Product Safety
WACKER provides information on the safe use of its products and is continually working to prevent or reduce the use of substances which are harmful to human health or the environment in products. We pursue this aim in a number of ways:
- We try to replace harmful ingredients with alternative substances.
- In the absence of an alternative, we restrict the sale of products containing harmful substances to commercial and industrial customers wherever possible.
- We develop innovative alternatives to conventional products containing harmful substances.
As a guide for our product developers, we maintain a list of about 550 substances that WACKER products may no longer contain. In addition to prohibited and restricted chemicals (such as materials listed in REACH Appendices XIV and XVII), these also include substances that are the subject of heated public debate or undesired by individual companies. We avoid substances that are on the European Chemicals Agency’s List of Substances of Very High Concern (SVHC).
Product Information
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. When there are new findings that have to be included in the substance safety report to comply with REACH requirements, 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.
The following are a few examples of how our advertising provides product sustainability information:
- Our “Polysilicon – Before There Is Solar Energy There Is WACKER” brochure describes how WACKER’s hyperpure polysilicon makes it possible to manufacture efficient solar cells.
- We present examples of applications for medical and rehab purposes in a brochure on ELASTOSIL® (German-language version only) and in a video.
- We describe the use of VINNEX® as an additive for bioplastics, particularly biopolyester, in a brochure.
Material Safety Data Sheets
Only some 40 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. WACKER publishes over 75,000 material safety data sheets in up to 37 languages.
WACKER publishes a wide range of information in its material safety data sheets 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
- Legislation
- Other information
Nanomaterials
There is no standard definition to date for the term “nanomaterial” as far as regulatory issues are concerned, and there are no standardized specifications for analysis methods. WACKER continues to identify nanomaterials on the basis of the EU recommendation for defining these materials (2011/696/EU); this recommendation, in turn, is based on the ISO TC 229 “Nanotechnologies” standard.
Nanomaterials can possess innovative properties that significantly enhance products and processes. What is true of all chemical substances also applies to nanomaterials: the possible risk of inhalation, dermal or oral exposure to production staff and users must be taken into account. Nanomaterials do not pose a hazard per se. Their specific properties may entail effects on health that might chiefly be caused by the inhalation of particulate, fibrous or plate-like nanomaterials.
Based on existing studies, absorption through the skin is considered less relevant, as only minimal, if any, dermal resorption was observed in most cases. (German Hazardous Substances Committee (AGS), Announcement on Hazardous Substances, BekGS 527, “Manufactured Nanomaterials” (German-language version only) dated June 2016.) The biodurability or solubility of nanomaterials in biological media represents a key criterion in their hazard analysis. If such materials are highly soluble, a conventional hazard analysis can be performed.
All the nanomaterials that we produce or use have been recorded and their hazards and risks assessed. We have created an internal measurement strategy to assign 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.
These nanostructured products include HDK® pyrogenic silica, a powder that we have sold as a thickening agent, filler and flow enhancer for over 40 years. 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 its high solubility (> 100 mg/l), HDK® is eliminated rapidly from the lung and, unlike biodurable nanomaterials, consequently does not exhibit any long-term effects after inhalation.
We collaborated with the Technical University of Dresden to compile standard operating procedures on the granulometric characterization of SAS (specifically WACKER’s HDK®) and on the examination of its dustiness. In the course of this partnership, we also validated methods for measuring nanoparticle number concentrations. We investigated the potential release of nanoparticles from HDK® at our labs and at our HDK® production facility, finding no evidence of relevant HDK® nanoparticle release.
During the current 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 of how our products are classified and of issues relating to regulatory compliance.
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 prevents anything from being released into the atmosphere. WACKER itself does not make any genetically modified substances, nor does it distribute them.
REACH
REACH legislation, which came into force in 2007, governs the registration, evaluation, authorization and restriction of chemicals within the European Union. Comprehensive data are gathered through REACH, REACH imposes high 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 the expected risks. Particularly high-risk substances are subject to regulatory approval.
Total of 192 Registration Dossiers Submitted as Part of REACH
As part of REACH, WACKER had submitted 192 registration dossiers to the European Chemicals Agency (ECHA) by late 2016. For some of the phase-one and phase-two dossiers, submitted in 2010 and 2013, ECHA required additional information, which we provided in 2016.
As part of China REACH, we submitted 94 registration dossiers to the Chinese environment ministry by late 2016, while 610 such dossiers were filed in Taiwan.
WACKER’s close contact with its suppliers extends to matters relating to their preregistrations for REACH and their already completed registrations. To obtain authoritative information, we systematically ask our suppliers about their registration status and the further availability of raw materials, especially in view of the expiration of the final registration phase for phase-in substances on May 31, 2018. Even after this deadline expires, our global supply chains will continue to make it necessary to ask about the above issues.
REACH demands extensive information about 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.
European Chemicals Agency’s REACH Schedule: Deadlines for Submitting Dossiers
European Chemicals Agency’s REACH Schedule: Deadlines for Submitting Dossiers
1 New substances >1 metric ton/year
2 Phase-in substances >1 metric ton/year
3 R50/53 substances: “highly toxic to aquatic organisms” and “may have long-term harmful effects in bodies of water”
4 CMR substances: carcinogenic, mutagenic or toxic to reproduction
5 Phase-in substances: predominantly old substances listed on the EINECS inventory (European Inventory of Existing Commercial Chemical Substances on the market before 1981)
GPS
The ICCA (International Council of Chemical Associations) has developed the Global Product Strategy (GPS), which is a guideline on how to assess chemical properties and provide product safety information. In Europe, most GPS requirements are satisfied by REACH and by CLP (Classification, Labeling and Packaging of Substances and Mixtures). Manufacturers are asked to publish descriptions written in layman’s terms on the safe and environmentally sound use of chemicals (Safety Summaries). By the end of 2016, we had published 75 Safety Summaries on the ICCA chemicals website for the substances we registered under REACH.
GHS
GHS (Globally Harmonized System of Classification and Labeling of Chemicals) is a United Nations initiative for harmonizing the classification and labeling of hazardous substances. It is up to individual countries to decide whether to adopt the system, and, if so, which modules to accept, and when. GHS was introduced to Europe in January 2009 with the European Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (the CLP Regulation). More information on this regulation is available online from the European Commission.
Overview of Hazard Symbols in the EU
By mid-2015, the GHS Regulation on the Classification and Labeling of Chemicals had replaced the previous orange hazard symbols in Europe with new symbols consisting of a white square set at a point in a red frame.
By 2015, we reclassified our mixtures pursuant to EU GHS (7,000 mixtures). The ECHA has set up a central classification and labeling register for hazardous substances. We have been registering all relevant substances here since 2011. The cost to WACKER of changing to GHS came to around €4 million. This system switchover required us to check, reclassify and relabel every product, as well as reclassify tens of thousands of substances and mixtures, change material safety data sheets and redesign hazardous substance labels to accommodate the new symbols and hazard information.
We provide our employees with online training and a wide range of informative literature on GHS. Not only production and laboratory workers (who handle GHS-labeled chemicals on a daily basis) must attend certain mandatory courses, but also, for example, safety officers (who prepare SOPs). Employees who label vessels, piping and equipment have to attend these courses as well.