• Homepage
  • SDS Services
    • SDS Authoring
    • Understanding SDS Compliance
    • SDS Updating Services
    • SDS Hosting & Management
    • SDS Translation
    • GHS Labels
  • Label Services
    • Cosmetic Labels
    • Retail Label Compliance
    • Retail Label Design
    • Proposition 65 Compliance
  • Regulatory Services
    • Technical Translations
    • Properties Testing
    • REACH Compliance
    • DIN Registrations
  • Contact
Nexreg
  • SDS Services
    • Understanding SDS Compliance
    • SDS Authoring
    • SDS Review Services
    • SDS Updating Services
    • SDS Hosting & Management
    • SDS Translation
    • GHS Labels
  • Label Services
    • Cosmetic Labels
    • Retail Label Compliance
    • Retail/Consumer Label Review
    • Retail Label Design
    • Combined GHS + Consumer Labels
    • Proposition 65 Compliance
    • Packaging Compliance
    • Canadian Cannabis Packaging & Labeling
  • Regulatory Services
    • California Right To Know Act (RTK)
    • Natural Health Product Services
    • Chemical Emergency Response
    • Technical Translations
    • Properties Testing
    • REACH Compliance
    • Transportation Regulations & Guidance
  • News
  • Toll Free: 1 866-361-3032
  • Local: +1 519 488 5126
  • About
  • Regulatory Webinars
  • Privacy Policy
  • Contact
  • en English
    ar Arabiczh-CN Chinese (Simplified)nl Dutchen Englishfr Frenchde Germanit Italianpt Portugueseru Russianes Spanish
  • Search
  • Menu
  • Home
  • Privacy Policy
  • Nexreg Response to COVID-19
  • Detergent & Hand Soap Legislation (COVID-19)
  • Surface Disinfectant Legislation (COVID 19)
  • Hand Sanitizer Legislation (COVID-19)
  • SDS Services
    • SDS Authoring
      • South Africa SDS Authoring
      • Australia SDS Authoring
      • Austria SDS Authoring
      • Belgium SDS Authoring
      • Brazil SDS Authoring
      • Bulgaria SDS Authoring
      • Canada SDS Authoring
      • Chile SDS Authoring
      • China SDS Authoring
      • Colombia SDS Authoring
      • Cyprus SDS Authoring
      • Czech Republic SDS Authoring
      • Denmark SDS Authoring
      • Estonia SDS Authoring
      • Finland SDS Authoring
      • France SDS Authoring
      • Germany SDS Authoring
      • Greece SDS Authoring
      • Hungary SDS Authoring
      • India SDS Authoring
      • Indonesia SDS Authoring
      • Ireland SDS Authoring
      • Israel SDS Authoring
      • Italy SDS Authoring
      • Japan SDS Authoring
      • Korea MSDS Authoring
      • Latvia SDS Authoring
      • Lithuania SDS Authoring
      • Luxembourg SDS Authoring
      • Malaysia SDS Authoring
      • Malta SDS Authoring
      • Mexico SDS Authoring and HDS Authoring
      • Netherlands SDS Authoring
      • New Zealand SDS Authoring
      • Pakistan SDS Authoring
      • Philippines SDS Authoring
      • Poland SDS Authoring
      • Portugal SDS Authoring
      • Romania SDS Authoring
      • Russia SDS Authoring
      • Singapore SDS Authoring
      • Slovakia SDS Authoring
      • Slovenia SDS Authoring
      • Spain SDS Authoring
      • Sweden SDS Authoring
      • Taiwan SDS Authoring
      • Thailand SDS Authoring
      • Turkey SDS Authoring
      • United Kingdom SDS Authoring
      • United States (US) SDS Authoring
    • Understanding SDS Compliance
    • SDS Updating Services
    • SDS Review Services
    • SDS Hosting & Management
    • SDS Translation
    • GHS Labels
      • Australia Workplace Label Review
      • Austria E.U. Workplace CLP Label Review
      • Belgium E.U. Workplace CLP Label Review
      • Bulgaria E.U. Workplace CLP Label Review
      • Canadian Workplace Label Review
      • United Nations GHS Labels
      • China Workplace Label Review
      • Cyprus E.U. CLP/DPD Label Review
      • Czech Republic E.U. Workplace CLP Label Review
      • Denmark E.U. Workplace CLP Label Review
      • Estonia E.U. Workplace CLP Label Review
      • Finland E.U. Workplace CLP Label Review
      • France E.U. Workplace CLP Label Review
      • Germany E.U. Workplace CLP Label Review
      • Greece E.U. Workplace CLP Label Review
      • Hungary E.U. Workplace CLP Label Review
      • India Workplace Label Review
      • Indonesia Workplace Label Review
      • Ireland E.U. Workplace CLP Label Review
      • Italy E.U. Workplace CLP Label Review
      • Japan Workplace Label Review
      • Latvia E.U. Workplace CLP Label Review
      • Lithuania E.U. Workplace CLP Label Review
      • Luxembourg E.U. Workplace CLP Label Review
      • Malaysia Workplace Label Review
      • Malta E.U. Workplace CLP Label Review
      • Mexico Workplace Label Review
      • Netherlands E.U. Workplace CLP Label Review
      • New Zealand Workplace Label Review
      • Pakistan Workplace Label Review
      • Philippines Workplace Label Review
      • Poland E.U. Workplace CLP Label Review
      • Portugal E.U. Workplace CLP Label Review
      • Romania E.U. Workplace CLP Label Review
      • Slovenia E.U. Workplace CLP Label Review
      • South Korea Workplace Label Review
      • Spain E.U. Workplace CLP Label Review
      • Sweden E.U. Workplace CLP Label Review
      • United Kingdom E.U. Workplace CLP Label Review
      • United States Workplace Label Review
    • GHS Label Example
    • GHS Label Printers
  • Label Services
    • Canadian Cannabis Packaging & Labeling
    • Proposition 65 Compliance
    • Cosmetic Labels
      • Canada Cosmetic Label Review & Notification
      • European Union (EU) Cosmetic Label Review
    • Packaging Compliance
    • Retail Label Compliance
      • Australia Consumer Label Review
      • Austria E.U. Consumer CLP Label Review
      • Belgium E.U. CLP/DPD Label Review
      • Bulgaria E.U. CLP Consumer Label Review
      • CCCR 2001: Canadian Consumer Label Review
      • China Consumer Label Review
      • Cyprus E.U. Consumer CLP Label Review
      • Czech Republic E.U. Consumer CLP Label Review
      • Denmark E.U. Consumer CLP Label Review
      • Estonia E.U. Consumer CLP Label Review
      • Finland E.U. Consumer CLP Label Review
      • France E.U. Consumer CLP Label Review
      • Germany E.U. Consumer CLP Label Review
      • Greece E.U. Consumer CLP Label Review
      • Health Canada Compliance
      • Hungary E.U. Consumer CLP Label Review
      • India Consumer Label Review
      • Indonesia Consumer Label Review
      • Ireland E.U. Consumer CLP Label Review
      • Italy E.U. Consumer CLP Label Review
      • Latvia E.U. Consumer CLP Label Review
      • Lithuania E.U. Consumer CLP Label Review
      • Luxembourg E.U. Consumer CLP Label Review
      • Malta E.U. Consumer CLP Label Review
      • Mexico Consumer Label Review
      • Netherlands E.U. Consumer CLP Label Review
      • New Zealand Consumer Label Review
      • Pakistan Consumer Label Review
      • Philippines Consumer Label Review
      • Poland E.U. Consumer CLP Label Review
      • Portugal E.U. Consumer CLP Label Review
      • Romania E.U. Consumer CLP Label Review
      • Russian Federation Consumer Label Review
      • Slovakia E.U. Consumer CLP Label Review
      • Slovenia E.U. Consumer CLP Label Review
      • South Korea Consumer Label Review
      • Spain E.U. Consumer CLP Label Review
      • Sweden E.U. Consumer CLP Label Review
      • United Kingdom E.U. Consumer CLP Label Review
      • United States Consumer Label Review
    • Retail/Consumer Label Review
    • Combined GHS + Consumer Labels
    • Retail Label Design
  • Regulatory Services
    • California Right To Know Act (RTK)
    • Chemical Emergency Response
    • Technical Translations
    • Properties Testing
    • Natural Health Product Services
    • REACH Compliance
    • Transportation Regulations & Guidance
  • News
  • About
  • Contact
    • Submission Received
  • Industries Served
  • Label Compliance by Jurisdiction
  • Regulatory Webinars
  • Search
  • Menu

Surface Disinfectants – Preparing to Enter the Market

Written by Cassandra Taylor, Senior Regulatory Consultant, Nexreg Compliance

Surface disinfectants are a key tool for resisting the spread of Coronavirus disease 2019 (COVID-19). Safe and effective antimicrobial cleaning agents are needed to decontaminate high traffic surfaces such as door handles and light switches. As a result, we are seeing a sharp increase in the demand for biocidal cleaning agents. As companies prepare to meet the high demand of the current market, Nexreg is committed to making the process as straightforward as possible for our clients. This article describes the regulatory requirements for sale of surface disinfectants in the USA, Canada, and Europe.

USA

The United States Environmental Protection Agency (EPA) regulates antimicrobial pesticides, including surface disinfectants effective against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus that causes COVID-19. Surface disinfectants must be registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and there are specific labelling requirements. Registrants must first obtain a company number before registering a pesticide with EPA. Additionally, registrants that plan to produce their own products must obtain an establishment number.

EPA is expediting the review process for new disinfectant products. Currently, only electronic submissions are being accepted. Additionally, EPA is expediting requests for company numbers and establishment numbers so that new manufacturers of pesticides can come online as soon as possible.

EPA is adapting processes to ensure disinfectant supply keeps up with demand. A new measure was recently announced that allows manufacturers of disinfectants that are already registered to obtain certain active and inactive ingredients from any supplier without first checking with the Agency. EPA continues to add chemicals to its list of commodity inert ingredients, which may be used without listing the suppliers on the Confidential Statement of Formula (CSF) Form (EPA Form 8570-4).

List N: Disinfectants for use against SARS-CoV-2 (List N ) now includes over 360 products that meet EPA’s criteria for use against corona virus.

More information and resources about EPA’s efforts to address SARS-CoV-2 can be found here: www.epa.gov/coronavirus

 

Canada

In Canada, disinfectants are classified as non-prescription drugs. Health Canada governs the sale of surface disinfectants as drugs under the Food and Drugs Act.

Sterilants and disinfectants intended for use on surfaces, inanimate objects and to reprocess medical devices are required to list a Drug Identification Number (DIN) on the label. In order to obtain a DIN for a new product, a disinfectant drug application must be submitted. Disinfectant drug applications must support the general safety, efficacy, and quality requirements outlined by Health Canada and must satisfy the labelling requirements set out by the Food and Drugs Act and Regulations.

In order to ease the regulatory burden on companies, Canada has introduced some interim measures which will allow certain products to be sold in Canada. These include:

  • products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling, different packaging from what was authorized); and
  • products that are not authorized for sale in Canada but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.

Additionally, Health Canada is expediting approvals for disinfectant products.

There is lots of helpful guidance available for those looking to enter the disinfectant market in Canada:

  • The Safety and efficacy requirements for hard surface disinfectant drugs Guidance document is intended to provide applicants of hard surface disinfectants and disinfectant-sanitizers the necessary information to comply with the Food and Drugs Act and Regulations.
  • The Management of Disinfectant Drug Applications Guidance document provides an overview of the way Health Canada manages submissions for market authorization of disinfectant products regulated as drugs and submitted in accordance with the Food and Drug Regulations. Additionally, it outlines the responsibilities and expectations for applicants of disinfectant drug submissions throughout the application review process.

Europe

The European Chemicals Agency (ECHA) regulates surface disinfectants under the Biocidal Products Regulation (BPR), (EU) No 528/2012. Biocidal products, including disinfectants used for hard surfaces, require authorization by ECHA before they can be placed on the European (EU) market. Additionally, the active substances in the product must be previously approved.

ECHA’s COVID-19 page is updated regularly with new information. ECHA has stated that it is supporting EU and European Economic Area (EEA) countries and companies to ensure that disinfectants can quickly enter the market. Some tools ECHA has provided so far include:

  • Q&As for companies seeking to place disinfectants on the EU/EEA market;
  • Acceleration of technical equivalence assessments for propan-1-ol and propan-2-ol;
  • Support of EU/EEA authorities to apply derogations from the normal authorisation requirement for biocidal products.

Companies seeking to enter the EU market with disinfectant products that contain an approved active substance may apply for permission to the relevant national authority by relaying on Article 55(1) of the BPR. The provision grants authorities the ability to give time-limited derogations from the standard authorization procedures in situations where there is a threat to public health.

Several UE/EEA countries have already issued decrees that grant special permissions to companies looking to manufacture disinfectants. Additionally, a centralised submission to ECHA is being developed in order to obtain authorization for several countries. We will be sure to post updates as things progress.

For guidance on disinfectant registration and labelling, contact Nexreg today!

We’re SDS Experts

For quality compliance resources for companies of all sizes across the world.

Contact Us

Categories

  • Blog
  • Regulatory News

Archives

Address: 1828 Blue Heron Dr, London, N6H 0B7
Toll Free Phone: 1-866-361-3032
Local Phone: +1 519-488-5126
Province: Ontario

© Copyright 2019 Nexreg Compliance Inc. All rights reserved.
  • Twitter
  • Facebook
  • Linkedin
  • Instagram
  • About
  • News
  • Privacy Policy
  • Contact
Derogations for the manufacture and supply of biocidal hand sanitizer products... Canada Consumer Product Safety Act (CCPSA) Incident Reporting During COVID-...
Scroll to top

This site uses cookies. By continuing to browse the site, you are agreeing to our use of cookies.

OK
en English
ar Arabiczh-CN Chinese (Simplified)nl Dutchen Englishfr Frenchde Germanit Italianpt Portugueseru Russianes Spanish

Contact Us

 

Please fill out the following form.

 

  • How would you like us to follow-up with you?
  • Please provide a detailed description of your inquiry (Note: Nexreg does not respond to spam or solicitations).
  • This field is for validation purposes and should be left unchanged.