Application form for biocidal pesticides on transitional period
Guidance for the applicant:
Biocidal (non-agricultural) pesticides include insecticides, acaricides and insect repellents.
This application form is used during transitional period for products containing active substance which has been used on the EU-market as a biocide before 14.5.2000 and has been notified but not yet approved in accordance with biocidal products regulation (EU) Nr 528/2012.
Biocidal products need to be authorised according to BPR when the biocidal active substance has been approved. If the product contains a new active substance or an approved existing substance, an authorisation has to be applied for from Tukes. Please see more detailed information on authorisation on website http://www.tukes.fi/biocides.
The complete dossier shall be submitted according to the list in Annex 1 of the application form. The application form and the appendixes under sections 1-3 are submitted as a single paper copy or electronically to Finnish Safety and Chemicals Agency (Tukes). The application form, appendixes and the dossier can be submitted in Finnish or English except for the product label proposal and safety data sheet, which have to be written both in Finnish and Swedish. The draft product label should include classification and labelling according to the CLP-regulation (EU) Nr 1272/2008, range of use, instructions for use, possible restrictions of use and instructions for waste management as well as instructions for protecting workers and environment where appropriate.
An invoice will be sent to the applicant after the authorisation decision has been made. The application for re-authorisation must be sent 12 months before the present approval expires.
The application form with Annexes is available on internet as Word-document (http://www.tukes.fi).
The application concerns:
1) authorisation of product
2) re-authorisation of product
1 GENERAL INFORMATION1.1 Product name
1.2 Applicant (name, address, telephone and e-mail address)
Contact person (name, telephone and e-mail address)
1.3 Manufacturer (name, address, telephone and e-mail address)
1.4 Packager (if not the same as the manufacturer)
1.5 Representative in Finland (name,
address, telephone and e-mail address)
Contact person (name, telephone and e-mail address)
1.6 Marketing agent in Finland (if not the same as the representative)
1.7 Authorisation to use the dossier
· In case the applicant is not the manufacturer the active substance, does the applicant have the right to use the data of the active substance (justification, i.e. letter of access) / Appendix
1.8 VAT-number of the applicant
1.9 Invoicing address
2 INFORMATION ON THE PRODUCT
2.1 Active substance(s)
· State name of the active substance according to ISO, chemical name according to CA or IUPAC and concentration (g/l or g/kg and % w/w) in the product as well as CAS- and EC-numbers (use separate appendix if necessary).
2.2 All other components of the product
· State clearly the chemical name for each component according to CA or IUPAC and the concentration (g/l or g/kg and % w/w) in the product as well as CAS- and EC-numbers.
· The function of the components shall be stated, e.g. solvent, stabilizing agent etc. If variations occur in the composition of the individual components (e.g. hydrocarbon solvents) this shall be mentioned (use separate appendix if necessary).
· If material safety data sheet has been made as required by the Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH), it has to be submitted.
2.3 Physical state of the product and type of formulation.
· e.g. aerosol
2.4 Description of intended use and product type according to Finnish Government decree 418/2014
· E.g. to control flies in livestock, insects indoors. Is the product used for professional purposes?
2.5 Dose and application method
3 PROPOSAL FOR CLASSIFICATION AND PRODUCT LABEL
3.1 Proposal for classification and labelling
· Please use the form in annex 2 to the application form / Appendix
3.2 Proposal for product label in Finnish and Swedish
· Please submit on a separate sheet / Appendix
3.3 Package
· Package material, type (plastic, bottle, bag etc.), size (volume for fluids, weights for others)
3.4 Material safety data sheet in Finnish and Swedish.
· If a safety data sheet is not required, comparable information to protect humans, animals and environment shall be submitted. Please submit on a separate sheet.
4 DATA PACKAGE (DOSSIER)
4.1 Data package required for the product and active substance(s)
· Data package should contain studies according to the list in annex 1. / Appendix
4.2. Summary of the studies on active substance
· Please use the form in annex 3 to the application form / Appendix
5 AUTHORISATION IN OTHER COUNTRIES
5.1 Name of the product, country and range of use
6 OTHER INFORMATION
Place and date / Applicant’s signature and clarification
National Decrees:
Kemikaalilaki, Chemicals Act (599/2013)
Ympäristöministeriön asetus biosidivalmisteita ja niiden tehoaineita koskevista hakemuksista ja ilmoituksista (419/2014)
Sosiaali- ja terveysministeriön asetus kemikaalien luokitusperusteista ja merkintöjen tekemisestä (807/2001 with amendments); corresponding 1999/45/EC and 67/548/EEC respectively
CLP Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
Työ- ja elinkeinoministeriön asetus Turvallisuus- ja kemikaaliviraston maksullisista suoritteista (636/2013)
Finnish Safety and Chemicals Agency / Helsinki / Tampere / Rovaniemi / Tel. +358 29 5052 000P.O. Box 66 (Opastinsilta 12 B) / Kalevantie 2 / Valtakatu 2 / www.tukes.fi
FI-00521 Helsinki / FI-33100 Tampere / 96100 Rovaniemi
Finland / Finland / Finland / Business ID 1021277-9