Staphyt Regulatory Affairs informs you
We share with you some latest regulatory news that may impact your products registration and development.
Biocidal Product Committee : 2 substances supported for approval, one for non-approval
During the June meeting of the Biocidal Product Committee, the committee supported the approval of the thermally treated garlic juice (formerly named « garlic extract ») for product-type 19 and the approval of the Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) (KPMS) for product-types 2, 3, 4 and 5. During the same meeting, the committee supported the non-approval of the Willaertia magna C2c Maky for the product-type 11. The formal opinions are now awaited on the BPC webpage.
ADBAC/BKC (CAS n°68424-85-1) : approval for product-type 2 confirmed!
The Biocidal Product Committee delivered its opinion on ADBAC/BKC (CAS n°68424-85-1) approval for product-type 2 on 2 December 2021, adopted by simple majority. Following some feedback from several Member States, the Commission requested ECHA to reconsider its opinion with regard to the assessment of the risks to the soil compartment. During the June meeting of the Biocidal Product Committee, the committee confirmed the opinion concerning the risks to the environment by consensus, and confirmed its support for approving of ADBAC/BKC for product-type 2.
IUCLID updated with new REACH and BPR information requirements
The latest update to the International Uniform ChemicaL Information Database (IUCLID) reflects the amended information requirements for registering chemicals under the REACH Regulation, but also for BPR Summary of product characteristics (SPC) and introduction of the first version of the format to accommodate the requirements of the Drinking Water Directive.
New Proposal for a Directive on substantiation and communication of explicit environmental claims
The European Commission has published its awaited Proposal for a Directive on substantiation and communication of explicit environmental claims, which aims to put an end to the non-relevant claims of environmental benefit (so-called ‘greenwashing’). This Proposal is an important part of the Unfair Consumer Practices Directives (UCPD) framework, and aims to provide a harmonised set of rules for businesses wishing to make ‘explicit environmental claims’. It clearly indicates, in its article 3, that Member States should ensure that claim substantiation should be based on ‘an assessment’.
Incoming updates for the Regulation on detergents and surfactants
On the 28th April, European Commission proposed a revised Regulation on detergents and surfactants, with revised rules wich aim to cover new innovative products like micro-organisms and sustainable new practices like the refill sale of detergents. These new rules also introduce a digital labelling and a product passport for detergents and surfactants.
First draft Guidance for the Assessment of Risks to Bees from the Use of Biocides
The new ECHA Draft Guidance for the Assessment of Risks to Bees from the use of Biocides has been published on April 2023. This Guidance Document describes how to perform a risk assessment for bees, in accordance with Article 19(1)(b)(iv) of the BPR. It proposes a tiered approach scheme for biocidal active substances for the exposure estimation in different scenarios, hazard characterisation and a risk assessment methodology covering both dietary and contact exposure.
Member States’ plans to submit assessment reports
Overview of dates when evaluating competent authorities are planning to submit assessment reports for biocidal active substance approvals or renewals. This table provides an overview of the planned submission dates for BPR active substance approval/renewal cases from the eCA to ECHA for opinion forming of the Biocidal Products Committee (BPC) of the Agency.
Next approval deadlines
Substance name | EC /List no | CAS no | Product-type | Approval start date |
---|---|---|---|---|
(13Z)-hexadec-13-en-11-yn-1-yl acetate | 642-968-2 | 78617-58-0 | PT19 | 01/06/2023 |
L-(+)-lactic acid | 201-196-2 | 79-33-4 | PT6 | 01/11/2023 |
Didecyldimethylammonium chloride(DDAC) | 230-525-2 | 7173-51-5 | PT1 | 01/02/2024 |
Didecyldimethylammonium chloride(DDAC) | 230-525-2 | 7173-51-5 | PT2 | 01/02/2024 |
Chrysanthemum cinerariaefolium extract produced with supercritical carbon dioxide | 289-699-3 | 89997-63-7 | PT19 | 01/02/2024 |
Chrysanthemum cinerariaefolium extract produced with hydrocarbon solvents | 289-699-3 | 89997-63-7 | PT19 | 01/02/2024 |
Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-16)) | 270-325-2 | 68424-85-1 | PT1 | 01/07/2024 |
Ozone generated from oxygen | – | – | PT2 | 01/07/2024 |
Ozone generated from oxygen | – | – | PT4 | 01/07/2024 |
Ozone generated from oxygen | – | – | PT5 | 01/07/2024 |
Ozone generated from oxygen | – | – | PT11 | 01/07/2024 |