On September 6, the European Chemical Agency (ECHA) communicated its intention to add 6 more substances to the REACH Substances of Very High Concern (SVHC) List.
(https://echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification).

One of these substances is Bisphenol A, also known as BPA. It is included in the list because of its toxicity to reproductive health or in REACH lingo: it belongs to hazard class reproductive toxicity category 1B under article 57 (c). As you might recall -- or maybe I do because I had babies at that time -- a couple of years ago there was a lot of uproar about BPA in baby bottles and sippy cups. Consequently, both the EU and the US banned the use of BPA based plastics in baby bottles.

Impact to Your Product

Where else does one find BPA in your products and supply chain? To sum it up in one word: Everywhere. Bisphenol A is one of the most used chemicals in the world.

Here are just a handful of examples:
It is a key monomer in the manufacturing of Polycarbonate plastic in which it can show up as an unreacted monomer. Polycarbonate is used in optical media such as CDs and DVDs, in housing for electronic equipment, in electrical switches, in medical equipment, in food containers and in tableware such as cups, plates and water bottles.

It is also used in the manufacturing of flexible PVC and epoxy resins used in printed circuit boards, composites, internal coatings for canned foods and drinks, adhesives and varnishes.

You can also find it in flame retardants such as Tetrabromobisphenol A present in printed circuit boards or as Tetrachlorobisphenol A in polymers, resins and adhesives.
Other fluids that can contain BPA are paint hardeners, lubricants, brake fluids, hydraulic fluids and heat transfer fluids.

And finally, BPA is present in thermal paper for printing receipts to develop the color when the paper is heated.

Your Company’s Obligations Under REACH

Your company’s obligations depend on the type of products you manufacture and ship into the EU as well as your position in the supply chain. I therefore urge you to analyze the specific REACH requirements for your situation. 

That said, most companies that deal with physical products and components will have to comply with the following:

• Identify whether your products contain SVHC and restricted substances at the component level through testing or supplier statements.
• If your product contains an SVHC above 0.1% (1000 ppm) by mass of each component then you must inform recipients of your product about the presence of that SVHC; at least its name and how to safely use the product. If on top of this, you ship more than 1 tone per year of the SVHC into the EU, you also have to notify the ECHA.
• Respond to enquiries about the presence of an SVHC in your product within 45 days. Remember that anyone can request this information from you. Consumers, NGOs, your competitors, et cetera.
• If the SVHC is on the Authorization List and the date is past the sunset date for that substance, you are not allowed to ship this SVHC into the EU unless your company has obtained an authorization.
• Provide REACH compliant Safety Data Sheets (SDS) to your downstream users when requested.

Net net, check that your product’s components don’t contain SVHCs above 0.1% by weight of each component and you make your life a lot easier.

Impact on the Industry

Due to the widespread use of BPA, putting it on the SVHC list will create another major supply chain interrogation effort for a lot of companies. No doubt this will further drive the need for full material disclosures throughout the supply chain and systems to store all this information and analyze the impact.

Oracle Agile PLM has a module called Product Governance & Compliance (PG&C) to do just that. And Zero Wait State has a lot of expertise implementing this module and helping companies keep track and make sense of all the data. PG&C is tightly integrated with Oracle Agile PLM’s Product Collaboration (PC) module so that SVHCs (especially above the 0.1% threshold value) can be found quickly and immediately turned into product design or manufacturing changes.

We're here to help. Leave a comment or contact me at ddhooghe@zerowait-state.com.