Biocides Regulatory Services
Expert compliance and registration support for biocidal products in Malta and the EU
Leading Biocides Regulatory Consultants in Malta
Biocides are essential for maintaining safe, hygienic, and sustainable environments across households, commercial spaces, agriculture, healthcare, and water treatment facilities. At Gouder & Associates, we provide comprehensive biocides regulatory services to help manufacturers, importers, and distributors navigate the complex compliance landscape.
Our expertise ensures your biocidal products meet all requirements under Regulation (EU) No 528/2012 (Biocidal Products Regulation - BPR) and national standards, enabling successful market authorization while maintaining the highest safety and efficacy standards.
Our Biocides Regulatory Services
BPR Compliance & Authorization
Complete support for Biocidal Products Regulation (EU) 528/2012 compliance. We guide you through the entire authorization process, from active substance approval to product registration, ensuring your biocides meet stringent EU and Maltese regulatory requirements.
Product Registration & Dossier Preparation
Expert preparation of biocidal product registration dossiers. Our team manages technical documentation, efficacy data, safety assessments, and labeling requirements to streamline your product's path to market authorization.
Safety & Efficacy Assessments
Comprehensive safety and efficacy evaluations for biocidal products. We coordinate with scientific experts to ensure your products demonstrate proper effectiveness against target organisms while maintaining acceptable safety profiles for users and the environment.
Regulatory Strategy & Planning
Strategic regulatory planning for biocides market entry. We develop tailored compliance strategies considering product type (PT1-PT22), application method, target markets, and regulatory timelines to optimize your authorization pathway.
Ongoing Compliance Support
Continuous regulatory monitoring and compliance updates. Our team stays current with evolving BPR policies, active substance reviews, and regulatory changes to ensure your products maintain compliant status throughout their market lifecycle.
Labeling & Distribution Guidance
Expert advice on biocides handling, labeling, and distribution best practices. We ensure your product labeling meets CLP Regulation requirements and provide guidance on safe handling procedures, storage, and environmental safety protocols.
Biocides Applications We Support
Household & Commercial
Disinfectants, sanitizers, preservatives
Agriculture & Crops
Plant protection, pest control products
Healthcare Facilities
Medical disinfectants, sterilization agents
Water Treatment
Water purification, swimming pool treatments
Industrial Applications
Anti-fouling, preservatives, industrial hygiene
Food & Beverage
Food contact materials, processing equipment
Why Choose Our Biocides Regulatory Services?
BPR Expertise
Deep knowledge of Regulation (EU) 528/2012 and authorization processes
Scientific Excellence
Strong foundation in efficacy data and safety assessments
Current Knowledge
Up-to-date with evolving BPR policies and substance reviews
Minimized Risk
Proven strategies to reduce compliance risk and regulatory delays
Ready to Navigate Biocides Regulations?
Bring your biocidal products to market with confidence. Our regulatory experts ensure full BPR compliance and efficient authorization.
Get Expert Guidance