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Biocidal Product Disinfectants – Global Biocidal Product Regulations

We ensure a swift journey for your product’s Regulatory compliance

Overview

Biocidal Product Regulations - Overview

Biocidal Products are Disinfectants/Antimicrobial products that have gained new meaning and purpose with the spur of the COVID-19 pandemic. These products are called/identified and regulated differently across countries and regions making it very challenging for the manufacturers to market the products.

Different terms and Regulatory classifications applicable for these products include chemical disinfectants/HUHS/biocide/pesticide/OTC/quasi drug/antimicrobial pesticide and even Consumer Products, Cosmetics, Medical Devices, and Medicinal Products. In most markets, product classification and regulations are driven by the chemical composition and the claims made on the product label or other advertisement and promotional material.

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

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

Table 1: Regulatory Summaries for Major Markets

Country

Classification

Authority

 

Registration/Notification

Active Substance Supplier Requirements

Requirements

Standards

Timelines

Europe

Biocides

ECHA & associated individual member state (EU 27)/EU BPR 528/2012 transitional measure (article 89) & harmonized authorization

Yes

Active substance suppliers should be approved suppliers mentioned in the Article 95 list.

Efficacy/ Chemistry/CLP requirements

CEN/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)

US

Antimicrobial Pesticide (surface disinfectant used on inanimate objects)

US EPA under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Yes

The US EPA-approved active ingredient & supplier

Efficacy/ Chemistry/ Toxicology & GHS requirements

EPA standards and other international standards fulfilling the requirements

Six (06) months to twelve (12) months

Canada

Disinfectant Drugs/Pesticide (HS code – 380894)

Natural and Non-prescription Health Products Directorate (NNHPD) & PMRA

Yes

None

Efficacy/ Safety & Quality

ASTM & other international standards fulfilling the requirements

One (01) to two (02) years (depending on the submission type)

South Africa

Chemical Disinfectant

Surface Disinfectant (environment surfaces/ inanimate objects) to be registered by the National Regulator for Compulsory Specifications (NRCS) following SANAS standards

Yes

None

Efficacy/ Chemistry/ Safety and GHS requirements

SANAS standards and other international standards fulfilling the requirements

Approximately six (06) months

Singapore

General Consumer Product

Health Science Agency

No

None

Consumer goods safety requirement compliance

International and SS standards

Not Applicable

UK

Biocide

GB Biocidal Product Regulation (BPR)

Yes

GB article 95 listed suppliers only

Efficacy/ Chemistry/Safety and CLP requirements

CEN standards and other international standards fulfilling the requirements

Three (03) months to 1.5 years (depending on the type of authorization)

Philippines

Category 3 HUHS (household urban pesticides)

FDA circular 2020-025 listing via FDA e-portal.

Yes

None

Efficacy/ Chemistry/ Safety and GHS requirements

CEN and other international standards fulfilling the requirements

Three (03) months (approx.)

Malaysia

Surface Disinfectant (used on non-porous surfaces) (HS code – 380894)

National Pharmaceutical Regulatory Agency (NPRA) registration

No

(Import Licence may be required)

None

Efficacy/ Chemistry/ Toxicology

ECHA/ EPA accepted standards other international standards fulfilling the requirements

Four (04) to six (06) months (approx.)

UAE

Biocide

Dubai Municipality and Health Safety Department

Yes

None

Chemistry/Safety/ Efficacy

EU and other international standards

Up to one (01) week from the application completion date

To place a biocidal product in any market or set of markets, companies are first required to build robust strategies to comply 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 the global markets.

Freyr Expertise and Advantages
Expertise

Biocidal Product Regulations - FREYR EXPERTISE

  • Categorization of Consumer Products.
  • Developing Product Notification/Registration Strategies.
  • Regulatory Applicability Review and Interpretation.
  • Preparation of Notification Dossiers.
  • Application Preparation & Submission for Relevant Introductions.
  • Sustainability & Packaging Solutions.
  • Regulatory Intelligence Support.
Advantages

Biocidal Product Regulations - FREYR ADVANTAGES

  • End-to-end chemical Regulatory services.
  • Expert advice on Regulatory strategy.
  • Easily navigate the complexities of Regulatory authorities.
  • Support for region-specific Regulatory complexities.
  • A structured and cost-effective approach to ensure compliance.
  • Robust partner network in Australia.
  • Focused compliance solution.
  • Quick turnarounds and faster time-to-market.