Since many of our chemicals are classified as hazardous substances and mixtures, we must ensure that they pose no risk to people or the environment. We therefore comply with an array of national and international regulatory requirements, statutes and guidelines, an approach that is crucial to our business activities. In addition, we strive to meet the expectations that stakeholders such as customers and employees have of a comprehensive hazard management system.
Our approach to safe chemical products
Product safety is one of our top priorities. Starting at the development stage, we investigate the potential adverse impacts chemical substances may have. Along the entire value chain of our chemicals – from cradle to grave – we fulfill all statutory requirements, often even exceeding them. We furthermore publish extensive information on our website so that both our customers and the general public can learn about our products and how to handle them safely.
How we ensure chemical product safety
Our Healthcare, Life Science and Performance Materials business sectors each have their own organizational structures in place to provide guidance on product safety. These units work in close collaboration with our Group-wide governance function Corporate Regulatory Affairs Chemicals (EQ-R) to ensure our products’ safety. Their tasks include registering chemicals, classifying hazardous substances and communicating risks by means of safety data sheets and labels.
Our Group Product Safety Committee (GPSC) monitors regulatory requirements worldwide to check for relevant changes, initiating and reviewing the measures needed to integrate these changes into our processes.
Corporate Regulatory Affairs Chemicals (EQ-R) ensures regulatory compliance Group-wide. Reporting directly to the head of our Group function Corporate Environment, Health, Safety, Security, Quality, EQ-R is independent of our business sectors and not subject to any operational commitments. Any necessary corrective or preventive action is carried out by the operating units within each business sector. EQ-R further supports individual units in implementing and harmonizing efficient processes.
Our commitment: statutory regulations and Group-wide guidelines
We have implemented Group-wide guidelines that guarantee compliance with national and international regulatory requirements, and have also endorsed general voluntary commitments of the chemical industry such as the Responsible Care® Global Charter.
To meet the product safety regulations relevant to our company, we have enacted our Regulatory Affairs Group Policy, which details our Group-wide processes for managing and implementing product safety, including the necessary management structures. The statutory requirements applicable to our operations include the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and its implementation in regional and national legislation (such as the CLP regulation in the European Union and HazCom 2012 in the United States), the EU chemicals regulation REACH, the amended U.S. Toxic Substances Control Act (TSCA), and the amended German Federal Banned Chemicals Ordinance (ChemVerbotsV). Our Group-wide policy also incorporates legal norms concerning the transport of hazardous chemicals, biocides, cosmetics, and products used in food and animal feed. In 2018, we furthermore implemented our Group Label Standard, which provides a consistent framework for labeling products according to GHS requirements.
In this period, there were no incidents of non-compliance with regulations or voluntary standards involving chemical product labeling.
REACH registration complete
In 2018, we finished registering all substances covered by REACH, doing so within the allotted time. In the third and final REACH registration phase, to be completed by June 2018, we evaluated and registered all substances produced or imported in annual quantities greater than one metric ton. This process also incorporated the substances added to our portfolio through the acquisition of Sigma-Aldrich.
In line with the Strategic Approach to International Chemicals Management (SAICM), a global policy framework, a growing number of countries are recognizing the requirements for registering and licensing chemicals, such as the Toxic Substances Control Act (TSCA) in the United States and the Act on the Registration and Evaluation of Chemicals (AREC) in Korea. Thanks to our expertise in implementing REACH, we are well prepared for such a procedure and are already registering chemicals as required.
Transcending laws
In an effort that goes beyond statutory requirements, we support the goals of the Global Product Strategy, an international initiative of the chemical industry. In this vein, we publish product safety summaries for all lead substances that we have registered under REACH, making them available on the website of the International Council of Chemical Associations (ICCA).
Safety analysis during product development
We believe that product safety starts during the development stage. By conducting hazard, exposure and risk assessments, we work to ensure our chemicals can be safely used later down the road. All our innovations undergo an EHS analysis, which examines factors such as their impact on human health and the environment. Before launching a new product, we evaluate all relevant hazardous substance data and classify the product according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), along with locally applicable regulations such as CLP in Europe. In conducting these safety assessments, our employees in our Life Science and Performance Materials business sectors are advised by their respective Regulatory Affairs unit.
Our approach to nanotechnology
Nanotechnology is a highly innovative field of development that researches and uses structures 50,000 times thinner than a human hair. This technology makes it possible to produce materials with completely new properties and functions for a myriad of applications.
Nanotechnology opens up many opportunities for our Group. In our Life Science and Performance Materials business sectors, we utilize nanomaterials to develop products with new functions and properties, thereby making resource and energy consumption more efficient. In our Healthcare business sector, we collaborate with research institutes and other European companies to explore the use of nanomaterials to improve therapeutic options. Under the auspices of European research partnerships, we are also investigating whether nanoparticles are suitable vehicles to deliver active pharmaceutical ingredients to the required site of action.
Despite their promise, the unique structure of nanoparticles may harbor risks, which we assess in line with statutory requirements such as REACH. Moreover, we only utilize this new technology with the greatest care, abiding by the precautionary principle and taking nanomaterial safety very seriously. In doing so, we consider Group-wide requirements for safety, environmental stewardship and health impact mitigation, employing our existing product safety processes and systems. Whether using nanomaterials in pharmaceutical and chemical laboratories, production facilities, filling plants, or warehouses, we follow our Group-wide Policy for Use and Handling of Nanomaterials.
In the manufacture and processing of our products, we adhere to all statutory regulations along with standards such as those of the German Federal Institute for Occupational Safety and Health (BAuA), as well as the German Chemical Industry Association (VCI). We also provide our customers safety data sheets containing information on the proper handling of nanomaterials during transport, processing, storage, and disposal.
Sharing nanotech knowledge
Over and above our internal efforts, we continuously engage other companies, associations and regulatory agencies in a dialogue on the opportunities and risks of nanotechnology. We also take part in committees and working groups, including the Nano Panel of VCI’s Technology and Environment committee, as well as Responsible Production and Use of Nanomaterials, a joint technology working group of the Society for Chemical Engineering and Biotechnology (DECHEMA) and the VCI. Under the auspices of the VCI, we furthermore review current scientific literature in order to stay abreast of new advances in nanotechnology.
Standardized product safety information
As part of our efforts to communicate the potential dangers of our products, we provide our customers with in-depth informational material on all our chemicals. These brochures contain instructions on proper use and handling to prevent them from posing a danger to people and the environment. Our goal is to give our customers product safety information that has been standardized worldwide.
We issue all chemicals classified as hazardous with safety data sheets, which, in accordance with UN regulations, follow a globally harmonized format. These sheets contain information on the physicochemical, toxicological and ecotoxicological properties of the agent, and reflect the relevant regulatory requirements of the countries in which they are published. We therefore produce country-specific safety data sheets in 44 languages for our Performance Materials business sector and in 37 languages for our Life Science business sector. Although not mandated by law, we also provide safety data sheets for the non-hazardous materials and finished medicinal products manufactured by our Healthcare business sector. Since all these documents must be kept up to date and consistent, we have automated the majority of our Group-wide hazard communication processes. Within Performance Materials, we draft all safety data sheets Group-wide using a single system.
In 2018, we also automated most of the safety data sheet creation process for our Life Science business sector and also developed an app that provides our Life Science customers with access to the latest product safety information. Covering the whole life cycle of the product along its entire supply chain, the information is available worldwide in the respective national language and accounts for country-specific regulations. To access it, customers need merely scan the product’s barcode or enter it manually.
~25
million safety data sheets in total are made available to our customers.
Informing and educating customers
All information on the safe use of our products is also available on our website, where our customers can additionally access the ScIDeEx® program. This tool allows them to check whether they can use chemicals safely within the boundaries of the REACH exposure scenarios.
Taking a more active approach, we also endeavor to educate people on the safe handling of hazardous chemicals, providing users with best practice advice and information. To this end, we regularly conduct seminars and information sessions worldwide that teach basic lab safety rules such as the handling of flammable solvents and the storage of hazardous chemicals in safety cabinets and warehouses.