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Authorisation of auxiliary products in plant protection

Auxiliary products in plant protection are products used for the detection of occurrence of harmful organisms or of beneficial organisms, bioagens or products applied to plants or plant products, which do not fall within the definition of plant protection products and/or fertilizers. Only such auxiliary product that has been authorized by the Central Control and Testing Institute in Agriculture in Bratislava (hereinafter referred to as the “Control Institute”) may be placed on the market and used. The applicant for authorization must have his place of business or be established in a Member State.

The authorization of auxiliary products in plant protection is regulated by the Act No. 387/2013 Coll. on auxiliary products in plant protection and the Decree of the Ministry of Agriculture and Rural Development of the Slovak Republic No. 477/2013, which lay down the requirements and authorization procedures. Both legal acts are available at

https://www.uksup.sk/slovenska-legislativa-pp/ .

The application for authorization and the dossier shall be submitted to:

Ústredný kontrolný a skúšobný ústav poľnohospodársky v Bratislave

Odbor registrácie pesticídov

Matúškova 21

833 16 Bratislava

Slovakia

Contact for possible consultations:

Department of Pesticides Registration

Director of the Department

Phone No .: +421 2 59 880 328

E-mail: pesticides@uksup.sk

Authorization requirements depend on the authorization procedure. In principle, there are two procedures how to authorise auxiliary products in Slovakia – a standard authorization procedure with the evaluation of a dossier and a mutual recognition. Mutual recognition may be used if the auxiliary product has been manufactured or placed on the market in a State party to the Agreement on the European Economic Area or in Turkey or Switzerland under national rules ensuring the same level of protection of human and animal health and the environment.

Requirements for the standard authorization procedure

Filled-in application form for authorization (available for download at https://www.uksup.sk/orp-pomocne-pripravky)
Draft label in the Slovak language in electronic form (prepared in accordance with the template provided at http://www.uksup.sk/orp-vzory-etikety/ )
Dossier in English, Slovak or Czech, preferably in electronic form (data requirements depend on the type of the auxiliary product, detailed information is specified in Annex No. 5 to Decree No. 477/2013)
Letter of access to the dossier (if the applicant is not the owner of the dossier)
Certificate of incorporation not older than 3 months from the date of submission of the application; it is submitted only at the first application for authorization and/or if the data in the commercial or trade register have changed,
If the applicant is represented by another company, a power of attorney shall be submitted (original or certified copy in Slovak, Czech or English)
Payment of an administrative fee of € 33 (payment will be requested by the Control Institute by e-mail upon receipt of the application),
Billing information (information about the company to be invoiced) - company name, exact address, VAT registration number, name of the bank, IBAN, registration company number and full registered company address (for limited company only)

Requirements for mutual recognition

Filled-in application form for authorization (available for download at https://www.uksup.sk/orp-pomocne-pripravky),
Draft label with which the product will be placed on the market in the Slovak Republic in the Slovak language in electronic form (prepared in accordance with the template provided at http://www.uksup.sk/orp-vzory-etikety/)
Evidence that the auxiliary product has been manufactured or placed on the market in a State party to the Agreement on the European Economic Area, or in Turkey or Switzerland (e.g. authorization decision),
Information on the legislation under which the auxiliary product was placed on the market in the country of origin (if not already mentioned in the document/authorization decision)
Information on the competent authority that issued the document/authorization decision (if not stated in the document)
A copy of the label with which the auxiliary product is placed on the market in the country of origin,
Material safety data sheet if the auxiliary product is classified
Certificate of incorporation not older than 3 months from the date of submission of the application; it is submitted only at the first application for authorization and/or if the data in the commercial or trade register have changed,
If the applicant is represented by another company, a power of attorney shall be submitted (original or certified copy; in Slovak, Czech or English)
Payment of an administrative fee of € 33 (payment will be requested by the Control Institute by e-mail upon receipt of the application)
Billing information (information about the company to be invoiced) - company name, exact address, VAT registration number, name of the bank, IBAN, registration company number and full registered company address (for limited company only)

Time schedule for granting a new authorization

Standard procedure

After submitting the application for authorization, the Control Institute will assess within 30 days whether the product to be authorised is an auxiliary product in plant protection and then (after a positive opinion) a request to external expert institutes and internal experts will be submitted to prepare experts´ opinions; the experts shall deliver their opinion within 120 days from the receipt of the request. The Control Institute shall decide on the application within 120 days of receipt of the application, with the exception of the period of suspension of the procedure (the procedure is suspended for the period necessary for elaboration and delivery of experts´ opinions and / or for delivery of missing application details by the applicant).

Mutual recognition

After submitting the application, the Control Institute will assess within 30 days whether the product to be authorised is an auxiliary product in plant protection and then (after a positive opinion) will request external experts institutes and internal experts to prepare experts opinions; the experts shall deliver their opinion within 20 days from the receipt of the request. The Control Institute shall decide on the application within 60 days from the delivery of the application, with the exception of the period of suspension of the proceedings (the procedure is suspended for the period necessary for elaboration and delivery of experts´ opinions and / or for delivery of missing application details).

Period of authorization of an auxiliary product

The maximum period of authorization of an auxiliary product is 10 years.

Fees:

The Control Institute invoices activities in accordance with the price list valid at the time of the submission of the application (the risk assessment fee is separately invoiced by the external experts institutes performing risk assessment).

https://www.uksup.sk/cennik-vykonov/

External experts institutes:

Národné referenčné laboratórium pre pesticídy Univerzity veterinárskeho lekárstva a farmácie v Košiciach (National ReferenceLlaboratory for Pesticides of University of Veterinary Medicine and Pharmacy)

Assessment of risks to non-target organisms (except bees and non-target arthropods) and assessment of risks to human health.

Národné poľnohospodárske a potravinárske centrum (National Agricultural and Food Centre)

Assessment of risks to bees and non-target arthropods other than bees.

Slovenský hydrometeorologický ústav (Slovak Hydrometeorological Institute)

Risk assessment to surface water and air.

Úrad verejného zdravotníctva Slovenskej republiky (Public Health Office of the Slovak Republic)

Impact of residues on human and animal health

Výskumný ústav vodného hospodárstva (Water Research Institute)

Risk assessment to ground water and soil