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Developing the technical guidance document on data requirements for biocidal products
1998 - IRG/WP 98-50101-02
Finland has been developing a discussion document for EC and the Member States concerning the specified data requirements for 23 biocidal product types, including wood preservatives, and their active substances. This data is required when applying for authorisation for a wood preservative according to the forthcoming Biocides Directive. The data requirements comprise of the core data set, which is common for all product types, and the product type specific additional data sets. The core data set has been outlined in the common position of Biocide Directive adopted by the EU Council and has only been complemented with some technical details. The data required in the additional data set is supplementary to the core data set and it takes into consideration the product type specific properties and direct and indirect human and environmental exposure. At the same time other guides have also been preparing: a guide for risk assessment of active substances by Sweden and a guide for risk assessment of biocidal products by UK. Close cooperation with these projects is an essential part of the preparatory work. After finalizing the draft discussion papers by the end of February 1998 the formal discussion on these will take place with EC and the Member States during 1998. The proposals on the data requirements will be circulated for comments to the EC, the Member States, industry and other interested parties. The final document will be addressed to the authorities and the applicants.
P Karvinen, E Nikunen
Guidance for corresponding members in preparing annual reports
1995 - IRG/WP 95-60056
Guidance for corresponding members in preparing annual reports
2003 - IRG/WP 03-60178
What is OECD doing to promote harmonization of biocide regulations
1999 - IRG/WP 99-20182
OECD began work on biocides in 1997 to help Member countries co-operate in the assessment and registration of these products. The work is a part of OECD's Pesticide Programme, and is co-ordinated by the Biocides Steering Group. The goal is to harmonize regulatory approaches to allow countries to conduct evaluations of biocides more efficiently. More efficient evaluations can advance the protection of human health and the environment and result in more timely decisions for industry. The first activity done was the Survey of OECD Member Countries' Approaches to the Regulation of Biocides performed in 1997-1998. The survey collected information on countries' regulatory procedures covering the following aspects: · categorisation, regulation and responsibilities (which ministries are involved) · data requirements (detailed information for each use category) · regulatory procedures · efficacy · labelling requirements · human exposure assessments · environmental exposure assessments · risk assessment · other issues (minor uses, low risk products and biological biocides). It focused on the following seven broad biocide groups: (1) disinfectants/sanitizers; (2) preservatives/ microbiocides; (3) anti-fouling products; (4) wood preservatives and structural treatments; (5) microbiocides for waste disposal and strip mine sites; (6) products used in aquatic non-food sites (molluscides, lampricides, algicides..) and, (7) products used for vertebrate and invertebrate pest control. The new work programme Following completion of the survey, a work programme was agreed by the Pesticide Forum in November 1998. It includes activities in the following six areas: · harmonization of data requirements; · efficacy - testing and acceptability criteria; · development of test guidelines for human health and environmental fate and effects; · hazard/risk assessment - with an emphasis on exposure assessment; · co-operation between countries in biocide reviews; · risk reduction - focusing on information exchange. OECD Specific Activities on Wood Preservatives Activities specific to wood preservatives include: 1. Identification of data requirements for wood preservatives through descriptions of (a) use patterns (b) tasks involved in application, handling methods, etc, and (c) other exposure scenarios that underlie data requirements 2. Exposure assessment of wood preservatives. The objectives of the work on exposure assessment are to (a) exchange information on current approaches in Member countries, and (b) to develop, to the extent possible, a harmonized approach for future use. Two workshops will be held, one related to human exposure, the other to environmental exposure of wood preservatives. The workshops are scheduled to take place in the first half of 2000. 3. The development of a guidance document on efficacy testing and assessment for biocides including wood preservatives. 4. Test guidelines for leaching/migration from treated materials.
M Paneli, N Grandy
Guidance on the European Biocidal Products Regulation Concerning Efficacy of Wood Preservatives
2017 - IRG/WP 17-20627
In Europe wood preservatives belong to Product Type 8 (PT8) of the Biocidal Products Regulation (BPR, EU n. 528/2012), which regulates the authorisation of biocidal active substances and products in the European market. The applicant, who aims to obtain authorization to place a product onto the European market, needs to submit data to substantiate the label claims for the intended uses. Label claims are a central issue in the assessment of efficacy. The aim of this paper is to raise awareness of the recently issued “Guidance on the Biocidal Products Regulation” concerning the evaluation of efficacy of wood preservatives. This guidance document is addressed to the applicants as well as to the competent authorities of the member states of Europe in charge of assessing efficacy data, and has been in the public domain, in its latest version, since February 2017. The CEN/Technical Committee 38 “Durability of wood and wood based products” / WG 22 "Performance, assessment and specification” decided to bring the Guidance to a wider audience with the aim of disseminating the information and to trigger discussion among the experts of IRGWP. An excerpt of the Guidance that is relevant to wood preservative products is presented in an Annex to this paper.
I Stephan, M Kutnik, E Conti, M Klamer, L Nunes, J Van Acker, R Plarre