TAG overview

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 all relevant national and international regulatory requirements, laws and guidelines, an approach that is crucial to our business success. At the same time, we aim to meet the expectations that stakeholders such as customers and employees have of a comprehensive hazard management program.

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 – during import, manufacture and commercialization – we fulfill all regulatory requirements, often even exceeding them. We publish extensive information on the safe handling of our products (see emdmillipore.com and emdgroup.com) on our websites.

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 support and guidance on product safety. The employees responsible for product safety from all three units work in close collaboration with each other as well as with our Group-wide governance function Corporate Regulatory Affairs Chemicals (-R) to ensure the safety of our products. 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 the measures needed to integrate new requirements into our processes and reviewing their progress.

EQ-R ensures that our company complies with all regulatory requirements Group-wide. Because it is not subject to any operational commitments and reports directly to the head of our Group Environment, Health, Safety, , Quality function, EQ-R operates independently of our business sectors. Any necessary corrective or preventive actions are the responsibility of each business sector. EQ-R furthermore supports individual units in implementing and harmonizing efficient processes.

Integrating Versum Materials and Intermolecular

In the process of integrating Versum Materials and Intermolecular, we are verifying whether their product safety practices comply with the applicable regulatory requirements as well as our internal standards, adapting the underlying processes as needed.

Our commitment: Legal requirements and Group-wide guidelines

Through Group-wide guidelines, we guarantee continual with national and international regulations and have also endorsed general voluntary commitments of the chemical industry, such as the Responsible Care® Global Charter.

Our Regulatory Affairs Governance Policy details our Group-wide processes for managing and implementing product safety and sets out the necessary management structures. To meet the product safety regulations relevant to our company, in 2019 we revised our Regulatory Affairs Governance Policy to more clearly define the , rights, powers, and responsibilities within our Group.

The legal requirements applicable to our operations include the Globally Harmonized System of Classification and Labeling of Chemicals () and its implementation in regional and national legislation (such as the regulation in the European Union and in the United States). Our Group Label Standard provides a consistent framework for labeling products according to GHS requirements. In addition to these, we also comply with the EU chemicals regulation REACH, the amended U.S. Toxic Substances Control Act (TSCA), and the amended German Federal Banned Chemicals Ordinance (ChemVerbotsV).

No significant incidents of non-compliance with regulations or voluntary standards involving chemical product labeling were reported in 2019.

REACH registration

In 2018, upon completing the third registration phase of the EU chemicals regulation , we committed ourselves to the following actions: We shall continuously review our own to verify quality and keep the information up-to-date, improving the dossiers as needed. In 2019, we developed and implemented the processes necessary to accomplishing this.

ICCA Product Safety Summaries

By mid-2019, we had made available on the website of the International Council of Chemical Associations (ICCA). Effective October 1, 2019, the website had been taken down by the ICCA because information on chemical substances is available on other web portals. We provide information on the safe handling and use of our chemicals on the websites of our Life Science and Performance Materials business sectors.

Safety analysis during product development

We believe that product safety starts with development. By conducting hazard, and risk assessments, we work to ensure that our chemicals can be safely used later on. As stipulated by law, we analyze all products in terms of their impact on human health and the environment, complying with the relevant regulatory requirements. Before launching a new product, we evaluate all pertinent hazardous substance data and classify the product according to the Globally Harmonized System of Classification and Labelling of Chemicals (), along with locally applicable regulations such as CLP in Europe. In conducting these safety assessments, the employees in our Life Science and Performance Materials business sectors receive advice and guidance from 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 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 that can help make resource and energy consumption more efficient, for example. In our Healthcare business sector, we explore the use of nanomaterials in medical therapies.

Despite their promise, the unique structure of nanoparticles may harbor risks, which we assess in line with legal requirements such as . Our Group-wide Policy for Use and Handling of Nanomaterials underpins our approach to this technology. In the manufacture and processing of our products, we adhere to all legal requirements 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 furthermore provide our customers with safety data sheets containing information on the proper handling of nanomaterials during transport, processing, storage, and disposal.

In principle, 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 observe Group-wide requirements for safety, environmental stewardship and health impact mitigation, and leverage our existing processes and systems to ensure product safety.

Sharing nanotech knowledge

Beyond our internal safety efforts, we regularly engage other companies, associations and regulatory agencies in a dialogue on the opportunities and risks of nanotechnology. We 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. Within the VCI, we furthermore review the latest scientific literature in order to stay abreast of new advances in nanotechnology.

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.

We provide all chemicals classified as hazardous with safety data sheets. These 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. 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 and standardized the majority of our Group-wide hazard communication processes within our business sectors.

In 2019, we updated 12 million safety data sheets for our Life Science business sector.

26 m.

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

We offer an app that enables our Life Science customers to access 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 takes country-specific regulations into account. To access it, customers only need to scan the product’s barcode or enter it manually.

Informing and educating customers

In 2019, we ran the Docs Online project within our Life Science business sector, which allowed us to verify that customer documents such as CoAs (Certificates of Analysis), CoOs (Certificate of Origin) and safety data sheets are up-to-date and available on the Sigma-Aldrich website, which has belonged to Merck KGaA, Darmstadt, Germany since 2015. Additionally, it is now easier to locate the documents. For individual special product groups, we contact our customers directly if needed, for instance when legal requirements change. Through our ScIDeEx® program, our customers can check whether they can use a chemical safely within the boundaries of the EU REACH exposure scenarios.

Our Group Environment, Health, Safety, Security, Quality function.
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 the company.
Adherence to laws and regulations as well as to voluntary codices that are internal to a company. Compliance is a component of diligent corporate governance.
Merck KGaA, Darmstadt, Germany uses a market-oriented system to rate positions within the company. To facilitate consistency across the organization, each position is assigned a specific role, with an overarching job architecture classifying each role as one of 11 levels, 15 functions and an array of career types (Core Operations, Services & Support Groups; Experts; Managers; Project Managers).
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.
Short for “Classification, Labelling and Packaging of Substances and Mixtures”, this is a European regulation 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.
Registration dossiers
One part of the complex and time-consuming REACH registration process is the preparation of a technical dossier and its submission to the European Chemicals Agency (ECHA). The information that a registration dossier should contain includes the physical-chemical, toxicological and ecotoxicological characteristics of the substances, human and environmental exposure, intended uses, classification and labelling, and recommended risk management measures.
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.
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.
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.

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