Many chemical products of the Merck KGaA, Darmstadt, Germany product portfolio are classified as hazardous and their proper use is a prerequisite for the safety of humans and the environment. Therefore, we provide our customers with extensive, up-to-date information on safely using our products.

Numerous regulatory requirements exist to ensure that chemical products not pose any danger to humans or the environment. When it comes to the import or production, marketing, handling, recycling and disposal of our chemical products, it is crucial that we comply with these regulations. In order to satisfy both national and international safety product requirements, the company has set up corporate, business-specific and local guidelines and signed broader industry self-commitments like the Responsible Care^® Global Charter .

Corporate Regulatory Affairs, a unit within the company's Environment, Health, Safety, Security, Quality (EQ) Group function, and local regulatory affairs units are accountable for compliance with relevant product safety regulatory requirements. Corporate Regulatory Affairs is responsible for all operational regulatory activities within the company, such as hazard exposure and risk assessment, hazard communication via safety data sheets (SDS), and chemical product registration. Its goal is to ensure global consistency and harmonization of hazard communication to our customers.

With our Group-wide "Product Safety Chemicals" policy, we have established global processes for steering and implementing product safety, as well as the corresponding management structures. This policy covers all relevant national and international regulations for the chemical industry, including: 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 EU and HazCom 2012 in the United States), the EU chemicals Regulation REACH , the U.S. Toxic Substances Control Act (TSCA ), and the German Federal Law on protection from hazardous substances (ChemG). This policy also incorporates statutory standards that relate to the transport of, for instance, hazardous chemicals, biocides, cosmetics, chemicals used in food, and animal feed. It is regularly updated to reflect new regulatory requirements.

To continuously monitor changing regulatory requirements around the globe, as well as initiate and steer necessary implementation projects (such as GHS and REACH), we have put in place the Group Product Safety Committee (GPSC). It reports directly to the Executive Board Member Bernd Reckmann, who is responsible for chemicals product safety. Besides managing regulatory affairs, members of the GPSC represent Merck KGaA, Darmstadt, Germany’s individual businesses, each having specific responsibilities for matters such as legal questions, production and quality management, and marketing. The GPSC also supervises SAP EHSM (our product safety database and expert system), as well as internal and external communication processes.

To ensure independent detection of critical compliance gaps, in 2013 and 2014 we set up a corporate governance function that reports directly to the head of Corporate Regulatory Affairs. The operational units within Corporate Regulatory Affairs are then responsible for appropriate mitigation measures after discussion with all stakeholders relevant for us. One example is the U.S. GHS Compliance Program. Because Merck KGaA, Darmstadt, Germany had acquired product portfolios in the USA that lacked some safety information, we initiated a multinational program in 2012 to push regulatory coverage and bring the portfolios up to our renowned standards. Our target is not only to close existing compliance gaps, but to also be the frontrunner in implementing the new GHS requirements under HazCom 2012 in the USA, which will take effect in June 2015. Merck KGaA, Darmstadt, Germany is already well prepared for chemical products imported into and produced in the United States. By the end of 2014, our major production sites there had started delivering GHS-labeled chemical products.

Safety analyses during product development

In the company, we utilize various instruments to ensure that the development process yields products that are safe to use. This includes different hazard, exposure and risk assessments. We subject all product innovations to a formal Environment, Health and Safety analysis that investigates aspects such as human health and environmental impacts. The Corporate Regulatory Affairs unit provides support and advises our employees on safety assessments during the product development phase.

Transparent information to boost product safety

Proper hazard communication for chemical products via safety data sheets or labels is a prerequisite for the safety of humans and the environment. For all of our products, we provide extensive information on safe use. We deliver our hazardous chemicals with safety data sheets that comply with current local regulatory requirements, available in 35 languages. Although not required by law, we provide safety data sheets for non-hazardous substances as well as ensure that our customers have all currently available information. Non-hazardous substances only used in small volumes in lab applications are provided with a safety data sheet replacement letter.

Merck KGaA, Darmstadt, Germany keeps multiple hundreds of thousands of safety data sheets updated and continuously launches numerous new products, which means we have achieved a very high level of automation in the hazard communication process. Within the Group, six regulatory affairs hubs around the globe share dedicated responsibilities in hazard communication processes. These hubs report to Corporate Regulatory Affairs, which drives the work processes throughout the Group. Thanks to our regulatory expertise and stable processes, we receive around one complaint per week on incorrect hazard communication.

All information related to the safe use of our products is also accessible on our website, which furthermore features an application called ScIDeEx^® . This tool enables customers to check whether a chemical can be safely used under the conditions in which they plan to utilize it. The current version, ScIDeEx^® 3, is based on the latest model of ECETOC TRA version 3.1, a program that is recognized by the European Chemicals Agency (ECHA).

In our 2014 stakeholder survey, labeling of chemicals was identified as a material issue for Merck KGaA, Darmstadt, Germany. With regard to chemical product labeling, the company's regulatory goals include establishing, optimizing, and harmonizing global hazard communication processes, which will allow us to efficiently support businesses and customers with globally harmonized labels and GHS-compliant safety data sheets. We implemented a dedicated function within Corporate Regulatory Affairs that is accountable for global label management, thus reflecting the importance of this topic for the company.

We are committed to product safety that goes beyond the legal requirements and support the goals of the Global Product Strategy, an international initiative of the chemical industry. In this vein, we provide product safety summaries that are available on the website of the International Council of Chemical Associations (ICCA ).

REACH registration

Merck KGaA, Darmstadt, Germany completed the second phase of the REACH implementation process in June 2013 and had registered all substances we produce or import in quantities ranging from 100 to 1,000 metric tons per year – around 70 substances – with the European Chemicals Agency (ECHA). The next step, part of the third phase, is for us to register all substances produced or imported in quantities ranging from one to 100 metric tons by the beginning of June 2018. We have already started this process and are on schedule with our activities.

Due to the Strategic Approach of International Chemicals Management (SAICM), REACH-like requirements will take effect in South Korea (Act on the Registration and Evaluation of Chemicals, abbreviated AREC). Based on our expertise with the EU REACH implementation, we will be well equipped to handle these requirements as well.

Nanotechnology

Nanotechnology is a highly innovative field of development that researches and uses structures that are 50,000 times thinner than a human hair. This technology makes it possible to produce materials with completely new properties, benefits and functions for a wide variety of applications.

Nanotechnology offers many opportunities for our company. In our Life Science and Performance Materials business sectors, we can use nanoscale materials to develop products with new functions and properties – thus, for instance, making resource and energy use more efficient. In our Healthcare business sector, we partner with external companies to explore the use of nanomaterials to improve therapeutic options. Within the scope of joint European research projects, we are also investigating the suitability of nanoparticles as vehicles for active pharmaceutical ingredients.

However, the special structure of nanoparticles can also entail risks. We assess these risks and utilize the new technology only with the greatest care. We take into account Group-wide requirements for safety as well as environmental and health protection, employing our existing processes and systems for product safety. We follow the precautionary principle and take nanomaterial safety issues seriously. In 2014, we updated our Group-wide "Use and Handling of Nanomaterials" policy; this document governs the handling of nanomaterials, whether used in pharmaceutical and chemical laboratories, production plants, filling plants, or warehouses.

In manufacturing and processing products, we strictly adhere to compliance with all statutory regulations and other applicable standards, such as the guidelines of the German Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin – BAuA) as well as the German Chemical Industry Association (Verband der Chemischen Industrie  – VCI). We also provide our customers with information on the proper handling of nanomaterials, for example during transport, processing, storage, and disposal.

Both internally and externally, we are constantly engaged in an exchange regarding the opportunities and risks of nanotechnology. Our internal nano-coordination group consists of analysts, researchers, toxicologists, safety experts, and experts from other relevant areas of the company. We also maintain a continuous dialogue with other companies, associations and regulatory agencies, through channels such as the nano-coordination group of the VCI’s Technology and Environment (Technik und Umwelt) committee, and the Responsible Production and Use of Nanomaterials group, a joint technology working group of DECHEMA (Society for Chemical Engineering and Biotechnology) and the VCI.

Training seminars

In 2013 and 2014, we conducted product safety seminars in various countries around the world. Here, we focused not only on our core markets but also offered training in developing countries. We aim to increase awareness as well as provide best practice advice and information on using hazardous chemical products safely and easily. This includes lab safety rules such as the handling of flammable solvents and storage of various chemicals in warehouses or safety cabinets. We are planning to hold such seminars in the future as well.