Short summary

On 8 November 2023 the ECHA’s Enforcement Forum published its advice on the enforceability of the proposed PFAS restriction prepared by five national authorities.

The Forum’s advice is an integral part of the REACH restriction process and it will be considered in the next steps of the process together with ECHA’s committees’ opinions and the restriction report.

The advice concludes that as it stands, the PFAS restriction proposal will be challenging to enforce and that it needs improvement in several aspects.

Major remarks of the written advice

Scope

Circa 10.000 PFAS substances in scope are identified by structural criteria using the definition provided by the Organization for Economic Cooperation in Europe (OECD), while there is no reference to a list of substances or their respective CAS numbers.

The use of fluorinated gases containing a mixture of two or more PFAS is not covered by the potential ban.

The restriction applies only to precursor chemicals and leaves out laboratory degradation products.

Concentration limits

Lack of clarity on the applicability of restrictions on articles. The advice notes that, without any specification, the concentration of PFAS will be calculated on the whole product instead on its single parts containing PFAS (e.g., coating).

Legislative overlap

Restrictions on the use of PFAS are already provided in EU legislation such as the REACH Regulation, F-GAS Regulation, and Persistent Organic Polluters Regulation. The advice warns against a risk of unharmonised interpretation on restrictions imposed to specific products and/or substance applications.

Analysis of substances

Only a limited number of analytical methods for the calculation of the limit values are standardised. The report estimates that target analysis methods are only available for circa 1% of the 10.000 PFAS substances in scope.

The availability of targeted PFAS analysis as the criterion to establish limit values is deemed unspecific since it is subject to continuous validation and accreditation processes, potentially leading to an uneven application timeline among EEA Member States.

Enforcement costs

• High financial and manpower costs
• Expected over-deployment of resources by national enforcement agencies to conduct inspections
• Expected annual average incremental administrative cost of EUR 55.000 per sector for the whole EEA area. The figure includes administrative costs of inspections but not testing costs.

Recommendations provided in the advice

• Developing new targeted analytical methods
• Clarifying whether the limit values need to be applied in a cumulative manner or independently
• Reconsidering definitions and wording which are either unclear or not supported by an identifiable legal reference
• Including distributors in the list of economic actors subject to the obligations concerning storage and handling activity
• Need for decision tree and guidance

Positions and actions

The Eurovent Task Force ‘F-GAS’ (TF-FGAS) will keep monitoring the PFAS dossier and consider the published advice at its next meetings.

Timeline

The next steps are summarised below:

• Draft opinion of SEAC    
• RAC & SEAC (draft) Background document (and annexes)
• Start of SEAC draft opinion consultation 
• Deadline for comments on SEAC draft opinion     
• Comments on SEAC draft opinion             
• Compiled RAC and SEAC opinion (and minority positions)
• Final background document (and annexes)           
• Adopted restriction/Commission communication

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Consultation

The European Chemicals Agency invites interested parties to send in scientific and technical information on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS) by 25 September 2023.

The consultation aims to give anyone with information on PFAS the opportunity to have their say. Of particular interest is information relevant to the risks, socio-economic aspects, and alternative substances.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will use the consultation input to evaluate the proposed restriction and to form an opinion on it.

Online information session

An online information session will be held on 5 April from 11:00 to 13:00 Helsinki time. During the session, experts from ECHA and the five national authorities will explain the restriction process, the content of the proposal and how to participate in the consultation. They will also respond to questions from the participants.

PFAS restriction proposal

On 7 February 2023, the European Chemicals Agency (ECHA) published the PFAS restriction proposal. The proposal published by ECHA was prepared by authorities in Denmark, Germany, the Netherlands, Norway and Sweden and submitted to ECHA on 13 January 2023. It aims to reduce PFAS emissions into the environment and make products and processes safer for people.

If accepted, the proposals would enter into force in 2025 and allow an 18-month transition period to alternatives.

However, there are several proposed exemptions, some of which relate to the air conditioning, heat pump and low-temperature refrigeration sector. In its Annex XV Restriction report, the proposal accepts that technically and economically feasible alternatives will not be available at the date of entry into force and suggests an unlimited exemption for refrigerants in HVACR equipment in buildings, where national safety standards and building codes prohibit the use of alternatives.  

It also proposes a transition period of 18 months and a 12-year exemption for maintenance and refilling of existing HVACR equipment where drop-in alternatives are not available.

Next steps

RAC will form an opinion on whether the proposed restriction is appropriate in reducing the risks to people’s health and the environment, while SEAC’s opinion will be on the socio-economic impacts, i.e. benefits and costs to society, associated with the proposal. Once the opinions are adopted, they will be sent to the European Commission who, together with the EU Member States, will then decide on the potential restriction. The proposed timeline is reported below:

Interested Members are invited to attend the online session on the 5th of April and to carefully assess the proposal and provide the Eurovent TF-FGAS with their comments to contribute to the consultation. 

Additional resources

More information can be found on the dedicated ECHA webpage on the PFAS restriction proposal.

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Introduction

The proposal published by ECHA was prepared by authorities in Denmark, Germany, the Netherlands, Norway and Sweden and submitted to ECHA on 13 January 2023. It aims to reduce PFAS emissions into the environment and make products and processes safer for people.

All PFASs in the scope of the proposal are very persistent in the environment. If their releases are not minimised, people, plants and animals will be increasingly exposed, and without a restriction, such levels will be reached that have negative effects on people’s health and the environment. The authorities estimate that around 4.4 million tonnes of PFASs would end up in the environment over the next 30 years unless action is taken.

Preliminary assessment

If accepted, the proposals would enter into force in 2025 and allow an 18-month transition period to alternatives. However, there are a number of proposed exemptions, some of which relate to the air conditioning, heat pump and low temperature refrigeration sector. This proposal appears to have taken on board the industry’s concerns that the suggested timescale would compromise the EU Green Deal and REPowerEU decarbonisation goals.

In its Annex XV Restriction report, the proposal accepts that technically and economically feasible alternatives will not be available at the date of entry into force and suggests an unlimited exemption for refrigerants in HVACR equipment in buildings, where national safety standards and building codes prohibit the use of alternatives.  

It also proposes a transition period of 18 months and a 12-year exemption for maintenance and refilling of existing HVACR equipment where drop-in alternatives are not available.

Next steps

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will check that the proposal meets the legal requirements of REACH in their meetings in March 2023. If it does, the committees will begin their scientific evaluation of the proposal. A six-month consultation is planned to start on 22 March 2023.

RAC will form an opinion on whether the proposed restriction is appropriate in reducing the risks to people’s health and the environment, while SEAC’s opinion will be on the socio-economic impacts, i.e. benefits and costs to society, associated with the proposal. Both committees form their opinions based on the information in the restriction proposal and the comments received during consultations. The committees also consider advice from the Enforcement Forum on the enforceability of the proposed restriction. Once the opinions are adopted, they will be sent to the European Commission who, together with the EU Member States, will then decide on the potential restriction.

An online information session will be organised on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation.

The proposed timeline is reported below:

Recommended actions

Eurovent Members are invited to carefully assess the proposal and provide the Eurovent TF-FGAS with their comments in view of the upcoming consultation.

The post ECHA publishes PFAS restriction proposal appeared first on Eurovent.

Proposal submitted to ECHA and next steps

On 13 January, ECHA received the PFASs restriction proposal submitted by the five national authorities.

Please note below some important dates mentioned in the ECHA’s press release:

• 7 February 2023: the proposal and supporting documents are made available in ECHA website. On the same date, a hybrid media conference will be organised by the national authorities in Brussels (11:00 to 12:30 CET).
• 22 March 2023: start of a six-month open consultation.
• 5 April 2023: online information session to explain the restriction process.

Plan d’actions Ministériel sur les PFAS

On 17 January, the French Ministry of Environment published its PFAS Action Plan (‘Plan d’actions Ministériel sur les PFAS’) which includes establishing safe environmental concentration limits, increasing monitoring and significantly reducing industrial emissions. The French Action Plan gives explicit support to the wider EU PFAS restriction proposal by Denmark, Germany, the Netherlands, Norway and Sweden, saying that a broad ban of uses is needed at EU level to tackle the risks of products containing the chemicals. It is a strong encouragement for the further actions on PFAS at EU level.

Recommended actions

Interested Members are invited to monitor the ECHA website to access the proposal once published and to attend the online information session. Comments on the proposal are welcome to develop a position in the context of the six-month open consultation.

The post PFAS restriction proposal has been submitted appeared first on Eurovent.

The European Fluorocarbons Technical Committee (EFCTC) will launch a stakeholder survey to collect more information on the F-Gas industry sector regarding the PFAS restriction proposal. The survey will run for 4 weeks (until 2 May), and both trade associations and downstream users are invited to participate.

EFCTC is also organising a webinar to better explain the survey; it will take place on March 23rd, 2022, at 14:00eurovent-market-intelligence/news/eurovent-market-intelligence/-16:00 CET. The webinar invitation and the survey will be shared via email with the interested participants. Therefore, EFCTC is asking stakeholders to please express their interest in participating to both the webinar and the survey as soon as possible by sending an email to eco@cefic.be and/or EFCTC_SEA@ricardo.com.

Recommended actions

Interested parties are invited to participate to both the webinar and the survey.

Companies producing or using PFAS, selling mixtures or products containing these substances and those using alternatives to PFAS, as well as scientists and NGOs are especially invited to take part.

The post EFCTC socioeconomic assessment on PFAS restriction appeared first on Eurovent.

REACH Regulation (EC 1907/2006)

The REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulates the chemicals that present risks to human health and the environment.

Under the REACH Regulation, companies must register their substances with the European Chemical Agency ECHA. ECHA receives and evaluates individual registrations for their compliance. ECHA also deals with requests formulated by Member States to evaluate selected substances that may present concern regarding human health or the environment.

Further to preparatory work, Netherlands, Denmark, Germany, Sweden and Norway have introduced on 15 July with the ECHA Register of Intention the request to consider a restriction on manufacture, placing on the market and use of PFAS. This is supported by a 6-page regulatory management option analysis (RMOA) developed by the countries over 18 months and proposes a restriction of PFAS (GEN – 1269.01).

The F-Gas Regulation is handled by DG Environment.

F-Gas Regulation (EU 517/2014)

The objective of the F-Gas regulation is to reduce and control the emissions from fluorinated greenhouse gases (F-Gases). The phase-down aims to reduce the emissions by two-thirds compared with 2014 levels. The regulation is being reviewed and a Commission proposal is expected by the end of 2021 (See GEN – 1250.00).

The F-Gas Regulation is handled by DG Clima.

Request for a restriction on manufacture, placing on the market and use of PFAS

Further to preparatory work The Netherlands, Denmark, Germany, Sweden, and Norway have introduced on 15 July with the ECHA Register of Intention the request to consider a restriction on manufacture, placing on the market and use of PFAS. The restriction would apply to non-essential uses of PFAS. This is supported by a 6-page regulatory management option analysis (RMOA) developed by the countries over 18 months and proposes a restriction of PFAS (GEN 1269.01).

The HVACR industry may note that the proposed restriction includes chemicals that are used as refrigerants and that are subject to the F-Gas Regulation.

2nd Stakeholder Consultation on a Restriction for PFAS until 19 September

The questionnaire and related documents allow interested parties and authorities to check the presented data to ensure that the correct information is used for the assessment and preparation of a proposal for restriction on PFAS (known as REACH Annex XV Restriction Dossier).

Within the 66-page questionnaire links are provided to the analysis of 16 uses. For the HVACR industry the F-Gas uses are detailed in two documents:

• GEN – 1269.02 – Report summary F-Gas uses (28 pages)
• GEN – 1269.03 – F-Gas use in the European Economic Area (16 pages)

The uses in the construction, metal plating and manufacturing of metal products refer to PFAS in paints, varnishes and coatings that might also have some relation to equipment produced within the HVACR industry. The other uses do not seem to relate to the HVACR industry.

Timing

The five Member States have until July 2022 to finalise the file (REACH Annex XV Restriction Dossier).

After this a Public Consultation will take place that would take 6 months.

With the input received that Commission may then draft an amendment to restrict non-essential uses of PFAS. The development of this amendment would start in early 2023.

Related

The Commission has started with a Roadmap in May 2021 the process to review both the REACH Regulation and the related Classification, Labelling and Packaging (CLP) Regulation, the latter dealing with the classification and labelling of substances and mixtures. These reviews have put within the context of the Green Deal.

ECOS, the Environmental Coalition on Standards, issued in May 2021 a report into the climate impact of modern fluorinated refrigerants. It is enclosed for information (GEN – 1269.04).

Activities by European associations

APPLiA and EPEE have invited associations (ACEA, AREA, CEFIC, EHI, EFCTC, EHPA, Eurovent, JRAIA, Orgalim, PU Europe) to three meetings to assess the situation. APPLiA and EPEE propose to host in September a one-hour webinar that would allow ECHA, national REACH and national F-Gas experts to meet and exchange.

Recommended actions

Associations and companies with specific knowledge on chemicals are recommended to check and respond to the consultation by 19 September:

• https://link.webropolsurveys.com/Participation/Public/c4d58b80-5227-4f31-b656-92bc0669e41e?displayId=Ger2322406

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