Responsible Use of Chemicals
Assuming responsibility for our products, from medicines to complex solutions for agriculture, is always at the core of what we do. These should satisfy the highest quality standards and contribute to a better life. This means that neither their development and manufacture, nor their disposal should cause damage to people and the environment. For this reason, we conform strictly to regulations and laws all over the world, and our voluntary commitment and internal standards go beyond these in a variety of areas.
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.
As a result, our products cannot be sold on the market until they have been approved by a competent authority or an official registration has been granted. A prerequisite for approval is that the prescribed efficacy and safety of the individual products are demonstrated.
In addition to regulating finished products, extensive statutory regulations also apply to the chemical substances handled by Bayer during product manufacture. Chemical substances are subject to the respective regional chemical regulations. These include e.g. REACH in the European Union, the Lautenberg Chemical Safety Act (formerly TSCA) in the United States and the Measures for Environmental Management of New Chemical Substances (Order No. 7) of the Ministry of Environmental Protection (MEP) in China.
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.
Learn more about the Regulatory conditions in our Sustainability Report.
We voluntarily apply comparable standards around the world, independent of the respective national legislation. For all handled substances with an annual volume of more than one metric ton that are not subject to the REACH regulation, we have (voluntarily) undertaken to successively provide comparable minimum data sets on ecotoxicology and toxicology. This data can be used to access the hazard potential of the majority of our substances.
Assessment 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 for mitigating risks.
As early as the research and development stage, we assess the properties of our active ingredients and all other substances that are contained in a product and could thus impact the properties of a finished product (e.g. additives that support the actual active ingredients). We discontinue the development of active ingredients with undesirable properties, applying 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. The focus should not be unilaterally on the hazard potential, but on a balanced risk-benefit evaluation.
Read more in our Sustainability Report.
Crop Science – Product stewardship management approach
In cooperation with growers and partners across the value chain, we are committed to ensuring that the development and usage of crop protection products and technologies is safe for operators, consumers and the environment.
As a leader in agriculture, we have an obligation to oversee the entire life cycle of our products to ensure they are produced, distributed, and used responsibly.
By maintaining the availability and integrity of our Crop Science products (seeds and traits, crop protection products, and services), Product Stewardship helps to facilitate trade, maximize product potential, promote sustainability, and minimize risks to human and animal health, as well as protecting the environment. We strive for sustainable management of our products and services and do this by upholding multiple voluntary commitments in addition to complying with all legal and regulatory requirements.
Ensuring our products meet the highest standards of safety starts with uniting the entire life cycle of our products – from R&D up to responsible use and disposal of obsolete stock – under the same basic procedures and ideals. For example,
- Each R&D project in crop protection must undergo comprehensive assessments of potential impacts on the health of humans and animals, as well as impacts on the environment as defined by respective regulatory frameworks.
- To ensure the safe use of our crop protection products based on adequate research, we market only those crop protection products whose active ingredients are registered in at least one OECD (Organisation for Economic Cooperation and Development) country or, in the case of new active ingredients, for which an OECD data package has been compiled.
- Development and in-licensing projects for crop protection products whose toxicology is classified as World Health Organization (WHO) class 1a or 1b, or that do not meet the OECD Guidance for Pesticide Registration, will not be pursued.
- Through targeted training courses, we show farmers, seed treatment professionals and distributors how to use our products both effectively and safely. A complete explanation of our key requirements is available in our Group Regulation on Product Stewardship Commitment, Principles and Key Requirements.
Further details are available at:
https://www.bayer.com/en/agriculture/product-stewardship
https://www.bayer.com/en/agriculture/highly-hazardous-pesticides-management
Quality and safety of pharmaceuticals and medical devices
The quality management system of the Pharmaceuticals and Consumer Health divisions is based on internationally recognized standards and applicable legal, regulatory and ethical requirements for all stages of the provision of a pharmaceutical or a medical device – from development to registration, production and distribution. In particular, these standards include the rules for good working practice (GxP) in the development and manufacture of pharmaceuticals, ISO certifications, and the guidelines of the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
Drug development is a complex and time-consuming process and is subject to stringent rules. New active ingredients need to be tested as prescribed by law and they are subject to strict guidelines and governmental controls.
Before the pharmaceutical can then be submitted for approval, its efficacy, safety and tolerability must be examined in various phases (Phases I-III) of preclinical and clinical trials.
The collection and evaluation of safety-relevant information about our products are the responsibility of the global Patient and Drug Safety (Pharmacovigilance) department. The safety management 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 reported side effects are entered into our pharmacovigilance database. Should risks be identified, we immediately take steps to safeguard the health of patients and consumers in coordination with the authorities.
Moreover, our Pharmaceuticals and Consumer Health divisions carry out eco-toxicological investigations on active pharmaceutical ingredients. These investigations serve as the basis for the environmental risk assessments within marketing authorization for human pharmaceuticals in Europe and the United States. In line with legal requirements, we thus evaluate possible environmental risks that could result from the intended use of human pharmaceuticals.
Read more in our Sustainability Report.
Protection against Product Counterfeiting
Counterfeit medicines, crop protection products or seeds 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.
Read more in our Sustainability Report.
For more information on the topic of counterfeits in agriculture - https://www.bayer.com/en/agriculture/counterfeits-in-agriculture.
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 lab animals and to employ alternative methods whenever possible and we target reducing animal studies.
In early active ingredient screening, Bayer continuously establishes different computer-based and in-vitro processes that help reduce the number of animal studies or the impact on animals in subsequent testing. Included in this are our activities in connection with organ-on-a-chip, a biochip method used to investigate the behavior of complete organs in vitro. In this context, Bayer has since established several organ systems and platforms that are deployed for both toxicological and pharmacological issues.
Applying performance indicators, we analyze the development of animal numbers, the distribution according to species and the impact on our test animals each year, while evaluating studies and discussing possible steps in accordance with the 3Rs principle (replace, reduce, refine).
PFAS
EU authorities recently started regulating certain types of PFAS under the Persistent Organic Pollutants (POPs) regulation and via REACH restrictions. Additionally, they are currently reviewing a proposal from five EU member states to restrict a wide range of PFAS uses; importantly, pesticide and pharmaceutical active ingredients are exempt from the proposed restrictions because of the comprehensive regulatory oversight already in place for these products.
No Bayer products are currently restricted under any PFAS regulations. PFAS regulations are at an early stage, and like all other companies across industries, Bayer is monitoring the evolving regulatory definitions and rules related to PFAS and will continue to comply with all relevant regulations.
