Informative Notice
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Notification
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.
Conditions
These terms apply to activity Market availability and use of biocidal products
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If the biocidal product is already on the market in one of the other Member States of the European Union or in third countries, the application must be accompanied by appropriate proof of registration in other countries.
Evidence
- A copy of the permit or
- other evidence from the competent authority of the country where the biocidal product was first placed on the market, or
- a label with a registration number indicating that the biocidal product is authorized in another country.
Legal basis
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In the procedure of notification of a biocidal product, the applicant must prove the supply with a statement or confirm that the company listed as a supplier of the active substance is included in the List of active substances and suppliers pursuant to Article 95 of the BPR. The applicant must demonstrate, by means of the statement referring to the supplier of the active substance, that the company indicated as the manufacturer/formulator of the biocidal product purchases these active substances from the supplier listed in the List of active substances and suppliers.
Evidence
- Delivery confirmation statement
- Statement with reference to the supplier
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The biocidal product must have an appropriate property based on the efficacy tests against target organisms.
More detailed requirements regarding the effectiveness of hand disinfectant products can be found at this link.
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
Performance data
Legal basis
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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
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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
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For a biocidal product, a label proposal must be submitted during the notification process. The label is intended for the user of the product and must therefore provide the user with clear information on the biocidal product and its intended use.
It must contain all the elements referred to in the second paragraph of Article 69 of Regulation (EU) No. 528/2012, except for the license number, which is not awarded in the notification procedure. In accordance with this paragraph and the fourth paragraph of Article 25 of Regulation (EC) No. 1272/2008, the holder of the authorization must ensure that the label is not misleading as to the risk to human, animal or environmental health.
The label is prepared in the Slovenian language. It can also be multilingual.
In the process of reviewing the draft label, the Office reviews and, if necessary, draws attention to possible irregularities on the label. Office can propose changes, but does not approve the label, as the notifier is responsible for the content of the label on the biocidal product packaging; its compliance with regulations is checked by a chemical inspector.
Indications of specific organisms on the label of disinfectants
Only proven effects may be indicated on the label in accordance with the Guidance on the Evaluation of the Effectiveness of Biocidal Products (Guidance on the BPR: Volume II Parts B + C Version 3.0 April 2018, page 48).
There are numerous potential target microorganisms for disinfectants, so it is practically impossible and also unnecessary to test all target microorganisms. The guidelines and European standards specify the reference species of target microorganisms (bacteria, fungi, viruses, etc.) against which the basic biocidal effect indicated on the label have to be demonstrated, e. g. bactericidal, fungicidal, virucidal, etc. In this case, the reference species of target microorganisms used in the tests shall not be indicated on the label.
The indication of specific target microorganisms on the label, those already included in the basic biocidal effect, may mislead users, and can give an undue impression of a disinfectant with better properties, and is therefore not permitted. For example, any disinfectant that is effective against enveloped viruses or the viruses in general will also be effective against SARS-CoV-2, rotavirus and norovirus, so there is no need to emphasize these particular viruses on the label.
Specific species of target microorganisms may be indicated on the label only if they are the sole or the most relevant organism or have a different susceptibility to disinfectants than other members of the same group, but such a product must first have a basic biocidal effect, e.g., anti-bacterial effect against Mycobacterium tuberculosis should not be reported unless a general bactericidal effect has been demonstrated.
The guidelines also allow for the possibility that the label indicates an effect against a specific target microorganism, but in this case efficacy tests must be performed with this particular species of microorganism and this effect must not mislead the user and give the user a false sense of superior disinfectant efficacy as already represented by basic biocidal effect.
Indication of efficacy on the disinfectant label
Indicating efficacy in percentages of target organisms’ reduction may give the user the impression that such a disinfectant is better than disinfectants for which the percentage is not given.
The guidelines for determining efficacy, Annex IV (p. 264), clearly specify the required logarithm reduction of target organisms. For Phase 2 Step 1 tests these requirements differ for bacteria: 99.999% (5 log), for yeasts and viruses 99.99% (4 log). Lower reduction rates (e.g., "destroys 99.9% of bacteria, viruses and yeasts") do not meet the prescribed requirements and may not be used or indicated on the label to present a biocidal effect.
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Any advertisement for biocidal products must comply with Article 48 of Regulation (EC) No. 1272/2008 on classification, labeling and packaging of substances and mixtures and with Article 72 of Regulation (EU) No. 528/2012 on the making available on the market and use of biocidal products. It should also include the sentence: “Use biocides safely. Always read the label and product information before use.” The strike must be clearly visible and legible throughout the advertisement.
Advertisers may replace the word 'biocides' in the prescribed sentences with a clear reference to the type of product being advertised.
The trade name of the biocidal product must not be misleading in terms of the risk that the product represents and must not contain statements from the second paragraph of Article 69 of Regulation 528/2012/EU or terms/statements accepted at the EU level. The trade name and any other presentation of the biocidal product must in no case contain the following:
- low-risk biocidal product,
- non-toxic,
- harmless,
- natural,
- environmentally friendly,
- animal friendly or any other similar designation as:
- bio,
- naturally,
- organic,
- eco,
- ecological,
- green,
- safe and similar.
Procedures
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Notification
Personal
Procedure costs
Costs for the product registration: 210,00 €
Renewal term
The authorization under the notification procedure shall be valid until the date of approval of the last active substance of the biocidal product concerned.