EUU, Alm.del - 2022-23 (2. samling) - Supplerende svar på spørgsmål 49: Spm. om, hvilke interessenter, virksomheder mv. ministeriet har været i dialog med i forbindelse med ønsket om at indføre et forbud imod anvendelsen af PFAS, til miljøministeren, kopi til udenrigsministeren

Europaudvalget 2022-23 (2. samling)
EUU Alm.del
Offentligt

Application for derogation from PFAS REACH restriction for use in

membranes that facilitate air and/or sound transmission whilst

providing ingress protection for devices that may be used for

communications

November 2022

EUU, Alm.del - 2022-23 (2. samling) - Supplerende svar på spørgsmål 49: Spm. om, hvilke interessenter, virksomheder mv. ministeriet har været i dialog med i forbindelse med ønsket om at indføre et forbud imod anvendelsen af PFAS, til miljøministeren, kopi til udenrigsministeren

Table of Contents

Acronyms ................................................................................................................... 3

Technical description .................................................................................................. 3

2.1

2.2

2.2.1

2.2.2

2.2.3

Application description ........................................................................................ 3

Properties and function of PFAS in the membrane ............................................... 4

Tortuous microstructure traps dust and debris ............................................................................... 5

Oleophobic surface repels water and fluids..................................................................................... 5

Ingress protection whilst allowing transmission of air and/or sound .............................................. 6

Consumption and emissions of PFAS in the EU ............................................................ 7

3.1

3.2

Consumption of PFAS in smartphones placed on EU market ................................ 7

Emissions of PFAS in waste smartphones disposed to landfill or incineration....... 8

Criticality to functioning of society .................................................................... 11

Availability of alternatives ................................................................................. 11

Substitute materials ....................................................................................................................... 11

Alternative technologies ................................................................................................................ 11

Essential Use Assessment ......................................................................................... 10

4.1

4.2

4.2.1

4.2.2

Development of possible substitutes......................................................................... 13

5.1

5.2

Actions taken to develop alternative technologies or substitute materials ........ 13

Stages and timeframes needed to establish possible substitute materials ......... 14

6. Request for derogation for use of PFAS in membranes that facilitate air and/or sound

transmission whilst providing ingress protection for devices that may be used for

communications .............................................................................................................. 14

Annex: Verification statement from Fraunhofer IZM........................................................ 16

1. Acronyms

EoL

ePTFE

PFAS

REACH

End of life

Expanded polytetrafluoroethylene

Polyfluoroalkyl substances

Regulation (EC) No 1907/2006

2. Technical description

2.1

Application description

In today’s society, the general public in Europe rely on their smartphones and headphones

to continue to provide two-way communications in an emergency. In the future, society

may come to rely on other devices for communications.

This derogation application is based on smartphones because these are the main devices on

the market today that consumers currently rely on for communications. The European

Chemicals Industry (CEFIC) case study

highlights that all types of communication devices

need protection from dust and water ingress so that life-saving information can reach its

recipient during an accident or emergency. Therefore, this derogation application is also

applicable to headphones and other devices that consumers may come to rely on for

communications in the future.

The acoustic paths of microphones and speakers in a smartphone are open to the external

environment and this exposes the microphones and speakers to risk of contamination by

dirt, debris, dust, water and other liquids. Smartphones use vents to equalise the air

pressure and to protect the microphones and the speakers from damage by water and

contaminants while enabling transmission of air and/or sound, Figure 1. Without effective

protection against these elements, the smartphone will fail.

As electronic devices operate, they generate heat which can cause internal temperatures to

increase and therefore pressure to build up inside the housing. Internal pressure can also

change rapidly if the device is exposed to sudden changes in external temperatures or

altitudes. The acoustic paths for microphones and speakers can be constructed to provide

some protection against large debris, however all smartphones need vents to protect

against dust, water and other liquids and to allow atmospheric pressure to equalize on both

sides of the microphones and speakers. Without such pressure equalising vents, the

difference in pressure across the microphone and speaker will create transducer bias

which degrades the microphone and speaker performance such that the sound becomes

unintelligible.

https://www.fpp4eu.eu/case-studies/pfas-protects-communication-devices-from-dust-and-water/

Transducer bias is distortion of the pressure-sensitive diaphragm which is located inside the transducer of the

microphone or speaker

Figure 1: Vent for air and/or sound transmission in a typical smartphone

The front cavity is a gap in the smartphone housing that leads to the microphone or

speaker. Typically, the front cavity gap for a microphone is 1 mm diameter or less.

2.2

Properties and function of PFAS in the membrane

The membranes which are used in these vents for air and/or sound transmission are

typically engineered from expanded polytetrafluoroethylene (ePTFE), a material with a

unique structure that optimizes vent performance and device reliability.

ePTFE is a PFAS.

The ePTFE material is engineered to produce a very thin and low-mass membrane with

mechanical properties and porous microstructure that enable optimal transmission of air

and/or sound.

ePTFE membranes can enable sound transmission in two different ways. In some cases, the

membrane vibrates easily and quickly in response to sound waves, converting their airborne

energy to mechanical vibrations. These vibrations are reproduced on the other side of the

membrane to create high-quality acoustics. In other cases, the microstructure is permeable

enough to allow direct transmission of the sound waves through the membrane’s porosity.

The optimal transmission properties of ePTFE also enable the vent structure to rapidly

equalize pressure changes, protecting sensitive electronics against condensation and

minimizing stress on device seals.

Vents

for air and/or sound transmission

for smartphones have a diameter of about 4 mm

(with an inner diameter of 1.6mm) and the thickness of the ePTFE membrane is about 0.007

mm. The typical density of ePTFE in smartphone vents is about 0.4 gm / cm

and so the

weight of ePTFE in a vent is about 0.035 mg.

Although the ePTFE membrane is very thin, the

PFAS has two essential properties which

enable it to

repel water effectively and provide ingress protection. The microstructure of the

membrane provides effective protection against dust particles and the oleophobic treated

surface

effectively repels oils, sweat, cleaning solutions and other

common fluids that can

threaten device reliability.

2.2.1

Tortuous microstructure traps dust and debris

PTFE, a polymerized tetrafluoroethylene known for its chemical inertness, high thermal

stability, low coefficient of friction and other distinctive properties, can be stretched rapidly

to create a strong microporous material known as expanded PTFE, or ePTFE. The ePTFE

structure consists of nodes, fibrils and pores, Figure 2. This structure facilitates the

transmission of air and sound, while effectively repelling water, other fluids and

particulates.

Figure 2. Complex, three-dimensional microstructure in ePTFE membrane

ePTFE membranes for vents for air and/or sound transmission have a complex, three-

dimensional microstructure which provides a tortuous path through the material. This

complex, tortuous path traps very small particles with great efficiency.

2.2.2

Oleophobic surface repels water and fluids

ePTFE is naturally hydrophobic and has a surface energy of 21 dynes per centimeter

(dyn/cm)

. This allows it to easily repel fluids with surface tensions above 40 dyn/ cm, such

as water (72 dyn/cm) and coffee (40 dyn/cm), Table 2.

The ePTFE membrane may be further treated with additional fluoropolymer (which is also a

PFAS) to make it even more hydrophobic, to create a material which is sometimes called

‘super hydrophobic’ or ‘oleophobic.’ Oleophobic treated ePTFE has a reduced surface

energy and can effectively repel fluids with very low surface tensions. For example, the

surface tension of household cleaners ranges from 27–32 dyn/cm, and the surface tension

http://www.accudynetest.com/polymer_surface_data/ptfe.pdf

of isopropanol is 22 dyn/cm, Table 2. In addition to reducing the ingress of liquids, the

oleophobic properties of treated ePTFE reduces the wettability of the acoustic vent

membrane, so that liquids do not remain on the membrane and degrade acoustic

performance.

Table 1. Surface tensions of some typical fluids

Fluid

Water

10% Methyl Alcohol in Water

Castor Oil

Benzene

Ethyl Alcohol

Acetone

Methanol

Isopropanol

Source: https://acct.chemnetbase.com

Surface Tension (dynes/cm)

2.2.3

Ingress protection whilst allowing transmission of air and/or sound

Table 1 illustrates the ingress protection rating system and format of

the

international

standard

IEC/EN 60529 which classifies the degree of protection provided by mechanical

casings and

electrical enclosures

against intrusion of debris,

dust

and

water.

The first digit

indicates the level of protection provided against ingress of solid foreign objects such as

debris and dust particles. The second digit indicates the level of protection provided against

harmful ingress of water.

Table 2. Ingress Protection Rating format: IP X Y

Protection Against Foreign Solid Object (X)

No protection

Solid foreign objects (≥ 50 mm in diameter)

Solid foreign objects (≥ 12.5 mm in diameter)

Solid foreign objects (≥ 2.5 mm in diameter)

Solid foreign objects (≥ 1.0 mm in diameter)

Protection Against Liquid (Y)

No protection

Drops of water or condensation falling

vertically on an enclosure

Water sprayed at an angle up to 15° on

either side of vertical

Water sprayed at an angle up to 60° on

either side of vertical

Water splashed against the enclosure from

any direction

Dust entry is limited so that operation of the

apparatus or safety is not compromised

No dust particulates enter the enclosure

Water projected in low-pressure jets against

the enclosure from any direction

Water projected in high-pressure jets against

the enclosure from any direction

Temporary immersion in up to 1 meter of

water for 30 minutes

Continuous immersion in more than 1 meter

of water under manufacturer conditions

Steam directed at a high pressure against the

enclosure from any direction

Source: International standard

IEC 60529 “Degrees of protection provided by enclosures”

90% of smartphones placed on the market in the EU are equipped with ePTFE membrane

vents and thus achieve an ingress protection rating according to IP 67 or IP 68. IP 68 means

that the smartphone provides protection against foreign sold objects up to level 6 “No

dust

particulates enter the enclosure” and protection against liquid ingress up to level 8

“Continuous

immersion in more than 1 meter of water under manufacturer conditions”.

The 10% of smartphones that do not use ePTFE membrane vents are lower specification

models that have open apertures, where there is no protection between the

speaker/microphone and the environment.

3. Consumption and emissions of PFAS in the EU

3.1

Consumption of PFAS in smartphones placed on EU market

In 2021, the total number of new smartphones sold in the EU was 94 million and the

number of refurbished smartphones imported into the EU was 8 million, resulting in 102

million smartphones being placed on the market, Figure 3. 90% of these smartphones use

ePTFE membranes to achieve IP67 or IP68 ingress protection ratings. The remaining 10% of

smartphones are lower specification models that do not include ingress protection and

therefore do not contain ePTFE membranes. This application for a derogation from the

REACH restriction of PFAS for use in membranes is needed by all smartphone manufacturers

that achieve IP67 or IP68 ingress protection ratings for their devices.

A typical smartphone has four microphones (two at the bottom of the phone, one at the top

of the phone and one on the back of the phone to assist with video recording) and two

speakers (one at the bottom of the phone and one at the top of the phone). Therefore, the

total amount of ePTFE in a typical smartphone is about 0.2 mg which results in an estimated

total annual weight of ePFTE in smartphones placed on the market in the EU of 19 kg per

year.

Figure 3. Smart phones placed on the EU market and collected for reuse and recycling in 2021, all manufacturers

Source: Refurbished Smartphone Market Update, 2021, Counterpoint, March 2022,

https://www.counterpointresearch.com/devices/smartphones/

3.2

Emissions of PFAS in waste smartphones disposed to landfill or incineration

In 2021, about 70 million smartphones were collected for recycling and reuse in the EU as

follows, Figure 3:

•

34 million were exported for reuse as-is

•

12 million were sold for reuse as-is in the EU

•

15 million were refurbished in the EU and sold for reuse in the EU

•

2 million were refurbished in the EU and exported for reuse

•

7 million were repaired or recycled in the EU

The 70 million smartphones that were collected for recycling and reuse in 2021 in the EU

represent over 69% of the 102 million smartphones that were placed on the market in the

EU in 2021. However, that does not mean that 32 million old smartphones were disposed of

to landfill or incineration in 2021.

In 2019, the Royal Society of Chemistry commissioned an Ipsos MORI survey of 2,353 people

in the UK which found that 23% of households have an unused mobile phone and 69% of

households intend to store these unused phones as spare devices

In view of this survey data, we conservatively estimate that less than 50% of these 32 million

old smartphones (that were not collected for recycling and reuse in 2021) were disposed of

to landfill or incineration, Figure 5. Therefore, we estimate that 3 kg of ePTFE is disposed to

landfill or incineration in the EU in waste smartphones each year.

PTFE emissions from controlled landfills in the EU

Since 2016, most European countries have introduced restrictions on landfilling waste which

have generally been implemented in Member States as bans on landfilling specific waste

streams such as plastic, textiles and carpet wastes, and these wastes are increasingly

incinerated. Furthermore, the revised Waste Framework Directive has set a target for

reducing the amount of municipal waste sent to landfills of 10% of total waste by 2035. In

landfill conditions

mechanical breakdown can cause PFAS to detach and become mobile.

PTFE decomposition during controlled incineration in the EU

PTFE gradually starts decomposing at around 260 °C followed by a rapid decomposition

above 400 °C

. The degradation products depend on the incineration conditions.

Recent research

has found that municipal incineration of PTFE does not generate

significant amounts of other PFAS substances and instead mainly results in emissions of

hydrofluoric acid and carbon dioxide. Hydrofluoric acid can be removed from municipal

incinerator flue gas and neutralized

Pyrometallurgical treatment in one of the EU’s copper smelters, for example Aurubis

(Germany), Boliden (Sweden), or Umicore (Belgium), operates at higher temperatures of

between 900 and 1,500 °C. These smelters are equipped with state-of-the-art flue gas

cleaning technologies which destroy any residual emissions.

https://www.rsc.org/new-perspectives/sustainability/elements-in-danger/#surveyfindings

Conesa et al. (2001): “Polytetrafluoroethylene decomposition in air and nitrogen”, Polymer Engineering and

Science 41 (12), S. 2137–2147. DOI: 10.1002/pen.10908.

Aleksandrov et al. (2019): “Waste incineration of Polytetrafluoroethylene (PTFE) to evaluate potential

formation of per- and Poly-Fluorinated Alkyl Substances (PFAS) in flue gas”.

https://www.sciencedirect.com/science/article/pii/S0045653519306435.

Chen et al. (2019): “Performance analysis of an online lime separation system in a refuse incineration plant.”

https://www.sciencedirect.com/science/article/pii/S0032591019311556

Emissions from PTFE in waste treatment outside the EU

As highlighted in Figure 3, some of the smartphones that are placed on the EU market are

exported for reuse outside the EU. This includes exports to developing countries which may

not operate controlled landfills or controlled incineration to the same performance levels

that are required in the EU. When these devices reach their end of life, they may be treated

in uncontrolled landfill or incineration processes which can give rise to higher emission

levels of PFAS and other decomposition products than would be the case if these devices

were disposed to landfill or incineration in the EU.

4. Essential Use Assessment

As part of the Chemicals Strategy for Sustainability published October 2020, the European

Commission will “define

criteria for essential uses to ensure that the most harmful chemicals are only allowed

if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives

that are acceptable from the standpoint of environment and health. These criteria will guide the application of

essential uses in all relevant EU legislation for both generic and specific risk assessments.”

Figure 4. Essential Use Concept in Chemicals Strategy for Sustainability

Use of PFAS in membranes that facilitate air and/or sound transmission whilst providing

ingress protection for devices that may be used for communications, meets these criteria

for essential use.

4.1

Criticality to functioning of society

In 2020, 472 million people in Europe (86% of the population) subscribed to mobile

services

. In today’s society, the general public in Europe rely on their smartphones to

provide effective two-way communication in an emergency. The European Chemicals

Industry (CEFIC) case study

highlights that all types of communication devices need

protection from dust and water ingress so that life-saving information can reach its recipient

during an accident or emergency. Therefore, this use of PFAS is also critical to the

functioning of society for headphones and other devices that consumers may come to rely

on for communications in the future.

In September 2022, the European Commission published draft EcoDesign regulations under

the

Energy-related Products Directive (ErP) 2009/125/EC which will require

mobile phones

and slate tablets to achieve reliability requirements which include protection from dust and

water ingress

. The new regulations are expected to be signed into law in early 2023 and

the reliability requirements will come into force 12 months later in 2024

. Headphones and

other devices for communications may also be required to meet similar reliability

requirements in the future. These EcoDesign regulations further underline that ingress

protection for devices that may be used for communications is critical to the functioning of

society.

4.2

Availability of alternatives

The availability assessment of alternatives includes

•

Potential substitute materials for use in membranes, which could provide similar

properties and functions to ePTFE

•

Alternative technologies which could potentially eliminate the need for membranes

4.2.1

Substitute materials

At present, there are no available substitute materials that could replace ePTFE in

membranes and provide the unique air permeability, acoustic properties and

chemical/water resistance that is required for vents that facilitate air and/or sound

transmission whilst providing ingress protection.

4.2.2

Alternative technologies

Open apertures

About 10% of smartphones on the market today are lower specification models that have

open apertures, where there is no protection between the speaker/microphone and the

https://www.gsma.com/mobileeconomy/europe/

https://www.fpp4eu.eu/case-studies/pfas-protects-communication-devices-from-dust-and-water/

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12797-Designing-mobile-phones-and-

tablets-to-be-sustainable-ecodesign_en

https://www.izm.fraunhofer.de/en/news_events/tech_news/eu-regulations-set-to-make-smartphones-and-

tablets-more-sustainable.html

environment. Such open apertures provide unimpeded sound, but provide no protection

from dust, liquids or immersion — hazards that nearly all

smartphones will

encounter.

Designs with open apertures are highly susceptible to component failures, decreased device

life and consumer perceptions of poor quality.

These phones could be protected from water and dust particles by placing them in plastic

containers, however they are of limited use in many emergency situations. When the

phone is taken out of the container for use during storm weather and heavy rains, the

phone will become wet and will cease to function. In case of a construction site or other

location with high levels of dust, the particulates will penetrate to the microphones and

loudspeakers and the phone will also cease to function.

As mentioned in section 4.1, from 2024 all

mobile phones and slate tablets placed on the

market in the EU will be required to achieve reliability requirements which include

protection from dust and water ingress. Smartphones with open apertures may not be able

to meet these new regulatory requirements.

Sealed housings

Sealed housings can protect electronic devices by providing a barrier against water or dust,

for example by using non-porous covers such as urethane, silicone or PEEK can be used to

cover apertures. However, these materials do not breathe to allow pressure equalisation.

As electronic devices operate, they generate heat, which can cause internal temperatures to

increase and therefore pressure to build up inside the housing. Internal pressure can also

change rapidly if the device is exposed to sudden changes in external temperatures or

altitudes. These internal pressure changes put significant stress on the housing seals. Over

time this leads to failed seals, which then allow water and contaminants to enter the device.

When external pressure in the front cavity builds (due to operation of the phone, the

external temperature or altitude changes), the pressure on the compliant surfaces of the

microphone transducer and speaker transducer increases. This pressure creates transducer

bias that can significantly degrade microphone and speaker performance such that the

sound becomes unintelligible. As a result, sealed housings are not a viable option.

Woven mesh covers

Woven mesh covers offer a partial solution, in that they can protect an aperture from liquid

splash, spray or rain. Mesh covers are available in pore sizes ranging from 150 microns

down to 7 microns.

The mesh covers consist of a single-layer grid and spacing pattern with a defined hole size.

Any dust particles smaller than the defined hole size will pass through the screen and

deposit on the transducer, or they will propagate through the device, potentially causing

device failure.

For example, a human hair has a surface area equal to or larger than the

specified pore size of many woven materials, yet it can still pass through the material

because of its shape, Figure 5.

Figure 5. A human hair’s shape enables it to pass through a woven material with an 80 microns pore size

Source:

https://www.gore.com/resources/testing-for-ingress-protection-of-portable-electronic-devices

In contrast to woven mesh covers, ePTFE membranes provide a

three-dimensional tortuous

path structure which allows them to effectively capture particles of varied shapes and sizes,

Figure 6.

Figure 6. Schematic of mesh cover with defined hole size, ePTFE membrane with three-dimensional tortuous path

Source:

https://www.gore.com/products/gore-acoustic-vents

5. Development of possible substitutes

5.1

Actions taken to develop alternative technologies or substitute materials

At present, there are no available substitute materials or alternative technologies that could

replace ePTFE membranes and provide the unique air permeability, acoustic properties and

chemical/water resistance that are required for vents that facilitate air and/or sound

transmission whilst providing ingress protection. A range of alternative non-PFAS materials

are being investigated to identify possible substitutes that may have suitable properties that

can be further developed. However, these possible substitute materials are many years

away from being available as commercial solutions that are ready for use by industry.

5.2

Stages and timeframes needed to establish possible substitute materials

Smartphone manufacturers are working with their suppliers to investigate whether

alternative non-PFAS polymer vents could be developed which have similar properties. We

estimate it could take at least another three to five years to identify and develop possible

substitute polymer materials. The below Table 3 outlines the individual stages and the

timeframes.

Table 3. Stages and timeframes needed to establish possible substitutes

Stage

Identify and develop suitable alternative materials

Optimise material for specific application

requirements (e.g. ingress protection and acoustic

performance)

Reliability testing of manufactured components

Supply chain development (new production

capabilities and capacity for mass production)

Total

Timeframe

3 - 5 years

1 year

1.5 years

7 – 9 years

The possible substitute materials will need further development to optimise them for

specific application requirements (e.g. ingress protection and acoustic performance). We

estimate that this stage could take about 1 year. The ingress protection and acoustic

properties of these alternative materials will need to be evaluated to ensure that they

provide adequate performance.

The final optimised material will then need to be manufactured into vent components so

that reliability testing can be carried out in assembled smartphones, headphones and other

devices that consumers may come to rely on for communications in the future.

The final stage is supply chain development. This stage focusses on developing and

optimizing new supply chain production capabilities (equipment and process) and

developing supply chain capacity to support development and mass production

requirements.

6. Request for derogation for use of PFAS in membranes that facilitate air

and/or sound transmission whilst providing ingress protection for devices

that may be used for communications

This derogation application is based on smartphones because these are the main devices on

the market today that consumers currently rely on for communications. The European

Chemicals Industry (CEFIC) case study

highlights that all types of communication devices

need protection from dust and water ingress so that life-saving information can reach its

recipient during an accident or emergency. Therefore, this derogation application is also

applicable to headphones and other devices that consumers may come to rely on for

communications in the future.

As highlighted in section 5.2, we estimate that it may take smartphone manufacturers about

nine years to work with their suppliers to establish possible substitutes. These possible

substitutes could potentially be used to provide ingress protection for headphones and

other devices that consumers may come to rely on for communications in the future.

If the proposed REACH restriction of PFAS takes effect in 2025, we estimate that

smartphone manufacturers would need a derogation from this restriction until December

2031 for use of PFAS in membranes that facilitate air and/or sound transmission whilst

providing ingress protection for devices that may be used for communications.

Our proposed draft text for this derogation request is

“use

of PFAS in membranes that facilitate air and/or sound transmission whilst providing

ingress protection for devices that may be used for communications, until December 2031”

As highlighted in section 3.2, we estimate that 3 kg of ePTFE is disposed to landfill or

incineration in the EU in waste smartphones each year. If the proposed REACH restriction of

PFAS takes effect in 2025 and this derogation is permitted until December 2031, we

estimate that this derogation would result in less than 21 kg of additional ePTFE disposed of

to landfill or incineration from waste smartphones.

We believe that this time-limited derogation would be proportionate based on the essential

use of PFAS in membranes in devices that may be used for communications compared to

the very small additional emissions of PFAS from landfill or incineration whilst smartphone

manufacturers establish possible substitutes.

https://www.fpp4eu.eu/case-studies/pfas-protects-communication-devices-from-dust-and-water/

Annex: Verification statement from Fraunhofer IZM