Developing new products for any market is complex. Changing regulations, both locally and globally, and consumer preferences can affect the material options for products. Therefore, cost and availability of alternatives impact product development from the start. Being aware of relevant regulations and trends early in the design process is a strategic advantage for your new product.
One of the first steps of your project should be a quick scan of the latest regulations in your country and those of the countries where your new product will likely be sold. Specifically, look for regulations and restrictions relating to the market and the materials you’re considering. In the last 10 years, there have been many regulation changes, and there have been a few reasons for that.
By now, almost everyone has heard about the European Union (EU) regulation called Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). Some may have already experienced its effects firsthand.
Implemented in 2007, REACH helps improve the protection of human health and the environment from the risks that can be posed by chemicals. The regulation applies to all chemical substances, and it places the burden of proof for safety on companies that produce or use chemicals. To comply, companies must identify and manage the risks linked to the substances they manufacture and market in the EU.
The European chemicals regulation has dramatically shifted the conversation on substances of very high concern (SVHC) in the eight short years the regulation has been in force. As of November 2015, the SVHC list includes 163 chemicals, and several of those chemicals have started the authorization process for restricting further use.
The European Chemicals Agency (ECHA) has stated in their SVHC Roadmap to 2020 Implementation Plan document that the number of identified SVHCs will increase dramatically in the coming five years, further accelerating the speed with which such chemicals are identified.
Several industries, such as building and construction, automotive, and consumer goods, heed SVHC listings and demand that suppliers phase out listed chemicals from their products. This communication up and down the supply chain marks REACH as a new, deeper-reaching regulatory scheme, and one that product designers and developers need to monitor closely.
Closer to home
Of course, REACH is not alone in identifying chemicals of concern. California’s Proposition 65 has been responsible for identifying almost 900 chemicals of concern since 1988. The Proposition 65 list of chemicals is used by multiple entities as a base for their own restricted lists, collectively known as “red lists”.
Oftentimes, a Proposition 65 listing compels reformulation to remove the listed chemical from products to avoid labeling. The main difference between REACH and Proposition 65 is that Proposition 65 only requires products containing a listed chemical to carry a label, while REACH aims to ultimately remove SVHCs from commerce (using the Authorization process). Regardless, both regulations have had dramatic effects on how multiple industries specify acceptable materials.
In the United States, the Toxic Substances Control Act (TSCA) is the law of the land for chemicals regulation on a national level. TSCA was implemented in 1976 and has not been updated significantly since then. There is a large movement currently afoot to implement a complete revamp of the regulation, and both houses of Congress are discussing those changes now. Stay tuned for how TSCA reform efforts might affect your product development efforts.
Beyond regulations, activities of non-governmental organizations (NGOs) are portraying some chemicals as too dangerous for human health or the environment. Often, these NGOs will have an interest in a specific market such as children’s toys or building materials, or covering specific exposures to chemicals such as in workers, children or waterways.
NGO actions are frequently picked up in the blogosphere and sometimes popular media, and can be far-reaching. This was seen in mid-2015 with the Safer Chemicals, Healthy Families report on phthalates in flooring. That report led to Home Depot, Lowe’s, Menards, and Lumber Liquidators agreeing to only sell phthalate-free flooring by the end of 2015.
Another emerging trend is that of brand owners creating their own red lists of substances they restrict or ban from their products. A few examples are Nike, Ford and the like-minded Zero Discharge of Hazardous Chemicals group, which incorporates the thinking of many brand owners and retailers. Thus, design and development projects must consider regulations and popular culture from the start to reduce risks.
Frequently referenced chemicals of concern
One extremely versatile material used for products ranging from water pipes and window profiles to flexible medical devices, toys, flooring and tool handle grips is polyvinyl chloride (PVC), also known simply as vinyl. If flexible PVC is one possible material of choice for your product or products, recent years may have proved challenging due to phthalates coming under fire. Phthalates are used as plasticizers in PVC products to give flexibility and durability.
Currently, several members of this chemical family appear on the REACH SVHC and Proposition 65 lists, including all of the highest-volume phthalates used in PVC applications. In fact, the REACH SVHC list includes 13 phthalates. Fortunately, there is good news if PVC makes sense for your product. Several alternative general-purpose plasticizers are available in the market with similar properties, but none of the toxicity issues associated with phthalates.
The highest-volume alternative is diethylhexyl terephthalate (DEHT), also known as dioctyl terephthalate (DOTP). DEHT is manufactured globally, and it has chemical properties similar to di-ethylhexyl phthalate (DEHP) and diisononyl phthalate (DINP), two of the targeted phthalates and the highest-volume plasticizers in the world. DEHT can be used in most flexible PVC applications.
In Europe, 1,2-Cyclohexane dicarboxylic acid diisononyl ester (DINCH) is available in significant quantities, and, similar to DEHT, it can be used in most PVC applications. BASF sells under the Hexamoll DINCH trade name, while Evonik sells under the Elatur CH trade name.
Of course, several bio-based alternatives are now available, including Grindsted Soft-n-Safe, Drapex Alpha 200, Pevalen and several others introduced in the last few years.
Looking past PVC
Outside of PVC, there has been focus on bisphenol A (BPA) and its close relative bisphenol S (BPS). These are mainly used to manufacture polycarbonate-based products and the epoxy linings of cans for foods. Apparently there are little or no alternatives for these substances for use in epoxy resins for canned foods.
For plastic containers, however, there are alternative materials to polycarbonate, such as Eastman Tritan copolyester — a material that is not manufactured with bisphenols — as well as other clear plastics. Although BPA and BPS are not identified as SVHCs under REACH, BPA is on the Proposition 65 list. In addition, there is intense focus on these chemicals, especially by NGOs, so the risks associated with using either one in your design must be calculated in the risk analysis for your product.
Product designers and developers need to be aware of regulations and related pop-culture activities when selecting materials. Although Europe’s REACH and California’s Proposition 65 are important regulations to consider with product development, they are only part of the consideration when selecting materials.
Awareness of the NGO and brand-owner communities also is essential in avoiding emerging substances of concern. Knowing about the extant and emerging concerns will reduce risks associated with your new product’s longevity and can provide your company with a strategic advantage in the marketplace.
Filed Under: Materials • advanced