The Biocidal Products Regulation (EU) No. 528/2012 was introduced in July 2012 and is considered the most demanding biocidal legislation in the world.

It regulates the placing on the market of disinfectants, preservatives and material protection agents, insecticides and antifouling products in contact with water. Biocides are used to protect people, animals, materials, or objects from harmful organisms, pests, or bacteria. The distinction from other legal areas and the regulatory requirements for developers and distributors of biocidal products are complex.

We are aware of these major challenges and offer you expert advice and active support in the development of BPR approval strategies, including the creation of tailored active substance and product dossiers and product family concepts.

The REACH Regulation governs the registration, evaluation, authorization, and restriction of chemicals. The regulation's primary focus is on protecting people and the environment from hazards chemical substances can pose. It affects not only the trade with chemical products but also chemicals in preparations and articles.

Under REACH, all substances (including substances in mixtures) manufactured in quantities of more than one tonne per year or imported from a country outside the EU must be registered by the manufacturing or importing companies. An application for authorization must be submitted for the placing on the market and use of substances identified as being of very high concern due to their hazardous properties. Manufacturers, importers, and downstream users can apply for this authorization.

For substances that pose an unacceptable risk to human health or the environment, the production, distribution, or use can be restricted or even prohibited.

Together with you we will find practical approval solutions and guide you safely through all regulatory processes. Our services in detail:

• Strategic consulting, including demarcation issues regarding substances, mixtures, or articles ("Impact Analysis")
• Support in negotiating Letters of Access (LoA)
• Classification and labeling of substances and products according to CLP/GHS
• Summary of substance or product properties (e.g., SPC) and dossier submission via the relevant portals (e.g., R4BP, REACH-IT), and subsequent handling of queries from authorities
• Notification/registration/authorization of (biocidal) products in all EU member states under national transitional law
• Advice on demarcation issues between legal areas and the status of treated articles and their labeling
• Task force or consortium management
• Within the framework of REACH, we examine your role as a downstream user and clarify your obligations and expectations regarding the flow of information in the supply chain to ensure safe handling
• Trainings and workshops on regulatory affairs