The European Commission has published a Delegated Regulation, 492/2014, which covers the renewal of national authorisations for biocidal products under the Biocidal Products Directive, having been previously subject to mutual recognition.
This requires, amongst other things, applicants to provide “a draft summary of the biocidal product characteristics containing the information required under Article 22(2) of Regulation (EU) No 528/2012, in the official languages of the reference Member State and of the Member States concerned which, where relevant, may differ between Member States in accordance with Article 1(3) of this Regulation”, which would include identification of the biocidal active substance(s), and all relevant compositional data. If data is to be recognised by mutual recognition, we would expect that the methodology used to produce such data be produced using an accredited test method, which would be recognised across all signatories of the ILAC convention.
Filed under: Biocides, EU Information, EU Regulation/Legislation | Tags: Biocides, risk assessment, toxicity testing
The European Commission has rejected the refusal of authorisations of biocidal products containing bromadiolone notified by Germany in accordance with Directive 98/8/EC. Bromadiolone is used in products belonging to product-type 14, Rodenticides.
The German authorities objected to the risk assessment carried out by the UK, which comprised the derivation of a dermal absorption value which was considered to resemble more closely the actual exposure conditions for professional users loading wax blocks in bait stations.
This ruling validates the preferred UK approach of risk assessments which take into account the actual pattern of use of any substances requiring assessment, rather than looking solely at the hazardous nature of a substance, which is commonplace in some EU Member States.
Filed under: Biocides, ECHA | Tags: Biocides, chemicals, CLP; REACH; Chemicals; ECHA
The European Commission have approved Cypermethrin as an existing active substance for use in biocidal products. The approval is until the end of May 2015.
The European Chemicals agency, ECHA, has published a further guidance document regarding biocides, “Guidance on applications for technical equivalence“.
This Guidance document informs potential applicants about their obligations resulting from the provisions of Article 54 of the Biocidal Products Regulation, when they need to apply for an assessment of technical equivalence and on the procedural steps in making that application. The guidance also informs potential applicants about the assessment process conducted by the Agency and the approach used for assessing the technical equivalence of the alternative source of an active substance versus its reference source.
Technical equivalence is defined in the BPR in Article 3(1)(w): “technical equivalence means similarity, as regards the chemical composition and hazard profile, of a substance….. Therefore, the need to conduct appropriate analytical measurements on the biocidal product, or active ingredient contained therein is of prime importance, alongside establishing the risk from the product.
The document is comprehensive and provides very good guidance to applicants. Similarities to the approaches used previously with REACH are apparent, which is helpful to applicants who have previously registered substances under REACH as well as for consistency of approach for Agency staff.
Filed under: Biocides, chemicals, UK Government Information | Tags: pesticides
The Chemicals Regulatory Directiorate (CRD) of the UK’s Health & Safety Executive (HSE) has provided an update to clarify the position regarding the use of metaldehyde as a molluscicide.
Commission Implementing Directive 2011/54/EU of 20 April 2011 amending Council Directive 91/414/EEC to include metaldehyde as active substance and amending Commission Decision 2008/934/EC has a specific provision that molluscicides should contain an effective dog repellent agent.
CRD now advise that, following advice from the Advisory Committee on Pesticides, the following substances at the stated concentrations were considered to be effective dog repellents, and are therefore in compliance with the Regulations:
Bitre: 016 – 0.024%
Repulsif R: 0.2-0.4%
Alamask: 0.5-1.0 %
The European Chemicals Agency, ECHA, has published guidance documents to assist companies in complying the the Biocides Product Regulations (BPR).
The specific guidance is very detailed and covers such measurement-specific topics as substance identity (correct identification and nomenclature) and methods used for determining chemical and physical properties. These methods include spectroscopic data, particle size distribution, viscosity, solubility, the identification of impurities or by-products and an accurate measurement of the concentration of the active substance in the product, where the results of measurements of 5 representative production batches are required.
The guidance covers both active substances within the product and the biocidal product itself.
The UK Competent Authority, the Chemicals Regulatory Directorate (CRD) of the HSE, are holding 2 workshops on 22 and 24 October on Biocides Requirements under Regulation 528/2012.
Filed under: Biocides, chemicals, ECHA, REACH/CLP | Tags: CLP, CLP; REACH; Chemicals; ECHA
ECHA have launched a public consultation on two proposals for harmonised classification and labelling (CLH) of hydroxyisohexyl 3-cyclohexene carboxaldehyde and the pesticide bupirimate.
Hydroxyisohexyl 3-cyclohexene carboxaldehyde is used in products such as air fresheners, detergents and cosmetics.
Bupirimate is approved under Regulation (EC) No 1107/2009 which covers the placing of plant protection products on the market.