Product Safety

WACKER provides information on the safe use of its products and is continually working to prevent or reduce the use of product ingredients that are harmful to human health or the environment. WACKER sells its products in compliance with the chemical legislation applicable in the country of destination.

For our product developers, we maintain a list of about 650 substances that WACKER products must or should 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).

During the reporting period, we set up the Identifying Substances and Mixtures of Concern (ISC) system for the systematic assessment of products in a database, and we are now testing it.

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 examples of how our advertising provides product sustainability information:

• With (PDF:) BELSIL^® eco, WACKER SILICONES has established a product line for silicone fluids that are produced using biomethanol obtained from renewable resources such as straw or grass clippings.

• During the reporting period, WACKER POLYMERS developed its (PDF:) VINNECO^® product line, which consists of binders based on renewable raw materials.

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 such data sheets in up to 35 languages.

WACKER publishes a wide range of information in its MSDS 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

REACH

How REACH Works

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, imposing 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.

As part of REACH, WACKER had submitted 480 registration dossiers, including any revisions, to the European Chemicals Agency (ECHA) by late 2018. In the course of its regular evaluation activities, ECHA requires additional information for many of the dossiers, all of which we provided on time in 2018.

The industry had to register what are known as phase-in substances (essentially substances that have been established on the market for some time) over the course of three phases extending from 2010 to 2018. WACKER has been working intensively on preparing for and implementing REACH since 2006. To this end, we created a REACH team, headed by Corporate Product Safety (CPS) and composed of experts from CPS (toxicologists and registrants), Raw Materials Procurement and the business divisions.

The final REACH registration deadline for phase-in substances (greater than one metric ton per year) expired on May 31, 2018. WACKER was in close contact with its suppliers, systematically requesting definitive statements about registration status and the further availability of raw materials. The registration process has meanwhile been concluded for all relevant substances.

As part of China REACH, we submitted 119 registration dossiers to the Chinese environment ministry by late 2018, while 619 such dossiers were filed in Taiwan.

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.

How REACH Works

Evaluation of Registration Dossiers and Substances

European Chemicals Agency’s REACH Schedule

GPS

To promote the safe use of chemicals, 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 the EU’s REACH and CLP (Classification, Labeling and Packaging of Substances and Mixtures) regulations. By the end of 2018, 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 in the form of the EU’s CLP Regulation (on the classification, labeling and packaging of substances and mixtures). More information on this regulation is available online from the European Commission.

Overview of Hazard Symbols in the EU

By 2015, we had reclassified our mixtures pursuant to EU GHS (some 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.

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.

Nanomaterials

There are several definitions of the term “nanomaterial,” which depend 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 recommendation, in turn, is based on the ISO TC 229 “Nanotechnologies” standard and is to be incorporated into REACH legislation as of January 1, 2020.

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 most cases. (Source: German Hazardous Substances Committee (AGS), Announcement on Hazardous Substances, BekGS 527, “Manufactured Nanomaterials” (in German only), September 2016.)

The resistance to biodegradation or 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 have assessed 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 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 rapidly 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 of how our products are assessed 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.