New EU biocidal active substance approval decisions published - Does this impact your products?
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Recently, the European Chemicals Agency (ECHA) published several active substance approval regulations. These regulations detail the approval dates and legal entry into force of the approval under EU BPR of:
Didecyldimethylammonium chloride (DDAC) for Product Types 1 (Human hygiene) and 2 (Disinfectants and algaecides not intended for direct application to humans or animals)
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide for Product Type 19 (Repellents and attractants)
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents for Product Type 19 (Repellents and attractants)
L-(+)-lactic acid for Product Type 6 (Preservatives for products during storage), including uses as the active substance in treated articles.
Below we provide an overview of the regulatory obligations which will now affect all companies supplying products which contain any of the above active substances and how Yordas can provide expert support to meet these obligations.
Regulatory obligations and next steps
Under the EU BPR, all products must undergo a two-stage evaluation process. First, the active substance is evaluated for potential health or environmental risks, and acceptable efficacy for a specific Product Type (PT), by an EU Member State Competent Authority (CA). This CA will then provide an assessment report that is sent to the Biocidal Products Committee (BPC), who reviews the report and provide their approval or non-approval decision. The active substances of interest in this report have all reached the end of this stage of the process. The second stage is the authorisation of each BP consisting of, containing or generating the approved active substance(s)
Since the active substances discussed above have all been approved, it is now required under the EU BPR that each product or group of similar products (referred to as a product family) be evaluated before they go to market in each Member State of the EU. The approval regulations include the approval start dates (when the active is added to the Union List), which are set at a specified amount of time after the approval regulations have been issued. Following the approval of an active substance for a product type, a biocidal product authorisation needs to be submitted - no later than the Approval Start Date of the active substance, to ensure continuity on the EU market. The approval regulations will also contain any substance-specific information, which, needs to be considered during the preparation of a BPR product authorisation application dossier.
The approval date for Didecyldimethylammonium chloride, PT 1 and 2, Chrysanthemum cinerariaefolium extracted from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide and extracted from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents for Product Type 19 (Repellents and attractants) is the 1st February 2024. The approval date for L-(+)-Lactic acid (CAS:79-33-4) is 1st November 2023. These dates act as the regulatory deadline for submission of a biocidal product authorisation application for any product currently placed on the EU market.
How can we help?
Under the EU BPR, there is a range of possible application types, including, but not limited to:
National Authorisation applications - authorisation of a single product for sale in a single member state
Mutual Recognition applications - simultaneous or subsequent authorisation of a product approved in a different member state through the National Authorisation process
Same Biocidal product application - an authorisation application for a product which is either already approved or for which an authorisation has already been made to the same member state. For example, this can be useful where a supplier product is already authorised, and the applicant rebrands it under their trade name but wishes to be the authorisation holder for their product.
Biocidal Product Family application - allows a group of products which comply with strict similarity criteria to be authorised under a single application.
Given the complex nature of the EU BPR and the range of possible application types, Yordas can, through our expert knowledge, provide strategic support to identify the best possible route for your products.
In addition to the overall BPR strategy, we also provide information regarding the possible submission of applications under Member State national regulations under Article 89 of the EU BPR to allow your products to benefit from the transitional period. Some countries do not allow the submission of applications under national legislation after the approval date for the active substance is published while others set a deadline for these submissions which can range from the date of approval to 18 months before the final active substance approval date. As such, if you wish to benefit from the transitional rules of the BPR for a product containing any of these active substances, these should be submitted as soon as possible to avoid any possible market freeze.
Once we have identified the most appropriate route to authorise your products, we can also provide expert analysis to determine what data you might need and produce a Data Gap Assessment (DGA) and Integrated Testing Strategy (ITS). This will help provide the full details of what data needs to be generated for the chosen application route to maximise the chances of the submission dossier getting accepted by the evaluating CA (eCA). If desired, we can also provide study monitoring services and coordinate testing with Contract Research Organisations to produce data that meets the standards required by the regulatory authorities.
We can coordinate with prospective eCAs and provide ongoing support for the entire dossier preparation process, which includes preparation of IUCLID dossiers, Product Assessment Reports, risk assessments and study summaries, dossier submission through R4BP3 and post-submission requests from the authorities.
If any of the above services are of interest to you, please contact us. You can also visit our Antimicrobials, Pesticides & Biocides Services page to learn how Yordas can help you in becoming compliant.