Many of our chemicals are classified as hazardous substances and are therefore subject to an array of national and international regulatory requirements to ensure that they do not pose any risk to people or the environment. Fulfilling these statutes and guidelines is crucial to our business activities. In addition, we strive to meet the expectations such as customers and employees have of a comprehensive risk management system.

Our approach to safe chemical products

Product safety is our top priority. Starting in the development stage, we investigate the potential impacts chemical substances may have. Along the entire value chain of our chemical products – from import or production through commercialization, handling, recycling, and disposal – 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 use them safely.

How we ensure the safety of chemical products

Our Life Science and Performance Materials business sectors each have their own Product Safety units. Working in close collaboration, these units are responsible for all product safety activities such as registering chemical products, classifying hazardous substances and communicating risks through safety data sheets and labels. In addition to these activities, they also assume similar duties for our Healthcare business sector.

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.

Our Group-wide governance unit Regulatory Affairs (EQ-R) ensures that steps are taken to address gaps in regulatory as soon as these arise. Reporting directly to the head of our Group function Corporate Environment, Health, Safety, , Quality, EQ-R is independent of our business sectors and is 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: Observing 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, in 2017 we adopted the 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 (GHS) and its implementation in regional and national legislation (such as the regulation in the European Union and in the United States), the EU chemicals regulation REACH, the amended U.S. Toxic Substances Control Act (TSCA), and the German federal law on protection from hazardous substances (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.

REACH registration on schedule

We are working to register all our chemical substances under . We successfully completed registration phase 1 in 2010 and registration phase 2 in 2013. The next step, part of phase 3, is due by June 2018 and requires us to evaluate and register all substances produced or imported in quantities ranging from one to 100 metric tons annually. This process now also includes the substances added to our portfolio through the acquisition of Sigma-Aldrich and is on schedule.

In line with the Strategic Approach to International Chemicals Management (SAICM), a global policy framework overseen by the United Nations, requirements for registering and licensing chemicals are being recognized in a growing number of countries. Thanks to our experience in implementing REACH, we are well prepared for such a procedure and have already initiated the registration process for select substances.

Transcending laws

In an effort that transcends statutory requirements, we support the goals of the , an international initiative of the chemical industry. In this vein, we publish for all lead substances we've registered under REACH 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, and risk assessments, we seek to ensure that our chemical products can be safely used later down the road. All our product innovations undergo a formal analysis, which examines aspects such as their impact on human health and the environment. Before launching a new product, we evaluate all relevant hazardous substance data and classify it accordingly. In conducting these safety assessments, Regulatory Affairs provides advice and support to employees in our Life Science and Performance Materials business sectors.

Safe 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 can use nanoscale materials to develop products with new functions and properties – meaning, for instance, that resources and energy can be used more efficiently. In our Healthcare business sector, we partner 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 the suitability of nanoparticles as vehicles to deliver active pharmaceutical ingredients to the required site of action.

However, the special structure of nanoparticles can also entail 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 issues very seriously. In doing so, we consider Group-wide requirements for safety as well as environmental and health protection, employing our existing processes and systems for product safety. Whether using nanomaterials in pharmaceutical and chemical laboratories, production plants, filling plants, or warehouses, we abide by our Group-wide Policy for Use and Handling of Nanomaterials.

In the manufacture and processing of our products, we adhere strictly to all statutory regulations and other applicable standards, such as the guidelines 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.

Consolidating knowledge of nanotechnology

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 participate in committees and working groups such as the Nano-coordination group of the VCI's Technology and Environment committee, as well as Responsible Production and Use of Nanomaterials, a joint technology working group of DECHEMA (Society for Chemical Engineering and Biotechnology) and the VCI. Under the auspices of the VCI, we furthermore help to review current scientific literature in order to glean new findings on 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 chemical products. These brochures contain instructions for 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 ecotoxilogical 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 41 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.


million safety data sheets in total are made available to our customers.

Since all these documents must be kept up to date and consistent, in 2017 we automated the majority of our Group-wide hazard communication processes. Now the aim is to centralize the creation of safety data sheets in our business sectors. Within Performance Materials, for instance, we began drafting all safety data sheets Group-wide using a single system this year.

Informing customers and increasing awareness

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 a chemical agent safely in line with the EU chemicals regulation REACH.

We aim to increase awareness for 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 chemicals in safety cabinets and warehouses.

People or organizations that have a legitimate interest in a company, entitling them to make justified demands. Stakeholders include people such as employees, business partners, neighbors in the vicinity of our sites, and shareholders.
Adherence to laws and regulations as well as to voluntary codices that are internal to Merck KGaA, Darmstadt, Germany. Compliance is a component of diligent corporate governance.
This term stands for all necessary measures and governance activities to detect, analyze, handle, and mitigate security- and crime-based threats to the company. This helps to protect employees as well as the tangible and intangible assets of Merck KGaA, Darmstadt, Germany.
Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
An international standard system to classify chemicals that covers labeling as well as safety data sheets.
The European CLP regulation (Classification, Labelling and Packaging of Substances and Mixtures) is based on the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.
HazCom 2012
A U.S. OSHA (Occupational Safety and Health Administration) standard pertaining to the safe handling of chemicals in the workplace, with an emphasis on occupational safety and environmental protection. This standard requires manufacturers and distributors to provide information on the hazards posed by a product as well as ways to minimize risks.
A European Union chemical regulation (EC No. 1907/2006) that took effect on June 1, 2007. REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals.
Global Product Strategy
An initiative of the International Council of Chemical Associations (ICCA) through which participating companies of the chemical industry make a commitment to comprehensive product responsibility.
Product safety summary
Intended to provide a general overview of the chemical substance and its use. It cannot take the place of a safety data sheet.
Exposure assessment
The U.S. Environmental Protection Agency defines exposure assessment as the determination or estimation (qualitative or quantitative) of the magnitude, frequency, duration, and route of exposure between an agent and an organism. This analysis forms part of the chemical safety assessment process.
Environment, Health and Safety describes environmental management, health protection and occupational safety throughout the company.

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