Comments on ECHA’s Draft 10th Recommendation for Dicyclohexyl phthalate (DCHP) (EC number: 201-545-9) 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 Dicyclohexyl phthalate (DCHP) (EC number: 201-545-9). 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_dchp_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	
3469
2020/04/01	STMicroelectronics ,
Company,
Switzerland	It is used in specific glue for electronics components manufacturing. In this specific application no exposure is expected for workers, thanks to the strictly controlled measures. No exposure arises during use phase of electronics components as well.	A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
Thank you for the information provided	
				
3492
2020/05/28	Nouryon Functional Chemicals B.V. ,
Company,
Netherlands	The registrant agrees with the prioritization of DCHP. No further comments.	Thank you for your opinion.	
				
3535
2020/06/04	COIM S.p.A.,
Industry or trade association,
Italy	1. Intrinsic properties
No comments in regards to the intrinsic properties of the substance and its identification as a SVHC. The Fish Sexual Development Test (OECD 234) for the evaluation of whether the substance could have any endocrine properties on fish is still in progress. We have no comments on the score given for the prioritisation (7)

2. Volume used in the scope of authorisation
It is expected that the volume of the substance present in the European market (produced and imported) should be in the range of 100 -1000 t/a, or if the tonnages exceed this tonnage range, it should be just above 1000 t/a.
The score given for the prioritisation (12) should therefore be decreased to 9 considering that the total tonnage band is assumed to be in the range of 100-1000 t/y and not in the 1000 – 10000 t/y.

3. Wide-dispersiveness of uses
The uses have been changed regarding the registered uses. The substance is not handled in a wide or in a dispersive way, as its use is limited in the industrial and professional sectors. No consumer uses or inclusion in articles are identified for DCHP.
The wide-dispersiveness of uses is primarily assessed based on the types of actors which are relevant for the use of a substance. There are three main use types: industrial (IND), professional (PROF) and consumer (CONS) uses. DCHP uses are currently uses at industrial sites and uses by professional workers. No consumer uses are identified. No inclusion in articles are applicable for the substance and in any case even if it is included, it is not expected to be released under the normal conditions of use.
The score given for the wide-spreadness takes in consideration the older uses, a new score should be considered. The control of release and the wide-spreadness is undoubtfully decreased due to the fact that the consumer and service life are not applicable. A refined score of 12 was assigned as the substance had both Industrial and Professional uses, and in addition was used in articles in volumes ≥10 t/y (and assuming that the release from those articles is not considered negligible). Since only industrial and professional uses are present, the WDU score should be decreased to 10.
Consumer uses are no longer a relevant use for DCHP, as per the registrant currently submitting the comments. However, it is worth noting that the restriction of the substance that results to a maximum concentration of 0.3 % in articles, could significantly reducing the risks to human health of exposure. Any associated risks for the environment from the articles in scope would also be reduced as a result of the proposed restriction. Also, the use of the substance in mixtures at concentrations equal to or above 0.1 % requires authorisation, therefore, this may furthermore reduce occupational risks due to possible substitution of DCHP in its use in mixtures in the EU.

4. Further considerations for priority setting
The phthalates present in Annex XIV have different applications and uses and therefore an increase of the tonnages of DCHP due to a substitution is not expected. An important note is that from the
phthalates manufactured/imported at the greatest tonnage band, the sunset date was in 2015, while five phthalates have as a sunset date July 2020. Therefore, if DCHP was used as an alternative for some of the uses of the specific substances, it would have been expected that the tonnages of DCHP would have been increased exponentially. The later assumption has not been verified by the tonnages of the last three years of the registrant currently submitting the comments. Last but not least, DCHP is not recommended as an alternative substance for the substitution of the four phthalates (DEHP, BBP, DBP, DIBP); other substances are suggested instead. There is a wide range of applications in which non-phthalate plasticisers are currently being used. However, it is showed that there is no single alternative that covers all applications. This is because of the very broad application of DEHP and to some extent DINP/DIDP which are the most commonly used alternatives to DEHP. It also seems like there are other factors that act as barriers for substitution.
In contrast with the rest of phthalates, DCHP is not used for the production of PVC and is not contained in articles. A minimal use of DCHP was used in PVC during the previous years, however, this use is not applicable for the substance and no consumer use or use in articles with intentional release is identified. DCHP is predominantly used as a flame retardant in organic peroxides	A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.2.01. Priority assessment: Request to lower volume score from 12 to 9
A.2.02. Priority assessment: Request to lower WDU score from 12 to 10 as consumer uses and article service life are not considered relevant
A.2.03. Restricting the use of DCHP in articles would reduce exposure
A.2.04. Claim that DCHP is not used to substitute phthalates already included in Annex XIV	
		3535_Comments on the public consultation_DCHP_PUBLIC.pdf

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II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3479
2020/04/30	Murata Electronics Oy,
Company,
Finland	Latest application date should be as long as possible, (24 months), because changes in automotive applications require long qualification and acceptance.	B.1.2.2. Lack of alternatives, socio-economic aspects	
				
3492
2020/05/28	Nouryon Functional Chemicals B.V. ,
Company,
Netherlands	The registrant supports Latest Application (LAD) of Date of inclusion in Annex XIV plus 18 months and a Sunset date of 18 months after LAD for DCHP. No further comments.	Thank you for your opinion.	
				
3535
2020/06/04	COIM S.p.A.,
Industry or trade association,
Italy	1.Latest application and sunset dates
The latest application date, i.e. 24 months after the date of inclusion in Annex XIV is proposed. The study conducted according to the OECD 234 is still in progress and its results could trigger another hazard classification or the need of a higher tier test in order to conclude on the endocrine properties of the substance to fish. Therefore, the latest application date would permit the consideration of the need of a risk assessment in both humans and environment (in case the environment triggers any concern).

2. Review period for certain uses
Different substances have been suggested as alternative substances for the four phthalates (DEHP, BBP, DBP, DIBP)) mainly for their use as plasticiser, a use no longer applicable for DCHP. These phthalates have different uses from DCHP and therefore it should not be taken for granted that the specific alternatives could be a good alternative for all the uses of DCHP. It is therefore requested to include in Annex XIV a review period for dicyclohexyl phthalate.	B.1.3.1. Upfront review periods
B.2.01. Request for LAD of 24 months to await outcome of the ED ENV assessment (via SEV)	
		3535_Comments on the public consultation_DCHP_PUBLIC.pdf
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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	
3479
2020/04/30	Murata Electronics Oy,
Company,
Finland	Semiconductor packaging material / Industrial adhesives used in automotive products, should be exempted.
In these products reliability is key factor in safety.
Adhesive is not touched by consumers in these products.
	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation	
				
3492
2020/05/28	Nouryon Functional Chemicals B.V. ,
Company,
Netherlands	None. The registrant does not request exemption for the uses reported in his REACH dossier.	Thank you for your comment.	
				
3535
2020/06/04	COIM S.p.A.,
Industry or trade association,
Italy	No exempted uses are proposed.	Thank you for your comment.	
		3535_Comments on the public consultation_DCHP_PUBLIC.pdf
Confidential attachment removed