Your EU Biocidal and/or Plant protection Products regulatory partner !
Management in Iuclid 6, R4Bp3, SPC Editor, Poison Center Notifications, Chesar, EUSES, BPR
Biocidal products are regulated in the European Union by the BP Regulation (EU) No 528/2012 and Plant protection products are regulated by the PPP Regulation (EU) No 1107/2019. Placing a product on the market should pose no unacceptable risk to human health, animals or the environment. The burden of complying with the Regulation firmly rests with industry, and we can help you by being the partner of your regulatory projects!
Elys Consulting can support you for both, active substance approvals and product authorisations across the EU for Biocidal and Plant Protection Products. And for any related tasks as described below:
*Application for national authorisation, mutual recognition or Union authorisation, extension of use...
*Grouping of similar biocidal products into product families
*Compiling of active substance and/or product dossiers in IUCLID (for Biocides and also PPP if required)
*Application submission via R4BP 3 (Register for Biocidal Products version 3)
*Summary of the product characteristics (SPC) , using the SPC Editor for Biocides
*Submission of data sharing inquiry to ECHA
*Assessment of technical equivalence (Assessment of Chemical Similarity)
*Classification, labelling and packaging in accordance to CLP
*Submission of data sharing inquiries
*Test strategy and monitoring
*Exposure estimation (Risk Assessments)(Eco-) toxicological assessment and Endocrine disruptor assessment of coformulants and evaluation of required studies for ED assessment of active substance..
*Poison Center Notification (UFI, submissions…)
*IT tools related to Regulatory matters support
*SME aplication...
Alliance Regulatory expert team can help you to understand your regulatory obligations/burdens and provide cost effective solutions/evaluations.
Chosing Alliance Regulatory is the good decision to always have a competent consultant at your side that helps you with the appropriate advice about acquiring the lacking or necessary data/study/test to build or complete your dossier/project.