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Permit for parallel trade
A parallel trade permit shall be issued (in Slovenia, Member State of introduction) for a biocidal product authorized in another Member State (Member State of origin) if that biocidal product is identical to a product already authorized in Slovenia (reference product).
- both products were manufactured by the same company or an associated company or produced under license in accordance with the same production process;
- they are identical in specification and content in terms of active substances and in the type of formulation;
- they are the same in terms of the content of inactive substances;
- they are identical or equivalent in terms of size, material or shape of the packaging in terms of possible adverse effects on the safety of the product in terms of human health, animal health or the environment.
An applicant who intends to place a biocidal product on the market in Slovenia shall submit an application for a permit for parallel trade to the Chemicals Office of the Republic of Slovenia.
The application must be submitted through R4BP 3 of the European Chemicals Agency (ECHA). It must contain the following information:
- the name and authorization number of the biocidal product in the Member State of origin;
- the name and address of the competent authority of the Member State of origin;
- name and address of the applicant;
- the trade name given to the biocidal product in the Member State of introduction;
- the name and authorization number of the reference product in the Member State;
- a sample of the biocidal product if the competent authority deems it necessary.
In order to be authorized, a biocidal product must meet the requirements for appropriate labelling and have a safety data sheet.
The authorization shall be subject to the payment of a fee in accordance with point 2.2 of the Annex to the Regulation implementing the Regulations (EU) on the making available on the market and use of biocidal products.
These terms apply to activity Market availability and use of biocidal products
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).
Summary of the biocidal product characteristics
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.
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
Renewal term: 10 years