Your search resulted in 299 documents. Displaying 25 entries per page.
An appraisal of methods for environmental testing of leachates from salt-treated wood (2)
1998 - IRG/WP 98-50110
For wood preservatives for use in hazard class 4 information on the ecotoxicity of preservatives and ingredients as well as on the effect of losses from impregnated timber is needed for a proper environmental risk assessment. In the evaluation of a suitable test procedure the leaching behaviour of copper-based formulations was studied using analytical and ecotoxicological test methodology. These studies included an analytical comparison of end grain sealed and not sealed wood blocks. Using sensitive bioindicators in ecotoxicological studies, real effects of the leachates gained from EN 84 were measured. The possibility to use a laboratory test procedure based on the leaching according to EN 84 is shown and discussed for the risk assessment of treated timber.
H W Wegen, A Platen, G M F Van Eetvelde, M Stevens
Environmental risk assessment of preservative treated wood
1998 - IRG/WP 98-50101-19
This paper reviews the status of the environmental risk assessment of preservative treated wood and confirms the distinction between the risks presented by wood preservatives and preservative treated wood. The paper proposes a tiered approach to risk assessment and discusses the rationale. Flowcharts are presented which summarise the tiered approach to risk assessment, show the tests required, and show how the results can be used to make an environmental risk assessment of preservative treated wood. The need to generate data specifically for risk assessments, particularly PEC and PNEC values, is recognised. Test methods in existing Standards (EN 84, EN1250-2) are shown to be unsuitable to produce data which can be used in risk assessments. Realistic test methods are proposed using commodity-sized treated wood exposed to simulated in-service situations. A test method to generate risk assessment data for wood in ground contact and wood above ground is described. The results show that boron is adsorbed by soil, and that leaching of boron from treated wood in ground contact, even after 5 days exposed to severe rainfall conditions, is less than 10% of the boron in the wood before exposure.
E F Baines, S J Davis
Less environmental impact of wood preservatives by considering the risk of attack in addition to the hazard class system
1995 - IRG/WP 95-50040-10
Hazard classes, which are standardized in Europe in EN 335, are most useful to direct chemical wood preservation towards the organisms which may attack wood in the various fields of utilisation. However, hazard only signifies the fact that an attack may occur without considering the actual risk to attack. To minimize the application of chemicals with respect of less environmental impact it is necessary to consider both, the hazard of attack and the risk which implies the probability, how often attack may occur and how important this will be. In addition, also the consequences of the failure of a wooden commodity will influence the need of chemical wood preservation. It is therefore proposed to combine the hazard classes as specified in EN 335 or in similar non European regulations with a risk assessment including time assessment as a basis for the requirement on chemical wood preservation. For this, details are given in the paper.
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 is usable for environmental risk assessment; the most relevant data are kinetic curves of emissions over time, which show clearly the non-linear emissions behaviour of treated wood over time. The EFG has suggested real exposure conditions for treated timber in the environment, and listed typical exposure scenarios. Five representative scenarios are characterised in detail, for use in the calculation of Predicted Environmental Concentrations (PECs). The existing methods to determine emissions from treated wood have been reviewed. Most existing experimental models cannot be used to predict environmental emissions. Monitoring of commodities in service has its specific constraints. Chemical analysis and ecotoxicity testing have also been reviewed and their relationship has been discussed. Principles for the design of experimental models, for the determination of emission fluxes from treated wood to the environment, have been established.
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
Environmental risk assessment of treated wood - A mesocosm study
2005 - IRG/WP 05-50224-8
In order to evaluate the environmental impact of treated poles, we have developed physical models (mesocosms) containing around 250 kg of natural soil and a treated pole. On the top of each mesocosm, a spraying mechanism, which can distribute ultrapure water through several nozzles, was built. On the lower part of each mesocosm, a small tank, which can contain some litres of leachate, was placed. During 2 years, the mesocosms were run in order to obtain leachates and soil samples. The migration of active ingredient from wood to the closed environment was followed with chemical analysis (Cu,Cr, As and B analysis were carried out on soil and leachate samples). In parallel, ecotoxicological analysis were made on the leachates and on the soil samples; environmental impact on soil was also studied through soil microbial activities with biomarkers analysis.
P Marchal, F Poly
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. The principles of environmental risk assessment are reviewed with particular reference to wood preservatives. The protocol is described and an example flowchart is included.
E F Baines
Ecotoxicological behaviour of leachates from superficially treated timber as an approach for a test strategy of environmental risk assessment in wood preservation
1998 - IRG/WP 98-50101-09
At present for wood preservatives, which in Germany are subject to the quality mark of the RAL-Gütegemeinschaft Holzschutzmittel, health and safety as well as environmental aspects are evaluated by official authorities, as BgVV (Federal Institute for Consumer Health Protection and Veterinary Medicine) and the UBA (Federal Environmental Agency). From the environmental point of view to day there are additional requirements concerning the environmental behaviour of RAL-preservatives for timber used in hazard class 3. Information on the ecotoxicity of preservatives and ingredients as well as on the effect of losses from treated timber is requested in general. There is a lack of generally approved and harmonized test procedures in this field of wood preservation assessment. Therefore, a first test model was developed in accordance with the German federal environmental agency. This test procedure follows existing standards on efficacy of wood preservatives such as EN 84 and ecotoxicological testing of chemicals. Otherwise, it takes into account practical aspects of the application of wood preservatives. Ecotoxicological studies using fish, daphnids, green algae and luminescent bacteria as bioindicators were conducted with a range of formulations based on modern biocides. The ecotoxicity of leachates from treated timber is compared with the acute ecotoxicity of the formulations themselves. It becomes obvious, that a clear differentiation must be made between the effects of the formulations and the timber treated with them. In all trophic stages tested, it was shown, that enormous safety factors are existing for properly treated timber. It is possible to use the described test model for an environmental assessment with regard to the European Biocidal Products Directive. If ecotoxicological studies of a wood preservative are in accordance with the designed test model, additional ecotoxicological tests on the product or environmentally relevant components of it can be avoided or justifiably confined to a minimum.
H W Wegen, U J Lucks
Future Directions Regarding Research on the Environmental Impacts of Preservative-Treated Wood: Environmental Impacts of Preservative-Treated Wood. February 8-11, 2004, FL, USA
Workshop – Research Needs
2004 - IRG/WP 04-50222
This paper presents a series of documents that focus on research needs for potential future work focusing on the environmental impacts of preservative-treated wood. These documents were developed through a conference sponsored by the Florida Center for Environmental Solutions (FCES), located in Gainesville, Florida. The conference was held in Orlando, Florida, February 8 – 11, 2004 and the title of the conference was, “Environmental Impacts of Preservative-Treated Wood.” Approximately 150 people from 15 countries attended the conference. The “research needs” documents developed to date were summarized from: 1) feedback received from conference participants prior to the conference and 2) a two hour workshop held at the conclusion of the conference. A draft voting ballot has been prepared from these documents. This ballot is currently being reviewed by the FCES conference Technical Advisory Committee and a final ballot will be released in mid-April for a vote among the conference participants. A copy of the draft voting ballot is included at the end of this document. Results of the vote will be released at the 35th Annual IRG Meeting in Slovenia.
H M Solo-Gabriele, J D Schert, T G Townsend
Development of a model system to assess the efficacy and environmental impact of a chromated fluoride remedial treatment for creosoted distribution poles
1992 - IRG/WP 92-2395
A closed model system was designed to facilitate a controlled study of the leachability and environmental fate of a remedial preservative under laboratory conditions. The elements of the model include a precipitation apparatus above a treated pole section which is positioned in a representative soil profile supporting a sward of perennial ryegrass. The model will allow detailed examination of the movement of any toxic preservative constituents, in soil and water, released by an accelerated regime of simulated rainfall. Chemical analysis of soil and leachate will be complimented by plant analysis to identify bioaccumulation of any soil contaminants leached from the treated pole section. This paper details the design and development of the system from earlier environmental models, the difficulties encountered in construction and the sampling regimes to be employed. The benefits of such a system for inclusion in preservative testing protocols is discussed.
D C R Sinclair, G M Smith, A Bruce, B King
Environmental risk assessment of wood preservatives in the Netherlands
2001 - IRG/WP 01-50166-10
Before biocides can be introduced to the Dutch market, they have to be authorised under the Pesticides Act (1962). The criteria for authorisation of biocides have been laid down in the Dutch Decree on Environmental Requirements for the Authorisation of Pesticides Used in Fields Other than Agriculture. In 1998, the EU Biocides Directive (98/9/EC) entered into force, and it was implemented in May 2000. The authorisation currently is a national procedure. The inclusion of an active substance of a product in Annex 1 or 1a of the Biocides Directive, will follow the required EU steps. According to the first Review Regulation, existing active substances of wood preservatives are among the first to be evaluated at EU level. In the Netherlands, the Agency responsible for the authorisation is the Board for the Authorisation of Pesticides (CTB). The CTB is an independent regulatory body. With the request for authorisation, a complete dossier has to be submitted by the applicant. After a check of the admissibility of the dossier, the CTB commissions independent institutes for the evaluation of the dossier and to perform the risk assessment. In general, risk assessments are based on the information that is submitted by the applicant, but CTB can decide to include additional (literature) sources when necessary. One of the evaluating institutes is the National Institute of Public Health and the Environment (RIVM), that covers the aspects of both human and environmental health. This paper is concerned with the environmental risk assessment as it is done in the Netherlands. The environmental risk assessment consists of an exposure assessment, resulting in predicted environmental concentrations (PECs) and an effects assessment, resulting in predicted no-effects concentrations (PNECs). In the Netherlands, the active ingredient of the biocidal product is the main subject of the assessment, other components or metabolites are dealt with if they may present a concern. One of the basic tools for risk assessment in the Netherlands is the USES computer program, in which models and methods for the assessment of exposure and effects are implemented. The USES program has been developed under the supervision of a steering committee with members from government, institutes, academia and industry and is approved by CTB. USES includes EUSES and is fully in line with published EU-Technical Guidance Documents (TGDs).
E Smit, P van der Zandt, J Appelman
Ecotox Testing of Leachates as an Alternative Approach for Environmental Impact Assessment of Wood Preservatives
2002 - IRG/WP 02-50185
Driven by the implementation of the EU Biocidal Product Directive (BPD) in the environmental assessment of treated wood different methodologies and test strategies are at present under discussion within industry, regulatory authorities and standardizing comittees. Test procedures for the analytical determination of emissions to different environmental compartments according to exposure scenarios are suggested for international harmonization. In addition ´fate and behaviour´ modelling as well as the PEC/PNEC consideration are proposed to produce an environmental risk assessment of treated wood. As an alternative approach direct ecotoxicological testing of leachates is presented with leachates from solvent based preservatives treated timber as example. Daphnids as very sensitive bioindicators exhibited differences due to the included biocides of the preservative formulation tested as well as the leaching procedure used. The methodology of direct ecotoxicological testing as an alternative to PEC/PNEC comparison is discussed for suitability in wood preservation.
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 such products under existing national law. The main difference with the BPD approach is the introduction of risk based decision making. This required the development of models to estimate exposure, guidelines for measuring exposure and several guidance documents for risk assessment for man and environment. The preparation of dossiers to support the listing of active substances for use in wood preservatives in annex I of directive 98/8/EC revealed strengths and weaknesses in the current approach and allows suggestions for improvement. Products had to be selected covering the current uses and the uses for the future. This at a time that most of the guidance documents were in draft form or not yet available. Emission scenarios had to be selected and the data for input. Leaching data are critical and harmonized laboratory test methods were not available. Field leaching data and monitoring data, if already available, are difficult to bring into the models. A close cooperation within industry on one side, from manufacturers of active substances over formulators to the end users, and consultation with competent authorities on the other side is a prerequisite to successfully market wood preservatives within the scope of the biocides directive. Resource and investments are becoming so significant that a global approach is the only way forward.
Life cycle approached environmental information to promote treated timber
2005 - IRG/WP 05-50224-13
This paper exemplifies the possibilities to compare products and product systems with help of life cycle assessment (LCA) as a tool for environmental assessment. IVL Swedish Environmental Research Institute has developed a concept for evaluation of environmental impacts based on normalisation, based on so called environmental quality objectives (EQO). This concept makes it possible to compare a product’s relative contribution to different impacts categories including, amongst others, climate change and acidification etc but also human and ecological toxicity. It is not possible to determine whether one building material as such is more favourable than another, from an environmental point of view, if not the functionally related to its applications is concerned. Instead, different parts of the building systems or the whole building are the ultimate context for assessment. The sustainability issue concerning treated timber should therefore be addressed as follows: In which applications are treated wood preferable to other materials from an environmental as well as economic perspective? The applications described above represent the strategically sustainable market segment. The next logical step will then be to identify them.
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
Alternative methodology for the environmental impact assessment of treated wood: the wood emissions ecotoxicology
2000 - IRG/WP 00-50161
Preservative products and technologies are important for optimising the use of wood and wood products in our society. The regulations of their use under the european Biocidal Products Directive 98/8/EC will require an evaluation of the environmental impact of treated wood. The methodology currently used for this determination is the PEC/PNEC ratio. It consists of calculating PEC values (Predictive Environmental Concentration) from emissions test data using mathematical models and PNEC values (Predictive No Effect Concentration) from ecotoxicological tests, including a safety factor for the results obtained (the more ecotoxicological data available, the smaller the safety factor). This approach was developed for agrochemical industry and has been in use for a couple of years. Since the exposure scenarios for treated wood are different to the agro-chemicals compounds, there is an urgent need to provide a test methodology to be included in the technical guidance document of wood preservatives. For that case, we suggest applying a "wood emissions ecotoxicological methodology" which can be summarised as follows : a laboratory and/or pilot scale emission protocol for treated wood, resulting in realistic wood leachates, on which ecotoxicological tests can be performed. This suggests that a whole toxicity assessment of the leachate has to be performed : it is well known that wood matrix is a chemically complex structure and that natural compounds can leach from wood into the receiving environmental compartment. This means that chemical analysis of active ingredients alone will not take into account the complex mixture of organic and inorganic substances that a wood leachate represents (active ingredients, modified or metabolised active, tannins, salts …). The toxicity from modelled components can moreover be different from the whole toxicity of leached components complex from wood. Furthermore, it is very difficult in the standard methodology to take the chemical speciation and bioavailability of the released active ingredients into account. The result obtained from this methodology is a more realistic one than the PEC/PNEC ratio estimation and could allow a simple scale classification of the wood emissions' environmental toxicity. This method is complementary to the chemical analysis which has to be carried out in parallel on the active ingredients (especially if the leachate is ecotoxic). Further analysis could also be made (metabolite analysis , leachate biodegradation…) in order to go deeper into the environmental behaviour. If the leachate is not ecotoxic, the emission evaluation can be stopped at this stage. A decision flow chart will also be included in this paper.
P Marchal, H W Wegen, J Van Acker, E Melcher, R-D Peek, W J Homan, D Aston, D Rudolph, E F Baines
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 emission values for the active substance from the treated wood. This document describes experiments to measure the emission of active substances from treated timber in storage, using a commercially sized pack of treated timber exposed outdoors, to natural rainfall. The scenario is critically examined and the experimental data presented which demonstrates that the parameters and the assumptions of the scenario are incorrect. Realistic values, based on the measured data, are proposed: the ‘realistic worst case’ for emission from a pack of timber in storage is 0.0028 % of the initial quantity in the wood. Refinements of the scenario are proposed, for use in the Product Authorisation stage of the BPD.
E F Baines
Emission Rates of Active Substances from Preserved Wood in Use Class 3
2008 - IRG/WP 08-50256
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 scenarios for preserved wood (e.g. cladding on a house), in which the predicted environmental concentration (PEC) in soil is calculated, using an emission rate for the active substance from the treated wood. The emission rate is critical to the environmental risk assessment of preserved wood and ultimately to the risk mitigation measures required for the preserved wood in storage and in service. This document reviews the published literature concerning the estimation of emission rates from preserved wood, covering laboratory leaching tests, such as EN84 and OECD Guideline tests, and emissions from board and panel tests in outdoor exposure. The results are compared with the results from a modified EN84 test which explains the ‘exponential’ profile of results in laboratory leach tests, and a ‘single board’ outdoor exposure test which shows a ‘sawtooth’ profile. The results are also compared with the emission values which have been used in the Biocidal Products Directive evaluation of active substances and published in the Evaluation Reports. Proposals are made for the use of a harmonized approach and realistic emission rates in the Product Authorisation phase of the BPD.
E F Baines
Environmental Emission of Wood Preservatives: Interpretation of Data Relevant to BPD Risk Assessments
2009 - IRG/WP 09-50259
The risk assessments for the use of wood preservatives proposed by the OECD and used under the Biocidal Products Directive (BPD) (98/8/EC) require the derivation of leaching rates for active substances. These rates are to be used as input data in to agreed exposure scenarios. The leaching rates can be derived from laboratory testing and from field testing. The relationship between laboratory and field tests has been studied in order to determine the correlation between the two modes of testing. EN84 tests have been used as a method. However, the determination of environmental leaching rates is beyond the scope of this test and it has been found to over-estimate leaching. The OECD guideline 1 (dipping) test has been designed specifically to determine environmental leaching rates from UC3 wood. This paper compares the leaching fluxes derived from OECD guideline 1 dipping tests to those derived from field tests. This allows a comparison of both the magnitude of flux rates and leaching flux profiles derived from the two tests. The magnitudes of the flux rates require the application of correlation factors in order to get agreement; these factors are presented and found to be of the order 5 – 10. The leaching flux profiles are found to be very different when the flux rates are plotted against time. The laboratory test gives an “exponential” profile, i.e. a profile that decreases quite sharply with time and then levels off. The field test produces profiles that are “sawtooth” patterns with time. This “sawtooth” pattern correlates with rainfall. This is in agreement with, and confirms, data previously presented (Baines, 2008). In the present study, however, an alternative method of data analysis is explored. If the field data is normalised according to the amount of rain falling then it is found that the laboratory and field tests produce very similar leaching profiles. Thus, the contrast previously discussed is shown to be an artefact of the method of analysing the data obtained from field tests. This is due to the inherent variability of weather patterns with time that cannot be replicated in the laboratory. If annual average rainfall figures are used, the risk assessments at differing time points can be carried out as assessments at average rainfall amounts. This alternative method of data analysis according to rainfall rather than time suggests a method of analysing the models for OECD risk assessment that can increase their utility.
D G Cantrell
Danish wood preservatives approval system with special focus on assessment of the environmental risks associated with industrial wood preservatives
2001 - IRG/WP 01-50166-01
The following is a description of the procedure used by the Danish Environmental Protection Agency to assess the environmental risks associated with preservatives used in the pressure impregnation of wood. The risk assessment covers issues considered to be of significance for the environment and which are adequately documented so as to allow an assessment. Such issues are persistence and mobility in soils, bioaccumulation and the impact on aquatic and terrestrial organisms. Unless required in special circumstances, the assessment does not apply to birds and mammals as the normal use of preservative treated wood is not expected to involve any noteworthy exposure of these groups. Approval of wood preservatives will be based on a general assessment of the environmental risk associated with the normal use of wood treated with the preservative in a realistic worst case situation. The assessment may address other aspects such as disposal and total life cycle.
La rôle de l'expert dans l'évaluation toxicologique
1990 - IRG/WP 3589
Surveillance médicale des personnels exposés aux produits de préservation du bois
1990 - IRG/WP 3588
The collaborative developement of soil acceptance criteria for timber treatment chemicals in New Zealand
1995 - IRG/WP 95-50040-34
In New Zealand, the issue of potential contamination on timber treatment sites arose in the late 80's due to the long history of use of PCP by the industry. One of the recommendations from the task group set up to investigate the issue was the development of a set of acceptance criteria to define trigger levels for remediation. A technical group from the government, industry and regional councils supported by experienced environmental consultants was formed by the Ministry for the Environment to prepare the criteria. Guidelines for soil and landfill criteria were drafted covering the commonly used preservative products based primarily on human health risk exposure. Guidelines were also developed for specific beneficial uses where other risk exposures may dominant. The guidelines have been peer reviewed and issued in draft form for public comment. Several benefits have flowed from this process namely, a relatively short timeframe, low cost, multiple party ownership, practicality of application and ease of administration.
H C Boyd
Risk assessment and the approval of wood preservatives in the United Kingdom
1995 - IRG/WP 95-50040-23
An approval system operates in the United Kingdom (UK) for the regulation of wood preservatives. The regulatory authority uses a risk assessment approach to evaluate how far the potential for harm to people and the environment from wood preservatives is likely to be realised in practise, and hence the controls required for products to be, used safely. The evaluation for approval purposes also takes into account the effectiveness of wood preservatives. A tiered approach is adopted to data requirements, and likely exposures are considered under the proposed conditions of use so that testing is minimised and controls are commensurate with risk.
R M Turner
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.
Second international symposium on wood preservation "The challenge safety-environment" 8-9 February 1993, Cannes-Mandelieu, France
1993 - IRG/WP 93-50001
Contains the following 34 Documents (IRG/WP 93-50001/1 - IRG/WP 93-50001/34) and 4 abstracts: A methodology for the life-cycle assessment of treated timber products (IRG/WP 93-50001/1) Initial results and observations of a model system to assess the efficacy and environmetal impact of preservative treated wood (IRG/WP 93-50001/2) Borates as wood preservatives - an environmental, health and safety perspective (IRG/WP 93-50001/3) The shower test method. A leaching test for assessing preservative losses from treated timber under simulated open storage conditions (IRG/WP 93-50001/4) A comparative study of CCA type C and B treated poles in service (IRG/WP 93-50001/5) Laboratory experiments on aerial emissions from wood treated with wood stains (IRG/WP 93-50001/6) Depletion of preservatives from treated wood: Results from laboratory, fungus cellar and field test (IRG/WP 93-50001/7) Modelling of PCP migration in the environment: Feeding the models with laboratory data (IRG/WP 93-50001/8) Programme d'études sur le pentachlorophénol (IRG/WP 93-50001/9) Système informatisé d'aide à la décision pour la gestion de la migration du pentachlorophénol dans l'environnement (IRG/WP 93-50001/10) Health hazards and environmental aspects when using Cu-HDO-containing wood preservatives in vacuum pressure plants (IRG/WP 93-50001/11) On-site test for indicative determination of leaching of components of preservatives from treated timber (IRG/WP 93-50001/12) Assessment of losses of wood preservatives from treated wood by leaching into the environment (IRG/WP 93-50001/13) Le séchage arificiel du bois. Simple opération de traitement du metériau ou méthode douce de préservation? [Wood kiln drying. Simple process of material treament or soft method of preservation?] (IRG/WP 93-50001/14) Social and economocal impact of an extension of service life resulting of an adequate preventive treatment. Application to wooden components used in urban areas with a high density of population (IRG/WP 93-50001/15) Extending the useful life of creosoted electricity distribution poles in service (IRG/WP 93-50001/16) Utilisation industrielle du bois. Préservation de la matière première par des utilisations rationnelles successives de ses propriétés (IRG/WP 93-50001/17) The potential for reuse of treated wood poles removed from service (IRG/WP 93-50001/18) Development of a commercial-scale CCA chemical sludge recycling system (IRG/WP 93-50001/19) Persistance of active ingredients in treated wood (IRG/WP 93-50001/20) Solidification - A viable option for the safe disposal of CCA treatment plant wastes (IRG/WP 93-50001/21) Microbial decomposition of salt treated wood (IRG/WP 93-50001/22) Délavabilité de bois ronds traités avec un sel CCA dans des conditions réelles de stockage. Incidence pratique de la fixation accélérée par étuvage. Impact effectif sur l'environnement (IRG/WP 93-50001/23) The microbiological treatment of chlorophenolic preservative in spent utility poles (IRG/WP 93-50001/24) The fate of salt preservatives in facility yard soils and decontamination of soils and drainage waters (IRG/WP 93-50001/25) Decomposition of biocides in aqueous media cases of MTC and TCMTB (IRG/WP 93-50001/26) Quantification des émanations de substances dans l'air ambiant a partir des bois traités (IRG/WP 93-50001/27) A voluntary system to control the usage of wood preservatives in Austria (IRG/WP 93-50001/28) Health and safety in use of antistain chemicals (IRG/WP 93-50001/29) Dutch work programme for environmental measures in wood preserving industry (IRG/WP 93-50001/30) Dutch national environmental policy strategy (NMP): Implications throughout the life cycle of treated timber and for the Dutch preservation industry (IRG/WP 93-50001/31) Eco-tax - A new threat for wood preservation? The Belgian experience (IRG/WP 93-50001/32) Inventaire des "déchets" ou produits connexes de la filière bois (IRG/WP 93-50001/33) Trends in environmental management in industry. Implications for wood preservation activities (IRG/WP 93-50001/34)