Wells Performance Materials PFAS and PPWR Regulatory Statement

Dear Valued Customer,

Wells Performance Materials Limited is recognised as a significant manufacturer of polymer processing aid (PPA) masterbatches within the European marketplace and the materials produced in the UK have been used extensively to provide processing benefits and advantages in the polyolefin film, sheet and fibre extrusion market for over 30 years.

The benefits provided include the elimination of melt fracture and improved film quality such as enhanced optical transmission, whilst also increasing machine throughput via reduced die pressure and reducing die-lip build-up. Some of the PPA masterbatches produced by Wells PM utilise fluoropolymer chemistry as one of the active ingredients, albeit ultimately at a very low level in the end application.

As you may be aware Poly-and Perfluoroalkyl Substances (PFAS), as a material set, are currently undergoing a regulatory review in a number of constituencies, primarily the EU, UK and US. The current status of these various regulatory reviews is summarised below:

EU

1. REACH Annex XV Restriction study, ECHA

On 13^th January 2023 an Annex XV Restriction Report – Proposal for a Restriction of Per- and polyfluoroalkyl substances (PFAS) was submitted by the Danish, German, Dutch, Norwegian and Swedish authorities to ECHA. 

The basis of the concern and justification for the restriction proposal was stated as “The main concern for all PFASs and/or their degradation products that are in the scope of this restriction proposal is the very high persistence, exceeding the criterion for very persistent (vP) according to Annex XIII of the REACH Regulation by far.”

The chemical scope of the restriction proposal was defined as: “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it). It is aligned with the OECD definition of PFASs that was published in 2021, and that has been scrutinized by the international scientific community and is widely accepted.

This definition encompasses more than 10,000 PFASs, including a few fully degradable PFAS subgroups. As these fully degradable subgroups, which can be described by their key structural elements, do not fulfil the underlying concern of high persistence (see above), they are excluded from the scope of this restriction proposal.”

The six-month consultation on the restriction proposal started on 23 March 2023 and generated in excess of 5,600 submitted comments from stakeholders.  This vast response resulted in ECHA having to develop a plan for RAC & SEAC to review and address these comments.  This has significantly impacted the timeline for the proposal with RAC & SEAC discussions continuing into spring/summer 2025, meaning the restriction is unlikely to be finalised until 2026/27.  Alongside the RAC & SEAC opinion generation the Dossier submitters are also reviewing the comments received and developing the restriction proposal further with the possibility of other restrictions options other than a ban being considered.

1. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC

The European Commission proposal for a Packaging and Packaging Waste Regulation (PPWR), issued on 30 November 2022, will repeal and replace the current Packaging and Packaging Waste Directive 94/62/EEC (PPWD).

The PPWR was adopted by the European Parliament on 24^th April 2024, at the first reading, and then on 28^th November 2024 the final text of the regulation was approved by the European Parliament.

The final stage of gaining formal approval is from The European Council and this is timetabled to occur on 16^th December 2024.  It will then be published the Official Journal of the European Union (OJEU) most probably in early 2025 and it will enter into force 20 days after publication and will then apply 18 months after entry into force (EIF), expected to be summer 2026.

The scope of the proposed PPW regulation has been expanded to include measures to reduce (over)packaging and packaging waste alongside measures to increase and improve packaging reuse and recycling, and to drive the uptake of recycled content in packaging.  It aims to mandate recyclability for all packaging, minimize substances of concern (e.g. harmful chemicals), and improve the information available to consumers by setting labelling requirements.

The PPWR, as proposed, will prohibit food packaging from being placed on the EU market if it contains per- and polyfluorinated alkyl substances (PFAS) in a concentration of or above the following limit values:

1. 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification);

1. 250 ppb for the sum of PFAS measured as the sum of targeted PFAS analysis, where applicable with prior degradation of precursors (polymeric PFAS excluded from quantification); 

1. 50 ppm for PFASs (including polymeric PFAS); (if total fluorine exceeds 50 ppm proof shall be required of the quantity of fluorine measured as content of either PFAS or non-PFAS)

These limits, together with the definition of PFAS, appear to be directly taken from the REACH PFAS restriction proposal published by ECHA and will apply from the application date of the PPWR (i.e. Summer 2026) significantly in advance of any proposed restrictions that may be defined by ECHA. 

 

UK

The HSE published a Regulatory Management Options Analysis (RMOA) on PFAS in April 2023.  A RMOA is a document drafted to support regulatory decision-making and can give an insight into future legal developments.  The RMOA proposed potential regulatory options for the use and disposal of fire-fighting foam that includes PFAS where non-PFAS alternatives are available; the use of PFAS in wide dispersive materials such as coatings and cleaning agents; and the manufacture and placing on the market of consumer articles from which PFAS are likely to be released or directly transferred to human, including textiles, upholstery and rugs, leather and paints, varnished and other related articles.

It also stated that such restrictions “need not apply to low hazard groups or low risk uses, for example; fluoroplastics or fluoro-elastomers (low hazard groups)…”

Although, since the ROMA publication there have been few developments for PFAS under UK REACH, the HSE is currently considering responses to a June 2024 call for evidence on PFAS-containing fire-fighting foams and has confirmed that PFAS will be a substance of focus under UK REACH from 2023 to 2025.

USA

In general, the USA has taken a chemical and/or application specific approach to the restriction or banning of PFAS. At a federal level the EPA has established drinking water standards that limit the permitted levels of 6 named PFAS chemicals. The EPA has also removed PFAS from the Safer Choice program’s Safer Chemical Ingredients List and taken action to remove 12 PFAS from the list of inert ingredients approved for use in non-food pesticide products.

A number of states have also enacted bills which restrict or ban PFAS (either named chemicals or defined by a range of definitions) in specified end products, most widely firefighting foams and children’s products but 5 states include food packaging.  Many of these bills relate to intentionally added PFAS.

Alternative Solutions – PFAS Free Processing Aids

If you are directly affected by any of these regulations you may wish to try the Wells PM range of PFAS free processing aid masterbatches which have been specifically developed to provide excellent performance in blown film extrusions, if so please contact either your account manager or use sales@wellspm.com .