8. Product Stewardship
Our products and services are designed to benefit people and improve their quality of life. We consider product stewardship to mean that our products are safe for people, animals and the environment when properly used. This is a key factor in creating lasting trust in our products and maintaining our business foundation over the long term.
All substances and finished products undergo extensive testing and evaluation to ensure a high degree of safety. We assess the possible health and environmental risks of a product along the entire value chain – starting with research and development and continuing through production, marketing and use by the customer through to disposal. From this we derive suitable steps to mitigate risks based on the observation of legal requirements and internal standards that go beyond these.
Bayer has put in place suitable directives and management systems for the implementation of regulatory and voluntary product stewardship requirements that are steered by our HSEQ HSEQ stands for health, safety, environment and quality. (health, safety, environmental protection and quality) departments. These efforts are underscored by the Bayer Group’s target of completing the assessment of the hazard potential of all substances (>99%) used in quantities exceeding one metric ton per annum by 2020.
Implementing statutory requirements
Extensive legal regulations apply to all products manufactured by Bayer. Chemical substances are subject to the European chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and the CLP regulation (Regulation on Classification, Labeling and Packaging of Substances and Mixtures). The classification and labeling of chemicals is intended to clearly inform employees and consumers in the European Union about the risks associated with chemicals.
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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 fulfil the complex requirements of REACH, we have approved Group-wide and subgroup-specific regulations. 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. This is indeed the case for some Bayer substances. The authorities enforce the implementation of REACH through regular inspections. So far none of the inspections at Bayer has resulted in complaints. As we also use many substances from other manufacturers, we maintain close contacts with our suppliers and ensure that they reassure conformity with REACH for the substances they supply.
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 material 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 under this stringent process to determine whether it is safe for people, animals and the environment.
Furthermore, the end products from our Life Science units – 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.
Since 1994, Bayer has supported the voluntary Responsible Care™ initiative of the chemical industry, which was globalized in 2006 with the introduction of the Responsible Care™ Global Charter. We cover all main elements of the charter at all Group sites with our HSEQ management systems and activities. We are also actively involved in the further development of scientific risk assessment through our work in associations and initiatives.
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International associations such as the European and international chemical industry associations (CEFIC, ICCA) and the OECD (Organisation for Economic Co-operation and Development), as well as initiatives such as ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals) and the EPAA (European Partnership for Alternative Approaches to Animal Testing), 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 in the ICCA Long-Range Research Initiative, for example, and endorse the goals of the WHO and E.U. action plans for improving health and environmental protection. We also 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 concern ourselves intensively with our substances’ properties and regularly evaluate them already at the research and development stage. In application of the precautionary principle, the development of substances with undesirable properties is discontinued.
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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 that must be rectified. There should not be a unilateral focus on hazard potential, but rather a balanced risk-benefit evaluation.
To assess the effects of our products, especially on human health, but also on nature and the environment, animal studies are legally required. Wherever possible, we use existing data or approved alternative test methods to avoid animal studies. We set high animal welfare standards in this regard. For more information, see the section “Focusing on Animal Welfare.”
assessment of the hazard potential of all substances > 1 metric t on p.a.
The safe handling of chemicals is a top priority in the manufacture of our products (see also Chapter 9). 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 exceed statutory requirements and are ensuring that substance assessments comparable to those established under REACH will also be applied at Bayer sites that are not subject to this European regulation. How we aim to realize this target is established in our Bayer Group Regulation “Substance Information and Availability.”
To ensure the safe handling of chemicals, risk assessments are carried out applying recognized scientific methods such as the Guidance on Information Requirements and Chemical Safety Assessment of the ECHA (European Chemicals Agency).
Should the assessment or new findings reveal that it is not safe to use a certain chemical, we take the steps to mitigate risks. We support our customers in the safe handling and use of our products through close, trust-based cooperation. Bayer compiles material safety data sheets for all products regardless of whether or not they are legally required. All end consumer products come with suitable packaging information, an example being package inserts for pharmaceuticals.
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Risk mitigation measures can range from revised application recommendations through the withdrawal of support for a certain application to the substitution of a substance. In this case, a replacement substance must be sought that is economically and technically feasible. The substitution of chemicals is basically a continuous task of the chemical and pharmaceutical industry to obtain new or substantially improved products and processes. This is integral to our commitment to Responsible Care.
Material 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 the safe use of the substance or mixture. In addition, technical information is provided for professional use.
In accordance with the respective product safety and information obligations, all subgroups compile product information – regardless of whether it is for raw materials, intermediates or end products. To ensure worldwide access to this information, Bayer uses appropriate IT systems, including those for product labeling. This data compilation is updated accordingly whenever new legal requirements are established.
Another important element of our product stewardship is the monitoring of all products that are already on the market. We have established processes in all subgroups aimed at addressing inquiries on product safety or problems with our products. This feedback and these experiences are systematically accounted for in our assessment of risks, which also covers substances that are regarded as potentially high-risk by regulatory authorities and independent institutions.
In all subgroups, we examine additional steps that go beyond the legally required disposal specifications.
Product stewardship in the use of biotechnology
Biotechnological methods are used for product development in our Pharmaceuticals and Crop Protection businesses.
Biotechnology has already gained significant importance in pharmaceutical product development. The HealthCare products Betaferon™ / Betaseron™, Eylea™ and Kogenate™ are manufactured by a biotechnological process. Further biotechnologically manufactured active ingredients are undergoing clinical development.
Plant biotechnology can improve crop yields, yield security and the stress tolerance of plants through both genetic engineering and conventional breeding methods but with the same input of resources.
Safety is Bayer’s top priority in the use of biotechnology, too. Beyond our observance of all relevant legal provisions, we have formulated a Bayer Group Regulation “Position on the Responsible Use of Gene Technology” and specific regulations for HealthCare and CropScience. We provide our stakeholders with comprehensive, transparent and reliable information about our products and services in accordance with our Bayer Responsible Marketing & Sales Policy.
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HealthCare has established strict safety measures for handling biological agents in research, development and production in its “Biological Safety” regulation and its “Requirements for the safe handling of biological agents” procedure.
CropScience has included the responsible measures taken when utilizing plant biotechnology in both the Product Stewardship Policy and the Seeds Stewardship Directive. CropScience maintained its focus on product stewardship for customers both within and outside the company through its activities in the context of the industry’s Excellence Through Stewardship Program (ETS). Audits by ETS-certified auditors are required to maintain our ETS membership, and in 2015 CropScience successfully completed audits of its operations in Brazil and Argentina which included for the first time the new ETS Insect Resistance Management best practices for biotechnology-derived plant products.
Focusing on animal welfare
Animal studies are legally required and essential from a scientific viewpoint to assess the safety and efficacy of pharmaceuticals and other chemical compounds. We aim to minimize the use of study animals and to employ replacement and complementary methods wherever possible.
In our handling of animals, we respect all legal requirements pertaining to animal welfare. Bayer’s principles on animal welfare and animal studies apply in countries without special animal welfare legislation and in the case of external studies compliance with these guidelines is contractually agreed. Bayer’s in-house Global Animal Welfare Committee – comprised of the animal welfare officers at our research sites and further Bayer experts – monitors compliance with our principles on animal welfare and animal studies within the Bayer Group and in external studies. It defines supplementary standards that are essential for carrying out animal studies in the Bayer Group.
Bayer ensures that international and national laws and directives are strictly observed during all animal studies. This is verified by both regulatory authorities and internal audits. Bayer additionally deploys its own animal welfare experts at all sites at which animal studies are carried out.
Our principles also apply to both the research institutes we commission and our suppliers, whose compliance with our animal welfare requirements we regularly monitor. The information provided in supplier self-evaluations is verified through on-site audits. Current figures and further information are available on our website.
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The Global Animal Welfare Committee has defined performance criteria. Each year we analyze the development of animal numbers, the distribution according to species, the burden placed on our test animals and the ratio of regulatorily required studies to exploratory 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: 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 the animals’ suffering. . We are thus 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 31 animals in 2015.
We continuously update our internal database, which combines all information about our own animal studies and the evaluation of our cooperation partners and makes it available to all employees in this area. All subgroups apply clear rules to ensure that animal welfare standards are comprehensively observed by our partners.
Bayer also participates in several European consortia that aim to reduce the number of animal studies or improve their validity, such as the European Partnership for Alternative Approaches to Animal Testing (EPAA). HealthCare is involved in the leadership of the eTOX project and the MARCAR and K4DD projects of the Innovative Medicines Initiative 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. (IMI). Bayer is a member of the scientific advisory boards of the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) and the Long Range Research Initiative (LRI). In Germany, we support the Foundation for the Promotion of Alternate and Complementary Methods to Reduce Animal Testing (SET).
Protection against product counterfeiting
Counterfeit medicines and crop protection products harbor substantial risks for patients and consumers. Product counterfeiting is a global problem that 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 try to protect patients and our products through extensive measures of our own.
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The focus of HealthCare’s activities is on raising awareness and providing information to ensure the clear identification of our original products, as well as on legal steps aimed at minimizing illegal trade. Through our “Beware of Counterfeits” campaign, we inform patients on the internet about the risks of counterfeit pharmaceuticals and provide 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 also 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 (PIICC) of Interpol to counteract pharmaceutical counterfeiting through global prosecution and the elimination of related criminal networks. We participate in the SecurPharm initiative in Germany. Since 2015, Bayer has contributed its expertise to a research project (ALPhA) supported by the German Ministry of Education and Research to prevent the sale of counterfeit pharmaceuticals on the internet.
For crop protection products, too, a worldwide increase in the trade of counterfeit and illegal products can be observed. According to a study conducted in 2015 on behalf of the European Commission, such products account for an average of 10% of the total market across all E.U. member states. To protect against the import of counterfeit and illegal crop protection products into the E.U., CropScience intensively advocates the uniform interpretation and implementation of existing E.U. regulations in all E.U. member states. In addition to supporting regulatory authorities with the identification of counterfeit products through chemical analysis, we conduct our own inspections in the market and also actively support initiatives by associations.
To educate about the potential dangers and risks of counterfeit and illegal crop protection products, we provide information material and train customers, dealers, farmers and regulatory authorities as part of our product stewardship programs. We document all indications of suspicious and potentially counterfeit or illegal CropScience products in an established, systematic process. CropScience’s efforts yield measurable results: in 2015, for example, we successfully asserted our patent protection rights against an illegal Chinese producer. In Brazil, counterfeit CropScience products with a market value in the double-digit million range were confiscated.