In our previous article, we explored the growing awareness of risks associated with per- and polyfluoroalkyl substances (PFAS). As governments around the world consider stronger regulation or even outright bans of these substances, electronics companies must be ready to modify product designs or supply chains in order to remain compliant. Below, we discuss several regulatory initiatives and their potential impact.
PFAS are being considered for restriction in numerous jurisdictions, including the U.S. and EU, and requirements are coming much sooner than many companies anticipated. PFAS threaten global market access due to regulation and restriction under numerous evolving regulations, including RoHS, REACH, Prop 65, POPs, TSCA, etc.
EU Regulatory Risks
The European Commission has committed to phasing out all PFASs allowing their use only where they are proven to be irreplaceable and essential to society. The recast of the Drinking Water Directive, which took effect on January 12, 2021, includes a limit of 0.5 µg/l for all PFAS.
- REACH, POPs, and the EU MDR (Medical Device Regulation) restrict many PFAS.
- C9-14 PFCAs will be restricted through REACH in 2023 as part of the Annex XVII Restricted List.
- Five countries are preparing a REACH restriction proposal to include up to 4,700 PFAS chemicals which are expected in 2023 and would take effect as early as 2025.
The Organisation for Economic Cooperation and Development (OECD) maintains a list of over 4,700 PFAS substances. The EU Plans to set a strategy on chemicals for sustainability to extend the reporting on PFAS usage which can result in market access loss, among other things.
Timeline of ECHA publication on PFAS restriction proposal
The details of the proposed restriction of around 10,000 PFASs are now available on ECHA’s website. ECHA’s scientific committees will now start evaluating the proposal in terms of the risks to people and the environment, and the impacts on society.
- Opinions of ECHA’s committees sent to the European Commission which prepares their legislative proposal for the EU member states for discussion in the REACH committee. Eventually, the member states vote on their restriction. Before the restriction can be adopted, it will be scrutinized by the European Parliament and Council.
- ECHA committees adopt their opinions.
- Evaluation of the risks by ECHA’s Committee for risk assessment (RAC)
- Evaluation of the proposal’s impacts on society by ECHA’s Committee for Socio-Economic- Analysis (SEAC). It includes a 60-day consultation of the draft opinion of SEAC.
- April 5, 2023 – Online Information Session
- March 22, 2023 – Start of six-month open consultation.
- February 7, 2023 – Proposal made available on ECHA’s website – The proposed restriction targets all PFAS. It is one of the broadest restrictions proposed in the EU’s history.
- January 13, 2023 – Restriction Proposal submitted to ECHA – EPA proposed a rule that would prevent anyone from starting or resuming, without a complete EPA review and risk determination, the manufacture, processing, or use of an estimated 300 PFAS that have not been made or used for many years, known as “inactive PFAS.”
North American Regulatory Risks
The U.S. Environmental Protection Agency (EPA) has the authority to regulate PFAS through the Toxic Substances Control Act (TSCA), the Safe Drinking Water Act (SDWA), the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), and other regulatory authorities. The EPA currently tracks over 12,000 substances. On August 26, 2022, the EPA issued a proposal to designate two of the most widely used PFAS as hazardous substances under CERCLA, or Superfund. This rulemaking would increase transparency around the release of these harmful chemicals and help to hold polluters accountable for cleaning up their contamination.
Beginning January 1, 2023, a manufacturer of a product for sale in the U.S. state of Maine that contains intentionally added PFAS shall submit a notification to the Maine Department of Environmental Protection (DEP).
North American PFAS Compliance Requirements
One of the strongest signs for future restriction comes from the U.S. EPA, which launched an EPA Council on PFAS with a clear directive to assess and reduce the risks created by these substances. The Council will continue to coordinate across all EPA offices and Regions to accelerate progress on PFAS. Additionally, the EPA proposed a new rule under the Toxic Substances Control Act (TSCA) Section 8(a)(7), which would require companies manufacturing, importing, or selling within the U.S. to identify and digitally report on their use of PFAS for 10 years. Required data in these reports would include:
- Category of use
- Descriptions of byproducts created from substances during the total lifecycle of a product
- Environmental and toxicological information
- Exposure information
- Disposal data
This rule coincides with other rules the EPA issued in January 2023, which place restrictions on persistent, bioaccumulative, and toxic (PBT) chemicals. Requirements concerning one substance group are drawing the attention of compliance professionals.
Asian Regulatory Risks
As the US and Europe tighten their controls over the use of PFAS, few Asian countries appear to be meeting their basic requirements under international law towards moving to strengthen their regulations.
Chemical Substances Control Act (CSCA). In April 2021, PFOA was added to the list of Class I Specified Chemical Substances under the CSCA. However, PFOA-related substances are excluded from the scope of regulation.
List of Priority Control Chemicals (2nd Edition). In November 2020, 18 substances, including PFOA, were placed on the list of Priority Control Chemicals. As a result, environmental risk control measures based on various laws and regulations will be taken in the future.
Environmental Protection and Management Act. It was partially amended in 2019 to add PFOA as a regulated substance. A license is required for its import.
Hazardous Substances Act. On 21 December 2022, the Ministry of Industry officially published “Notification of Ministry of Industry B.E. 2565 (2022): List of hazardous substances (No.7)”, adding PFOA, its salts, and PFOA-related compounds to the list.
Law on Environmental Protection. On January 10th, 2022, Decree No. 08/2022/ND-CP was published whose section 3 of chapter 4 stipulates POPs regulations, and Annex XVII of the decree lists regulated POPs, including PFOA.
Law on Chemicals. On Oct. 18, 2022, Vietnam’s government issued a governmental decree (Decree No. 82/2022/ND-CP) that partially revises Decree No. 113/2017/ND-CP, and listed PFOA in the ANNEX II of Decree 113/2017/ND-CP.
The Electronic industry is complex, with multi-tiered manufacturing processes and an intricate and complex supply chain. Identifying PFAS in this industry is a challenge, not only due to the sheer number of chemicals falling into the PFAS category but also due to the resources needed to identify them. Reporting PFAS usage and the possibility of bans is on the horizon, and the best way for the industry to respond is by preparing and providing policymakers with data and facts on PFAS use. Chemical regulations are not a new concept, but a broad PFAS ban has the potential to greatly impact the electronics industry.