Sustainable Conduct – Safety for People and the Environment Product Stewardship Product stewardship means for us that our products satisfy the highest quality standards and are safe for people, animals and the environment when properly used. All substances and finished products undergo extensive evaluation and testing in the interest of product safety. We assess possible health and environmental risks along the entire value chain and use this to derive appropriate measures to mitigate risks. We strictly observe the legal requirements, and our voluntary commitment and internal standards go beyond these in many areas. Implementing statutory requirements Extensive legal regulations apply to all Bayer products. Chemical substances are subject to the European chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and the CLP (Classification, Labelling and Packaging of Substances and Mixtures) regulation. The registration obligation under REACH applies irrespective of marketing activities for all substances that we produce or import in quantities of more than one metric ton. The classification and labeling of chemicals enables users in the European Union to become informed about the risks associated with chemicals. Bayer assesses all its marketed products and implements the Globally Harmonized System (GHS) of the CLP for the classification and labeling of chemicals worldwide. The authorities enforce the implementation of REACH through regular inspections. So far, none of the inspections at Bayer has resulted in complaints. We require our suppliers to confirm conformity with REACH for all substances they supply to us. Online Annex: A 18.104.22.168-1 limited assurance Alongside the standard registration obligation under REACH there is also an authorization procedure that can lead to the replacement of, or a ban on the use of, particularly hazardous substances. To fulfill the requirements of REACH, we have approved Group-wide and segment-specific policies. Already registered substances are also regularly evaluated by the authorities. For Bayer substances this can result in additional testing requirements, new risk management measures or inclusion in the REACH authorization procedure. To date, two Bayer substances have been affected, with authorization already being granted for one of these. Before any of our products is introduced to the market, we first assess the product itself to determine whether it is safe. Furthermore, the end products such as pharmaceuticals, crop protection products and biocides schließen Biocides are substances and products that control pests such as insects, mice and rats, as well as algae, fungi and bacteria. are subject to specific and detailed approval procedures. Voluntary commitment by Bayer Since 1994, Bayer has supported the voluntary Responsible Care™ initiative of the chemical industry and the associated Responsible Care™ Global Charter. We cover all main elements of the charter at all Group sites with our HSEQ schließen HSEQ stands for health, safety, environment and quality. management systems. We are actively involved in the further development of scientific risk assessment through our work in associations and initiatives. Online Annex: A 22.214.171.124-2 limited assurance Comprehensive support for association activities International associations such as the European and international chemical industry associations (CEFIC, ICCA) and the OECD, as well as initiatives such as ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals), work to enhance the scientific assessment of chemicals, develop new test methods and oversee the implementation of statutory regulations. Bayer actively supports these efforts through its activities in the associations. In addition, we are involved, for example, in the ICCA Long-Range Research Initiative and in the WHO and E.U. action plans for improving health and environmental protection. We also support the Strategic Approach to International Chemicals Management (SAICM), which combines chemicals safety activities at the global level under the umbrella of the United Nations Environment Programme with the goal of minimizing negative effects of chemicals on the environment and human health by the year 2020. The approach aims to create the necessary structures, especially in developing countries. We evaluate our substances’ properties already at the research and development stage. We discontinue the development of products with undesirable properties in application of the precautionary principle as defined in Principle 15 of the Rio Declaration of the United Nations and Communication COM (2000) 1 of the European Commission. In our view, the focus here should not be unilaterally on hazard potential, but rather on a balanced benefit-risk assessment. Group target 2020: assessment of the hazard potential of all substances > 1 metric ton p.a. In Europe, Bayer operates under strict legal requirements. We voluntarily apply comparable standards around the world, independent of the respective national legislation. In this way we are ensuring that substance assessments comparable to those established under REACH will also be applied at all non-European Bayer sites. We support this through our Group target for product stewardship: By 2020, we will have assessed the hazard potential of all substances (> 99%) used in quantities exceeding one metric ton per annum. By the end of 2017, we had assessed 76% of these substances. We carry out risk assessments for chemicals according to recognized scientific methods such as those described in the Guidance on Information Requirements and Chemical Safety Assessment of the ECHA (European Chemicals Agency). Should the analysis reveal that it is not safe to use a certain chemical, we take steps to mitigate risks. The applicable assessment steps and measures are established in a corporate policy. As part of our trusting working relationship with them, we support our customers in the safe handling and use of our products. Bayer compiles safety data sheets for all products regardless of whether or not these are legally required. Appropriate packaging information is provided for all end consumer products, an example being package inserts for pharmaceuticals. Online Annex: A 126.96.36.199-3 limited assurance Continuous examination and communication Risk mitigation measures can range from revised application recommendations to the substitution of a substance. In this case, the use of the substitute must be economically and technically feasible. The substitution of chemicals is basically a continuous task for the chemical and pharmaceutical industry in order to generate new or substantially improved products and processes. This is integral to our commitment to Responsible Care™. Safety data sheets are the central tools of communication for safety-relevant information about substances and mixtures in the supply chain. Targeting professional users, they contain information on the substance’s properties and on its safe use. In addition, technical information is provided for professional use. In accordance with the respective product safety and information obligations, we compile product information both for raw materials and for intermediates or end products and make these available within the company all over the world, e.g. for product labeling. Risk assessment of products on the market Our stewardship also involves the monitoring of all products that are already available on the market. We have established processes throughout the company aimed at addressing inquiries on product safety or problems with our products. This feedback is consistently accounted for in our risk assessment, which also covers substances that are regarded as potentially high-risk by regulatory authorities and independent institutions. We also assume responsibility for the active ingredients in our products. We conduct environmental risk assessments or implement risk management measures even subsequent to their registration. We also help to tackle questions about active ingredients in the environment and ensure that concerns are addressed through sound risk assessments and analyses. To this end, we have established a balanced risk-benefit assessment process for active ingredients that adequately accounts for customer needs relative to potential or known environmental risks. Responsible use of biotechnology Bayer applies biotechnology both in pharmaceutical product development and production, for example of Kogenate™ and Kovaltry™, and in the area of crop protection. Further biotechnologically manufactured active ingredients are undergoing clinical development. In plant biotechnology we use genetic engineering as well as conventional breeding methods to improve crop yields, yield security and the stress tolerance of plants without increasing the input of resources. For Bayer, safety for people and the environment is a priority in the use of biotechnology. In addition to meeting legal and regulatory requirements, Bayer has specified the responsible use of genetic engineering and strict safety measures in handling biological substances in corresponding corporate policies. We provide our stakeholders with information about our products and services in accordance with our Responsible Marketing & Sales Policy. Online Annex: A 188.8.131.52-4 limited assurance Specific procedural instructions regulate the handling of genetic engineering and biological substances in our segments. Crop Science has established the necessary requirements for the responsible use of biotechnology in both the Product Stewardship Policy and the Seeds Stewardship directives. Furthermore, Crop Science maintained its membership in 2017 of the Excellence Through Stewardship (ETS) organization. Audits by ETS-certified auditors are required to maintain ETS membership, and in 2017 Crop Science completed audits in Japan, Australia and India. Our commitment to preserving biodiversity In the course of our business activities we aim to use natural resources responsibly and respect biodiversity and the diversity schließen Diversity designates the variation within the workforce in terms of gender, origin, nationality, age, religion, sexual orientation and physical capability. of ecosystems. We have integrated our principles on biodiversity in the Bayer Human Rights Policy and established our own position on this issue. In this, we express our commitment to the United Nations Convention on Biological Diversity and the associated Nagoya Protocol, which regulates the balanced and fair sharing of the benefits arising from the use of genetic resources. Segment-specific measures are applied to implement this. Online Annex: A 184.108.40.206-5 limited assurance Crop Science commits itself through an internal policy to ensure that it only acquires and uses genetic resources in harmony with international and national legislation. Biodiversity strengthens the resilience of ecosystems, and thus plays a key role in maintaining and promoting sustainable agriculture. We therefore support agricultural ecosystems by promoting various ecological enhancement measures such as planting flowering strips as a habitat for animals and the more extensive cultivation of slopes to protect against erosion. These measures can help farmers to improve soil fertility and water regulation in their fields or boost the pollination activities of insects and thus increase their yields or biodiversity. We work together with farmers and other experts on solutions and demonstrate at the Bayer ForwardFarms how sustainable agriculture can be implemented in practice. As a member of the Association of Research-Based Pharmaceutical Companies, Bayer supports the association’s position on the U.N. Convention on Biological Diversity. An internal position on plant-based medications documents how natural substances can be used with respect to compliance with the Convention on Biological Diversity. Commitment to animal welfare Animal studies are legally required and essential from a scientific viewpoint to assess the safety and efficacy of our products. We aim to minimize the use of study animals and to employ alternative methods whenever possible. This includes the phototoxicity test developed by Bayer and others that replaces some animal studies in the investigation of the possible phototoxic effects of drug candidates. We respect all legal requirements pertaining to animal welfare, compliance with which is verified through both regulatory authorities and internal audits. In addition, Bayer’s principles on animal welfare and animal studies apply. Bayer’s Global Animal Welfare Committee monitors compliance with these guidelines within the Bayer Group and in external studies. Our principles also apply to both the research institutes we commission and our suppliers, whose compliance with our animal welfare requirements we regularly monitor. Online Annex: A 220.127.116.11-6 limited assurance Commitment to reducing animal studies Based on the performance indicators of our Animal Welfare Committee, we each year analyze the development of animal numbers, the distribution according to species and the burden placed on our test animals, as well as evaluate studies and discuss possible steps in accordance with the 3Rs principle (replace, reduce, refine) schließen 3Rs principle (replace, reduce, refine) Replace: prior to each project, Bayer checks whether an approved method is available that does not rely on animal studies and then applies it. Reduce: in case no alternative method exists, only as many animals are used as are needed to achieve scientifically meaningful results based on statutory requirements. Refine: Bayer ensures that animal studies are performed in a way that minimizes any suffering. . The number of study animals used (including animals in Bayer studies performed by contract research organizations) could be reduced from 96 animals per €1 million research budget in 2005 to around 30 animals in 2017. Bayer participates in several internationally renowned consortia and projects that aim to reduce the number of animals used in studies or improve the studies’ validity. Protection against product counterfeiting Counterfeit medicines and crop protection products harbor substantial risks for patients and consumers. Product counterfeiting can only be addressed internationally through a joint approach by industry, associations, governmental agencies and nongovernmental organizations. Bayer consistently advocates the resolute application and, where necessary, the strengthening and expansion of existing laws and provisions aimed at the identification and confiscation of illegal products. We want to additionally protect customers and products through extensive measures of our own. Online Annex: A 18.104.22.168-7 limited assurance Combating counterfeit medications Through the “Beware of Counterfeits” campaign, Bayer informs patients on the internet about the risks of counterfeit pharmaceuticals and provides patients with tips on how they can protect themselves. Through the use of various technological means in production, we constantly strive to ensure that patients, too, can distinguish between original and counterfeit products. Close cooperation between all stakeholders is necessary to achieve practical success in fighting counterfeiting and prevent the sale of counterfeit pharmaceuticals particularly on the internet. We therefore support the establishment of a Europe-wide system for the identification of original pharmaceuticals that satisfies the requirements of the E.U. Falsified Medicine Directive. In addition, Bayer participates in the Pharmaceutical Industry Initiative to Combat Crime of Interpol to counteract pharmaceutical counterfeiting, in the “Innovation Power for Safety in Industry” initiative and, since 2017, in the LiDaKrA (Integration of Networked Data and Early Detection of Organized Crime Phenomena) research program of the German Federal Ministry of Education and Research, which deals with the automated evaluation of data related to internet crime. Combating counterfeit and illegal crop science products To protect against the import of counterfeit and illegal products (crop protection products and seeds) into the E.U., Crop Science intensively advocates the uniform interpretation and implementation of existing E.U. regulations in all member states. We support regulatory authorities worldwide through chemical analysis to identify counterfeit products. In addition, we conduct our own inspections in the market in all countries and actively support initiatives by associations. In 2017, we rolled out our global strategy for combating the production, trade and use of counterfeit or otherwise illegal crop science products. The goal of this strategy is to reduce the risk for people and the environment and to limit the financial damage resulting for Bayer. As part of our product stewardship programs, we provide information material about the risks of counterfeit and illegal crop science products and train customers, dealers, farmers and regulatory authorities. We document all indications of suspicious and potentially counterfeit or illegal products. We work constantly to counterfeit-proof our products through the use of security features. In 2017, we identified patent and trademark violations in China and Brazil, and successfully asserted our legal rights. Pharmaceuticals and Consumer Health Benefit-risk management for pharmaceuticals and medicinal products The most important regulatory authorities for Bayer are: the U.S. Food and Drug Administration (FDA) the European Medicines Agency (EMA) the Pharmaceuticals and Medical Devices Agency Japan (PMDA) the China Food andDrug Administration (CFDA) The Pharmaceuticals and Consumer Health segments continuously assess the medical benefit-risk profile of their pharmaceuticals, medicinal products, dietary supplements and cosmetics throughout their entire product life cycle. The efficacy, safety and tolerability of pharmaceuticals are investigated in preclinical and Phase I to III clinical development studies. The documentation submitted to the regulatory authorities contains the results of these studies and a comprehensive benefit-risk assessment of the pharmaceutical. It is essential for the market authorization of a new pharmaceutical that it complies with regulatory safety requirements. The same applies to medicinal products, dietary supplements and cosmetics. According to these regulations, the segments continue to compile safety-relevant information in a dedicated database following market launch of the product. This information is continuously assessed and the benefit-risk balance of pharmaceuticals, medicinal products, dietary supplements and cosmetics regularly evaluated by medical experts of various disciplines in the global Pharmacovigilance schließen Pharmacovigilance is defined as activities and the science they are based on that relate to the identification, assessment, comprehension and prevention of side effects or other problems associated with pharmaceutical products. Department. In this process, Bayer works closely with the regulatory and supervisory authorities at the international and national levels. Further safety-relevant information is compiled using Post-Authorization Safety Studies (PASS) conducted after approval. The results are entered into the PASS registry in compliance with E.U. pharmacovigilance legislation. Online Annex: A 22.214.171.124-8 limited assurance Global pharmaceutical monitoring system The Pharmaceuticals and Consumer Health segments have a global pharmaceutical monitoring system in which experts from various disciplines work together in safety management teams (SMTs). These teams evaluate internal benefit and safety data, clinical trials, post-marketing studies, external databases and scientific publications to identify potential safety concerns at an early stage and detect possible changes in the benefit-risk profile. All data evaluated are entered in our pharmacovigilance database. In particular, the evaluation includes potential side-effects reported to us as a producer and to the health authorities via various communication channels by a range of different sources such as physicians, pharmacists and patients themselves. Producers evaluate the steps resulting from these reports in close cooperation with the relevant health authorities. Should risks be identified, Bayer immediately takes steps to safeguard the health of patients and consumers in coordination with the authorities. These range from updating product information for patients, users, pharmacists and physicians through patient education brochures and further training measures for medical specialists to direct communication with medical experts (Direct Healthcare Professional Communication, DHPC) and even product withdrawals. All of these processes are documented, regularly updated and integrated into the quality management system. Implementation of risk mitigation activities is coordinated by our local SMTs in the country organizations. The information on the side-effects of medicines compiled by Bayer is reported to the national health authorities in the relevant countries, where it is processed. The European Union centralized this process in 2017. European marketing authorization holders such as Bayer are now required to enter all suspected cases of undesired side-effects directly in EudraVigilance, the European Medicines Agency’s electronic information system. That means that Bayer no longer has to report them separately to the 27 national agencies in the European Union. The EudraVigilance database supplements Bayer’s established safety monitoring, further optimizing the safe use of our products. Analysis of residues of pharmaceuticals in the environment Active pharmaceutical ingredients can enter the environment through human or animal excreta, through improper disposal or during production. Surface waters are particularly relevant here. For their own active ingredients, Pharmaceuticals and Consumer Health carry out ecotoxicological investigations of pharmaceutical residues and degradation products to assess the potential environmental impact of these products. In connection with the approval process for human and veterinary pharmaceuticals in Europe and the United States, an environmental risk assessment takes place for all new active ingredients. Furthermore, to our knowledge, the existing concentrations of individual active pharmaceutical ingredients in drinking water do not have any relevant adverse effects on human health. On the basis of its report on mixtures of active pharmaceutical ingredients in drinking water published in 2017, the WHO currently does not identify any immediate health risks and consequently sees no need to act in the short term. To further guarantee the safety of drinking water resources partly against the background of a potential increase in the use of pharmaceuticals, the WHO recommends that this issue be observed comprehensively over a longer period of time. Bayer is actively participating in the stakeholder dialogue. Different requirements regarding wastewater thresholds apply at our production sites. Compliance with these is reviewed by supervisory authorities and external assessors and also at regular intervals through on-site audits by internal experts. To reduce or exclude the release of active ingredients into the environment, we take further action in our production facilities. We are also participating actively in various research projects to develop further reduction measures such as acting as a coordinator in the “Intelligence-led Assessment of Pharmaceuticals in the Environment” project in Europe, which seeks new ways to improve environmental risk assessment. Online Annex: A 126.96.36.199-9 limited assurance Bayer is involved in the German government’s stakeholder dialogue on the issue of a trace substance strategy. This dialogue process is aimed at developing a strategy to prevent the water-polluting effects of certain chemicals, including active pharmaceutical ingredients. The first results and recommended measures were summarized in a position paper drafted as a ministerial submission in 2017. Crop Science Focusing on product safety Product safety and environmental compatibility play a key role in the development of crop protection products and technologies to ensure that their use is safe for people and wildlife and does not cause unjustifiable damage to the environment. They therefore require official approval, which is governed by numerous international and national laws and regulations. Crop Science satisfies all the regulatory requirements of the countries in which our products are sold. In tests required by law, Crop Science already examines the products during the early development phase with regard to their mode of action, their (eco)toxicological properties and the extent of potential residues in plants and the environment. Every new crop protection active ingredient and every new technology must undergo these studies and tests. Furthermore, Bayer has made a voluntary commitment to market only those crop protection products whose active ingredients are registered in at least one OECD country or, in the case of new active ingredients, for which an OECD data package has been compiled. Since 2017, we have made safety-related data on our crop protection products transparent. More than 200 freely accessible summaries of scientific studies submitted in connection with the registration procedures for our active ingredients in the European Union are already available on an online platform. These documents include information on toxicological and ecotoxicological studies and investigations into degradability. From the start of 2018, noncommercial users will be given access to the full reports on request. In its sale and application of crop protection products and technologies, Crop Science observes the International Code of Conduct on Pesticide Management of the United Nations Food and Agriculture Organization (FAO). The principles of our responsible product handling are established in our Product Stewardship Policy and implemented in the Product Stewardship Program. The targeted use of crop protection products is crucial to minimize discharge outside of the treated crops. To support the safe use of its products in agricultural practice, Crop Science is particularly committed to protecting users, bee health and surface waters. Training customers and partners We support our customers and partners worldwide in the proper and safe handling of our seed and crop protection products. Targeted training measures particularly for farmers and dealers are designed to improve safety for users, the environment and thus consumers as well. Our objective is to increase the outreach of our training activities worldwide. Users of our products can contact Crop Science through a range of communication channels if they have complaints or feedback or wish to report any incidents. These include direct contact with our sales staff; our standard hotline, which is printed on all our product packaging; and, in Germany for example, the “Agrar Telefon” expert hotline. Online Annex: A 188.8.131.52-10 limited assurance Training for farmers and Bayer employees Our training activities teach farmers how to use crop protection products effectively and safely, and thus increase the yield and quality of their harvested goods. Subsequently, new marketing possibilities can arise that offer smallholder farmers in particular the chance to generate higher profits. In 2017, more than a million farmers worldwide received safety training from Bayer. The majority of these training activities took place as part of customer events because safety training is an integral part of our business activity. Additional training courses were conducted in cooperation with partners such as local, regional and international associations. Bayer focuses on training activities in countries where there are no statutory requirements or certification for users regarding the safe handling of crop protection products. With our regional organizations, we therefore establish plans of action for the respective prioritized countries that are then implemented locally. Our Product Stewardship Policy provides information on the principles for the responsible handling of our products, combined with specific instructions for use for our employees and those who work with our products. Our product stewardship measures also particularly include training activities for our sales representatives. Bayer Bee Care: strengthening bee health Healthy bees and other pollinators are important for sustainable food production. Promoting the health of pollinators and sustainable agriculture is therefore of tremendous importance for our business. Within our Bee Care Program, we aim to strike a balance between contributing to the health and biodiversity of pollinators and helping farmers to optimize their agricultural production. We operate two Bee Care Centers in Germany and the United States for this purpose and have established a global Bee Care network. Bayer participates in numerous projects and partnerships with local scientists and research institutions worldwide to strengthen bee health and safety. Online Annex: A 184.108.40.206-11 limited assurance Objectives of the Bee Care Program The health of bees and other pollinators can be impacted and impaired by a number of complex factors that can differ from one region to another. Relevant factors include pests and diseases, the availability of food sources in sufficient quantity and quality, agricultural practices and, in the case of honey bees, the quality of beekeeping practices. Through our Bee Care Program we reach out and connect with a broad range of stakeholder groups and actively support constructive and open dialogue. Our goal is to jointly seek opportunities for cooperating on health issues concerning bees and other pollinators. With the Feed a Bee Program in North America we address organizations and individuals to help extend food sources for bees and other pollinators by sowing plant seeds and creating additional flowered areas. Between 2015 and the end of 2017, more than a million individuals and over 120 partner organizations helped to grow in excess of three billion flowering plants by spreading individual Bayer seeds packs. In Germany, Bayer is conducting a major multiyear study in agricultural landscapes to investigate how ecology-enhancing measures to promote insect biodiversity in agriculture are having an effect. In South America, we support projects studying the attractiveness of various crops to bees so as to better understand the relationship between pollinators and local crops and to optimize the use of crop protection products with regard to their bee safety. With its Healthy Hives 2020 Program, Bayer conducts important research projects in the United States whose results will benefit beekeeping. Through the equivalent program in Latin America, which is currently being initiated, we want to contribute to improved local honey bee health through research activities such as the monitoring of factors that influence honey bee health and through beekeeper training activities. In our efforts to find new ways of effectively controlling the Varroa mite, a dangerous parasite for honey bees, the Animal Health segment has developed a new product consisting of a plastic strip treated with an active ingredient that protects beehives from mite infestation. Since 2017, the product has been available to beekeepers in many E.U. countries. The authorization procedure is ongoing for additional countries. To minimize risks to bees, we perform extensive safety testing, risk assessments, product stewardship measures and the development of bee-friendly crop protection products and processes. Ongoing re-evaluation of neonicotinoids Bayer is convinced that neonicotinoids schließen Neonicotinoids are a chemical class of systemic insecticides. are user-safe insecticides with a favorable environmental safety profile, and are not dangerous to bees when used according to label instructions. This has been confirmed by risk evaluations performed during marketing authorization reviews by the responsible authorities of countries outside Europe. In Europe, however, Bayer products that contain two of our neonicotinoid compounds have been prohibited since 2013 from use in crops that are attractive to bees. The European Commission has instructed the European Food Safety Authority (EFSA) to examine all newly available data and reports from the past four years. The results are expected in spring 2018. Bayer brought the restriction on neonicotinoid use in the E.U. before the Court of Justice of the European Union in August 2013 in order to clarify the legal basis of the Commission’s decision. This decision is based on an assessment by the EFSA that in turn is based on neither a validated nor an officially recognized risk assessment system. With a view to future investment decisions, the company is primarily asking that the court clarify the regulatory framework. Model projects for water protection in agriculture Crop Science develops strategies and solutions to support the agricultural industry in sustainable water usage. Online Annex: A 220.127.116.11-12 limited assurance In the area of water pollution mitigation, we advise our customers and recommend biological remediation systems such as Phytobac™ to them, for example. This system is intended to prevent discharges into water bodies of crop protection active ingredients that are generated during the filling and cleaning of spraying devices or the disposal of residual liquids. The system is being tested in numerous E.U. countries and offered commercially by suppliers. In Europe, more than 4,600 remediation systems are currently installed. Erosion and runoff processes on agricultural land can also lead to substance emissions into adjacent water systems. In this context, we are collaborating with external partners on the development of a digital geoinformation system for water protection in agriculture. This enables the visualization of site-related risks by means of high-resolution risk maps supplemented with proposals for proven procedures. This system will be used as an advisory tool for water protection in agricultural operations. To more effectively account for increasing demands with regard to environmental protection and occupational safety, Crop Science and the company agrotop GmbH have developed the easyflow system. This is a closed, contamination-free discharge system for liquid crop protection products from sealed and unsealed canisters that enables partial and full discharge and cleans itself fully. The system has already been successfully introduced in practice for small plant sprayers used in fruit and vegetable cultivation. A new version for larger sprayers used in farming is currently being introduced to the market. Animal Health Safety standards for animal health products In line with the statutory requirements, strict safety and quality standards also apply to animal health products, animal feed and feed additives. Within the scope of the approval / authorization procedures, Animal Health carries out detailed studies in order to ensure the safety of its products for the treated animals, people and the environment alike. A particular focus lies on monitoring veterinary pharmaceutical safety and on activities aimed at responsible product use. In line with our Prudent Use Policy, we support the responsible use of antibiotics and promote their proper use, for example through strict guidelines. We also work on the development of alternative strategies to antimicrobial treatment. Since 2015, we have been marketing Zelnate™, a nonantibiotic immunostimulant. Online Annex: A 18.104.22.168-13 limited assurance Safety and control system for animal health products We continuously compile all safety-relevant information such as reports of suspected adverse effects of pharmaceuticals in our global safety database. This information is evaluated and reported to the responsible authorities in accordance with national regulations. In this process, Animal Health works closely with the responsible regulatory and supervisory authorities at the national and supranational levels. This includes especially the European Medicines Agency (EMA) and the national agencies in the European Economic Area, the U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA), and the responsible authorities in other countries. We work together with veterinarians, pharmacists, farmers and private animal-owners worldwide to promote the correct handling of our products. We participate in the European Platform for the Responsible Use of Medicines in Animals and engage in dialogue with stakeholders from academia, politics and society.