Specialists in regulation of biocidal products
Regulation (EU) 528/2012
The BPR Regulation (EU Regulation 528/2012 on biocidal products), which entered into force on 1 September 2013 repealing Directive 98/8/EC, regulates the placing on the market and use of biocidal products and ensures a high level of protection for human health and the environment.
In order to place a biocidal product on the market under the BPR Regulation, it must be authorised in each of the Member States where it is to be placed on the market (national authorisation) or throughout the European Union (EU authorisation).
Active substances must be approved before a biocidal product containing them is authorised. To this end, a review programme for active substances has been set up and is being evaluated by the Member States before they are approved by the European Commission and included in the List of Approved Active Substances.
However, active substances included in the review programme and biocidal products containing them may be placed on the market pending a final decision on approval if they have the relevant permits to be placed on the market in accordance with the regulations applicable in each country of the European Union.
Within the chemical sector, different solutions have been proposed to address the application for authorisation in the most affordable way. One of the most attractive options is the creation of consortia, in which the companies jointly prepare the documentation and share the testing costs, substantially reducing the economic outlay involved in submitting an application for individual authorisation.
ServiREACH offers you the necessary support to comply with the regulations applicable to the marketing of biocidal products in all the member states of the European Union.
Diagnosis We determine your company’s obligations under Regulation (EU) 528/2012 to assess the current level of compliance and define the appropriate strategy to meet them.
Application for biocidal product authorisation – BPR We process the application by carrying out risk assessments, providing advice on determining the required tests, and preparing all the technical documentation necessary for the submission of the dossier to the competent authorities.
Application for biocidal product authorisation – Applicable legislation before approval of the active substance We process the application in accordance with the applicable regulations.
Economic study of application for biocide authorisation – BPR We identify all the costs associated with any application for authorisation for the financial analysis of the company with the aim of determining the return on investment.
Compliance study We evaluate how the BPR Regulation affects each of your products, check their obligations and propose a list of actions to correct the breaches detected.
Consultancy Based on our personalized advice, we can solve your queries efficiently and conveniently – and become your trusted ally offering a swift solution on any areas of doubt.