please see the  ECHA's webpage.

Fees for biocides in Estonia:
Mutual recognition: 1375 EUR
Administrative change: 345 EUR

All Bank Transfer Charges to Appliers Account.
Beneficiary customer: RAHANDUSMINISTEERIUM
Beneficiary's account: IBAN EE89 1010220034796011
Beneficiary's Bank: AS SEB PANK (Address: Tornimäe 2; City: Tallinn; Postcode: 15010; Country: Estonia) 
BIC: EEUHEE2X
On cross-border payment order, details of payment, must have: Terviseamet - 2900082304, name of biocide.