The Regulation on biocidal products (RPB, Regulation (EU) No. 528/2012) governs the marketing and use of biocidal products, which are used to protect humans, animals, materials or products against harmful organisms such as pests or bacteria thanks to the active substances these biocidal products contain.
The obligations for companies derived from biocide regulations are:
Application for Approval of Active Substances: Companies must apply for the approval of an active substance by submitting a Dossier to ECHA.
Application for Authorisation of Biocidal Products: Following the approval of an active substance, those companies wishing to market biocidal products in a Member State must apply for an authorisation of the product.
REACH Integra provides advice to companies on the following activities associated with biocidal regulation:
For active substances contained in certain biocidal products not covered by Directive 98/8/EC but are however within the scope of BPR5 marketed before 1 September, 2013, an application for approval by 1 September, 2016 must be submitted, otherwise, marketing of these products must be discontinued by 1 September, 2017.
Applications for approval of active substances must be submitted in IUCLID 5 format and submitted through the R4BP3 platform.
With the aim of marketing biocidal products in different EU countries, REACH Integra advises companies in their preparation of applications for product authorisation through R4BP3 for the Member State Competent Authority where it intends to market.
Reach Integra prepares the Authorisation Dossiers including preparation of the data gap and risk assessment.
National authorisation of the biocidal product in a Member State may be extended to other Member States through the mutual recognition procedure, which may be carried out sequentially or in parallel.
Regarding sequential mutual recognition, companies first need to obtain approval of the product in one Member State and then request the other Member States to recognize this first authorisation. However, for mutual recognition in parallel, the company can submit an application for product authorisation in one Member State and simultaneously enquire other countries to recognise the authorisation as soon as it is granted.
Applying for authorisation of a biocidal product throughout the EU is also possible without having to obtain a specific national authorisation. To do so, the product must have similar uses throughout the EU and not contain any active substances that fulfil the exclusion criteria or belong to product types 14, 15, 17, 20 and 21.
Only the less harmful biocides may benefit from the simplified authorisation procedure. All the active substances contained in the biocidal product must appear in Annex I of the Biocide Product Regulations (BPR) and comply with the specified restrictions: It must not contain any substance of concern; it must not contain any nanomaterials; it must be sufficiently effective and its use should not require Personal Protection Equipment.
The purpose of technical equivalence is to determine the similarity with regards to the chemical composition and hazard profile, of substances produced from a source different from the reference source or from the reference source but following a change in the manufacturing process and/or manufacturing location compared to the substance of the reference source in respect of which the initial risk assessment was carried out.
REACH Integra prepares the Technical Equivalence application files for active substances for both Tier I and Tier II and submits them to ECHA. Assessed in Tier I are substance identity, chemical composition, analytical profile of five representative batches, description of the analytical method used for the determination of the substance and absorption spectra while Tier II is based on the hazard profile using toxicological and eco-toxicological data.
