Product Stewardship
For us, product stewardship means that our products satisfy the highest quality standards and are safe for people, animals and the environment when properly used. Not only do the desired properties of substances and products need to be taken into consideration but also the possible risks for people and the environment. We respect legal requirements, and our voluntary commitment and internal standards go beyond these in a variety of areas.
Bayer has put in place suitable directives and management systems to implement regulatory and voluntary product stewardship requirements. These are steered by our Corporate Health, Safety & Environment enabling function and the quality functions as well as specialized stewardship functions within the divisions.
At issue here are not just the safe handling and use of our products, but also the transparent communication and transfer of product safety information.
Regulatory Conditions
Bayer’s finished products, such as pharmaceuticals, crop protection products, seeds and biocides, are subject to very stringent regulations prescribing specific and detailed approval and authorization procedures.
In addition to the regulation of finished products, extensive statutory regulations also apply to the chemical substances handled by Bayer during product manufacture.
Assessments and Testing
Our substances and finished products undergo extensive assessment and testing to ensure product efficacy and safety. We examine possible health and environmental risks along the entire value chain and use this to derive appropriate measures to mitigate risks.
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.
Since 1994, Bayer has supported the 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.
We believe in the responsible use of plant biotechnology to improve the productivity and quality of crop plants. Biotechnology is used hand-in-hand with traditional plant breeding. Tools such as marker-assisted breeding and genetic modification can be used to make plants more resistant to pests and environmental stress conditions, thus helping to increase the yield and quality of food, feed, fibers and renewable raw materials in an environmentally friendly way. We use plant biotechnology in full compliance with all applicable laws, regulations and industry standards. Furthermore we participate in open and constructive dialogue with our stakeholders.
More about product stewardship and assessments and testing
More about product stewardship for crop protection products and seeds.
More about product stewardship for pharmaceuticals and medicine products.
Bayer’s response on ChemSec’s assessment 2024 (PDF, 206 KB)
Product Stewardship in the Use of Biotechnology
Bayer applies biotechnology processes both in the area of seeds and in pharmaceutical product development and production, such as for Kogenate™, Kovaltry™™ and Jivi™. Further biotechnologically manufactured active ingredients are undergoing clinical development. In plant cultivation, we conventional breeding methods and genetic engineering.
For us, safety for people and the environment is always a top priority in the use of biotechnology. In addition to meeting legal and regulatory requirements, we have specified the responsible use of genetic engineering and strict, globally applicable safety measures in handling biological substances in corresponding corporate policies.
The development and commercialization of genetically improved seeds is also subject to stringent laws and regulations. We have additionally established internal processes to ensure the responsible use of biotechnologically manufactured products throughout their life cycle. Furthermore, in 2019, Crop Science maintained its membership in the Excellence Through Stewardship (ETS) organization.
More information on biotechnology in crop protection products and seeds
More information on biological safety
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 lies with the Bayer Global Animal Welfare Committee. We respect all legal requirements pertaining to animal welfare, compliance with which is verified both by regulatory authorities and by means of internal audits. In addition, Bayer applies its own principles on animal welfare and animal studies, which are specified in a corporate policy published in 2020.
The situation in the Consumer Health division is a little different, since animal studies are prohibited unless required for, or in support of, a submission to a regulatory authority. For all other purposes, alternative techniques must be used, such as in-vitro and in-silico models. A “3R” approach is applied to Replace, Reduce and Refine animal testing wherever possible.
The Global Animal Welfare Committee monitors compliance with these principles within the Bayer Group and in external studies. Our principles also apply to the research institutes we commission and to our suppliers, whose compliance with our animal welfare requirements we regularly monitor.
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Protection against Product Counterfeiting
Counterfeit medicines and crop protection products harbor substantial risks for patients and consumers. Product counterfeiting is an enormous problem worldwide, due particularly to the increase in e-commerce and can only be addressed internationally through a joint approach by industry, associations, governmental agencies and nongovernmental organizations. We endeavor to resolutely and effectively prevent counterfeiting so as to ensure access by our customers to our safe and effective original products, protect our innovations and intellectual property rights, reduce potential financial damages for Bayer and safeguard the company’s reputation. The basic principles of our strategic actions against counterfeit or otherwise illegal products and the corresponding organizational implementation for all divisions are defined in a corporate policy.
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