In early 2023, five European countries (the Netherlands, Germany, Denmark, Sweden and Norway) initiated discussions to adopt a new restriction under REACH, a European regulation for the registration, evaluation, authorisation and restriction of chemicals.
The overall objective is to restrict the manufacturing, use and placing on the market of a group of chemicals called PFAS in the European Economic Area (EU plus Iceland, Liechtenstein, and Norway). PFAS are a group of chemicals used to make fluoropolymer coatings and products that resist heat, oil, stains, grease and water.
PFAS have become a growing global concern. They have captured the media and public spotlight due to a growing body of scientific data showing environmental persistence and, for some of them, negative human health impacts.
Consequently, phasing out the production and use of PFAS have now become a priority. Key global players, the EU and US, are making significant inroads towards minimising the manufacture, import, sale and use of PFAS.
Many companies and business associations, including those involved in the manufacturing and importation of PFAS chemicals and PFAS-containing articles, have expressed major concerns over the likelihood of businesses moving outside of the EU
However, due to the decades-long and widespread use of PFAS across numerous industries and commercial applications, a complete elimination of such substances from the marketplace will be extremely challenging. This is due to their role in the functionality and performance of many products. Identifying and using viable replacements may take several years and will represent various challenges.
The proposed restriction has a very wide scope as it would cover more than 10,000 substances falling under the PFAS definition. Some regard it as the most complex restriction in the history of the European Union.
It is likely that the impact on the European industry of a possible restriction on PFAS will be significant, particularly since the proposal does not as yet differentiate between substances that may have different toxicity profiles.
Many companies and business associations, including those involved in the manufacturing and importation of PFAS chemicals and PFAS-containing articles, have expressed major concerns over the likelihood of businesses moving outside of the EU due to the lack of predictability of the final regulatory outcome of the PFAS restriction.
Supply of chemicals needs to be ensured to avoid market disruptions and/or significantly increased prices. SMEs will be the first ones to be affected. As such, there is legitimate concern over the inevitable decrease in foreign direct investment in the European chemicals industry due to this newly proposed restriction.
Attesting to this, the European Federation of Pharmaceutical Industries has argued that a total ban on PFAS would see European medicine manufacturing grind to a halt in under three years. This would lead to over-reliance on imports from outside of the EU.
According to a number of discussions held at EU level, the EU’s PFAS regulatory approach is likely to enter into force in the next years, depending on the development of the discussions. In the restriction proposal, various time-limit derogations have been proposed in view of the current lack of suitable alternatives.
The EU PFAS restriction proposal is by far considered as being the most stringent and broadly scoped legislation heavily impacting multiple industry sectors.
The EU intends to avoid substance-by-substance evaluation as a regulatory risk management option for this large and complex group of chemicals. Many PFAS are deemed as essential use for socioeconomic reasons. These include hydraulic fluids used in aviation and aerospace, semiconductors, fluoropolymers used in petroleum and mining and safety parts in the automobile industry.
To identify, develop, manufacture and certify alternatives, the EU proposal has recommended a 12-year derogation for specific uses. For some industrial applications, such as hard chrome plating, refrigeration, and mobile air-conditioning, evidence supports the feasibility for the development of economically viable and functionally suitable substitutions. Hence, a five-year derogation is being recommended in the EU proposal for the industry to adapt. Yet, one has to see the final outcome of the negotiations.
A total ban on PFAS would mean that a number of EU and local manufacturers may need to reengineer their production processes, procure different equipment and use other materials.
A smooth transition, which will also depend on the adjustment period negotiated, calls for thorough research and planning by industry. This restriction is anticipated to lead to increased costs for operators and consumers of products that currently contain PFAS.
Maltese companies are being encouraged to familiarise themselves with this restriction, stay ahead of changing PFAS regulatory terms and be part of the discussions.
In anticipation of the expected legislative amendments, Malta Enterprise will host an information session on March 27 to raise awareness among leading stakeholders and industrialists on the proposed REACH restriction on PFAS. During the in-person event, an expert from the European Chemical Industry Council (CEFIC) will address the participants. Those interested can register here.
Greta Camilleri is the EU Affairs manager at the Economic Intelligence, Research, EU Affairs Unit at Malta Enterprise.