The application intending to market a biocidal product in the Republic of Slovenia, which contains an active substance that has already been assessed for this type of product or is in the assessment procedure for the inclusion on the list of approved active substances of the Union, must perform a preliminary national approval procedure and notify the authorisation at the Slovenian Chemicals Office.
The application for the notification of the biocidal product is prepared in Slovenian. For the notification, the biocidal product must fulfil all registration conditions in other countries, have appropriate data on efficiency, be appropriately labelled and have a safety sheet.
When the entry cost is finished and the procedure costs are paid, the competent authority enters the biocidal product into the register of biocidal products. By entering the biocidal product into the register, all conditions for the accessibility of the biocidal product in the Slovenian market are fulfilled.
After the notification procedure, the authorisation applies until the date of approval of the last active substance of the subject biocidal product. If, as the holder of the authorisation, you wish to continue making the product available in the market, you are obliged to lodge an application for a national authorisation or mutual recognition of the authorisation with the competent authority on the date of approval of the active substance at the latest.
If the active substance is not approved, the competent authority deletes the product from the register after 60 days and withdraws it from the market.
These terms apply to activity Accessibility and use of biocidal products on the market
If a biocidal product is already on the market in any other EU member state or third countries, suitable evidence on the registration in other countries must be attached to the application.
A copy of the authorisation or other evidence by the competent authority in the country in which the biocidal product was first placed on the market, or a label with a registration number displaying that the biocidal product is permitted in another country.
A product must have suitable characteristics which are based on performed efficiency tests for all organisms against which the biocidal product is to be used.
The testing of efficiency of biocidal products may be performed by a laboratory with validated methods.
Data of efficiency
Biocidal products must be suitably classified, packed and labelled in accordance with the approved summary of product characteristics.
The label of the biocidal product must not be misleading concerning the risk the product presents to human and animal health and the environment, and must never contain the following statements, i.e. low-risk biocidal product, non-toxic, harmless, natural, environment-friendly, animal-friendly or similar. The label must also include:
- a designation of every active substance and its content in units of measures;
- nanomaterials if the product contains them and thus related special risks, including the word nano in brackets upon the provision of nanomaterials;
- number of the approval allocated to the biocidal product by the competent authority or the Commission;
- name and address of the approval holder;
- type of formulation;
- permit to use the biocidal product;
- instructions for use;
- data on possible direct or indirect adverse effects and instructions on first aid;
- if instructions are enclosed, the following sentence must be added: “Read the enclosed instructions before use.”;
- instructions on the safe disposal of the biocidal product and its packaging;
- number or label of the formulation series and expiry date in normal storage conditions;
- when necessary, the period necessary for the biocidal product to achieve its effect;
- when necessary, categories of users to whom the use of the biocidal product is limited;
- when necessary, information on any other special hazard to the environment, particularly relating to the protection of non-targeted organisms and the prevention of water pollution;
- and special requirements relating to the labelling of microorganisms.
Member states may require:
- the submission of models or drafts of packaging, labels and instructions;
- that biocidal products be labelled in the language of an individual member state.
A safety data sheet must be prepared for active substances and biocidal products. The purpose of drafting a safety data sheet is to establish the hazardous characteristics of a certain substance. A safety data sheet is intended for the user of the substance.
A safety data sheet is prepared in the official language of the member state in which the product is to be sold, unless a member state determines otherwise.
A safety data sheet includes the following items:
- identification of the substance and the company;
- findings on hazardous characteristics;
- composition/information on compounds;
- first-aid measures;
- fire-fighting measures;
- measures in case of accidental release;
- handling and storage;
- exposure control/personal protection;
- physical and chemical properties;
- stability and reactivity;
- toxicological information;
- ecological information;
- disposal considerations;
- transport information;
- legally prescribed information;
- and other relevant information.
The submission of safety data sheets is not necessary if hazardous substances or preparations are equipped with sufficient information enabling users to take all measures necessary to protect human health, safety and the environment unless this is required by further users or the distributor.
More detailed instructions on drafting a safety data sheet can be found in Annex II to Regulation (EC) No 1907/2006.
Safety data sheet
- REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), esta blishing a European Chemicals Agency, amending Directive
- REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning the making available on the market and use of biocidal products
After the notification procedure, the authorisation applies from the date of approval of the last active substance of the subject biocidal product.