Putting product safety and regulatory standards first
Heubach attaches particular importance to product stewardship and ensures products can be used over their entire life cycle in a safe manner by employees and customers and for the public and the environment. We have developed comprehensive guidelines and systems to ensure product and production safety and avoid unnecessary animal testing, and at the same time ensure products are in accordance with applicable laws, regulations, and internationally accepted guidelines.
Our Global Product Stewardship team is responsible for ensuring that our product portfolio corresponds to applicable environmental and safety standards at national and regional levels, such as those specified by REACH (Registration, Evaluation, Authorization and Restriction of Chemical substances), as well as constantly looking for opportunities to further enhance product safety and sustainability. Employee training takes place on a regular basis, while processes, procedures and measures are continually monitored both internally and by means of external audits. Through comprehensive evaluation and customer communication on how to safely manage and use our chemicals, we uphold this commitment to chemical safety. Furthermore, we aim to consistently minimize any risks to the environment and public health and ensure that clear sustainability perspectives are embedded in product development, allowing for a sustainable business and a product portfolio based on sustainability.
A GLOBAL PRODUCT STRATEGY
The Global Product Strategy (GPS) was developed in 2006 by the International Council of Chemical Associations (ICCA) as part of its commitment to the United Nations Strategic Approach to International Chemicals Management (SAICM) program. The program promotes the safe use of chemical products through the entire life cycle and enhances product stewardship throughout the value chain.
It will also reduce the differences in the safe handling of chemical substances between developing, emerging and industrialized countries. The Global Product Strategy is the approach to perform risk assessments and the safe management of chemicals across geographical boundaries. Communication and transparency are important key elements for the implementation of the Global Product Strategy by the chemical industry. So-called GPS safety summaries, a base set of information for the safe use of chemical products giving a general overview of the characteristics and uses of a chemical substance, are intended to provide transparent access to important information in a suitable format and in a general, understandable language. In this way, the aim is to increase public confidence that chemicals are handled safely throughout their life cycle.
SUBSTANCE RISK ASSESSMENTS
Sound chemicals management is a global responsibility. In this respect, regulatory bodies worldwide, like the European Chemicals Agency (ECHA) and the International Council of Chemical Associations (ICCA), have adopted specific statutory regulations and guidance to improve the protection of human health and the environment from the risks that can be posed by chemicals. As a chemical company, Heubach ensures that it complies with the regulations and guidance set out by the ECHA and ICCA. A risk assessment is the process of analyzing information to determine whether an exposure to identified chemical hazards might cause harm to human health and/or the environment and consists of four general steps: hazard identification, dose-response assessment, exposure assessment, and risk characterization.
- Hazard identification refers to the characterization of inherent adverse toxic effects of substances.
- Dose-response-assessment refers to the characterization of the relationship between doses of hazardous substances and incidences of adverse effects in exposed populations
- Exposure assessment refers to the characterization via measurement or estimation of the intensity, frequency, and duration of exposure to substances
- Risk characterization refers to the estimation of the incidence of effects to human health and/or the environment under various conditions of exposure
The chemical risk characterization depends directly on the results from the hazard characterization (including dose-response analysis) and exposure assessment steps and allows qualitative and quantitative statements about respective risks including the exposure conditions under which the risk may occur. In its simplest terms, risk characterization basically represents the use of exposure information to interpolate along the dose-response curve. However, this is somewhat over-simplified as risk characterization usually involves more extrapolation than interpolation, and many different types of extrapolation are generally necessary for establishing robust risk characterization results, e.g. inter- and intraspecies extrapolation, high to low dose extrapolation, exposure duration extrapolation, etc. The final outcome of the risk assessment process, the risk characterization step, defines the nature and degree of a certain risk to a certain hazard under specific exposure conditions in sufficient detail to allow consideration of appropriate risk management options for chemicals.
INTELLIGENT TESTING METHODS
Chemical substances are processed into most products we use today – in cars, in jeans, in laundry detergents, in televisions and telephones. The list is endless. This is why such chemicals are subject to stringent testing procedures and evaluations, regulated and required by law, which also includes mandatory testing on animals. Maintaining and respecting animal welfare are both issues of great societal and ethical concern and subject to regulation and mandatory obligations. Heubach’s overall objective is to conduct animal studies only when scientifically or legally required to do so and when no viable alternative is yet available. For some of the complex toxicity endpoints, like specific organ toxicity or reproductive toxicity, animal models cannot be replaced immediately. However, increasing ethical concerns in addition to the scientific need to use more human-relevant data has set the stage for the development of alternative approaches like in silico, in chemico and in vitro methods to assess the human and ecological toxicity potential of chemicals. We place a strong emphasis on applying new approach methodologies in our testing strategies and integrated testing techniques such as computer modelling and in vitro techniques. We are also proactively engaged – directly or through industry associations – in scientific and regulatory exchanges in order to promote the development of alternative methods and the validation process of these methods.