Putting product safety first

Clariant’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS) addresses the classification of chemicals by types of hazard and proposes harmonized hazard communication elements, including labels and safety data sheets, in order to enhance the protection of human health and the environment during the handling, transport and use of these chemicals.

The GHS also provides a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level; also an important factor for trade facilitation.

The Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) implements GHS in the European Union (EU) and replaces all previous regulations into the EU. Pictograms are used to warn of hazards, together with warning terms such as “Danger” or “Beware” depending on the level of risk.

Clariant’s Product Stewardship organization operates an implementation program to ensure the incorporation of all new legal requirements into its business processes and documents according to the transition periods for REACH respective CLP. CLP & REACH compliant Safety Data Sheets for classified substances were introduced by 1 December 2010.

In addition to that Clariant naturally extends the application of GHS on a global level. It monitors GHS implementation across the world and ensures that the company systems ensure legal compliance with the varying requirements.

The European Community Regulation on the Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH) came into force on June 1, 2007. The main aims of REACH are to ensure a high level of protection for human health and the environment, to improve the communication of information on handling chemical products, and to preserve and enhance the competitiveness of the chemical industry in the European Union.

REACH requires industry-wide registration of about 30,000 existing substances in accordance with the transitional provisions of REACH.

Clariant is fully committed to the REACH targets. Our Product Stewardship organization ensures the efficient implementation of REACH and close communication with customers and suppliers to ensure the compliance of all marketed Clariant products.

In May 2013, registration phase II was completed on schedule and in full for products produced or imported by Clariant in Europe with annual volumes of 100 – 1 000 t. 255 different chemical substances were registered during this phase, involving 66% more chemicals produced in the EU and imported into EU by Clariant in comparison to REACH phase 1.

At the end of May 2018, Clariant completed registration phase III. During this phase, Clariant registered data with the European Chemicals Agency (ECHA) on all chemical substances manufactured or imported by the company in excess of 1 tonne per year. It amounted to almost 1,000 dossiers in total.

Having successfully registered all relevant chemicals in 2018, Clariant ensures that all product dossiers are kept up to date. The company is committed to the European Chemical Industry Council’s multi-annual Action Plan. The goal of the Action Plan is to achieve a better alignment between the data that have been submitted in good faith by registrants and ECHA’s current expectations on the content of dossiers. Since there is no perfect REACH dossier template and every case is different, the Action Plan will be implemented in cooperation with ECHA. Learn more at Cefic.org.

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.

Clariant is committed to the Global Product Strategy and is making available GPS summary reports of substances it places on the market via the International Council of Chemical Associations.

To learn more about the Global Product Strategy in our North America Region, go to:
Implementation of the Global Product Strategy in North America

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, Clariant 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.

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. Clariant’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. Clariant promoted this development from very early on through its concept of an intelligent testing strategy, implemented in 2011, which is focused on the 3R principles (refinement, reduction, replacement of animal use).

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.

Learn more about these new approaches to product risk assessment here.