Comments on ECHA’s Draft 9th Recommendation for Tetraethyllead (EC number: 201-075-4) and references to responses

The present document compiles the comments received during the public consultation on the draft 9th recommendation for inclusion of substances in Annex XIV of REACH for Tetraethyllead (EC number: 201-075-4). The public consultation took place between 5 September 2018 and 5 December 2018.

For each of the comments there is also a reference to specific section(s) of a document containing the responses to comments (“Response document”, available at https://echa.europa.eu/documents/10162/13640/9th_recom_respdoc_tetraethyllead_en.pdf). The responses in the Response document are arranged by thematic block and level of information (see more detailed explanations at the beginning of that document).

PUBLIC VERSION

Content
	
I - General comments on the recommendation to include the substance in Annex XIV
II - Transitional arrangements. Comments on the proposed dates
III - Comments on uses that should be exempted from authorisation, including reasons for that

I - General comments on the recommendation to include the substance in Annex XIV
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3287
2018/11/14	Netherlands,
Member State	The Netherlands has taken note of ECHA’s draft recommendation to the European Commission that tetraethyllead (EC 201-075-4, CAS 78-00-2, further: TEL) should be included in Annex XIV of the REACH regulation.
In the draft background document that ECHA made available on its website, it is stated that the main use of TEL in the EU is as an anti-knocking agent in aviation gasoline (avgas). The document further states that “The professional and consumer use of aviation gasoline (volume unknown) appears to be outside the scope of authorisation because the substance is present in the gasoline at concentrations below the specific concentration limit (SCL).”

The Netherlands would like to draw the attention of ECHA to the fact that the most widely used formulation of avgas in civil aviation (Avgas 100LL) has a TEL concentration just above the SCL, at 0.125% w/w. According to the ASTM-specifications that avgas has to meet in order for it to be safely used in piston engines, Avgas 100LL should contain 0.56 g Pb/L, corresponding to a TEL-concentration of 0.84 g/L. With a density of 690-760 g/L of the avgas mixture, it is clear that the TEL concentration in avgas will exceed the SCL.
Avgas 100, which is also still in use for some aircraft, has a TEL-content twice as high as Avgas 100LL, at 0.25% w/w.

It is noted that ECHA bases the draft background document on the registration dossier. The government of the Netherlands is, through the ministry of Defense, also a user of Avgas 100LL and has notified its supplier of the fact that the TEL concentration in avgas is probably incorrectly documented in the CSR, since it leads to the interpretation that concentrations are below the SCL. In any case, it would be appreciated if the draft background document could also describe the possible consequences for the aviation sector in Europe if TEL would be placed on Annex XIV, taking into account that the TEL content in avgas exceeds the SCL.
	A.2.01 Claim that TEL content in aviation fuel could exceed concentration limit	
		
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3308
2018/11/30	Innospec Limited,
Company,
United Kingdom	Volume and Use
Innospec’s UK facility is the sole manufacturer of TEL and formulator of the finished fuel additive containing TEL in the world.  Innospec currently manufacture ca. XXXX  tonnes per annum of the substance at our COMAH 1 facility in the UK.  At the same Innospec site all the manufactured TEL is blended into a fuel additive containing 61.5% wt. TEL and packaged in a dedicated ISO container fleet for shipment worldwide.  TEL is only placed on the market as the formulated fuel additive.

Of the total produced volume, half is exported outside the EU and used solely in the production of motor gasoline in one remaining country and is already subject to phase out in next 1-2 years.

The remainder of TEL use is in the production of aviation gasoline, with only a small amount (ca. 15%) supplied in the EU to only X  fuel refineries/fuel blenders involved in the production of aviation gasoline as used by spark ignition piston engined aircraft.  Therefore, outside the UK production facility, within the EU, use of this substance is significantly lower than indicated in the draft proposal document and is for industrial use only by only a very small number of downstream users.  There is no consumer use or wide dispersive exposure to the substance or the fuel additive formulation containing TEL.

The remainder of the additive formulation volume is directly exported from the Innospec facility to similar fuel refineries and blenders outside the EU for the same aviation gasoline use.

Existing Legislation
The only use of TEL in the EU is as a mandated additive in aviation gasoline (Avgas 100LL as specified by ASTM D910 and UK Def. Stan 91-90 specifications covering aviation gasoline quality in the EU, US and worldwide).

Furthermore, exports of the TEL containing additive outside the EU are subject to, and controlled by, the conditions of the Rotterdam Convention (PIC Regulations).

Within the EU and wider EEA, use of aviation gasoline is regulated by the European Aviation Safety Agency (EASA) which is specifically responsible for the issuance of Type Certificates as required by current EU Regulations, which in particular govern aviation safety.  These Type Certificates, amongst other things, define the fuel each given aircraft type must operate on in order to ensure the legal requirement for continuing airworthiness is met.  Many of these Type Certificates for spark ignition piston engined aircraft mandate the use of high octane aviation gasoline containing TEL to standards ASTM D910 and UK Def Stan 91-090.

EASA can only issue new Type Certificates, Type Certificate Amendments and Supplemental Type Certificates permitting aircraft to operate on a new fuel once any alternate fuel has been demonstrated not to compromise flight safety.  In order to meet this requirement, a fuel without TEL with a broad fleet-wide application intended to completely replace the current fuels containing TEL, would be required to undergo a considerable amount of technical work if flight safety is to be assured in the large number of aircraft and engine combinations in the legacy fleet.

As such, the use of TEL should be considered as exempt from this process under Article 58 (2) as sufficient existing legislation is already in place covering the use of TEL in aviation gasoline production and use of aviation gasoline.

Alternate Technology
There is an essential social need for the continued, uninterrupted use of the GA fleet.  This requires the continued availability of a high octane gasoline fuel which meets international performance and safety standards.  For such a fuel, TEL is currently the only approved and mandated octane additive permitted.

EASA has taken the position that they will observe and follow the US Piston Fuel Aviation Program (PAFI) which is conducting efforts to develop an alternative to TEL.  PAFI was formed in response to the US Environmental Agency (EPA) request to reduce, or eliminate, TEL additives in aviation gasoline fuels and it is the principle worldwide program working towards the safe elimination of TEL in aviation fuels. PAFI represents a multi-industry stakeholder project funded by the US government, managed and overseen by the Federal Aviation Administration (FAA) with the specific aim to test and subsequently approve unleaded aviation gasolines for fleet-wide application in spark ignition, piston-engine aircraft.  This program is not due to complete the technical evaluation of all potential options until mid-2020 so it will be at least 3-4 years before an alternate fuel without TEL may be available commercially and EASA will be in a position to consider issuing Type Certificate Amendments approving its legal use in aircraft within the EU.

Summary
In conclusion, due to a) the limited volumes and users of TEL (significantly lower than indicated in the draft proposal document), b) the non consumer/wide dispersive use of the substance, c) other existing legislation controlling the supply and use of TEL in aviation gasoline and d) an ongoing multi-stakeholder program to develop unleaded alternatives which is well-founded and well-advanced, we do not see the authorisation listing of tetraethyl lead as a priority for further regulatory action at this time.

Without an alternative fuel that has been fully tested and approved, the GA aircraft fleet will be potentially grounded if Innospec are not able to manufacture/formulate this substance and our downstream users were unable to produce aviation gasoline with incalculable damage to the downstream industries, and huge competitive disadvantage to the EU.	A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.2.02 Request to re-consider the volume score due to export  outside the EU
B.1.1.3. ECHA's proposal for latest application dates
B.1.2.2. Lack of alternatives, socio-economic aspects
C.2.01 Exemption request based on TEL use in aviation fuel below concentration limit
C.2.02 Request for exemption similar to motor fuels (Art. 56(4) of REACH)
C.2.03 Claim that substance is well controlled and mandated by international fuel specifications (e.g. ASTM D910, UK Def. Stan 91-90)
C.2.04 Claim that import/export of TEL containing additive from/to outside the EU is  regulated by Rotterdam Convention (PIC regulation 649/2012)
C.2.05 EU regulation on civil aviation and establishing EASA (EU 2018/1139)
Thank you for the information provided	
		Attachment: 3308_ECHA authorisation text.pdf

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3320
2018/12/04	Total,
Company,
France	The use of tetraethyllead in aviation is only as additive for the fuels called avgas, European avgas market, which is much smaller than the US avgas market can be roughly estimated to 100-200 kt per year,  is concerning small aircrafts equipped with piston engine for private use and professional use (including pilot training). Around 15 800 aircrafts in EU must use this fuel (more can be found in reports as the General Aviation Manufacturer Association, GAMMA, 2017 report https://gama.aero/wp-content/uploads/GAMA_2017_AnnualReport_ForWeb_0518.pdf).

It is apart from well-known jet A1 used by turbine engine aircrafts.

Now mainly two grades of avgas are available: avgas UL91 unleaded (suited only for some piston engine aircrafts), and 100LL (LL is standing for Low Lead) as lead content has already be lowered. EU market for tetraethyllead can be roughly estimated (0,1% of avgas market) to 100-200t.

For the EU Avgas supply chain there is a limited number of actors, with mainly 4 suppliers, blending the tetraethyllead additive in the fuel. With regards to this antiknock additive there is only one EU based producer,  located in UK, which has achieved the only REACH registration of tetraethyllead. Nevertheless uncertainty linked to the evolution of Brexit has already started to add complexity to the supply chain. In the future tetraethyllead will need to be imported to EU to be used in the avgas formulations.

Leaded avgas is required under two standards: ASTM D 910 and DEFSTAN 91-90 and also required by  Aircrafts operation manual. Avgas is a fuel designed with very specific requirements for aircrafts for safety issues which are aimed  mainly to avoid any engine loss of efficiency or stop during take-off, flight and landing.

In the eventuality of an authorization mainly the industrial operations of blending in  the  production of avgas would be concerned. The production of avgas outside of Europe would not fall under authorization, this could lead to important changes in the supply chain with possible lower industrial hygiene exigence and also possibly  include actors less involved in the substitution process. The possibility to refuel outside of the fences of EEU would be limited due to the low range of these aircrafts.
	A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Potential competitive disadvantage
A.2.04 Uncertainties due to BREXIT
C.2.03 Claim that substance is well controlled and mandated by international fuel specifications (e.g. ASTM D910, UK Def. Stan 91-90)
Thank you for the information provided	
				
3329
2018/12/05	Puma Energy International B.V. ,
Company,
Netherlands	Puma Energy in these comments refers to the Puma Energy Group.  This Group is headed by Puma Energy Holdings Pte. Ltd and Puma Energy International B.V. is a member of the Puma Energy Group.

(1) Priority is not warranted based on the information in the background document

- ECHA has calculated an overall priority score for tetraethyllead ("TEL") of 18.  This score comprises the following scores: a score of 1 for inherent properties, a score of 12 for relevant volumes and a score of 5 for wide dispersiveness of uses.
- ECHA has provisionally recommended a record 18 substances to be included on the Annex XIV priority list.  This is a large number and therefore ECHA should exclude TEL based on its already low priority score (18) and its lack of grouping with other substances (9 proposed substances have a higher score (between 19 and 29); 3 other proposed substances share a score of 18 but they are all grouped with other substances; and 5 remaining substances with lower scores are all grouped with other substances).

(2) The UK's planned exit from the EU is a further consideration against prioritisation for TEL

- As ECHA is well-aware, TEL is only produced by Innospec in the United Kingdom ("UK").  Innospec, in turn, uses TEL to make TEL-based additives for the production of fuel.  The only TEL-based additive practically used further downstream in the EU is the TEL-B additive, which is used by companies to make aviation fuel ("Avgas").
- Because the UK is currently an EU Member State, all of Innospec's volumes used to make TEL additive solutions have been taken into account for the volume aspect of the priority assessment.  However, when the UK leaves the EU internal market, only the volumes of Innospec which relate to the EU-27 market will be relevant for REACH purposes.
- As of the date of submitting these comments on 5 December 2018, it is possible that the UK will leave the internal market on 29 March 2019 (if a withdrawal agreement is not concluded) or this may follow a transition period which would normally be expected to end on 31 December 2020 (if a withdrawal agreement is concluded).
- Currently, volumes are assessed at 1,000-10,000 tons, giving a volume score of 12.  The Puma Energy Group company, AS Alexela Terminal in Estonia, produces Avgas.  Based on Puma Energy's knowledge of its own use of TEL B and the world market for Avgas [certain supporting information submitted on a confidential basis], it is clear that any relevant volumes for the purposes of REACH will be significantly below 1,000 tons once any uses of TEL by Innospec are excluded, i.e. when only the use of TEL by EU-27 Avgas producers is taken into account.  Puma Energy expects that Innospec will confirm this position.
- ECHA should take into account the unique impact of the UK's exit from the EU on the likely use of TEL in the EU as a further consideration against prioritisation of TEL in the current round.  In this regard, Puma Energy notes that it is unlikely that any final decision to include TEL as an Annex XIV substance would be taken for a number of years.  Deferring priority would avoid undue reassessments (and administrative complexity) that would be required if the UK leaves the EU after ECHA makes a recommendation but before the Commission is able to take a final decision.  It would also ensure that a priority decision is based on the normally foreseeable uses on the EU market rather than historical data which is no longer relevant.
	A.2.03 Ask ECHA to exclude TEL from recommendation due to high number of substances included and its relatively low priority
A.2.04 Uncertainties due to BREXIT
Thank you for the information provided	
		
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3330
2018/12/05	Puma Energy International BV,
Company,
Netherlands	Puma Energy in these comments refers to the Puma Energy Group.  This Group is headed by Puma Energy Holdings Pte. Ltd and Puma Energy International B.V. is a member of the Puma Energy Group.

(1) Priority is not warranted based on the information in the background document

- ECHA has calculated an overall priority score for tetraethyllead ("TEL") of 18.  This score comprises the following scores: a score of 1 for inherent properties, a score of 12 for relevant volumes and a score of 5 for wide dispersiveness of uses.
- ECHA has provisionally recommended a record 18 substances to be included on the Annex XIV priority list.  This is a large number and therefore ECHA should exclude TEL based on its already low priority score (18) and its lack of grouping with other substances (9 proposed substances have a higher score (between 19 and 29); 3 other proposed substances share a score of 18 but they are all grouped with other substances; and 5 remaining substances with lower scores are all grouped with other substances).

(2) The UK's planned exit from the EU is a further consideration against prioritisation for TEL

- As ECHA is well-aware, TEL is only produced by Innospec in the United Kingdom ("UK").  Innospec, in turn, uses TEL to make TEL-based additives for the production of fuel.  The only TEL-based additive practically used further downstream in the EU is the TEL-B additive, which is used by companies to make aviation fuel ("Avgas").
- Because the UK is currently an EU Member State, all of Innospec's volumes used to make TEL additive solutions have been taken into account for the volume aspect of the priority assessment.  However, when the UK leaves the EU internal market, only the volumes of Innospec which relate to the EU-27 market will be relevant for REACH purposes.
- As of the date of submitting these comments on 5 December 2018, it is possible that the UK will leave the internal market on 29 March 2019 (if a withdrawal agreement is not concluded) or this may follow a transition period which would normally be expected to end on 31 December 2020 (if a withdrawal agreement is concluded).
- Currently, volumes are assessed at 1,000-10,000 tons, giving a volume score of 12.  The Puma Energy Group company, AS Alexela Terminal in Estonia, produces Avgas.  Based on Puma Energy's knowledge of its own use of TEL B and the world market for Avgas [certain supporting information submitted on a confidential basis], it is clear that any relevant volumes for the purposes of REACH will be significantly below 1,000 tons once any uses of TEL by Innospec are excluded, i.e. when only the use of TEL by EU-27 Avgas producers is taken into account.  Puma Energy expects that Innospec will confirm this position.
- ECHA should take into account the unique impact of the UK's exit from the EU on the likely use of TEL in the EU as a further consideration against prioritisation of TEL in the current round.  In this regard, Puma Energy notes that it is unlikely that any final decision to include TEL as an Annex XIV substance would be taken for a number of years.  Deferring priority would avoid undue reassessments (and administrative complexity) that would be required if the UK leaves the EU after ECHA makes a recommendation but before the Commission is able to take a final decision.  It would also ensure that a priority decision is based on the normally foreseeable uses on the EU market rather than historical data which is no longer relevant.
	A.2.03 Ask ECHA to exclude TEL from recommendation due to high number of substances included and its relatively low priority
A.2.04 Uncertainties due to BREXIT
Thank you for the information provided	
		
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3348
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of tetraethyllead for inclusion in Annex XIV.	Thank you for your opinion.	
				
3364
2018/12/05	Norway,
Member State	In general, the Norwegian REACH CA supports measures that will reduce the use and emission of lead and lead compounds. We consider the prioritisation criteria to be fulfilled and support that tetraethyllead is prioritised for inclusion in Annex XIV.	Thank you for your opinion.	
				
3368
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of tetraethyllead for inclusion in Annex XIV.	Thank you for your opinion.	
				
3404
2018/12/05	BP,
Company,
United Kingdom	Leaded Avgas is produced according to two standards: ASTM D 910 and DEFSTAN 91-90. Avgas is a fuel designed with very specific requirements for aircrafts. This is for safety and is aimed mainly to enhance engine efficiency and avoid stop/failure during take-off, flight and landing.	C.2.03 Claim that substance is well controlled and mandated by international fuel specifications (e.g. ASTM D910, UK Def. Stan 91-90)
Thank you for the information provided	
				
3420
2018/12/05	General Aviation Manufacturers Association (GAMA),
Industry or trade association,
Belgium	Tetraethyl lead (TEL) is an important additive for aviation gasoline  (AVGAS 100LL), which is used by thousands of piston engine general aviation aircraft across Europe. These aircraft are of used in a diversity of roles, some critical to the welfare of European citizens, e.g. medical evacuation, and to the EU economy, e.g. flight training schools for airline pilots. Most of these aircraft operating in Europe today were certified over 40 years ago and installing new engine types and/or re-certifying for different fuel types is not an economically viable proposition.
GAMA recognises and appreciates the need to ensure the safe use of TEL and appropriate measures are needed to protect citizens who handle such chemicals. However, restricting the use of TEL in aviation fuel could have a significant impact on EUropean aviation. Therefore, in accordance with the new provisions of Article 87(2) of Regulation EU 2018/1139, the Basic Regulation of the European Aviation Safety Agency (EASA), GAMA strongly urges ECHA to engage the expert opinion of EASA on impact of implementing any restrictions on the use of TEL in aviation fuel before committing to any restrictions. As defined in this regulation, there is a need to balance the interdependencies between health, aviation safety, environmental and economic impacts as well as technological feasibility of alternatives fuels.
	A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.6. Socio-economic benefits of continued use
C.2.05 EU regulation on civil aviation and establishing EASA (EU 2018/1139)
Thank you for the information provided	
				
3421
2018/12/06	AOPA/EAA/GAMA/IAOPA,
Industry or trade association,
United States		A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.2.01 Claim that TEL content in aviation fuel could exceed concentration limit
C.2.05 EU regulation on civil aviation and establishing EASA (EU 2018/1139)
Thank you for the information provided	
		Attachment: 3421_2018-12-05 AOPA-EAA-GAMA-IAOPA REACH Comments.pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3287
2018/11/14	Netherlands,
Member State	Avgas and aircraft engine producers are actively searching for lead-free alternative fuels for piston engines through the US FAA’s PAFI programme. According to information provided by the FAA, this programme is currently scheduled to deliver conclusions in mid-2020. If the outcome would be that no viable lead-free alternative can be produced for the majority of piston engines, it may be appropriate to introduce a long review period for the use of TEL in avgas.	B.1.2.2. Lack of alternatives, socio-economic aspects
B.1.3.1. Upfront review periods	
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3308
2018/11/30	Innospec Limited,
Company,
United Kingdom	Worldwide there is currently no alternative to Avgas 100LL for the general aviation fleet, or any alternative, certified additive that can perform the same function.  Without TEL and 100LL aviation gasoline the only alternative is to stop these aircraft from flying.

Due to the nature of the aviation gasoline market (ca. 60% of 100LL avgas is used in the US), most research into alternatives is being done in the US.  Due to the worldwide integrated nature of the aviation fuel business, EU and other countries are working with the US and will have to adopt the same alternative solutions.

The major research program into alternate fuels for these aircraft is the US Piston Fuel Aviation Program (PAFI).

https://www.faa.gov/about/initiatives/avgas/

PAFI was formed in response to the US Environmental Agency (EPA) request to reduce, or eliminate, TEL additives in aviation gasoline fuels and it is the principle worldwide program working towards the safe elimination of TEL in aviation fuels. PAFI represents a multi-industry stakeholder project funded by the US government, managed and overseen by the Federal Aviation Administration (FAA) with the specific aim to test and subsequently approve unleaded aviation gasolines for fleet-wide application in spark ignition, piston-engine aircraft.  This program is not due to complete the technical evaluation of all potential options until mid-2020 so it will be at least 3-4 years before an alternate fuel without TEL may be available.

When a suitable alternative is identified, the US program is also looking at the transition process necessary to introduce the new fuel and move away from 100LL avgas.  This transition will include processes for the recertification of all aircraft to run on any new fuel, the changes necessary to produce and supply the new fuel and all necessary specification and legislation changes.  These changes are expected to take a further 2-3 years thereafter in the US.

Within the EU and wider EEA, EASA has taken the position that they will observe and follow the US Piston Fuel Aviation Program (PAFI).  As such it will be at least 3-4 years before an alternate fuel without TEL may be available and EASA will be in a position to consider issuing Type Certificate Amendments approving its legal use in aircraft in the EU.

The phase out of leaded avgas or the non-availability of TEL ahead of this therefore would have catastrophic effects on several industries. Without this substance, there would be no fuel available which will meet aircraft performance specifications that is proven for use in the application which would allow aircraft to fly safely. The premature phase out may lead to the alternative program rushing to bring in any workable alternative.  Among others this would impact emergency service aircraft and agricultural crop spraying aircraft that would be unable to operate safely.

In conclusion, there is an ongoing multi-stakeholder program to develop alternatives to TEL in aviation gasoline, so we do not see the authorisation listing of this substance as a priority for further regulatory action or other transitional arrangements.  We would recommend that ECHA should not list TEL on the authorisation list at this time and reconsider the process when the US PAFI program considering alternatives and any recommended new fuel has been approved so that there is clarity of the phase out timetable of 100LL avgas in both the EU and the rest of the world.	B.1.2.2. Lack of alternatives, socio-economic aspects	
		See the corresponding embedded attachment in table 1 of Part I:
3308_ECHA authorisation text.pdf

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3320
2018/12/04	Total,
Company,
France	European actors have already lower the amount of tetraethyllead in avgas and several initiatives worldwide are aimed to substitute tetraethyllead in avgas. Substitution process includes also change of motorization of existing aircraft, normal fleet replacement (lifespan of concerned aircrafts is of about 30 years, to be compared to 10 years for ground vehicles). Aircraft turnover is limited to few as the replacement cost is very high. For example a typical replacement cost of these aircrafts is 250k€ - 350k€.

Substitution process takes times, moreover technical issues may arise in the numerous technical tests required,  and also full qualification for aircraft under aviation standards is also required.

Due to fleet normal evolution leaded Avgas 100 LL is a decreasing market. Industry is already committed to provide substitution fuel for the concerned existing fleet. Moreover, due to the development of Ultra-Light Motorized engines, which use dedicated unleaded avgas UL91 (and also conventional ground unleaded 98 fuel): for the consumer market, a decrease at a higher rate than for the professional market, is anticipated.
	A.1.5.2. Authorisation is disproportionate and/or means a ban
B.1.2.2. Lack of alternatives, socio-economic aspects	
				
3329
2018/12/05	Puma Energy International B.V. ,
Company,
Netherlands	As discussed above, Puma Energy considers that prioritisation of TEL is not appropriate at this time.  However, should ECHA make a recommendation, the LAD for TEL should be calibrated to maximise the ability to take into account impacts of the UK's exit from the EU and more specifically the nature of the long-term relationship ultimately agreed between the EU and the UK.   The finally determined long-term relationship will have significant impacts on any authorisation process.  Assuming a withdrawal agreement is concluded and there is a transition period from 29 March 2019, at this stage it appears unlikely that there would be any certainty on the nature of a future relationship until at least the latter part of 2020, if not later.  Therefore, if the EU and the UK agree a withdrawal agreement, TEL should be given an especially late LAD of at least 24 months in order to give the greatest opportunity for actors in the TEL supply chain to organise authorisation applications based on actual long-term market circumstances.	A.2.04 Uncertainties due to BREXIT
B.1.1.3. ECHA's proposal for latest application dates
B.1.2.2. Lack of alternatives, socio-economic aspects	
		
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3330
2018/12/05	Puma Energy International BV,
Company,
Netherlands	As discussed above, Puma Energy considers that prioritisation of TEL is not appropriate at this time.  However, should ECHA make a recommendation, the LAD for TEL should be calibrated to maximise the ability to take into account impacts of the UK's exit from the EU and more specifically the nature of the long-term relationship ultimately agreed between the EU and the UK.   The finally determined long-term relationship will have significant impacts on any authorisation process.  Assuming a withdrawal agreement is concluded and there is a transition period from 29 March 2019, at this stage it appears unlikely that there would be any certainty on the nature of a future relationship until at least the latter part of 2020, if not later.  Therefore, if the EU and the UK agree a withdrawal agreement, TEL should be given an especially late LAD of at least 24 months in order to give the greatest opportunity for actors in the TEL supply chain to organise authorisation applications based on actual long-term market circumstances.	A.2.04 Uncertainties due to BREXIT
B.1.1.3. ECHA's proposal for latest application dates
B.1.2.2. Lack of alternatives, socio-economic aspects	
		
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3364
2018/12/05	Norway,
Member State	In general, we are in favour of the shortest LAD slot.	B.1.1.3. ECHA's proposal for latest application dates
Thank you for your opinion.	
				
3403
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	The aerospace sector relies on surveys and encourages affected downstream users to collaborate in authorisation consortia (by joining or contributing) and voluntarily provide relevant data to third party consultants that aggregate the available data.  In the short 18 to 24 month timeframe after substance listing on Annex XIV and the Last Application Date, there is not always sufficient time to encourage enough supply chain actors to develop an accurate and comprehensive application.	B.1.1.3. ECHA's proposal for latest application dates
B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)	
				
3404
2018/12/05	BP,
Company,
United Kingdom	European manufacturers/users have already worked to lower the amount of TEL in Avgas and several initiatives worldwide are aimed to substitute TEL in Avgas. The substitution process also includes change of motorisation of existing aircraft. The normal fleet replacement (lifespan of concerned aircrafts is of about 30 years, to be compared to 10 years for ground vehicles). Aircraft turnover is limited as the replacement costs are very high. For example a typical replacement cost of these aircrafts is €250k - €350k.

The substitution process takes time and technical issues may arise in the numerous technical tests required. Due to fleet normal evolution, leaded Avgas 100 LL is a decreasing market. Industry is already committed to provide substitution fuel for the concerned existing fleet. Moreover, due to the development of Ultra-Light Motorized engines, which use dedicated unleaded avgas UL91 (and also conventional ground unleaded 98 fuel): for the consumer market, a decrease at a higher rate than for the professional market, is anticipated.	A.1.5.2. Authorisation is disproportionate and/or means a ban
B.1.2.2. Lack of alternatives, socio-economic aspects	

III - Comments on uses that should be exempted from authorisation, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3287
2018/11/14	Netherlands,
Member State	The fuel that is allowed to be used in a specific aircraft is prescribed in the airworthiness certificates of aircraft (as part of the type-certificate), which are issued based on EU regulation 216/2008, this could be interpreted as specific EU legislation that addresses the TEL-content in aviation gasoline. Therefore it should be considered whether an exemption for this use based on Article 58(2) needs to be proposed in the final recommendation, taking into account that the TEL-content of the most widely used avgas mixture exceeds the SCL.	C.2.05 EU regulation on civil aviation and establishing EASA (EU 2018/1139)
C.2.06 Aircraft certificates based on EU regulation 216/2008	
		
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3308
2018/11/30	Innospec Limited,
Company,
United Kingdom	The only use of this substance in the EU is as an additive in aviation gasoline.  As the application is mandated for this use in fuel specifications and well controlled, we consider there are sufficient grounds for exemption from inclusion on the authorisation list:

• As well as the extremely restricted number of users of TEL, use of the substance is already well controlled by international fuel specifications (ASTM D910, UK Def. Stan 91-90)

• TEL import/export is controlled by the Prior Informed Consent Regulation (PIC, Regulation (EU) 649/2012).

• Article 56 (4) of REACH provides exemptions to authorisation of motor fuels which are subject to fuel specifications laid down in EU Directives.  Similarly aviation gasoline is subject to equivalent international fuel standards as previously indicated so a similar exemption should apply.

• TEL is added to aviation gasoline in concentrations less than 0.1% w/w, so exemptions indicated in REACH Articles 57 (d), 57 (e), 57 (f) and 56 (6) (a) should be considered.

• The phase out of this substance is already well managed under the FAA-PAFI program, which is developing and approving alternative options.  As soon as this program delivers, the transition over to the new fuels will begin, and the substance will be phased out in a controlled manner, designed to minimize downstream and consumer disruption.

• EASA can only issue new Type Certificates, Type Certificate Amendments and Supplemental Type Certificates permitting aircraft to operate on a fuel without TEL once any alternate fuel has been demonstrated not to compromise flight safety.  In order to meet this requirement, an unleaded fuel with a broad fleet-wide application intended to completely replace the currently ubiquitous leaded fuels, would be required to undergo a considerable amount of technical work if flight safety is to be assured in the large number of aircraft and engine combinations in the legacy fleet.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01 Exemption request based on TEL use in aviation fuel below concentration limit
C.2.02 Request for exemption similar to motor fuels (Art. 56(4) of REACH)
C.2.03 Claim that substance is well controlled and mandated by international fuel specifications (e.g. ASTM D910, UK Def. Stan 91-90)
C.2.04 Claim that import/export of TEL containing additive from/to outside the EU is  regulated by Rotterdam Convention (PIC regulation 649/2012)
C.2.05 EU regulation on civil aviation and establishing EASA (EU 2018/1139)	
		See the corresponding embedded attachment in table 1 of Part I:
3308_ECHA authorisation text.pdf

Confidential attachment removed
		
3320
2018/12/04	Total,
Company,
France	For ground transportation “use as fuel” is exempted from the authorization process in the REACH legal text. As already quoted in the draft recommendation report  for inclusion in the authorization list, “use as fuel” for avgas would not fall under the “authorization” as tetra-ethyl lead content  in avgas, is now around or under 0,1% w/w (mixtures are not concerned by authorization for substances below 0,1% w/w).

Due to the acceptable limits specified in the above quoted standards: 0,56 g/l expressed in  lead content, it is possible that some specific avgas contains up to 0,125% w/w  of tetraethyllead additive (after conversion of lead content expressed in g/l of avgas, to tetraethyllead content in avgas  in w/w, taken into account the density of avgas).

The eventuality of getting avgas with over 0,1% w/w of tetraethyllead should be regarded as the point of concern for Health and Safety in the professional and consumer use. Therefore authorization for consumer and professional use may be difficult to manage, and would address a very small part of the market.

	A.1.5.1. Potential other regulatory actions
A.2.01 Claim that TEL content in aviation fuel could exceed concentration limit
C.2.01 Exemption request based on TEL use in aviation fuel below concentration limit	
				
3321
2018/12/05	Warter Fuels SA,
Company,
Poland	Excluding use as a fuel additive

Product speciﬁcations are a mechanism by which producers and users of a product identify and control the properties necessary for satisfactory and reliable performance.
In the case of fuels, including leaded gasoline, the quality specification is determined by ASTM - American Society of Testing and Materials.
ASTM is made up of many committees. Subcommittee J of Committee D-2 (Petroleum Products and Lubricants) maintains D 910, Standard Speciﬁcation for Aviation Gasolines.
The United Kingdom Ministry of Defence also maintains an AVGAS speciﬁcation: Defence Standard 91-90. Its requirements for the most important properties – knock ratings, distillation proﬁle, and vapor pressure - are identical to those of D 910.
Only additives speciﬁcally approved by the speciﬁcation may be used in AVGAS. The approved additives are identiﬁed by their chemical formulas. For the leaded grades of AVGAS, tetraethyl lead additive and the identifying dye are mandatory; antioxidant, anti-icing, and electrical-conductivity additives are optional.
The most important avgas additive is tetraethyl lead. It is added as part of a mixture that also contains ethylene dibromide and dye. Tetraethyl lead (TEL) is an effective antiknock additive because it interrupts the chain reactions that lead to autoignition. The aviation gasoline is analyzed in terms of the performance number. This is an indicator of the resistance of aviation gasoline to the phenomenon of detonation in spark-ignition engines working on a rich mixture. This parameter allows to determine the percentage of the power developed by the engine. For AVGAS 100LL, the value of the performance number should be at least 130. Due to the need to obtain a performance number on the appropriate HIGH standard ASTM D910 and DEF STAN 91-90, they require the use of TEL additive for the aviation gasoline producers. Tetraethyl Lead, shall be added in the form of an antiknock mixture containing not less than 61 mass percent of tetraethyl lead and sufficient ethylene dibromide to provide two bromide atoms per atom of lead. Ethylene dibromide acts as a scavenger for lead. When avgas is burned in an engine, the lead in tetraethyl lead is converted to lead oxide. Without a scavenger, lead oxide deposits would quickly collect on the valves and spark plugs. If the deposits become thick enough, they can damage the engine. Ethylene dibromide reacts with the lead oxide as it forms and converts it to a mixture of lead bromide and lead oxybromides. Because these compounds are volatile, they are exhausted from the engine along with the rest of the combustion products. Just enough ethylene dibromide is added to react with all of the lead.
The standards also specify an acceptable minimum and maximum content of lead, i.e. from 0.28 to 0.56 g/liter. Historically, market survey and test engine data have indicated that for Avgas 100LL, tetraethyl lead concentration typically must exceed 0,28 g lead per liter. Fuels containing substantially less lead may not satisfy the octane requirements.
The above standards also impose on the manufacturer the obligation to control and report the content of lead in fuel, referring to other standards strictly specifying the method of testing the content of lead in fuel. [1,2,5]
An unleaded fuel that would satisfy the most critical piston engines in the existing aircraft ﬂeet would need the same antiknock performance as Grade 100LL.  Scientists are working to develop such a fuel. However, the challenge is daunting because the antiknock properties of tetraethyl lead are truly unique.
Other metal-organic substances that improve the anti-knock properties of the fuel are known, e.g. TML, MMT, ferrocene, iron pentacarbonyl, nickel carbonyl, tetraethyl tin. These compounds, however, are more toxic, more expensive to produce and they generate harmful secondary effects as a result of wear. [3,4,5]
Research aimed at removing TEL-B from use as a aviation fuel additieve has been carried out for 20 years, however, no substance has been found to replace it. A huge number of aircrafts powered with leaded fuel are still used and they probably will be used for a long time. Therefore, the lead-free replacement should be compatible with these existing aircraft.

1.      DEF-STAN-91-090 › Gasoline Aviation: Grades UL91, 100/130 and 100/130LL Joint Service Designation: AVGAS 100 and AVGAS 100LL, Issue 4, Oct. 30, 2015
2.      ASTM International, Designation: D910 – 17a, Standard Specification for Leaded Aviation Gasolines
3.      J.C. Guibet, „Fuels and Engines”, Volume 1 and Volume 2, Editions TECHNIP, France, Paris 1999
4.      Edited by Barbara Elvers, Handbook of Fuels, Energy Sources for Transportation,WILEY-VCH Verlag GmbH&Co. KGaA, Germany, Weinheim 2008
5.      Surinder Parkash, PH.D. „Petroleum Fuels Manufacturing”, McGraw-Hill Companies, USA 2010
6.      https://www.faa.gov/
	A.1.5.2. Authorisation is disproportionate and/or means a ban
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.03 Claim that substance is well controlled and mandated by international fuel specifications (e.g. ASTM D910, UK Def. Stan 91-90)	
				
3322
2018/12/05	THETA Doradztwo Technicze Tomasz Gendek,
Company,
Poland	excluding use as a fuel additive

1. Product speciﬁcations are a mechanism by which producers and users of a product identify and control the properties necessary for satisfactory and reliable performance.
In the case of fuels, including leaded gasoline, the quality specification is determined by ASTM - American Society of Testing and Materials.
ASTM is made up of many committees. Subcommittee J of Committee D-2 (Petroleum Products and Lubricants) maintains D 910, Standard Speciﬁcation for Aviation Gasolines.
The United Kingdom Ministry of Defence also maintains an AVGAS speciﬁcation: Defence Standard 91-90. Its requirements for the most important properties – knock ratings, distillation proﬁle, and vapor pressure - are identical to those of D 910.
Only additives speciﬁcally approved by the speciﬁcation may be used in AVGAS. The approved additives are identiﬁed by their chemical formulas. For the leaded grades of AVGAS, tetraethyl lead additive and the identifying dye are mandatory; antioxidant, anti-icing, and electrical-conductivity additives are optional.
The most important avgas additive is tetraethyl lead. It is added as part of a mixture that also contains ethylene dibromide and dye. Tetraethyl lead (TEL) is an effective antiknock additive because it interrupts the chain reactions that lead to autoignition. The aviation gasoline is analyzed in terms of the performance number. This is an indicator of the resistance of aviation gasoline to the phenomenon of detonation in spark-ignition engines working on a rich mixture. This parameter allows to determine the percentage of the power developed by the engine. For AVGAS 100LL, the value of the performance number should be at least 130. Due to the need to obtain a performance number on the appropriate HIGH standard ASTM D910 and DEF STAN 91-90, they require the use of TEL additive for the aviation gasoline producers. Tetraethyl Lead, shall be added in the form of an antiknock mixture containing not less than 61 mass percent of tetraethyl lead and sufficient ethylene dibromide to provide two bromide atoms per atom of lead. Ethylene dibromide acts as a scavenger for lead. When avgas is burned in an engine, the lead in tetraethyl lead is converted to lead oxide. Without a scavenger, lead oxide deposits would quickly collect on the valves and spark plugs. If the deposits become thick enough, they can damage the engine. Ethylene dibromide reacts with the lead oxide as it forms and converts it to a mixture of lead bromide and lead oxybromides. Because these compounds are volatile, they are exhausted from the engine along with the rest of the combustion products. Just enough ethylene dibromide is added to react with all of the lead.
The standards also specify an acceptable minimum and maximum content of lead, i.e. from 0.28 to 0.56 g/liter. Historically, market survey and test engine data have indicated that for Avgas 100LL, tetraethyl lead concentration typically must exceed 0,28 g lead per liter. Fuels containing substantially less lead may not satisfy the octane requirements.
The above standards also impose on the manufacturer the obligation to control and report the content of lead in fuel, referring to other standards strictly specifying the method of testing the content of lead in fuel. [1,2,5]
An unleaded fuel that would satisfy the most critical piston engines in the existing aircraft ﬂeet would need the same antiknock performance as Grade 100LL.  Scientists are working to develop such a fuel. However, the challenge is daunting because the antiknock properties of tetraethyl lead are truly unique.
Other metal-organic substances that improve the anti-knock properties of the fuel are known, e.g. TML, MMT, ferrocene, iron pentacarbonyl, nickel carbonyl, tetraethyl tin. These compounds, however, are more toxic, more expensive to produce and they generate harmful secondary effects as a result of wear. [3,4,5]
Research aimed at removing TEL-B from use as a aviation fuel additieve has been carried out for 20 years, however, no substance has been found to replace it. A huge number of aircrafts powered with leaded fuel are still used and they probably will be used for a long time. Therefore, the lead-free replacement should be compatible with these existing aircraft.

1.      DEF-STAN-91-090 › Gasoline Aviation: Grades UL91, 100/130 and 100/130LL Joint Service Designation: AVGAS 100 and AVGAS 100LL, Issue 4, Oct. 30, 2015
2.      ASTM International, Designation: D910 – 17a, Standard Specification for Leaded Aviation Gasolines
3.      J.C. Guibet, „Fuels and Engines”, Volume 1 and Volume 2, Editions TECHNIP, France, Paris 1999
4.      Edited by Barbara Elvers, Handbook of Fuels, Energy Sources for Transportation,WILEY-VCH Verlag GmbH&Co. KGaA, Germany, Weinheim 2008
5.      Surinder Parkash, PH.D. „Petroleum Fuels Manufacturing”, McGraw-Hill Companies, USA 2010
6.      https://www.faa.gov/

2. Fuels are exempted from authorities so it is a reason to exclude additive too.	A.1.5.2. Authorisation is disproportionate and/or means a ban
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.03 Claim that substance is well controlled and mandated by international fuel specifications (e.g. ASTM D910, UK Def. Stan 91-90)	
				
3364
2018/12/05	Norway,
Member State	Norway does not support that any exemptions from the authorisation requirement should be proposed.	Thank you for your opinion.	
				
3404
2018/12/05	BP,
Company,
United Kingdom	Due to the acceptable limits specified in the above quoted standards: 0.56 g/L expressed in  lead content, it is possible that some specific Avgas contains up to 0.125% w/w  of tetraethyllead additive (after conversion of lead content expressed in g/L of Avgas, to tetraethyllead content in Avgas in w/w, taking into account the density of Avgas). A restriction on the use of TEL (with an exemption for use in aviation fuel) may be a more appropriate risk management measure. A restriction would allow the development of a suitable alternative that would meet all the appropriate specification. This would be more effective than working against a timescale set by authorisation and expediating additives/chemicals which then prove to fail. We would recommend a restriction (with exemption of up to 0.56 g Pb/L in aviation fuels) as a more appropriate risk management measure.	A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban