Ensuring Safety and Environmental Standards
In line with its Sustainability Policy and as part of its Responsible Care® commitment, Clariant attaches particular importance to product stewardship and ensuring products can be used over their entire life cycle in a safe manner by employees and customers and for the public and the environment. Clariant has developed comprehensive guidelines and systems to ensure product and production safety and minimize the impact of its business. The company’s Product Stewardship organization is responsible for ensuring that the 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. Employee training takes place on a regular basis, while processes, procedures and measures are continually monitored both internally and by means of external audits.
These measures include Reach @ Clariant, a Globally Harmonized System, a Global Product Strategy, and an Intelligent Testing Strategy. Read more about these initiatives here.
The "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.
GHS is a UN recommendation and an invitation to competent authorities to introduce GHS elements into local or regional legislation. The worldwide implementation of GHS is a dynamic process throughout different countries of the world.
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.
New pictograms are used to warn of hazards, together with warning terms such as “Danger” or “Beware” depending on the level of risk. The previous R and S phrases have been replaced by hazard phrases (H phrases) and precautionary phrases (P phrases).
The CLP Regulation has to be implemented for substances by December 1, 2010, and for mixtures by June 1, 2015.
Clariant’s Product Stewardship Organization has set up 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. Safety Data Sheets for mixtures were phased in before the 2015 deadline.
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.
Clariant has successfully completed registration phase I, requiring the registration, by 30 November 2010, of substances with a volume of more than 1 000 t per year as well as substances of very high concern. In this phase, Clariant registered a total of 152 chemicals with a quantity of more than 1000 tonnes.
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.
Clariant’s product stewardship organization has developed efficient structures and processes throughout the organization in order to meet REACH targets. The framework of REACH implementation efforts is shifting away from registration to dossier updates, evaluation, authorization or restriction, and includes work on supply chain communications such as extended Safety Data Sheets.
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 on the GPS Chemicals Portal on the ICCA’s web page.
For more information on the Global Product Strategy, see this link.
To learn more about the Global Product Strategy in our North America Region, see this link.
A worldwide in-depth search, inside and outside Clariant (scientific databases, libraries, and archives) on properties and effects of chemical substances is carried out, including personal experience from researchers.
Identification and grouping of substances into chemical categories based on common and comparable structures, properties and (expected) effects.
Use of all existing building blocks of ITS (e.g. existing data, mechanism-based predictive tools, computer based simulation models, analogy considerations) that integrate all available information about the biological/toxicological behavior of a substance to close knowledge gaps and ensure proper scientific evaluation of the substance of interest.
If additional information is still necessary, alternative (in chemico and/or in vitro) test methods will be performed to close existing data gaps without using animals to the greatest degree possible.
In summary, integral components of Clariant’s `intelligent testing and evaluation strategy` (ITS) are
- mechanism-based predictive “in silico” models using “early indicators” of toxicity for the identification, prioritization and simplification of chemical groupings and read-across possibilities (analogy considerations)
- computational simulation models for the evaluation of the biological behavior of sub-stances and the identification of structural alerts of compounds alternative (in vitro) test methods for reduction / replacement of animal tests
Any further testing may be dispensed at this point in the process, provided the ITS approach does not result in new, additional or remaining concerns.
Here's how it works
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.
Because ethical practices and innovative research go hand in hand at Clariant, we have developed an Intelligent Testing Strategy (ITS) aimed, in the mid and long term, at largely eliminating the need for animal testing.
Clariant is committed to regulatory, scientific and ethical requirements, guidelines and policies to ensure animal welfare and the the 3R principles - i.e. to Replace, Reduce and Refine animal testing - and actively pursue and promote their application.
The three-phase ITS approach pools knowledge from various internal and external data sources in order to predict effects and properties of chemical substances “realistically” based on computer models and simulations (“in silico”) across the full lifecycle of a given substance.
The Intelligent Testing Strategy combines and optimizes the use of limited research resources with enhanced innovation potential, thereby effectively safeguarding animal welfare.
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.