2000-06

BPD: Registration and Testing Strategies.

Biocides Today: 1999

TNO organised this symposium to give companies interested in biocide production and development the chance to update their knowledge on the current state of affairs concerning the new EU Biocidal Products Directive. Approximately 70 people from all over Europe participated in this symposium. At the moment TNO is considering organising a similar symposium within the next two years. If you would like to be kept informed on this 2nd symposium, please contact Ms. Randi Hanstveit about this and other matters relating to the B.P.D. (Randi Hanstveit tel. +31 15 2696121; fax +31 15 2572649; e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.)

Part 1 - THE PROCEDURES

Directive 98/8/EC - The Biocidal Products Directive (BPD) seeks to harmonise legislation in the EU and provide a high level of protection for man and the environment i.e. in parallel with the Veterinary and Human Medicines, the Pesticides, and the New Chemical directives. This particular legislation was first drafted in 1991 as the Non-Crop Pesticide Directive. It was modelled on 91/414/EEC but despite this early activity, 98/9/EC only came into force in May 1998 and must be implemented in all Member States by May 2000. However, this is dependent on having the Technical Guidance documentation approved and published. The Technical guidance will provide data requirements for the 23 product types, procedures for assessment and "positive" listing of active substances in Annexes 1/1A/1B plus detailed rules for member states on how to authorise products. Currently this guidance is not available, and there is still much debate over many aspects of the Directive; for example the core set of toxicological data is currently much more comprehensive than for other chemicals, and the question therefore arises as to whether all the data are needed for an adequate risk assessment. A positive aspect is that the Directive is based on RISK and not HAZARD. Unfortunately this fact has not been taken on board by all member states and even for those member states familiar with the concept, exposure data is difficult to obtain, there being no robust model available for human exposure determination. Issues still under consideration are: data requirements, comparative assessments data protection, forced data sharing and mutual acceptance of data. Concerns from the point of view of manufacturers and formulators can be summarised as follows:

-a reduction of ca. 50% in the number of active substances currently on the European market is expected.

-the diversity of biocides may decrease

-the high cost of supporting existing active will preclude the development new "greener/safer" actives

-biocides are small businesses - ca. 0.1% chemical industry

-ca. 75% of biocides are antimicrobials, they are not simply alternative uses of "agricultural pesticides"

-most industrial manufacturing processes require biocides

When fully operative, the BPD will treat new and existing biocides differently. New biocides will need formal approvals before marketing. Existing biocides will be retrospectively reviewed over a time period which will probably span some 10 to 20 years. Ultimately only those biocidal actives listed in Annex I will be permitted in biocidal products, currently the first active is scheduled to be on Annex I in 2003.

THE BIOCIDAL PRODUCTS DIRECTIVE - HOW MIGHT WORK IN PRACTICE

The Biocidal Products Directive (98/8/EC) (BPD) seeks to establish a high level of protection for humans and the environment and to eliminate barriers to trade by harmonising the process involved in placing biocidal products on the market. It will operate as a two-stage process. Firstly, it will establish, at community level, a list (Annex I of BPD) of active substances. Products containing these active substances can then be authorised for use in individual Member States. There is a system for the mutual recognition of authorisations. Data protection rules will prevent, without authority, third part access to data submitted in support of either Annex I listing of active substances or authorisation of biocidal products. The BPD has been quoted as being one of the most complex pieces of European legislation. Consequently, it is essential that, in its implementation, the procedures are practical and cost-effective, the data required are the minimum necessary for risk assessment and that the controls are proportional to these risks posed by biocidal products in use. The 14 May 2000 is the latest date for the BPD to be implemented in all Member States. On that date Annex I will be empty. Active substances currently used in biocidal products ('existing active substances') will be reviewed to determine whether they can be added to Annex I. A phased review programme will take place over a 10-year period and a list of existing active substances is being compiled by the authorities to facilitate this. During this time biocidal products containing such active substances remain outside scope of the BPD, but subject to existing EU or national legislation. This applies to both existing and new products formulated using existing active substances. Active substances not currently used in biocidal products are called 'new'. Products containing them cannot be authorised until the active substance has been evaluated and a decision taken to include it in Annex I. The review programme for existing active substances is proposed to take place in two phases. A Review Regulation will be published for each phase containing all provisions necessary for establishment and implementation. In the first phase, applicants must indicate support for active substances by submitting, in summary form, the data required in Annex VIIA of Directive 67/548/EEC, together with available Annex IIA data from the BPD. Applicants must indicate that they have legitimate access to these data, which will then be used to prioritise active substances for review. In the second phase decisions will be published on the phase-out of existing active substances that were not supported. It will also establish priority lists of active substances and the timetable for submission of full dossiers. There will be guidance on the format for submitting such dossiers and the full data requirements from Annexes IIA and IIIA for each product type. The process will be 'tested' by a 'pilot' review project. It is possible that there will be a first list of active substances identified by the Member States as a priority, without the submission of summary data. Clearly, for such work must be complete. New and existing active substances can only be listed on Annex I if a product based on them can be shown to be used without significant risk. Biocidal products pose a range of potential risks due to the diversity of product types, user groups, types of formulation and application method, etc.. For a full assessment of such risks it is likely that a wide range of products must be submitted in support of the listings on Annex I of existing active substances. This should enable 'precedents' (groups of broadly similar products determining a maximum concentration of the active substance above which safe use cannot be certain and a minimum below which efficacy is not certain) to be established. This is a practical way of reducing the number of detailed risk assessments whilst maintaining a high level of protection for humans and the environment. It will not prevent novel product authorisations being considered by Member States without re-evaluation of the Annex I listing. Once an active substance has been listed on Annex I, products containing it can be authorised by Member States following assessment of a dossier on both the active substance and the product. The dossiers must enable an assessment of the safety (i.e. identify relevant hazards, exposure and relevant risks from use) and efficacy of the product to be made in accordance with the Common Principles (Annex VI of the BPD). However, full test data are not necessarily needed. A 'Letter of Access' to a third party's data can be provided for the active substance or product. For the product there are opportunities to 'read across' to existing data on a similar product or use the requirements for authorising 'Frame Formulations'. In addition, Task Forces may form to co-operate in generating a single dossier on individual active substances and key products to their mutual benefit. Once a product has been authorised in one Member State, it should, as a rule, be mutually accepted in other Member States following an application. The exceptions to this are limited to the target species not being present in harmful quantities, where there is a demonstrable unacceptable tolerance or resistance, or other factors such as climatic or pest breeding period differences. Member States will make charges to cover the cost of meeting their obligations under the BPD. These will be met by those companies having placed or seeking to place biocidal products on the market or supporting entries of active substances on Annex I. Charges are likely to vary between member States, reflecting both differences in costs and methods of their determination. At the present time many of the practical procedures have yet to be developed and so will not be tested in practice for a long time yet. The first active substances from the first priority list are unlikely to be considered for Annex I listing until 2004-5, with product authorisations following approximately 12 months later.

Part 2 - RISK ASSESSMENT STRATEGIES

The Biocidal Product Directive (98/8/EC) requires, amongst others, a risk assessment for humans based on comparison of the hazard of the product and its components, with the levels of exposure in the relevant use scenario's. The aim of risk assessment is to protect the health of those who apply the product, those who work or live in treated surrounding and those coming into contact in any whatever way with treated materials or residues of the biocidal product. The hazard is determined by the intrinsic (combined) properties of the substituents of the biocidal product, whereas the level of exposure is largely determined by the conditions of use and generally not so much by the product itself. For a proper risk assessment, both hazard and exposure should be quantified for each relevant use scenario. The hazard of a compound is quantified on the basis of toxicology test results. The Directive contains a detailed list of tests that are required for the active substance, called the core data set. This core data set generally includes semi-chronic toxicity tests in two species, as well as reproductive toxicity tests, amongst others. Additional tests are required for the product itself. This refers mainly to short term tests and data on non-actives. Risk assessment requires: i) the evaluation of the toxicological profile, ii) the evaluation of the exposure-response relationship, iii) consideration of the relevant self-employment scenarios and concomitant exposure levels, and if required, a risk management evaluation, leading to appropriate exposure control. Currently, discussions between Member States and industry are considering whether the core data set is not too large for many biocidal actives. A tiered approach, or alternatively, a waiving approach, for the toxicology testing strategy to produce a smaller set of test data, has been proposed. The reason for this is the notion that the core data set considers biocides more as agricultural pesticides than as general chemicals. There is no reason to believe, however, that some biocides because of their risk deserve to be treated as agricultural pesticides while others should be handled more as general chemicals. In any case the approach should be firmly based on a risk assessment, in which exposure must be below accepted human (workers and consumers) exposure values. Probably no consensus for automatic waiving approaches will be reached, indicating the need for case-by-case decisions in the risk assessment process. It should be noted that, although the toxicology tests are generally carried out by oral testing in various animal species, human exposures are through the oral route (especially for consumers), but also through inhalation and the dermal route, requiring extensive extrapolation from animal to human and from one route of exposure to another, especially for workers. Published exposure data for biocidal uses are scarce, or are not all that relevant for use in the risk assessment process. Through an EU-funded project, the Biocides Steering Group (BSG) on Human Exposure Assessment has attempted to collate all relevant exposure information for the present purpose and has come up with an outline for an approach using task-based exposure information. In this way, the many different use scenarios for biocides could be reduced to around fifty different tasks in four phases of activity: i) mixing and loading, ii) application, iii) post application (re-entry) and iv) removal. Exposure information can be extrapolated from one use to another using the task as the relevant unit of operation. The various tasks have been described, and to some extent ranked, with respect to level of exposure. In addition, various screening models have been described which may be used for assessing consumer exposure. Databases and mathematical models for worker exposure are indicated, but need much further elaboration. The overall approach is a tiered one, starting with generic plus exposure data using reasonable worst case assumptions for relevant exposure reducing factors plus inhalation and dermal absorption. If the compound fails in this comparison, in the second tier a further attempt is made through use of the detailed use patterns, mitigation by control measures, and absorption estimates. If, in the comparison , the compound fails again, in a third tier individual exposure studies and/or absorption studies will be needed, preferably using biological monitoring, to estimate exposure. This is the ultimate test. It is to be noted that personal control measures are generally considered unacceptable for mitigation of consumer exposure. Since scarce exposure data are generally log-normally distributed, some may lead to completely erroneous interpretations, unless they are carefully considered. Furthermore, the underlying principle for extrapolation from one scenario to another, using task-based exposure information, requires great care and reasonable worst case approaches. For a well-known log-normal distribution, the typical value to be used in a risk assessment for chronic effects is not to be geometric mean, but the arithmetic mean, which is numerically comparable to the 75th-percentile. For acute effects, one should consider use of even higher percentiles for risk assessment purposes. Such percentiles only have relevance when the distribution is well-known. For this reason an approach using a set of mathematical (log-normal) distributions with varying median and geometrical standard deviations (spread) in a worst-case approach has been proposed by the BSG. When the development of a tiered approach or waiving system to identify the required toxicological test data for an optimal balance between exposure and hazard has been completed, it should be possible to commence harmonized risk assessments for active substances in Europe, with respect to the toxicological profile. Exposure surveys are needed for several (groups of) tasks, as well as further development of mathematical and database models. The approach using a set of mathematical distribution models looks especially promising, since it may require a smaller amount of detailed survey studies. Nevertheless it seems essential to carry out some collaborative exposure studies for the most relevant tasks. Collaboration will be necessary among the Member States, together with industry. This will mean a major learning process in a harmonized risk assessment throughout Europe, since currently there are large differences in the legislation throughout the Member States, with respect to biocides, especially specific biocidal product types. The work done by Biocides Steering Group should be continued to fill in the further detail of the proposed approaches and to ensure optimal harmonisation in the human exposure assessment in the European Community. The Commission should support further support this.

DATA REQUIREMENTS OF BIOCIDES: A RISK ASSESSMENT POINT-OF-VIEW

The Biocidal Products Directive is based on 23 usage groups and gives an opportunity for product-type specific data requirements as a basis for risk assessment. TNO has developed a framework for defining product-type specific data requirements for biocides, based on risk assessment and life cycle assessment principles (BIOEXPO1 Project commissioned by the Umweltbundesamt, 1996-1998). The data requirements for a product type follow from the questions:

-which environmental compartments are exposed as a result of the intended use of the product (water, seawater, soil, sediments, waste water treatment plant (WWTP), air)?

-which information is needed for the risk assessment of a chemical in a specific environmental compartment?

The first question can be answered by carefully studying the life cycle of the product, in order to make an inventory of the most relevant emission pathways. The second question can be answered by studying the removal processes in the various environmental compartments, and listing the data that is needed to execute a risk assessment. Generic risk assessment models are generally available. Environmental risk is generally based on the ratio of the Predicted Effect Concentration (PEC, fate side) and the Predicted No Effect Concentration (PNEC, effects side). According to the BPD, the data shall be the "minimum necessary to carry out an appropriate risk assessment", and data which is not " scientifically necessary or technically possible" needs not to be supplied. We translated this to the following guidance:

-data requirements must be compatible with risk assessment methodology (i.e. data which cannot be used in the assessment needs not to be supplied);

-data requirements must be technically feasible (i.e. test protocols/guidelines must be available).

Additional data items must have a clear benefit for results of the assessment:

-enable a compartment specific assessment (e.g. toxicity data for soil or sediment dwelling species);

-enable a chemical specific assessment (e.g. partitioning data for surfactants);

-increase the field relevance of the assessment (e.g. simulation tests for degradation in a WWTP or multi-species toxicity tests)

With these criteria, risk assessment-based data sets can be generated for the relevant environmental compartments. The product-type specific data set is simply a combination of the data sets for all the compartments likely to be exposed to the biocide during its life cycle. A risk assessment can be performed as a stepwise procedure of increasing complexity. The data required to assess the risk for man and the environment increases when the assessment becomes more refined. An initial assessment is executed with a generic model such as EUSES, and requires only basic physico-chemical, fate and ecotoxicity data. The objective of the initial assessment is to determine the critical emission and/or critical environmental compartment. When the result of the initial assessment is "of concern" (PEC:PNEC ratio), the assessment must be refined. Depending on the outcome of the initial assessment, the local and/or regional exposure scenario's can be refined (by including information on emission pathways or specific environmental conditions) or measured concentrations can be used (if available). Another way of refining the assessment is to generate more test data, e.g. fate or toxicity in a specific environmental compartment. The choice of executing more tests can be supported by pre-evaluating the effects of the additional data items in a "sensitivity analysis" using the generic model. A combination of risk and life cycle assessment techniques can be used to define specific data requirements for the 23 product types defined in the directive. Furthermore, risk assessments should be executed as a step-by-step process. This has a consequence for data requirements: in the early stages of the assessment, only basic physical-chemical, fate and ecotoxicity data should be necessary. Only when the substance proves to be "of concern" in the initial assessment, a more refined assessment based on more information will be required. This is proposed as a method of defining the core data set (environment) for each product group/compartment combination.

PART 3 - PRESENTATION ON TESTS SPECIFICALLY USEFUL FOR BIOCIDES

For many organic chemicals, biodegradation is the most important loss function from the environment. Biodegradation profoundly affects a chemical's concentration in specific environment compartments and its dispersion through the biosphere. Consequently, an accurate exposure assessment for determining the risk to the environment of a chemical discarded down the drain is contingent upon accurately estimating in situ biodegradation rates in sewage treatment and natural environments (i.e. natural waters receiving sewage effluent). Furthermore, a holistic risk assessment requires an understanding of the intermediates formed during biodegradation and their rates of formation and disappearance. Therefore, a need exists for biodegradation data that ate obtained under in situ conditions with regard to chemical concentration and the physical environment and includes all relevant processes including parent loss, metabolite formation and disappearance and mineralization. Furthermore, if the chemical is or will be continuously discharged to the environment, the test system should be appropriately acclimated since the chemical represents a stable ecological niche for microbes present in those receiving compartments. The relevance of acclimation is particularly great if the chemical is new and will be continuously discharged following commercialization. To generate such data, it is necessary to bring a representative piece of the environment into the laboratory, maintain it under ambient conditions, dose it with a realistic concentration of the chemical in question and use specific analytical methods to follow disappearance of parent, formation and disappearance of metabolites, uptake into biomass and mineralization to carbon dioxide. The environmental samples can be maintained in short term dynamic mode (e.g. continuous activated sludge system). Furthermore, if the chemical is new and will be discharged continuously, steps should be taken to insure realistic acclimation of the test systems. As a consequence of the need for more accurate biodegradation data, a series of new tests have been developed based upon the concepts described above. These tests include i) an activated sludge die-away test to evaluate the kinetics of primary and ultimate biodegradation during sewage treatment, ii) an effluent in river water die-away test that evaluates the fate of portion of the chemical not removed during treatment that is discharged to surface water in sewage effluent, and iii) an anaerobic sludge die-away test that determines the fate of the portion of chemical, removed by sorption to sludge, which is subsequently anaerobically digested. In addition, refinements have been made to the continuos activated sludge test, which make it possible to determine the complete disposition of a test material at steady state. In summary, these tests involve incubating freshly collected environmental samples, which have been dosed with environmentally relevant concentrations of radiolabeled test material. Abiotic samples, prepared through autoclaving and addition of mercuric chloride, serve as controls for analytical recovery of the parent, non-specific recovery of radioactivity into the various biomass fractions, and abiotic losses resulting from hydrolysis, absorption to the test vessel or volatilization. Periodically sub-samples are removed from both treatments and lyophilized. The lyophilized solids are then extracted with an appropriate solvent to recover parent and likely metabolites. These extracts are analyzed by liquid scintillation counting (LSC) to determine total radioactivity and Rad TLC (Thin Layer Chromatography) to determine the relative abundance of parent and various metabolites. The extracted solids are analyzed directly or quantitatively transferred to microcentrifuge tubes for biochemical fractionation of the biomass. They are sequentially extracted with cold thrichloacetic acid (TCA) to recover low molecular cytoplasmatic components, ethanol/ether to recover lipids, hot TCA to recover nucleic acids, and 10 N NaOH to recover proteins. After each extraction step, the microcentrifuge tubes are centrifuged and the supernatant is recovered and counted by LSC. The final step involves combustion of the fully extracted solids to determine incorporation into cell walls. Data for each fraction is corrected using the abiotic control. 14CO2 is determined by acidifying sub-samples from the bioactive and abiotic treatments and comparing the difference. Alternatively, evolved 14CO2 is trapped in base and quantified by LSC, and dissolved 14CO2 is determined by acididifying sub-samples in biometer flasks and quantifying the evolved radioactivity following trapping in base. When acclimation is considered appropriate, activated sludge is placed in a porous pot reactor and fed with raw sewage and the test chemical at its predicted level in sewage influent. The porous pot simulates the biologically relevant conditions in an activated sludge treatment plant with regard to food source and other growth conditions (i.e. hydraulic retention time and solid retention time). After an acclimation period of few weeks, activated sludge from the porous pot is placed in an activated sludge die-away test. In addition, activated sludge liquor from the porous pot is used as effluent in river water die-away. With this approach, it is possible to demonstrate the effect of acclimation on the fate the test chemical in two important and realistic scenarios and has proved valuable in accurately predicting the fate of new surfactant technologies prior to commercialization. Compared to other chemicals, an accurate assessment of biocide biodegradability is particularly challenging. Biocides are designed to be toxic to microorganisms; therefore, there is a high probability that the inocula of standard biodegradation tests will be inhibited at normal test substance concentrations. Furthermore, some biocides may not serve as sole carbon and energy sources, but are biotransformed and biograded through cometabolic processes. Cometabolism is the gratuitous metabolism of a substrate by organism, using other compounds as a source of energy and nutrients. As a result, there is a higher probability that a biocide will produce a false negative result in standard biodegradation than other compounds. In the environment, biocide concentrations are expected to be very low (ng/L - mg/L) limiting potential inhibitory effects and maximizing the opportunity for cometabolism. The new generation tests simulate these conditions. To demonstrate their application for assessing the fate of biocides, an important and representative biocide, Triclosan, was evaluated in activated sludge die-away and continuous activated sludge test systems. Previous work indicated no evidence of biodegradability in standard ready and inherent tests. Since Triclosan is in commerce, no additional acclimation was needed. A fresh sample of activated sludge was obtained from a treatment plant, receiving primarily domestic wastewater. The sludge was dosed with ~7 mg/L of 14C Triclosan, which was uniformly labeled in the 2,4-dichloro ring. The level of parent Triclosan immediately began to decline. Concurrent with the disappearance of parent was the transient appearance of a low level (<8%) of polar materials, the formation of 14CO2 and uptake into biomass. After 24 hours, more than 88% of the Triclosan had undergone primary biodegradation with >53% converted to 14CO2. These findings were confirmed in a continuous activated sludge experiment. The bench top reactor was fed with raw sewage amended with 10 mg/L of 14C Triclosan. At steady state, parent removal equaled 94.7% and removal of total radioactivity exceeded 89%. The majority of the radioactivity was evolved as 14CO2 and incorporated into biomass. These results unequivocally demonstrate that Triclosan is biodegradable and that biodegradation is a dominant and highly effective removal mechanism during sewage treatment. The new test methods were essential for establishing Triclosan's biodegradability, which was not possible using conventional methods. In summary, the new testing approaches provide significant information about the biodegradation of a chemical under realistic conditions including: i) kinetic descriptions of primary and ultimate biodegradation, which are useful for exposure modeling, ii) detailed accounting of disappearance of parent, formation and disappearance of metabolites, uptake into biomass and mineralization, which are useful for demonstating completeness of biodegradation and iii) an understanding of the biodegradation mechanism and the metabolites that might be formed and enter the environment, which is useful for holistic risk assessments. As the results for Triclosan in activated sludge demonstrated, these new testing approaches hold significant promise for more accurately assessing the fate of new and existing biocides in the environment, which will result in improved exposure estimates for environmental risk assessment.

PROGRESS IN THE DEVELOPMENT OF THE CEN DISINFECTANT EFFICACY TESTING STANDARDS

The Technical Notes for Guidance currently in preparation for Directive 98/8EC, are expected to provide details of the data requirements. In Annex V of this Directive an extensive range of 23 product types are listed in 4 Main Groups. Main Group 1 covers disinfectants and general biocidal products and includes the following product types:

-human hygiene biocidal products

-private area and public health including the disinfection of air, surfaces, materials, equipment and furniture which are not used for direct food or feed contact in private, public and industrial areas, including hospitals

-veterinary hygiene biocidal products including areas where animals are housed, kept or transported

-food and feed area products which are used for the disinfection of equipment, containers, surfaces or pipework associated for production, transport, storage or consumption of food, feed or drink for humans and animals

-drinking water disinfectants

As mentioned under the Common principles for the evaluation of dossiers for biocidal products (Annex VI of the Directive) the development of standard methods for evaluation of the efficacy of biocides are of great importance. The European Committee for Normalisation (CEN), a legal association, is one of the bodies responsible for planning, development and adoption of European standards. CEN/TC 216, starting in 1990, is developing guidelines for the application and interpretation of European Standards for Chemical Disinfectants. The scope includes standardisation of terminology, requirements, test methods (including potential efficacy under in-use conditions) and labelling recommendations for use and dosing in the whole field of chemical disinfection and antiseptics. Areas of activity include agriculture, domestic services and other industrial fields as well as institutional, medical and veterinary applications. CEN/TC 216's objective is to produce a limited number of harmonised European Standards. Within CEN/TC 216 three application areas are defined and presented by three Working Groups (WG's) developing standard tests for the assessment of the bactericidal, fungicidal, sporicidal and virucidal activity in the following application areas: human medicine, veterinary medicine as well as food, industrial domestic and institutional hygiene. (Note: swimming pools are not covered by CEN/TC 216). The standards developed can be used by manufacturers of raw materials and/or formulators of disinfectant products, in order to support technical dossiers, required by competent authorities for authorisation. Official institutes will assess the microbiocidal activity for recommendation of dosing and use. Labelling will give information about application area as well as the concentration, contatct time and micro-organisms, which can be killed under clean and not clean conditions. Basically the objectives of the CEN/TC 216 are to develop these tests in a sequential mode and the programme of work includes 3 phases:

-phase 1 suspension test to establish that a product has bactericidal or fungicidal or sporidicidal or virucidal activity without regard to specific conditions of intended use (basic activity);

-phase 2/step 1 suspension tests to establish that a product has bactericidal or fungicidal or sporicidal or virucidal activity under laboratory conditions appropriate to its intended use (representative for practical use);

phase 2/step 2 other laboratory tests e.g. handwash, handrub and surface tests simulating practical conditions;

phase 3 field tests under practical conditions.

Some tests are already nominated, others are in discussion or will be published in the near future following the working program. In Europe the process on harmonisation of biocides is in full progress and standards to evaluate the efficacy of raw materials and biocidal formulations are important in relation to the implementation Biocidal Products Directive. In order to support product dossiers for registration, Cen/TC216's objective is to deliver the methodologies needed to prove biocidal activity. Although only a few of these are published now it is the challenge to CEN/TC216 to get these tests endorsed for use in product dossiers prepared in the context of the BPD approval scheme.

Fine Chemicals: 1999 results for Lonza.

Chimie Hebdo: May 2000

In 1999 Lonza's net profit rose 35.1% to SFR 273 M.  Without a change in the accounting system, this would have been a rise of 16.3% to SFR 235 M.  Net turnover rose 1.4% to SFR 2183 M.  (The group was floated on the stock exchange in Nov 1999, after becoming an independent company in Oct 1999)  Operating profit for the fine and speciality chemicals division rose 29.7% to SFR 297 M, on turnover up 3.7% to SFR 1605 M.  Demand was strong for disinfectants and new products launched included monoclonal antibodies, biocides and treatments for wood and paper.  Turnover for the intermediates and additives division fell 5.9% to SFR 493 M, for a 30% fall in operating profit to SFR 40 M, due to poor trading conditions and difficulties with bringing online a new isophthalic acid plant in Singapore.   The group expects better results in 2000, especially in 2H 2000.  Overall the employee numbers rose from 5651 to 5697.

 

USA: Biocides demand to reach USD 2.2 bn in 2004.

European Coatings Journals: May 2000

US demand for biocides is forecast to increase nearly 5% per year to $2.2 billion in 2004, driven by heightened concern over the proliferation of bacteria, tightening environmental standards, and the continuing replacement of commodity chemicals by specialty formulations. Gains will also result from the improving performance of some key end-use markets, such as the food and beverage industry. Advances will be limited by slower growth in the large wood preservation and recreational water treatment markets, and continued competition from alternative technologies such as aseptic food and beverage packaging and ultraviolet radiation in water treatment. These and other trends are presented in Biocides, a new study from The Freedonia Group, Inc., a Cleveland-based industrial market research firm.

Halogen compounds will remain the largest product segment of the specialty biocides market, due to the widespread use of chloroisocyanurates, iodophors, and other halogen compounds in such large markets as pools and spas, industrial water treatment, and disinfectants and sanitizers. Within this segment, bromine-based products such as sodium bromide and hydantoins will register the fastest growth, due to their increasing replacement of chlorine in nonrecreational water treatment applications. Metallic compounds will remain a major product segment, although advances will be slower due to concerns about the environmental impact of their use in wood preservation and marine coatings.

Preservative applications will continue to account for about half of total biocide demand through 2004. The increasing predominance of water-based coatings which are more vulnerable to microbial attack than solvent-borne formulations will trigger demand in the paints and coatings market. Strong gains will also be posted in the food and beverage and the cosmetics and toiletries markets. Water treatment applications will account for about 30 percent of total biocides demand. Pools and spas will remain by far the largest segment of the water treatment market, but stronger gains will be posted in commercial and industrial water treatment applications due to the increased use of specialty products in lieu of chlorine and chlorine dioxide.

Wood preservation and pools and spas will remain the largest end-use markets for biocides, although growth potential in these markets will be limited by their comparative maturity. Growth prospects will be strongest in the foods and beverages, cosmetics, and coatings markets, where modifications to finished products will heighten the need for antimicrobials.

Arch & SNPE form Biocide Alliance to produce IPBC.

Chemical Online: June 2000

Arch Chemicals, Inc. (Norwalk, CT) has announced a strategic alliance with Tolochimie, a subsidiary of France’s SNPE Group, for production of Omacide iodopropynyl butylcarbamate (IPBC) products and intermediates.

"This gives Arch an immediate and significant increase in capacity for Omacide IPBC, and improves our cost position through backward integration into the isocyanate raw materials,” says Arch global industrial biocides business manager Douglas Simpson.

Under the agreement, Tolochimie will produce IPBC at its Pont de Claix, France, complex. It currently produces propynyl butylcarbamate (PBC), an IPBC intermediate, and other agricultural fungicides and specialty chemical products at the site.

The alliance is important to Tolochimie, says SNPE agrochemicals GM Jean-Pierre Morgades. "It allows us to partner with a market leader in biocides, and offers us a new business in an exciting growth product."

IPBC is used as a biocide in wood protection, architectural coatings, metalworking fluids, and cosmetic preservation. Arch entered the business in 1995 and is the second largest marketer of IPBC in the world. SNPE has supplied intermediates to Arch for a number of years.

Arch produces IPBC products in Rochester, NY, and through an alliance with M&G, GmbH in Horhausen, Germany.

"Arch will continue to manufacture Omacide products in Rochester and Germany," says Simpson. "Our alliance with SNPE will strengthen our cost position in IPBC, and will allow us to continue to invest in technology, technical service and new product development for our customers."

Biocides are part of Arch’s Performance Chemicals segment, which also manufactures specialty polyols, hydrazine propellants and solutions, and sulfuric acid. Other company segments include Microelectronic Chemicals and Water Chemicals. Spun off from Olin Corp. in 1999, Arch employs more than 3000 individuals worldwide and has manufacturing capabilities in North America, South America, Europe, Asia and Africa.

New Directive could ban 75 % of Biocide Actives.

Press Release: May 2000

The May 2000 implementation of the Biocidal Products Directive (BPD) will dramatically transform the European specialty biocides market, according to a new report. By the end of its 10-year implementation period, says the study, the new directive will have effectively eliminated 75% of existing biocidally active products from use in the European Union.

The problem, says the study, is that the BPD will force producers, formulators,  and distributors to pay an estimated $5 million in authorization costs for each active product.

"Despite the uncertainties surrounding the time scale of implementation, and the product authorization process, it is anticipated that the cost to the biocides industry is going to be immense," says analyst Clare Webster.

Many biocides have too small a market to support such costs. As a result, Webster expects both the number of biocides and number of manufacturers to shrink as the industry consolidates. High BPD- related costs will also limit biocide research and development.

"The competitive structure of the biocides market is also expected to change, as companies either drop out, or are acquired by their competitors," says Webster. "Formulators are already beginning to look for new suppliers of the active ingredients which they require, and importers outside of the EU are reassessing their position in the European market."

Despite the turmoil, the market remains attractive. Webster projects demand to rise 2.1% annually, to US $984.0 million, from US $851.9 million in 1999. Hygienic products represent the main market. Webster sees several new applications, as well as a growing market in the Far East and Eastern Europe.

Bayer is currently the leading competitor in the biocides market, followed by BASF, Avecia, and Rohm & Haas. Despite the maturity of the market and the number of players, relatively few mergers and acquisitions have taken place in recent years. Recent examples include Clariant's take over of BTP and Rhodia's acquisition of Albright & Wilson. Webster expects the BPD to accelerate industry consolidation.