Product Safety testing & Animal Welfare Policy
Introduction
At Umicore, we are dedicated to delivering and developing safe, sustainable, and innovative solutions that enhance the quality of life for people and the planet.
Umicore complies with international regulations concerning the safety of these products for both humans and the environment. Recognizing and following these regulations is a key piece for ensuring the health and safety in the value chain.
These regulations may require animal testing. This Product Safety Testing & Animal Welfare Policy describes our commitment to minimizing the use of in vivo testing, and, when it is unavoidable, the ethical treatment of animals and the rigorous attention to animal welfare in the context of product safety testing.
Objective
The objective of this policy is to frame how we ensure safety testing and animal welfare are in alignment with both regulations and our Let’s Go for Zero ambitions of ensuring Zero Harm.
Scope
This policy applies to the Umicore Group’s consolidated activities.
Regulatory frameworks
Umicore is subject to international chemicals regulations in the regions where its products are manufactured/imported and/or marketed. Umicore does not manufacture any cosmetics or consumer goods and product testing is therefore aligned to regulatory requirements for industrial chemicals.
Regulations such as REACH[1] (Registration, Evaluation, Authorisation and Restriction of Chemicals) in Europe, TSCA (Toxic Substances Control Act) in the USA, K-REACH in Korea and China REACH require all chemical substances and intermediates produced[2] to be registered and/or evaluated, which may involve toxicology tests for new, unregistered substances.
The European Union is a frontrunner in the development of chemical regulations. The EU REACH regulation aims to protect man and environment from chemical risks and requires registrants to document hazard and risk assessments on the chemical substances produced or imported in the EU. As part of this, registrants must collaborate to generate one dossier per substance[3]. The EU REACH regulation requires companies to use alternative methods whenever possible – so that in vivo testing only occurs as a last resort. Testing proposals for complex and high-tier tests must be submitted to the European Chemicals Agency (ECHA) before testing on vertebrate animals (annex IX and X requirements under REACH) can be performed. In addition, every three years, ECHA publishes a report on using alternatives to animal/in vivo testing for the REACH regulation.
Other international regulations, e.g., in Asia, are introducing updates on their chemical regulations where EU REACH is often the reference to identify data requirements during the hazard assessment of the chemicals. As a result, Umicore applies the same approach of filling data gaps using the EU REACH process and sharing existing data where possible and acceptable by the regulators.
General Principles
Umicore is committed to ensuring that all products can be used in a safe way. This commitment is supported by the work we do with other members of industry to share and compile data efficiently.
We share society’s concern about animal testing, and our goal is to reduce and eventually eliminate it. Animal/in vivo studies are only conducted when legally required and when no scientifically viable alternative has been identified.
We act to apply the 3R principle, where:
- Replacement: replacing in vivo procedures with alternatives not using animals;
- Reduction: reducing to a minimum number of in vivo procedures without compromising the quality of results;
- Refinement: using methods that attempt to avoid pain, suffering or distress, or lasting harm, or -to improve the care, treatment and living conditions of animals.
We first apply the latest integrated testing strategies such as: computer modeling of effects, in vitro assays, in vivo test-waiving approaches, and read across. We follow the latest developments in testing techniques such as NAMs (New Approach Methodologies in toxicology) and implement them into our approach when they are endorsed by regulators.
We seek to limit new testing/ avoid duplication by collaborating with industrial partners with the same data needs wherever possible.
Should an in vivo study be unavoidable, we are committed to conducting studies that treat animals responsibly and with great regard for their welfare. We do not conduct any in vivo testing ourselves. Studies are performed by third parties vetted for ethical and animal welfare standards. Umicore’s toxicologists, who are European Registered Toxicologist (ERT) certified, ensure that any studies comply with all applicable laws, regulations and licensing. Before they start, all studies are subject to an ethical assessment at local or national level by the laboratory conducting the study. Study monitoring is executed by, or under the supervision of, the ERT certified Umicore toxicologists in close interaction with the study director(s) ensuring the standards are being followed correctly during the studies.
Implementation & Monitoring
This policy is aligned with the implementation of the Umicore EHS Product Stewardship Policy, in which each Business Unit has identified a person responsible for Product Stewardship. In support of the Business Product Stewardship managers, the Umicore Corporate EHS ERT-certified toxicologists are responsible for implementing this policy.
The following are the main elements of the implementation:
- Evaluating and defining the best approach for hazard assessment, giving priority to non-animal testing approaches.
- Defend this position in the external industry associations and consortia.
- In case of unavoidable animal testing, guarantee that the highest ethical and animal welfare standards (e.g., AAALAC) are followed by the external testing facilities via site visits and audits.
- Perform study monitoring in close collaboration with the study director and/or the scientific consortia managers.
Corporate EHS may perform site visits and/or audits of the external testing facilities to ensure compliance and to guarantee consistency with this policy. An internal guidance document on how to conduct the audits and auditable points is available.
Umicore has a systematic approach for the hazard assessment of its portfolio of low volume chemicals[4] , using a hierarchy of sources, from in-house data to publicly available information. The outcomes of the hazard assessments are stored in Safety Data Sheets (SDS) and shared with Umicore customers and partners directly.
Umicore is a member of over 20 REACH consortia and sector associations that support the industry in data sharing and compiling the REACH dossiers in the most efficient way considering alternative tests and read across (copying hazard data from one substance to another) ensuring the compliance to the OSOR principle under REACH.
Beyond ensuring implementation of this policy, we monitor alternative approaches and continuously advocate for metal-specific non-animal testing strategies as part of our engagement in relevant sector associations.
Governance
The Supervisory Board's Sustainability Committee ensures the necessary sustainability-related policies and processes are in place, and reviews performance linked to them. In the management board, the EVP ESG oversees sustainability/ESG integration/ Environment, Health and Safety (EHS) compliance, performance, strategy, engagement, and disclosure.
The Senior Vice-President (SVP) for EHS ensures environmental, health and safety compliance, risk mitigation and data reporting across Group activities and has dedicated chemical compliance, REACH, toxicology, product safety expertise in their team to manage implementation of this policy and support the Business Units.
Business Units are responsible for the products they use, develop, manufacture, and bring to the market, and the related risks and benefits, irrespective of where production is located or where their markets are. Each Umicore Business Unit has a Product Stewardship Manager. The Product Stewardship Managers, under the guidance of Corporate EHS, assure that all raw materials, intermediates, and products in the scope for EU REACH or non-EU chemical regulations, are identified and subject to registration.
Corporate EHS offers guidance and practical assistance to the Business Units and sites in meeting their legal obligations and Group requirements. The Business Units are responsible for engaging with the ERT-certified Umicore toxicologists in Corporate EHS to evaluate and minimize the impact of activities and products on humans and the environment.
We regularly review our practices with a view to improving them, staying at the forefront of developments in both animal welfare and testing technologies.
This policy was approved by the EVP ESG. Group ESG & Corporate EHS are responsible for reviewing the policy by December 2025. The last update was recorded on March 12, 2024.
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Footnotes