Why does rubber compliance matter?
Rubber compliance serves a variety of important functions, from health and safety to the commercial success of rubber goods.
Perhaps the primary driving force behind rubber compliance is consumer safety. Many rubber compliance standards were developed to monitor and limit the use of potentially hazardous chemicals and other substances in rubber materials. In order to achieve compliance, companies must disclose whether certain chemicals are present in their rubber products and report their exact quantities. The stringency of consumer safety standards can vary between governing bodies, so it’s important for companies to understand the rubber compliance expectations of every market where they plan to sell their products.
Rubber compliance is also motivated by environmental concerns. In some cases, rubber compliance serves to limit the use of substances that might be hazardous to the natural world. But rubber compliance can also mitigate waste. For example, electronic products often include rubber components, and if those components include hazardous materials, the product may not be recyclable. However, if the product’s rubber components adhere to rubber compliance standards that limit the use of hazardous materials, the product can be recycled rather than placed in a landfill.
Finally, rubber compliance is often vital to the success of a business. Some regulatory standards are categorized as voluntary compliance and are not monitored or enforced by a legal entity. But many companies refuse to purchase products or materials that do not meet certain voluntary compliance standards. So even if a certain standard is not legally enforceable, companies who choose not to demonstrate compliance may disqualify themselves from valuable business relationships. Prioritizing rubber compliance can be a boon to the growth and commercial success of a company that produces rubber materials, components, or products.
What kinds of rubber compliances should be considered?
Rubber compliance can differ greatly between states and countries.
In 2002, the European Union released the first of three directives on the Restriction of Hazardous Substances (RoHS). Additional directives were released in 2011 and 2015. The purpose of RoHS is to limit the use of certain substances in rubber components found in electrical and electronic products. Substances regulated by RoHS include mercury, cadmium, lead, flame retards, phthalates, and more. The allowable percentage of each substance is defined by RoHS.
RoHS dictates that all rubber components in a given product must be tested for these substances, including insulation materials, rubber buttons and keypads, gaskets, seals, and more. In order to achieve RoHS compliance, companies must prove that no regulated substances are present above allowable levels in their products and components.
Like RoHS, REACH is a European Union regulation. First released in 2007 by the European Chemical Agency (ECHA), REACH stands for the Registration, Evaluation, Authorization, and Restriction of Chemicals. REACH regulates the use of over 200 different chemicals, called Substances of Very High Concern (SVHC), that may pose a threat to the health of human beings or the environment.
A few of the SVHCs regulated by REACH can be used to make silicone and other rubber products. REACH limits how much of a given SVHC can be present in a given product or material. Companies must report the presence and quantity of SVHCs in their products via data from a third-party testing laboratory in order to achieve REACH compliance.
Cal Prop 65 Compliance
The Safe Drinking Water and Toxic Enforcement Act, familiarly known as Prop 65, became law in 1986. Prop 65 requires manufacturers selling products in the state of California to disclose the presence of certain substances to consumers via product labeling.
Prop 65 includes around 900 chemicals known to cause cancer, birth defects, and other issues. If even one chemical included in Prop 65 is present above a certain level, the product must be labeled accordingly. Many of these chemicals can be detected and quantified by an accredited testing laboratory.
21 CFR 177.2600
21 CRF 177.2600 is an FDA regulation for “rubber articles intended for repeated use.” This could include anything from manufacturing components to packaging and transportation components. 21 CRF 177.2600 often refers to rubber components used in the preparation, storage, and transportation of food. In order to achieve compliance, rubber materials must be food safe per 21 CRF 177.2600 criteria and not present any risk of altering food substances as a result of prolonged or repeat contact.
How do you test for rubber compliance?
A rubber testing laboratory may utilize a variety of test methods and techniques to test for rubber compliance, including:
Gas Chromatography Mass Spectrometry (GC-MS)
GC-MS is a powerful chromatographic technique for separating compound mixtures so that each element can be identified individually. GC-MS identifies and quantifies individual molecules based on their mass spectrum, which allows for more precise identification and confident reporting. GC-MS is an excellent method for identifying highly volatile compounds, including many substances regulated by RoHS, REACH, and Prop 65.
Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
ICP-MS is a type of mass spectrometry commonly used to detect trace amounts of metals in a material sample. An ICP-MS instrument can identify and quantify substances within a sample at an elemental level. This level of precision allows for exact quantification of a given substance.
X-Ray Fluorescence (XRF)
XRF uses X-Ray technology to determine elemental composition of a given product or material. Because XRF is non-destructive, it’s a popular method for scanning art, historical artifacts, and other precious objects. XRF is an excellent technique for detecting and quantifying heavy metals, including those regulated by Prop 65 and RoHS, in a finished product or material.
ACE Rubber Compliances Services
The team at ACE Laboratories is deeply knowledgeable on the subject of rubber compliance. We can help you determine which rubber compliance standards are most important for your product or material. Our rubber testing laboratory in Ravenna, Ohio is fully equipped with state-of-the-art instrumentation to detect and quantify even the most minute traces of regulated substances so we can provide you with valuable reports on your products.
Whether you need to demonstrate rubber compliance or are seeking testing for another purpose, ACE Laboratories can help. We offer a full portfolio of physical and analytical testing for rubber products. Get in touch with our team >
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