Global Biocides and Cosmetic Regulatory Project Support
Challenge
Our client wanted to market several hygiene products in the following 19 countries: Canada, France, Italy, Japan, Saudi Arabia, South Korea, Spain, Belgium, The Netherlands, Qatar, UAE, Australia, Hong Kong, Poland, Romania, Brazil, Israel, Mexico and Singapore. The client needed to identify their regulatory obligations and costs for compliance in order to determine their next steps.
Client
A global manufacturer of infection prevention control products.
Our Solution
Scoping assessment
Using our team of experts we conducted a regulatory scoping assessment for each country of interest. A scoping assessment is an assessment of a product's composition, labelling, claims and uses in relation to the applicable regulations to understand the legal obligations to market in each country of interest and determine a strategy for compliance ( i.e Biocidal product marketed in EU> EU BPR obligations). Depending on the country of interest the products may fall within the biocide/pesticide regulation, the cosmetic regulation or other country specific regulation. The client wanted to understand which regulation would apply to their products, if a registration was required in each country and the costs, timelines and requirements if applicable. The assessment included reviewing the clients products, their composition presentation and claims to define the country specific biocidal/ cosmetic product regulations applicable to their products.
Once the appropriate country specific applicable legislation was determined, the legal obligations associated with the clients products, uses and claims were defined including:
Requirements for compliance with relevant legislation - registration, notification etc
Labelling requirements
Timelines and costs for registration
An overview of steps taken can be found below with example registration routes determined for Canada and Japan.
Overview of process
Canada
Japan
Benefits for the Client
This allowed a clear registration pathway and strategy to be set out for the client in order for them to prepare, budget and prioritise target markets appropriately.