Placing biocidal products on market

From 1st September 2013, Biocidal products are regulated in the EU by the EU Biocides Regulation (BPR) which replaced the older Biocidal Products Directive (BPD) which applied to biocidal products prior to 1st September 2013.
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 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.

Authorised biocidal products

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:
1) application form
2) documents certifying the right of representation in case the applicant is not the producer of the biocidal product
3) instruction for use
4) proposal for label
5) copy of the receipt of fee payment.
You may fill in the application form in English. But we would like to get the instruction for use and the label of the product in Estonian.

The fee for the registration is 345 EUR.
The fee for the change of the registration is 150 euros.

NB! Notifications regarding CLP are free of charge. Only new label and MSDS are needed to make the required changes.


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|ä|terviseamet.ee) and delivered by mail to:
Health Board
Department of Chemical Safety
Paldiski mnt 81
10617 Tallinn
Estonia

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.

Registered Biocidal Products

 
Viimati uuendatud:  esmaspäev, 28 august 2017 12:46