Safety for People and the Environment
We consider product stewardship to mean 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 testing and evaluation in the interest of product safety. We assess possible health and environmental risks along the entire value chain and implement the appropriate measures to mitigate risks based on this.
We strictly observe the legal requirements, and our voluntary commitment and internal standards go beyond these in many areas. This is steered by the Corporate Health, Safety & Sustainability function, which is responsible for implementing the related policies and maintaining the HSE management systems.
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 regulation (Regulation on Classification, Labelling and Packaging of Substances and Mixtures). The classification and labeling of chemicals enables users in the European Union to become informed about the risks associated with chemicals.
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Requirements of the REACH and CLP regulations met
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. There is also an authorization procedure that limits the use of particularly hazardous substances or can lead to their replacement or ban. 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, one Bayer substance has required authorization. The authorities enforce the implementation of REACH through regular inspections. So far none of the inspections at Bayer has resulted in complaints. We also require our suppliers to confirm conformity with REACH for all substances they supply to us.
In the European Union, the Globally Harmonized System (GHS) for the classification and labeling of chemicals is implemented through the CLP regulation. The purpose of the GHS is to achieve a globally standardized system for classifying chemicals and labeling them appropriately on packaging and in safety data sheets. Bayer assesses all its marketed products and implements the GHS worldwide.
Before any product is introduced to the market, we assess it to determine whether it is safe. Furthermore, the end products from our Life Science Life Sciences This term describes Bayer’s activities in health care and agriculture and comprises the Bayer Group excluding its legally independent subsidiary Covestro. It refers to the businesses of the Pharmaceuticals, Consumer Health and Crop Science divisions and the Animal Health business unit. segments – such as pharmaceuticals, crop protection products and biocides 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 approval / authorization 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 HSEQ stands for health, safety, environment, quality. management systems. We are also actively involved in the further development of scientific risk assessment through our work in associations and initiatives.
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Comprehensive support for association activities
International associations such as the European and international chemical industry associations (CEFIC, ICCA) and the OECD (Organisation for Economic Cooperation and Development), as well as initiatives such as ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals), work to evolve 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. We are also 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. In addition, we support the Global Product Strategy (GPS), a voluntary commitment of the chemical industry initiated by the International Council of Chemical Associations (ICCA). Its objective is to improve knowledge about chemical products, especially in Emerging Markets and developing countries, and thus increase safety in the handling of these products.
We continuously evaluate our substances’ properties already at the research and development stage. The development of products with undesirable properties is discontinued in application of the precautionary principle.
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We accept the precautionary principle as explained in Principle 15 of the Rio Declaration of the United Nations and communiqué COM (2000) 1 of the European Commission as a possible consumer protection and risk management tool. It is applied whenever there is no final scientific certainty in a given area and evidence also exists that people or the environment could suffer significant or irreversible damage. In our view, the focus should not be unilaterally on hazard potential, but rather on a balanced benefit-risk evaluation.
In Europe we operate 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 assess the hazard potential of all substances of our Life Sciences (> 99%) used in quantities exceeding one metric ton per annum. By the end of 2016 we had assessed 66% of these substances. The applicable assessment steps and measures are established in our Corporate Policy “Substance Information and Availability.”
Group target 2020:
assessment of the hazard potential of all substances > 1 metric ton p.a.
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 the steps to mitigate risks.
Product information for safe use
We pay special attention to 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. We offer suitable packaging information for all end consumer products, an example being package inserts for pharmaceuticals.
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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 means 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, all segments compile product information both for raw materials and for intermediates or end products. IT systems enable worldwide access to this information, including as regards 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.
Responsible use of biotechnology
We currently use biotechnological methods in pharmaceutical product development and production and in the area of crop protection. At Pharmaceuticals, the products involved include Betaferon™ / Betaseron™, Eylea™ and Kogenate™, while at Animal Health this concerns Zelnate™ – a nonantibiotic immunostimulant product. Further biotechnologically manufactured active ingredients are undergoing clinical development. Plant biotechnology can improve and secure crop yields and the stress tolerance of plants.
For Bayer, safety is a priority in the use of biotechnology. In addition to legal and regulatory requirements, Bayer has formulated a corporate policy on the responsible use of gene technology. We provide our stakeholders with comprehensive information about our products and services in accordance with our Corporate Policy “Responsible Marketing & Sales.”
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Activities of the segments
Pharmaceuticals, Consumer Health and Animal Health have established strict safety measures for handling biological agents in the global “Biological Safety” and the “Requirements for the safe handling of biological agents” procedural instructions.
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 focus on the conscientious use of plant biotechnology products through its membership of the Excellence Through Stewardship (ETS) organization. Audits by ETS-certified auditors are required to maintain ETS membership, and in 2016 Crop Science completed eight audits in Europe, the United States and Africa.
Our commitment to preserving biodiversity
We take into account influences on biodiversity throughout the entire value chain and have established our principles in our own position. There we commit ourselves to the United Nations Convention on Biological Diversity Diversity designates the variation within the workforce in terms of gender, origin, nationality, age, religion, sexual orientation and physical capability. and the associated Nagoya Protocol, which regulates access to genetic resources and the balanced and fair sharing of the arising benefits. Crop Science commits itself through an internal policy to ensure that Bayer only acquires and uses genetic resources in harmony with international and national legislation.
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Biodiversity strengthens the resilience of ecosystems and is a key condition for the maintenance of sustainable agriculture. With its products and services, Crop Science contributes to this. Our goal is to help our customers to integrate responsible crop protection methods into agricultural operations and to preserve soil and water quality and the habitats of insects, pollinators and birds. We work together with farmers on solutions for producing more food through sustainable agriculture without, for example, increasing the use of crop protection products.
Various ecological enhancement measures are undertaken to support resilient ecosystems, such as enhancing the biodiversity of pollinators by planting flowering strips and the more extensive cultivation of slopes to protect against erosion. These, for example, can help farmers improve soil fertility and water regulation in their fields, or boost the pollination activities of insects and thus increase their yields and biodiversity. At the Bayer ForwardFarms, the host farmers and the company demonstrate to the public how sustainable agriculture and ecological enhancement measures work in practice.
In addition, 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. Among other things, a corresponding policy, which applies to all sites of Pharmaceuticals and Consumer Health, takes into account that both segments concentrate on the chemical synthesis of substances using state-of-the-art technologies in medicinal, combinatorial and computational chemistry. If natural substances are used during research into new pharmaceuticals, they are first checked 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. We respect all legal requirements pertaining to animal welfare, compliance with which is verified through both regulatory authorities and internal audits. Bayer’s principles on animal welfare and animal studies apply in countries without special legislation. 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.
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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) 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: if 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. . We are able to demonstrate that since 2005, the number of study animals used per €1 million research budget (including animals in Bayer studies performed by contract research organizations) has declined from 96 animals to around 27 animals in 2016.
Bayer participates in several consortia and projects that aim to reduce the number of animals used in studies or improve the studies’ validity. We participate, for example, in the Center for Alternatives to Animal Testing (CAAT), and scientists from Pharmaceuticals are involved in the leadership of the eTOX project and in the MARCAR and K4DD projects within the scope of the Innovative Medicines Initiative (IMI Innovative Medicine Initiative (IMI) is a public-private partnership developed by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) with the goal of promoting biomedical research in Europe. IMI finances research projects aimed at overcoming the major bottlenecks in the research and development of new pharmaceuticals. The partnership provides funding to project participants from academic institutes, small and medium-sized businesses, patient organizations and other institutions. The pharmaceutical industry contributes to these projects by donating capacities and resources. ). Employees from Crop Science are represented on the Board of Administration and the Scientific Committee of the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). In Germany, we are active in the Centre for Documentation and Evaluation of Alternative Methods to Animal Experiments.
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 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.
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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.
We 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 2016, a research project (ALPhA) supported by the German Ministry of Education and Research with Bayer’s participation was completed. This established the need for a minimum harmonization of criminal conduct definitions and penalties at the E.U. level in criminal law relating to medicine. Close cooperation between all stakeholders is necessary in the future to achieve practical success in fighting counterfeiting and prevent the sale of counterfeit pharmaceuticals on the internet. Bayer is intensively involved in such alliances and has been a partner to the “Innovation Power for Safety in Industry” initiative since 2016.
Combating illegal crop protection products
To protect against the import of counterfeit and illegal crop protection products into the E.U., Crop Science intensively advocates the uniform interpretation and implementation of existing E.U. regulations in all E.U. 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 2016, we reviewed our strategy to protect against illegal crop protection products and rolled the revised version out worldwide.
As part of our product stewardship programs, we provide information material about the risks of counterfeit and illegal crop protection products and train customers, dealers, farmers and regulatory authorities. We document all indications of suspicious and potentially counterfeit or illegal Crop Science products. We work constantly to counterfeit-proof our products through the use of security features. In 2016, we identified patent and trademark violations in China, India and Brazil, and successfully defended our rights.
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 and medicinal products throughout their entire product life cycle. The efficacy, safety and tolerability of pharmaceuticals are studied in Phases I-III of preclinical and clinical development. The documentation submitted to the regulatory authorities contains the results of these studies and a comprehensive benefit-risk assessment. It is essential for a new pharmaceutical or medicinal product to satisfy regulatory safety requirements if it is to receive marketing authorization. According to these regulations, the segments continue to compile safety-relevant information in a dedicated database following market launch. This information is continuously assessed and the benefit-risk balance regularly evaluated by medical experts of various disciplines in the global Pharmacovigilance Pharmacovigilance is defined as the science of, and activities related 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 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.
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 and Drug Administration (CFDA).
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Responsibility of safety management teams
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 the benefit and safety data and other relevant product information so as to identify potential safety concerns at an early stage or detect possible changes in the benefit-risk ratio.
In addition to internal safety data from clinical trials, post-marketing studies and spontaneous adverse event reports, the company uses external databases and information from scientific publications to conduct assessments. SMTs produce detailed safety risk management plans that are updated as soon as relevant new benefit-risk data become available. Implementation of risk mitigation activities is coordinated by local SMTs in the country organizations. All processes are documented, regularly updated and integrated into the quality management system.
Should risks be identified, Bayer immediately undertakes steps to safeguard the health of patients and consumers in coordination with the authorities. These measures range from updating product information for patients, consumers 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 if necessary.
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. Pharmaceuticals and Consumer Health carry out their own 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. Based on currently available information, the existing concentrations of individual active pharmaceutical ingredients in drinking water do not have any relevant adverse effects on human health. This subject is dealt with in particular by a WHO report on pharmaceuticals in drinking water published in 2012 that comes to the conclusion that traceable effects on human health through the current extent of exposure via drinking water are highly improbable. We are following the discussion and actively participating in the stakeholder dialogue.
Bayer complies worldwide with all statutory requirements regarding wastewater thresholds at its production sites. In line with the regulatory requirements, these are reviewed by supervisory authorities and external consultants and also at regular intervals through audits by internal experts.
To further reduce or completely avoid traces of pharmaceuticals entering the environment, we are taking our own measures in production. In addition, as part of the Eco-Pharmaco-Stewardship initiative of European pharmaceutical associations, we have adopted their methods for the risk assessment of pharmaceutical traces in production wastewater. Bayer has reviewed its production sites according to these methods and, where necessary, taken site-specific measures aimed at a further reduction. We are also participating actively in various research projects to develop reduction measures.
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Participation in extensive research projects
Bayer coordinates the “Intelligence-led Assessment of Pharmaceuticals in the Environment” project in Europe, which seeks new ways to improve environmental risk assessment. The goal is to develop models and methods for determining possible environmental risks of pharmaceutical substances in early development stages and to prioritize for further environmental assessment existing substances that previously have not been evaluated.
In Germany, Bayer, as member of the steering committee, participated in the “Risk Management of Emerging Compounds and Pathogens in the Water Cycle” initiative sponsored by the German Ministry for Education and Research (BMBF). At the conclusion of the initiative in 2016, the results were presented and, overall, Germany’s flowing waters were attested to be in good condition. Within the scope of the precautionary principle, however, further-reaching purification of wastewater is recommended for the future.
Bayer is also involved in the stakeholder dialogue initiated by the German government in 2016 on the issue of micropollutant strategy. This dialogue process is aimed at developing a strategy to prevent the water-polluting effects of certain chemicals, including active pharmaceutical ingredients. The results and recommended measures are expected to be summarized in a position paper in the summer of 2017.
Focusing on product safety
Product safety and environmental compatibility play a central role in the development of crop protection products and technologies so that they are harmless to people and animals and can be used without constituting an unjustifiable ecological burden. For this they require official authorization, which is regulated by numerous international and national laws and provisions. The requirements for marketing authorization, particularly as pertains to the environment, have risen sharply in recent years. 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 development phase with regard to their mode of action, their (eco)toxicological properties and the extent of potential remaining trace concentrations in plants and the environment. Each new crop protection active ingredient and each new technology must undergo these studies and tests to ensure that the active ingredient can be applied effectively as a product and that its use or that of the relevant technology is safe for people, animals and the environment.
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. 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). We implement all major aspects of responsible product handling in our Product Stewardship Program, which is based on the principles of our Product Stewardship Policy.
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Model projects for water protection in agriculture
The targeted use of crop protection products that minimize discharge outside of the treated crops is very important to Crop Science. Through best management practices, Crop Science supports agriculture in safe and environmentally friendly land cultivation and the disposal of residual liquids following the application of crop protection products.
In the area of water pollution mitigation, we give recommendations and advice to our customers particularly with regard to biological remediation systems such as Phytobac™. These systems are intended to prevent point source discharges of crop protection active ingredients into water bodies that are generated during the filling and cleaning of spraying devices or the disposal of residual liquids. The system is now being tested in numerous E.U. countries and offered commercially by suppliers. In Europe, around 4,100 remediation systems are currently in operation.
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 web-based 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. It is planned for this system to be used as an advisory tool for water protection in agriculture.
To more effectively account for increasing demands with regard to environmental protection and occupational health and safety, Crop Science and its external partner agrotop GmbH have developed a closed, contamination-preventing discharge system for liquid crop protection products. It consists of sealed canisters that enable partial and full discharge and completely clean themselves.
Bayer Bee Care: strengthening bee health
As a Life Science company, we know how important healthy bees are as pollinators for sustainable food production and are aware of the key role they play in ecosystems. Promoting the health of pollinators and sustainable agriculture is of tremendous importance for our business. Within our Bee Care Program, we combine all activities in the area of pollinator health and safety. We operate Bee Care Centers in Germany and the United States for this purpose and have also established a global Bee Care network.
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Objectives of the Bee Care Program
Health problems among bees and other pollinators are caused by a number of complex factors. These include pests, parasites, disease, extreme environmental and weather conditions, the availability of food, and certain agricultural and beekeeping practices. Bayer is involved in numerous projects and partnerships to more closely study these factors and strengthen bee health.
Within the framework of the Bee Care Program, we proactively approach numerous stakeholder groups – including industry partners, scientists, farmers, beekeepers, governmental agencies, nongovernmental organizations, investors and representatives of the food value chain. Our goal is together to seek opportunities for cooperating in the field of bee and general pollinator health and to make our activities more transparent. For example, in 2016 we participated in a round of discussions in London on bee protection organized by Hermes Investment Management.
Activities to effectively protect bees
In North America, Bayer has launched a public appeal to create new foraging habitat for bees as part of its “Feed a bee” initiative. In addition, in the United States, through the partnership with the bee research society “Apis m.,” important stimulus was gained in 2016 for implementing research projects whose results benefit beekeeping (Healthy Hives 2020 program).
In Germany, Bayer looks at how insect biodiversity-enhancing measures work and is conducting a major, multi-year study on this subject in agriculturally oriented regions. In South America, we finance projects studying the attractiveness of various crops so as to better understand the relationship between pollinators and local crops and to optimize the use of crop protection products.
In connection with research into controlling the Varroa mite, a dangerous parasite for honey bees, Bayer has developed a plastic strip treated with an active ingredient that protects beehives from mite infestation. The product is expected to be available to beekeepers by 2017 to combat the Varroa mite.
We do everything possible to minimize risks to bees – through extensive safety testing, risk assessment, product stewardship measures and the development of bee-friendly crop protection products and processes.
Ongoing re-evaluation of neonicotinoids
We are convinced that neonicotinoids Neonicotinoids are a chemical class of systemic insecticides. are user-safe insecticides with a positive environmental profile, and are not dangerous to bees when used responsibly and according to labeling instructions. This was 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 recently instructed the European Food Safety Authority (EFSA) to examine all newly available data and reports from the past two years. The results are expected for the beginning of 2017.
Bayer has brought the restriction on neonicotinoid use in the E.U. before the Court of Justice of the European Union 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.
Involving customers and partners
The application of crop protection products requires the greatest possible care. We therefore 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 and thus also the environment and consumers. The objective is to increase the scope of our training activities worldwide.
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Training for farmers and Bayer employees
We continued our training activities worldwide in 2016. Farmers were taught how to use crop protection products effectively and safely, and thus increase the yield and quality of their harvested goods. Subsequently, new marketing possibililties can arise that offer smallholder farmers in particular the chance to generate higher profits.
Safe use training offerings are an important aspect here. In 2016, around 950,000 farmers worldwide were trained in the safe use of crop protection products. The majority of these training measures took place as part of customer events since safety training is an integral part of our business activity. We also conducted safe use training courses in numerous countries in 2016 in cooperation with partners such as local, regional and international associations.
Bayer focuses on training activities in countries where there are no statutory requirements as regards certification in the safe handling of crop protection products. We therefore establish plans of action with our regional organizations for the respective prioritized countries that are then implemented locally.
Our product stewardship measures also include internal employee training measures. Our Product Stewardship Policy provides information on all principles for the responsible handling of our products, combined with specific instructions for use for our employees and those who work with our products.
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 hotline, which is printed on all our product packaging; and, in Germany for example, the “Agrar Telefon” expert hotline.
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.
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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 own 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 EEA, the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the responsible authorities in other countries.
Responsible use of antibacterial active ingredients
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.
In line with our “Prudent Use Policy,” we support the responsible use of antibiotics, in particular of fluoroquinolones. We are convinced that effective antibacterial active ingredients are essential for the treatment of infectious diseases in animals. Animal Health promotes their proper use, for example through strict guidelines. We also work intensively on the development of alternative strategies to antimicrobial treatment. Since 2015, we have been marketing Zelnate™, a nonantibiotic immunostimulant.
Comprehensive assessment of health, safety and environmental risks
The safe handling and use of our products are of utmost importance. Besides statutorily required safety information, therefore, Covestro provides additional information such as safety summaries within the scope of the Global Product Strategy (GPS) of the International Council of Chemical Associations (ICCA). Covestro complies with all regulatory requirements for the protection of consumer health, including the use of the chemical bisphenol A. The company makes available both GPS information and product safety assessments through the “Product Safety First” internet portal.
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As a contribution to the safe handling of chemicals, risk assessments are conducted according to recognized scientific principles. Here Covestro makes use, for example, of the Guidance on Information Requirements and Chemical Safety Assessment of the ECHA (European Chemicals Agency). On the basis of a hazard assessment and an exposure assessment, it is determined what additional information is required to describe the risk posed by a product. All product groups undergo a multi-stage product safety assessment.