National Authorisation Procedure

Biocidal Products – National Authorisation Procedure

The national authorisation procedure for biocidal products applies to products containing existing active substances under evaluation or being assessed under Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014, where at least one active substance has not yet been approved for the relevant product-type.

Marketing authorisation may be granted if the following conditions are met:

1. The product meets the definition of a biocidal product as outlined in Article 3(1)(a) of Regulation (EU) No 528/2012 of the European Parliament and of the Council;
2. The intended use falls within the product-types and groups described in Annex V of Regulation (EU) No 528/2012;
3. The product contains existing active substances under evaluation or in the assessment phase under Regulation (EU) No 1062/2014, not yet approved for the given product-type;
4. The product is effective against the target harmful organism;
5. Safety measures have been defined for the use of the biocidal product;
6. The supplier of the active substance (or the biocidal product) is listed under Article 95 of Regulation (EU) No 528/2012.

The marketing authorisation specifies:

1. Name of the biocidal product;
2. Authorisation number, date of issuance, and validity period;
3. Name and address of the responsible entity (company or individual);
4. Name and address of the manufacturer;
5. Chemical name(s) of the active substance(s), CAS and EC numbers (if available), and concentration in metric units;
6. Product-type group;
7. Formulation type and intended use of the biocidal product;
8. Target user type (e.g. professional, general public);
9. Packaging type;
10. Shelf life of the biocidal product;
11. Label content in the national language (e.g. Polish).

Applications for marketing authorisation must be submitted to the competent authority — in Poland, this is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).

The application must include:

1. Name and address of the responsible entity (company or individual);
2. Name of the biocidal product;
3. Name and address of the manufacturer;
4. Chemical name(s) of the active substance(s), CAS and EC numbers (if available), and concentration in metric units;
5. Information on the intended use, product-type group, and formulation type;
6. Target user type;
7. Packaging type;
8. Shelf life of the biocidal product.

Documents to be attached to the completed and signed application form:

1. Proof of payment for application processing;
2. Document confirming the legal status of the responsible entity;
3. Label content in the national language (e.g. Polish);
4. Original or notarised copies of effectiveness study report;
5. Statement of product identity (if applicable);
6. Letter of access to data (if applicable);
7. Safety Data Sheet (if applicable);
8. Name of the active substance or biocidal product supplier listed in accordance with Article 95 of Regulation (EU) No 528/2012;
9. Power of attorney (if applicable).

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