WACKER provides information on the safe use of its products. We work continually to prevent or reduce the use in products of any substances harmful to human health and the environment. WACKER complies with the chemical legislation applicable in the destination countries to which it ships its products. The expense involved in following and implementing such legislation worldwide continues to rise steadily.
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 of the EU’s REACH Regulation), these include substances that are undesired by many companies. As far as possible, we avoid substances that are on the European Chemicals Agency’s List of Substances of Very High Concern (SVHC).
For assessing the sustainability of our products, we provide support in the form of our “Identifying Substances and Mixtures of Concern” (ISC) database. We use ISC to evaluate and improve our product portfolio in terms of health, environmental compatibility and avoiding potential risks (such as SVHCs, or Substances of Very High Concern). We maintain a list of observations that allows us to account for future developments when developing products and optimizing ingredients.
We continually update our product information and constantly revise our risk assessments – which relate, for example, to safety aspects and environmental impacts – to promptly take account of new findings. We revise our risk assessments to reflect new findings that need to be included in the chemical safety report as per REACH.
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.
The following two brands, which have been certified in accordance with REDcert2, offer examples of our use of sustainability statements for advertising purposes.
- In developing LIOSIL® eco, WACKER has created the world’s first silicone-based products for home care and cleaning applications, in which 100% of the fossil-based components have been offset through the use of biomethanol from renewable raw materials. Certified according to strict criteria, the manufacturing process and use of biobased raw materials are monitored by TÜV Süd.
- Silicone sealants are produced through the use of silica sand and coal in combination with other raw organic materials, particularly methanol. ELASTOSIL® eco for DIYers and professional builders and decorators is the first generation of sealant to be made without any raw materials derived from petrochemicals. In the biomass balance method, 100% of the organic material in the product is derived from certified sustainable biomass rather than from fossil raw materials.
More information on our sustainable products can be found on our website.
Material Safety Data Sheets
A material safety data sheet (MSDS) is only required by law for some 50% of WACKER products. We go beyond these requirements and compile these sheets for all our sales products – not just for those classified as hazardous substances. WACKER publishes over 80,000 material safety data sheets in up to 38 languages.
WACKER’s material safety data sheets cover a wide range of information to ensure that substances and mixtures are handled correctly:
- Designations of substances and mixtures
- Potential risks
- Composition and information about ingredients
- First-aid measures
- Fire-fighting measures
- Response in the event of accidental release
- Handling and storage
- Restriction and monitoring of exposure / personal protective equipment
- Physical and chemical properties
- Stability and reactivity
- Toxicological data
- Environmental data
- Notes on disposal
- Transportation guidelines
- Other information
REACH legislation, which came into force in 2007, governs the registration, evaluation, authorization and restriction of chemicals within the European Union. REACH involves the collection of extensive data.
REACH imposes stringent requirements on the manufacturers, importers and users of chemical products. All substances on the European market that are used or imported 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.
As part of REACH, WACKER had submitted 670 registration dossiers, including any revisions, to the European Chemicals Agency (ECHA) from when registrations began in 2008 through the end of 2020. In the course of its regular evaluation activities, ECHA requires additional information for many of the dossiers, all of which we provided on time during the 2019/2020 reporting period.
As part of China REACH, we submitted 199 registration dossiers to the Chinese environment ministry by late 2020, while 709 such dossiers were filed in Taiwan.
WACKER’s close contact with its suppliers extends to matters relating to substances not yet registered under REACH. 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 in what it calls Infocards, which contain the data from the registration dossiers.
REACH requires a broad range of information on the properties of chemical products, which necessitates an increase in mandatory animal testing. WACKER makes every effort to avoid animal testing and only performs ECHA-required tests. 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 2,500 products on ECHA’s PCN (Poison Centre Notification) portal as of late 2020.
There are several definitions of the term “nanomaterial”, depending on the specific regulatory context. There are as yet no definitive specifications for many nano-specific analysis methods. WACKER identifies these materials on the basis of the EU Recommendation on the Definition of Nanomaterial (2011/696/EU). This definition 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 by, or dermal or oral exposure to, 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 non-nanoparticles, especially as regards inhalation.
The significance of oral intake is primarily being discussed for food applications. In 2018, the European Food Safety Authority (EFSA) published guidance for investigating and assessing nanomaterials.
Based on existing studies, absorption through the skin is considered less relevant, as only minimal, if any, dermal resorption was observed in the majority of cases. (Source: Hazardous Substances Committee [AGS], Technical Rules for Hazardous Substances [TRGS] 527 “Activities with Nanomaterials,” January 2020; German-language web content only.) The Scientific Committee on Consumer Safety advises the European Commission and published its “Guidance on the Safety Assessment of Nanomaterials in Cosmetics” in 2019.
The resistance to biodegradation and/or the solubility in biological media of nanomaterials represents a key criterion in their hazard analysis. If such materials are sufficiently soluble, a conventional hazard analysis can be performed.
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.
We collaborated with the Technical University of Dresden to compile standardized test instructions on the granulometric characterization of silicas and on the examination of their dustiness. In the course of this partnership, we also validated methods for measuring nanoparticle number concentrations (aggregate/agglomerate < 100 nm). We investigated the potential release of nanoparticles from HDK® at our labs and during HDK® production, finding no evidence of relevant HDK® nanoparticle release.
During the reporting period, we continued exploring the issue of nanomaterials, working in national and international committees and task forces. As part of these efforts, we pay particular attention to nano-specific regulatory requirements (such as national nanoproduct registers and specific REACH requirements), which we implement accordingly. We inform our customers about how our products are assessed and about issues relating to regulatory compliance.
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 prevents anything from being released into the atmosphere. WACKER itself does not make any genetically modified substances, nor does it distribute them.