Biocide Regulatory Insights

Dear reader,

We are very happy to issue the seventh edition of our biocides newsletter, the third of 2024, and we are humbled by your increasing interest.

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 Tips

ISO 7851:2023

Healthcare associated infections have long been a major cause of illness and mortality worldwide with an estimated 5 million cases, and 135,000 deaths per year, in Europe alone. In recent years, surfaces or materials have been treated with, or incorporate, biocidal products or certain metals to claim bactericidal properties to protect the user. As a user of these materials, such as hospital privacy curtains, beside units and high-touch plastics, how do we know these surfaces are fulfilling their claims to help protect us? The newly published ISO 7581:2023 Standard, Evaluation of bactericidal activity of a non-porous antimicrobial surface used in a dry environment addresses the need for these surfaces to adequately demonstrate their biocidal efficacy under ambient conditions found in healthcare facilities. The method utilises the standard vegetative bacterial test organisms typical of the medical area: ??. ????????????????????, ??. ????????????, ??. ?????????? and ??. ???????? and simulates the contamination of a surface by a microdroplet, such of that representative of a sneeze. The Standard is designed to determine the bactericidal (not bacteriostatic) activity of non-porous surfaces within a 60-120 min contact time, between 18-25°C with a relative humidity between 30% and 65%; the pass criteria is ≥ 2 log reduction in bacteria under these test conditions.

Whilst the ISO 22196:2011 Standard already exists to measure the antibacterial activity of plastics and other non-porous surfaces, its test method relies on > 90% humidity for 24 h which is unrealistic in most healthcare environments. In comparison, the dry environment simulation of ISO 7581:2023 applies a 30% to 65% humidity, which is more realistic to ambient room conditions in healthcare facilities.

In the future, the method will be adapted to include the testing requirements for different sectors and also a method for simulation of aged surfaces. Of course, bactericidal surfaces do not replace the need for the use of traditional detergents, biocidal products and good hygiene practices!

Europe

Highlights from ECHA

Active substance approval

The Biocidal Product Committee (BPC) has adopted the following favourable opinions on active substances:

Highlights from Competent Authorities (CA)

The 103rd meeting of CA took place on March 14th and 15th. The topics discussed during the meeting were many. Below are some of the topics that we deem more interesting, for the other CA documents please click here.

CA-March24-Doc.4.9 Article 19(5) and mutual recognition authorisation

Purpose: to cope with exceptional circumstances requiring the use of a biocidal product not complying with the conditions set in Article 19(1) (b)(iii) and (iv) or requiring the use of a biocidal product meeting Article 19(4)(c) by the general public.

It is possible to grant authorisations in accordance with Article 19(5) in mutual recognition (MR) procedures and the reference Member State (refMS) and concerned Member States (cMSs) need to assess whether not authorising the product would result in disproportionate negative impacts for society. This assessment may lead to some different terms and conditions even in the context of a mutual recognition, which should be kept to a minimum.

During MR several situations might occur, for instance:

• It is possible that some cMSs will decide that the product does not comply with the condition of Article 19(5)
• refMS does not grant the authorisation according to Article 19(5), so no mutual recognition is possible in sequence. In parallel, a pragmatic solution could be: another cMS takes over the role of refMS. To be agreed with the applicant.
• The document lists other possible situations.

Authorities will discuss if the differences between MSs in the SPC and in the PAR need to be addressed, developing a specific procedure to handle these authorisations in mutual recognition.

CA-March24-Doc.5.4 Streamlining the process for substances meeting the exclusion criteria

Extensive discussions have occurred between CA on the evaluation of active substances meeting the exclusion criteria of Article 5(1) of BPR. Member states were requested to answer the following questions:

Question #1: should the first approval of a substance meeting exclusion criteria be an open approval without banning uses not assessed? or the approval should be restrictive, which would potentially allow only the uses specifically assessed in the evaluation phase?

Answer #1: A restrictive approval approach should be retained for substances meeting the exclusion criteria. At the same time, eCAs and the BPC should take into consideration all the uses referred to in the elements submitted by the applicant to the eCA on the analysis of Article 5(2) as well as in information coming from the third parties consultation, aiming to provide an analysis of Article 5(2) covering also these additional uses.

Question #2: should the analysis of derogation conditions of Article 5(2) cover only the uses specifically applied for in the application dossier? or additional uses referred in the third parties consultation(s) should be also analysed in terms of derogation conditions of Article 5(2)?

Answer #2: For those uses for which a risk assessment has not been presented by the applicant, the eCA and BPC should do their best to provide some indications on the risks, and if not possible to conclude they should indicate that this was not possible. The impact to society of not approving/renewing the substance for those uses should be considered, including the consideration of suitable and suitable alternatives. If the impact of a ban would be disproportionate to society, the eCA and the BPC should investigate measures to limit exposure related to those uses, which could be considered in the approval conditions.

If the substance is approved, the uses which were not supported by the applicant nor were referred in the public consultation will not be allowed in the approval.

CA members are invited to take a position on the proposals referred in this document.

CA-March24-Doc.5.5 Disodium tetraborate: renewal of approval and biocidal products

Disodium tetraborate: renewal of approval and biocidal products

The application for the renewal of disodium tetraborate approval was submitted only for disodium tetraborate pentahydrate and not for the anhydrous or decahydrate forms.

CA questioned whether measures have to be taken to reflect that situation and maintain the approval only for that form of disodium tetraborate.

Two options are described, and option #2: keep the latest extension of approval valid as such (expiring on 31 August 2026) and solve the issue via the renewal of the active substance - where the scope of the substance would be properly determined and seems to be the less time consuming approach. MS are invited to agree on the way forward.

CA-March24-Doc.7.3 Applicability of ECHA guidance on bees for biocides

Based on the discussions held in the CA meetings and the newsgroup contributions, and the fact that sufficient time is needed to generate the requested data on active substances or product applications, the Commission services propose that the ECHA Guidance on the assessment of risks to bees from the use of biocides;

• would not be applicable to active substances dossiers in the review programme;
• would be applicable to procedures (active substances, products), for which the application would be submitted two years after the date of publication of the guidance, so as from 1st February 2026. It would therefore not be applied to applications submitted before that date.

To be agreed by CA.

CA-March24-Doc.7.4 Applicability of ECHA/EFSA guidance on the impact of water treatment

The proposed way forward is similar to that on applicability of the Bee guidance:

• would not be applicable to active substances dossiers in the review programme, in line with the agreement reached in document CA-Dec23-Doc.5.4 - Final - Extension of RP beyond 2024.docx;
• would be applicable to procedures (active substances, products), for which the application would be submitted two years after the date of publication of the guidance. It would therefore not be applied to applications submitted before that date.

To be agreed by CA.

CA-March24-Doc.7.6.a - In-situ proposal ECHA

A very informative presentation prepared by ECHA, provided proposals on how to answer important regulatory questions such as:

• What is approved in the AS approval process of an isAS?
• Can the composition of the in situ generated active substance (isAS), approved in the AS stage, differ from the composition of the isAS applied for in product authorisation?
• Is technical equivalence needed for isAS?

For further information click here.

UK

GB active substance expiry dates postponed

The HSE has announced a postponement of the active substance expiry dates for 110 biocidal active substance/product type combinations because it is unlikely that a renewal decision under GB BPR will be made before the expiry of the existing approvals. The expiry date postponements apply to biocidal active substance/product type combinations due for expiry between 1 January 2024 – 31 December 2026, with postponement until 31 January 2027, subject to a timely renewal application being submitted and accepted. The HSE website lists the active substance/product type combinations that have met these requirements already. GB Product authorisations for new biocidal products or new trade names containing these active substances can still be applied for but must not be made available on the market until product authorisation is granted.

Updated GB-MCL list

The HSE (as the GB CLP Regulating Agency) has, this month, issued an updated version of its GB mandatory classification and labelling list?(.xlsx). For GB CLP to operate effectively, divergences from the EU CLP Regulation are continuing. In addition to the GB-MCL update in October 2023, this recent update includes the new/revised mandatory classifications and labelling for 25 substances, with entry into force on 2nd March 2024 (compliance date: 2nd September 2025). The GB CLP Regulation applies to GB-based importers, manufacturers, downstream users and distributors supplying the GB market and the voluntary application of these new classifications applies for the typical 18-months. On the compliance date and beyond, the compulsory use of the MCL will apply to these substances.

Asia

South Korea

New treated articles guidance for the automotive industry

The Ministry of Environment (MoE) published a new guidance document on treated articles towards the end of last month. There was already a very complete guidance document on the topic published back in 2021, but this time, the new guidance focuses more on a niche topic of high relevance to industrial manufacturers in Korea – cars. Whenever a car component or a part of the interior of the car is treated with a biocidal product, this is considered, as per the definition included in the Consumer Chemical Products and Biocides Safety Control Act (the K-BPR), a treated article, and obligations stemming from the Act can thus apply.

MoE published this guidance as part of their efforts to increase awareness in the automotive industry that even if not manufacturing biocidal products or active substances directly, the act of using a biocide itself could still be regulated by the K-BPR. Possible examples of treated articles included in cars commonly include air conditioning filters and upholstery treated with a preservative to prevent their deterioration or to prevent growth of microorganisms. The guidance is freely available in Korean on the official K-BPR government IT portal (CHEMP).

If you are using biocides in South Korea and are curious as to whether you have responsibilities under the K-BPR, please feel free to reach out to our team of experts at [email protected] and we will be happy to help!

The Philippines

Announcement: Licensing seminar for household/urban hazardous substances establishments (LS-HUHS)?

The Philippines FDA is hosting an insightful seminar to delve into the implementing guidelines of A.O. No. 2019-0019. This ordinance reinstates licensing requirements for entities involved in specific Household/Urban Hazardous Substances (HUHS) activities, with exemption details from prior registration/notification of products. The seminar covers essential topics such as Regulated HUHS products, Types of establishments, LTO requirements, General and Specific guidelines, and an informative ePortal V2 walkthrough. Save the date for the FREE webinar on June 28, 2024.

?USA

EPA launches new list of disinfectants effective against HIV, Hepatitis B, and Hepatitis C viruses

The U.S. Environmental Protection Agency (EPA) has combined and updated information from several disinfectant lists to create a new list titled “EPA-Registered Antimicrobial Products Effective Against Bloodborne Pathogens (HIV, Hepatitis B and Hepatitis C) [List S]." EPA launched this new disinfectant list to increase the accessibility, accuracy, and functionality of the information for all readers, including healthcare providers and hospital staff.?

The new List S combines product information from the following former EPA disinfectant lists:?

• List C: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 Virus;?
• List D: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus;??
• List E: EPA’s Registered Antimicrobial Products Effective Against Mycobacterium tuberculosis, Human HIV-1 and Hepatitis B Virus; and??
• List F: EPA’s Registered Disinfectants for use Against Hepatitis C.??

EPA Lists C, D, E and F are now retired and will be redirected to the new List S.??

This new list includes products that are effective against HIV, Hepatitis B and Hepatitis C viruses and specifies which products are not effective against one or more of these viruses. For example, if a product is only effective against HIV it will be included on the list but will have “NA” for “not applicable” for Hepatitis B and C.?

EPA has reviewed required laboratory testing demonstrating that products on the new list kill?HIV, Hepatitis B and/or Hepatitis C viruses. The list does not include supplemental distributer products (products with the same chemical composition and efficacy as the primary products, but often have different brand or product names). If you have a product that is eligible for inclusion but not on the new list, please contact knoell for support and guidance.

knoell Academy: Upcoming seminars ????

Discover a diverse range of seminars waiting for you to explore!

Risk Assessment under the Biocidal Products Regulation (Human Health and Environment) ??

Join our web-seminar spanning 2 sessions over 2 days, aiming to enhance participants' expertise in human health and environmental exposure assessments for biocides. Topics include regulatory updates, risk characterization, and more. Ideal for those seeking to elevate their skills in this field. Language: English. Basic knowledge of Biocidal Products Regulation (BPR) required.

Seize the opportunity and attend our seminar: Risk Assessment under the Biocidal Products Regulation (Human Health and Environment) | knoell academy

FCM Regulations in Switzerland and Migration Testing Conditions ????

Delve into FCM Regulations in Switzerland and Migration Testing Conditions in our 3-hour web-seminar. Explore topics such as migration limits, worst-case calculations, and risk assessment steps. Ideal for Regulatory Affairs Managers and Product Stewardship Specialists in the food contact supply chain.

Here is the registration link: FCM Regulations in Switzerland and Migration Testing Conditions | knoell academy

Understanding and Applying the GHS-/CLP-Criteria for Classification and Labelling ??

Explore GHS & CLP principles in our training session, also available as a web-seminar. Learn about classification elements, global implementation of UN-GHS, and more. Ideal for hazardous material officers, health and safety experts, and those in the chemical industry.

For registration, please follow the link: Understanding and Applying the GHS-/CLP-Criteria for Classification and Labelling | knoell academy

Meet us ??

Discover a diverse range of seminars waiting for you to explore!

CONGRèS DéTERGENCE 2024 I Paris, France

Meet our colleagues at this important event. They will be pleased to meet you!

CLEANING PRODUCTS EUROPE I Prague, Czech Republic

Meet our colleague Radu Adrian Gropeanu and join his talk on "Overview of EU microplastics regulations (2024 Update)".

He will be pleased to meet you!

THE BIOCIDAL PRODUCTS REGULATION I Mainz, Germany

Join our colleagues Lonne Gerritsen and Carolina Vieira and listen to their interesting talk about:?

Experiences with Simplified Authorisation of biocidal products: Regulatory procedure and data requirements

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 impactful presence, 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's contact page for more information.