Regulations are typically implemented at a deliberate pace, often carrying years of lead time before enforcement is threatened. However, building an effective compliance program also takes time, which is why forward-looking compliance professionals are able to better construct programs to meet future requirements.
Requirements concerning one substance group in particular are drawing the attention of these compliance professionals. Per- and polyfluoroalkyl substances (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.
A variety of industries use these substances. You can find PFAS in certain items of clothing or footwear, and they are often present in carpets, cosmetics, and even fire-fighting foam. In the EU and certain other jurisdictions, restrictions are in place for specific PFAS, namely perfluorooctane sulfonic acid (PFOS) and its derivatives as well as perfluorooctane acid (PFOA). These chemicals have been replaced by other, non-restricted PFAS, but broader restrictions would necessitate finding new alternatives.
One of the strongest signs for future restriction comes from the U.S. Environmental Protection Agency (EPA), which launched an EPA Council on PFAS with a clear directive to assess and reduce the risks created by these substances. 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, which place restrictions on persistent, bioaccumulative, and toxic (PBT) chemicals.
TSCA has a new look, and companies will need to navigate it to stay in the U.S. market. Learn everything you need to know in our guide, The TSCA Section 6 Handbook: Your Guide to Compliance.
PFAS & the EU
The European Chemicals Agency, the enforcement body responsible for the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation, has proposed a restriction on the manufacture and market placement of PFAS with specific chemical structures (seen here). The agency is accepting comments on the proposal until October 17, 2021, and is expected to formally submit its decision on July 15, 2022.
As mentioned earlier, expanding PFAS restrictions will require a substantial investment from companies as they will have to adapt their product compliance programs and find alternative substances. The risk of supply chain disruption caused by such restrictions is real. In the U.S., the EPA’s proposed restriction of PIP 3:1 caused a stir across industries. Ultimately, the EPA delayed its enforcement of PIP 3:1 restrictions, but criticized companies for their delayed response in scoping for the chemical.
The EU has grown increasingly tough on regulatory enforcement. From the alignment of penalties under the EU Market Surveillance Regulation to the implementation of the publicly-searchable Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database, there’s never been more incentive for companies to build strong compliance programs.
How Assent Can Help
Assent streamlines this process by combining automated platform technology with a dedicated Customer Success team that reduces your workload and gives you hours back in your day. Guided by world-class expertise, Assent’s solution is built to scale with your growth and respond immediately to regulatory changes.
That agility is essential to navigating issues like the PFAS restrictions. Jurisdictions will move at different paces and impose slightly different rules. These discrepancies do more than eat time — they lead to increased risk of human error and missed deadlines, ultimately placing your company at risk of non-compliance penalties. To learn more about Assent and how it addresses these challenges, contact our experts.