Top 5 Compliance Challenges of 2019

Before we (all of us compliance junkies, as well as those forced into this as a new job requirement) get slammed by the onslaught of regulatory changes in 2020, let’s take a look back at the challenges we faced in 2019.

Hindsight is 2020!

Ok…so let’s recap:

1. Update to RoHS 2

Just when you think you’ve got compliance to RoHS 2 down, an amendment comes along and adds more hazardous substances!

Amendment EU 2015/863 references the restriction of the original 6 substances in RoHS. It also added four (4) new substances in the form of the phthalates:

  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Butyl benzyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP)

Many of these substances are used broadly across the electronics industry.

Start by looking at your products that contain soft plastics. Parts and products that have flexible tubing, coatings, buttons, lacquers, and PVC, all would be affected.

2. Additions to the EU REACH Candidate list (EU REACH 201)

This is one of the most challenging regulations to keep up with as there are new adds every 6-9 months!

In 2019, we saw the list add ten (10) new SVHCs. The current candidate list contains two-hundred and one (201) SVHCs.

Here is a link to the ECHA website and Candidate list:

How does this affect your job?

It means you need to poll your suppliers again, making sure that the SVHCs are all below threshold levels. Suppliers need to disclose how much and where used in their parts and products. Ask your suppliers for an updated supplier declaration that references the EU REACH Candidate 201 list and store the new declaration in your records.

We’ll keep you updated on developing changes, here on the blog!

3. Safe-Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)

This regulation is confusing to many companies. Companies are unsure whether or not they need to comply due to being part of a supply chain and/or not selling directly to consumers in California. This includes online sales.

If your company places products on the market in California or has operations in California, you have an obligation to notify consumers and workers of any potential exposure.

If your company is part of a supply chain and does not sell to a consumer or have operations in California, you do not have a legal obligation to comply.

If your company sells to another company that incorporates your part or product into their product and then sells the product in California, there is a high likelihood one of your customers will expect you to comply. They will ask you for Prop 65 declarations and about your labeling program.

Keep in mind, there are a little over one thousand (1,000) substances and materials on the Prop65 list as of September 13, 2019.

Below is a link to the OEHHA website, where the list is maintained and managed:

Be prepared and be aware of Prop65 lawyers acting as bounty hunters! According to the state of California, there were over 843 settlements, totaling almost $26 million through the end of 2019.

If you need help with building a Prop 65 program, drop us an email!

4. Companies Disclosing Conflict Minerals and the Use of Cobalt

Companies have been bombarded with requests for U.S. Conflict Minerals disclosures since 2012.

The U.S. Conflict Minerals regulation focuses on tin, tantalum, tungsten, and gold (3TG) from the Democratic Republic of Congo. Complying with this regulation has been an enormous challenge for years. It requires companies to poll their supply chains for data that in many cases the company has not tracked in the past. It requires companies to determine the country of origin for 3TG materials as far back in the supply chain as the smelter.

Thankfully the Responsible Business Alliance (formerly EICC-GeSi) has worked on a software polling tool the last 8 years. This tool is the de facto industry standard and it is also integrated into the major compliance software available today.

Download the CMRT 5.12 template here:

Another danger that was in the spotlight in 2019 was Cobalt. The processing involved in cobalt production has been proven to have serious toxic consequences for workers and those involved along the supply chain.

In an effort to better identify and manage the dangers, the Responsible Minerals Initiative launched a new tool to help poll suppliers for information.

Download the Cobalt (CRT) version 2.0 template here:

We see more attention being paid to the dangers of cobalt in 2020. Reach out if you have questions or need help.

5. China RoHS2 Deadline

China RoHS has been a challenge for many companies since its inception. It requires companies importing materials, parts, or products into China to apply specific labeling called an EFUP (Environmentally Friendly Use Period) on all products listed in the regulations categories. Additional labeling requirements were added in 2019.

Compliance requires that you fill out a risk matrix and supply technical data to Chinese customs. Be careful what type of intellectual property is released. Protect your company.

Although the new regulation changes became effective July 2019, most companies worried about the November 1st requirement. The new requirement is to provide a completed conformity assessment.

There is also a reference document called the “China RoHS 2: Qualification Management Catalogue (First Batch)” which specifies the twelve product types considered in scope.

Those product types include:

  • Refrigerators
  • Air conditioners
  • Washing machines
  • Electric water heaters
  • Printers
  • Copiers
  • Fax machines
  • TVs
  • Monitors
  • Micro-computers
  • Handheld phones for mobile communication
  • Telephone sets

Needless to say, China RoHS 2 is complex and requires a solid plan for managing and collecting data, as well as determining what level of data is safe, low-risk, and acceptable to share with foreign companies and governments.

If you’re new to product compliance, if you need help getting started, or if you’ve already got a program and just need a second set of eyes – we’re here to help.

Remember – Make safe products, sell globally, and stay out of compliance trouble!

by Kelly Eisenhardt

Subject Matter Expert, Product Compliance & Technology – Kelly spent 20 years working in IT technology, environmental software design, and product compliance management for EMC/Dell Corporation, Parametric Technology Corporation (PTC), and Fair Factories Clearinghouse. She specializes in compliance consulting, training, and compliance automation. She co-founded BlueCircle Advisors in 2014.