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. We respect legal requirements, and our voluntary commitment and internal standards go beyond these in various areas.

The general processes and conditions of the acquired agriculture business are comparable with those of Bayer. Responsibilities and implementation are handled locally in many cases, however, and are not centrally documented. As a result, these processes are not directly comparable with those of Bayer, which is why the following cross-segment information does not include the acquired agriculture business. However, the sector-specific data for Crop Science does include the acquired agriculture business.

Assessments and testing

Our substances and finished products undergo extensive assessment and testing regarding product safety. We examine possible health and environmental risks along the entire value chain and use this to derive appropriate measures to mitigate risks.

We assess the properties of our substances and active ingredients already at the research and development stage. We discontinue the development of those 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.

We also conduct environmental risk assessments or implement risk management measures for our active ingredients subsequent to their registration. Moreover, we help to tackle questions about the impact of active ingredients in the environment and ensure that concerns are addressed through sound risk assessments and analyses. To this end, we have established a risk-benefit assessment process for active ingredients that adequately considers customer needs relative to potential or known environmental risks.

We carry out the risk assessments for our substances 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 the use of a certain substance is not safe, we take steps to mitigate risk. These can vary from revised application recommendations to substitution of a substance. In this case, a replacement that is economically and technically viable needs to be sought. The applicable assessment steps are established in a corporate policy.

We also monitor all our products that are already available on the market. For this purpose, we have established processes throughout the company aimed at addressing inquiries on product safety or problems with our products. This feedback is integrated into our risk assessment.

Information on substances and products

Bayer compiles safety data sheets for all chemical substances regardless of whether or not this is required by law. Targeting professional users, they contain information on a substance’s properties and on its safe use. In addition, technical information is provided for professional use. All end consumer products contain appropriate information in their packaging, an example being package inserts for pharmaceuticals.

In accordance with the respective product safety and information obligations, we compile product information both for raw materials and for intermediates and end products and make this information available across the company worldwide.

General conditions

Extensive legal regulations apply to all Bayer products. Chemical substances are subject to the respective national chemical regulations (e.g. REACH in the European Union or TSCA in the United States). The classification and labeling of chemicals enables users to become informed about the risks associated with chemicals. Bayer implements the Globally Harmonized System (GHS) for the classification and labeling of chemicals worldwide.

Furthermore, the finished products such as pharmaceuticals, crop protection products and 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.

Authorities in the European Union enforce the implementation of obligations resulting from chemicals legislation through regular inspections. For this reason, we require our suppliers to acknowledge conformity with REACH for all supplied substances.

We voluntarily apply comparable standards around the world, independent of the respective national legislation. We are successively assessing the hazard potential of all substances (> 99%) we use in quantities exceeding one metric ton per annum. By the end of 2018, we had assessed 85% (2017: 76%) of these substances. Starting in 2019, the substances used in these quantities by the acquired agriculture business will be included in the assessment.

Commitment

We are actively engaged in product stewardship activities through our work in relevant associations and initiatives. Since 1994, Bayer has supported the voluntary Responsible Care™ initiative of the chemical industry and the associated Responsible Care™ Global Charter. We actively participate in the further development of scientific risk assessment and are involved in several associations, such as the European (CEFIC), U.S. (ACC) and international (ICCA) chemical industry associations and the OECD, as well as in initiatives such as European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). We also support the Strategic Approach to International Chemicals Management (SAICM) with the goal of further minimizing negative effects of chemicals on the environment and human health through 2020.

Quality management

The Quality corporate function ensures uniform quality standards across all segments and functions along with the continuous improvement of all quality-related processes. The quality requirements derived from regulatory requirements, permits and authorizations, relevant standards of nongovernmental organizations and industry associations and customer expectations are regularly reviewed and integrated into an internal quality management system. Compliance with the statutory requirements, relevant standards in production and registered product specifications is regularly audited by internal experts, regulatory authorities and external assessors. These audits also cover institutes subcontracted by Bayer, service providers and our suppliers.

Our segments have quality management systems based on sector-specific international standards. We indicate the degree of coverage with this kind of certification in relation to the reference parameter energy consumption. In 2018, 67.9% of our production sites had a certified quality management system (2017: 75.4%, excluding the acquired agriculture business).

Quality management of segments

The quality management system of the Pharmaceuticals and Consumer Health segments forms the basis for the highest possible safety standards in the manufacturing of pharmaceuticals and medical devices, which are subject to strict quality requirements. It is based on internationally recognized standards such as ISO (e.g. ISO 9001, 17025 and 13485) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), as well as on rules for good working practices ( GxP is a collective term for all guidelines that govern “good working practice” and are particularly relevant for the fields of medicine, pharmacy and pharmaceutical chemistry. The “G” stands for “Good” and the “P” for “Practice,” while the “x” in the middle is replaced by the respective abbreviation for the specific area of application – such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Agricultural Practice (GAP). These guidelines are established by institutions such as the European Medicines Agency or the U.S. Food and Drug Administration. ) in the development and manufacture of pharmaceuticals, such as Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Clinical Practices (GCP).

Our veterinary medicine products also comply with stringent GxP quality standards stipulated in the relevant statutory requirements applying to development, approval, manufacture, marketing and safety monitoring. According to these, safety is to be ensured for the animals to be treated, people and the environment alike.

Product manufacture at Crop Science (including the acquired agriculture business) is performed according to ISO 9001. Our products are authorized by the relevant national authorities and thus fulfill the respective requirements with regard to quality and user safety.

Responsible use of biotechnology

Bayer applies biotechnology both in the area of seeds and in pharmaceutical product development and production, such as for Kogenate™ and Kovaltry™. Further biotechnologically manufactured active ingredients are undergoing clinical development. In plant cultivation, 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, globally applicable 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.

Our commitment to preserving biodiversity

In the course of our business activities, we aim to use natural resources responsibly and respect biodiversity. Our principles on biodiversity are set forth in both the Bayer Human Rights Policy and 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.

Biodiversity in the segments

Crop Science commits itself through a directive to acquire and use genetic resources only in harmony with international and national legislation. At the same time, Crop Science is committed to the preservation and improvement of crop plants and to the equitable distribution of access to their utilization. We support sustainable agriculture that takes account of people’s nutritional needs and safeguards farmers’ livelihoods, while at the same time conserving a healthy environment. In this context, Crop Science promotes and supports ecological enhancement measures in agriculture and the recovery and protection of natural and semi-natural habitats. Together with farmers and scientific experts, we are working to find solutions to preserve biodiversity. At the Bayer ForwardFarms, we demonstrate how sustainable agriculture can be realized in practice.

Bayer is a member of the Association of Research-Based Pharmaceutical Companies and supports its 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.

When planning new production sites, Bayer takes into account that they must not be set up in areas that are statutorily protected with regard to their natural characteristics, biodiversity or other factors. Due to our portfolio changes in 2018, we will undertake an updated comparison of the geographical coordinates of our production sites against those of internationally recognized protected areas in 2019.

Commitment to animal welfare

Animal studies are legally required and essential from a scientific viewpoint for assessing the safety and efficacy of our products. We aim to minimize the use of study animals and to employ alternative methods whenever possible. Responsibility for animal welfare at Bayer including in the acquired agriculture business lies with the Bayer Global Animal Welfare Committee. The acquired agriculture business’s own animal welfare principles and processes will remain valid until the newly acquired sites have been fully integrated into Bayer’s existing animal study and animal welfare processes. Unless indicated otherwise, the information below therefore refers to Bayer excluding the acquired agriculture business.

Bayer participates in international validation programs to find replacement methods, such as a process to record the estrogenic effects of crop protection products that forgoes the use of rats. In early drug screening, furthermore, Bayer continuously establishes different computer-based and in-vitro processes that help to reduce the number of animal studies or the impact on animals in subsequent testing.

We respect all legal requirements pertaining to animal welfare, compliance with which is verified both by regulatory authorities and through internal audits. In addition, Bayer’s principles on animal welfare and animal studies apply. Bayer’s Global Animal Welfare Committee monitors compliance with these principles 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.

Commitment to reducing animal studies

Based on performance indicators, we each year analyze the development of animal numbers, the distribution according to species and the impact on our test animals, while evaluating studies and discussing possible steps in accordance with the 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) was reduced in the last 10 years from 64 animals per €1 million of research and development spending in 2009 to 30 animals in 2018. These figures include the acquired agriculture business since closing.

We participate in several internationally renowned consortia and projects that aim to reduce the number of animals used in studies and to improve the studies’ validity.

Protection against product counterfeiting

Counterfeit products harbor substantial risks for patients and consumers. Through the Beware of Counterfeits campaign, Bayer is taking up the fight against counterfeit pharmaceuticals together with public authorities in Germany and abroad. The website of the same name contains information on the risks of counterfeit pharmaceuticals and offers patients tips on how to protect themselves. Crop Science has also implemented a global strategy to combat product piracy that is based on close cooperation with crop protection and law enforcement authorities. On the Counterfeits in Agriculture website, we provide information on how to identify counterfeit and illegal crop protection products or seeds and what risks they harbor, while giving farmers tips on how to protect themselves against counterfeiting.

Product counterfeiting can only be addressed internationally through a joint approach by industry, associations, governmental agencies and nongovernmental organizations. We advocate the resolute application and, where necessary, the strengthening and expansion of existing laws and provisions that serve to enable the identification and confiscation of illegal products. We support these efforts through extensive measures of our own in the areas of production and packaging that are designed to enable users and customers to distinguish original from counterfeit products.

Pharmaceuticals and Consumer Health

Benefit-risk management for pharmaceuticals and medicinal products

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 comply with regulatory safety requirements. The same applies to medicinal products, dietary supplements and cosmetics.

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 in Japan (PMDA)
– the China Food and Drug Administration (CFDA)

According to these regulations, we 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 profile of pharmaceuticals, medicinal products, dietary supplements and cosmetics regularly evaluated by medical experts of various disciplines in the global 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, we work 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.

Global pharmaceutical monitoring system

Pharmaceuticals and Consumer Health 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 is entered in our pharmacovigilance database. In particular, the evaluation includes potential side-effects reported both to us as a producer and to the health authorities via various communication channels and stakeholders 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, we immediately take steps to safeguard the health of patients and consumers in coordination with the authorities. These measures 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 that we compile is reported to the national health authorities in the relevant countries, where it is processed. As processes in the European Union are centralized, 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.

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. According to 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 all aspects of this issue be observed over a longer period of time.

Compliance with the relevant wastewater thresholds at our production sites worldwide 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 by 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. Moreover, Bayer is involved in the stakeholder dialogue initiated by the German government with the goal of developing a strategy for dealing with trace substances in bodies of water.

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, wildlife and 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.

The development and commercialization of genetically improved seed is also subject to stringent international and national laws and regulations. We have additionally established internal processes to ensure the responsible use of biotechnologically manufactured products throughout their life cycle. Furthermore, in 2018, Crop Science maintained its membership in the Excellence Through Stewardship (ETS) organization. Audits by ETS-certified auditors are required to maintain ETS membership. In 2018, facilities involved in plant biotechnology product development in the United States and Brazil were recertified by ETS-certified external auditors.

Processes in plant biotechnology

According to information from the nonprofit organization ISAAA (International Service for the Acquisition of Agri-biotech Applications), genetically modified crops are grown on more than 190 million hectares in over 24 countries. GMOs are developed using transgenesis, whereby a copy of a gene of interest from a nonrelated organism is added to improve the plant. They have delivered strong agronomic, economic and environmental benefits since they were introduced to agriculture in the 1990s. GMOs can help farmers manage difficult growing conditions better and increase productivity by protecting harvests from pests and weeds while using fewer natural resources. They offer economic growth opportunities for farmers, especially for small-scale producers in less developed parts of the world. The safety of biotech crops has been confirmed by more than a thousand studies and third-party peer reviews overseen by regulators in 67 countries.

Gene editing is another modern approach largely based on improving plants’ existing genetics, for example by switching off a negative effect or amplifying a plant’s ability to thrive in drought or nutrient-poor conditions or to produce more nutrient-rich vitamins. Modern plant breeding methods including CRISPR can be used to more efficiently and more precisely develop the new crop varieties needed to sustainably secure a safe, affordable and healthy food supply.

We already examine our crop protection 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, in tests required by law. Each new crop protection active ingredient undergoes a thorough safety assessment and suitable scientific studies and testing. 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.

Bayer aims to strengthen our customers’ and stakeholders’ confidence in our products through transparency and is therefore the first company in its industry to make safety-relevant data on crop protection products publicly available. More than 230 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 reports include information on toxicological and ecotoxicological studies and investigations into degradability.

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.

Users of our products can contact Crop Science through a range of communication channels should they have complaints or feedback or wish to report any incidents. These include direct contact with our sales staff; our standard hotlines, which are printed on all our product packaging; and, in Germany for example, the “Agrar Telefon” expert hotline.

The targeted use of crop protection products is crucial when it is a matter of minimizing 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 and the environment.

Training customers and partners

In dedicated training courses, we teach farmers, seed treatment professionals and dealers how to use our products effectively and safely and thus increase the yield and quality of their harvested goods. Our objective is to increase the outreach of our training activities worldwide.

Training farmers and Bayer employees

In 2018, Bayer trained more than one million farmers around the world in the safe handling of crop protection products. The majority of these training activities took place as part of customer events, as safety training is an integral part of our business activities. The data for 2018 does not yet include the acquired agriculture business. Additional training was 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. Bayer also organizes safety training for its own employees and contract workers from outside companies, in particular for sales force employees. We also train farmers in various technical areas such as resistance management and the correct use of products such as XtendiMax™ with VaporGrip™ technology and dicamba. More than 25,000 users in the United States completed certification mandated by the U.S. Environmental Protection Agency (EPA) in 2018.

Impact of crop protection products on the environment

Bayer Bee Care: strengthening bee health

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. Our Bee Care Program is a central industry platform to promote bee health. Through this, we want to create a balance between promoting the health, safety and biodiversity of pollinators and optimizing agricultural productivity. We contribute our experience in crop protection and animal health to numerous projects and partnerships with the goal of protecting and improving pollinator health. We operate a global Bee Care network and a Bee Care Center in Germany to promote dialogue on the topic of pollinator protection with all stakeholder groups.

Bee safety and crop protection products

To minimize risks posed to bees by our crop protection products, we perform extensive safety testing, risk assessments and product stewardship measures and develop bee-friendly crop protection products and processes. The first tests to measure bee toxicity are conducted already at the development stage.

We are also convinced that Neonicotinoids are a chemical class of systemic insecticides. are insecticides with a favorable environmental safety profile and are not dangerous to bee colonies when used according to label instructions.

Glyphosate helps to control weeds and contributes to sustainable farming

Glyphosate is a nonselective herbicide that is frequently used in several markets globally for effective and at the same time simple and cost-effective weed control management. This active ingredient was first introduced in 1974 and has since been marketed under a number of different tradenames in hundreds of crop protection products around the world by several dozen different companies. In Europe, most glyphosate-based herbicides are used according to the label to control weeds in production fields of a wide range of crops. Some glyphosate-based products can be used according to the label to control weeds in gardens and noncultivated areas, such as industrial complexes and along railway tracks.

Glyphosate works in plants by specifically inhibiting an enzyme that is essential to plant growth. This enzyme is not found in cells of humans or animals. Glyphosate has a 40-year history of safe use when used according to label directions. This is confirmed by science-based evaluations conducted by regulatory bodies and other scientific institutions such as the U.S. Environmental Protection Authority (EPA) as well as the Canadian Department of Health, Health Canada, which in January 2019 confirmed that “[n]o pesticide regulatory authority in the world currently considers glyphosate to be a cancer risk to humans at the levels at which humans are currently exposed.”

We offer extensive information on the public debate surrounding the safety of glyphosate for users and the environment on our website. More information on the lawsuits against Bayer in the United States can be found in the notes to the consolidated financial statements.

Model projects for water protection in agriculture

Crop Science develops strategies and solutions to support the agriculture industry in sustainable water pollution mitigation. We recommend that farmers use biological remediation systems, for example, such as Phytobac™. We are also developing a digital geoinformation system for agriculture with external partners to prevent discharges into water bodies of substances through erosion and runoff processes on agricultural land and a closed discharge system for liquid crop protection products.

Animal Health

Safety standards for animal health products

In line with statutory requirements, strict safety and quality standards also apply to animal health products and biocides. 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.

A particular focus lies on monitoring veterinary pharmaceutical safety and on activities aimed at responsible product usage. In line with our Prudent Use Policy, we support the responsible use of antibiotics and promote their proper usage, for example through strict guidelines. We also work on the development of alternative strategies to antimicrobial treatment. We market Zelnate™, a nonantibiotic immunostimulant. 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.

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