Biocide Regulatory Insights
Dear reader,
We are very happy to issue the sixth edition of our biocides newsletter, the second of 2024, and we are very pleased by your ongoing 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
This month, ECHA published the Guidance to assess the risks to bees from the use of biocides.
The first draft was published in April 2023.
The Guidance proposes a risk assessment approach to assess the risk to bees from product type (PT) 18 (insecticides, acaricides and products to control other arthropods) emission scenarios. The possible sources of exposure covered in the guidance are:
The guidance was written upon the request of the European Commission, who recommended ECHA to take into account EFSA’s Guidance on the risk assessment of plant protection products on bees.
This ECHA guidance considers two main routes of exposure to bees:
In the risk assessment, a tiered approach is applied for both exposure and effect.
In the exposure tiers, residue intake or residue deposition need to be quantified by calculating the Predicted Exposure Quantity (PEQ) to address the dietary and contact exposure of the bees from the use of a biocide.
In the effect tiers, the lower tier assessment will define dose response curves (DRC), which are parameters to describe the steepness of the dose-response relationship obtained from the standard laboratory tests. In the higher tier tests the imposed exposure is called ‘Estimated Exposure Dose’ as a potential way for refinement in case unacceptable effects are observed in the lower tier assessment.
In these exposure and effect assessments both acute and chronic effects, as well as adults and larvae as different life-stages are considered. Thereby, four risk cases have been defined: acute-contact; acute-dietary; chronic-dietary; larvae-dietary.
For each of these risk cases, respective PEQj for exposure and DRCj for effects are derived with a suffix j indicating the specific risk case, which are combined to predict the overall effect at colony/population level.
Furthermore, a risk assessment scheme for metabolites and biocidal products (mixtures), and considerations of risk mitigation measures, instructions for use and a warning sentence are also included in the document.
Europe
Highlights from ECHA
IUCLID Service Release (v7.12.4) (5th February 2024)
ECHA has released a new version of IUCLID which contains:
SPC into IUCLID format went live on 10th February
From 10th February 2024, the SPC (Summary of Products Characteristics) has to be submitted as an IUCLID file in R4BP 3. The old SPC editor is now discontinued.
The document “Recommendations on preparing a Summary of Product Characteristics (SPC) for single biocidal products and biocidal product families“, Version 2.0 ?has been published in February 2024. It takes into account the change of the SPC format from xml to i6z and the newest CG and CA agreements affecting SPC relevant information. To reflect the switch in SPC preparation from the SPC editor to IUCLID, the technical guides and application instructions of the Biocides Submission Manuals have been recently updated.
The new “BSM Technical guide: How to prepare a biocides dossier“, version 4.9, includes a whole new chapter which describes how to provide information for the SPC when starting with an empty dataset. Please note that it does not include instructions on how to revise an existing product dataset in IUCLID in order to create the SPC.
New chemicals database: ECHA CHEM
ECHA CHEM is a new solution for publishing information on chemicals. The first release, available now, includes information from all REACH registrations – and there will be more to come. You can access it from the link below: https://chem.echa.europa.eu/
Getting familiar with ECHA’s biocide guidance for the risk assessment of bees
On 3rd March 2024, ECHA will hold a seminar on its new biocide guidance for the risk assessment of bees.
NAMs project
ECHA requested to start a project to conduct scientific studies on the reliability and relevance of new approach methodologies (NAMs) as alternatives to animal studies.
The goal of the project is to increase the acceptance of Non-Animal Methods (NAMs) for regulatory purposes, consequently minimizing the need for animal studies in safety assessments of substances. The project is developed by a consortium led by the Fraunhofer-Gesellschaft, based in Germany.
Highlights from European Parliament
Greenwashing fight
Last year, during the Competent Authorities meetings, the document CA-June23-Doc.4.9-Final_rev1?was issued. It contains a list of names that cannot be used on biocidal products, in order to avoid greenwashing. Greenwashing refers to the deceptive or misleading practice of conveying a false impression or exaggeration of a company's commitment to environmental and sustainable practices.
The CA document is not legally binding, but the European Parliament is working on two directives that will provide a legal support to the greenwashing fight. To learn more, please click here.
UK
New guidance published on addressing toxicology data requirements for products without in vivo vertebrate testing
A new guidance document for applicants on how to address toxicology data requirements for biocidal products without in vivo vertebrate testing has been published by HSE. To reduce any unnecessary in vivo testing on vertebrate animals, the GB BPR requires that vertebrate tests should only be conducted as a last resort and shall not be repeated for the purposes of GB BPR.
GB BPR Annex III sets out the toxicological information that applicants must submit to support their applications for authorisation. The new guidance, in line with the provisions of Article 62 (Data Sharing) of the GB BPR, details how to meet the requirements of skin, eye and respiratory irritation and sensitisation as well as oral, dermal, inhalation toxicity and dermal absorption, discussing bridging approaches and in cases, only accepting previously submitted data for evaluation. The guidance also presents examples of acceptable justifications for the non-submission of test data.
The guidance should be used for applications with immediate effect. For further information see the HSE website on vertebrate testing.
领英推荐
Asia
South Korea
Possible new grace periods for selling and storage of biocidal products
As some of our readers may know, according to the rules of the Consumer Chemical Products and Biocides Safety Control Act (“K-BPR”), biocidal products in Korea can be granted a grace period during which an authorisation is not required. This grace period is equal to the grace period of the active substances contained in the product (for example, 31st December 2023), plus two years (for example in this case, 31st December 2025). During this grace period activities with the biocidal product such as import and manufacture, and also storage and sale, are allowed without an authorisation in place. However, what happens if the active substance in the product is not approved by the end of the grace period of the active substance?
The answer is that biocidal products containing such active substances are then subject to a one-year phase-out period. This would mean that for an example product containing an active substance with an original grace period of 31st December 2023, if the active substance is not approved in time, all activities with the biocidal product would have to cease by 31st December 2024. The activities forbidden would also include storage of the biocidal product, which would compel distributors in Korea to have to destroy or withdraw products with little notice.
However, fortunately, a draft amendment to the K-BPR has been proposed, which would now implement an extra six-month grace period after the end of the phase-out period exclusively for “sale, gifting, presenting, exhibiting, or stored for the purposes of sale or gifting”. In our example therefore this would be allowed until 30th June 2025, granting the hypothetical company marketing the biocidal product some extra breathing room.
This is still not yet in law and is only a proposal by the Ministry of Environment, but we are keeping our fingers crossed that this will be soon implemented. If you need any advice or assistance with K-BPR interpretation or approval applications under the K-BPR our experts would be happy to help.
Thailand
Thailands FDA takes strides in regulating hand sanitizer cosmetics
The Cosmetics and Hazardous Substances Control Division of Thailand's Food and Drug Administration (FDA) recently unveiled two significant notifications aimed at enhancing the oversight of hand sanitizer cosmetics containing alcohol.
The first draft focuses on "Determining the Criteria for Deviation Limits of Main Ingredients in Cosmetics Containing Alcohol for Hand Sanitizing." The proposal suggests a range between 15% and 18% for the alcohol content in these cosmetics, encompassing ethyl alcohol (ethanol), isopropyl alcohol (isopropanol), and n-propyl alcohol (n-propanol[k1]?). This draft emphasizes the need for compliance with these specified limits and is currently under review by the Regulatory Body.
Simultaneously, the second draft, titled "Determining the Characteristics of Cosmetics Containing Alcohol for Hand Sanitizing Prohibited for Manufacture, Import, or Sale," seeks to repeal a previous notification dated March 9, B.E. 2563 (2020). According to this new proposal, cosmetics with alcohol as their active ingredient, designed for hand sanitizing without water, must have a concentration of either ethanol, isopropanol, n-propanol, or a mixture thereof, not less than 70% vol. or 65% wt.. Importantly, this draft aims to enforce stricter guidelines for the manufacture, import, and sale of such products to ensure public safety.
These proactive measures by Thailand's FDA underline the government's commitment to regulating and maintaining the quality of hand sanitizer cosmetics containing alcohol. Stakeholders in the industry are encouraged to stay informed about these proposed regulations and actively participate in the consultation process to contribute valuable insights and feedback. The proposed changes are pivotal in fostering a safer environment for consumers and promoting responsible manufacturing practices within the cosmetics sector.
USA
Navigating the EPA pre-application process with expert guidance
The Environmental Protection Agency (EPA) pre-application meeting is a critical step in product registration or amending a product registration. This meeting is a strategic opportunity to engage with the EPA to discuss and confirm the specific data and labelling requirements relevant to your product. Understanding the significance of this meeting and approaching it with the proper preparation, can significantly impact the success and efficiency of your registration process.
At the core of a successful pre-application meeting is the need for thorough preparation. This involves not just an understanding of your product and its implications but also an awareness of the regulatory framework and the specific requirements of the EPA.
An expert understanding of the EPA's processes can help you navigate this complexity, ensuring your pre-application meeting is as productive and informative as possible.
A well-experienced consultant can assess whether such a meeting is necessary, for your particular situation, saving you valuable time and resources and when a pre-application meeting is beneficial, can help you prepare the necessary documentation, coordinate, and ask EPA relevant questions.
EPA's requirements can be intricate and highly specific, so it's easy to overlook critical details that could delay your application or lead to requests for additional information.
knoell Academy: Upcoming seminars
Discover a diverse range of seminars waiting for you to explore!
Carriage of radioactive material (annual training according to 1.3 and 1.7.2.5 ADR) ??
We are delighted to announce our upcoming seminar on the Carriage of Radioactive Material, designed for individuals involved in the transportation of radioactive goods. This annual training, in accordance with ADR 1.3 and 1.7.2.5, aims to provide comprehensive insights into the legal, physical, and safety aspects associated with the carriage of radioactive materials.
For registration, please follow the link: Carriage of radioactive material (annual training according to 1.3 and 1.7.2.5 ADR) | knoell academy
The Principles of REACH: Basic Knowledge, Legal Framework and Practical Considerations ????
The principles of REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) are outlined in the European Regulation (EC) No 1907/2006, designed for the European Economic Area (EEA). This regulation mandates manufacturers, importers, and downstream users to assess the risks associated with substances to ensure adequate protection of health and the environment.
Seize the opportunity and attend our seminar: The Principles of REACH: Basic Knowledge, Legal Framework and Practical Considerations | knoell academy
IUCLID 6 Basic Training – Background & Practice ??
The training course covers the basic knowledge of the IUCLID 6 version in two main focuses. On the one hand, the participants are provided with an overview of the structure and function principles of IUCLID 6. On the other hand, practical and hands-on activities are covered in this training course.
Here is the registration link: IUCLID 6 Basic Training – Background & Practice | knoell academy
Meet Us At
ANIMAL HEALTH, NUTRITION AND TECHNOLOGY INNOVATION EUROPE 2024 I LONDON, UK
Taking place over three days in early March, this is a key event in the animal health conference calendar, and knoell will be attending as an Associate Partner.
CROPLIFE EUROPE ANNUAL CONFERENCE I BRUSSELS, BELGIUM
Meet our colleagues at this important event. They will be pleased to meet you!
BIOEX 2024 I SHANGHAI, CHINA
Our knoell experts will be at this interesting event and Sean McCarthy will be giving a talk about:
Borderline substances: Plant Protection Products or Fertilising Products
Join them there, they will be pleased to meet you!
24TH CHINA INTERNATIONAL AGROCHEMICAL & CROP PROTECTION EXHIBITION I SHANGHAI, CHINA
Our colleagues will also be at this exciting event! Meet them at our?booth #81F212?and listen to Sean McCarthy talk about?"Pesticide Product registration in North Africa - Morocco, Algeria, Tunisa"
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.
Prüfungen für Ihre Medizinprodukte und Desinfektionsmittel individuell angepasst ?? Mit hoher Fachexpertise zum gewünschten Nachweis der internationalen Normenstandards ??????
1 年thx for the updates ?? Claudia Hildebrandt Virginia E.