Comments on ECHA’s Draft 9th Recommendation for Dechlorane Plus (EC number: -) 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 Dechlorane Plus (EC number: -). 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_dechlorane_plus_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	
3286
2018/11/06	ADAMA Agriculture B.V.,
Company,
Netherlands	Concerning intrinsic substance properties, ADAMA Agriculture B.V. does not agree to the outcome of the weight-of-evidence approach performed by member state UK and the resulting evaluation of Dechlorane Plus as a vPvB substance as already indicated in previous consultations (SVHC listing).

The annual tonnage for registered uses of Dechlorane Plus in the EU is not above 300 t/a; the assumption from authorities considering tonnage bands of 1000 t/a is far away from the reality. In its function as a flame retardant, Dechlorane Plus can be (and has been) used as an alternative for DecaBDE (CAS 1163-19-5, EC 214-604-9), corresponding brominated/halogenated flame retardants and other substances already listed as SVHC or in annex 14. Furthermore, it has to be stressed that a certain degree of persistence is required for a substance to work effectively as a flame retardant on a long-term basis in safety-critical applications e.g. from the aviation or automotive sectors.

According to our knowledge there is no alternative known which could replace Dechlorane Plus in these uses with equivalent effectiveness and broadness of applicability concerning polymer base materials (see also performance comparison table on https://www.flameretardants-online.com/flame-retardants/performance-comparison ).
	A.1.1.5. New information and next steps towards the final recommendation
A.1.2.1. Volume in the scope of authorisation
A.1.5.5. Availability of suitable alternatives
A.2.02. Not agreeing with hazard assessment of Dechlorane Plus
A.2.03. Not agreeing with the use of the tonnage band (volume is 300, given tonnage band 1000)
A.2.04. Alternative to DecaBDE	
				
3312
2018/12/04	IMPAG AG,
Company,
Switzerland	The product was only 6 months on the candidate list before recommendation to add it to Annex XIV. In such a short timeframe, the suppliers and customers don’t have time to setup and clarify the bioaccumulation of the product.

As far as we know, Pyrovex SG / Dechlorane Plus is mixed in with other products in a closed system (contact of employees with the actual chemical is minimized), with facilities having proper containment equipment. The product is mixed with other chemicals and is not intentionally released.

It’s our understanding that a product must be extremely dangerous and exposure to the chemical must be widespread for it to be prioritized. Both of these conditions are not met in our opinion.

Products with excellent fire retardant properties are always needed. If it will be added to Annex XIV, jobs and money my get lost in the EU, transfered to the outside and re-imported to the EU.	A.1.1.2. Legal basis for prioritisation
A.1.1.5. New information and next steps towards the final recommendation
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.3.1. Scope of the assessment of wide-dispersiveness of uses
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Potential competitive disadvantage
A.2.01. Short time between CL listing and recommendation
A.2.02. Not agreeing with hazard assessment of Dechlorane Plus	
		
Confidential attachment removed
		
3324
2018/12/05	Huber+Suhner AG,
Company,
Switzerland		A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use	
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3332
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of Dechlorane Plus for inclusion in Annex XIV.	Thank you for your opinion.	
				
3354
2018/12/05	Norway,
Member State	The Norwegian CA supports the prioritisation of Dechlorane Plus for inclusion in Annex XIV according to Article 57 (e) for vPvB properties. We consider the prioritisation criteria to be fulfilled.
The uses of Dechlorane Plus are mainly as a flame retardant in various polymer plastics, such as nylon, polyurethane, polypropylene, neoprene, silicone rubber, TPU and TPE. The materials may be used in electrical cables and wires, cars, roofing materials and hard plastic connectors. This widespread use is likely to lead to both consumer and environmental exposure. Dechlorane Plus has also been marketed as replacement for decaBDE.
The EU tonnage seems to be lower than may be expected from the environmental presence of Dechlorane Plus, which is noted to be present in many environmental matrixes. In recently published results from the Norwegian monitoring programme Environmental pollutants in the terrestrial and urban environment (http://www.miljodirektoratet.no/Documents/publikasjoner/M1076/M1076.pdf), Dechlorane Plus was present in all samples analysed, including air, soil, earthworms, eggs from several bird species and liver from several mammals. In the monitoring programme Environmental Contaminants in an Urban Fjord (http://www.miljodirektoratet.no/Documents/publikasjoner/M1131/M1131.pdf), Dechlorane plus was the dominant contaminants in eggs from Herring gulls and was also found in high concentrations in eggs from eider ducks. Dechlorane Plus has also been demonstrated to be able to undergo long range transport, possibly adsorbed to particulates in air. A recently published air-monitoring report ( http://www.miljodirektoratet.no/Documents/publikasjoner/M1062/M1062.pdf) shows that Dechlorane Plus is found in air samples of remote arctic mountain air, Zeppelin station, although the obtained concentrations for Dechlorane Plus was close to the analytical limit of detection. However, Dechlorane Plus was detected in all samples of Arctic biota in a recent monitoring campaign (http://www.miljødirektoratet.no/Documents/publikasjoner/M1080/M1080.pdf). Without substantial local sources, these findings clearly show that Dechlorane Plus are subject to long-range transport and emphasise again the importance of immediate action. Dechlorane Plus is also found frequently and in high concentrations in indoor dust, indicating that human exposure is very likely (http://www.miljodirektoratet.no/Documents/publikasjoner/M818/M818.pdf).	A.1.1.5. New information and next steps towards the final recommendation
Thank you for your opinion.	
				
3382
2018/12/05	Rolls-Royce PLC,
Company,
United Kingdom	The prioritisation has not considered that there are critical uses of dechlorane plus in the manufacture of aerospace and defence engines where the substance is used as a flame retardant in void fillers and cannot easily be replaced due to the stringent qualification requirements of the industry.	A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use	
		Attachment: 3382_RR dechlorane comments AXIV consultation.docx
		
3386
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of Dechlorane Plus for inclusion in Annex XIV.

Dechlorane Plus has already been listed on ChemSec's Substitute It Now (SIN) list since 2014 due to the concerns about its persistent and bioaccumulative properties and the detection in the environment including mammals and birds around the globe. Dechlorane Plus has also been found in human cord serum, indicating transfer across the placenta and exposure of human foetuses. In CHEM Trust´s view regulatory measures are long overdue and therefore the LAD and sunset date should be short and no exemptions granted in order to ensure that any additional emissions are avoided.
	B.1.1. General principles for setting latest application dates/sunset dates
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
Thank you for your opinion.	
				
3387
2018/12/05	Velsicol Chemical,
Company,
United States	Unjustified Prioritisation of Dechlorane Plus: It is our understanding that for a substance to be prioritised for placing on Annex XIV a substance must display a high potential risk to health and/or the environment whereby the substance has a severe hazard (CMR or PBT/vPvB) and a significant exposure (wide, dispersive use).  There was only six months between the placing of Dechlorane Plus on the Candidate List and the recommendation to place the substance on Annex XIV which is significantly quicker than most other SVHCs and was done before the Lead Registrant was able to put in place studies to clarify the bioaccumulation characteristics of the substance, so for the substance to be prioritised so quickly it should very clearly meet the requirements for prioritisation.  The substance has one significant use whereby it is used as a flame retardant within plastic products such as cabling.  The substance is mixed with polymers and other additive to generate the final polymeric mixture in a granular form.  This process is performed within a closed system at approximately 15 sites across the EU with relatively few workers exposed to the substance.  The industrial sites have containment systems in place that ensure release of the substance to the environment is minimised. The polymeric mixture is then formed into final articles that are used in a range of sectors.  There is no intended release of the substance from the plastic article.  Therefore we do not believe that the use of the pure substance in the manufacture of polymeric articles is either wide or dispersive.  As there is no intended release of the substance from the plastic articles the use of the substance within the articles is dispersive.  Therefore the substance should not have been prioritised for placement on Annex XIV as it has.

Authorisation is not the best method for risk reduction: The manufacture of fire resistant plastic articles is a process that occurs both inside and outside the EU.  The final articles are relatively low mass and volume and can easily be transported around the globe.  Therefore a foreseeable outcome of placing the substance on Annex XIV is that the manufacture of the cabling will continue outside the EU and these will then be imported into the EU for use in systems that require the optimal flame retardation offered by Dechlorane Plus.  Therefore the wide usage of article containing Dechlorane Plus will not be significantly reduced by authorisation and will result in the transfer of money and jobs from the EU to outside the EU.  Therefore we do not believe that authorisation is not the best approach to reduce the risk arising from use of the substance within the EU.  Authorisation was not used as the regulatory risk management measure for a substance with a similar toxicological profile and use (decabromodiphenyl oxide).

The authorisation process is not suitable for a vPvB substance: There have been eight substances that have been placed on Annex XIV because of their PBT/vPvB properties.  Of these only HBCDD has had users who have sought authorisation and these were only for a bridging time period to finalise the development of alternatives.  The comments on these authorisation dossiers from the RAC and SEAC admitted that it was not possible to generate a reasonable Socio-Economic Analysis on such substances as there are no adverse toxic effects associated with the substance. This means it is not possible to quantitatively cost the adverse impacts of the use of the substance.  Therefore we do not believe that authorisation an appropriate method to control the risk arising from the continued use of the substance.

	A.1.3.1. Scope of the assessment of wide-dispersiveness of uses
A.1.3.2. Assignment of WDU score based on use types and their associated volumes
A.1.3.3. Refinement of WDU score based on article service-life
A.1.5.1. Potential other regulatory actions
A.1.5.4. Control of risks
A.1.5.7. Potential competitive disadvantage
A.2.01. Short time between CL listing and recommendation
A.2.02. Not agreeing with hazard assessment of Dechlorane Plus
A.2.05. Not agreeing that use of the substance in articles is considered for WDU assessment	
				
3400
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	AIA understands the intent of ECHA under REACH to limit the risk of certain hazardous chemicals and prevent the regrettable substitutions using substances with similar chemical structure by regulating all similar chemical substances.  However ECHA’s practice of identifying substances by text description rather than using definitive chemical identifiers creates uncertainty in industry.  The aerospace sector employs (tens of) thousands of formulations from hundreds (thousands) of suppliers.   A good faith search has turned up numerous examples of CAS numbers for substances that fit the definition, but it is clear that our list(lists?) are not exhaustive, and there are clearly chemical structures possible that fit the definition. Because naming conventions are not always consistent we cannot be sure that we have not missed a substance that is in use that meets the definition.  If the substance is added to Annex XIV we are concerned that we may identify the presence too late to develop an application before the Last Application Date (LAD).	A.2.06. Missing substance identifiers	

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3286
2018/11/06	ADAMA Agriculture B.V.,
Company,
Netherlands	Concerning ECHA suggestions for LAD and Sunset Date, ADAMA Agriculture B.V. asks to extend both time intervals significantly for the following reasons:

• Dechlorane Plus is used in a variety of electronic applications from the automotive and consumer electronics industry sectors by many different companies; very  important is the use of Dechlorane Plus in the aircraft industry. ADAMA Agriculture B.V. as the only representative acting on behalf of the unique manufacturer supplying to Europe and holding a REACH registration will have to inquire and evaluate information from many downstream users across different industry sectors without involvement of additional manufacturers supporting the application for authorisation e.g. via a consortium.

• Performing R&D on possible alternatives for highly regulated applications e.g. in the aviation sector requires significant effort (in terms of time and cost) for conducting required testing and obtaining all relevant approvals to ensure an excellent replacement of the chemical for these uses.
	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)

B.1.2.2. Lack of alternatives, socio-economic aspects	
				
3312
2018/12/04	IMPAG AG,
Company,
Switzerland	As previously mentioned, the product is used by our customers in cables. Especially for the automotive industry. This industry is highly regulated. Any change in components requires extensive re-testing. If Pyrovex SG / Dechlorane Plus is placed on Annex XIV, the review periods should be extended at least as much as that of the chromium compounds for the aerospace industry.

As mentioned, the flame retardant properties of the product don’t have a replacement yet and the timeframe to research one should be taken into consideration	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)

B.1.2.2. Lack of alternatives, socio-economic aspects	
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3354
2018/12/05	Norway,
Member State	In general, we are in favour of a short LAD slot.	B.1.1. General principles for setting latest application dates/sunset dates

3382
2018/12/05	Rolls-Royce PLC,
Company,
United Kingdom	The LAD of 18 months after addition to annex XIV would be problematic for aerospace and defence companies to compile the detailed Authorisation dossiers that would be needed to justify the continued use whilst the search for acceptable alternatives, and validation thereof, continues. An 18 month LAD window would cause additional workload and resource constraints on aerospace and defence companies who are already managing other Authorisations in parallel e.g. for annex XIV substances such as ethoxylated nonyl/octyl phenols and hexavalent chromium compounds. Suitable technical expertise to achieve an Authorisation dossier of a suitable standard may also be concentrated on parallel Authorisation activities and therefore difficult to engage if working to similar timeframes for submission of Authorisation dossiers. A delayed sunset date and LAD would help to manage the workloads for aerospace and defence Authorisations to more realistic levels, if the Dechlorane plus is added to Annex XIV for aerospace and defence applications.	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)

B.2.01. Aerospace resources bound in other AfAs	
		See the corresponding embedded attachment in table 1 of Part I: 3382_RR dechlorane comments AXIV consultation.docx		
3387
2018/12/05	Velsicol Chemical,
Company,
United States	Requirement for extended review periods for granted authorisations: Some of the plastic articles that are formed from the mixture containing Dechlorane Plus are the plastic sheathing for low voltage electric cables.  These are used in products where optimal flame retardation is essential to avoid catastrophic fires, such as aerospace, automobiles and power stations.  These sectors have tight regulations over the safety testing of the final vehicle whereby changing the quality of the components in the vehicle would require extensive and prolonged re-certification.  Therefore, we believe that if the substance is placed on Annex XIV, any review period should be extended to a similar extent that was applied to the use of hexavalent chromium compounds in the aerospace industry (e.g. application 066-01).

Lack of viable alternative will require extended review period: The only flame retardants that display a similar standard of flame retardation are the brominated organic flame retardants (e.g. decabromodiphenyl oxide) that are also either PBT or vPvB, are on the Candidate List and are restricted under entry 67 of Annex XVII.  As such, these are are not viable alternatives.  Any review period must be long enough to conclude a research project to identify a viable alternative.

	A.2.04. Alternative to DecaBDE
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)
B.1.2.2. Lack of alternatives, socio-economic aspects
B.1.3. Review periods	
				
3400
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.

With regards to Dechlorane Plus, as we have indicated in the previous question, the lack of chemical identifiers make it extremely difficult to identify affected formulations.  This creates additional complexity in identifying relevant actors in the supply chain.  Additional time needs to be allotted to allow for this coordination.
	A.2.06. Missing substance identifiers
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)	

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	
3286
2018/11/06	ADAMA Agriculture B.V.,
Company,
Netherlands	ADAMA Agriculture B.V. proposes to exempt the following use categories from the authorisation requirement:

• Use as a flame-retardant additive in the aviation industry sector
• Use as a flame-retardant additive in the automotive industry sector

According to REACH art. 58 (2), ADAMA Agriculture B.V. assesses the risk for human health and the environment to be properly controlled since for these sectors of application determined EU regulations or equivalent global industry standards exist to ensure controlling of risks for humans and environment (like EU regulation 748/2012 “Laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations” or the GADS list / IMDS for the automotive sector).
	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation
C.2.02 Exemption for use as flame retardant in aerospace and automotive industry sectors (reference to Regulation 748/2012 and GADS list)	
				
3312
2018/12/04	IMPAG AG,
Company,
Switzerland	R&D - needed to research alternatives
Cables - used in automotive industry, highly regulated, highly effective fire retardants necessary to save lifes	C.1.1. General principles for exemptions under Art. 58(2)

C.1.3. Aspects not justifying an exemption from authorisation
	
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3324
2018/12/05	Huber+Suhner AG,
Company,
Switzerland	Use as a flame retardant in polymer compounds for cable insulation.
There is presently no substitute material available which results in the same technical performance.	C.1.1. General principles for exemptions under Art. 58(2)

C.1.3. Aspects not justifying an exemption from authorisation
	
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3387
2018/12/05	Velsicol Chemical,
Company,
United States	One minor use of Dechlorane Plus is within the development of fireworks.  The fireworks made using Dechlorane Plus are not placed on the market and the usage is less than 100 kg per year.  Therefore we believe that this use of the substance is exempted from authorisation under the Research and Development exemption as long as the fireworks are not placed on the market.
	C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01. Use in fireworks should fall under Research and Development exemption because they are not put on the market