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.

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).

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.

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

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.