Many of our chemicals are classified as hazardous substances. However, they must not pose any risk to people or the environment. In developing these substances, product safety is our primary consideration. We fulfill all statutory requirements, often exceeding them, and provide our customers with extensive information so that they understand our products and can use them safely.
Statutory regulations and Group-wide guidelines
Numerous national and international regulatory requirements have been put in place to ensure that chemical products do not pose any danger to humans or the environment. We have implemented Group-wide guidelines that guarantee compliance with these regulations at all times when it comes to the import, production, commercialization, handling, recycling, and disposal of our chemical products. We have also signed general voluntary commitments of the chemical industry such as the Responsible Care® Global Charter.
To meet the product safety regulations relevant to our company, our Product Safety Chemicals policy details our Group-wide processes for managing and implementing product safety, including the necessary management structures. These include the Globally Harmonised System of Classification and Labeling of Chemicals (GHS) and its implementation in regional legislation (such as the CLP regulation in the European Union 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). Our Group-wide policy also incorporates legal norms concerning the transport of hazardous chemicals, biocides and cosmetics, as well as the chemicals used in food and animal feed.
Safety analysis during product development
At Merck KGaA, Darmstadt, Germany, product safety starts during the development stage. By conducting hazard, exposure 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 EHS analysis, which examines aspects such as impact on human health and the environment. In conducting these safety assessments, Regulatory Affairs provides advice and support to employees in our Life Science and Performance Materials business sectors.
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 for all our chemical products that contains 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 that contain information on the physicochemical, toxicological and ecotoxicological properties of the agent. Our safety data sheets reflect the latest local regulatory requirements and are available in 37 languages as well as 61 language-country combinations. Although not legally required, our non-hazardous substances also come with safety data sheets. In total, we make roughly 22 million safety data sheets available to our customers. Since all these documents must be kept up to date and consistent, in 2015 and 2016, we automated the majority of our Group-wide hazard communication processes and are now harmonizing the systems of our business sectors and sites.
In an effort that transcends 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 we've registered under REACH on the website of the International Council of Chemical Association (ICCA).
Organizational structure for product safety
In response to the acquisition of Sigma-Aldrich, a U.S.-based life science company, we adapted our organizational structures for product safety in the 2015-2016 period. 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 risk assessment, hazard communication in the form of safety data sheets and safety labels, as well as the registration of chemical products.
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 Corporate Governance unit ensures that critical gaps in regulatory compliance are independently addressed. This unit reports directly to the head of the Group function Corporate Environment, Health, Safety, Security, Quality. Any necessary corrective or preventive action is carried out by the operating units within each business sector.
Take for instance the U.S.-based GHS Compliance Program. Since we had acquired several product portfolios in the United States that lacked safety information, in 2012 we initiated a multinational program to push regulatory coverage and bring the portfolios up to our stringent standards. Our objective was not only to close existing safety gaps, but also to be the front runner in implementing the new GHS requirements under HazCom 2012 in the United States, which took effect in June 2015. We fully achieved this goal while also meeting the deadline.
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 – thus, for instance, helping use resources and energy more efficiently. In our Healthcare business sector, we partner with external companies to explore the use of nanomaterials to improve therapies. Under the auspices of European research partnerships, 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 furthermore only utilize the new technology with the greatest care. 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. We abide by the precautionary principle and take nanomaterial safety issues very seriously. Our Group-wide Policy for Use and Handling of Nanomaterials governs the handling of nanomaterials, whether used in pharmaceutical and chemical laboratories, production plants, filling plants or warehouses.
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 with information on the proper handling of nanomaterials across their life cycle, including transport, processing, storage, and disposal.
We are continuously engaged in a discourse on the opportunities and risks of nanotechnology. Our internal nano-coordination group consists of analysts, researchers, toxicologists, safety experts, and other professionals from relevant areas of our company. To guide our decisions and actions, we participate in committees and working groups that include other companies, associations and regulatory agencies. Examples of such groups include 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.
Training and awareness
We aim to increase awareness of, as well as provide best practice advice and information on, the safe use of hazardous chemicals. To this end, we regularly conduct seminars worldwide that teach basic lab safety rules such as the handling of flammable solvents and the storage of chemicals in safety cabinets and warehouses.
REACH registration on schedule
We are working to register all our chemical substances under REACH. We successfully completed registration phase 1 in 2010 and registration phase 2 in 2013. The next step, part of phase 3, is for us to evaluate and register all substances produced or imported in quantities ranging from one to 100 metric tons annually by June 2018. This process now also includes substances from 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, the Act on the Registration and Evaluation of Chemicals (AREC) took effect in Korea in early 2015. The requirements of AREC are very similar to those of REACH, so much so that AREC is often referred to as “K-REACH”. 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.