Union authorisation

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

• 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

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

• 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

Biocidal products must be properly classified, packaged and labelled in accordance with the approved summary of product characteristics. The labelling of a biocidal product must not be misleading as to the risk posed by the product to human health, animal health and the environment and shall in no case contain the words "low-risk biocidal product", "non-toxic", "harmless", "natural", "environmentally friendly", "animal-friendly" or similar indications. In addition, the label must show the following information:

(a) the identity of every active substance and its concentration in metric units;

(b) the nanomaterials contained in the product, if any, and any specifically related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;

(c) the authorization number allocated to the biocidal product by the competent authority or the Commission;

(d) the name and address of the authorization holder;

(e) the type of formulation;

(f) the uses for which the biocidal product is authorized;

(g) directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorization;

(h) particulars of likely direct or indirect adverse side effects and any directions for first aid;

(i) if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;

(j) directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;

(k) the formulation batch number or designation and the expiry date relevant to normal conditions of storage;

(l) where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport;

(m) where applicable, the categories of users to which the biocidal product is restricted;

(n) where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;

(o) for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.

Member States may require:

• submission of packaging models or drafts, labels and instructions;
• that biocidal products are labelled in the language of each EU Member State.

Evidence

Draft label

Legal basis

• 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

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

The applicant should, as soon as possible, or at the latest 2 years before the planned submission of the application, ask the Competent Authority to take over the role of the evaluating Competent Authority. The following information should be provided: name of the applicant, UUID number of applicant, type of application (Union authorisation: individual product or biocidal product family), product type, active substance and its date of approval, date of planned submission of the application.

The applicant should enclose the written confirmation of the evaluating Competent Authority when submitting the application via R4BP3.

Evidence

Agreement