Comments on ECHA’s Draft 10th Recommendation for Octamethylcyclotetrasiloxane (D4) 
(EC number: 209-136-7) and references to responses

The present document compiles the comments received during the consultation on the draft 10th recommendation for inclusion of substances in Annex XIV of REACH for Octamethylcyclotetrasiloxane (D4) (EC number: 209-136-7). The consultation took place between 5 March and 5 June 2020.

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/10162/13640/10th_recom_respdoc_d4_d5_d6_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	
3470
2020/04/08	IPI Global Ltd,
Company,
United Kingdom	page 6. We are proposing a Technical alternative to the handling recommendations provided in this document for reducing exposure to Octamethylcyclotetrasiloxane (D4) significantly below OELs in accordance with the EU[4],[5],[6] directives on carcinogens and mutagens – the IPI closed system has been proved effective for handling CMR liquids in Europe.
These Directives clearly acknowledge the usefulness of a closed system for the protection of workers. In fact, it is specifically mentioned that “where possible, a carcinogenic (mutagenic and reprotoxic) substance should be substituted with a less-hazardous alternative – otherwise carcinogens (mutagenic and reprotoxic) must, so far as is technically possible, be manufactured and used in a closed system to prevent exposure of workers”.
Together with the OQEMA-HSE study on Hydrazine Hydrate (Carc.1B) with level below 0.02 ppm, Archroma exposure result for Formaldehyde (carc.1B) with level around 0.03 ppm and SAFECHEM exposure to Tetrachloroethylene 25 times below the established level recommended, it confirms that using our closed loop system can help to reduce drastically the exposure of the operator and the environment even further below the threshold recommended by scientists and EU and World Regulatory Agencies.
Moreover, closed loop technology can also help compliance with the EU Circular economy[8] stipulations and amended EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 94/62/EC of 20 December 1994 on packaging and packaging waste[9] with the latest Commission Implementing Decision (EU) 2019/665 of 17 April 2019[10] and the UN SDG[11] to protect the environment reducing the amount of plastic, metals, water, raw material, energy, etc. and gives a significant economic return for companies.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.2.21 Suggesting a closed loop system as a technical alternative to reduce exposure below the recommended threshold	
		3470_OCTAMETHYLCYCLOTETRASILOXANE (D4).pdf
		
3482
2020/05/12	ELECTRICITE DE FRANCE,
Company,
France		A.1.5. Aspects not considered in ECHA's prioritisation
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
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.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
		Confidential attachment removed		
3494
2020/05/28	Wacker Chemie AG,
Company,
Germany		C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.01. Request to clarify generic exemption for laboratory use
C.2.04. Questioning that formulation for export requires AfA	
		Confidential attachment removed		
3503
2020/06/02	Heraeus Quarzglas Bitterfeld GmbH & Co. KG,
Company,
Germany	OMTCS is converted in an industrial process to the gaseous state and in the subsequently at elevated temperatures transferred to silicon dioxide (SiO2) in purity >> 99.9 %. OMCTS is used as an intermediate product! Delivery, filling in storage tanks, supply to transformation and chemical transformation is done in a closed system under strictly controlled conditions. In case of any issue, process will be automatically switched off and interlocked into a safe state.	A.2.11 Understanding that use of D4 in production of high purity quartz glass for fibres is intermediate use	
		Confidential attachment removed
		
3513
2020/06/03	Cefic - CES Silicones Europe,
Industry or trade association,
Belgium	CES – Silicones Europe is the trade organisation representing all major producers of silicones in Europe. CES is a sector group of the European Chemical Industry Council (Cefic), which is both the forum and voice of the European chemical industry.
While contributing to this consultation we are very aware we are experiencing unprecedented times, with events none of us have lived through before. Cefic endeavours to maintain a high standard in our responses to public consultations. While we are confident that this contribution adequately reflects our views at the current time, we recognise that public and private sector responses to the crisis and its aftermath, both in the EU and globally, have the potential to significantly affect industry’s operating conditions.
Europe has set itself very ambitious policy targets to reform the European economy. Chief among them are the policies to address the twin challenges of the green and the digital transformations, namely the European Green Deal and the Industrial strategy.  Cyclo-siloxanes and the silicone polymers manufactured from D4 as an intermediate are vital to achieve both. The unique physio-chemical properties of the cyclosiloxanes, including D4, include among others, durability, insulating properties, water resistance, flexibility, resistance to chemical or UV damage, and the ability to withstand heat and cold or pressure without loss of physical properties. To this end, a potential authorisation listing would be highly counterproductive as it would impact the availability of this key enabling technology. To achieve 2050 carbon neutrality target, Europe will need to rely on silicone uses in construction materials that make buildings more energy efficient. To produce vast amounts of green energy, silicones enable the construction of turbines with bigger blades that increase the power output. Thanks to silicones, power output has increased more than 40 times over the past 20 years. Also, solar panels cannot be built without silicone materials. In electric cars, silicones insulate batteries and protect them from electric surges or battery fires. On balance, using products made with silicones, one saves 9 times the greenhouse gases than what was emitted during manufacturing and disposal of that product. This means that the use of silicone products in Europe, North America and Japan yields greenhouse gas emissions reductions equivalent to about 54 million tons of CO2.
D4, D5 and D6 have unique physico-chemical properties due to their ‘hybrid’ nature, namely an inorganic backbone chain of successive silicon and oxygen atoms (Si-O-Si units) and methyl groups on the Si atoms of the chain. The inorganic backbone drives the unique properties of these siloxanes and makes this type of chemistry distinctly different from carbon-based chemistry (as one basic example, the Si-O bond is stronger than a C-O bond resulting in different chemical interactions). This unique molecular structure also drives the behaviour of D4, D5 and D6 in the environment: the interactions with water and lipids in biota are therefore different from those of carbon-based chemicals. Although D4, D5 and D6 all have this unique molecular structure there are clear differences in how these 3 substances behave in the environment.  This is evident when looking at the summary of physical chemical properties for D4, D5 and D6.
D4, D5 and D6 are cyclic methylsiloxanes but they have significantly different properties from carbon-based analogues and from each other.
D4, D5, and D6 have different physicochemical properties from their carbon-based analogues due to their ‘hybrid’ nature, namely an inorganic backbone chain of successive silicon and oxygen atoms (Si-O-Si units) and organic entities on the Si atoms of the chain. The inorganic backbone drives the unique properties of these siloxanes and makes this type of chemistry distinctly different from carbon-based chemistry.  One basic example of the chemical difference is the Si-O bond is stronger than a C-O bond, resulting in different chemical interactions. This unique molecular structure also drives the behaviour of D4, D5 and D6 in the environment: the interactions with water and lipids in biota are therefore different from those of carbon-based chemicals.  Although D4, D5 and D6 all have this unique molecular structure there are clear differences in how these 3 substances behave in the environment.  This is evident when looking at the summary of physical chemical properties for D4, D5 and D6.
• Different rates of degradation in the environment: D4 is more volatile and reactive in water and sediment compared to D5 and D6.  This allows D4 to clear more rapidly from these compartments limiting presence and exposure in those compartments.
• Different rates of degradation in living species: when D4 is taken up into biota, D4 is more rapidly biotransformed and volatilized in exhaled air in air breathing organisms, limiting exposure to biota under realistic environmental relevant conditions. D5 and D6 are less volatile and reactive compared to D4 and may have a higher half-life in compartments such as water and sediment but due to their even lower water solubility, significant binding to organic carbon and still appreciable partitioning to air, they will not be found in surface water. D5 and D6 have increasing molecular weight and size, which limits their bioavailability (D6 more so than D5) to biota in sediment. The low level that is taken up will be biotransformed and eliminated from aquatic biota and biotransformed and eliminated or eliminated as parent in exhaled air in air breathing organisms.
Given these differences in water solubility, lipophilicity, vapor pressure, reactivity, and environmental degradation and biotransformation, it is important to assess each substance based on its own properties, especially when assessing any impact to the environment.

CES would like to recall that the restriction route, and not the authorisation route, was considered by ECHA to be the most appropriate measure to regulate the use and placing on the market of D4, D5 and D6, as stated in ECHA’s own annex to its proposal for a REACH restriction on D4/D5/D6 in consumer and professional products: “The Dossier Submitter notes that a targeted restriction on the use of D4, D5 and D6 was proposed and adopted to Annex XVII of REACH in preference to the Authorisation process. As such, further risk management is appropriate under the restriction regime, rather than Authorisation.” (P 34).
This same conclusion has also been reached in previous reports, such as:
(1) Opinion of the RAC and Draft Opinion of the SEAC on an Annex XV dossier proposing restrictions on Octamethylcyclotetrasiloxane (D4); Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6) (2020): “SEAC agrees with the Dossier Submitter that a restriction is the most appropriate EU-wide measure to address the concern caused by emissions of D4, D5 and/or D6 to the environment and that the choice of the proposed restriction option is justified. […] Overall, the analysis conducted has provided sufficient justification for SEAC to conclude that the proposed restriction is the most appropriate EU-wide measure to limit the emissions to the environment and reduce the stock. SEAC agrees with the Dossier Submitter’s conclusion that the other risk management options assessed are not as appropriate as a restriction under REACH due to limitations in scope and effectiveness.”(p21); and “SEAC agrees with the Dossier Submitter that update of registration dossiers or authorisation under REACH would be a less effective way to reduce the releases of D4, D5 and D6 to the environment form the uses within the proposed scope.”(p22)
(2) The German SVHC dossier on D4/D5 (2018): “Authorisation does, however, not address the main use of D4 and D5 as a chemical intermediate, which may lead to significant impurities of D4 and D5 in silicone polymers. Other uses in the scope of authorisation are expected to cease if the follow-up restriction on D4/D5 in other consumer/professional products under development by ECHA would be adopted. Once D4 and D5 are included in Annex XIV, they could no longer be subject to targeted restrictions, except for restrictions relating to imported articles. Therefore, the dossier submitter recommends not to include these substances in Annex XIV immediately after their identification as a SVHC.” (P 32 (41))
(3) German RMOA (2017): “While Candidate Listing is often seen solely as a first step to authorisation, it has direct effects even when the substance is not included in Annex XIV. Candidate Listing will lead to a formal recognition of the PBT and vPvB properties. It would require the registrants to acknowledge the PBT/vPvB status of D4 and D5 and to minimize emissions of these substances to the environment by the help of substance tailored operational conditions and risk management measures. The present hazard assessment can also be seen as a supporting first step for potential future risk management options.”
(4) UK RMOA (2015): “At this stage, the UK considers a targeted restriction for the manufacture and use of personal care products will be the most appropriate route to reduce environmental concentrations. Of the measures available under the REACH Regulation, restriction is preferred to authorisation because:
• It provides a more flexible approach to achieve the aims of emission reduction as it can be targeted to those uses that pose the greatest risk (i.e. waste water discharges from relatively minor uses of the substance).
• It is likely to achieve a significant reduction in environmental concentrations more quickly.
• It can cover all relevant parts of the life cycle, including the presence of D4 as an impurity in polymeric products (where relevant) and higher molecular weight homologues like D616.
• It would avoid the creation of an unnecessary burden on companies whose products do not lead to significant waste water discharges.
• It will prevent the substitution of D5 with D4.” (P.25)

Moreover, it is CES’ understanding that once the restriction of leave-on personal care products and other consumer/professional products enters into force, in addition to the restriction for wash-off cosmetic products, the vast majority of uses that would potentially require an authorisation will be covered. Thus, the existing and ongoing REACH restrictions are expected to already remove all significant wide dispersive uses of D4, D5 and D6. This makes the added risk management value of Annex XIV listing questionable.
Indeed, the restriction on D4 and D5 in wash-off cosmetics and the proposed restriction on D4, D5 and D6 in consumer and professional products will impact all wide-dispersive uses. The existing Annex XVII “Wash off” restriction , which targets what was identified as 78% for D4 (p. 72) of releases to surface water is already meeting its reduction targets for D4. Furthermore, it is indicated in the Annex XV Restriction Report - Proposal for a Restriction Annexes that over 90% emission reductions for D4, D5 and D6 [from the remaining 22 % of emissions after use of the “wash-off” restriction] are expected through the Annex XV restriction proposal. Therefore, in total the reduction potential of the 2 restrictions will cover about >97.8 % of all D4 emissions. In view of this de minimis level of potential environmental exposure, the economic and reputational damage caused by prioritization for Authorisation is without environmental benefit and is unjustified and disproportionate.
We would note that ECHA’s guidance on “Prioritisation of substances of very high concern (SVHCs) for inclusion in the Authorisation List (Annex XIV)”  states that “Other on-going regulatory risk management activities can also be considered when deciding on which substances to include in a specific recommendation.” In the case of D4, D5 and D6, we would argue that due consideration should be given to the conclusions drawn by ECHA with respect to the appropriateness of Authorisation in the context of the existing and ongoing REACH restrictions.

In the background document, ECHA reports that D4 uses considered in scope of authorisation are the use of the substance in the production of electronic articles (specifically, D4 seems to be used as processing aid in the semiconductor industry). It must be noted that a high volume of silicone polymer is used for electronic devices and other electronic components critical to the telecommunications industry. The silicone polymer is produced from D4 (also from D5 and D6) as monomers.  Additionally, D4 is used as a precursor in the manufacture of silicon-based electronic components to produce ultra-pure thin layers of silicon dioxide.  In this use the D4 is fully transformed and is thus an intermediate which is exempt from authorisation. This use has not been reported separately because the D4 is fully transformed in the process and is included within the broader category of intermediates; as such is not subject to authorisation or reporting under REACH.
According to ECHA’s background document, “based on registration information D4 is used in non-metal surface treatment. The use appears to be for the production of surface treated silica.” CES members acknowledge that D4 is used for surface treatment of silica. This has not been separately reported in the CSR as it is an intermediate use where the D4 is chemically changed and covalently bound to the silica. The use as a chemical intermediate is exempted from authorisation.
To the best of our knowledge there is currently no direct use of D4 in consumer or professional products, and no wide dispersive use.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
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.2.04 Restriction route considered as most appropriate by the SVHC or Restriction dossier submitter, RAC and SEAC
A.2.05 Questioning the intrinsic properties of siloxanes as PBT/vPvB substances
A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
A.2.12 Understanding that the use of D4 in non-metal surface treatment is intermediate use
A.2.13 Understanding that use of D4 in chemical vapour deposition is intermediate use
A.2.14 Claim that there are no wide-dispersive uses of D4
A.2.17 Claim that Authorisation does not address siloxanes as impurities in silicone polymers and is therefore not an adequate risk management option
A.2.18 Difficulty to provide comments during the current global health and social crisis
A.2.19 Importance of siloxanes and silicone polymers to achieve the green deal
A.2.20 Considering Candidate listing sufficient to trigger minimization of releases
B.2.01. Request a LAD of 24 months, because of high complexity of supply chain
C.2.01. Request to clarify generic exemption for laboratory use
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
		3513_D4 CES Submission ECHA.pdf
		
3517
2020/06/04	Japan Cosmetic Industry Association,
Industry or trade association,
Japan	Dear Sirs/Madams,

On behalf of Japan Cosmetic Industry Association representing interests of cosmetic industries of Japan, I expressed our concern that there is no scientific justification to introduce restriction of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasilxane (D6) in the letter dated September 19, 2019 (see attached).  However public consultaion of the draft recommendation for inclusion in the Authorisation List of D4, D5 and D6 was posted without reflecting our concern. Again, I would like to express our great concern on the restriction of D4, D5 andD6 followed by the draft recommendation.

Our comments are as follows:

1. Global Harmonization for vPvB/PBT evaluation

We believe that global harmonization of current chemical risk management is highly important. In case of internationally common chemicals, risk assessment and risk management with sound science should be shared to avoid misguiding of risk assessment and to develop/maintain global harmonization [1, 2, 3, 4, 5, 6, 7]. In this REACH recommendation, these Cyclic siloxanes are categorized as PBT [8]. However, the Chemical Substances Control law in Japan, at least, D5 was not regarded as PBT because of lack of toxicity. Although D4 and D6 are categorized as monitoring substances instead of PBT, none of these Cyclosiloxanes are prohibited for use in any products including cosmetics in Japan [1]. Considering the situation in Japan, we believe there is no sufficient scientific evidence to conclude PBT judgment of these substances.

Other science based regulatory review also concluded not to restrict the current use of D5 in direct use [2, 3]. For instance, a front-end risk-based approach on vPvB/PBT assessment, Canadian Authority’s WoE (Weight-of evidence) evaluation of the date for Cyclic siloxanes concluded D5 are not bioaccumulative and persistence is observed in sediments only [2, 4]. The Canadian Board of Review for their chemical regulation evaluated that D5 does not biomagnify through the food chain; and that there is no evidence which demonstrates that D5 is toxic to any organisms tested up to the limit of solubility and therefore “D5 will not accumulate to sufficiently great concentrations to cause adverse effects in organisms in air, water, soils or sediments.” [2, 4, 5, 6, 7]

The Australian review also concluded that these siloxanes are hydrophobic and that “these chemicals are expected to dissipate rapidly from the water column by a combination of volatilization, hydrolysis and partitioning to suspended particulate matter and sediments” and therefore “The direct risks to aquatic life from exposure to these chemicals at expected surface water concentrations are not likely to be significant.” [3]

In general, vB judgment is based on result of a test evaluating BCF. With this evaluation, usual environmental monitoring data corresponds well to bioconcentration as seen for chemicals such as PCB. However, in the case of cyclosiloxane (D4), a discrepancy is observed in publicly available monitoring results of bioaccumulation in an actual environment [6, 9, 10]. This result demonstrates that solely use of BCF is not appropriate for assessment of environmental impact of chemicals. In addition, the judgments of vPvB for D5 and D6 by ECHA are based on BCF data determined in a closed system, however it is reported that cyclic volatile methyl siloxanes show lower bioconcentration due to their superhydrophobicity [9, 10, 11, 12]. These results suggest that various parameters should be applied in order to assess bioconcentration and/or bioaccumulation impact of substances with properties of cyclosiloxanes (hydrophobicity and volatility).

According to the international PBT assessment guidance [9, 13], the criteria set out in REACH for the characterization of PBT and vPvB properties might be not appropriate for siloxanes. The REACH regulation specifically states that the criteria for PBT and vPvB properties identified in Annex XIII of the regulation only apply to “organic substances, including organo-metals”. The siloxanes under question should therefore not be examined under these criteria because they are not purely organic substances. D4, D5, and D6 are constituted of an inorganic back bone chain of silicone and oxygen atoms as well as organic side groups [9, 10, 12, 14,15]. As such, these compounds have a “hybrid” nature and properties that differ significantly from other “purely” organic compounds. In our view, the improper application of the Annex XIII criteria for D4 and D5 has led to controversial findings regarding bioaccumulation and persistence and subsequently towards burdensome and unnecessary regulatory restrictions [11, 12,13, 14,15].

2. Environmental exposure and fate of Cyclosiloxanes

According to the Canadian and Australian latest reviews of Siloxanes environmental fate, the key findings are consistent: “there is negligible risk to water column and sediment receptors from Siloxanes discharged from MPF facilities after onsite wastewater treatment or from municipal WWTPs  (Waste Water Treatment Plants) that may treat a mix of industrial and consumer wastewater” [2, 3].

D5 shows the specific physic-chemical property at around normal temperature, such as low Water solubility (0.017 mg/L at 23℃) and high Henry's Law Constant (3,342,000 Pa m3/mol at 25℃). These data indicate Siloxanes are easy/rapidly evaporating into the air. It may course Siloxanes drop down with rain into the water environment again. In that case, these Siloxanes are also evaporated again to the air from the surface of water, because of its physic-chemical property [11, 12, 14, 15]. SIAJ (Silicone Industry Association of Japan) also shows the scientific review of the lifecycle of volatile Siloxanes (VMS) in air environment. Their report suggested that “In air, VMS are degraded in the presence of sunlight, ultimately to silica, water and carbon dioxide.” And “On account of their relatively short atmospheric life they do not reach the upper atmosphere to affect the ozone layer.” [16]

3. Lack of Risk Assessment of Cyclosiloxanes (D4, D5 and D6)

It should be noted that risk characterization of D4, D5 and D6 were not performed in the ECHA Restriction Report. The risk to environmental concern from exposure to Cyclosiloxanes is determined by comparing the Predicted Environmental Concentrations (PECs) in freshwater/marine water to the Predicted No Effect Concentrations (PNECs) [11, 12]. For human health, the risk is determined by comparing PECs in air to the Derived No-Effect Levels (DNELs) [11, 12].

According to the specific risk characterization of Cyclosiloxanes for REACH purpose [11], for water environment the RCR values is <1.1 x 10-3, that is a safety margin of just under 1000. For human health, risk assessment of Siloxanes via air results in the RCR value to be 6.5 x 10-7 (D4), 6.2 x 10-6 (D5) and 6.5 x 10-7 (D6) respectively, to put it another way the risk has a safety margin of around million [11, 12].

The RCR values indicate that the risk to aquatic environment from water and to humans from air is very far from being a concern. Given that the substances are suspected to be vPvB/PBT on the basis of persistence in aquatic sediment, the report was concluded that the risk indicates by ECHA from the substances in the air compartment and the pelagic water compartment are very low and do not merit further regulation to control such a negligible risk [11].

4. Conclusion

In conclusion, there are not sound scientific grounds enough to justify even the restriction report of D4, D5 and D6 as PBT/vPvB. We request ECHA to carefully reconsider the authorisation of volatile Cyclosiloxanes (D4, D5 and D6. The recommendation from ECHA is not only scientifically inappropriate but also a cause of severe economic damages in international cosmetic industry, as well as undermining consumers’ benefits.  For the purpose of evaluation of realistic risk of these related compounds, we shall use risk assessment approach. However, the recommendation by ECHA “possibility of unpredictable long-term effects due to possible accumulation in ecosystem” is not justified even in aquatic environment by risk assessment with weight of evidence approach using available scientific data.

Furthermore, we would like to emphasize the following points:
- Cyclosiloxanes do not meet the hazardous criteria, PBT or vPvB, therefore do not meet the criteria for inclusion in the Authorisation list.
- Cyclosiloxanes have a low risk on the environment and there is no need for further mandatory controls.
- Risk-based evaluation and management are important from the two perspectives of chemical substance management and socioeconomic efficiency and it is appropriate to apply the sound management to Cyclosiloxanes.

We appreciate to have an opportunity to comment on ECHA’s recommendation and sincerely request to reconsider the inclusion in the Authorisation List of volatile Cyclosiloxanes (D4, D5 and D6).

Respectfully yours,

Yamamoto Junji
Senior Managing Director
Japan Cosmetic Industry Association (JCIA)
 

References
1. METI – Japanese Ministry of Economy, Trade and Industry, (2017) the Chemical Substances Control law in Japan, Cyclic Siloxanes Review
https://www.meti.go.jp/shingikai/kagakubusshitsu/shinsa/pdf/173_01_00.pdf
2. Canadian Board of Review, (2016) Quantitative weight-of-evidence analysis of the persistence, bioaccumulation, toxicity, and potential for long-range transport of the cyclic volatile methyl siloxanes. Toxicol Environmental Health. https://www.tandfonline.com/doi/full/10.1080/10937404.2016.1200505
3. Australia - NICNAS, (2018) Cyclic volatile methyl siloxanes: Environment tier II assessment  https://www.nicnas.gov.au/chemical-information/imap-assessments/imap-assessments/tier-ii-environment-assessments/cvms
4. Mackey D., et. al., (2015) Risk assessment and regulation of D5 in Canada: Lessons learned. Environ Toxicol Chem. 2015 Dec;34(12):2687-8. https://www.ncbi.nlm.nih.gov/pubmed/26213177
5. Mackey D., et. al., (2015) Risk Assessment and Regulation of D5 in Canada: DECAMETHYLCYCLOPENTASILOXANE (D5) ENVIRONMENTAL SOURCES, FATE, TRANSPORT, AND ROUTES OF EXPOSURE. Environ Toxicol Chem., 34 (12), 2689–2702.
https://setac.onlinelibrary.wiley.com/doi/pdf/10.1002/etc.2941
6. Gobas F., et. al., (2015) Risk Assessment and Regulation of D5 in Canada: FUGACITY AND ACTIVITY ANALYSIS OF THE BIOACCUMULATION AND ENVIRONMENTAL RISKS OF DECAMETHYLCYCLOPENTASILOXANE (D5). Environ Toxicol Chem., 34 (12), 2723–2731.
http://rem-main.rem.sfu.ca/papers/gobas/Gobas_et_al-2015-Environmental_Toxicology_and_Chemistry-Fugacity_and_activity.pdf
7. Gobas F., et. al., (2015) Risk Assessment and Regulation of D5 in Canada: BIOACCUMULATION OF DECAMETHYLPENTACYCLOSILOXANE (D5): A REVIEW. Environ Toxicol Chem., 34 (12), 2703–2714.
http://rem-main.rem.sfu.ca/papers/gobas/Gobas_et_al-2015-Environmental_Toxicology_and_Chemistry(2).pdf
8. Committee for Risk Assessment (RAC), Committee for Socio-economic Analysis (SEAC) (2016). Opinion on an Annex XV dossier proposing restrictions on Octamethylcyclotetrasiloxane, Decamethylcyclopentasiloxane. European Chemicals Agency.
9. Powell D. et.al., (2018) Bioaccumulation and trophic transfer of cyclic volatile methylsiloxanes (cVMS) in the aquatic marine food webs of the Oslofjord, Norway. Sci. Total Environ. 622-623, 127-139. https://www.sciencedirect.com/science/article/pii/S0048969717332941
10. Mackay D. et.al., (2015) Bioconcentration and Aquatic Toxicity of Superhydrophobic Chemicals: A Modeling Case Study of Cyclic Volatile Methyl Siloxanes. Environ. Sci. Tec. 49, 11913-11922
https://pubs.acs.org/doi/pdfplus/10.1021/acs.est.5b03195
11. PFA-Brussels, (2019) ECHA Public Comment on the web “D4/D5/D6 Risk Assessment report for Reconsile”. https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e181a55ade
12. CES, (2019) ECHA Public Comment on the web “Initial Report for cVMS (D4 & D5) Restriction Monitoring in EU Program – EXECUTIVE SUMMARY”. ERM Study Number: 0383878.
https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e181a55ade
13. Klečka G.M. et. al., (2009) Science-Based Guidance and Framework for the Evaluation and Identification of PBTs and POPs: Summary of a SETAC Pellston Workshop. https://cdn.ymaws.com/www.setac.org/resource/resmgr/publications_and_resources/pbtpopsexecutivesummary.pdf
14. Cosmetics Europe, (2019) ECHA Public Comment on the web “Assessment of the fraction of D5 released to wastewater following application of leave-on personal care products”.
https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e181a55ade
15. Personal Care Products Council. (2019) ECHA Public Comment on the web “Personal Care Products Council Submission to the Public Consultation on the Proposed Restrictions for D4; D5; D6 in Leave-On Cosmetic Products”.
https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e181a55ade
16. Silicone Industry Association of Japan, (2018) lifecycle of Cyclic Siloxane in environment. http://www.siaj.jp/ja/silicone_world/env.html#envi	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks
A.1.5.6. Socio-economic benefits of continued use
A.2.05 Questioning the intrinsic properties of siloxanes as PBT/vPvB substances
A.2.06 Claim that no risk assessment was performed during restriction
A.2.07 Claim that for its draft recommendation, ECHA has not considered comments submitted during Restriction process	
		3517_20200603_JCIA comment.zip

3524
2020/06/04	GLOBALFOUNDRIES,
Company,
Germany		A.1.5. Aspects not considered in ECHA’s prioritisation
A.1.5.3. Use specific considerations
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.2.13 Understanding that use of D4 in chemical vapour deposition is intermediate use
A.2.15 Questioning the volume of D4 estimated for uses in the manufacture of electronic articles and claiming that those uses are wrongly reported in registration dossiers
A.2.16 Claim that D4 is not present in electronic articles and therefore no WDU score for use in articles should be assigned
B.1.1.3. ECHA’s proposal for latest application dates
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset 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)
B.1.2.2. Lack of alternatives, socio-economic aspects
B.2.01. Request a LAD of 24 months, because of high complexity of supply chain
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions	
		Confidential attachment removed		
3525
2020/06/04	Eli Lilly Kinsale Limited,
Company,
Ireland	No comments	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.5. Availability of suitable alternatives
A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
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.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
		3525_Eli Lilly Kinsale Limited_ Comments on Inclusion of D4, D5 and D6 in the Authorisation List.pdf
		
3528
2020/06/04	Elkem Silicones,
Company,
France		A.1.5. Aspects not considered in ECHA’s prioritisation
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.2.12 Understanding that the use of D4 in non-metal surface treatment is intermediate use
A.2.13 Understanding that use of D4 in chemical vapour deposition is intermediate use	
		Confidential attachment removed		
3530
2020/06/04	Sanofi Group,
Company,
France		A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.2.01 Interplay between restriction and authorisation with regard to prioritisation
A.2.02 Claim that industry was unprepared for draft recommendation without further notice
A.2.04 Restriction route considered as most appropriate by the SVHC or Restriction dossier submitter, RAC and SEAC
A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates
B.1.2.2. Lack of alternatives, socio-economic aspects
C.1 Process information
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.03. Request for exemption based on derogations from upcoming restriction
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
		3530_Sanofi D4 D5 D6 AUTHORISATION COMMENT.pdf
		
3543
2020/06/05	SEMI Europe,
Industry or trade association,
Germany	Please see attached our comments.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Potential competitive disadvantage
A.2.04 Restriction route considered as most appropriate by the SVHC or Restriction dossier submitter, RAC and SEAC
A.2.13 Understanding that use of D4 in chemical vapour deposition is intermediate use
A.2.15 Questioning the volume of D4 estimated for uses in the manufacture of electronic articles and claiming that those uses are wrongly reported in registration dossiers
A.2.16 Claim that D4 is not present in electronic articles and therefore no WDU score for use in articles should be assigned
C.1.3. Aspects not justifying an exemption from authorisation	
		3543_SEMI Europe Comments on the draft recommendation of Octamethylcyclotetrasiloxane_D4_for inclusion in Annex XIV_Final.pdf
		
3550
2020/06/05	Germany,
Member State	The German CA welcomes the opportunity to comment on the draft tenth recommendation for the inclusion of substances in Annex XIV concerning the cyclic methylsiloxanes D4, D5 and D6. In the SVHC identification process for D4 and D5, we considered that the authorisation procedure was not appropriate for these substances at that point in time and stated this clearly in the Annex XV dossiers. According to the information that was available to us, we had the impression that - in addition to the large share of intermediate uses - only small quantities relevant for authorisation would remain after the ongoing restriction procedures. The current situation appears to be different and the tonnages of the uses relevant for authorisation remain relatively high, even after the restriction for leave on personal care products and other consumer/professional products would come into force as proposed.	A.2.03 Recognition that volumes remain high after upcoming restriction will apply	
				
3556
2020/06/05	European Semiconductor Industry Association,
Industry or trade association,
Belgium	Summary:
The Semiconductor industry uses small quantities of D4 (< 5 tons / year) in an essential manufacturing step, where it is used destructively in a highly controlled plasma process to form very thin films (measured in nanometers) of an inorganic glass-like material. This thin film serves as a very specialized high performance and high reliability electrical insulator (dielectric) in advanced technology semiconductor chips.
There is no worker exposure, and D4 precursor residues are not present in final products (finished die patterned wafers). Emissions of D4 to the environment from semiconductor manufacturing are de minimis - if at all occurring.
There is NO viable alternative available to the use of D4 as a precursor material for creation of the specific dielectric layers within transistors of advanced semiconductor devices.

The European Semiconductor Industry is a provider of key enabling technologies. The industry creates innovative solutions for industrial development, contributing to economic growth and responding to major societal challenges. Being ranked as one of the most R&D intensive sector by the European Commission, the European Semiconductor ecosystem supports approx. 200.000 jobs directly and up to 1.000.000 induced jobs in systems, applications and services in Europe. Overall, micro- and nano-electronics enable the generation of at least 10% of GDP in Europe and the world.

Semiconductor device fabrication is among the most complex and sophisticated manufacturing processes in the world, taking place in a strictly controlled and safe production environment (the cleanroom). All manufacturing processes are performed in dedicated and closed process equipment tools. Here the presence of uncontrolled particles, as well as impurities in the form of chemical vapors and gases constitutes an unacceptable risk from a safety and health as well as from a production quality viewpoint.
The Semiconductor industry uses very small quantities of D4 in an essential manufacturing step, where it is used destructively in a highly controlled plasma process to form very thin films (measured in nanometers) of an inorganic glass-like material, known as SiCOH. Because of its exceptional dielectric constant and mechanical strength, this thin film serves as a very specialized high performance and high reliability electrical insulator (dielectric) in advanced technology semiconductor chips.
Any disproportionate regulatory risk management option such as an annex XIV entry for authorization for D4 could jeopardize manufacturing continuity or even the ability to operate in Europe.  ESIA wishes to highlight concerns regarding the conclusion of the prioritization results, which proposes to add D4 to Annex XIV, thus creating legal uncertainty regarding its continued use, even though the European semiconductor industry utilizes D4 in such a manner that mitigates the risk of worker exposure, environmental release or consumer exposure.

Volume
With respect to the volumes of uses, D4 was assigned a score of 12 - same as the refined score of 12 for D4 use at industrial sites and by professional workers.
The European semiconductor sector is a very minor direct user of the overall consumption of D4 across the various industry sectors. ESIA member companies state that the use volume of OMCTS in semiconductor manufacturing is less than 5 tons / year.
That number is in sharp contrast to the ECHA estimates in the background dossier Annex I regarding the complete total volume of D4 in the scope of authorisation:
“The use of the substance in the production of electronic articles is reported in registrations. Based on available information D4 seems to be used as processing aid in the semiconductor industry. Volumes per use are not provided in registrations …..based on realistic worst case assumptions it is estimated that 1,000 - <10,000 t/ y of D4 are used for the production of electronics….”

ESIA wants to clarify that semiconductor manufacturing use of OMCTS (D4) is currently below a volume of 5 tonnes per year, which clearly does not correspond to the “realistic worst-case assumptions” of 1,000 - <10,000 t/ y of D4”.

Specifically, ESIA would like to point out that the D4 REACH registration dossier includes volumes per year and identified uses for electronics manufacture with a Product Category PC 33 Semiconductor that do NOT correspond at all to the EU semiconductor industry’s annual use volume and PROCs:
• a registered volume of >= 10 tonnes per registrant for the Product Category PC 33 Semiconductor. Combined European semiconductor industry manufacturing uses D4 in a volume < 5 tonnes per year, so a registered use for semiconductor manufacturing of >= 10 tonnes per year does not match at all.
• the relevant Process Categories (PROC): some of the registered uses include PROCs that do not correspond at all to techniques relevant to semiconductor manufacturing (that occurs in fully automated and closed controlled tools in a cleanroom). These not applicable PROCS are  listed in the dossiers as PROC 5: Mixing or blending in batch processes PROC 7 (Industrial spraying), PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities, PROC 9 (Transfer of substance or mixture into small containers (dedicated filling line, including weighing)) PROC 10 (Roller application or brushing), PROC 13 (Treatment of articles by dipping and pouring), PROC 14 (Tabletting, compression, extrusion, pelletisation, granulation).
Consequently, the current information on D4 use volume and PROCs for semiconductor manufacturing in the REACH registration dossier is understood to be generally incorrect.

Wide Dispersiveness of Uses

With respect to the wide dispersiveness of uses, D4 was assigned a score of 5 and refined score of 7 for use at industrial sites and by professional workers.
ESIA would like to clarify that D4 use in semiconductor manufacturing is not a use that qualifies as a wide dispersive use.
Details on D4 Use in Semiconductor Manufacturing:
Semiconductor devices (microchips) are ubiquitously present in electrical and electronic devices.

Semiconductor device fabrication is among the most complex and sophisticated manufacturing processes in the world, taking place in a strictly controlled and safe production environment (the cleanroom). All manufacturing processes are performed in dedicated and closed process equipment tools. Here the presence of uncontrolled particles, as well as impurities in the form of chemical vapors and gases constitutes an unacceptable risk from a safety and health as well as from a production quality viewpoint.

The fabrication process includes a sequence of lithographic and chemical processing steps (anywhere from 1000 to 1200 process steps) during which electronic circuits are gradually created on a substrate made of silicon (semiconductor material). These electrical circuits are made one layer at a time by the combination of depositing a layer on the surface of the wafer and using a patterning process to then remove designated parts of the layer to leave behind a specific shape. For a better understanding of semiconductor manufacturing dimensions, it needs to be understood that the features (including the individual layers) on a semiconductor device (microchip) are measured in nanometers.

Within that overall process flow, D4 is used as a technology critical precursor in a specific chemical vapor deposition (CVD) process of a specific dielectric layer, that is a critical building block in transistors in advanced semiconductor technologies. This specific CVD process is a radio frequency plasma-enhanced CVD (RF PECVD) process, that uses D4 as a precursor chemical, and by the action of the plasma and co-reactants, converts it destructively to a distinctly different material than D4, called SiCOH, that is deposited in a very thin layer (measured in nm) on the silicon wafer
The term” SiCOH” describes the elements present in the thin dielectric layer (it does not represent the stoichiometry). The SiCOH film structures (composed of Si, C, O and H atoms) are extensively cross-linked with little relation to the molecular composition of the D4 precursor. It can best be described as an inorganic porous glasslike material with a molecular structure, that has been reported to be similar to SiO2, but which also contains C and H atoms. It also may be characterized as an organosilicate glass.
To be clear: the resulting SiCOH dielectric layer does not include any D4 impurities. In fact, the resulting transistors in the microchip would not be functional if residual D4 impurities were present.

No Emissions of D4 to the environment from semiconductor manufacturing
After a defined number of SiCOH deposition steps in a RF PECVD tool, the RF PECVD tool process chambers that have been covered with SiCOH as well during the deposition step, are cleaned in a plasma cleaning process to remove all residues from the chamber.
The RF PECVD tools’ gaseous emissions (which are not likely to contain residual non decomposed D4 precursor material) are usually connected to point-of-use thermal abatement units, which per standard practice operate at a very high destruction removal efficiency for D4, that is understood to be around 98 % and higher. The exhaust gas from the point-of-use abatement is typically routed to an acid scrubber where a subsequent washing process of acid exhaust is taking place. The resulting waste water is typically routed to the industrial waste water treatment plant.

RF PECVD tools do not have direct aqueous emissions. Also under regular production conditions no waste is generated in the described RF PECVD process, and empty D4 precursor bottles are returned to the supplier.
In conclusion, emissions of D4 to the environment from semiconductor manufacturing are de minimis - if at all occurring.

No worker exposure of D4 in semiconductor manufacturing
Semiconductor manufacturing takes place in a strictly controlled and safe production environment (the cleanroom). All manufacturing processes are performed in dedicated and closed process equipment tools, in this case in a RF PECVD tool. Generally, the presence of uncontrolled particles, as well as impurities in the form of chemical vapors and gases in the cleanroom constitutes an unacceptable risk from a safety and health as well as from a production quality viewpoint.

There is also no worker exposure in the following steps that occur in addition to the actual CVD deposition step:
• D4 precursor containers as supplied by the supplier are connected to the RF PECVD tool tanks as delivered - no filling or mixing or similar steps take place. The delivery of the D4 precursor from the RF PECVD tool tank to the RF PECVD process chamber is through a Helium rinsed line. The D4 precursor is injected and vaporized into the RF PECVD tool process chamber through a valve using Helium as a carrier gas. Change of D4 precursor containers in the RF PECVD tool tank do not require any emptying or filling or cleaning of the D4 precursor containers, or any tool opening, or tool shut down.
• Maintenance of RF PECVD tool chambers is only done after completion of the automated plasma cleaning step of the closed RF PECVD tool chamber that removes all residues from the chamber.
• Also, we would like to note that no in-process sampling is performed.
 
Identified Use of D4 as a Precursor in Semiconductor Manufacturing:
ESIA member companies have reassessed the identified use that is provided as per Table 1 below.
(Table 1 in non confidential attachment submission)
Referring to the description of the use above, ESIA concludes that in terms of Environmental Release Category (ERC), the use of D4 as a precursor in semiconductor manufacturing can best be described as “Industrial use resulting in manufacture of another substance (use of intermediates)”. This is assessed with the rationale that D4 is used in order to manufacture a dielectric substance layer (a D4 transformation product) on a silicon wafer – with D4 being fully decomposed in the process.
There is no worker exposure, and emissions of D4 to the environment from semiconductor manufacturing are de minimis - if at all occurring. D4 precursor residues are not present in final products (finished die patterned wafers).
Annex I of the background dossier, states as follows:
“The use of the substance in the production of electronic articles is reported in registrations. Based on available information D4 seems to be used as processing aid in the semiconductor industry. Volumes per use are not provided in registrations …..based on realistic worst case assumptions it is estimated that 1,000 - <10,000 t/ y of D4 are used for the production of electronics….”

ESIA would like to state that an identified use if D4 as a processing aid does not accurately or realistically describe the use of D4 as a precursor in semiconductor manufacturing, in which D4 transformation product(s) are included into / onto the semiconductor wafer, upon reaction of D4 precursor during semiconductor manufacturing use (in the radio frequency plasma-enhanced CVD process).

Additionally, ESIA would like to emphasize that the D4 REACH registration dossier includes some identified uses for electronics manufacture with a Product Category PC 33 Semiconductor that do NOT correspond at all with the EU semiconductor industry’s use.
The discrepancies are in the data provided for
• the registered volumes of >= 10 tonnes per registrant. Combined European semiconductor industry manufacturing uses D4 in a volume < 5 tonnes per year, so a registered use for semiconductor manufacturing of >= 10 tonnes per year does not match at all.
• the relevant Process Categories (PROC): some of the registered uses include PROCs that do not correspond at all to techniques relevant to semiconductor manufacturing (that occurs in fully automated and closed controlled tools in a cleanroom). These not applicable PROCS are  listed in the dossiers as PROC 5: Mixing or blending in batch processes PROC 7 (Industrial spraying), PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities, PROC 9 (Transfer of substance or mixture into small containers (dedicated filling line, including weighing)) PROC 10 (Roller application or brushing), PROC 13 (Treatment of articles by dipping and pouring), PROC 14 (Tabletting, compression, extrusion, pelletisation, granulation).
Consequently, the current information on D4 use volume and PROCs for semiconductor manufacturing in the REACH registration dossier is understood to be generally incorrect.

In conclusion:  The semiconductor manufacturing industry sector use of D4 cannot be accurately characterized as having a wide and dispersive use profile.
	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
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.2.11 Understanding that use of D4 in production of high purity quartz glass for fibres is intermediate use
A.2.15 Questioning the volume of D4 estimated for uses in the manufacture of electronic articles and claiming that those uses are wrongly reported in registration dossiers
A.2.16 Claim that D4 is not present in electronic articles and therefore no WDU score for use in articles should be assigned
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset 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)
B.1.2.2. Lack of alternatives, socio-economic aspects
B.2.01. Request a LAD of 24 months, because of high complexity of supply chain
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	
		3556_ESIA ECHA Consultation D4 10th Dr Priority List June 5 2020.pdf
		
3558
2020/06/05	MedTech Europe,
Industry or trade association,
Belgium	Annex XV restriction dossier

An Annex XV  dossier is currently under review to restrict the manufacturing, placing on the market and use of D4, D5 and D6. The consolidated RAC/SEAC opinion concluded that the restriction approach is the right way to manage the risks related to these substances. On this basis, the additional inclusion of D4, D5 and D6 in the Authorisation list would be disproportionate and not aligned with the conclusion of the restriction dossier.

Uses of D4, D5 and D6 in medical devices and IVDs

The below provides examples of medical devices and in vitro diagnostic (IVD) medical devices which may use D4, D5 or D6 in the manufacturing and/or in the final product, or which may contain D4, D5 or D6 as an impurity above 0.1%. Some of these uses would be within the scope of Authorisation, for others this is less clear. We have included all identified uses for completeness reasons, including the potential socio-economic impact if they were in scope. We would appreciate confirmation from ECHA and the EU Commission on uses which would not be in scope of Authorisation.

Medical devices

Industrial use of silicone based polymers and mixtures containing such polymers

D4, D5 and D6 are used as starting materials (monomers) to produce silicone polymers. The degree of polymerisation will never reach 100%, therefore residual monomers/impurities of the cyclic siloxanes will be always present after polymerisation above 0,1 % (w/w).

Medical device manufacturers use silicone based polymers to manufacture a wide range of medical device articles such as (but not limited to):

- Cured silicone elastomer moulded parts: These parts are often components of medical devices, such as sleep apnea masks, needleless access ports etc.
- Cured silicone elastomer extruded articles such as catheters, drains and shunts
- Transdermal drug delivery patches, wound/scar/ostomy dressings and medical tape
- Needles, IV sets, tubing, components for medical devices for injection
- Blood glucose monitor components

Some of the mixtures used to manufacture these medical devices may contain more than 0.1% of D4, D5 or D6 as impurities from polymers.

MedTech Europe understands that ECHA considers polymers and thereby unintentionally present residues or impurities of D4, D5 or D6 out of scope of Authorisation. The reason for this is that when monomers are converted to polymers, they cease to exist, and a new polymer substance is formed. The polymer substance would therefore be a different substance and out of scope of Authorisation, and unintentional residues of the monomers are not considered as uses (see ECHA Q&A on Authorisation No. 565 and ECHA Q&A on Polymers and monomers No. 67).

Medical devices for scar treatment and stoma care

D5 is of particular importance for the barrier forming properties of some medical devices, such as those for scar treatment and stoma care. The concentration of D5 in products in the scar and stoma care categories can range from 5 to >50% depending on the indication of the product. The mode of action is to act as a quick drying carrier material allowing easy dispensing and application of a product which rapidly forms a barrier over the area to be treated. Total volumes of D5 used in these medical devices is estimated at < 14 tonnes per year (based on company data).

The products are applied directly to the body and are not intended to be washed off but may be worn away by clothing etc. They are actively replaced by the patient based on their clinical need. The frequency of application is related to the indication and individual patient’s needs.

Alternatives need to be assessed to ensure that:

- The product is at least as efficacious as the current formulation using D5
- The safety profile is maintained
- The formulation is stable and suitable for commercial manufacture

No alternative has been identified for use in a scar gel treatment to date. The drying time, skin feel, viscosity, safety profile and physical characteristics of D5 are not matched by any product assessed. The volatility of D5 makes it a particularly suitable ingredient. When correctly applied, the gel dries in around 5 minutes. The remaining components combine to form a silicone elastomer that binds to the stratum corneum through a variety of physicochemical and electrostatic effects. The resultant film is relatively strong, smooth and cosmetically pleasant, with properties of gas permeability and water impermeability which are necessary for normal scar resolution. Increasing the concentrations of the non-D5 components has two potential undesirable effects: firstly, the drying time is greatly increased, making it less convenient for the patient; secondly, although the durability of the elastomer is increased, it will bind less strongly to the skin, which will reduce the effectiveness of the product.

Due to the method of application and the known properties of D5, almost the entirety of the D5 in any medical device applied to the body, and not immediately rinsed off with water, will volatilise into the air compartment where the half-life is expected to be 10.4 days, minimal deposition is expected. Any deposition to the soil or water compartments due to localised weather effects would be expected to re-enter the air compartment when conditions returned to normal. A winter deposition figure of 0.004% was recorded and referenced in the original HSE restriction report.

Release into the air compartment would be expected to lead to degradation by hydroxyl radicals to easily degradable Silanols and ultimately to Silicon and Carbon Dioxide.

Based on the consolidated RAC/SEAC opinion a total direct release factor to the aquatic compartment of between 0.1% and 2.6% is expected from use and manufacture of medical devices which are not rinsed off immediately, which is negligible when set against the benefit to patients.

Additionally, studies reporting fish populations in isolated lakes with no connection to ground or waste water sites showed levels of D5 below the limit of detection or at negligible levels. This strongly supports that deposition of the substance from the air compartment poses a limited risk to the environment due to limited potential for entry to other compartments from the air and therefore into biota.

Needles, IV sets, tubing

The following products are manufactured in the EU using raw materials (such as PDMS) containing D4, D5, D6. The raw materials are purchased within the EU and imported from outside the EU to support medical device manufacturing sites in the EU:

- Hypodermic needles (used in multiple medical devices such as syringes, IV sets, catheters etc.)
- IV sets
- Blood collection tubes
- Tubing

Due to the wide use of raw materials containing D4, D5, D6 across a very high number of medical devices, and the length of time required to source, validate and switch to alternative materials (and most likely requiring a change in the current processes and technology) there is a likelihood that medical device manufacturers, rather than pursue an Authorisation, will withdraw a number of devices from the EU market.

Pen-needles for injectable medicinal products

The needles are shaped in such a way as to reduce the force required to pierce and penetrate the skin. A thin layer of silicone coating on the tip of the needle lubricates the needle and reduces the friction of the metal surface of the needle considerably both during the puncture of the skin and when the needle is dragged back. This is essential for pain relief and for prevention of skin damage when using the needles. The lubricants may contain trace amounts of D4 and D6. The concentration of the cyclosiloxanes in the lubricated needles is less than 1 %.

Pen-needle manufacturers comply with international product standard ISO11608-2:2012, Section 4.7, which states that lubrication must be applied to the tips of the needle. Shifting to a different lubricant may impact patient perception and cause pain and thus thorough re-testing on patients will be needed. Silicone has been used for decades due to its chemical stability and inreactivity.

Plungers for injectable systems for injectable medicinal products

Siliconisation is needed to reduce the friction in the injectable system and thus facilitate both the device manufacturing process and injection of the medicinal product while maintaining drug product purity and function to deliver precise doses. The silicone used contains 0.1 – 1.0 % cyclosiloxane (D6) while the final siliconised injection systems contain only trace amounts of the cyclosiloxane.

The lubricant properties are critical to the performance of the medical device and no alternatives are currently known. Removing the current lubricant would affect functionality and patient safety significantly. Such a change would cause problems for weak patients using the injectable device and eventually this would impact the product approval.

Blood glucose monitors

D4, D5, and D6 are present as impurities in the aminopropyl terminated polydimethylsiloxane (PDMS) used in the biocompatible membrane of blood glucose monitors. PDMS is imported from outside the EU and mixed with another substance before being coated onto the glucose monitor in the EU.

PDMS represents 0.13 wt. % (0.0011 mg) of the glucose monitor. Independent analyses found that the combined quantity of D3, D4, D5 and D6 cyclic oligomers present in PDMS was <7 wt. %. This corresponds to 0.009 wt.% of cyclic oligomers present in the glucose monitor.

Between May 2019 and April 2020, one medical device company used 0.953 kg of aminopropyl terminated PDMS in the manufacture of blood glucose monitors. There is no suitable available alternative to the aminopropyl terminated PDMS that medical device companies currently use. Given that PDMS is a polymer and that D4, D5 and D6 are unintentional impurities, we understand PDMS is out of scope of REACH Authorisation for use, as per ECHA Q&A No. 565.

Also lancing devices and lancets used for blood glucose monitoring have been found to contain D5 in a 50% medical grade dispersion. Calculations based on the individual components of the lancing device and the 2 variants of the lancet (the needle is integrally moulded into the protective cover and housing, the needle and lancet must be regarded as a single unit), the following quantities of D5 have been found:

Lancing device: 0.0069 % w/w silicon
Needle 1: 0.0025 % w/w silicon
Needle 2: 0.0014 % w/w silicon

D5 is used as a coating on the polymer parts of the device and on the needle, itself helping the lancet puncture the skin and providing a relatively pain free procedure. Lancets and lancing devices are an essential part of the diabetic patients’ daily regime in aiding the management of their condition, as such having easy to use devices that reduce pain is essential.

Moving to alternative coatings for the lancets and lancing devices would take a significant amount of time (> 3 years) and cost to identify suitable alternatives to develop and test products whilst ensuring that they are equivalent to current products. The lancing devices are designed to be reusable with the ability of being disinfected over a lifetime of approx. 4 years. The lancets are sterile single use medical devices being disposed of in sharps containers as biohazardous waste.

The lancing devices and lancets are manufactured outside of the EU. They are imported as finished product and distributed within the EU. These products are deemed outside the scope of Authorisation.

In vitro diagnostic medical devices (IVDs)

Antifoam used to produce IVDs

D4, D5, and D6 are found in antifoams used to manufacture in vitro diagnostic (IVD) medical devices. Commercially available polydimethylsiloxane-based antifoam is made using cyclics (D4, D5, D6). They contain D4, D5 and D6 as residual impurities, they are not deliberately added and are technically unavoidable. Antifoam is used to control unwanted foaming in IVD products. Foam is produced when mixing in manufacturing, shipping, or handling product. As foaming can impact product stability and the analytical test, IVD companies use antifoams to mitigate foaming and protect product performance.

Use of polydimethylsiloxane-based fast antifoam is imperative for medical diagnostics and therapeutics in the healthcare sector. IVD products demand fast foaming mitigation to prevent product degradation during manufacturing, transport and handling. This application includes prevention of liquid detection errors or improper sampling that could lead to incorrect patient results during analytical test processing, thus potentially leading to medical reportable and non-reportable events. For this, suitable antifoaming/ defoaming agents must act within seconds to minutes. The only type of defoamers suitable for IVD applications have been proven to be polydimethylsiloxane based defoamers containing silica particles also known as fast defoamers. Other defoamers do not defoam fast enough. There is no suitable alternative to the fast-acting polydimethylsiloxane-based antifoam that are required for use in IVDs.

The volumes associated with this use for one of the largest IVD companies are as follows (based on 2019 projections):

D4 = 3.386kg
D5 = 3.386kg
D6 = 176g

MedTech Europe considers use of antifoam with unintentional residues of D4, D5, D6 out of scope of Authorisation, as per ECHA Q&A No. 565. Our interpretation is that D4, D5, D6 are incidental to the use of the antifoam and are therefore not a “use” in the context of Authorisation.

One of the largest IVD companies estimates their contribution to total volumes of D4, D5 and D6 as follows:

Total volume D4: 1,000 t/y to <10,000 t/y
0.003386 tons IVD company contribution

Total volume D5: > 10,000 t/y
0.003386 tons IVD company contribution

Total volume D6: 1,000 t/y to <10,000 t/y
0.000176 tons IVD company contribution

Authorisation for IVD products would therefore only marginally contribute to the overall effort to reduce D4, D5 and D6 in the environment, whereas the socio-economic impact of including these uses is substantial.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
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.2.01 Interplay between restriction and authorisation with regard to prioritisation
A.2.04 Restriction route considered as most appropriate by the SVHC or Restriction dossier submitter, RAC and SEAC
A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.02. Generic exemption of the uses in medical devices and/or medicinal products
Thank you for the information provided
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
				
3563
2020/06/05	DuPont de Nemours BvBa,
Company,
Belgium	see attached document	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.2.04 Restriction route considered as most appropriate by the SVHC or Restriction dossier submitter, RAC and SEAC
B.2.03 Transitional arrangements to be aligned with restriction transitional period
C.2.03. Request for exemption based on derogations from upcoming restriction
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
		Confidential attachment removed		
3568
2020/06/05	TEDAE,
Industry or trade association,
Spain		A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.2.04 Restriction route considered as most appropriate by the SVHC or Restriction dossier submitter, RAC and SEAC	
		Confidential attachment removed		
3570
2020/06/05	GlaxoSmithKline,
Company,
United Kingdom		A.2.01 Interplay between restriction and authorisation with regard to prioritisation
A.2.09 Request to include D4 in some derogations for D5 and D6 in upcoming restriction
A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
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. Request for exemption based on derogations from upcoming restriction
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
		3570_D4 D5 D6 Authorisation comment for proposal Public  (003) (002)_redacted.pdf

Confidential attachment removed

		

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3503
2020/06/02	Heraeus Quarzglas Bitterfeld GmbH & Co. KG,
Company,
Germany	OMTCS was suggested for inclusion to REACH Annex XIV. Within the framework of the Public Consultation opened on March 5th, 2020 we want to point to a use of OMTCS in a high-tech future technology.

OMTCS is converted in an industrial process to the gaseous state and in the subsequently at elevated temperatures transferred to silicon dioxide (SiO2) in purity >> 99.9 %. OMCTS is used as an intermediate product! Delivery, filling in storage tanks, supply to transformation and chemical transformation is done in a closed system under strictly controlled conditions. In case of any issue, process will be automatically switched off and interlocked into a safe state.

The produced SiO2 is processed in several working steps to optical fiber cables.

Optical fiber cables are a future-proof basis material - currently the development of 5G network technology - within the in digital communication sector. Future availability of this product is indispensable for this sector. In future, we see a high continuing demand for SiO2 in glass fiber cables. Heraeus Comvance as market leader, is working in cooperation with other companies to satisfy this demand.

Heraeus Comvance assists to lead world into next industrial era and to realize the idea of the internet of things. We use our experience of the production of quartz glass for further innovation:

- Implementation of industry 4.0 standards - e.g., increasing efficiency through logistical optimization
- Digitalisation in medical technology - e.g. communication between doctors, patients and surgeons
- Promotion of KI projects - e.g. decentralized data evaluation through worldwide networking of servers	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.6. Socio-economic benefits of continued use
Please see references to responses in section I	
		Confidential attachment removed
		
3513
2020/06/03	Cefic - CES Silicones Europe,
Industry or trade association,
Belgium	Cyclo-siloxanes are the building blocks of silicone polymers and these polymers have thousands of uses in construction, digital technologies, renewable energy, healthcare, transportation, and other critical markets.  There are no identified direct uses of D4; the use of D4 is as a monomer and intermediate in the manufacture of other silicon-based products.  As these monomer/intermediate uses are exempted from Authorisation, CES does not identify any volumes of D4 that would qualify for potential Authorisation and therefore inclusion of D4 to Annex XIV is completely unnecessary.	A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
A.2.14 Claim that there are no wide-dispersive uses of D4
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation	
		See the corresponding embedded attachment in Part I: 
3513_D4 CES Submission ECHA.pdf		
3543
2020/06/05	SEMI Europe,
Industry or trade association,
Germany	Please see attached our comments.	Please see references to responses in section I	
		See the corresponding embedded attachment in Part I: 
3543_SEMI Europe Comments on the draft recommendation of Octamethylcyclotetrasiloxane_D4_for inclusion in Annex XIV_Final.pdf		
3556
2020/06/05	European Semiconductor Industry Association,
Industry or trade association,
Belgium	With respect to the very complex nature of the manufacturing process, the long R&D and investment cycles of the semiconductor industry as well as the nature of the supply chain (mostly being located outside of Europe), ESIA requests that the 24-month timeframe would be chosen for the Latest Application Date.
Although ECHA requests that inputs regarding the present lack of alternatives or the estimated time to change industrial processes will not be given consideration with respect to the Latest Available Date, these are critical practical concerns that semiconductor manufacturers would have to manage to file an application for authorization.
Without being given the appropriate time to prepare an application – and if such authorization not granted, the semiconductor industry’s ability to operate in Europe would be at stake, and it could force semiconductor companies to stop production in Europe with tremendous negative economic and social impact.
	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.7. Potential competitive disadvantage
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset 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)
B.1.2.2. Lack of alternatives, socio-economic aspects
B.2.01. Request a LAD of 24 months, because of high complexity of supply chain	
		See the corresponding embedded attachment in Part I: 
3556_ESIA ECHA Consultation D4 10th Dr Priority List June 5 2020.pdf		
3563
2020/06/05	DuPont de Nemours BvBa,
Company,
Belgium	see attached document	Please see references to responses in section I	
		Confidential attachment removed		

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	
3503
2020/06/02	Heraeus Quarzglas Bitterfeld GmbH & Co. KG,
Company,
Germany	Heraeus Comvance assists to lead world into next industrial era and to realize the idea of the internet of things. We use our experience of the production of quartz glass for further innovation:

- Implementation of industry 4.0 standards - e.g., increasing efficiency through logistical optimization
- Digitalisation in medical technology - e.g. communication between doctors, patients and surgeons
- Promotion of KI projects - e.g. decentralized data evaluation through worldwide networking of servers
	Please see references to responses in section I	
		Confidential attachment removed		
3513
2020/06/03	Cefic - CES Silicones Europe,
Industry or trade association,
Belgium	To the best of our knowledge there is currently no direct use of D4 in consumer or professional products, and no wide-dispersive use.
CES considers laboratory use and laboratory use in quality control of D4, D5, and D6 need to be exempted from authorisation. We believe that the laboratory use and sampling for laboratory use of D4, D5 and D6 in quality control is still part of the manufacturing process. These uses follow standard laboratory practice with respect to emissions and use of personal protection equipment as well as the waste treatment of such laboratory samples (e.g. treatment by incineration).	A.2.14 Claim that there are no wide-dispersive uses of D4
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.01. Request to clarify generic exemption for laboratory use	
		See the corresponding embedded attachment in Part I: 
3513_D4 CES Submission ECHA.pdf		
3525
2020/06/04	Eli Lilly Kinsale Limited,
Company,
Ireland	An outline of the reasons why industrial uses of antifoam formulations containing silicone polymers which contain D4, D5 and D6 as residual monomer impurities above 0.1% (w/w), is provided in the attachment included in Section IV	A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation
	
		See the corresponding embedded attachment in Part I: 
3525_Eli Lilly Kinsale Limited_ Comments on Inclusion of D4, D5 and D6 in the Authorisation List.pdf		
3530
2020/06/04	Sanofi Group,
Company,
France	Dear Sirs,
Sanofi would like to add a comment on uses which should be exempted from Authorisation. This comment is applicable to all 3 substances under the scope: D4, D5 and D6. Please take into account also our attached pdf version of our comment.

COMMENT ON THE PUBLIC CONSULTATION OF THE DRAFT RECOMMENDATION FOR INCLUSION OF D4, D5 AND D6 IN THE AUTHORISATION LIST

1. CONTEXT / PRODUCTS AND USES AT STAKE:
Industrial uses of:
• Antifoam agents used by the pharma industry including vaccines & biologics
• Stoppers and lubricants used for stoppers as primary packaging components
• Tubings, cables, gaskets and valves used in single use systems
The pharmaceutical industry needs to secure the future of vaccines and any other pharmaceutical product’s production to be able to serve the patients and because of public health.

D4, D5 and D6 are siloxane derivatives which were identified as SVHC substances with PBT (persistent, bioaccumulative and toxic) / vPvB (very persistent, very bioaccumulative) properties and have been included in the candidate list on 27, June 2018.

a) Octamethylcyclotetrasiloxane (D4), EC Number: 209-136-7, CAS Number: 556-67-2
b) Decamethylcyclopentasiloxane (D5), EC Number: 208-764-9CAS Number: 541-02-6
c) Dodecamethylcyclohexasiloxane (D6), EC number: 208-762-8, CAS number: 540-97-6

D4, D5, D6 substances are present above the REACh regulatory threshold mentionned in Art.56.6 for substance contained in a mixture in a concentration that goes beyond 0,1% w/w quantity in polymers which are part of several silicone based products used by the pharmaceutical industry, for example in biotechnology and vaccines production.
D4, D5, D6 are used as monomers to synthetize silicone polymers, which are components of the final products under the scope of this communication. But as the degree of polymerization will never be 100%, residual D4, D5 and D6 monomers as impurities will be always present after polymerization above a 0,1 % (w/w).
Sanofi performed an in-depth analysis by documented contacts with suppliers. The impacted suppliers all confirmed that the D4, D5, D6 contents in their products are in each case impurities resulting from the polymerization processes during manufacturing the silicon polymer component of their product. None of the above-mentioned products contain intentionally added D4, D5 and D6 content, since their presence is only due to the residual monomer content in the polymer, as impurities.

The anti-foam agents are crucial to the manufacturing process. They are often added to bioprocesses to control the foam produced, which can be responsible of an overflow of fermenters due to the presence of persistent foam and the inhibition of growth due to poor oxygenation of the medium and / or due to the molecule itself, in this way its use ensure and guarantee the appropriate yield and product quality.
It is very constraining to substitute any well working anti-foam agent with other alternatives in biotech processes as the sourcing and screening of alternatives is based on small-scale comparative trials and then on industrial scale on the basis of in-process and final tests on the drug substance, with the addition of the supplier approval process based on quality and regulatory requirements.
In the past, especially in vaccines production, Sanofi observed that the substitution can have a significant effect on the yield therefore, it is endangering the whole vaccines accessibility.

Tubings, cables, gaskets and valves used in single use systems are broadly used during manufacturing steps of active pharmaceutical ingredient and during final drug production. The use of single use technology results in a reduced risk of cross-contamination and increased assurance of sterility due to elimination of cleaning between batches.
Primary packaging components such as stoppers and lubricants used for stoppers are impacted by the authorisation propsal. These products are critical components that are difficult to substitute.

2. RESTRICTION PROCESS
In 30.01.2019, the European Chemical Agency initiated a restriction dossier for D4, D5 and D6 if used above a concentration > 0,1% w/w on the basis of Article 69(1) of the REACH Regulation. The scope of this proposal is limited to the placing on the market of professional and consumer substances and mixtures containing D4, D5 and D6 as that was the scope set out in the request from the European Commission.
Both RAC cand SEAC agreed that the proposed restriction is the most appropriate risk management measure to control the risks of the three siloxane derivative substances.
The restriction proposal was aimed to focus on consumer and professional uses, nevertheless there were some confusions for industrial users. The proposed restriction text of the Annex XV report was adjusted after the RAC-SEAC opinion was published.
• In both the Annex XV report (version number: 1.1 date: 20 March 2019) and in SEAC-RAC opinion report the Brief title of the restriction is: ”Restriction of D4, D5 and D6 in consumer and professional products” and industrial uses are not highlighted.
• Furthermore, it is also highlighted in the RAC opinion that the restriction proposal excludes industrial uses of D4, D5 and D6 (such as formulation of mixtures, production of silicone polymers or production of articles). These are therefore not in the scope of the proposed restriction or of this opinion.
Nevertheless, we observed significant differences between the new restriction proposal text of the SEAC draft opinion and the original ANNEX XV report related to industrial uses.
• The Annex XV restriction report of D4, D5 and D6 stated in the original proposed text of the restriction among the derogations that the “restriction shall not apply to uses at industrial sites”
• While in the RAC-SEAC OPINION, the proposed restriction text has been changed and only certain industrial use examples highlighted to be exempted.

3. AUTHORISATION PROCESS
Authorisation process implies two steps :
1) First: SVHC / Inclusion in the candidate list
2) Second : Recommendation for inclusion in the Authorisation list / Annexe XIV
For D4, D5 and D6 a public consultation for authorisation has been launched on 05.03.2020 (draft recommendation for inclusion in the Authorisation List/ Annex XIV).
It raises the key question whether an impurity may be concerned by the REACh authorisation.
4. REGULATORY CONCERNS
4.1. Regarding the Restriction process
The new text in the SEAC-RAC opinion report is confusing on the question to determine whether industrial uses are generally exempted or just the highlighted specific industrial uses are exempted. As drafted in the new SEAC-RAC opinion report, the highlighted industrial uses do not cover all segments of the industry and there can be also new industrial uses identified in the future.
We highlighted these concerns during the public consultation period of the SEAC draft opinion and we also adviced to highlight as an exemption the industrial use of D4, D5 and D6 (as residual monomers) in polymers as part of mixtures used as anti-foam agents
We feel that these concerns were not taken into account nor by SEAC nor by the Agency despite the major impacts of such restriction.

4.2. Regarding the Authorization process
In addition to the restriction process which is currently ongoing, and very surprisingly, on the 5th of March 2020, ECHA published a news considering recommending D4, D5, D6 for the European Commission to include in the Authorisation List (Annex XIV to REACH).

If this initiative is accepted by the Commission, after the sunset date, the use of D4, D5 and D6 will be possible only after a successfull application for authorization. Such authorization is granted only for a limited time and a substitution plan will have to be attached. The recommendation to the authorization list clearly focuses on industrial uses which are not under the scope of the actual restriction proposal.

KEY QUESTIONS
Question 1: Is residual monomer content considered as an impurity and do impurities fall under the authorization process?
Based on Q&A on Authorisation (Modified Date: 03/10/2018, ID: 0565, Version: 1.0):
“The authorisation requirement applies to the placing on the market and use of a substance on its own as listed in Annex XIV. Therefore, it usually does not apply if the Annex XIV substance is only an impurity or additive or constituent of another substance, unless this is specified in the Annex XIV entry (e.g. substance W and substances X, Y and Z containing substance W in a concentration ≥ x %) or the other substance is also listed in Annex XIV. If a substance listed in Annex XIV is included as a component in a mixture, the authorisation requirement applies for this use (i.e. the formulation of the mixture). Further, the placing on the market and use of such mixtures require authorisation, unless the Annex XIV substance is present in the mixture below the concentration limits set out in REACH Article 56(6).”
Furthermore, regarding the substance definition: (Article 3, REACH):
“substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;”
We want to emphasize that the D4, D5, D6 content is coming from the manufacturing process of the polymer, and the aim of the process is to produce the polymer, not to have a monomer content.
In addition, based on ECHA Q&A 67 (Modified Date: 04/06/2015, ID: 0067, Version: 1.0)
„What is an impurity in a polymer?
An impurity in a polymer is defined as an unintended constituent present in the manufactured polymer substance. It may originate from the starting materials, such as the monomers or any other reactants, or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added. Examples of impurities in a polymer include unreacted monomers or other reactants, residual polymerisation catalyst, or any contaminant from the manufacturing process
Therefore, it appears that residual monomers can be considered as impurities and do not fall under authorisation.
 

Question 2: Are monomers used for the manufacturing of polymers exempted from authorisation?
The ECHA Guidance precises that any substance used as a monomer in the manufacturing of a polymer is by definition an intermediate (section 2.1 Guidance for monomers and polymers v. 2.0)
Therefore our understanding is that based on REACH article 2,  8.(b) monomers which are used as intermediates are exempted from authorization.
Therefore, we are on the standpoint that D4, D5, D6 used as monomers to manufacture silicone polymers are exempted from REACH authorization.

Question 3: Which regulatory pathway is considered as major (authorisation or restriction) for industrial uses of D4, D5, D6 ?
We are also confused by the fact that in addition to the ongoing restriction process for D4,D5,D6,  an additional new process to recommend D4, D5, and D6 for authorisation has been launched by ECHA without any previous notice which left the industry unprepared.
As a matter of fact, in principle the restriction is considered as the most appropriate risk management measure by ECHA.
In addition the restriction proposal text in the Annex XV report and the SEAC opinion was completely different from each other and confusing in the view of industrial uses.
It would be important to have a clarification from ECHA wich risk management measure they focus on and to clarify the scope of the planned restriction and authorization (overlap of procedures).
The industry would like to secure the future of pharmaceutical products, including vaccines and biologics production to be able to serve our patients and because of public health.

To summarize, we need ECHA’s confirmation whether the use of D4, D5, D6 as monomers in the synthesis of polymers and the industrial uses of antifoam agents, stoppers, tubings, cables, gaskets and valves and other products containing silicon polymers which contain D4, D5, D6 as residual monomer impurities above a 0,1% (w/w) are exempted from Authorisation or not?
In addition, we need clarification on the scope of the 2 regulatory pathways.

Compiled and submitted by the Sanofi Group

04.06.2020
	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.2.02 Claim that industry was unprepared for draft recommendation without further notice
A.2.04 Restriction route considered as most appropriate by the SVHC or Restriction dossier submitter, RAC and SEAC
A.2.10 Understanding that the use of D4, D5 or D6 in the production of (silicone) polymers is intermediate use
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.03. Request for exemption based on derogations from upcoming restriction
C.2.05. Claim that the use of silicone polymers and their mixtures are generically exempt from authorisation
	
		See the corresponding embedded attachment in Part I: 
3530_Sanofi D4 D5 D6 AUTHORISATION COMMENT.pdf		
3543
2020/06/05	SEMI Europe,
Industry or trade association,
Germany	Please see attached our comments.	Please see references to responses in section I	
		See the corresponding embedded attachment in Part I: 
3543_SEMI Europe Comments on the draft recommendation of Octamethylcyclotetrasiloxane_D4_for inclusion in Annex XIV_Final.pdf		
3556
2020/06/05	European Semiconductor Industry Association,
Industry or trade association,
Belgium	As per the comments on the semiconductor industry’s identified use of D4, ESIA member companies have reassessed the identified use as an “Industrial use resulting in manufacture of another substance (use of intermediates)”.
ESIA understands that generally substance use for the manufacture of articles does not qualify to be regarded as intermediate use. However, as in this case, D4 is used as precursor in a chemical processing steps to manufacture another substance layer on a (silicon semiconductor wafer) substrate that is to become a finished article (upon conclusion of all manufacturing steps). Therefore,  ESIA does consider that D4 precursor use may be regarded as an intermediate use for the exact manufacturing step of deposition of a specific dielectric layer.
With the overall exemption of intermediates from REACH Authorization provisions, it could be concluded that the use of D4 as a precursor for radio frequency plasma enhanced CVD deposition of a specific dielectric layer in wafer manufacturing would be exempted from the authorization requirement.
	A.2.13 Understanding that use of D4 in chemical vapour deposition is intermediate use
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions	
		See the corresponding embedded attachment in Part I: 
3556_ESIA ECHA Consultation D4 10th Dr Priority List June 5 2020.pdf		
3558
2020/06/05	MedTech Europe,
Industry or trade association,
Belgium	Medical devices for treatment/care of scars and wounds, prevention of wounds and care of stoma

An Annex XV  dossier is currently under review to restrict the manufacturing, placing on the market and use of D4, D5 and D6. In the context of this restriction, a derogation has been proposed for the use of D5 and D6 in medical devices for the treatment/care of scars and wounds, prevention of wounds and care of stoma. These applications have high societal value and the use of D5 and D6 is recognised in the Annex XV dossier as state of the art in the above mentioned treatments.

Including these uses in the scope of Authorisation would prevent these specific medical devices to be produced in Europe without the submission of an Application for Authorisation. MedTech Europe recommends exempting these uses from Authorisation, in alignment with the proposed derogation in the restriction dossier. This would maintain the social and health benefits of the mentioned medical devices and avoid negative effects on the international competitiveness of EU companies manufacturing (formulating) them.	C.2.03. Request for exemption based on derogations from upcoming restriction	
				
3563
2020/06/05	DuPont de Nemours BvBa,
Company,
Belgium	see attached document	Please see references to responses in section I	
		Confidential attachment removed