Management Report & Annexes | Fundamental Information About the Group

10. Product Stewardship

We assess the possible health and environmental risks of a product along the entire value chain. This starts with research and development and continues through production, marketing and use by the customer through to disposal.

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. Product stewardship involves both compliance with statutory requirements and voluntary commitment. Here, we also take into account 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.

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We accept the precautionary principle as a possible tool for consumer protection and/or risk management. 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. However, a balance between risks and opportunities must always be ensured. The focus should not unilaterally be on the hazard potential.

Bayer monitors all products that are already on the market. Furthermore, we have established processes in all subgroups aimed at addressing inquiries on product safety or problems with our products. This feedback is 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.

As a contribution to the safe handling of chemicals, risk assessments are carried out applying recognized scientific principles such as those described by the echa (European Chemicals Agency) in its Guidance on Information Requirements and Chemical Safety Assessment.

Should this assessment or new findings reveal that it is not safe to use a certain chemical, we take the necessary steps to mitigate risks. Such 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 so as to obtain new or substantially improved products and processes. This is the basis of the reach (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation, and is also integral to our commitment to Responsible Care.

Since 1994 Bayer has supported the voluntary Responsible CareTM initiative of the chemical industry, which was globalized in 2006 with the introduction of the Responsible CareTM Global Charter. We cover all main elements of the charter at all Group sites with our hseq (health, safety, environmental protection and quality) 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 the 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, research new test methods and monitor the implementation of statutory regulations. Bayer actively accompanies these efforts in its association activities. 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, for example with the further development of human biomonitoring through an alliance with the German Chemical Industry Association (vci) and the German Federal Ministry of the Environment.

Implementation of regulations and voluntary programs pertaining to chemicals

Since 2007 we have operated in accordance with the European chemicals regulation reach (Registration, Evaluation, Authorization and Restriction of Chemicals). It affects all our activities as a manufacturer, importer and user. To adequately address the scope and complexity of the reach requirements, we have approved Group-wide and subgroup-specific regulations. 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.

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We observe the required registration phases for existing chemicals. The final registration phase will end on June 1, 2018. Substances registered already during the first two phases are now being assessed by the competent authorities. In the future this could result, for example, in additional testing requirements, new risk management measures or inclusion in the authorization procedure.

A number of Bayer substances are also affected by the reach authorization procedure, which restricts the use of particularly hazardous substances or can lead to their replacement or ban.

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 products from other manufacturers, we maintain close contacts with our suppliers and ensure that they confirm conformity with reach for these products.

The Bayer Group’s product stewardship target is to conclude the assessment of the hazard potential of all substances used in quantities exceeding one metric ton per annum by 2020. 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. The procedure for the implementation of this target is established in our Bayer Group Regulation “Substance Information and Availability.”

At the same time, we are implementing the Globally Harmonized System (ghs) for the classification and labeling of chemicals, which came into force in the European Union (e.u.) in 2009. The purpose of this regulation is to achieve a globally standardized system for classifying chemicals and labeling them appropriately on packaging and in material safety data sheets.

We also support the Global Product Strategy (gps), a voluntary commitment by the chemical industry initiated by the International Council of Chemical Associations (icca). Its objective is to improve knowledge about chemical products, especially in emerging and developing countries, and thus increase safety in the handling of these products. The icca has established an information portal through which summarized details on products (gps Safety Summaries) are made available. gps is of particular relevance for MaterialScience.

In accordance with the respective product safety and information obligations, all subgroups compile product information, whether on raw materials, intermediates or end products. To ensure worldwide access to this information, our subgroups use appropriate it systems, including ones for product labeling.

Product stewardship in the use of biotechnology

The product development departments in our Pharmaceuticals and Crop Protection businesses make use of biotechnological methods. Biotechnology has already gained significant importance in pharmaceutical product development. The HealthCare products BetaferonTM/BetaseronTM, KogenateTM and EyleaTM are manufactured by a biotechnological process.

Plant biotechnology can help to improve crop yields, yield security and the stress tolerance of plants through both genetic engineering and conventional breeding methods without the need for an increased 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 the subgroups and service companies.

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Before any product reaches market maturity, we subject it to a stringent approval procedure to determine whether it is safe for human health, animals and the environment.

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 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. Product stewardship and quality management processes are the top priority in all activities connected to plant biotechnology.

We provide our stakeholders with comprehensive, transparent and reliable information about our products and services in accordance with our Bayer Group Regulation “Responsible Marketing & Sales.”

Focusing on animal welfare

Animal studies are legally required and essential from a scientific viewpoint to assess the effects of our products, especially on people, but also on nature and the environment. During research into new active pharmaceutical ingredients, they are only replaceable to a certain extent. In our handling of animals, we respect all legal requirements pertaining to animal welfare. If animal studies are required to assess our substances, Bayer respects the so-called 3Rs principle:

  • replace: prior to each project, we check whether an approved method is available that does not rely on animal studies and then apply 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: we make sure animal studies are performed in a way that minimizes suffering of animals.

This year for the first time, we are offering an internal 3r Award that rewards and publicizes within the company special contributions to animal welfare.

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 at our website.

Bayer’s Global Animal Welfare Committee monitors compliance with our principles on animal welfare and animal studies within the Bayer Group and in external studies.

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Comprised of the animal welfare officers at our research sites and further Bayer experts, this committee has defined performance indicators. 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. 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 around 96 animals to around 51 animals in 2013.

We have also established an internal database that 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: we are active, for example, in the European Partnership for Alternative Approaches to Animal Testing (epaa) and our HealthCare subgroup is involved in the leadership of the eTOX project and the marcar project of the Innovative Medicines Initiative (imi). We participate in the lri (Long-Range Research Initiative), which is currently pursuing projects connected with the issue of “eye irritation.” In Germany, we support the Foundation for the Promotion of Alternate and Complementary Methods to Reduce Animal Testing (set).

Protection against product counterfeiting

Illegal trade with counterfeit medicines and crop protection products is on the rise worldwide. Counterfeit products harbor substantial risk for patients and consumers, and substandard quality also causes considerable financial damage for producers and users.

Industry, associations, governmental agencies and non-governmental organizations must join together to fight product counterfeiting. Bayer continuously advocates the strengthening and expansion of existing laws and provisions aimed at the identification and confiscation of illegal products. We undertake a wide range of measures to inform our customers about both the danger posed by, and the insufficient effectiveness of, counterfeit products.

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According to a report by the European Commission, counterfeit pharmaceuticals rank near the top of the e.u.’s customs statistics. For example, the authorities confiscated around 3.7 million counterfeit pharmaceutical products in 2013 – a five-fold increase compared with the previous year. In close cooperation with the authorities, Bayer works to protect the health of patients, customers and users. The focus is on raising awareness and providing information to ensure the reliable identification of our original products, as well as on legal steps aimed at minimizing illegal trade. 

Through the internet platform “Beware of Counterfeits,” HealthCare informs patients about the risks of counterfeit pharmaceuticals and provides patients with tips on how they can protect themselves. 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 also support the establishment of a pan-European system for the verification of pharmaceutical packaging that satisfies the requirements of the e.u. Falsified Medicine Directive. We participate in the SecurPharm project in Germany.

According to the most recent estimate by Europol, illegal products account for more than 10% of the crop protection market and 25% in some e.u. member states. CropScience provides information, training materials and services (manuals, workshops, chemical analysis, etc.) to dealers, farmers and authorities to ensure that counterfeit products can be accurately identified and combated. In 2014 training courses were conducted, for example, in China and in e.u. countries in which Bayer warned of the dangers of product counterfeiting and explained options for better combating it. In this connection, we also support initiatives by global and regional association committees such as the Anti-Counterfeiting Expert Group of the European Crop Protection Association (ecpa) and the Anti-Counterfeiting Steering Committee of the industry association CropLife International (cli). One example is the training of national industry associations at the European Association Network Anti-Counterfeiting Forum.

CropScience works together intensively with national and international authorities. This frequently enables the confiscation of counterfeit products, as was the case again in 2014 due to the company’s clear support for the European authorities in the investigation of criminal networks. CropScience works together with shipping companies and European ports of entry to prevent the transport of counterfeit products by more closely inspecting freight and customers, among other measures. Most counterfeit products originate in Asia and reach Europe through European cargo ports. With our support, substantial quantities of illegal products were confiscated by the port authorities again in 2014. CropScience also carries out its own inspections of suspicious goods shipments. We have registered noticeable progress in our longstanding active efforts to combat illegal parallel trade (for example in Germany). Far fewer illegal parallel trade product samples were found in 2014 than in 2013. Legal steps were successfully initiated here as well.

HealthCare

Benefit-risk management for medicinal products and medical devices

HealthCare continuously assesses the medical benefit-risk balance of its medicinal products and medical devices throughout their entire life cycle. For this process, experts from various disciplines form cross-functional Safety Management Teams (smts). These teams jointly evaluate the available benefit and risk data along with other relevant information on the product in order to identify possible safety risks at an early stage and assess the medical benefit-risk balance. The evaluation also makes use of external databases so as to ensure as broad a base of data as possible. Should significant risks be identified, HealthCare immediately takes measures to minimize them, such as updating the product information for patients and physicians.

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Further tools in risk minimization programs can include targeted information, e.g. patient education brochures, and training measures for physicians and patients. smts compile medical benefit-risk data and information and produce detailed safety risk management plans. These plans are updated as soon as relevant new benefit-risk data become available. Implementation of risk minimization activities is coordinated by local smts in the country organizations.

The Global Pharmacovigilance unit of HealthCare pools safety-relevant information on our products in the company’s own global pharmacovigilance database on an ongoing basis. This information is continuously updated and evaluated by experts. In this process, Bayer works closely with the responsible regulatory and supervisory authorities at the international, national and regional levels. These include the u.s. Food and Drug Administration (fda), the European Medicines Agency (ema) and Germany’s Federal Institute for Drugs and Medical Devices (BfArM).

HealthCare’s quality and risk management functions make further contributions to increased safety. We examine external and internal quality assurance requirements for our products through systematic internal inspections – not just in research and development, but also in production. These inspections also cover institutes sub-contracted by us and our suppliers. Through our safety risk management system, drug product risks are systematically identified and assessed, and the necessary steps initiated. Countries and regions receive continuous support to help them comply with regulatory requirements for pharmaceuticals.

Scientific publications by our researchers satisfy recognized international standards that we have committed ourselves to observe in our Good Publication Policy. We base the implementation of all clinical studies on the Good Clinical Practice guidelines of the World Health Organization (who) and on the guidelines of the International Conference on Harmonization (ich). We disclose the methods and results of clinical trials.

Analysis of pharmaceutical trace amounts in the environment

Active pharmaceutical ingredients can enter the environment through human excreta or livestock excrement, improper disposal by users or residues in wastewater from pharmaceutical production.

Measurements carried out by authorities and scientific institutes have revealed that the concentration of individual active pharmaceutical ingredients from human or veterinary medicines present in drinking water is lower than the level that would have pharmacological effects in humans. On the basis of our current knowledge, the presence of individual active pharmaceutical ingredients in bodies of water or drinking water does not pose any risk to humans. This is also confirmed by the most recent who Report on Pharmaceuticals in Drinking Water.

To assess the potential environmental impact of our pharmaceutical products, HealthCare carries out ecotoxicological investigations of the environmental behavior of trace amounts and degradation products.

When submitting dossiers to European regulatory authorities for both veterinary and human pharmaceuticals, an environmental assessment is required that is published in the European public assessment reports (epar). The u.s. Food and Drug Administration (fda) also requires the submission of an environmental compatibility assessment. It must be demonstrated during the approval procedure that no significant risk exists for the environment when the drug products are used correctly.

Internal company wastewater threshold values ensure that no risk to the environment results from the release of traces of active ingredients in wastewater from production sites. All HealthCare production sites worldwide are evaluated with regard to these threshold values. Site-specific measures aimed at a further reduction are proposed should it not be possible to observe these standards over the long term. Additional active ingredient-specific retention measures are applied in addition to biological treatment in water treatment facilities.

HealthCare maintains regular contact with various stakeholder groups with regard to these issues.

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HealthCare has committed itself to continue developing its strategy for dealing with pharmaceutical residues in the environment. At the scientific level, HealthCare participates in projects aimed at further researching pharmaceutical residues in the environment and introducing targeted measures.

Bayer is represented on the Scientific Advisory Board of noPILLS, the e.u.-sponsored project to reduce pharmaceutical trace amounts in water. The project studies the question of whether and to what extent strategies can be successful that are applied at the source – in other words at the point where residues enter water – rather than at the wastewater treatment stage. The city of Dülmen, Germany, has been selected as a model for more closely studying such pathways. The preceding project – pills – had come to the conclusion that although the content of active ingredients in wastewater can be reduced through the establishment of treatment facilities in hospitals that employ special water purification technology, such technology would still result in substantial costs. Building on the pills project, noPILLS now expands the focus to pharmaceutical residues in wastewater overall and the change in consumer behavior in test regions, for example as regards the disposal of expired drug products. In 2014 HealthCare advised two of the project partners in the preparation of a campaign to collect iodinated X-ray contrast media in hospitals.

In Germany, HealthCare participates in the “Risk Management of Emerging Compounds and Pathogens in the Water Cycle” (RiSKWa) initiative sponsored by the German Ministry for Education and Research. HealthCare is a member of the steering committee.

Safety and quality standards at Animal Health

In line with the statutory requirements, strict quality standards apply to all Animal Health product classes. Safety and quality standards comparable to those governing human medicine apply for veterinary pharmaceuticals such as parasiticides, dewormers (anthelmintics) or antibiotics. Within the scope of the approval procedures, Animal Health carries out studies in order to ensure the quality, efficacy and safety of its products, as well as minimize the environmental impact of the products’ use.

We partner with veterinarians, farmers and private users to promote the responsible use of our products. The prudent use of antibiotics is especially important for public health. For this reason, we have established clear guidelines for the use of fluoroquinolones. In this context, we also support the European Platform for the Responsible Use of Medicines in Animals, which brings together various partner organizations from politics, industry and society.

CropScience

Safety is also the top priority with products from CropScience. We analyze already prior to the development of a product whether the envisaged solution is compatible with our sustainability approach. During the development phase, we examine the products in stringent tests that are monitored by the authorities. At issue here are an active ingredient’s toxicological properties on the one hand and on the other hand the question of how significant the remaining trace amount of a crop protection product is following proper application to the plants. Before a product is introduced to the market, we conduct numerous further safety tests with regard to its use and environmental behavior, depending on the product area.

CropScience allowed the sale of all remaining who Class i insecticide formulations for leaf and soil applications and seed treatments to expire at the end of 2012. All insecticides affected were replaced by modern, targeted and more environmentally friendly formulations.

CropScience observes the International Code of Conduct on the Distribution and Use of Pesticides of the United Nations Food and Agriculture Organization (fao). The principles of this code cover the entire life cycle of a product, from its development to its application and beyond. 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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Even beyond its core business, CropScience participates specifically in projects aimed at increased product stewardship. We are a member of the Better Sugarcane Initiative, which works to promote sustainable sugarcane cultivation in Brazil, and the International Sustainability & Carbon Certification organization, which is working to establish a system for certifying biomass and bioenergy. We also take part in the Round Table for Responsible Soy, which works to promote sustainable soybean production, as well as in the Round Table for Sustainable Palm Oil Production.

Responsibility for customers and partners

The application of crop protection products requires the greatest possible care. Supporting our customers and partners in the proper and safe handling of the products is therefore a focus of product stewardship at CropScience. We address farmers and dealers particularly through numerous programs worldwide. Targeted workshops are aimed at enabling effective application of our products and ensuring the safety of users, the environment and consumers. Furthermore, we provide our customers with guidelines explaining the safe use, storage and disposal of all of our products.

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Our training activities focused on the Asia and Latin America regions again in 2014. In India, for example, CropScience has trained more than 32,000 farmers in good agricultural practice. They learn how they can enhance the growth of their produce, use crop protection products effectively and safely, and thus increase the quality of the goods they produce. Furthermore, they are also shown new ways of marketing their products, which particularly help smallholders gain increased profit from them.

Promoting agricultural development is often a more effective way to fight hunger and poverty than other forms of support. Higher incomes in turn enable farmers to improve their standard of living and invest more in their children’s education and their own businesses. Value is created for society as a result of the increased production of high-quality food. With the help of these measures, we contribute to the sustainable development of agriculture.

In Latin America, we combined all our activities dealing with product safety measures within our AgroVida program. This comprises various initiatives with which we have been continuously increasing the farmers’ safety awareness and specialist expertise since the 1990s. Safety training offerings for farmers play a role here, for example. In 2014 we trained almost 25,000 farmers in the Andean region and approximately 24,000 farmers in the Central America and Caribbean region (excluding Mexico), for instance. We also carried out safety training measures in numerous African countries in 2014.

In the area of water pollution control, we offer customers a biological purification system (PhytobacTM). This is intended to prevent the discontinuous discharge of crop protection active ingredients in the disposal of residual liquids that are generated during the filling and cleaning of spraying devices. In Europe, there are already approximately 3,000 PhytobacTM facilities. The system was introduced in China in 2014.

We also make the online tool “DressCode” available for determining the optimal protective clothing for the handling of our crop protection products – e.g. in the mixing and application of the products and the cleaning of spraying equipment.

Our product stewardship measures also include internal employee training measures. Our aforementioned Product Stewardship Policy also 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.

Bee health and crop protection

Products to protect crops and keep them healthy are necessary to safeguard harvests and thus guarantee the supply of nutrition for a growing world population both now and in the future. At the same time, it is essential to protect pollinators of plants that contribute to a wide variety of foods. The debate surrounding the use of certain neonicotinoid crop protection products and the subjective assessment of their impact on bee health has had an effect at the political level. As a result, the European Commission has suspended the use of a number of products in this active ingredient class for certain applications in Europe. Bayer considers the decision by the European Commission to be scientifically unjustified and legally flawed. The active ingredients in question were extensively examined with regard to their impact on bee health already during the approval procedure. Bayer has appealed the decision by the European Commission in order to ensure legal certainty for approval procedures. A decision is not yet available. Through its Bee Care Program, Bayer continues to work on behalf of bee health and the responsible use of crop protection products. The company invests in research to minimize the effects of crop protection products on honey bees.

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With our worldwide Bee Care Program, we aim to promote a better understanding of the many factors that can impact bee health. This program included the construction of the first Bayer Bee Care Center at the site of CropScience and HealthCare’s Animal Health Division in Monheim, Germany. CropScience’s center in Monheim combines Bayer’s extensive knowledge and expertise in bee health under one roof. It also serves as a platform for dialogue with stakeholders who share our interest in promoting bee health worldwide. A second Bayer Bee Care Center opened in 2014 that deals specifically with bee health issues in North America. This center is located at the u.s. headquarters of CropScience at Research Triangle Park near Raleigh, North Carolina, United States, and brings together important technological, scientific and academic resources.

There is broad consensus among scientists who work in the area of bee health that the difficult-to-combat Varroa mite presents the main risk to bee health, partly because this parasite can transmit numerous viral diseases to bees. The Animal Health Division of HealthCare is working with numerous researchers in Europe and the United States to develop the Varroa gate – an innovative way to control Varroa mites that is intended to keep this parasite from infesting beehives. However, another important factor that can impact bee health is generally more intensive agriculture in some regions, which limits suitable food sources for bees and wild bees and also breeding places. Bayer is active here as well, supporting the establishment of flowered areas and studying biodiversity promotion measures on agricultural land that are designed to benefit pollinators.

Also important to us are product stewardship measures associated with the use of our crop protection products to improve their bee-friendly application. These initiatives include: a conveyor technology in the United States for sowing machines that reduces friction and thus promotes the even flow of seed; the additional labeling of seed sacks; two technologies developed in Europe to treat waste air during sowing; and even more stringent quality control standards for seed dressing.

We have also launched an extensive bee monitoring program that is being implemented in five European countries (France, the United Kingdom, Germany, Hungary and Poland). The tests are carried out on winter oilseed rape, a crop that is very attractive for bees and that was treated with neonicotinoid seed dressings until the restrictions went into effect in the e.u. Monitoring activities can be undertaken despite these restrictions, as Bayer has received special exemptions for the aforementioned studies. The monitoring includes a scientific study led by an independent research institute that will be implemented at various sites in the above countries and that began with the sowing of winter oilseed rape in the summer of 2014. In addition, a network of agricultural demonstration facilities has been established in the same countries to illustrate these activities, which are targeted to last for two to three years.

Bayer is convinced that neonicotinoids are safe for bees if they are used responsibly and properly. Our view is supported by the analysis of monitoring studies that were carried out by independent institutes in addition to the studies generated in extensive approval procedures. The current findings and many years of safe application of these products in agricultural practice confirm the results of the risk assessments performed by the regulatory authorities in numerous countries around the world on neonicotinoid seed dressings. These results state that the products are harmless to bee colonies provided they are used according to the product information. The above additional monitoring study has been initiated independently of the numerous scientific studies that confirm the safety of neonicotinoids.

MaterialScience

The products of MaterialScience satisfy the most stringent of safety requirements. This applies not just to those substances subject to standard review in accordance with the European reach regulation. Within the context of the voluntary Global Product Strategy (gps) of the chemical industry, we also assess the substances we use and reduce potential health and environmental risks that could result from our chemicals. The product safety assessments apply to the entire life cycle of a product – from research and procurement through production and logistics to application, disposal and recycling. Our product stewardship does not just end with our company, but also includes suppliers, customers and partners. gps is accessible at MaterialScience through the “Product Safety First” internet portal, and is available worldwide in seven languages. Through this website, we inform customers and other interest groups about our activities and product safety assessments.

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A product safety assessment at MaterialScience takes place in several steps: first, chemicals that are subject to statutory regulations are identified and the corresponding rules compiled. We then examine their risk potential so as to provide a basis for the effective minimization of risks. Such steps can include proposals for technical measures such as protective clothing, or marketing restrictions. Finally, we produce the legally required material safety data sheets, technical information sheets and labeling for the chemicals.

For especially important products such as mdi, tdi, polycarbonate and polyether, MaterialScience additionally works with associations to draw up environmental product declarations and eco-balances certified according to iso 14040 and 14044 and based on industry averages.

With regard to substances that come into direct contact with food, MaterialScience is following the scientific discussion about the chemical bisphenol a (bpa), a feedstock for various plastics. Critics are concerned that health risks could result for users if traces of bpa are released from polymers. As documented by numerous scientifically valid studies, we are convinced that bpa can be safely used in its existing areas of application. This assessment is consistent with evaluations by the authorities responsible for food safety in Europe, the United States, Australia, Japan and other countries. In cooperation with the PlasticsEurope association, we work to make the discussion more objective based on scientific analysis.

Last updated: February 26, 2015  Copyright © Bayer AG
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