Your product's success is important to us.

We know what we're doing and are here to help. We meet you where you are, always fairly, independently and with high quality. We strive for long-term relationships in which we work together in a spirit of trust. The services we provide are constantly being adapted to meet your needs.

When dealing with regulatory and scientific issues, we always keep an eye on what is economically feasible. Our contribution can range from individual components to a complete package.

We look forward to hearing from you.

Dr. Gunnar Kleist Director Regulatory Services
Get in touch

Regulatory Affairs
Biocides

The European Biocidal Products Regulation (EU) No. 528/2012 (“BPR”) was introduced in July 2012 and is considered the world's toughest biocide legislation.

It regulates the placing on the market of disinfectants, preservatives, insecticides, rodenticides and anti-fouling products in contact with water. Biocides are used to protect humans, animals, materials or objects from harmful organisms, pests or bacteria. The distinction from other areas of law and the regulatory requirements for developers and distributors of biocidal products is a complex area of work.

We are aware of these major challenges and can offer you expert advice and active support in the development of BPR registration strategies, including the preparation of tailor-made active substance and product dossiers as well as product family concepts.

Our regulatory service for you
From dossier preparation to approval/authorisation

We will guide you safely through all regulatory processes, working with you to find practical solutions to regulatory challenges. Our services in detail:

  • Support in the negotiation of Letters of Access (LoA) to data 

  • Classification and labelling of substances and products in accordance with the CLP / GHS system

  • Summary of Product Characteristics (SPC) and dossier submission using R4BP, followed by dealing with regulatory queries from authorities

  • Notification/registration/authorisation of products in all EU Member States under national transitional legislation

  • Advice on borderline issues with other regulatory areas and on the status of treated articles and their labelling

  • Training courses and workshops (also tailored in-house to your individual needs), including preparation for the comprehensive and restricted expert knowledge examination under the German Chemicals Prohibition Ordinance (with/without biocidal products and plant protection products).

Regulatory Science
Study monitoring and risk assessment

We support you in the scientific areas of efficacy, physico-chemistry/analytics, human toxicology, ecotoxicology and environmental fate in the collection and evaluation of all scientifically necessary information required by the relevant legislation. We critically review what information is absolutely necessary in advance. We support your studies and describe them in the relevant study templates and/or IUCLID upon completion.

We are experts with many years of experience in the field of risk assessment of substances under various legislations. As part of the risk assessment process, the effects of a substance or product are compared with the exposure to it, both for humans and for the environment. We derive the necessary reference values and assessment factors to characterise potential effects. To determine exposure, we use existing emission/exposure scenarios, adapt them if necessary or develop new, tailor-made scenarios to cover your specific product application.

Our scientific service for your
Efficacy, Phys-Chem./Analytic, (Eco-)Toxicology, E-fate

In constant dialogue with you and the authorities, we provide scientific support throughout the registration process. Our services in detail:

  • Project management and study monitoring (contracting and supervision)

  • Exposure and risk assessment of active substances and biocidal products for humans and the environment, including substances of concern and endocrine disrupters (ED).

  • Preparation of the BPR dossier including the IUCLID file and the Product Assessment Report (Draft PAR)

  • Provision of individual dossier modules in IUCLID and PAR (e.g. environment, efficacy, physicochemical properties)

  • Responding to scientific comments received during the evaluation and peer review process

  • Training courses and workshops (also tailored in-house to your individual needs), e.g. in the area of environmental risk assessment

Areas of specialisation
Wood Preservation / Disinfectants / Medicinal products / Environmental Exposure

Our experts have specialised knowledge in the following areas and can actively support you:

  • Wood Preservatives: We have decades of practical experience, particularly in their efficacy. We are also recognised experts in environmental exposure, including the design and monitoring of leaching studies (laboratory and field)

  • Disinfectants: The efficacy of disinfectants and their exposure to the environment is another area in which we specialise. We offer innovative solutions for your substances and products

  • Medicinal products: we have extensive experience especially in the environmental risk assessment for medicinal products for human as well as for veterinary products. We provide support also in the preparation of applications according to the new guideline EMEA/CHMP/SWP/4447/00 Rev. 1.

  • Environmental Exposure: We have in-depth expertise in the area of environmental exposure across all legislation (biocides, REACH, pharmaceuticals, pesticides). We are your competent partner when it comes to creating emission scenarios or applying higher-tier simulation models.

News from our company

Show all news
March 4, 2024
Dream team brings regulatory expertise in-house
With a real "dream team", Dr. Brill Institutes will be able to offer customers from industry its own Regulatory Service in the future. Heike Schimmelpfennig and Dr. Gunnar Kleist, each with two decades of regulatory experience in different areas of industry and public authorities, offer a 360-degree view of chemical testing and approval of biocides (active substances and products). "With our wealth of experience from different perspectives, we are unique on the market," explains Dr. Gunnar Kleist confidently. "We offer our customers holistic project management, which can take five years from the first kick-off meeting to approval, depending on the process." The two are more than trustworthy sparring partners in a process that demands complete transparency and honesty from the customer. Thanks to its many years of experience, the Regulatory Services team is also able to master critical situations at short notice when companies get lost in the complex European chemicals legislation or miss important deadlines, which can sometimes threaten their existence. However, both prefer to work with the customer from the start of the process in order to avoid precisely such crisis situations. "In our role, we also see ourselves as a mediator between the needs of industry and the expectations of the authorities," says Heike Schimmelpfennig. "We know what the authorities want, but we also know the needs of industrial customers." Heike Schimmelpfennig has ten years of experience in the environmental risk assessment of chemicals in both a consultancy firm and an EU regulatory authority. Dr. Gunnar Kleist contributes his more than 20 years of corporate experience in industrial research, test method development and Regulatory Affairs. Their joint core competence is to incorporate all relevant information from their profound knowledge of internal company processes into an approval application in such a way that a smooth and successful completion of the entire procedure is guaranteed. The Regulatory Services are an independent island in the Dr. Brill family because their services can be booked independently of laboratory operations. The efficacy tests required for product approval can, but of course do not have to, be commissioned from Dr. Brill + Partner. However, the short line to the technical expertise of the associated test laboratories and the possibility of commissioning time-critical data packages at short notice within the network can be a decisive advantage for the customer in the approval process. Dr. Florian Brill, Owner and Managing Director of Dr. Brill Institutes, sums it up: "With the integration of Dr. Brill Regulatory Services GmbH into the Dr. Brill Institutes Group, we have gained a decisive new building block that will help us strategically. We are bringing regulatory expertise in-house. A large part of our work in the various laboratories results in an approval dossier according to BPR, for example, and now we can deliver this. Dr. Brill Regulatory Services was the missing component - and with Gunnar and Heike we have gained two superstars of the scene. I want them in my team and so do our customers. I'm really looking forward to everything else." In the coming weeks and months, the new Dr. Brill Regulatory Services team will be presenting itself to clients at conferences and presentations. Dr. Gunnar Kleist: "It is important that clients build up a basis of trust with us and also realize what makes us special. That we don't do anything by the book, but always create the best case for the customer. As a rather small team, we deliver what we promise with our personal expertise!" If you would like more information about our new service, please contact Heike Schimmelpfennig (heike.schimmelpfennig@brillregulatory.com) or Dr. Gunnar Kleist (gunnar.kleist@brillregulatory.com).  
September 4, 2023
Regulatory Affairs
Dr Brill + Partner GmbH will take over the regulatory affairs consultancy business of Knieler & Team GmbH at the turn of the year. "With this move, we are expanding our services to include another area of expertise: regulatory affairs, focusing on biocide authorisations and medical device issues. We are responding to the requests of many of our clients and see great potential for growth in this area," says Dr Florian Brill. Continuity and competence are guaranteed by Dr Gunnar Kleist. He will continue to manage and expand the activities of the independent Dr Brill Regulatory Services GmbH under the umbrella of the impartial Dr Brill + Partner GmbH.  "A great solution for everyone involved. The takeover gives our clients the security of receiving top consulting services in the future," says Dr Roland Knieler: "I will push the development of ecologically beneficial disinfectants with Knieler & Team GmbH". The services are now available on the new website www.brillregulatory.com. Any questions? Please feel free to get in touch with us: Florian Brill (florian.b@brillhygiene.com) or Roland Knieler (r.knieler@knielerundteam.de).   Best regards, Florian Brill and Roland Knieler
August 30, 2023
Biocides Europe 2023 - Meet us in Vienna!
With Dr. Florian Brill's presentation "The importance of practice-like efficacy evaluation of biocidal products - simulated use and field studies" we will be present at Biocides Europe 2023 this year. The conference will take place in Vienna on 11-12 December 2023. All information about the program and registration can be found at the following link. Use your participation also for a personal exchange with us on site. We would be happy to meet you again in Vienna. https://events.chemicalwatch.com/662069/biocides-europe-2023