By: Jacqui Jenskey, Principal Regulatory Affairs Consultant, email
On May 7, 2022, Health Canada published and proposed new regulations under the FDA called the Biocides Regulation. This new regulation will regulate disinfectants and sanitizers for use on hard or soft non-living or non-liquid surfaces (biocides) under a single regime. The new framework will transfer disinfectants currently regulated under the FDA and surface sanitizers regulated under the Pest Control Products Act (PCPA) that meet the definition of a drug and are for use on non-liquid surfaces, to the proposed Biocides Regulations. The proposed Biocides Regulations would come into force one year following the promulgation of the Regulations with a proposed 4-year implementation timeline.
It is important to note that Food-contact sanitizers (currently unregulated) will be included within the scope of the proposed Biocides Regulations. This will mean that companies selling Food contact sanitizers that do not require registration today, will require it in the future. Any claims related to these products will require efficacy data from a GLP certified laboratory using test methods acceptable to Health Canada. Labels will also require changes to meet the new regulation. These changes will have significant implications for companies predominantly in this unregulated space that have not dealt with Drug registrations previously.
Dell Tech can help you navigate these changes and if you have any questions please reach out to jjenskey@delltech.com or joanna@delltech.com for assistance.
Contact:
Dell Tech Laboratories
Jacqui Jenskey
Principal Regulatory Affairs Consultant
519-858-5021 x 2028
jjenskey@delltech.com
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