Product Responsibility, Quality and Safety

Bayer’s finished products, including pharmaceuticals, crop-protection products, seeds and biocides, are subject to regulatory requirements that may prescribe detailed approval, authorisation, registration and post-market obligations. The applicable requirements vary by product category and jurisdiction.

Where prior approval, authorisation or registration is required, a product may be placed on the relevant market only after the competent authority has granted the required approval, authorisation or registration. Such processes generally require evidence relating to the product’s quality, efficacy, safety and, where relevant, environmental characteristics, assessed in accordance with the applicable regulatory framework.

In addition to requirements applicable to finished products, chemical substances handled during product manufacture may be subject to regional chemical-control laws. These include, for example, the EU REACH Regulation, the Toxic Substances Control Act in the United States, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and China’s measures governing the environmental management of new chemical substances. The applicable requirements depend on the substance, its use and the relevant jurisdiction.

The classification and labelling of chemicals are intended to communicate relevant hazards and precautionary information to users. Bayer applies the Globally Harmonized System of Classification and Labelling of Chemicals, or GHS, in accordance with applicable local and regional requirements.

Further information is available in our Impact Report.

Bayer conducts assessments and testing of substances and finished products in accordance with applicable legal, regulatory and scientific requirements. These activities are intended to support the assessment of product performance, quality, safety and potential effects on human health and the environment.

During research and development, Bayer evaluates relevant properties of active ingredients and other substances used in a product, including substances that may influence the characteristics of the finished product. Where the available evidence indicates that a development candidate presents properties that cannot be appropriately managed within Bayer’s development and risk-management framework, Bayer may decide not to continue development.

Bayer’s approach takes account of the precautionary principle where relevant, as well as a science-based assessment of hazard, exposure, intended use and expected benefits. Decisions are made in light of the applicable legal and regulatory framework and the available scientific evidence.

Further information is available in our Impact Report.

Bayer’s Crop Science product-stewardship approach is intended to promote the responsible development, supply and use of seeds, traits, crop-protection products and associated services. In collaboration with growers, distributors and other partners across the value chain, Bayer seeks to support the safe and responsible use of its products in accordance with product labelling, local requirements and applicable stewardship measures.

Product stewardship addresses relevant stages of the product life cycle, including research and development, regulatory assessment, manufacturing, distribution, product use and the management of obsolete stock where applicable. Its objectives include supporting product integrity and availability, facilitating trade where appropriate, promoting responsible product use and helping to manage potential risks to human health, animal health and the environment.

Bayer supplements compliance with applicable legal and regulatory requirements through voluntary commitments and internal product-stewardship standards. The scope and implementation of these standards may vary according to the product, market and applicable legal requirements.

Among other measures: 

• Crop-protection research-and-development projects are subject to assessments of potential effects on human and animal health and the environment, in accordance with applicable regulatory frameworks and Bayer’s internal requirements.
• Bayer’s policy is to market crop-protection products only where the relevant active ingredient is registered in at least one OECD member country or in a country with a mature, risk-based regulatory framework, subject to applicable legal requirements and product-specific circumstances.
• Bayer does not pursue development or in-licensing projects for crop-protection products where the active ingredient is classified as World Health Organization Hazard Class Ia or Ib, or where the product does not meet the relevant OECD guidance for pesticide registration, subject to the scope and terms of Bayer’s applicable internal policy.
• Bayer provides training and educational materials for farmers, seed-treatment professionals and distributors on the effective and safe use of relevant products. Such training supplements, but does not replace, product-specific instructions, labelling and applicable local requirements

Bayer's key requirements are set out in our Group Regulation on Product Stewardship Commitment, Principles and Key Requirements.

Further details are available at:

Impact Report

Product Stewardship

Highly Hazardous Pesticides Management 
 

The quality-management systems of Bayer’s Pharmaceuticals and Consumer Health divisions are designed to support compliance with applicable legal, regulatory and ethical requirements throughout the life cycle of pharmaceuticals and medical devices, including development, registration, manufacture, distribution and post-market activities.

These systems draw on internationally recognised standards and requirements, including applicable good-practice requirements, ISO standards and relevant guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or ICH. The standards and requirements applicable to a particular product depend on its category, jurisdiction and stage of development or commercialisation.

Drug development is complex and subject to extensive legal, regulatory and scientific requirements. Before a new medicine may be submitted for marketing authorisation, its quality, safety, tolerability and efficacy are evaluated through the studies and development programme required by the applicable regulatory framework. Depending on the product and jurisdiction, this may include pre-clinical and clinical studies.

Bayer’s global Patient and Drug Safety organisation is responsible for collecting and evaluating safety-relevant information concerning Bayer products. Safety-management teams review relevant internal data, clinical-trial data, post-marketing studies, external databases and scientific literature to identify and assess potential safety concerns and possible changes to a product’s benefit–risk profile.

Adverse-event reports are processed and documented in Bayer’s pharmacovigilance systems in accordance with applicable requirements. Where a potential risk is identified, Bayer evaluates and implements appropriate measures, where necessary in coordination with the competent authorities, to support the protection of patients and consumers.

Bayer’s Pharmaceuticals and Consumer Health divisions also conduct ecotoxicological investigations relating to active pharmaceutical ingredients where required or appropriate. These investigations may support environmental-risk assessments conducted in connection with marketing-authorisation procedures for human pharmaceuticals in Europe, the United States and other relevant jurisdictions. In accordance with applicable requirements, Bayer assesses potential environmental effects associated with the intended use of human pharmaceuticals.

Further information is available in our Impact Report.

Counterfeit medicines, crop-protection products and seeds may pose risks to patients, consumers, growers and other users. Counterfeiting is a global challenge, including in the context of growing e-commerce activity, and requires collaboration among industry, associations, public authorities and other stakeholders.

Bayer maintains measures intended to help prevent and detect counterfeiting, protect its intellectual-property rights and support the availability of authentic Bayer products through legitimate supply channels. These measures are designed to contribute to product integrity and to help reduce potential risks associated with counterfeit products. No system can eliminate the risk of counterfeiting entirely.

Further information is available in our Impact Report and on counterfeits in agriculture.

Animal studies may be required by law or regulatory authorities and may be scientifically necessary to generate information relevant to the assessment of the safety and efficacy of certain products. Bayer seeks to apply the 3Rs principle -   replace, reduce and refine - and to use alternatives to animal studies where scientifically and regulatorily appropriate.

During early active-ingredient screening, Bayer develops and applies computer-based and in vitro methods that may reduce the need for animal studies or lessen their impact in subsequent testing. These activities include research involving organ-on-a-chip technologies, which may support the investigation of selected organ functions in controlled laboratory settings.

Bayer uses performance indicators to review the number and species of animals used in studies and to assess relevant welfare impacts. The results inform the evaluation of studies and the consideration of further measures consistent with the 3Rs principle and applicable requirements.

Regulatory approaches to per- and polyfluoroalkyl substances, or PFAS, are evolving across jurisdictions. In the European Union, certain PFAS-related measures have been introduced under the Persistent Organic Pollutants Regulation and through restrictions under REACH. EU authorities are also assessing a proposal submitted by five Member States that could restrict a broad range of PFAS uses.

The scope, exemptions, transitional provisions and final legal effect of PFAS-related measures remain subject to the applicable legislation and, in some instances, ongoing regulatory processes. The treatment of pesticide and pharmaceutical active ingredients under the proposed EU PFAS restriction is subject to the proposal’s terms and the outcome of the regulatory process.

Based on Bayer’s current assessment, certain Bayer products may not be subject to restrictions under PFAS-specific regulatory measures currently in force. This assessment is dependent on the applicable legal definitions, product composition, intended use and jurisdiction, and may change as legal requirements and regulatory interpretations develop.

Bayer monitors relevant PFAS-related regulatory developments and seeks to comply with applicable requirements.