Informative Notice
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Authorization under the simplified procedure
Simplified authorization may be granted for biocidal products that qualify for the simplified procedure.
The application must be submitted through R4BP 3 of the European Chemicals Agency (ECHA). The applicant shall inform the Agency of the name of the competent authority of the Member State which it proposes to evaluate the application.
In order to obtain authorization under the simplified procedure, a biocidal product must comply with the provisions of Article 25 of Regulation (EU) No 528/2012.
Upon receipt of the application, the competent authority shall inform the applicant of the amount, method and deadline for payment of the fee. The fee is set out in point 2.1 of the Annex to the Regulation implementing the Regulations (EU) on the making available on the market and use of biocidal products.
Conditions
These terms apply to activity Market availability and use of biocidal products
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Approval as per the simplified procedure may be issued for biocidal products fulfilling the following conditions:
- all active substances in the biocidal product are on the list in Annex I to Regulation (EU) No 528/2012 and comply with all restrictions provided in the relevant Annex;
- the biocidal product does not contain any hazardous substances;
- the biocidal product does not contain any nanomaterials;
- the biocidal product is sufficiently effective;
- no personal protective equipment is necessary for handling the biocidal product and during its use.
Legal basis
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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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Requirements for biocidal products used for disinfection of premises with automatic diffusion apparatus or disinfectants generated on site (in situ) by means of apparatus can be found at the following link.
Evidence
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Performance data
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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Simplified authorisation procedure
Personal
Procedure costs
Issuance of a permit under the simplified procedure: 11,700.00 € for a single biocidal product and 23,400.00 € for a biocidal product family.
The availability of the product on the market allowed in accordance with the simplified procedure is 470.00 € for a single biocidal product and 940.00 € for a biocidal product family.
Renewal term
Renewal term: 10 years