Biocidal Product Disinfectants – Global Biocidal Product Regulations

Freyr offers expert Regulatory support for biocidal products, ensuring compliance with global regulations. Our services include categorization, strategy development, dossier preparation, and application submission.

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Global Biocidal Product Regulations - Overview

Biocidal products are disinfectants/anti-microbial products that have gained new meaning and purpose after COVID-19. These products are identified and regulated differently across countries and regions, which makes it challenging for manufacturers to market them.

The different terms and Regulatory classifications applicable to these products include chemical disinfectants/HUHS/biocides/pesticides/OTC/quasi-drugs/anti-microbial pesticides, as well as consumer products, cosmetics, medical devices, and medicinal products.

While biocidal product regulations in some countries have a clear framework, with a well-defined registration process and timeline, many countries do not have well-defined structures and processes, resulting in uncertainties, data duplication, and delays in market access. Moreover, chemical regulations are dynamic and ever-evolving, considering new scientific data and pressure on sustainability.

The other key factors for market access and compliance are provided below:


Table 1: Regulatory Summaries for Major Markets

CountryClassification

Authority

 

Registration/NotificationActive Substance Supplier RequirementsRequirementsStandardsTimelines
EuropeBiocidesECHA & associated individual member state (EU 27)/EU BPR 528/2012 transitional measure (article 89) & harmonized authorizationYesActive substance suppliers should be approved suppliers mentioned in the Article 95 list.Efficacy/ Chemistry/CLP requirementsCEN/OECD & other international standards

Transitional measure: one (01) month to one (01) year (depends on EU MS)

Authorization: three (03) months to 1.5 years (depending on the type of authorization)

USAntimicrobial Pesticide (surface disinfectant used on inanimate objects)US EPA under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)YesThe US EPA-approved active ingredient & supplierEfficacy/ Chemistry/ Toxicology & GHS requirementsEPA standards and other international standards fulfilling the requirementsSix (06) months to twelve (12) months
CanadaDisinfectant Drugs/Pesticide (HS code – 380894)Natural and Non-prescription Health Products Directorate (NNHPD) & PMRAYesNoneEfficacy/ Safety & QualityASTM & other international standards fulfilling the requirementsOne (01) to two (02) years (depending on the submission type)
South AfricaChemical DisinfectantSurface Disinfectant (environment surfaces/ inanimate objects) to be registered by the National Regulator for Compulsory Specifications (NRCS) following SANAS standardsYesNoneEfficacy/ Chemistry/ Safety and GHS requirementsSANAS standards and other international standards fulfilling the requirementsApproximately six (06) months
SingaporeGeneral Consumer ProductHealth Science AgencyNoNoneConsumer goods safety requirement complianceInternational and SS standardsNot Applicable
UKBiocideGB Biocidal Product Regulation (BPR)YesGB article 95 listed suppliers onlyEfficacy/ Chemistry/Safety and CLP requirementsCEN standards and other international standards fulfilling the requirementsThree (03) months to 1.5 years (depending on the type of authorization)
PhilippinesCategory 3 HUHS (household urban pesticides)FDA circular 2020-025 listing via FDA e-portal.YesNoneEfficacy/ Chemistry/ Safety and GHS requirementsCEN and other international standards fulfilling the requirementsThree (03) months (approx.)
MalaysiaSurface Disinfectant (used on non-porous surfaces) (HS code – 380894)National Pharmaceutical Regulatory Agency (NPRA) registration

No

(Import Licence may be required)

NoneEfficacy/ Chemistry/ ToxicologyECHA/ EPA accepted standards other international standards fulfilling the requirementsFour (04) to six (06) months (approx.)
UAEBiocideDubai Municipality and Health Safety DepartmentYesNoneChemistry/Safety/ EfficacyEU and other international standardsUp to one (01) week from the application completion date

To place a biocidal product on any market or a set of markets, companies first need to build robust strategies to achieve compliance with market-specific regulations and exploit overlapping testing and certification requirements to minimize cost and time-to-market.

Freyr has extensive expertise in providing biocidal product classification and Regulatory solutions across global markets.

Biocidal Product Regulations

  • Categorization of consumer products.
  • Develop product notification/registration strategies.
  • Regulatory applicability review and interpretation.
  • Preparation of notification dossiers.
  • Application preparation and submission for relevant introductions.
  • Sustainability and packaging solutions.
  • Regulatory intelligence support.
  • End-to-end chemical Regulatory services.
  • Expert advice on Regulatory strategies.
  • Seamless navigation of the complexities of Regulatory landscapes.
  • Support for region-specific Regulatory complexities.
  • Structured and cost-effective approach to ensure compliance.
  • Robust partner network in Australia.
  • Focused compliance solutions.
  • Quick turnarounds and faster time-to-market.