Merck Sustainability Report 2021

Chemical product safety

TAG overview

Many of our chemical products have intrinsic hazardous properties. Therefore, we are working to minimize the potential risks to both human health and the environment resulting from their use. We continuously 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 that chemical substances may have. Along the entire value chain of our products – from raw materials to manufacture and commercialization – we provide relevant information on their hazardous properties and how to deal with them. These instructions facilitate the safe handling and use of our products in line with all regulatory requirements. We publish this information primarily on the relevant digital channels. Paper safety data sheets are still common in some countries and we can therefore also provide these upon request through our customer service.

We support the implementation of the European Green Deal and are preparing to integrate the relevant chemicals sustainability aspects into our business strategies. We are currently evaluating portfolio sustainability assessment concepts, which we will use to measure our adherence to existing and upcoming external and internal sustainability criteria. These concepts will also help us to create greater transparency regarding the most important aspects for improving sustainability.

Roles and responsibilities

Our Life Science, Healthcare and Electronics business sectors have organizational structures in place to implement our product safety strategy taking into account respective business requirements and customer needs. This approach includes registering chemicals, classifying hazardous substances and highlighting risks via the use of safety data sheets, labels and digital communications.

Our Group standards provide a framework for governing the set-up of effective operational processes for product safety, hazard communication and chemicals regulatory compliance throughout our business sectors. Our Group Chemicals Regulations Council monitors relevant regulatory developments.

This approach also applies to innovative fields of development such as nanomaterials, which we use 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 use of these materials.

Legal requirements and internal guidelines

Our internal guidelines define the roles, responsibilities and basic processes required to comply with national and international regulations. In addition, we have also endorsed 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 their local rules in line with existing regulatory frameworks such as REACH. We are well placed to comply with regulations of this kind in important markets, such as China, India, Japan, Korea, and Taiwan. Using the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) 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 to legal requirements and scientific developments in order to stay ahead of trends and best practices.

In 2021, there were no incidents of non-compliance with regulations, specifically concerning potential health and safety impacts and the labeling of our chemical products.

Safety analysis during product launch

Safe and sustainable by design implies that product safety starts with development. Therefore, at an early stage in our product launch process, we analyze innovations in terms of their impacts on human health and the environment. We also evaluate the intrinsic hazards of both our existing and new products to create relevant product safety information in line with all applicable rules.

Product safety information

Chemical product safety is all about protecting human health and the environment from adverse impacts resulting from the use of chemical products throughout their life cycle. To achieve this, we provide all relevant information to our customers and the public, which helps raise awareness of the hazards and build a greater understanding of how to mitigate risks and use the products safely.

To obtain all the relevant information on hazard profiles, we use industry-standard digital tools that gather all information available on 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 an internally agreed three-year review cycle. We have automated and standardized the majority of our hazard communication processes.

For products with little available information, we are investigating the feasibility of using alternative predictive, non-animal testing methods, such as read-across and (Q)SAR. 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

We employ the latest digital tools and continuously explore new technologies to share information with our product users.

Our Life Science customers and all interested stakeholders 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). Customers can retrieve this information by scanning a barcode on the product label or entering identifiers such as material numbers, names or CAS numbers.

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

(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 structures. These models are available for free or as commercial software.
Exposure assessment
Exposure assessment aims to make a quantitative or qualitative estimate of the dose / concentration of the substance to which humans and the environment are or may be exposed. Exposure assessment under REACH consists of two steps: 1) development of exposure scenarios and 2) exposure estimation. These steps must be iterated until it can be concluded that the resulting exposure scenarios would ensure adequate control of risks upon implementation.
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.
Role
Our company 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).
Stakeholder
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.

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