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- ADBAC/BKC in PT2 - Information on Approval Status
On 2nd of December 2021, the ECHA Biocidal Products Committee (BPC) recommended the approval of ABDAC/BKC and adopted the BPC opinion for PT2 by simple majority. Two Member States (Germany and Finland) raised their concerns about unacceptable risk for environment, mainly for the soil compartment. As the concerns could not be solved at the 76th meeting of the Standing Committee of Biocidal products (SCBP) on 24th June 2022, ECHA organized a dedicated meeting with the eCA, the concerned Member States and the Commission services on 23rd August 2022 to resolve the reservations of the concerned Member States. It became clear during the 77th meeting of the SCBP that further discussions and assessment are needed to be able to clarify whether the exposure of the active substance to soil compartment is resulting in an acceptable risk or not. Therefore, ECHA is requested to revise its opinion on ADBAC/BKC for PT2 considering the information available in the application for approval of the active substance, discussions and arguments expressed during the various expert and regulatory meetings (BPC Environment Working Group, BPC plenary, the Standing Committee meeting, and the ad-hoc meeting of 23 August 2022), as well as the additional arguments that may be put forward during the additional discussions it will organise. ECHA is requested to provide a revised assessment report and a revised opinion. As the opinion shall be adopted by 30th June 2023 at the latest, the approval of ADBAC/BKC for PT2 can be expected in July 2025. Sources: Mandate requesting ECHA opinions under Article 75(1)(g) of the BPR "Re-assessing the risk on the environment (soil compartment) posed by ADBAC/BKC from use in biocidal products of PT2"
- Framework Guidance: Analysis of alternatives tobiocidal active substances
ECHA developed in 2022 a recommended (i.e. not mandatory) framework guidance to applicants for approval of biocidal active substances but also to Member State Competent Authorities (MSCAs) on how to perform an analysis of alternatives (AoA) to active substances being candidate for substitution (CfS) according to Art. 10(1) of the Biocidal Products Regulation ((EU) 528/2012). The guidance has been adopted at BPC-45 meeting and published in January 2023. It provides a set of elements which can be used to assess the availability of suitable alternatives to substances meeting the exclusion criteria (Art.5(1)), and substances meeting the substitution criteria (Art. 10(1)), but not the exclusion criteria. It allows a flexible approach, tailored to the case and the entity performing the analysis of alternatives (i.e. an applicant or a MSCA). Applicants for CfS are advised to submit analysis of alternatives to MSCAs which are as comprehensive as possible, including a public version for publication, covering the different intended uses as part of their application. The submission of an AoA is not legally required but strongly recommended to support the comparative assessment at product authorisation stage as products containing a candidate for substitution will have to be subject to a comparative assessment by the receiving/evaluating competent authority at the time of authorisation and will only be authorised if there are no suitable alternatives (Art. 23(3)). Evaluating MSCAs also do not have a legal requirement to make an AoA per se in the active substance approval/renewal process but might be willing to make one themselves, e.g. as a complement to one submitted by an applicant. An analysis of alternatives is recognized to be very challenging due to numerous limiting factors such as limited and variable information on intended uses of biocidal products containing this active, limited information on number of uses, biocidal products and treated articles on the EU market, limited knowledge and expertise on the uses and potential active substance alternatives. Furthermore, approval of active substances according to different requirements and rules, different dossier types at different stages of the regulatory process also lead to uncertainties in the assessment of chemical alternatives. Despite these limitations, such analyses conducted by the applicants for CfS can provide a useful set of information for either the substance approval/renewal or for subsequent product comparative assessment. A good quality and sufficiently detailed analysis of alternatives provided by the applicant could lighten the workload for the more specific comparative assessments at product authorization stage. The information on alternatives collected at the stage of active substance approval/renewal can also be used by third parties willing to submit information on alternatives during the third parties’ consultations under Article 10(3). This guidance is mainly addressed to: The applicants to support their application for approval/renewal of a biocidal active substance which is meeting the exclusion or substitution criteria The MSCAs willing to perform an analysis of alternatives for active substances meeting the exclusion or substitution criteria (as a complement to one submitted by an applicant or for other reasons) It should be seen as a recommended non-mandatory framework guideline, providing advice on how to perform and structure an analysis of alternatives for active substances candidate for substitution. It is accompanied by a template which provides a structure for reporting this analysis. Applicants of such substances are advised to use this guidance and to submit an analysis of alternatives to their eCA as part of their application. A public version of this analysis is intended to be published on ECHA’s website. The guidance does not lead to clear-cut conclusions on the availability of suitable alternatives for the intended uses. This first version describes the desired content for AoA but not the content for the related aspects of the derogation criteria related to Art 5(2)(b)5 or Art 5(2)(c)6. For the latter criteria, the ECHA guidance on socioeconomic analysis may be mainly considered. Sources: Analysis of alternatives to biocidal active substances for applicants and authorities: a recommended framework guidance CA-Dec22 Doc.5.4.a AoA Guidance implementation Final.docx Template for analysis of alternatives ECHA guidance on socio-economic analysis
- REACH Chrome (VI): Towards a European Restriction to Protect Health and the Environment
The European Chemicals Agency (ECHA) has recently published a proposed restriction targeting several hexavalent chromium (Cr(VI)) substances , classified as proven carcinogens , to strengthen the protection of workers and communities near industrial sites. Transition from REACH Authorization to Restriction Main objective: Replace the current REACH authorization regime with a faster, clearer, and more effective restriction to better control the use of Chromium(VI) . The proposed restriction would apply to the following uses: Formulation of mixtures containing Chromium(VI) Electrodeposition on plastic substrates Electrodeposition on metallic substrates Use in primers and sludges Other surface treatment processes Functional additives or process auxiliaries ⚠️ These uses would only be allowed if occupational exposure limits and environmental emission limits are respected.All other uses would be prohibited. Public Consultation: A Crucial Opportunity A 6-month public consultation will start on June 18, 2025 . This is a key step for industrial users , allowing companies to voice their opinions and defend their uses by providing technical, scientific, or socio-economic data . Need Assistance? Our team, Stéphane Pierre and Alexia Contin , can support you with risk assessment, regulatory strategy, and participation in the consultation process .
- PPWR: A New Era for Sustainable Packaging Management in Europe
With the recent publication of the Packaging and Packaging Waste Regulation (PPWR) , Europe is entering a new chapter in circular packaging management , strengthening its commitment to sustainability and the reduction of plastic waste . This regulation introduces key principles that will reshape the packaging industry: Recyclability of Packaging The PPWR requires packaging to be fully recyclable, meaning that all materials must be efficiently processed and reused. This is a major step toward a more circular and sustainable economy. Mandatory Recycled Content The regulation sets a minimum percentage of recycled content for plastic packaging from post-consumer waste. This encourages the use of recycled materials, reduces reliance on virgin resources, and boosts the recycling market. Waste Minimization PPWR aims to reduce packaging waste by promoting efficient, lightweight designs that use fewer materials while maintaining functionality. Harmonized Labeling and Sorting The regulation introduces Europe-wide harmonization of packaging labeling and sorting instructions. This makes it easier for consumers to sort packaging waste and allows businesses to comply with consistent guidelines, improving overall waste management. CEHTRA: Your Partner for PPWR Compliance At CEHTRA, we support companies in adapting to these new requirements. Our expertise helps you stay compliant with regulations while implementing sustainable and circular packaging solutions. Ready to ensure your packaging is fully compliant? Contact us today to get expert guidance from CEHTRA.
- Annex VIII to CLP Regulation: Understanding Your Obligations for Poison Centre Notifications (PCN)
In March 2017, Annex VIII to the CLP Regulation was introduced to harmonise the poison centre notification (PCN) process across EU Member States. This harmonised system became fully effective in January 2021 (extended from January 2020). Who is concerned? All importers and downstream users placing hazardous mixtures (classified for health and/or physical effects) on the EU market must provide specific information about their mixtures to the centralised EU poison centre before placing them on the market. Key obligations To comply with Annex VIII, companies must: Register a Unique Formula Identifier (UFI) Include the UFI on the label for consumer and professional use Include the UFI in Section 1.1 of the Safety Data Sheet (SDS) for industrial use They must also submit a notification via the ECHA harmonised submission portal , including: The full chemical composition of the mixture Toxicological information (SDS Section 11) The product category (according to the EU Product Categorisation System – EUPCS) The SDS and label in the national language of the country where the product is placed on the market The UFI , a 16-character alphanumeric code that uniquely identifies the mixture and can be generated using ECHA’s UFI Generator Who holds the obligation? The obligation lies with the EU legal entity (importer or downstream user).A non-EU supplier cannot fulfil this requirement on behalf of the EU-based duty holder.However, a duty holder can entrust a third party , such as CEHTRA , to prepare and submit the PCN notification on their behalf. Compliance timeline Depending on the use of the mixture, the following deadlines apply: Hazardous mixtures for consumer and professional use: from 1 January 2021 Hazardous mixtures for industrial use: from 1 January 2024 Existing mixtures already notified under national systems: by 1 January 2025 How CEHTRA can support your PCN compliance CEHTRA provides a full range of regulatory support services to help you ensure compliance with Annex VIII requirements: Portfolio Review Screen your portfolio to identify mixtures that require PCN and determine notification deadlines. Safety Data Sheet and Label Review Perform a full compliance review of SDSs and labels to ensure they meet CLP and Annex VIII requirements. PCN Preparation and Submission Prepare and submit PCN notifications via the ECHA submission portal. UFI Generation Screen for full notification information and generate UFI codes for each mixture. Regulatory Advice Offer tailored regulatory advice on how best to fulfil your obligations under the CLP Regulation. With CEHTRA’s expertise, you can achieve and maintain full compliance with EU poison centre notification requirements efficiently and confidently.





