EU PFAS restriction proposals: Commissioners wait on impending risk assessments

06 Apr 2023 --- The European Commission (EC) is now waiting for the European Chemicals Agency (ECHA) committees to submit their evaluations of the proposed restriction of per- and polyfluoroalkyl substances (PFAS).

The Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC), falling under ECHA, will be carrying out the evaluations while also ensuring the proposal meet the legal requirements of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals).

“It is suspected that by September 2023, we will have the first discussion of the first draft opinions by RAC and SEAC,” shares Mercedes Marquez-Camacho, restriction process coordinator at ECHA, in a webinar held yesterday.

After the the EC will make a decision to enforce the PFAS restriction proposal. This will either entail a postponment or initiation of an 18-month phase-out of these hazardous chemicals, often used in food packaging, cosmetics and toiletries.

PFAS are also known as “forever chemicals” that are notorious due to their persistence in nature and their bioaccumulative toxic effects on human health. 

Will the REACH delay impact PFAS restriction?
ECHA previously detailed that its RAC and SEAC were to evaluate whether the proposal met the legal requirements of REACH.

However, on October 18, 2022, the EC announced that the revision for the REACH regulation would be postponed – scheduled for the final quarter of 2023.

In a previous interview, an EC spokesperson explained that the authority is finalizing the impact assessment, consultations with key stakeholders and is working on solid input for the Regulatory Scrutiny Board. “Once this file is ready, we will not hesitate to present it to the European Parliament and the Council.”

“We will propose a targeted revision of the legislation on REACH to secure European competitive advantages and innovation by promoting sustainable chemicals, simplifying and streamlining the regulatory process, reducing the burden and protecting human health and the environment,” the spokesperson told PersonalCareInsights.

On the other hand, further delaying the EU’s landmark reform on chemical laws may threaten its industry’s competitiveness and resilience in the long term, warned the European Environment Bureau (EEB) and CHEM Trust.

Tatiana Santos, head of Chemicals Policy at the EBB, previously told PackagingInsights that generic, fast-track restrictions of PFAS in everyday consumer products will only be possible once REACH is reformed.

The agencies stress that the current parliamentary term would have no chance to finish institutional negotiations before elections in 2024, significantly delaying the REACH revision.

Based on the delays of REACH revisions, the PFAS restriction evaluation may be time-bound.

Timeline so far
As an overview, Marquez-Camacho outlines that the restriction proposal was submitted to ECHA by five member states on January 13, 2023. This was published on ECHA’s website on February 7. On March 22 a six-month open consultation started and an online information session was carried out on April 4.

“At the same time, the committees started with the evaluation of the restriction proposal. So this step will continue until the committees adopt their opinion,” continues Marquez-Camacho. After this, the opinions of ECHA committees will be sent to EC.

“The member states will vote on the legislative proposal and any restriction will also be scrutinized by the European Parliament and EU Council before it can be adopted. The legislative proposal may differ from the proposed restriction presented on February 7. At the very start of the process, we cannot speculate the outcome of the process,” she previously told us. 

Cosmetic and food packaging pollutionCombined exposure to various PFAS cannot be ruled out.ECHA held a webinar on the restriction of PFAS substances under REACH yesterday. Wiebke Drost, from the German Environment Agency, explained that PFASs need to be regulated with a concern for environmental pollution.

She shares that environmental emissions occur in all life stages of PFAS-based products, with 75,000 metric tons of emissions in 2020. It is estimated that there will be 4.5 million metric tons of emissions over the next 30 years, including an estimated increase in PFAS use. “Environmental emissions release depends on the rate of environmental release of PFAS.”

Food contact materials and packaging were noted to have a >10 000 tonnage range and 0-5% of emission range in the manufacturing and use phase. The emission contribution to total emission is 0-1%.

For cosmetics, the tonnage range is 10–100, with > 95% of the emission range emitted in the manufacturing and use phase. The emission contribution to total emission is 0-1%.

PFAS functions can vary. For instance, they repel water, oil and dirt, are durable under extreme conditions and can be used in surfactants.

Fluoropolymer use may be impacted
Peter Juhl Nielsen at the Danish Environmental Protection Agency explains: “If there are no changes to the [PFAS restriction] proposal, then fluoropolymers could be banned for all uses. The reason is that fluoropolymers are very persistent like the other PFASs and we have to consider the entire lifecycle of these products.” 

“This includes the production, the use phase and the waste phase. So during production, the use of other PFASs and emissions may occur. Additionally, residuals may remain from the product, so wear and tear over time will release some other PFAS into the environment. 

Fluoropolymers are chemicals used in food packaging and cosmetics as bulking agents. 

“In the waste phase, recycling is nearly impossible when PFASs are used in these products. In the end, when products are in landfills or incinerated, there may be a chance that PFAS are emitted into the environment,” he continues.

Main application in food contact materials and packaging, sub-uses, which are non-exhaustive, fall under consumer cookware, food and feed packaging including paper and board packaging and plastic packaging, outlines Thijs de Kort, Coordinator for the Universal PFAS restriction at the National Institute for Public Health and the Environment, the Netherlands.

He adds that the main application in cosmetics, sub-uses, which are non-exhaustive, fall under skincare, toiletries, haircare, perfumes and fragrances and decorative cosmetics.

Why ban the entire PFAS group?
In the question and answer session of the webinar, a participant questioned why the entire PFAS group is proposed to be banned and not just PFASs that have proven harmful properties.

PFAS as a group is that they all share the same concern of being persistent. “The reason for assessing PFAS as a group is that they all share the same concern, so they are either persistent themselves or degrade to persistent PFAS. In addition to this persistence, we know that some PFAS are suspected carcinogens. They can cause harm to an unborn child or trigger effects at a low concentration, such as the liver,” answered Frauke Averbeck at the German Federal Institute for Occupational Safety and Health.

“PFAS are also potential endocrine disrupters and can adversely affect the aquatic environment. The knowledge on PFAS is increasing and all the information we get from this new information points toward similar adverse effects even for other PFASs.”

She also highlights that the combined exposure to various PFAS cannot be ruled out.

“Therefore, we think a group approach is justified and is the most efficient way to address this complex interplay of concerns – and also to avoid regrettable substitution, meaning replacement of one PFAS by another similarly hazardous substance,” continues Averbeck.

Moreover, exposure to PFAS is gaining attention, with New Zealand’s Environmental Protection Authority proposing to ban all PFAS substances in cosmetic products starting in 2026. California, US, was the first major jurisdiction to ban all PFAS in cosmetics.

Additionally, for the first time, PFAS was recently detected in Canadian fast-food packaging – specifically water-and-grease repellent paper alternatives to plastic. Toilet paper was also discovered to be an “unexpected” source of forever chemicals.

By Venya Patel