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Sell your biocides before
your competition!

We prepare a dossier for a successful registration of your transitional period biocide in only 48 hours!

Since 1996 we have successfully registered more than 30% of all biocides
on the Slovenian market. This is why we can help you get results that matter for you –
selling biocides as quickly as possible!

What do we provide in the scope
of a biocidal product registration?

First, we have a discussion with you. This enables us to understand your expectations and adapt our work so as to fulfil your goals in the set deadlines. At the same time you receive several solutions which might be more appropriate for you. Solutions that give you more space to make decisions. Then we help you acquire the information that is necessary for preparing a dossier in the shortest time possible. This means:

Transitional period notification

We help you acquire the documentation that is necessary for registration in the shortest time possible. This means:

  • review of your documentation,
  • assessment of the current situation,
  • assistance and advice on acquiring the lacking documentation,
  • preparation of the documentation.

You always have a biocidal product expert at your side that helps you with the appropriate advice and guides you to acquiring the necessary documentation. In this way you spare a lot of time and enable us to provide the entire service of successful registration of the biocidal product.

During the registration process we also prepare labels which are part of the registration application. At the end we submit the appropriately prepared documentation to the authorities and handle the registration procedure of the biocidal product with authorities!

Biocidal product authorisation

Authorisation of a biocidal product is a much more challenging and time-consuming project, which should always be approached with caution. Using the correct approach can help you eliminate a lot of issues. We offer all of the following services:

  • creation of a business plan,
  • review of the required documentation,
  • preparation of timelines,
  • estimation of costs,
  • preparation of studies,
  • preparation of a risk assessment,
  • preparation of a Product Assessment Report – PAR,
  • preparation of a Summary of Product Characteristics – SPC,
  • preparation of a IUCILD dossier,
  • preparation of an SDS and label,
  • management of the registration procedure in the R4BP system,
  • communication with competent authorities,
  • obtaining the decision from the competent authorities,
  • market expansion with a Mutual Recognition in Sequence - MRS,
  • introduction of changes to the authorised products (administrative, minor, major).

With our extensive knowledge, we help you avoid unnecessary complications and optimise the process to best fit your wishes and needs. We provide comprehensive service and offer full support for each step in the authorisation process.

Call us at +386 41 979 800 and ask
about the benefits we can offer you.

The registration of biocide Sanosil Super 25 Ag and its preparations was a very demanding project due to the specific formulation of the product. However, your quality and professional approach to work as well as your professional attitude enabled us to conclude all registration procedures and the implementation of necessary labels and documents. The work was done
in an extremely short time interval, thus enabling us a rapid launch in the market and
undisturbed operations. We thank you for our cooperation and look forward to your
consulting services in the future.

Ivan Sodnik, CEO
Valter d.o.o.

Frequently asked questions

What are biocidal products?

A biocidal product is any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

The criteria to be classified as a biocidal product are two:

  • The product must contain an active substance approved for one or more biocidal purposes. The active substance has a controlling effect on harmful organisms with biological or chemical action.
  • The product must actually be used for a certain purpose, e.g. for destroying bacteria, and as a repellent to mosquitoes. The content of a label on biocidal products is essential. Only one word can make a difference.

Which types of biocidal products do we know?

We know 22 different types of biocidal products. The most common biocidal products are:

  • Insecticides: products for destroying flies, mosquitoes and other insects;
  • Preservatives: chemicals used as preservatives in products and materials (e.g. colours and varnishes, detergents, fabric softeners etc.)
  • Disinfectants: cleaning and similar products used for disinfecting surfaces, materials and equipment, and products for disinfecting the skin and similar products for human hygiene;
  • Attractants, repellents: products used for the repulsion or attraction of harmful organisms (e.g. insects).

Which documents are used for the traceability of active substances?

Statement forms about the delivery confirmation which shall be used by the companies from the list in Article 95 of BPR:

Statement forms for companies placing biocidal products on the market:

Which are the procedures after placing the active substance on the list of approved active substances of the EU?

  1. National authorization
    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 in a part thereof.
  2. Mutual recognition in sequence
    Sequential mutual recognition of a national authorization for a biocidal product is a procedure under which an applicant applies for the authorization of a biocidal product in one or more Member States once the authorization for this biocidal product has been granted in one Member State in accordance with Article 17 of Regulation (EU) No. 528/2012.
  3. Mutual recognition in parallel
    Parallel mutual recognition of a national authorization for a biocidal product is a procedure under which an applicant applies for the authorization for a biocidal product and the authorization for this biocidal product has not yet been granted in accordance with Article 17 of Regulation (EU) No. 528/2012.
  4. Authorization for equal biocidal products
    The authorization for an equal biocidal product or family of products is granted for equal/identical products of the same or different company under the same provisions and conditions of an already granted authorization.
  5. Parallel marketing
    Authorization for parallel marketing is granted in a member state for a biocidal product for which an authorization has already been granted in another Member State (country of origin) and is identical to the product with an authorization in another Member State (reference product).

    Identity requirements:

    • the products are made by the same company, by an associated company or were made based on the licence according to the same production procedure;
    • the products are identical in their specifications and content, active substances and type of formulation;
    • the products are identical regarding the content of their inactive substances;
    • the products are identical or equivalent regarding their size, material or packaging shape in the sense of an unwanted effect on the product safety, human health, animal health or environment.
  6. Union authorization
    Union authorization is an administrative act by which the European Commission authorizes the making available on the market and the use of a biocidal product or a biocidal product family in the EU territory or in a part thereof.
  7. Simplified procedure

    Authorization based on a simplified procedure can be issued for biocidal products which meet the following conditions:

    • all active substances in the biocidal product are on the list from Annex II of Regulation (EU) No. 528/2012 and meet all conditions from the Annex;
    • the biocidal product does not contain any harmful substances;
    • the biocidal product does not contain any nanomaterials;
    • the biocidal product is effective enough;
    • no personal protective equipment is required for handling and using the biocidal product.

How can biocidal products be advertised?

Only biocidal products with a proper marketing authorization can be advertised, recommended or advised.

In case of advertising biocidal products, each advertisement must contain the following text:

"Use biocides safely. Always read the label and product information before use." The sentences shall be clearly distinguishable in relation to the whole advertisement.

Advertisers may replace the word "Biocides" in the prescribed sentences with an accurate description of the product-type being advertised.

Advertisements for biocidal products may not refer to the product in a manner which is misleading in respect of the risks from the product to man, animals, the environment or its effects.

Under no circumstances may the advertising of a biocidal product mention "low-risk biocidal product", "non-toxic", "harmless", "natural", "environmentally-friendly", "animal-friendly" or any similar indications.

What are treated products?

A "Treated product" is any substance, mixture or product which was treated with one or more biocidal products or contains them intentionally. A treated product with a biocidal function as primary is considered as a biocidal product.

A treated product may not be placed on the market unless all the active substances in the biocidal product which are used for the treatment of the product or are contained in the treated product, are on the list of approved active substances for this type of product and supplied by suppliers from the list in Article 95 of BPR.

The person responsible for placing the treated product on the market shall make sure the label includes:

  • a statement that the treated product contains biocidal products;
  • a justified biocidal characteristic of the treated product;
  • the names of all the active substances contained in the biocidal products without breaking Article 24 of the Regulation (EC) No. 1272/2008 (CLP);
  • names of all the nanomaterials contained in the biocidal products which have the word ‘nano’ written in brackets after the main word;
  • all relevant instructions for use, including all precautionary measures, which must be adopted due to the biocidal products used to treat the treated product or contained in the treated product.
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