Product stewardship

To meet our responsibility conscientiously, we need to monitor products throughout their life cycle – from development through production to application and safe disposal. Since 1994, we have oriented the risk assessment of our products to the voluntary Responsible Care® initiative of the chemical industry and its revised Responsible Care Global Charter – a document we signed in 2006. The Global Product Strategy (GPS) is part of this charter.

The aim of the GPS – based on an initiative of the International Council of Chemical Associations (ICAA) – is to improve and standardize the level of product stewardship in the chemical industry, particularly in emerging and developing countries. In 2009, we developed our own global product strategy in accordance with the ICCA guidelines that is particularly relevant for chemicals in the market. The strategy is implemented in a four-stage process. In this context, certain products are continuously assessed with regard to new findings, their hazard potential and possible risks, and a suitable risk management policy is implemented that includes communication of risks.

For all materials used by Bayer – be they raw materials, intermediates or end products – relevant safety information is available throughout the Bayer Group in product databases and in the form of safety data sheets. All subgroups possess suitable data acquisition systems for product information enabling them to meet the respective product safety and information obligations. We update the acquisition systems whenever this is necessitated by new statutory requirements.

Bayer HealthCare (BHC) is expanding its databases worldwide to further improve the accessibility of environmental, safety and substance data. This should enable new statutory requirements to be satisfied at short notice. In the context of its risk management process, BHC has also carried out risk analyses on such themes as label compliance. The analysis results have been incorporated into the “Regulatory Affairs” procedure governing the creation and revision of product labels and product information sheets.

Bayer CropScience uses the “E-Label Server” to record data for all products marketed in Europe and parts of Asia and Africa. Furthermore, the External Adverse Incident Guideline governs the internal reporting channels worldwide for incidents involving the company’s products. This enables risks to be identified and evaluated at an early stage and taken into account in product developments and market activities. The guideline has been revised and distributed worldwide throughout Bayer CropScience.

As a producer of high-quality materials, Bayer MaterialScience is subject to a wide variety of obligations concerning product safety and the publication of information. All relevant information is available worldwide through a product safety database. For external communications, Bayer MaterialScience is systematically supplementing its BayCare platform with information on industrial chemicals and adapting it to satisfy language requirements in the various regions, as the current examples in Brazil and China show.

Virtually all products manufactured by Bayer are subject to extensive legal requirements concerning the publication of information. In accordance with the European chemicals regulation REACH (Registration, Evaluation and Authorization of Chemicals), we successfully completed the pre-registration in 2008 of more than 800 substances that we either produce ourselves or import from outside the European Union. Bayer has thus created the necessary conditions for continued distribution of all these products. The Group-wide Directive on REACH Implementation, which was revised in 2009, stipulates the uniform procedure to be applied through 2018 so that REACH can be quickly implemented in all relevant areas: by the end of November 2010, we will draft registration dossiers for all substances that we produce or import in large volumes. Currenta’s Analytics, Toxicology and Process and Plant Safety departments are supporting the subgroups in the creation of the registration dossiers and in substance testing. Bayer participates in consortia with its competitors to promote the exchange of data between companies and obviate the need for additional animal studies. The company obligates its suppliers to provide only substances that satisfy REACH so that we are safe on the raw material side as well. REACH will generally enable more substance information to be passed on in the product chain too, for example through expanded safety data sheets. This applies both to our suppliers and to Bayer itself.

Bayer also supports international efforts to introduce a uniform global system of classification and labeling for substances and preparations (mixtures). The Globally Harmonized System (GHS) for chemicals took effect in Europe at the beginning of 2009; its aim is to standardize the classification and labeling of chemicals. In 2010, the system was expanded to include China. Bayer’s subgroups and service companies have formed a joint task force to coordinate all GHS activities throughout the Group. On behalf of this task force, Currenta’s Process and Plant Safety Department represents Bayer in legislative bodies of the United Nations as regards GHS and transport issues. Bayer Technology Services has developed the logistics software LEXSY® LabelPrint to support the uniform, legally compliant and cost-effective implementation of GHS. Bayer MaterialScience has made this software the global standard. To ensure the ghs-compliant labeling of substances and mixtures as of November 30, 2010, and May 31, 2015, respectively, Bayer CropScience and Bayer HealthCare are working with Bayer Business Services to implement an SAP-EHS-based labeling program called Global Label Management (GLM).

Through participation in international associations and the support of political initiatives, Bayer makes an important contribution to the scientific risk assessment of chemicals. In connection with the Long-Range Research Initiative (LRI) set up by the international chemical associations, we enhance understanding about potential hazards posed by chemicals and optimize the scientific methods used to assess possible risks. Together with the Organisation for Economic Co-operation and Development (OECD), the European Center for Ecotoxicology & Toxicology of Chemicals (ECETOC) and LRI, we are also active as regards the scientific validation of test methods, the further development of scientific risk assessment, and implementation in legal regulations.

Our association activities support important societal objectives: the goals set by the World Health Organization and by E.U. plans of action to improve health and the environment – and particularly children’s health – are an example of this, as is the further development of human biomonitoring as an element of chemical risk assessment. Bayer is supporting a joint project of the German Environment Ministry and the German Chemical Industry Association (VCI) on method development. Currenta’s Institute for Biomonitoring also plays an important role here through the association activities of its experts in such bodies as the German Research Society (DFG), the German Society for Occupational Health and Environmental Medicine (DGAUM) and the VCI. We also participate in organizations that focus on specific environmental aspects, such as the Society of Environmental Toxicology and Chemistry (SETAC) and the International Life Science Institute/Health and Environmental Sciences Institute (ILSI/HESI).

The precautionary principle is defined in Article 15 of the Rio Declaration of the United Nations Conference on Environment and Development (1992) and in the Communication from the European Commission. It is applied whenever there is sufficient evidence that people or the environment could suffer significant or irreversible damage, regardless of whether scientific certainty already exists. Bayer supports the application of the precautionary principle according to the stipulations given in the Communication from the European Commission. This means that the measures must be: proportionate, in other words satisfy the intended level of protection; applicable without discrimination, in other words comparable circumstances must not be treated in different manners; consistent with similar measures undertaken previously; and analyzed with respect to the costs and benefits associated with the application of the precautionary principle.

The measures undertaken are evaluated as soon as new scientific data are available for the particular circumstance.

As a research-based company, we depend on animal studies to investigate the effects of our products on people, animals and the environment. Such testing is scientifically necessary and is also prescribed by law in the majority of cases. We have anchored in our “Policy on animal welfare and animal studies” the basic principle of using only as many animals as necessary to attain scientifically meaningful results. The principles also apply to external studies and are monitored by our Animal Protection Officer.

Since 2005, Bayer has been a member of the European Partnership for Alternative Approaches to Animal Testing (EPAA), a joint initiative of the European Commission and industry. We support the EPAA’s “3R” principle with the aim of “reducing” the number of experimental animals, “refining” experimentation methods and “replacing” animal studies with other methods. Furthermore, for many years we have been active in German and international projects aimed at developing alternatives to animal studies, and we participate in studies organized jointly by pharmaceutical companies and universities.

In 2009, Bayer scientists conducted studies with 171,251 animals (2008: 157,710) worldwide. In the vast majority of cases, these animals were used in the development of drug products; in other cases, they were used in the development of new animal health products, crop protection agents or industrial chemicals. Most (approximately 92 percent) of the animals used in testing in 2009 were rodents, such as rats and mice. Fish accounted for 3.8 percent of animals used in testing, and birds for 2.3 percent. The total share of dogs, cats and monkeys used in research was 0.6 percent.

The increase compared to 2008 was due to the growth in the use of mice, fish and birds. As a result of increased research efforts in the field of oncology we now require more mice to characterize new active substances, including in response to regulatory inquiries. The larger number of fish tested resulted from the rise in ecotoxicological studies stipulated by the regulatory authorities. The evaluation of promising approaches in the treatment of poultry has led to an increase in the number of corresponding animals tested.

New statutory guidelines worldwide promote the additional generation of data through animal studies to determine the safety of substances. The Protection of Animals Act specifies that only those animals expressly bred for testing purposes may be used in animal studies. This act explicitly allows exceptions for agricultural livestock and fish, as test animals are not bred in these species.

For a research-oriented company like Bayer, nanotechnology is an important technology of the future. It is regarded as a key technology of the 21st century and harbors tremendous innovation potential for a variety of economic sectors and user industries. Nanoscience offers us ways of gaining a much better understanding of phenomena at the atomic level. Through nanotechnology we are able to develop materials and components that offer completely new properties, functions and levels of performance. Nanotechnology has relevance throughout the Bayer Group and can contribute to sustainable product solutions in all areas of the company.

As nanotechnology is a relatively new technology, a sound, scientific risk analysis is particularly important to protect human health and the environment. Bayer is assuming a pioneering role in safety, particularly as regards activities with carbon nanotubes. A comprehensive Product Stewardship Program supports the safe handling of these materials – from production through processing and use to disposal – in all areas in which this technology is used.

We have summarized our principles for the handling of nanotechnology in the Bayer Position on Nanotechnology. We also support safety projects promoted by the German Ministry of Education and Research such as CarboSafe. We are working intensively on the international harmonization of terminology and characterization at the ISO level and on the drafting of toxicological test guidelines at OECD level. Furthermore, we foster a very close stakeholder dialogue with committees, associations, industry partners, customers, authorities, universities and the public.

The manufacture of drug products and medical equipment is subject to stringent quality requirements and monitoring. The Global Pharmacovigilance unit of Bayer HealthCare pools all safety-relevant information on our medical products. This information is continuously updated and evaluated by experts. Bayer works closely with the responsible registration and oversight authorities at an international, national and regional level. These include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM).

The Bayer HealthCare Compliance Management System describes measures aimed at permanently and continuously satisfying regulatory requirements for quality assurance in human and veterinary medicine. The observation of compliance standards is verified through systematic internal inspection both for all functions summarized as global clinical development and for production. These audits also include contract service providers and suppliers. Risks are systematically identified and assessed with the help of a risk management system. Deviations, infringements and quality deficiencies are analyzed on a case-by-case basis, and preventive or corrective measures undertaken. Countries and regions continuously receive support in observing compliance

We continuously evaluate the benefit-risk profile of our pharmaceutical and medical products from their development until their registration and once they are being marketed. Within the scope of risk management at Bayer HealthCare, experts from various disciplines jointly evaluate the available data on a product so as to identify safety risks as early as possible and initiate measures aimed at improving understanding and at preventing or reducing the risk. These measures are summarized, for example, in risk management plans. Should adverse effects or other risks become known following the registration of a product, we immediately take steps to minimize the risks. These actions can range from revision of pack inserts through systematic and comprehensive information campaigns for physicians and patients to measures restricting marketing activities.

Bayer temporarily withdrew Trasylol® from the global market in 2007 after the interim results from an independent clinical study in Canada produced evidence of a possibly increased risk of mortality in patients treated with Trasylol®. Trasylol® (active substance: aprotinin) is a drug approved for use in managing the perioperative blood loss in patients undergoing coronary artery bypass graft surgery. The marketing suspension will remain in effect until the final results from the Canadian study have been analyzed and the benefit-risk assessment for Trasylol® can be re-evaluated together with the health authorities. In some countries, including the United States, Trasylol® continues to be available to certain surgical patients with an established medical need, however. As of April 21, 2010, there were approximately 1,500 lawsuits pending in the United States and served upon Bayer as well as three class actions in Canada. Additional lawsuits are anticipated. By April 13, 2010, Bayer had reached settlement agreements with approximately 60 plaintiffs without admission of liability. Bayer will continue to consider the option of settling individual lawsuits on a case-by-case basis, but will continue to defend itself vigorously against all claims that are not considered for settlement.

In August 2009, the British Medical Journal (BMJ) published two retrospective studies on the risk of venous thromboembolism (VTE) from the use of combined oral contraceptives (COCs). These conclude that COCs have a differential risk based on the progestin component. The VTE risk when taking Yasmin® is supposedly higher than with COCs containing levonorgestrel but lower than with COCs containing gestoden or desogestrel. These studies and our criticism of their methodology have been reported on extensively in the media over the past few months.

We are of the opinion that both studies have significant methodological weaknesses which call the validity of their results into question. We are convinced that Yasmin®’s risk profile is comparable with those of other COCs and base our judgment in particular on two large prospective epidemiological studies on more than 120,000 women that we have sponsored after extensive discussions with health authorities in Europe and the United States. These studies conducted by independent investigators in the United States and Europe confirm that the risk of VTE is comparable in all low-dosage COCs investigated. Additional major studies are ongoing.

We also adhere closely to provisions specified by national and international codes for the marketing of pharmaceuticals. In this connection, Bayer HealthCare has undertaken to uphold the ethical pharmaceutical advertising code of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the corresponding code of the European federation EFPIA. These codes contain provisions governing, among other issues, advertising material standards, the distribution of samples, and cooperation with members of medical and pharmaceutical specialist groups in connection with consultancy contracts, studies and scientific lectures. The global and European provisions are implemented through national codes, and various points generally tightened. By recognizing the code of the association “Voluntary Self-Monitoring by the Pharmaceutical Industry” (FSA), for example, we undertake to observe strict rules governing such provisions as the implementation of drug monitoring policies or the disclosure of donations to medical institutions. In the event of discrepancies between national and international rules, we apply the more stringent code in each case.

Since 2008, furthermore, we have observed specific rules in Europe pertaining to collaboration with patient organizations and disclosed cooperation with German patient organizations beyond these obligations, including all project-related data.

Trace amounts of pharmaceuticals can be found in bodies of water and occasionally in drinking water. One reason for this is the excretion of pharmaceuticals and their degradation products by patients following their use. In many cases, wastewater treatment facilities reduce or degrade these substances. However, some substances are not completely removed and can thus enter natural bodies of water.

Within the scope of its product stewardship, Bayer HealthCare aims to pursue an adequate, risk-based and responsible approach to pharmaceuticals in the environment (PIE). In this connection, a special PIE working group was established to verify and deal with the effects of pharmaceuticals in the environment. We strive to keep trace elements in the soil and groundwater as low as possible and to closely monitor the risks. We conduct tests on ecotoxicity and on the dispersal and degradation behavior of our pharmaceuticals.

Bayer also participates in important research projects. A specific activity in the context of cooperation with various partners, primarily from the water resources industry, is the European PILLS project (Pharmaceutical Input and Elimination from Local Sources), which is scheduled to run from 2007 to 2011. The PILLS partnership focuses on traces of human pharmaceuticals in the context of wastewater treatment. As it seems efficient to undertake measures at high-concentration point sources, the collaboration focuses on the development of local treatment facilities for hospitals and nursing homes. Bayer HealthCare Pharmaceuticals is represented in the scientific advisory committee of PILLS. Bayer’s efforts in this area are focused on the treatment of wastewater resulting from the company’s own production activities, with the goal of avoiding ecological risks.

Bayer HealthCare’s Animal Health Division has marketed products for livestock and companion animals for more than 100 years. Initially, human drugs were also used in veterinary medicine. The first medicine especially developed for animals came onto the market in 1919. The division now offers over 100 different products for animal health and pest control. These products are of benefit not just to the animals themselves, but also to people, as they prevent the transmission of possible pathogens and parasites to humans. At Animal Health too, we apply high safety and quality standards to our research, development, production, marketing and distribution activities that are comparable to those in human medicine and that we observe very thoroughly. Here we also focus particularly on the environmental compatibility of our products. Through training measures and information materials, we provide veterinarians, end users and consumers with targeted details on the proper and responsible use of our products.

Development and production in the area of pharmaceuticals and plant technology would be unthinkable today without the use of biotechnology. As a modern breeding method, biotechnology can help to enhance, for example, the performance potential and stress resistance of plants and thus increase crop yields. This is necessary in part to further increase the efficiency of agricultural production on limited growing acreages, which in turn enables a significant contribution to be made to feeding the growing world population. In pharmaceutical research and production as well, biotechnology has become increasingly important in recent years. Two of our best-selling products – the multiple sclerosis drug Betaferon®/Betaseron® and the hemophilia treatment Kogenate® – are manufactured in biotechnological processes. What’s more, active substances derived from the use of plants – known as “plant-made pharmaceuticals” – are tested with biological methods.

Safety is our top priority in the development and use of biotechnology. Bayer takes consumers’ concerns about genetically modified organisms (GMOs) seriously and respects their right to information and freedom of choice when purchasing products. It goes without saying that we observe all relevant legal provisions. We have spelled this out in our Position on the Responsible Use of Gene Technology and in specific regulations in the subgroups and service companies. Before any product reaches market maturity, it is subjected to a stringent registration process to determine whether it is safe for people, animals and the environment.

Bayer CropScience has successfully introduced the test conditions specified by the international Excellence Through Stewardship (ETS) program – a voluntary initiative by industry – and implemented the programs and quality management processes necessary for product safety.

Bayer HealthCare has established strict production safety measures in its Directive on Biological Safety and its “Requirements for a safe handling of biological agents” procedure.

Counterfeit or illegally marketed pharmaceuticals or crop protection agents harbor significant risks for people and the environment due to their quality deficiencies. A total of 34 million counterfeit tablets were confiscated during inspections in the 27 E.U. Member States within two months in 2008. No one can say exactly how many counterfeit products are in circulation on which markets, as there are no reliable data on this subject. However, the large number of confiscated tablets gives a valuable picture about the extent of the danger. The rate of counterfeit products in the crop protection market lies between about 5 and 7 percent.

Bayer actively addresses product counterfeiting to minimize negative effects on the health or lives of unsuspecting patients, customers or users, as well as to protect its own competitiveness. To this end, the subgroups cooperate intensively with the responsible regulatory authorities, law enforcement agencies and customs organizations.

On its “Beware of Counterfeits” Internet site (in German only), Bayer HealthCare informs patients of the considerable dangers associated with counterfeit products and provides advice on how they can protect themselves. At the European level, the company supports a proposal by the European pharmaceutical association EFPIA for coding and identifying pharmaceuticals. In this connection, manufacturers aim to ensure clear identification of pharmaceuticals upon sale to consumers through the use of a two-dimensional barcode. Between mid-September 2009 and the end of January 2010, 14 European pharmaceutical manufacturers – including Bayer HealthCare, which participated with two different products – worked with Bayer Technology Services to successfully carry out a four-month pilot project in Sweden involving around 100,000 packs. The feedback from the participating pharmacists, wholesalers and pharmaceutical manufacturers was consistently very positive.

Bayer CropScience supports the fight against illegal crop protection agents through participation in regional and global association committees such as the Anti-Counterfeiting Expert Group of the European Crop Protection Association (ECPA) and the Anti-Counterfeiting Steering Committee of CropLife International. As a result of the intensive cooperation with national and international authorities, large quantities of counterfeit crop protection agents in 2009 were confiscated in Hungary and destroyed. Bayer CropScience regularly organizes internal regional workshops to coordinate its activities to effectively counter illegal crop protection agents. Packaging materials for crop protection agents of Bayer CropScience generally feature specific identifying features that enable customers to distinguish between original and counterfeit products.

Bayer Technology Services offers a globally unique solution for the authentification of products without additional labeling: ProteXXion® is based on a laser-optic process from U.K.-based technology partner Ingenia Technology Ltd. ProteXXion® uses a laser scanner to read each individual surface of a product. This information is compared with the surface pattern of the registered original and serves as non-forgeable proof of authenticity.

Forgeries and counterfeit products not only present a risk to people and the environment, they also cause tremendous economic damage. Such piracy can impair innovation capability and competitiveness, leading to the loss of jobs and tax revenues worldwide.

With its research and development efforts in the areas of crop protection, seed and plant traits, Bayer CropScience helps to safeguard and boost harvest yields worldwide. These activities necessitate extensive scientific risk assessments of crop protection agents. Stringent country-specific regulations also apply to the registration, storage, use and disposal of such products. To ensure that these regulations are observed throughout the entire life cycle, Bayer provides all relevant product information in the respective official national language. Currenta maintains a global emergency hotline to provide immediate assistance in the event that products are ingested orally or come into contact with the skin during use.

In addition to developing technical solutions for safe application of our products, we hold training courses worldwide for customers and partners such as farmers, dealers and medical personnel – both alone and in cooperation with CropLife International – on the proper, safe and targeted handling (product stewardship) of crop protection agents. In the emerging markets, we have mainly focused on user safety. In Europe, we have additionally concentrated on optimizing application equipment (including sowing machines) to provide better protection for users and the environment.

In 2009, Bayer CropScience published a brochure providing a comprehensive overview of its stewardship activities with 12 basic principles: from product integrity, testing, registration and labeling through production processes, application technologies, training courses, adequate packaging, transport, storage, disposal and damage prevention to protection of intellectual property. The brochure is currently available in German, English, French and Spanish. The implemented measures are based on the Food and Agriculture Organization’s International Code of Conduct on the Distribution and Use of Pesticides.

In 2009, the European Union passed two bodies of legislation governing the harmonization of registration and the sustainable use of crop protection agents in the E.U. The regulations of the new E.U. registration policy will take immediate effect in Germany from June 14, 2011, while the Directive governing the sustainable use of crop protection agents will be implemented through national laws. Bayer CropScience welcomes the E.U.’s harmonization efforts and advocates a modern registration procedure that accounts for these challenges. However, Bayer CropScience considers the result of the deliberations on crop protection legislation to be an overinterpretation of the precautionary principle as evidenced by the introduction of hazard-related exclusion criteria. These equate to a departure from the principle accepted in technology assessment and society of including in the risk assessment not just the theoretical hazard potential, but also the exposure relevant in practice. When drafting this policy, the E.U. largely neglected to carry out a comprehensive assessment of the potential long-term consequences the law would have on consumers and the environment as a result of the non-registration of important crop protection agents, which could lead to lower agricultural productivity. There is already a significant dearth of products for tackling crop diseases in the cultivation of fruits, vegetables and smaller crops. It is a top priority for Bayer CropScience and the European agricultural industry to enact the new legislation based on independent scientific findings, so that the desired harmonization goals can be realized in practice as intended in the national plans of action. Bayer CropScience will continue to contribute its experience and expertise in this area so as to support appropriate solutions in scientific committees and in collaboration with authorities, associations, farmers and consumer organizations. In this context, we place particular value on the further development of agricultural production systems to satisfy the increasing requirements as regards biodiversity, climate and water protection, as well as the sustainable production of high-quality, affordable food products.

Bayer CropScience only distributes crop protection agents that have been granted regulatory approval by the authorities in the countries concerned, which are safe when used responsibly and as intended, and which pose no risk to either people or the environment. In streamlining its portfolio the company has committed itself to bringing products to market that have better environmental properties. As part of this strategy the portfolio is being continuously reviewed. We are accomplishing this, for example, by developing and introducing new active substances, products, application technologies and types of packaging. The portfolio was already significantly improved in recent years. The active substances discontinued during this period include methyl and ethyl parathion – we have not sold ethyl parathion in developing countries since 1992 – oxydemeton-methyl, monocrotophos, azinphos-methyl, amitraz and trichlorphon. We will discontinue the sale of products containing endosulfan worldwide by the end of 2010. New active substances with markedly better risk profiles, such as spiromesifen, flubendiamide and spirotetramate and their formulations, are now available to customers worldwide to replace the old products that have been withdrawn from the market. Bayer CropScience will systematically maintain this approach. However, there are still fields of application in which there are no suitable alternatives available. In these cases, we promote the safe use of the products in question by organizing numerous training events for users.

In the spring of 2008, Bayer CropScience made headlines because incorrectly treated corn seed resulted in the loss of bees in the Upper Rhine region of the German State of Baden-Württemberg. Investigations by both the authorities and Bayer found that the bee deaths were caused by improper application by the seed dressing companies of the crop protection agent clothianidin (trade name: Poncho® Pro) in seed treatment. Bayer CropScience has participated in the unrestricted clarification of the incidents in the Upper Rhine Valley and supports the proper use of its products through targeted dialogue with and information measures for the special interest groups affected. A corresponding multi-stage safety concept has been developed for seed dressing at the Seed Treatment Application Center in Monheim. Within the scope of this concept, training measures were carried out for employees around the world in workshops lasting for several days in order to instruct responsible parties at seed treatment companies. Furthermore, in close cooperation with sowing machine manufacturers and in coordination with the responsible registration and inspection agencies, a technical retrofitting concept for sowing machines has been developed that can considerably limit the spread of abrasive dust during the sowing of treated seed – the cause of the aforementioned incident in 2008 – through a ground-level waste air duct. The effectiveness of these retrofitting concepts was confirmed in extensive test procedures carried out by the Julius Kühn Institute (German Federal Research Institute for Cultivated Plants). These drift minimization processes developed by Bayer CropScience in collaboration with the agricultural machinery industry are setting the standard across Europe. Other regulatory authorities, such as in Austria, Slovenia, the Netherlands and also France, are already using the corresponding concepts as a guide in registration procedures. Implemented across the board, the measures developed can sustainably prevent a repeat of the incidents that took place in the Upper Rhine Valley.

While investigating the bee losses, the German Federal Office of Food Safety and Consumer Protection (BVL) in 2008 temporarily suspended marketing authorization for clothianidin-based seed treatments in the Upper Rhine region. The suspension was lifted again later in the same year for various crops with the exception of the type of corn originally affected. Bayer CropScience has submitted extensive documentation to enable assessment of the safety of clothianidin used as a corn seed dressing. Corresponding measures specified by the responsible authorities for sowing a type of corn seed treated with a different active substance proved their worth in the 2009 corn sowing season.

In accordance with the precautionary principle, the Italian authorities have also suspended the use of products based on neonicotinoid active substances in seed treatment. The absence of these substances and the limited options for fighting the corn rootworm have led to damages estimated at up to €90 million in Italian agriculture alone. On the other hand, clothianidin was newly or reapproved for use in corn seed treatment in Slovenia, the Netherlands and Greece in 2009 and 2010.