INTERNATIONAL BIOCIDES COMPLIANCE

ENSURE THE COMPLIANCE OF YOUR BIOCIDAL PRODUCTS WORLDWIDE
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As an expert in the risk assessment of biocidal products, EcoMundo assists you in the creation and submission of dossiers for biocidal products internationally, particularly in South Korea and North America.

FOCUS ON OUR SUPPORT IN COMPLYING WITH THE KOREAN REGULATION ON BIOCIDAL PRODUCTS (K-BPR)

T

he Korean Biocidal Products Regulation (K-BPR) is based on a compliance scheme similar to that of the European Regulation.

Three elements must be taken into account when bringing biocidal products into compliance in Korea:

  • Notifications to the local competent authority can only be made by legal entities based in Korea or by importers from European companies
  • Biocidal products may only contain active substances approved in the K-BPR
  • Active substances in biocidal products must be approved by foreign governments
Bonus:
  • Thanks to its office in Seoul, EcoMundo is able to assist you in the creation of your Active Substance Approval (AS) and Marketing Authorization (MA) dossiers.

FOCUS ON OUR SUPPORT FOR COMPLIANCE OF DISINFECTANT PRODUCTS IN THE UNITED STATES AND CANADA

I

n both the United States and Canada, hand sanitizers are considered Over-The-Counter drugs (OTC). Therefore, if you wish to export to North America, it is essential that your entire supply chain takes into account Good Manufacturing Practices (GMP - FDA).

EcoMundo can accompany you in your compliance process. Our experts :

  • Monitor the necessary tests that must be carried out according to North American standards for efficiency and stability (e.g. ATSM)
  • Create the regulatory dossier
  • Submit your dossier to the United States Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA)
  • The creation of the member dossier and its submission to the MoE

Note: the content depends on the composition of the product and the monograph of the active substance (AS).

Bonus:
  • Thanks to its office in Montreal, EcoMundo is able to accompany you in the compliance of your biocidal products in Canada.
  • EcoMundo can act as a US Agent for your biocide compliance in the United States.