Informative Notice
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Authorization of the same biocidal products
Authorization of the same biocidal products shall be granted for products that are identical to another biocidal product or biocidal product family for which an authorization has already been granted.
The application must be submitted through R4BP 3 of the European Chemicals Agency (ECHA).
The application for authorization of the same product shall contain the following information:
- the authorization number of the related reference product (or, if no authorization has already been granted, the application number of the related reference product in R4BP 3);
- an indication of the proposed differences between the same product and the related reference product and a proof that products are the same in all other respects;
- a statement on the availability of all data on the basis of which the authorization of the related reference product was granted;
- a draft summary of the biocidal product characteristic for the same product:
- a safety data sheet;
Upon receipt of the application, the Chemicals Office of the Republic of Slovenia shall inform the applicant of the amount, method and deadline for payment of the fee. The fee, as set out in point 2.2. of the Annex to the Regulation on the implementation of regulations (EU) on the making available and use of biocidal products on the market, is EUR 700 for an individual biocidal product or EUR 1400 for a biocidal product family.
Conditions
These terms apply to activity Market availability and use of biocidal products
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The applicant is obliged to draft a dossier or a letter of access of a biocidal product in compliance with Annex III to Regulation (EU) No 528/2012. The conditions which must be met include:
- active substances for the relevant types of product are approved;
- the biocidal product is sufficiently efficient;
- the biocidal product has no unacceptable effects on target organisms;
- the biocidal product has no prolonged adverse effects on human and animal health;
- the biocidal product has no unacceptable effects on the environment;
- it allows determination of its chemical identity, quantity and technical equivalence of active substances;
- the physical and chemical properties of the biocidal product are determined and acceptable for suitable use and transport of the product.
Evidence
Dossier in an IUCLID form for the biocidal product or a letter of access
Legal basis
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The applicant shall provide a detailed list of the proposed differences between the same biocidal product or family of products and the related reference products or family of products.
Evidence
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A summary of product characteristics SPCs must be drafted for every biocidal product or a summary of biocidal products within the framework of a family in the case of the family of biocidal products.
The summary of product characteristics must include:
- trade names of biocidal products from the family of biocidal products,
- name and address of the approval holder,
- qualitative and quantitative composition of active and inactive substances,
- producers of biocidal products (names and addresses, including the location of production facilities),
- producers of active substances (names and addresses, including the location of production facilities),
- type of formulation of biocidal products,
- hazard statements and precautionary statements,
- product type, if necessary, a detailed description of authorised use,
- targeted harmful organisms,
- dosage and instructions for use,
- groups of users; data on possible direct or indirect adverse effects,
- instructions for first aid and extraordinary measures for environmental protection,
- instructions for the safe disposal of the product and its packaging,
- storage conditions and expiry date,
- and if necessary, other information on the biocidal product.
When drafting the summary, consult the guidance document for the preparation of the report published on the website of the European Chemicals Agency (ECHA).
Evidence
Summary of the biocidal product characteristics
Legal basis
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The biocidal product must be prepared and submitted in accordance with Article 31 of Regulation (EC) No 1907/2006. The safety data sheet is intended for the user of a biocidal product.
It shall be drawn up in the official language of the Member State in which the product is placed on the market unless the Member State provides otherwise. The safety data sheet is prepared in the Slovenian language.
Safety data sheets do not need to be supplied if the biocidal products are provided with sufficient information to enable users to take all necessary measures to protect human health, safety and the environment unless required by the downstream user or distributor.
More detailed instructions for preparing the safety data sheet can be found in Annex II to Regulation 1907/2006/EU or its amendments 2020/878/EU.
Evidence
Safety data sheet
Legal basis
- 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
Procedures
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Authorisation for same biocidal products
Personal
Procedure costs
Issuance of a permit for the same products: 700.00 € for a single biocidal product and 1,400.00 € for a biocidal product family.
Renewal term
Renewal term: 10 years