Consultancy about Biocidal Products Regulation (BPR, EU 2012/528) and National Transitional Normatives in EU

If you have any doubts regarding the regulation and the concerning guidelines/standards or how to implement them, our experts can help you.

Feasibility studies & Data gap analyses

Feasibility studies include:
– Preliminary analysis of your product (is it BPR or borderline product?)
– Project preliminary design
– Experimental plan
– SOCs, EDCs and relevant regulatory milestones
– Business Plan of the regulatory project

BPR Dossier for Active Substance and/or Product

BPR one-stop-solution Dossier Management including:
– Consultancy activity
– Risk Assessment
– Experimental Study Monitoring
– Dossier Preparation, Submission and Post-submission
– Communication with Authorities

BPR Products Family

Design and description of the family approach upon CA-July19-Doc.4.2-Final – Guidance note on BPF concept: assessment of similarity in BPF by:
– Similarity of composition upon each component hazard assessment
– Similarity of Uses
– Similar levels of risk
– Similar level of efficacy

Substances of Concerns & Endocrine Disruptors

Toxicological and Risk assessment of:
– Substance of Concerns (SOCs)
– Endocrine Disruptive Chemicals (EDCs)
– Persistent Bioaccumulative and Toxicological substances (PBTs)

Transitional pre-BPR Normatives

– Notification, registration and/authorization procedures in European Countries (PMC, SIMMBAD, Real Decreto, HSE notification, etc)
– Communication with Authorities

Article 95

The step-by-step procedure to achieve Art95 compliance, including:
– Experimental studies for Technical Equivalence / Chemical Similarity
– Regulatory support / liaison for Letter of Access achievement
– Submissions and communication with Authorities

Study Monitoring

While Chemsafe has no internal laboratory, we can assist you during the testing phase thanks to our vast and versatile network and partnerships for:
– Chemical and stability studies
– Efficacy tests on different Product Types
– Safety endpoints

Task Force projects and Consortia

Chemsafe’s Task Force Management experience and innovative approach as a good balance between costs sharing and companies agile business strategies.