Biocides

Biocides

The requirements for biocides in the European Union (EU) are very complex, and not all products containing active substances can be placed on the EU market.

Until 2024, the EU will review and register biocidal active substances. In accordance with the revision program, a specific active substance will be approved or not approved. If the active substance is not approved, it can no longer be used as the active substance in the biocidal product.

If approved, each active substance has its own deadline by which the product containing the substance must be registered (authorization). Registration is carried out by the manufacturer of the product (importer in the EU). Other distributors of the biocidal product, in each EU member state, may carry out the procedure for mutual recognition of the already registered product (if the manufacturer himself has not undertaken to do so).

Products containing active substances that have been included in the review program but have not yet been evaluated can be placed on the market by local registration in the Member States (LV: inventory number assignment procedure, LVĢMC). In each Member State, this procedure is different.

In addition, another condition that active substances may be placed on the market onlyt if manufacturer or importer is included in the list of active substance manufacturers published by the European Chemicals Agency (ECHA),

http://echa.europa.eu/web/guest/information-on-chemicals/active-substance-suppliers

Manufacturer or importer of such products must supply distributor with a declaration of conformity with the requirements of Article 95 of Regulation 528/2012, which must be submitted during the local registration process or during an inspection visit.

The Independent Expert Bureau "GE & AL" offers the following services with local registration in Latvia:

  • determination of the status of the active substance in the product and determination of the actions to be taken.
  • preparation of labels and safety data sheets in Latvian.
  • preparation and submission of an application for an inventory number in LVĢMC.

In Lithuania, Estonia and the Czech Republic:

  • consultations on registration in these countries.
  • preparation of labels and safety data sheets in LT, EE, CZ languages.
  • preparation of a local registration application, communication with relevant authorities.

If you want to offer a biocidal product already registered in the EU that is a subject to a mutual acknowledgment procedure for distribution on the Latvian, Lithuanian, Estonian and Czech markets, we can help you in such services:

  • creation, management of your company’s R4BP 3 account (this is a site for registering biocides at the European Chemical Agency ECHA) and communication.
  • translation of a summary of the product characteristics SPC and submission to R4BP 3.
  • preparation of labels and safety data sheets in LV, LT, EE, CZ languages.
  • submission of documents R4BP 3.

For international companies that want to register biocidal products throughout the EU or LV / LT / EE / CZ, we offer:

  • translation of a summary of the product characteristics SPC.
  • preparation of labels and safety data sheets in LV, LT, EE, CZ languages.