Never a Dull Moment: the 2018 Regulatory Year in Review

Never a Dull Moment: the 2018 Regulatory Year in Review

Between labeling requirements and registration deadlines, 2018 saw an abundance of regulatory developments that directly impacted global supply chains. Many of the most significant changes in 2018 were related to product compliance and privacy laws, but there were also a few things that caught compliance teams off guard, such as retaliatory tariffs between the United States and China. Some of the most significant developments included:

  • The California Safe Drinking Water and Toxic Enforcement Act (Proposition 65) labeling requirements
  • The beginning of preparations for the four new Restriction of Hazardous Substances (RoHS) Directive phthalates that will be restricted in 2019
  • Registration deadlines for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, which impacted compliance and supply chain management teams
  • The EU General Data Protection Regulation (GDPR)
  • The escalating trade war between the U.S. and China

Proposition 65 Labeling Requirements

As of August 30, in-scope companies are required to comply with new labeling requirements for Proposition 65. The primary requirements include new warning label language and symbols for both long and short-form labels, and tailored warnings for specific products and industries.

The Office of Environmental Health Hazard Assessment (OEHHA) adopted amendments to  Article 6 to make warnings more meaningful and useful for the public, and to reduce over-warning. This impacted many companies, with at least one major retailer temporarily halting sales into California.

Preparing for New RoHS Phthalate Restrictions

In 2018, companies needed to start preparing for the additional restrictions on phthalates under the EU RoHS Directive, which come into force on July 22, 2019. The substances are:

  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Diisobutyl phthalate (DIBP)
  • Dibutyl phthalate (DBP)
  • Benzyl butyl phthalate (BBP)

These four phthalates are commonly found in items such as flexible tubing, resins and polymers, as well as injection mouldings, spray coatings and epoxies. Restrictions on these phthalates apply to all electrical and electronic equipment (EEE), except for medical devices and monitoring and control instruments (Categories 8 and 9). Restrictions for these categories come into effect on July 22, 2021.

REACH Deadlines

The May 31, 2018, deadline for REACH registration affected many companies, with suppliers facing an influx of new inquiries.

After May 31, any substance imported into the EU at more than one ton per year must be registered with the European Chemicals Agency (ECHA). Producers of chemical substances that did not register with the ECHA by the deadline were required to cease importation until they received approval.

By the registration deadline, 5,435 companies had submitted 33,363 registration dossiers.

EU General Data Protection Regulation

Companies that handle the Personally Identifiable Information (PII) of EU citizens were required to comply with GDPR as of May 2018.

The EU GDPR granted EU citizens the right to be forgotten, with controlled data protection for information such as identity, web activity, health and genetics, biometrics, ethnicity, political views and sexual orientation. These new privacy regulations placed a significant burden on companies, as well as their vendors, and heavily impacted legal teams throughout 2018.

Escalating Tariffs

The turmoil caused by escalating tariffs was the regulatory surprise of 2018. Both the U.S. and China announced retaliatory tariffs against each other, which heavily impacted companies that source products, materials and subcomponents from these countries — particularly aluminum and steel.

This came as a surprise to many trade compliance departments due to the previously consistent nature of trade compliance.

Additional Regulatory Changes

While the above regulatory shifts were significant throughout 2018, 2019 and beyond are shaping up to be equally challenging, as increasing regulatory requirements will place a heavier burden on companies. Regulatory topics compliance professionals will need to pay attention to in 2019 include:

With continually changing regulations, companies need to adapt their supply chain data management programs on a regular basis. Companies should be monitoring regulatory changes to ensure they are always collecting complete and accurate data from their suppliers.

Leveraging supply chain expertise and leading-edge technologies, the Assent Compliance Platform helps companies efficiently manage their programs and stay on top of their evolving regulatory requirements. Our diverse product suites streamline the data collection process for a variety of product compliance, corporate social responsibility and vendor management data types. To learn more about how Assent can help you manage your changing regulatory requirements, contact us at