Product Safety
WACKER ensures that all of its products, if used correctly, are free of any risk to human health or the environment. We seek to identify possible risks to health and the environment throughout a product’s entire life cycle – from the R&D stage through to production, use and disposal.
WACKER provides information on the safe use of its products. When manufacturing them, we work continually to avoid or reduce our use of any substances harmful to human health and the environment. WACKER also complies with the chemical legislation applicable in the countries to which it ships its products.
As a guide for our product developers, we maintain a list of substances that WACKER products may no longer contain. In addition to prohibited and restricted chemicals (such as materials listed in Annexes XIV and XVII to the REACH Regulation), the list includes substances that many companies find undesirable. As far as possible, we avoid substances on the European Chemicals Agency’s List of Substances of Very High Concern (SVHCs).
Evaluating the sustainability of our products also includes the application of “Identifying Substances and Mixtures of Concern” (ISC), a database-based system for systematically assessing the raw materials used in our products. We use ISC to evaluate and improve our product portfolio in terms of health, environmental compatibility and avoiding potential risks (such as SVHCs). We also follow chemical-policy discussions so that we can factor in future changes when developing products and optimizing ingredients.
Product Information
We continually update our product information and promptly incorporate new findings into our risk assessments, which are based on factors such as safety and environmental impact. When REACH requires us to include new findings in the chemical safety report, we adapt our risk assessments accordingly.
When advertising our products and services, we make sure that our brochures, for example, contain verifiable data and precise, legally compliant terminology and wording that reflect current scientific knowledge.
Only some 50 percent of WACKER products require a material safety data sheet (MSDS) by law. We go beyond these requirements and compile these sheets for all our sales products – not just for those classified as hazardous substances.
REACH
The REACH Regulation, which came into force in 2007, governs the registration, evaluation, authorization and restriction of chemicals within the European Union. REACH imposes stringent requirements on the manufacturers, importers and users of chemical products, compelling them to collect comprehensive data. All substances present in the European market in annual quantities exceeding one metric ton must be registered and evaluated. The scope of evaluation work is largely determined by the quantity produced or imported and by the expected risks. Particularly high-risk substances are subject to regulatory approval.
Under REACH, WACKER had submitted 779 new or revised registration dossiers to the European Chemicals Agency (ECHA) from the start of registrations in 2008 through to the end of 2022. In the course of its regular evaluation activities, ECHA required additional information for many of the dossiers, all of which we provided on time in 2022.
WACKER maintains intense contact with the companies that supply its chemical substances. We refer to our data when verifying the registration status and, where necessary, request information to ensure that we use only REACH-compliant raw materials.
To contribute to the safe use of chemicals, ECHA provides substance information on the internet in “Infocards” containing the data from the registration dossiers.
REACH requires a broad range of information on the properties of chemical products, which necessitates an increase in legally mandated animal testing. WACKER makes every effort to avoid animal testing to the greatest possible extent and contracts only those tests that are required by ECHA. Whenever possible, we use recognized alternative methods, such as in vitro tests. We classify substances with similar properties into groups for testing and work within REACH consortia to exchange scientific data with other companies.
As of January 2021, companies within Europe that commercially distribute hazardous substances must supply the ECHA notification system with comprehensive information for poison control centers. The European Commission, ECHA and the chemical industry have been working on technical solutions to this end. WACKER has set up an automatic notification tool and registered roughly 3,880 notifications to ECHA’s PCN (Poison Centre Notification) portal as of late 2022.
Nanomaterials
WACKER identifies these materials on the basis of the EU Recommendation on the Definition of Nanomaterial (2011/696/EU). This definition, in turn, is based on standard ISO TC 229 (“Nanotechnologies”) and was adopted on January 1, 2020, as part of a fundamental change in how nanomaterials are registered within the framework of the REACH Regulation.
Nanomaterials possess innovative properties that significantly enhance products and processes. As is true of all chemical substances, the possible risk of inhalation, skin contact or ingestion by production staff and users must be taken into account. Nanomaterials do not pose a hazard per se. It is, however, conceivable that their specific physical properties – size and surface area – may entail more pronounced effects on health than larger particles, especially as regards inhalation.
We have recorded all the nanomaterials that we produce or use and assess their hazards and risks in accordance with statutory requirements. We have created an internal measurement strategy to characterize products based on uniform standards.
Most of these products are nanostructured – a classification that includes materials whose internal structures are nanoscale (between 1 and 100 nanometers), but whose external dimensions are greater than the nano-range. Except for their surface-dependent properties, nanostructured materials generally behave similarly to non-nanoparticles.
Nanostructured products include our HDK® pyrogenic silica, a powder that we have sold as a thickening agent, filler and flow enhancer for over 40 years and which we use ourselves. The HDK® product group is part of the synthetic amorphous silica (SAS) substance class. We have collaborated with external scientific institutes to examine its physicochemical properties in detail, and extensive toxicological, eco-toxicological and epidemiological data are available. Due to their solubility, SAS are eliminated effectively from the lung and, consequently, do not exhibit any overloading of the lung’s cleaning function or lasting negative effects in the lung.
Genetic Engineering
The chemical industry is increasingly falling back on biotech processes to ensure its products are manufactured sustainably. WACKER is among the companies that exploit the potential of modern molecular biology and genetic engineering methods to produce high-value specialty and performance chemicals right through to complex proteins based on renewable raw materials. For instance, we use a genetically optimized E. coli system (ESETEC®) to produce pharmaceutical proteins as highly specific active ingredients for drugs.
We also prioritize safety when using genetically modified techniques, in that we comply with laws and regulations, industry-wide standards and our own rigorous internal safety provisions. We handle genetically engineered organisms solely in closed systems, which almost prevents anything from being released into the atmosphere. WACKER itself does not make any genetically modified substances, nor does it distribute them.
