BIOCIDE AND PESTICIDE PRODUCT REVIEW AND REGISTRATION
The Biocide Product Regulation (BPR, Regulation (EU) 528/2012) concerns the “placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product.” ( Biocidal Products Regulation. Retrieved from https://echa.europa.eu/regulations/biocidal-products-regulation)
The mere presence of a recognized “active substance” is not sufficient to identify a product as a Biocide. The company placing the product on the market must also be making claims regarding the function or use of the material in order for the product to be subject to this regulation. The BPR, combined with the Plant Protection Products Directive (PPP), would be similar to the US EPA requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA ).
Before a biocide (or pesticide) can be sold, the product must be registered. During this process, data must be presented to demonstrate that the material is not unreasonably hazardous to human or environmental health (other than the intended target).
ChemADVISOR’s experts will complete a product review that involves evaluation of the product and product substances to identify regulatory requirements for legal sale in accordance with the Biocidal Products Regulation (BPR). The review will summarize the current regulatory status of the active substances and any other ingredients, as well as the product as a whole. The product review stage will identify any gaps that need to be addressed, and steps needed before your material can be legally registered and sold as a biocide. To learn more details about this topic review our BPR & Treated Biocide Articles Training Course.
The Health Canada Pest Management Regulatory Agency (PMRA) is responsible for all pesticide regulation in Canada.
ChemADVISOR PMRA professionals are trained with in-depth knowledge on Health Canada’s present oversight of sales and use of pesticides with emphasis on product categories, registration dossiers, labeling and additional compliance responsibilities as it pertains to PMRA.
Our team can review with you what defines a Canadian pesticide, types of pesticide registrations and the responsibilities of pesticide Registrants, Manufacturers and Distributors as they go through the process of registration and maintaining compliance within the statute as outlined in PMRA’s implementing regulations. For an indepth review, find out more about our PMRA Training Course.
ChemADVISOR also is well versed in Health Canada’s registration and product re-evaluation process, PMRA regulations and how Health Canada works closely with the US Environmental Protection Agency (EPA), thereby providing Manufacturers and Distributors with the necessary comprehension on how to comply with this statute. It is our mission to provide an understanding of Health Canada’s PMRA and its requirements to avoid non-compliance penalties and promote sustainable pest management.
ChemADVISOR can assist clients with Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) compliance and FIFRA-related customer service by:
- PMRA Training Course
- Identifying applicable requirements, determining what actions need to be taken to comply with those requirements, and assisting in taking the necessary actions
- Facilitating communications with the U.S. EPA and with the client’s customers
Our services include, but are not limited to the following:
- EPA Company and Establishment Number Submittals
- Dossier preparation for Federal and State Registrations and Product Amendments
- Registration submissions to EPA for Biocides, Insect Repellents, Pesticide Products and Agricultural Chemicals
- Conditional Pesticide Registrations, Experimental Use Permits, State-Specific Registrations, Emergency exemptions
- Data Call-Ins (DCI)
- Supplemental Registrations
- Labeling development, preparation, and review
- FIFRA SDS development and review
- Formula compliance review
- Notice of Arrival of Imported Pesticides
- FPAS clearances for exported Pesticides