Product Stewardship

Strategy

• Global directives with uniformly high standards

Product stewardship is of central importance for us. We want to ensure that our products meet our customers’ quality expectations and pose no risk to people, animals or the environment when used in the manner intended. We are committed to continuously minimizing the negative effects of our products on the environment, health and safety along the value chain – from development to disposal – and to the ongoing optimization of our products. This commitment to product stewardship is enshrined in our Responsible Care^® charter and the initiatives of the International Council of Chemical Associations (ICCA). Our aim is to comply with all relevant national and international laws and regulations. Our global requirements define rules, processes and responsibilities, for example, to ensure uniformly high product stewardship standards worldwide. In some cases, voluntary initiatives exceed local statutory regulations. We regularly conduct internal audits to monitor compliance with global standards.

We maintain and evaluate environmental, health and safety data for all of our substances and products in a global database. This information is continuously updated. The database forms the basis for our safety data sheets, which we make available to our customers in around 40 languages. These include information on the physical/chemical, toxicological and ecotoxicological properties of products, potential hazards, first aid measures, measures to be taken in the case of accidental release, and disposal. Our global emergency hotline network enables us to provide information around the clock. In order to help users to quickly find out about our products and the risks associated with them, we use the Globally Harmonized System (GHS) to classify and label our products around the world, provided this is legally permissible in the country concerned. We take into account any national or regional modifications within the GHS framework, such as the CLP Regulation in the European Union or HazCom in the United States. We train our employees, customers and logistics partners worldwide on the proper handling and optimal use of selected products with particular hazard potential. In associations and together with other manufacturers, BASF is pushing for the establishment of voluntary global commitments to prevent the misuse of chemicals.

BASF supports the implementation of initiatives such as the Global Product Strategy (GPS) of the ICCA. GPS is establishing worldwide standards and best practices to improve the safety management of chemical substances and to support governments in the introduction of local chemical regulations. We are also involved in initiatives such as workshops and training seminars in emerging markets. In 2020, these included the virtual ASEAN (Association of Southeast Asian Nations) workshop on regulatory cooperation.

Global chemicals regulations

Most of the products we manufacture are subject to statutory chemicals regulations. We want to ensure compliance with these. We are bound by the relevant regional and national chemicals regulations, which continue to grow in number worldwide. Examples include REACH in the European Union, TSCA in the United States, KKDIK in Turkey or K-REACH in South Korea. BASF Group companies work closely together with a global network of experts to ensure that BASF complies with the applicable regulations. For example, we submitted the relevant substances to the Turkish authorities in 2020 – an important milestone in the pre-SIEF notification process.¹

After successfully registering all substances in Europe, our REACH activities concentrate on aspects such as dossier evaluation, substance evaluation, authorization and restriction. We are also required to continually update our registration dossiers. To satisfy the complex requirements of REACH, we are in regular contact with suppliers, customers, industry associations and government authorities. For example, BASF is working together with the European Chemicals Agency (ECHA) on a project to improve the quality of REACH dossiers. BASF was one of the first companies to join this industry-wide initiative.

Product stewardship for crop protection products and seeds

Crop protection products and seeds are highly regulated at national and international level, which brings with it strict requirements for registering and re-registering active ingredients and crop systems. Regulatory approval is only granted when extensive documentation can be provided showing that our products are safe for people, animals and the environment. Potential risks are assessed and minimized throughout the research, development and registration process, and on an ongoing basis following successful market registration. We regularly perform a large number of scientific studies and tests to ensure that, as far as possible, our registration dossiers address all questions on potential environmental and health effects.

We adapt our portfolio to the specific regional markets as crops, soils, climate conditions, plant diseases and farming practices vary around the world. Consequently, product approvals differ from country to country.

BASF adheres to the International Code of Conduct issued by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) for the distribution of crop protection products. These are only marketed once they have been approved by the relevant authorities. We want to ensure and meet high safety standards worldwide for our products. This applies in particular to distribution in countries that do not have their own or only low-level regulation for crop protection products, as is the case in many emerging markets. We no longer market WHO Class 1A or 1B products (high acute oral and dermal toxicity). Depending on availability, we offer our customers alternatives.

All of BASF’s crop protection products can be used safely under local farming conditions if the information and directions on the label are followed. Customers can contact us directly if they have any questions, complaints or issues, for example, by calling the telephone number printed on product labels, using the contact forms on our websites or by approaching our sales employees directly. We record all products incidents relating to health or the environment in a global database. If necessary, we take appropriate measures in the basis of this information, such as updating the instructions for use on the product label to minimize preventable incidents in the future. We communicate changes to instructions for use through channels such as our Farmer Field School initiatives in Asia and in training programs such as the On-Target Application Academy in the United States or our FarmNetwork Sustainability in Europe.

One of the ways we meet our commitment to product stewardship is by offering a wide range of courses and training on the safe storage and safe use of our products. In India, for example, BASF launched the Suraksha Hamesha program. Suraksha Hamesha means “safety all the time.” The program creates a platform for educating farmers and agricultural workers about the nine steps of responsible use of crop protection products and personal protection. Through Suraksha Hamesha, BASF has engaged with around 150,000 agricultural workers and around 29,000 users across India since 2016. BASF also involves government agencies and the central government’s farm extension teams in these meetings to support and promote farm safety. We are additionally involved in numerous scientific and public organizations and initiatives. Together, we are working on solutions for sustainable agriculture that meet long-term economic, ecological and social needs.

We also work closely together with associations such as Crop Life International and the European Crop Protection Association (ECPA) to promote the safe and proper use of crop protection products. For example, we support the two associations’ safe use initiatives and various programs on the proper disposal and recycling of product containers. Technological innovations developed together with industry partners such as the easyconnect closed transfer system in Europe or the Wisdom system in South America also help to make using crop protection products easier and safer.

Environmental and toxicological testing

• Use of alternative methods for animal studies

Before launching products on the market, we subject them to a variety of environmental and toxicological testing using state-of-the-art knowledge and technology. Animal studies are only conducted when they are required by law, for example as part of REACH, and none of the alternative methods approved by the authorities are available.

We adhere to the specifications laid down by the German Animal Welfare Act as well as the requirements of the Association for Assessment and Accreditation of Laboratory Animal Care – the highest standard for laboratory animals in the world. We develop and are continuously optimizing alternative methods to experimentally assess the safety and tolerance of our products without animal studies. Our aim is to replace, reduce and refine animal studies to minimize the impact on them. We already use alternative methods in more than a third of our toxicological tests. Currently, 35 alternative methods are being used in our labs and another 14 are in the development stage. BASF spent €3.5 million toward this purpose in 2020. The development of alternative methods for testing the potential of substances to induce developmental toxicity has been a focus area of our research since 2017.

Since 2016, BASF SE’s Experimental Toxicology and Ecotoxicology department has been working together with a total of 39 partners on one of the largest European collaborative projects for alternative methods. The project, planned to run for six years, aims to develop alternative methods to the point that chemical risk assessments can be efficiently conducted largely without animal testing. We are also involved in initiatives such as the European Partnership for Alternative Approaches to Animal Testing (EPAA) to strengthen the cross-sector development of alternative methods.

Management of new technologies

• Continual safety research on nano- and biotechnology

Nanotechnology and biotechnology offer solutions for key societal challenges – such as environmental and climate protection or health and nutrition. For example, nanomaterials can improve battery performance and biocatalytic methods can improve process resource efficiency. We want to harness the potential of both technologies. Using them safely and responsibly is our top priority.

Safe handling of nanomaterials is stipulated in our Nanotechnology Code of Conduct. In recent years, we have conducted over 250 scientific studies and participated in numerous Verbund projects related to the safety of nanomaterials in Germany and around the world. The results were published in more than 150 scientific articles.

Together with partners from academia and government authorities, we are working on E.U.-funded projects to develop and validate methods for evaluating and grouping nanomaterials without the use of animal studies. In particular, grouping nanoforms can reduce animal testing since individual forms do not have to undergo full toxicological testing – only one or more representative of the entire group. This is why we are developing new methods to group nanomaterials in groups with the same hazard potential in the E.U.’s PATROLS project. In the E.U.’s GRACIOUS project, we are developing concepts for defining and then evaluating the toxicological effects of these groups. In addition, together with the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), we developed an internet application (NanoApp) and put this online in late November 2020. This makes the concepts developed to date available for the entire industry together with the regulatory requirements. The aim is to simplify the registration of nanomaterial groups under REACH.

Appropriate OECD testing and implementation guidelines must be developed for the new requirements for nanomaterials under REACH, the European chemicals regulation. We support this process by contributing our expertise in various working groups of the European Chemicals Agency (ECHA) and the OECD’s Business and Industry Advisory Group (BIAC). Many of the methods developed for nanoparticles could, in our view, also be used to evaluate solid particles in the future, an approach we bring up in regulatory discussions.

BASF makes successful use of biotechnology. We produce a range of products with the help of biotechnological methods. This provides us with extensive experience in their safe use in research and development as well as in production. Biotechnological methods are used to develop and produce products such as natural flavors and fragrances, enzymes and vitamins. Another application is the development of seeds for agriculture. We use both conventional and molecular biological methods to develop plants with improved characteristics, such as greater resistance to drought, pests or the pathogens that cause plant diseases. Tolerance of certain herbicides also secures yields and enables sustainable, no-till crop systems to increase CO₂ retention in the soil. Innovative breeding technologies can play a key role in the sustainable development of agriculture, for example, with varieties that are better adapted to changing environmental conditions or that have higher disease tolerance. In using biotechnology, we want to adhere to all relevant standards and legal regulations governing production and marketing. We are also guided by the code of conduct set out by EuropaBio, the European biotechnology association.