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.

 

Active substance is under review (national requirements on transitional period)

 

If your active substance is still under review for your product type, then products can be brought to the market without needing to be authorised under the EU BPR. However you should apply for registration on transitional period in accordance with Estonian Biocides Act.

Needed documents for the registration are as follows:

  • application form (DOC)
  • documents certifying the right of representation in case the applicant is not the producer of the biocidal product
  • documents proving that the manufacturer/supplier of the active substance(s) used in the biocidal product is included in the BPR Art 95 list, eg. Safety Data Sheet of the active substance, purchase document, filled in and signed self-declaration or confirmation (DOC))
  • instruction for use in case not included on the label
  • proposal for label
  • Safety Data Sheet of the biocidal product
  • copy of the receipt of fee payment.

You may fill in the application form in English. But we would like to get the label, instruction for use and the Safety Data Sheet of the biocidal product of the product in Estonian.

The fee for the registration is 345 EUR per biocidal product or family.
The fee for the change of the registration is 150 euros.

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. 
Filled and signed application form with the other documents should be sent us by e-mail (bpr@terviseamet.ee).

Processing of an application and issuing the registration certificate usually takes 30 days.
Please note that once the review of the active substance is completed you will need to seek Authorisation for the product or remove it from the market.

According to the Article 45 to CLP regulation for biocidal products applies the notification procedure of the Poisoning Information Centre.
More information about this notification you could find from Poisoning Information Centre webpage.

List of 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.