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Dear Customers, Dear Business Partners,

Our company is here to serve you. Always fair, independent and of high quality, we meet you where you are. We want to build long lasting relationships where we work together trusting each other. Our services are constantly adapted to your needs. We look forward to hearing from you.
Kind regards,
Dr Gunnar Kleist

Dr. Gunnar Kleist Director of Regulatory Services
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The Biocidal Products Regulation (EU) No. 528/2012 (“BPR”), which is now in force throughout Europe, was introduced in July 2012 and is considered to be the most demanding biocide legislation in the world. It is more comprehensive than the previous Directive 98/8/EC and covers more active substances and products.

In-situ active substances and their precursors that could be used to generate an active substance are now covered, as are articles treated with biocidal products. In the case of detergents and cosmetics, biocidal product claims (e.g. antibacterial, antiviral) can also have serious consequences for the immediate marketability of your product. In addition, there are dual-use surface disinfectants in the healthcare sector that must comply with both biocidal and medical device regulations. All this places high regulatory demands on the developers and distributors of such products.

We are aware of these major challenges. We offer you competent advice and active implementation assistance: We'll work with you to find practical registration solutions. We'll help you navigate the authorisation process with the authorities and guide you safely through the EU's national transitional measures. Benefit from our experience and speed.

Who we are

We are experts in our field. When dealing with regulatory issues, we always look at what's commercially viable and what's going to work. Throughout the process, we do more than just compile documents for you - we are part of the thinking. Our contribution can range from modules to complete packages. We know when a small investment can make a big difference to the attractiveness of your products. We are convinced that we can add real value to your business: Reduced complexity and cost efficiency combined with safety and growth opportunities. You can rely on us to provide a high-quality service, backed up by our extensive regulatory experience and a large network of reliable partners.

Our key regulatory services for biocidal product approvals:

  • Development of BPR registration strategies, including the creation of tailor-made product family concepts.
  • Helping to negotiate Letters of Access (LoA) to obtain data  
  • Project management and study monitoring (initiating and follow-up)
  • Classification and labelling of substances and products in accordance with CLP/GHS
  • Exposure and risk assessment of active substances and biocidal products for humans and the environment, including substances of concern (SoC) and the assessment of endocrine disrupting (ED) properties.
  • BPR dossier preparation, including IUCLID file, Product Assessment Report (PAR) and Summary of Product Characteristics (SPC), as well as dossier submission via R4BP and subsequent handling of queries from the authorities.
  • Regulatory support: Providing individual dossier modules in IUCLID and PAR (e.g. efficacy, physicochemical properties).
  • Notification/registration/authorisation of products in all EU Member States under national transitional law (safeguarding as "existing product" prior to BPR post-authorisation to ensure continued marketability through the evaluation process).
  • Advising on borderline issues and the status of treated articles and their labelling
  • Training courses and workshops (also tailored in-house to meet your specific needs), including preparation for the comprehensive and restricted examination under the German Chemicals Prohibition Ordinance (with/without biocides and plant protection products).