In 2023, a number of regulations will be updated, creating new requirements for businesses to follow, new areas of risk, and more money and time spent adjusting to these changes. Non-compliance for any of these regulations could result in fines, seizure of goods, lost market access, and loss of customer trust.
That’s why Assent has compiled the most up-to-date information available about upcoming regulatory updates into this article. With it, you can start preparing for new product compliance needs.
Included in this blog is the latest information about:
- Proposition 65
A new rule for the Toxic Substances Control Act (TSCA) was released in October 2021, resulting in a delay to the compliance enforcement of the Persistent, Bioaccumulative and Toxic (PBT) chemical PIP (3:1). Due to concerns from stakeholders surrounding the prevalence of this substance in modern supply chains, the Environmental Protection Agency (EPA) is delaying enforcement on the restriction of PIP(3:1) until October 31, 2024. However, manufacturers should be proactive in identifying and removing the substance from their supply chain as this process will take time. Manufacturers should note that although enforcement of the material restrictions has been delayed, documentation obligations are still required as of March 8, 2022.
Additionally, these four PBT substances have been banned since March 8, 2021:
- 2,4,6 TTBP (EC: 211-989-5, CAS: 732-26-3)
- PCTP (EC: 205-107-8, CAS: 133-49-3)
- DecaBDE (EC: 214-604-9, CAS: 1163-19-5)
- HCBD (EC: 201-765-5, CAS: 87-68-3)
In separate TSCA activity, the EPA has identified the “First 10” chemicals that will undergo risk evaluation. Those 10 chemicals are:
- 1,4-Dioxane (EC: 204-661-8, CAS: 123-91-1)
- 1-Bromopropane (EC: 203-445-0, CAS: 106-94-5)
- Asbestos (EC: 603-721-4, CAS: 1332-21-4)
- Carbon Tetrachloride (EC: 200-262-8, CAS: 56-23-5)
- HBCD (also known as Cyclic Aliphatic Bromide Cluster) (EC: 221-695-9, CAS: 3194-55-6)
- Methylene Chloride (EC: 200-838-9, CAS: 75-09-2)
- NMP (EC: 212-828-1, CAS: 872-50-4)
- PV29 (EC: 201-344-6, CAS: 81-33-4)
- Tetrachloroethylene, also known as perchloroethylene (EC: 204-825-9, CAS: 127-18-4)
- Trichloroethylene (EC: 201-167-4, CAS: 79-01-6)
Specifically, HBCD and PV29 are expected to be evaluated first.
On top of that, the EPA has also identified the “Next 20” chemicals — chemicals that are designated as high-priority. These chemicals include:
- p-Dichlorobenzene (EC: 203-400-5, CAS: 106-46-7)
- 1,2-Dichloroethane (EC: 203-458-1, CAS: 107-06-2)
- trans-1,2-Dichloroethylene (EC: 205-860-2, CAS: 156-60-5)
- o-Dichlorobenzene (EC: 202-425-9, CAS: 95-50-1)
- 1,1,2-Trichloroethane (EC: 201-166-9, CAS: 79-00-5)
- 1,2-Dichloropropane (EC: 201-152-2, CAS: 78-87-5)
- 1,1-Dichloroethane (EC: 200-863-5, CAS: 75-34-3)
- Dibutyl phthalate (DBP) (EC: 201-557-4, CAS: 84-74-2)
- Butyl benzyl phthalate (BBP) (EC: 201-622-7, CAS: 85-68-7)
- Di-ethylhexyl phthalate (DEHP) (EC: 204-211-0, CAS: 117-81-7)
- Di-isobutyl phthalate (DIBP) (EC: 201-553-2; CAS: 84-69-5)
- Dicyclohexyl phthalate (EC: 201-545-9, CAS: 84-61-7)
- 4,4’-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) (EC: 201-236-9, CAS: 79-94-7)
- Tris(2-chloroethyl) phosphate (TCEP) (EC: 204-118-5, CAS: 115-96-8)
- Phosphoric acid, triphenyl ester (TPP) (EC: 204-112-2, CAS: 115-86-6)
- Ethylene dibromide (EC: 203-444-5, CAS: 106-93-4)
- 1,3-Butadiene (EC: 203-450-8, CAS: 106-99-0)
- 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) (EC: 214-946-9, CAS: 1222-05-5)
- Formaldehyde (EC: 200-001-8, CAS: 50-00-0)
- Phthalic anhydride (EC: 201-607-5, CAS: 85-44-9)
The Uyghur Forced Labor Prevention Act (UFLPA) will go into effect on June 21, 2022. This act creates a rebuttable presumption — a blanket presumption that allows for specific exceptions — that any and all goods made, either partially or wholly, in the Xinjiang Uyghur Autonomous Region (XUAR) of China are the product of forced labor. They are therefore banned from import into the U.S.
Penalties for non-compliance currently include product seizure at the U.S. border and fines.
Hear from Assent’s supply chain experts in the free webinar, The U.S. Uyghur Forced Labor Prevention Act: What it Means for Your Company. Watch the recorded webinar.
California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) evolved further by adding new substances to its list of chemicals that cause cancer, birth defects, or other reproductive harm. Given the act’s broad scope, it can encompass and restrict new substances as they are reviewed.
Toward the end of 2021 and at the beginning of 2022, the California Office of Environmental Health Hazard Assessment (OEHHA) added new substances. Those substances include:
- Perfluorooctane sulfonic acid (PFOS), its salts, and its degradation and transformation precursors
- Perfluorononanoic acid (PFNA), its salts, and its degradation and transformation precursors
- Tetrahydrofuran (TFH)
- 2-ethylhexyl acrylate (2EHA)
- Methyl acrylate (MA)
- Technical-grade trimethylolpropane triacrylate (TMPTA)
- Perfluorooctanoic acid (PFOA)
In separate Proposition 65 activity, OEHHA continues to revise their proposed changes to the so-called “short form” warning label, although the changes proposed in 2021 to include at least one specific substance on the label have remained throughout the revisions.
On January 1, 2023, the German Supply Chain Due Diligence Act (SCDDA) will go into effect. This act obligates all German companies with 3,000 employees or more to take “appropriate measures” in order to respect the environment and human rights in their supply chain. The goal of this act is to reduce or eliminate risks associated with human rights and the environment, while also ending the violation of duties related to these issues.
On January 1, 2024, the scope of this act will be tightened to companies with 1,000 employees or more. Even employees that work abroad are included in this number.
Learn more about the SCDDA and what it means for your business with Assent’s German Supply Chain Act: Setting the Stage for Global Due Diligence webinar, available here.
The EU Restriction of Hazardous Substances (RoHS) Directive is undergoing a revision process that could result in RoHS 3 as a “Regulation” versus the current RoHS 2 “Directive” status. That would present new challenges for businesses, as a Regulation would be consistent law for all Member States, rather than requiring separate, and possibly inconsistent, transposition into each Member State’s regulations.
Further, this revision could result in additional restricted substances, similar to when the 2015 amendment to RoHS 2 expanded the list of restricted substances from six to ten. Therefore, complex manufacturers will want to pay close attention to these developments as they unfold.
Perhaps most significant to the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation is the proposal to include metallic lead in the Annex XIV Authorisation List, which would require EU-based users of the substance to first obtain authorization from the European Chemicals Agency (ECHA). Expected to be included on May 2, 2022, this inclusion will present manufacturers with new challenges.
This is not an unexpected change: ECHA has been concerned about metallic lead for a number of years. In 2018, it was included on the REACH Candidate List of substances of very high concern (SVHCs). While not restricted (at least under REACH), manufacturers must provide notification to customers and the SCIP database when SVHCs like lead are present at the “article” level above 0.1 percent.
Considering how widespread metallic lead is, especially in products like batteries or materials like brass, it’s important for manufacturers to begin preparing now instead of waiting.
Stay Informed With Assent
The regulatory landscape is always shifting, incorporating new restrictions, laws, and product compliance needs. Keeping track of these changes can be both time consuming and financially draining for complex manufacturers. With Assent’s solutions and team of experts, you can stay on top of the landscape as it evolves, see deeper into your supply chain, work more efficiently, and protect your company from significant risk.