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NATIONAL BIOCIDAL PRODUCT APPROVAL PROCEDURES - NOTIFICATION

WHO

 

A natural or legal person (hereinafter: applicant) who intends to place a biocidal product on the market in the Republic of Slovenia.

 

WHERE AND HOW 

 

An application shall be delivered to the office in written form:
• by e-mail to the following address: Ministrstvo za zdravje, Urad RS za kemikalije, Ajdovščina 4, 1000 Ljubljana (hereinafter: Office);
• to the mailroom at the following address: Ministrstvo za zdravje, Štefanova 5, Ljubljana.

 

LEGAL BASIS

 

• Article 6 of the Decree implementing Regulations (EU) concerning the making available on the market and use of biocidal products (Uradni list RS [Official Gazette of the Republic of Slovenia], no. 20/14)

 

APPLICATION

 

The application for notification of a biocidal product shall be submitted in Slovenian. The application shall be filled in for all biocidal products, including those which are not classified as dangerous. The application shall consist of a completed form and mandatory enclosures: evidence of registrations issued in other EU Member States and/or third countries, efficacy tests of the biocidal product, proposals for original label(-s) and instructions for use, safety data sheets for the biocidal product and data on dangerous components of the biocidal product.
•  Evidence of registrations issued in other States: if the biocidal product has already been placed on the market in a certain other EU Member State, a copy of the permit shall be enclosed with the application, or other evidence issued by a competent authority of the State, in which the biocidal product has been placed on the market for the first time; or a label with the registration number from which it is evident that the biocidal product has been authorised for use in another state.
• Efficacy tests: data on efficacy shall be submitted based on efficacy tests performed for all organisms for which biocidal product will be used. Rules concerning the requirements to be met by laboratories testing biocidal products for the notification procedure (Uradni list RS, no.73/07)) lay down testing conditions.
• The wording on the label attached to a biocidal product shall be in compliance with Article 69 of Regulation 528/2012/EU (hereinafter: BPR) and the label dimensions in compliance with Regulation 1272/2008/EC (hereinafter: CLP).   There shall be no exemptions from the labelling. Until 1 June 2015, a biocidal product composed of several dangerous substances shall be classified and labelled in compliance with Directive 67/548/EEC, while after the mentioned date, it shall be classified and labelled exclusively in compliance with CLP. Classification and labelling of a biocidal product composed of a single active substance shall be in compliance with CLP. The attached Instructions for use shall constitute a part of the label.
• Safety data sheets for biocidal products shall be in compliance with Annexes to Regulation No 1907/2006 (REACH) (see Regulation No 453/2010), the same applies to safety data sheets for active substances and hazardous components of biocidal products.

IMPORTANT: A transitional measure in connection with access to documents on active substance: After 1 September 2015, every supplier of biocidal products placing on the EU market a biocidal product which is composed of, contains, or produces a relevant substance, shall be included in the list of suppliers under Article 95 of the BPR, according to the type of use of the product.


Therefore, no later than 1 September 2015, in the biocidal product notification procedure, you are obliged for the already approved biocidal product either to submit a new dossier for the active substance or the information that the supplier of the active substance has already been included in the EU programme of the active substance review and/or a statement on accessibility of data on the active substance which your product contains or a reference to the existing file for which the data protection period is no longer in force.

 

NOTIFICATION COSTS

 

The biocidal product notification costs shall be charged to the applicant. The application fee shall be EUR 210. The application fee is defined in the Annex which is a constituent part of Decree implementing Regulations (EU) concerning the making available on the market and use of biocidal products (Uradni list RS [Official Gazette of the Republic of Slovenia], no. 20/14).

 

The application fee shall be paid to the following suspense account:   (IBAN No:) SI5601100-8450080537 (SWIFT code: BSLJSI2X, Bank name: The Bank of Slovenia (Banka Slovenije), Slovenska cesta 35, Ljubljana, SLOVENIA) of the Chemicals Office of the Republic of Slovenia (Urada Republike Slovenije za kemikalije), the purpose of the payment (convocation/reference): name of the biocidal product. The proof of fee payment shall be enclosed to the application.

 

NOTIFICATION OF CHANGES TO NOTIFIED (REGISTERED) BIOCIDAL PRODUCTS

 

A holder of the notified biocidal product approval and/or a notifier is obliged to immediately notify the Office regarding any changes to the biocidal product which were made after the notification (registration) of the biocidal product. Changes shall be notified in written form, including the submitting of a changed application (the part which has been changed shall be marked) and all the enclosures in which the changes were made. It is obligatory to enclose a new safety data sheet for biocidal product, label and instructions for use. For certain changes, costs of changing the notification shall be charged.

 

Costs of changes to biocidal product notification:

– changes for which the applicant shall pay a fee in the amount of EUR 90 are the following:
• change of a trade name;
• notification of a synonym;
• minor changes to the composition of inert substances which have no significant impact on the properties of the biocidal product.
• change in the field of use

– the following changes shall not be charged: 
• a change to the safety data sheet;
• a change to classification and labelling when updating and/or translating the classification;
• a change of data regarding the notifier, producer and/or formulator;
• removal from the register;
• minor changes to instructions for use like removal of the indication of the target organism or special use, removal of the user categories;

Note: A change of the active substance present in the biocidal product shall be considered as a new biocidal product.

 

FRAMEWORK DEADLINE FOR GRANTING THE APPLICATION FOR NOTIFICATION OF A BIOCIDAL PRODUCT

 

The application shall not be considered until the notification fee is paid. After submitting the application for notification of biocidal product, the Office shall check whether the application is complete. If the application is not complete, the Office shall invite the applicant to complete it. After the additional documents are received and following the confirmation that the application is complete, the Office shall decide on the application on the basis of the data submitted. The deadline for consideration of the application is 30 days after the application is completed.

 

After the review and approval of an application for notification CORS lists the biocidal product in the Registry of Biocidal Product (RBP). By listing it into RBP this product may be placed on the market. At least once a month NCB  publishes RBP on his website and does not issue any additional certificates.  

 

ASSISTANCE / INFORMATION FOR USERS 

biocidi.uzk(at)gov.si or Office telephone: 01 400 60 51


ADDITIONAL INFORMATION

 

REGISTER FOR BIOCIDAL PRODUCTS

 

By entering the biocidal product in the register for biocidal products the conditions for the availability of biocidal products in Slovenia’s market are fulfilled.

If the applicant would like for the biocidal product to be considered a biocidal product which was accessible on the market before the date of the active substance’s inclusion in the list of authorised active substances, the applicant shall submit the application for notification before the date of inclusion of the active substance in the list of the EU authorised active substances.

 

VALIDITY OF APPROVAL AFTER THE NOTIFICATION PROCEDURE

 

Approval for the accessibility of the biocidal product on the market in Slovenia, issued in accordance with the notification procedure, shall be valid until the date of the approval of the latest active substance of this biocidal product on the Union list of active substances approved for use in biocidal products and/or until the date of decision of non-inclusion of the active substance (-s) on the Union list of active substances approved for use in biocidal products or until 31 December 2014, if the active substance present in the biocidal product, which is under the examination procedure, is not yet included in the Union list of active substances approved for use in this type of product, and/or the approval for it is not yet valid.

 

If you, after the notification procedure, as the holder of the approval for the biocidal product want to continue the biocidal project’s accessibility on the market and use, you should submit to the Office an application for national approval or mutual recognition of approvals in accordance with Article 17 of the BPR  no later than on the date of inclusion of the active substance or active substances on the Union list of active substances approved for use in biocidal products. If biocidal products contain more than one active substance, applications for approval shall be submitted no later than on the date of approval of the last active substance for that product type.

 

If an application for continuation of accessibility on the market in Slovenia is not submitted:

– the biocidal product shall no longer be made available on the market with effect from 180 days after the date of the active substance(s)’ approval;
– use of existing stocks of the biocidal product may continue until 365 days after the date of approval of the active substance(s).

 

RECORDS AND DATA COMMUNICATION

 

Article 68 of the BPR lays down mandatory keeping of records for the biocidal products that authorisation holders place on the market for at least 10 years after placement, or for 10 years after the date on which the authorisation was cancelled or expired, whichever is earlier. Holders of approvals shall make available the relevant information contained in these records to the competent authority on request.

 

Non-compliance with this provision is defined as an offence according to Article 10(1)(7) of the Decree implementing Regulations (EU) concerning the making available on the market and use of biocidal products (Uradni list RS, no. 20/14).