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TAG overview

Many of our chemical products have intrinsic hazardous properties. We are working to minimize the risk to human health and the environment resulting from their use. National and international regulatory requirements such as laws and guidelines form the basis of our data and documents. Beyond this, we strive to improve our product safety and reduce the environmental impact of our business through innovative solutions and digital communication tools.

Our approach to safe chemical products

Product safety is one of our top priorities. Starting at the product launch stage, we investigate the potential adverse impacts chemical substances may have.

Along the entire value chain of our products – from raw materials to manufacture and commercialization – we provide relevant information on the hazardous properties and related use instructions to allow the safe handling and use of our products, in line with regulatory requirements. We communicate this information mostly through relevant digital channels (Internet, e-mail, mobile apps). Paper safety data sheets are still common in some countries and can also be provided on demand through customer service.

We support developments related to the European Green Deal and are preparing to translate the pertinent elements into a dedicated chemicals sustainability strategy for our company.

How we ensure chemical product safety

Our Healthcare, Life Science and Performance Materials business sectors have organizational structures in place to implement our product safety strategy for their businesses and customers. This includes registering chemicals, classifying hazardous substances and highlighting risks by means of safety data sheets, labels and digital communications.

Our Corporate Governance function issues Group policies and standards as a framework to govern the setup of effective operational processes for product safety, hazard communication and chemicals regulations compliance throughout our various business sectors. Our Group Product Safety Committee monitors relevant regulatory developments.

This approach also applies to innovative fields of development such as nanomaterials, which we utilize with the greatest care in line with the precautionary principle. Furthermore, our Group-wide Policy for Use and Handling of Nanomaterials provides the necessary guidance on the utilization of this technology.

Legal requirements and internal guidelines

Through internal guidelines, we define the and responsibilities and basic processes required to comply with national and international regulations. We have endorsed general voluntary commitments of the chemical industry, such as the Responsible Care® Global Charter.

The legal requirements relevant to compliance with chemicals regulations are mainly related to hazard communication as well as local and regional chemical registration activities. These requirements are expanding globally, with a growing number of countries adapting local rules to existing regulatory frameworks such as REACH. We are well-placed to comply with emerging regulations of this kind in important markets such as China, India, Japan, South Korea, and Taiwan. Using the Globally Harmonized System () for hazard communication allows us to streamline our internal processes and provide consistent, harmonized and high-quality information to our customers.

Our worldwide network of regulatory experts in all three business sectors continuously monitors changes in legal requirements and scientific developments to stay ahead of trends and best practices.

In 2020, there were two minor incidents of non-compliance with regulations, specifically concerning potential health and safety impacts and the labeling of our chemical products. Neither human health nor the environment were negatively impacted.

REACH registration

In July 2020, our company signed the Cefic REACH Dossier Improvement Action Plan to review and improve the quality of our . This way, we also keep the information up-to-date and adapt to increasing regulatory requirements.

Safety analysis during product launch

We believe that product safety starts with development. At an early stage in the product launch process, we analyze innovations in terms of their impact on human health and the environment. In doing so, we can quickly identify any undesirable properties. In line with the applicable rules, we evaluate the intrinsic hazards of our existing as well as new products to create the relevant product safety information.

Product safety information

Chemical product safety is all about protecting human health and the environment from negative impacts resulting from the use of chemical products throughout a product’s life cycle. To achieve this, we provide all relevant information to our customers and the public, raising awareness of the hazards and building understanding of how to mitigate risks and use the products safely.

To obtain all the relevant information on hazard profiles, we utilize industry standard digital tools that gather all information available for the substances we use. We then cross-reference this data with local and regional rules to establish the relevant hazard classifications. We publish this information digitally on country-specific safety data sheets in multiple languages and on the labels of our products. The data sheets are maintained electronically and updated if there are relevant changes, or during a 3-5 year review cycle. We have automated and standardized the majority of our hazard communication processes.

For products with little information available, we are investigating the feasibility of using alternative predictive, non-animal testing methods such as and . For third-party products, we expect robust product safety documentation from our suppliers, which we feed into our processes or share directly with our customers.

Helping customers access safety information

To share information with our product users, we employ the latest digital tools and continuously explore new technologies.

Our Life Science customers can access product safety information in their respective language and according to country-specific regulations through a dedicated mobile app called “My M Safety” (Android and iOS). The information is retrieved by scanning a bar code on the product label or entering a material number.

Through our ScIDeEx™ web tool, anyone can check whether using a particular chemical is safe within the boundaries of EU REACH exposure scenarios. ScIDeEx™ is based on a full implementation of the ECETOC TRA 3 model for human in industrial and professional settings.

Role
Merck 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).
GHS
Short for "Globally Harmonized System of Classification and Labelling of Chemicals", this refers to an international standard system to classify chemicals that covers labeling as well as safety data sheets.
Registration dossiers
One part of the 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.
Read-across
Grouping of substances and read-across is one of the most commonly used alternative approaches for filling data gaps in registrations submitted under REACH. This approach uses relevant information from analogous (‘source') substances to predict the properties of ‘target' substances. If the grouping and read-across approach is applied correctly, experimental testing can be reduced as there is no need to test every target substance.
(Q)SAR
Structure-activity relationship (SAR) and quantitative structure-activity relationship (QSAR) models – collectively referred to as (Q)SARs – are mathematical models that can be used to predict the physicochemical, biological and environmental fate properties of compounds from the knowledge of their chemical structure. These models are available for free or as commercial software.
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.