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European Biocides Directive (98/8/EC): Programme for systematic examination of all active substances of biocidal products on the market on May 13, 2000 Article 16(2)
2001 - IRG/WP 01-50166-03
K Rasmussen, A B Payá Pérez
The Biocidal Products Directive ( 98/8/EC ) - its consequences for the wood preservation industry
2001 - IRG/WP 01-50166-04
1. The Current Position This European Union Directive is one of the most technically complex pieces of legislation that has been developed by the European Commission (EC). Although the Directive was to have been implemented in the legislation of individual Member States of the EU by May 2000 progress has been slow. A number of Member States have yet to declare the Competent Authority who will handle their legislation. The body text of the Directive cannot stand-alone and is dependent on ancillary regulations and the development of technical guidance for both the Competent Authorities in the Member States and also industry to understand their roles in the whole process for the regulation of biocides and the biocidal products containing them. The process is far from complete in terms of a piece of workable legislation and this leaves not only industry but also the Competent Authorities with significant areas of uncertainty. This is potentially economically and socially damaging to the marketing and use of biocides and biocidal products. Because of this evolutionary process this paper can only be written in general terms as by the time the symposium takes place some significant changes to the position at the time of writing may have occurred. 2. Background The Biocidal Products Directive (98/8/EC), (BPD), is a directive which requires that biocides ( as active substances) are approved for use within the EU and the individual biocidal products containing these active substances are approved for use by the Competent Authority(s) of the Member State(s) in which it is intended to market the product. The product authorisation obtained in the first Member State should be mutually recognised by the other Member States in which application for authorisation to place the product on the market is sought. The Directive has to be seen in the context various other Directives, notably the Plant Protection Directive 91/414/EC). Biocidal products are grouped in the directive into twenty three "product types" and wood preservatives are Product Type 8. The intention of the directive is to harmonise the requirements for the placing of biocidal products and active ingredients on the market throughout the EU. EU wide use of so-called Common Principles are intended to be used to assess the dossiers in order to achieve a common approach and eliminate the current situation where individual Member States apply their own particular national approaches and criteria in the assessment and regulation of products . Annex IIA of the directive identifies the data requirements for the active substance and Annex II B for the biocidal product. There are additional data requirements identified in Annexes IIIA and IIIB for each product type reflecting potential for exposure to man and the environment. 3. Entry onto Annex I Any new active substance will require approval before it or any biocidal products including it can be placed on the market. The dossier to be submitted to the EC will have to include additional data and risk assessments for the product types (as defined in the BPD) in which it will be intended to be used. For those active substances that are accepted as being existing substances on the market before May 2000 (say in wood preservatives) these will be ranked and prioritised. This process is being defined in the so-called: Review Regulations. 4. An environmental directive There is no doubt that this Directive has a high environmental content in terms of the data and the associated risk assessments which are to be prepared. The protocols and the end points for some of these data requirements are still being developed. In general the EC considers that modelling exposure using human and environmental exposure scenarios covering the end use of the product is an acceptable approach . Data are required to enable these scenarios to be modelled and risk assessments made. It is necessary that regulators do not make decisions based on hazard assessment alone in the absence of fully worked out and agreed emission scenarios to define exposure levels which generate a realistic worst case risk assessment. Risk is a function of both hazard and exposure. A lot of work has been done in the development of Technical Notes for Guidance intended to help the regulator and the applicant in the submission and the interpretation of the data. Whilst it may be the case that the human toxicity data requirements still leave questions to be answered it is in the environmental aspects part of the regulatory process where there is still much work to be done. The Directive would seem to rely heavily on the development of Pass / Fail criteria in simulation tests. This is a big subject and of key importance to the risk assessment. 5. Wood preservatives ---- a test case Wood preservation has achieved a certain reputation. On the one hand it is said that a prime reason for the development of the Biocidal Products Directive arose from European problems in the regulation of the marketing and use of dangerous substances, notably wood preservatives. On the other hand because wood preservatives have been regulated by a number of Member States for many years it is believed they are well understood. The EC and the Member States also wanted to be seen to have achieved early success in the implementation of the Directive therefore the decision was taken to start, following failings with the speed of progress of the Plant Protection Products Directive, with a product type they knew all about i.e. wood preservatives. There is no doubt that there is a much greater understanding on the exposure scenarios, both human and environmental, for wood preservatives than many other product types. However, would it not have been better to have tackled some of the other product types where such an understanding is much less well developed? It is regrettable that the EC and Member States did not feel able to accept the results of an EC sponsored study (Haskoning report) on the assessment of risks for all the product types covered under the BPD. The results of this study clearly showed that wood preservatives did not constitute the most significant risk to man or the environment and in fact the risk was significantly greater for other product types. 6. Wood preservatives and the OECD Biocides Programme Another speaker will be covering this subject in more detail. Suffice it to say that because of the perception there was good knowledge about wood preservatives again they were selected as the pilot for an OECD project looking at environmental and human exposure assessment under the OECD Biocides Programme. The findings from two OECD Workshops actually demonstrated there was still much to be learnt about wood preservatives in order to refine the risk assessments to a state where they would be sufficient for the requirements of the BPD. This work is ongoing but it clearly demonstrates the problems that both the regulator and industry will have in the preparation and the assessment of the dossiers for both the active substances and the biocidal products. This is especially the case for other biocidal products that have not been subject to the same kind of regulation that wood preservatives have subjected to in the past. 7. Inorganic and organic biocides With current wood preservation technology there is still a dependence on inorganic chemicals such as copper (in conjunction with other biocides) or with chromium, as well as arsenic and boron for many end use applications. This is very much the case where a long term service life is a key factor in the use of treated wood for that end use. These substances are commodity chemicals and are also covered under the Existing Substances Regulations (EC) 1488/94. There is also work going on revising the Technical Notes for Guidance covering them . This includes a significant addition in the environmental risk assessment area. Efforts are being made to integrate and coordinate the requirements for both the BPD and the Existing Substances Regulations and OSPAR ( OSPAR Convention for the Protection of the Marine Environment of the North-East Atlantic). OSPAR refers to the Oslo Paris Convention. Whilst the BPD seems primarily aimed at the regulation of biocides based on organic chemicals wood preservative products may contain both inorganic and organic components. Indeed there are probably few wood preservative formulations on the market that contain only one active substance. This must have a significant impact on the way the dossiers are prepared for the active substance and the biocidal products and how they are assessed both at the EC and the Member State level. 8. Consequences of the BPD for the wood preservation industry Whilst this paper addresses the consequences for the wood preservation industry per se, it must not be overlooked that there may be implications for the fabricaÈors of articles made from treated timber. Some current wood preservative formulations may over a period of time be withdrawn from the market because the risks and costs of generating the data and the preparation of the dossier make the product economically unviable. The presence of large working volumes of wood preservative solutions at treatment plants requires realistic withdrawal periods to avoid the unnecessary disposal and associated environmental risk of products that have been used satisfactorily for many years. 9. Availability of active substances The structure of the industry has changed dramatically in the past few months and there is no doubt that other changes both within and outside the wood preservation industry itself are yet to happen. The original differentiation between formulator of wood preservatives and active substance suppliers to the wood preservation industry has become blurred. Some of the active substances used in wood preservation are used in other either other biocidal product types or in products regulated under another directive, e.g. Plant Protection Products Directive 91/414/EC. 10. Data protection This continues to be a key issue for industry and some companies may find it strategically or financially necessary not to support an active substance in a particular product type thus leaving that sector without being able to use the active substance. The coming months will start to reveal which active substances are likely to be supported, at least through the notification process. Formulators are therefore in a close dialogue with their suppliers to try to determine their intentions on whether or not they intend to support their active substance. Today's wood preservative formulations are largely multi active substance based. Product costs, efficacy spectra, niche marketing and other considerations have made this process inevitable. New wood preservative formulations take time to research and develop and the continuity of availability of a choice of active substances is of key importance. A lack of adequate return on investment necessary to sustain the development of new products could have a negative impact on innovation and the rate of introduction of new products. It is extremely unlikely that any new active substance will be solely developed for use in wood preservation. This would be an effect contrary to expectations of the EC. The situation with wood preservatives is complicated by the fact that treated wood is a construction product and comes under the scope of the Construction Products Directive (89/106/EEC) (CPD). Products under the scope of the CPD are required to meet certain so-called essential requirements and one of these is durability. Demonstration of compliance involves the extensive suite of CEN wood preservative efficacy tests. Even relatively small changes in formulations may require extensive re-testing under the EN 599 regime in some Member States. 11. Task Forces Companies are encouraged by the EC to enter into Task Forces in order to reduce the burden of testing on animals and also to reduce the number of dossiers to be reviewed for each active substance. Ideally, and understandably, the EC would like one dossier per active substance. Parts of the wood preservation industry have been co-operating in Task Forces and much practical experience has been gained. Even closer co-operation will be required and this will enable companies to pool experience and expertise and manage their financial exposure to potentially high regulatory costs by sharing them amongst a larger number of parties. 12. Financial aspects Industry will have to make some best guesses with respect to its investment programmes for supporting its portfolio of products. Formulators and active substance suppliers are likely to group into Task Forces in order to reduce their costs in terms of data generation and the fees likely to be charged at the EU and the Member State level for the assessment of the dossiers. The compilation of the dossiers requires specialist expertise to assist the industrial applicant(s). This is likely to cost in the order of £100,000 per active substance, not including the costs of generating any data. The Rapporteur State's costs for reviewing the dossier is also expected to be of the same order. Clearly these kinds of costs will impact on innovation. An adequate payback must be available to the company to justify this level of investment. 13. Will mutual recognition work? Member States are required to recognise the authorisation of the biocidal product placed on the market in the first Member State when subsequent applications are made to place the product on the market. This is a fundamental principle of the BPD, although there is concern that Member States continue to have enough flexibility to prevent this happening if there are particular concerns in that Member State. Industry very much hopes this will not be the case and that mutual recognition, a fundamental principle of the BPD, will work in practice. 14. Environmental aspects Biocidal products such as wood preservatives are generally applied in controlled situations and not over large areas. Consequently any emissions can be considered to be from discreet sources, such as treated timber or potentially from timber treatment plants. This is in contrast to plant protection products and some other biocidal products that are usually dispersed over a relatively large area. Because of this a lot of work is required to be done to re evaluate how the environmental aspects of biocidal products such as wood preservatives can be assessed in an objective manner. The criteria that define an emission and how the PEC (Predicted Environmental Concentration) for each environmental compartment is determined are critical. The wood preservation industry, through the EWPM (European Wood Preservative Manufacturers Group), has been working with institutes and other interested parties in a co-operation known as the EFG (Environment Focus Group) to progress the development of appropriate methodology. Data will be required for both primary and secondary exposure to treated timber. The protocols for this work are yet to be agreed. This work is being further progressed in the OECD together with input from CEN TC 38 WG27. This co-operation between the OECD and CEN is extremely significant in that it is, I believe, the first time such a co-operation has taken place in the development of an OECD Guideline. If one considers all of the end uses where treated timber may be found carrying out a risk assessment with few guidelines on how it should be done is a very uncertain process for both industry and the regulator. Reliance on so-called expert opinion may be inadequate. 15. Comparative assessment (the substitution principle) This is a process whereby the health safety and environmental properties of acti_u101 ? substances used in the same product type could be compared and those with the most undesirable properties would not be placed on Annex I. Consequently biocidal products containing them would have to be removed from the market. This process is embodied in the BPD but it was initially considered that it would only be applied in the event of problems arising with active substances or products containing them rather than being used as a screening tool early on in the review process for active substances. This area is still an uncertain one with Member States having different interpretations of this principle. It is unfortunate that the wood preservation industry could be used to test out this concept at a European level. The consequences of this principle could be further losses of active substances available to the wood preservative formulators. 16. Substances of concern The BPD is not only concerned with the active substances that are formulated into the biocidal product but also with so-called "substances of concern". These are defined as any substance, other than the active substance, which has the inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to create such an effect. There are significant implications for the formulator of the biocidal product . The formulator may have to submit an extensive dossier containing toxicological and metabolic as well as ecological data on each of the substances of concern when seeking approval for the biocidal product. There may be classes of compounds that become unavailable to the formulator either because of the risks posed by the co-formulant or because the cost of generating data will be uneconomic. 17. The wood preservation Industry's view on the BPD Industry has supported the development of the BPD since its conception in 1989. It is still supportive it but believes that the degree of complexity is disproportionate to the level of risk when it comes to wood preservatives. After all wood preservatives have been regulated for a long time and in reality there have been few significant health safety and environmental problems associated with them. Industry believes there is no need to determine an absolute understanding about a biocide and its application but rather there is a need to determine the level of understanding that will enable characterisation so that a risk assessment can be made. The wood preservation industry has sought either directly or through representative bodies a pro-active and collaborative approach with the regulators although at times this appears to have encouraged inappropriate demands. The regulators have invariably responded positively to this however they may not always understand the burden in both time and resource in having made wood preservatives the test case. Industry hopes that its efforts to be pro-active will be recognised and will be dealt with equitably when considered before the other product types defined in the Biocidal Products Directive.
Environmental risk assessment of treated timber in service: The Environment Focus Group approach
2000 - IRG/WP 00-50162
In the context of the Biocidal Products Directive (98/8/EC), and of the OECD work on wood preservatives, the Environment Focus Group (EFG), comprising 8 institutes and the European Wood Preservative Manufacturers Group, has been working on the environmental risk assessment of treated timber in service. A literature review of emissions from treated timber has revealed that very little existing data...
G Deroubaix, G Labat, I Le Bayon, S Legay, P Marchal, C Yrieix, E Melcher, R-D Peek, S De Geyter, J Van Acker, W J Homan, D J Dickinson, R J Murphy, E D Suttie, A J Nurmi, A-C Ritschkoff, D Rudolph, I Stephan, D Aston, E F Baines, J B Simonin
The EWPMG proposal for the environmental risk assessment of wood preservatives
2001 - IRG/WP 01-50166-09
This paper reviews the protocol prepared by the European Wood Preservative Manufacturer's Group, which could be used by an applicant for product approval under the Biocidal Products Directive 98/8/EC, to produce a risk assessment for an active substance or product in the Product Type 8 Wood Preservatives, in support of the application. The background and scope of the protocol are reviewed...
E F Baines
Experiences with environmental risk assessment within the Biocidal Products Directive
2005 - IRG/WP 05-50224-21
The Biocidal Products Directive (98/8/EC, the BPD) aims to authorize biocidal products based on risk assessment for both man and the environment. Active substances for wood preservation products and rodenticides were selected for the first list under the review program (Regulations EC 1896/2000 and EC 2032/2003) because several member states had experience with the evaluation and authorization of ...
A review of the current status of the estimation of emissions from preserved wood and their use in the environmental risk assessment of wood preservatives under the Biocidal Products Directive
2005 - IRG/WP 05-50224-7
A review and update of the status of the issues concerning the estimation of emissions from preserved wood (e.g. amendments to the proposed ‘OECD Guidelines’), and the environmental risk assessment of wood preservatives under the Biocidal Products Directive (e.g. compartmental sizes, emissate ecotoxicity testing)....
E F Baines
Biocidal Products Directive 98/8/EC and PT 08
2005 - IRG/WP 05-50224-1
The ECB Biocides Work Area is responsible for the scientific and technical issues concerning the approval of active substances in biocidal products as laid down in Directive 98/8/EC concerning the placing of biocidal products on the market. The first part of the presentation will deal with the Review Programme, especially it's legal context, the status of submitted dossiers and the p...
K van der Jagt
Refinement of emission values for preserved wood in the ‘Storage Scenario’, for use in the environmental risk assessment of Wood Preservatives under the Biocidal Products Directive
2007 - IRG/WP 07-50244
The evaluation of an active substance or a biocidal product under the Biocidal Products Directive (BPD) requires that an environmental risk assessment is carried out. The risk assessment for wood preservatives includes a scenario for the treated wood in storage after treatment, in which the predicted environmental concentration (PEC) in soil, surface water and groundwater is calculated, using emis...
E F Baines
The role of chromium in wood preservatives under BPD - a review and the current situation in Europe
2008 - IRG/WP 08-30468
Already during the IRG-meeting in Trømso a paper was presented to give an overview regarding the situation on chromium (JÜNGEL et al. 2006). Already in that year there was an increased attempt to achieve a science-based correct and harmonised solution in Europe regarding the chromium-question by the European Commission. Nevertheless the competent authorities (CAs) and the industry were similarly...
P Jüngel, S Hellkamp
Developments in the protection of wood and wood-based products
1980 - IRG/WP 340
Technology is playing an increasingly important role in the field of wood protection. This current review highlights how modern techniques have provided greater insight into the biological and physical processes affecting the durability of wood and wood-based products. Emphasis is also given to developments in preservative testing methodology and to the encouraging changes towards both the correct...
J M Baker
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...
P Karvinen, E Nikunen
A roadmap for performance-based specification of wooden components based on service life prediction
2007 - IRG/WP 07-20351
The need for an unified and harmonised system for performance classification and specification of wood and wood-based products in Europe emanates from requirements of users and the European Construction Products Directive, CPD. A road to a feasible specification system is outlined. Exposure-related performance prediction was worked out as a key task on the way to product specification. Therefore s...
C Brischke, A O Rapp
Influence of Exposure Direction on Leaching of a Biocide from Painted Wood Surfaces
2014 - IRG/WP 14-50303
The objective of this project was to investigate the influence different exposure directions – North, East, South and West on the cumulative quantity of a biocide leached from painted wood surfaces due to rainfall and the consequences for the risk assessment. The study included a solvent-borne primer without biocides and a topcoat protected with a biocidal active substance. Both products were a...
Biocidal Products Regulation – Structure and Impact for Product Authorization and Testing in EU
2014 - IRG/WP 14-50308
Since September 2013 the Biocidal Products Regulations (BPR) has been in force in Europe. BPR replaces the Biocidal Products Directive (EC/98/8) and in some respect marks a turning point in the European legislation concerning registration of all types of biocides. BPR introduces some changes both for suppliers of active substances and for companies that produce and place biocide containing wood p...
Ensuring Quality of Treated Wood – Regulations, Certifications and Associative Background in the Field of Wood Protection in Europe
2017 - IRG/WP 17-20626
Beside legal requirements, buyers and end-users of wood preservatives and/or of treated wood and wood-based materials may require additional warranties regarding the quality and the performance of the products available on the market. These greatly enhance the confidence of end-users and the chance for a product of being marketed with a quality label. Additionally, quality control systems and trai...
M Kutnik, M Klamer, E Melcher
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 cla...
I Stephan, M Kutnik, E Conti, M Klamer, L Nunes, J Van Acker, R Plarre
A practical method to evaluate the dimensional stability of wood and wood products
1990 - IRG/WP 2342
This paper presents a new simple method to evaluate wood and wood products for their resistance to swelling and to assess wood preservatives for their ability to dimensionally stabilize treated wood exposed to water. Permeable wood of various dimensions and treated with different preserving chemicals have been measured for swelling in the radial and tangential direction during immersion in liquid ...
J P Hösli
Bioaccumulation of pentachlorophenol in rainbow trout and zebra fish muscles
1986 - IRG/WP 3372
The bioaccumulation of pentachlorophenol in Rainbow Trout and Zebra fish has been evaluated by partition coefficient n-octanol/water determination at ph 7 and measured in vivo according to the OECD guidelines and the European directive 79/831/EEC. The obtained results confirm the low bioaccumulation potential of this product in aquatic organims....
J C Palla, M Dion
Fungicidal combination products
1987 - IRG/WP 3426
Due to the increased pressure on some of the established fungicides used in wood preservation, possible alternative products become more interesting. The requirements for new chemicals are mainly lower toxicity and greater environmental acceptability. However the efficacy to target organisms should be as good as that of the currently used ones, preferably better. A possibility for progress in this...
H A B Landsiedel
Field trials of anti-sapstain products. Part 1
1991 - IRG/WP 3675
The results obtained in two field tests of anti-sapatain products, carried out in four locations in Portugal, are presented. Boards from freshly cut logs were hand-dipped, close staked and left to dry for periods from four to six months. The results obtained seem to indicate that some of the products tested performed at least as well and sometimes better, than a 3% NaPCP solution which was used as...
L Nunes, F Peixoto, M M Pedroso, J A Santos
Point sur la réglementation et contraintes administratives
1990 - IRG/WP 3575
J H Moneger
Forest products laboratory methodology for monitoring decay in wood exposed above ground
1995 - IRG/WP 95-20074
Research at the Forest Products Laboratory on the durability of wood in service has included a full complement of laboratory and field tests. In this report, we present a review of past and current methods used to evaluate the condition of preservative-treated wood exposed above ground. Current protocols are described for tests on wood packaging, roofing, and dimension lumber....
R C De Groot, T L Highley
Volatile borates in the treatment of wood and wood based panel products against subterranean termites
1995 - IRG/WP 95-30094
Blocks of pine solid wood, oriented strand board and plywood were treated with trimethyl borate by vapour treatment. It was meant to obtain either a full impregnation of the specimens or a shell treatment of the outer three millimetres. The efficacy of the treatments against subterranean termites (Reticulitermes lucifugus) was evaluated using an European Standard method....
L Nunes, D J Dickinson, R J Murphy
Biological performance of gypsum products containing borates
2000 - IRG/WP 00-30237
At suitable retentions borates have biostatic properties enabling them to be used for biodeterioration control in wood. They provide protection against decay fungi, mould, and termites, which are known to also attack gypsum products. Currently, many gypsum products contain added borates, which are used to improve physical and processing characteristics. Work examining the effect of borates at cont...
J L Fogel, J D Lloyd
Draft Business Plan of CEN/TC 38 - Durability of wood and wood-based products - Introduction
2000 - IRG/WP 00-20207
CEN Technical Committees and Business Planning. The extension of formal business planning to CEN Technical Committees (CEN/TCs) is an important measure which forms part of a major review of business processes (known as 'Optimization'). The aim is to align the CEN work programme with expressed market needs and to ensure the adequate resourcing of projects through their development...