Exponent’s Biocides team boasts a vast wealth of regulatory experience and expertise gained from working in government, industry, contract research organisations, and as independent regulatory consultants. We have a proven track record assisting clients to achieve positive active substance approvals/Annex I inclusions and product authorisations under the EU Biocidal Products Regulation (BPR) and Biocidal Products Directive (BPD). We evaluate and construct product family dossiers under the BPR, have experience analysing global biocide regulatory systems and have assisted clients with global national regulations in over 30 non-EU countries. We also provide consultation on regulatory strategy, product stewardship, portfolio management, and Task Force/Consortia management/representation and training.
- Regulatory Advice under BPR – Legislation; Transitional arrangements; Requirements for products; Requirements for treated articles; Requirements for Biocidal Product Families (BPF); Technical Equivalence; Regulatory options
- Product Stewardship – Assistance in promoting best practices through responsible manufacturing, communication and use of their products throughout Europe and globally
- Portfolio Management - A client-tailored service. Examples of these types of project range from acting as a local agent to support national registrations to developing and managing strategies for compounds in various stages of their regulatory lifecycle. For national registrations, we provide regulatory strategy and support to ensure that the product portfolio is maintained at the desired level in terms of investment in the compound/product and geographic reach of the registrations
Active Substance and Product Dossiers
We assist with active substance and biocidal product dossier preparation and submission under the EU Biocidal Products Regulation (BPR) in the following areas:
- Complete dossier in IUCLID including preparation of robust study summaries, end point summaries, classification and labelling, review of labels, SDS review or compilation, SPC generation and PBT assessment, when required.
- Interpretation and study summary preparation of physico-chemical, analytical methods, efficacy, environmental fate, toxicology, and ecotoxicology data
- Guidance on the interpretation of EU and national data requirements
- Proposals for classification and labelling of substances/products
- Compilation of summary dossiers, including IUCLID files
- Human health and environmental risk assessments:
- Advice on appropriate routes of potential exposure
- Interpretation of core, additional, and Product Type (PT) specific data
- Exposure and risk assessments
- Simulation modelling (PEARL, SIMPLETREAT)
- Strategies for dealing with unacceptable margins of exposure (MOE), margins of safety (MOS), acceptable exposure concentrations (AEC)
- Strategies for dealing with unfavourable PEC/PNEC ratios Dietary risk assessments
- Regulatory submissions
- Summary of Product Characteristics (SPC)
- Application documentation
- Submission via R4BP using IUCLID
Biocidal Product Family (BPF) Assessment
Biocidal Product Families
A biocidal product family (BPF) is a group of biocidal products that are used for similar purposes and contain active substances with the same specifications. Exponent has extensive experience of preparing biocidal product family dossiers, covering a variety of product types, for evaluation in the EU. Exponent can provide technical and regulatory expertise to assist with the grouping of products which may potentially fall within a family by examining the composition, classification (hazard and precautionary statements for the products), exposure and risk assessments and efficacy. We can also assist with compiling the product family dossiers for submission.
A biocidal product family has specified variations in the composition of the products to ensure that the level of risk is not increased, and that the efficacy of the product is not decreased. The risk is not just based on the classification, but also on the way in which the product is used, the risk mitigation measures (RMM) being the same within a Meta-SPC (the way in which a group of products or “family” is divided).
Several biocidal products can be grouped under a single authorisation, provided that the difference in the composition among the "members" of the family remains within a specified range. The composition can be either a reduction in the concentrations(s) of the active substance(s) or a variation of the concentration of non-active substances. The replacement of non-active substances, in products which are members of a product family, with other non-active substances presenting the same or lower risk, is also permitted. However, classification, hazard and precautionary statements for all products within the biocidal product family have to be the same, or less ‘severe’ than in the product first authorised.
Same Biocidal Products
The Same Biocidal Products Regulation (Regulation (EU) No 414/2013, amended by Regulation (EU) 2016/1802) introduces the possibility to go from wider to narrower authorisations (i.e. from a biocidal product family to a subset of one or more “family members”) or markets (i.e. from Union authorisation to national authorisation).
It is possible to apply for an authorisation for a single product (the ‘same product’), which is identical to another authorised biocidal product (the ‘reference product’), or, for which an application for such authorisation has been submitted (the ‘prospective reference product’).
Furthermore, it is possible to apply for national authorisation starting from a (prospective) reference product having (or seeking to have) a Union authorisation.
The same biocidal product (family) application process will result in an independent authorisation, but with the same expiry date as for the reference product (or product family) and can be changed or cancelled independently of the reference product. Exponent can assist with preparation and submission of the documentation required for same biocidal product authorisations.
Product support includes:
- Constructing the BPF, including consideration of Meta SPCs
- Chemical composition
- Use of the product
- Efficacy comparison
- Hazard and classification
- Risk characterisation
- Same Biocidal Product submissions
Data Gap Analysis, Waiving Strategy, and Bridging Arguments
- Maximising the benefit of existing data to address requirements through data gap analysis; (Q)SAR modelling; use of public literature;
- Preparation of data waivers and bridging arguments (read-across)
- Reducing the cost of testing
Study Placement and Monitoring
- Study design, protocol and report review, assistance with trouble-shooting
- Extensive expertise particularly in insecticides and disinfectants
- Assisting in the design of efficacy testing programmes including test protocols, using relevant guidance/methodologies (i.e. TNsG, EN, ASTM, OPPTS, OECD) to fulfil data requirements and data reporting standards
- Preparing efficacy testing programme, (including advising on study placement, study monitoring, reviewing reports, assessing and collating data)
- Providing expert assistance in drafting product labels
- Assisting with new regulatory requirements e.g. comparative assessment
- Providing training on all aspects of biocide efficacy
Exposure Modelling and Risk Assessments
Exponent has a vast amount of experience in tiered and refined human health and environmental risk assessments to support active substance and product authorisations. Our expertise enables us to ascertain when exposure scenarios may be unsuitable for a particular application and to present alternatives to regulators with confidence. We have expert knowledge of a wide range of environmental, operator, professional and consumer exposure models used around the world.
- EUSES (EU System for the Evaluation of Substances)
- Emission Scenario Documents (ESDs, e.g. EU-ESDs, OECD ESDs)
- BEAT (Bayesian Exposure Assessment Tool)
- ECHA Guidance for Human Health Risk Assessment, TNsG’s, HEEG Opinions (MOTA)
- WHO Generic Risk Assessment Model for Indoor and Outdoor Space Spraying of Insecticides
- EASE (Estimation & Assessment of Substance Exposure)
- POEM/EUROPOEM (Predictive Operator Exposure Model)
- AOEM/EFSA model
- WPEM (Wall Paint Exposure Model)
- EFSA (European Food Safety Authority Multi-Diet Spreadsheet Model)
- FOCUS (FOrum for Co-ordination of pesticide fate models and their USe)
- Surface Water: STEPS1-2, SWASH, MACRO, PRZM_SW, TOXSWA
- Groundwater: MACRO, PEARL, PELMO, PRZM_GW
- MAMPEC (Marine Antifoulant Model to Predict Environmental Concentrations)
In situ Generated Biocides
Exponent has been at the forefront of discussions with ECHA, the EU Commission and Member States with regard to the methodology and interpretation of the regulations regarding in situ biocides, in particular where the precursors cannot be authorised. Having successfully achieved completeness for in situ active substance dossiers we are now working with the Member States to establish practical solutions to regulatory data requirements that make business sense, meet the requirements of the BPR and permit successful authorisation of in situ-generated products and biocidal product families. For active substances that are generated from precursors (other than ambient air or water) the information requirements of Annex II, Title 1 of the BPR apply to both the in situ generated active substance and the precursors (exact details on the extent of the data required can be found in the ECHA Guidance ). For in situ generated active substances, the biocidal product is considered to be either the precursors that generate the in situ active substance, or in situations where the precursors cannot be authorised (e.g. ambient air or water including seawater) the in situ generated active, such as ozone or active chlorine. Exponent can provide both technical and regulatory expertise to assist in the preparation of in situ generated active substance product dossiers.
Technical Equivalence (TE) Assessment
- Preparation of Tier I and Tier II applications when there has been a change in manufacturing process or new source of the active substance
- Addressing Competent Authorities’ queries
- Attending ECHA Working Group (WG), Biocidal Products Committee (BPC) and Competent Authority (CA) meetings with or on behalf of clients
Global National Registration
Exponent has experience of biocide regulatory systems on a global scale. We can assist you with obtaining information about product notification or registration requirements and with regulatory submissions on a global basis.
- Advice on national legislation
- Data requirements for biocide product registration/notification
- Liaison with regulatory authorities/local contacts
- Submissions for national registration/notification
- Compliance advice and checks for products.
Task Force/Consortia Management
Exponent has many years’ experience in managing Task Forces/Consortia for biocides and is able to construct dossiers utilising data from different Task Force members whilst maintaining data confidentiality.
Exponent can provide training tailored to your specific needs. Training topics include:
- Legislation awareness
- Dossier compilation and submission
- Human health and environmental risk assessments
Exponent also offers a service that is complementary to your in-house expertise which has the advantage of a "fresh pair of eyes" and/or "inside track" views from former regulators on the likely acceptability of proposed courses of action. These aspects include:
- Peer reviewing documents
- Acting as a sounding board on potential courses of action/strategies
- Providing a "neutral viewpoint" to obtain views on particular issues from EU Regulatory Authorities without the need to disclose the compound of interest.
- Tailored training
- Provide organisational capacity within multi-disciplinary teams to address multiple projects