Surface Disinfectants – Preparing to Enter the Market

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!