EU chemicals agency begins risk assessment of PFAS “forever chemicals” as prohibition nears

08 Feb 2023 --- The European Union (EU) is taking a closer step toward restricting per- and polyfluoroalkyl substances (PFAS) in an effort to curb environmental pollution and reduce human exposure to these persistent toxic substances – also known as “forever chemicals.”

A proposal calling for a restriction on 10,000 PFAS drafted in a joint effort by five countries is now available on the website of the European Chemicals Agency (ECHA). 

At a media briefing yesterday, The Netherlands and Germany, taking the lead, strongly supported by Denmark, Norway and Sweden, presented their proposal for restricting PFAS. They discussed the proposal’s details, including the timeline for companies to find alternatives and the formal steps required before a restriction could be implemented.

“The proposed restriction on PFASs is set to be one of the largest ever on chemical substances in the EU,” they say.

ECHA details that its scientific committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will check that the proposal meets the legal requirements of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) in their meetings next month. The committees will then begin their scientific evaluation of the proposal – a six-month consultation is planned to start on March 22.PFAS are a large class of thousands of synthetic chemicals that are used throughout society, including cosmetics, household products, food processing and medical articles. 

“The decision on a potential restriction will be made in the European Commission [EC] with all EU Member States,” Mercedes Marquez-Camacho, restriction team leader at ECHA, tells PersonalCareInsights.

“The Member States will vote on the [EC’s] legislative proposal and any restriction will also be scrutinized by the European Parliament and EU Council before it can be adopted. The [EC’s] legislative proposal may differ from the proposed restriction as presented on February 7. At the very start of the process, we cannot speculate the outcome of the process.”

Dangers of PFAS
According to ECHA, certain PFASs are toxic for reproduction and can harm the development of fetuses. Several PFASs may cause cancer in humans, while some are suspected of interfering with the endocrine system.

PFASs are widely used as they have desirable properties, such as remaining stable under intense heat. Many of them are also surfactants and are used, for example, as water and grease repellents. 

ECHA details that all PFASs in the proposal’s scope are very persistent in the environment. The authorities estimate that around 4.4 million metric tons of PFASs would end up in the environment over the next 30 years unless action is taken.

This is a “historically extensive bill,” says Per Ängquist, Sweden’s director general of the Chemicals Inspectorate.

“Our bill means that several industries will have to change, but we are convinced that the costs resulting from continued emissions are even higher.”

The proposal provides a transitional period of one and a half years, during which the companies can adjust production. In the applications where the alternative to PFAS is to be developed, the transition period can be extended up to 13 and a half years.PFASs are released into the environment from direct and indirect sources, including during use of consumer products such as cosmetics, ski waxes, clothing, and from food contact materials.

The transition period also depends on the availability and functionality of the PFAS alternatives. The proposal accounts for the unavailability of alternatives.

Unlimited exemptions are provided for a few areas, such as active ingredients in plant protection products, biocidal products and human and veterinary medicinal products. These PFAS must be examined within the framework of the sector-specific regulations to minimize their entry into the environment.

A spokesperson at the German Federal Institute for Occupational Safety and Health which helped draft the proposal tells PersonalCareInsights that according to the proposed restriction there is no derogation intended for the personal care industry. 

“The standard transition period of 18 months after entry into force of the restriction applies. If the restriction is implemented as proposed, PFASs could then neither be manufactured and placed on the market for this use, nor be used in personal care anymore after that period,” they say.

“Landmark proposal”
Work on the restriction proposal will continue until 2025, when the European Commission and EU Member States must decide on a restriction on using PFAS.

“This landmark proposal by the five authorities supports the ambitions of the EU’s Chemicals Strategy and the Zero Pollution action plan,” asserts Peter van der Zandt, ECHA’s director for Risk Assessment.

“Now, our scientific committees will start their evaluation and opinion forming. While the evaluation of such a broad proposal with thousands of substances, and many uses, will be challenging, we are ready.”PFAS have been observed to contaminate groundwater, surface water and soil.

While the RAC will assess the proposed restrictions from the perspective of reducing the risks to people’s health and the environment, SEAC’s opinion will be on the socio-economic impacts, such as benefits and costs to society.

“The use of PFAS in consumer products should be banned, which is why consumer organizations support this proposal. We call on the EU to proceed as fast as possible with this restriction, while keeping the level of ambition high to protect people from forever chemicals,” shares Monique Goyens, director general at the consumer organization BEUC (Bureau Européen des Unions de Consommateurs).

Regarding the process of restricting chemicals under the EU’s REACH, Monique adds: “These chemicals should have never been put on the market in the first place. As the EU reforms its flagship law, which is expected to happen this year, it should ensure that REACH allows for early and precautionary action before the use of harmful chemicals becomes widespread in consumer products.”

“The proposal implies that as many products as possible must be free of PFAS so that we can slow down the release into the environment. For many applications, there are already alternatives to PFAS on the market. For others, their development needs to be boosted, and we hope this work will gain a prominent place in the industry,” concludes Grete Lottrup Lotus, function manager at the Danish Environmental Protection Agency.

By Radhika Sikaria