Market availability and use of biocidal products

Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.

An applicant intending to place on the market in the Republic of Slovenia a biocidal product containing an existing active substance that has already been evaluated for this type of product and has not yet been included in the list of approved active substances or is in the process of being evaluated for inclusion in the Union list of approved active substances, shall submit an application in accordance with the national notification procedure to the Chemicals Office of the Republic of Slovenia (hereafter: CORS).

The application for notification of a biocidal product shall be prepared in the Slovenian language. To be notified, a biocidal product has to meet the conditions for registration in other countries, have appropriate efficacy data, be properly labelled and have a safety data sheet.

Once the costs of the procedure have been paid and the biocidal product meets the requirements of the relevant regulation, the competent authority includes the biocidal product in the register of biocidal products. By listing the biocidal product in the register, the conditions for the making available of the biocidal product on the market and use in Slovenia are met.

The authorization under the notification procedure shall be valid until the date of approval of the last active substance of the biocidal product concerned. If the authorization holder wishes to continue making the biocidal product available on the market and use, he must submit an application for authorization under Regulation (EU) No 528/2012, e.g., national authorization, mutual recognition of authorization to the competent authority on the date of approval of the last active substance of the biocidal product at the latest.

If an application for an authorization under Regulation (EU) No 528/2012 has not been submitted on the day of approval of the last active substance for a specific product type at the latest, the biocidal product shall be deleted from the register of biocidal products within 180 days.

The notified biocidal products shall be deleted from the register of biocidal products within three years from the date of approval of the last active substance if an application for authorization or parallel mutual recognition has been submitted.

Notification of changes to notified biocidal products

The authorization holder of the notified biocidal product or the notifier is obliged to immediately notify the CORS of any changes that occur after the notification (registration) of the biocidal product. Amendments shall be notified in writing, with an application for notification of the biocidal product and an indication of a change in the notification. Only those points that are changing should be filled in the application, or only the part that is changing should be marked: all corrected attachments in which the change has occurred should be resent. For certain changes, the costs of changing the notification of biocidal products are charged.

Fees for changes to the notification of a biocidal product:

•  for changes for which the applicant pays a fee of 90 EUR:
  • change of trade name,
  • notification of a synonym,
  • minor changes in the composition of inert substances that do not significantly affect the properties of the biocidal product,
  • changing of the scope or adding new target organisms;
    
    
• changes without a fee are:
  • change of safety data sheet,
  • change of classification of the biocidal product,
  • change of data on the notifier, manufacturer or formulator, deletion from the register,
  • minor changes of the instructions for use such as removal of an indication of the target organism or specific use, withdrawal of the user category.«

Note: Other fees for changes not listed above are decided by the CORS. A change in an active substance of a biocidal product is considered to be a new biocidal product unless the active substance is renamed within the EU active substance review program.

Details

A national authorization is an administrative act by which the competent authority of a Member State authorizes the making available on the market and the use of a biocidal product or a biocidal product family in its territory or part of its territory.

The application must be submitted via R4BP 3 of the European Chemicals Agency (ECHA). The IUCLID 6 information tool is used to prepare the application dossier.

In order to be authorized, a biocidal product must meet the conditions for making available on the market and use of the biocidal product, be properly labelled and have 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 fees are 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.

Details

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.

Details

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.

Details

Legal basis

• COMMISSION IMPLEMENTING REGULATION (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Mutual recognition in a sequence of a national authorization for a biocidal product may be requested by the applicant in a case when another EU Member State has already issued the authorization.

The application must be submitted through R4BP 3 of the European Chemicals Agency (ECHA). In order to be authorized, a biocidal product must meet the conditions for making it available on the market and the use of the biocidal product, be properly labelled and have 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 is set out in 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.

Details

Mutual recognition in parallel of a national authorization for a biocidal product may be requested by the applicant in a case when the authorization has not been issued by any EU Member State yet. The applicant shall submit to the reference competent authoritiy an application for mutual recognition in parallel together with the list of all other Member States of its choice where a national authorisation is sought.  

The application must be submitted through R4BP 3 (External link) of the European Chemicals Agency (ECHA). In order to be authorized, a biocidal product must meet the conditions for making it available on the market and the use of the biocidal product, be properly labelled and have 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 is set out in 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.

Details

A Union authorization is an administrative act by which the European Commission authorizes the making available on the market and use of a biocidal product or biocidal product family in the territory of the Union or part of the territory of the Union.

A Union authorization shall confer on each Member State the same rights and obligations as a national authorization.

The application for authorization must be submitted to the European Chemicals Agency (ECHA) via the R4BP 3 application. The applicant shall inform the Agency of the name of the competent authority of the Member State it proposes to evaluate the application. The notification must be confirmed that the biocidal product will be used under similar conditions throughout the Union.

In order to be authorized, a biocidal product must meet the conditions for making available on the market and use of the biocidal product, be properly labelled and have a safety data sheet.

No authorization shall be granted for biocidal products relating to pest control products (rodenticides, avicides, piscicides, control of other vertebrates) and products related to antifouling agents.

The authorization fee must be paid to the European Chemicals Commission in accordance with Table 1 of Annex II to Commission Implementing Regulation (EU) No 564/2013 and the evaluating country, e.g., Slovenia. In this case, the Chemicals Office of the Republic of Slovenia informs the applicant of the amount, method and deadline for payment of the fee upon receipt of the application. The fees are 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.

Details

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).

Identity requirements:

• 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.

Details

Temporary permission

A provisional authorization for a biocidal product shall be granted for a biocidal product containing a new active substance that has not yet been approved.

If the Commission decides not to authorize a new active substance, the competent authorities which issued the provisional authorization, or the Commission shall withdraw that authorization. 

Testing permission

Any person intending to carry out an experiment or test that may involve, or result in, the release of the biocidal product into the environment shall first notify the competent authority of the Member State where the experiment or test will occur. The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health or impact on the environment. The notified experiment or test may be carried out only if approved by the competent authority.

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
• Restrictions on the Use of Alcohol Act (ZOPA)

The activity of trade in dangerous chemicals may be performed by legal and natural persons who demonstrate to the Chemicals Office of the Republic of Slovenia that they are implementing specific technical or organizational measures for trade in dangerous chemicals.

The measures include:

1. Compliance with restrictions on the marketing of dangerous chemicals in grocery stores
2. Appropriate user information
3. Measures for storage of hazardous chemicals

Observance of restrictions on trade in hazardous chemicals

Dangerous chemicals may not be placed on the market in food stores if they are marked as:

• acutely toxic hazard categories 1, 2 and 3 (H300, H310, H330, H301, H311, H331),
• germ cell mutagens, hazard categories 1A, 1B and 2 (H340, H341),
• carcinogenic, hazard categories 1A, 1B and 2 (H350, H351),
• toxic for reproduction, hazard categories 1A, 1B and 2 (H360, H361, H362),
• specific target organ toxicity for single exposure, hazard category 1 (H370),
• specific target organ toxicity for repeated exposure, hazard category 1 (H372).

Hazardous chemicals not listed in the previous paragraph may also be placed on the market in grocery stores, provided that they are separated from other goods and protected in such a way that their impact on other goods is not possible.

Appropriate user information

Legal and natural persons who place on the market as objects of general use dangerous chemicals, which are marked as:

• acutely toxic (H300, H310, H330, H301, H311, H331, H302, H312, H332),
• skin corrosives/skin irritations (H314, H315),
• cause serious eye damage/eye irritation (H318, H319),
• cause respiratory or skin sensitization (H334, H317),
• germ cell mutagenesis (H340, H341),
• carcinogenic (H350, H351),
• toxic for reproduction (H360, H361, H362),
• specifically toxic to target organs at single exposure (H370, H371, H335),
• specifically toxic to target organs from repeated exposure (H372, H373),
• Aspiration hazard (H304)

must have a reference to users in a visible place at the point of sale of these chemicals in accordance with Annex III to the Regulation.

The reference from the previous paragraph is in A3 size (420 x 297 mm), on a white background. Legal and natural persons trading in hazardous chemicals must provide the customer, at his request, with additional information on the meaning of the labels on the packaging, information from the safety data sheet or other general instructions on the safe use and handling of chemicals.

Measures for the storage of hazardous chemicals include:

• Storage classes
• Storage rules
• Technical storage requirements
• Organizational requirements for storage

and are specified in more detail in the Rules on technical and organizational measures for the storage of hazardous chemicals.

Legal basis

• Chemicals Act (ZKem)
• Rules on user information, register and the specific requirements for trade in dangerous chemicals
• Rules on technical and organisational measures for the storage of hazardous chemicals
• Restriction on the Use of Tobacco Products and Related Products Act (ZOUTPI)
• Rules on the requirements to be met by smoking rooms