Biocides Regulatory Insights

Dear reader,

As summer slowly comes to an end, and everyone returns from well-deserved vacations, it's time to ease back into the routine. To help you get back on track, we've compiled the most important updates in this newsletter. Whether you're catching up on missed news or looking for a quick refresher, we've got you covered with everything you need to know.

If you missed our previous issues, no worries! You can catch up on all the insightful content by clicking here.?

Best regards,?

The knoell Team?

Expert Tip

Navigating borderline issues: biocidal product PT4 vs. Food Contact Materials?

Navigating across the border between biocides regulation and food contact material regulation is an exciting journey! Ensuring that products in contact with food are safe and free from harmful residues is a top priority. Currently, an amendment to the Food Contact Material regulation (the so-called quality amendment) is in the works, which promises to sharpen the focus on this important issue. It's a great time for manufacturers and stakeholders to stay informed and proactive in monitoring and controlling biocidal residues. This way, we can all contribute to protecting consumer health and upholding high regulatory standards.? For more details on this fascinating topic, click on the knoell's article in the link below!? https://www.knoell.com/en/news/biocidal-product-pt4-vs-food-contact-materials??

Europe?

Highlights from the CA meetings?

CA-July19-Doc.4.1_Final_in situ rev4(1).docx?

This note (revised in June 2024) aims at addressing the regulatory aspects to be considered by prospective applicants and CAs in relation to the authorisation of biocidal products when ASs are generated in situ.?

In situ generation means the reaction of one or more precursors to generate the AS at the place of use for direct application without isolation, purification, storage or transport.?

This is done using an in situ generation system ('IGS'). The latter generates an in situ AS that covers the combination of:?

• The [formulation(s) containing the] precursor(s), which have to meet the conditions specified in the AS approval,?

• the relevant parameters affecting the generation process, including those to be applied in the relevant devices (if any). This includes addressing the devices used as part of the in situ generation process, which, however, are not authorised as biocidal products under the BPR.?

• The AS generated in situ which has to meet any condition specified in the AS approval and which includes any impurities, such as reaction by-products and/or any unreacted precursors, (the so-called “output” of the IGS).?

At the moment, 4 case-types of in situ products are available:?

Case-type 1: the in situ biocidal products involve an IGS based on the mixing of two or more [formulations containing the] precursors?

Case-type 2: the in situ biocidal products involve an IGS based on one or more [formulations containing the] precursors used in a device.?

Case-type 3: the in situ biocidal products involve an IGS based on a coating or a mixture containing a catalyst that when exposed to a mode of activation generates free radicals out of air and/or water present in the immediate environment of the coating or mixture.?

The figure below illustrates the case when UV light is activating the catalyst but other modes of activation may exist. In the application, the specific mode of activation must always be explained in details and scientifically demonstrated.?

Case-type 4: the in situ biocidal products involve an IGS generating the in situ AS from [formulations containing the] precursors that are not placed on the market for biocidal purposes and using a device.?

Or the in situ biocidal products involve an IGS generating an in situ AS from catalyst(s) not falling under case type 3 (e.g. free radicals generated from ambient air or water using a catalyst incorporated in an e.g. ceramic or plastic polymer object).?

Asia?

Thailand?

Ministry of Public Health Notification on Active Ingredients in Hazardous Substances B.E. 2567 (2024)??

The Ministry of Public Health has issued a notification specifying that hazardous substances under the Food and Drug Administration's jurisdiction will be classified as counterfeit if their active ingredients deviate less than 20 percent from the lowest levels or more than 20 percent from the highest levels of the allowed deviated levels of active ingredients. The adoption date is proposed for June 12, 2024, with enforcement starting on June 13, 2024.?

Read the full notification here: https://members.wto.org/crnattachments/2024/TBT/THA/24_04436_00_x.pdf???

Draft Notification on Exemption Criteria for Hazardous Substances for Education and Research B.E. ...??

This draft notification outlines the criteria for exempting hazardous substances imported for educational, testing, analytical, research, and development purposes from certain requirements under the Hazardous Substances Act B.E. 2535 (1992).??Importers must use the FDA's electronic system to submit exemption forms and documents.??The proposed adoption and enforcement dates are between December 2024 and January 2025.?

Read the draft notification here: https://members.wto.org/crnattachments/2024/TBT/THA/24_04437_00_x.pdf????

Draft Notification on Exemptions for Hazardous Substances Imports for Education and Research B.E. ...??

This draft notification will repeal specific clauses related to exemptions for importing hazardous substances for education and research.??It will replace the current notification with new criteria and methods.??Applications submitted before the effective date will be considered under the new rules.??The proposed adoption and enforcement dates are between December 2024 and January 2025.?

Read the draft notification here: https://members.wto.org/crnattachments/2024/TBT/THA/24_04438_00_x.pdf?

USA

EPA Releases Finalised Test Methods for Measuring Disinfectant Residue Levels on Hard Surfaces?

The U.S. Environmental Protection Agency (EPA) is releasing finalised test methods for measuring disinfectant residues on hard surfaces treated with two classes of disinfectants — quaternary ammonium compounds and phenolic compounds — after they have been rinsed with water (known as a potable water rinse or “PWR”). Estimating the amount of disinfectant residue after rinsing a treated surface, like cutting boards and countertops, with water is an important step in refining dietary risk assessments for disinfectant products that may come into contact with food.???

Many disinfectant product labels require a water rinse after use on hard surfaces to remove potentially harmful chemical residues. Where EPA does not have chemical-specific data, the Agency assumes that 100% of the disinfectant residues applied to the treated surface will contact food after the surface is rinsed with water, when evaluating the dietary risks of disinfectant pesticides. This estimated food-contact residue amount is then included in EPA’s dietary exposure assessments, which may produce an overly conservative risk assessment for a product. This may lead to a conclusion that more protective mitigation measures are necessary to register the product than would be required with more chemical-specific data.??

Quaternary ammonium compounds are chemicals used to kill bacteria, viruses and mould, and are found in many products like?sprays and wipes making disinfectant claims. Phenolic compounds are used to kill bacteria and are found in household and consumer products that claim to clean and disinfect treated surfaces. Based on their chemical properties, these two classes represent the range of disinfectant residues that could remain after a PWR. The quaternary ammonium compounds are expected to leave the most residues on the treated surfaces after the PWR, while the phenolic compounds are expected to leave the least, compared to other chemical classes commonly used in disinfectants and other cleaning products. The analytical techniques described in the finalised test methods were developed for quaternary ammonium and phenolic compounds, but can also be modified for use with other chemical classes of active ingredients in disinfectant products that require a PWR.????

These standardised test methods will not only serve as guidance in conducting residue studies in support of new and existing disinfectant product registration, but will also enable more refined dietary risk assessments by the Agency through the use of chemical-specific residue data in lieu of the 100% default value. EPA also plans to further examine the data from these test methods to develop a more refined default residue value (<100%) that could be used in future assessments when chemical-specific residue data are not available for a disinfectant active ingredient.???

The test methods announced in June 2024 were previously made available for public comment from Oct. 15, 2021, to Feb. 12, 2022. The comments received were generally supportive of EPA’s approach. The test methods and responses to the comments received can be viewed in docket ID EPA-HQ-OPP-2021-0626?

CANADA?

Biocides in Canada?

Currently, biocides are regulated under separate regimes which creates challenges for industry and regulators.?

In Canada a biocide may currently be authorised under the Food and Drug Regulations (FDR) or the Pest Control Products Act (PCPA).?

Authorised biocides include:?

• a surface disinfectant or disinfectant-sanitiser with an 8-digit number that follow the letters "DIN" on its label if the Natural and Non-prescription Health Products Directorate (NNHPD) has authorised the product under the FDR?

• a surface sanitiser with a registration number on its label if the Pest Management Regulatory Agency has registered the product under the PCPA the number will appear on the label as:?

• Registration No. (assigned registration number) Pest control products act or?

• Reg. No. (assigned registration number) P.C.P. Act?

How biocides will be regulated in Canada as of May 31, 2025?

The way biocides are regulated in Canada is changing. The Biocides Regulations were registered on May 31, 2024, and published in the Canada Gazette, Part II on June 19, 2024. The regulations will come into force on May 31, 2025.?

Under these regulations, biocides must undergo a pre-market assessment with the NNHPD and be issued a market authorisation before they can be imported, sold or advertised in Canada. As part of the pre-market assessment, it is required that an application is filed for a market authorisation, which includes detailed information on the biocide's safety, efficacy and quality.?

Through this pre-market assessment, the Minister must issue a market authorisation, in accordance with section 11 of the regulations, if the:?

• application meets the applicable requirements set out in section 10 or 26 of the regulations, as the case may be?

• applicant has provided the Minister with any additional information and material that is requested under subsection 10(4) or 26(5) of the regulations?

• Minister has sufficient evidence to support the conclusion that the biocide's benefits outweigh its risks, taking into account any uncertainties relating to the benefits and risks and?

• Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the Food and Drugs Act and the regulations?

An 8-digit identification number will be assigned to a biocide that has been issued a market authorisation. This identification number must appear on the label and indicates it has been authorised for sale.?

Inspectors will monitor and enforce the compliance of biocides with the FDA and the regulations through post-market regulatory activities. The Regulatory Operations and Enforcement Branch (ROEB) oversees these activities.?

Between now and May 31, 2025:?

Health Canada will review all applications for surface disinfectants and sanitisers received before May 31, 2025, according to the FDR or PCPA. If approved, the Canadian authorities will issue a drug identification number or a pest control product registration number, as appropriate. These biocides must transition to the regulations by the end of a 4-year transition period (by May 31, 2029).?

Applicants that submit an application for a new market authorisation for a biocide as of May 31, 2025, must meet the requirements in the regulations.?

Companies with a registration for a surface sanitiser under the PCPA or an authorisation for a disinfectant under the FDR have 4 years from the coming-into-force date to obtain an authorisation under the regulations. This can be achieved by filing a transition application.?

(Ref: https://www.canada.ca/en/health-canada/services/drugs-health-products/biocides.html )?

Meet us

September 2024

After a short summer break in which our colleagues have recharged their batteries, they are back on the road at various events in September and are looking forward to meeting you there! Meet them there, join their talk and get in touch!

https://lnkd.in/eW462nuQ

?? 04-06 September 2024 ?? XVII Pesticide Symposium Piacenza

?? 08-11 September 2024 ?? Eurotox 2024

?? 17-18 September 2024 ?? CIR | Chemical Industry Regulations

?? 24-25 September 2024 ?? Fresenius Detergents and Cleaning Products

For More Events and Information, Visit Our News Section: Stay in the loop with our dynamic calendar of events, scientific updates, and regulatory insights. To explore more events and learn about our impact, visit our news section here.

Reach out to us for personalized regulatory advice tailored to your specific needs. Whether you have questions about compliance, product registrations, or any regulatory matter, we're here to help. Contact us or visit our website for more information.