Comments on ECHA’s draft recommendation for amendment of Authorisation List entries and references to responses

Substance name: Diisobutyl phthalate (DIBP)

EC number:  201-553-2

The present document compiles the comments received for Diisobutyl phthalate (DIBP) during the public consultation on the draft recommendation for amendment of Authorisation List entries (12 December 2018 to 12 March 2019) as well as the previous public consultation hosted on behalf of the Commission (5 June 2018 to 6 August 2018) on that issue. All comments from both public consultations were considered for the amendment recommendation. 

 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/axiv_amend_recom_phthalates_respdoc_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 - Transitional arrangements: comments on the proposed Latest Application Date and Sunset Date
II - Comments on uses that should be exempted from authorisation, including reasons for that
III - Comments on uses for which review periods should be included in Annex XIV, including reasons for that

I - Transitional arrangements: comments on the proposed Latest Application Date and Sunset Date
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3439
2018/08/06	European Human Biomonitoring Initiative (HBM4EU),
Other contributor,
Germany	As representative of HBM4EU we argue for the earliest date possible for both, the Latest Application Date and Sunset Date.
Because of the high concern among the HBM4EU partners as well as the EU and national policy makers, phthalates were selected as one of the first prioritised substance groups in HBM4EU. As of 2019, human samples will be collected in different European countries in which the exposure to phthalates and the other priority substances will be measured. Human biomonitoring data from the European DEMOCOPHES study that included 17 countries showed already widespread exposure to phthalates in European citizens in 2011 when samples were taken (Den Hond et al. 2015). Recent human biomonitoring data from single European countries, e.g. collected within the ‘German Environment Survey’ (GerES V 2014-2017, paper in preparation) indicate that despite existing regulations, populations are still exposed to these phthalates.	B.2.07 Request for earliest possible Latest Application and Sunset Date	
		3439_HBM4EU_OpenConsultation_Phthalates_Attachment.docx
		
3446
2018/08/06	European Plasticisers,
Industry or trade association,
Belgium	Please see comments on bis(2-ethylhexyl) phthalate (DEHP) (reference number b8807f04-79c5-4a2f-9975-b8f46ea30292) in attachment	A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.2.04 Reminder that decisions by the Commission on some applications for authorisation for DEHP are still pending
A.2.07 Questioning the endocrine disrupting properties
A.2.08 Questioning the reproductive toxicity	
				
3458
2019/03/12	Health and Environment Alliance (HEAL),
International NGO,
Belgium	See attachment	A.2.03 Urging ECHA to set concentration limits below 0.1% for the four phthalates due to cumulative effects
B.1.2.2. Lack of alternatives, socio-economic aspects
B.2.07 Request for earliest possible Latest Application and Sunset Date
C.2.01 Use in medical sector, including (in vitro diagnostic) medical devices	
		3458_HEAL_contribution_PC_AnnexVIV_Amend_phthalates_short.pdf
		
3462
2019/03/12	Cefic - European Plasticisers,
Industry or trade association,
Belgium	I refer to comments made by European Plasticisers to DEHP via the attachment	A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.2.02 Claim that lower concentration limit will have negative impact on recycling rates of PVC
A.2.04 Reminder that decisions by the Commission on some applications for authorisation for DEHP are still pending
A.2.07 Questioning the endocrine disrupting properties
A.2.08 Questioning the reproductive toxicity	

II - 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	
3439
2018/08/06	European Human Biomonitoring Initiative (HBM4EU),
Other contributor,
Germany	In our view as representative of HBM4EU, there should be no exemptions from the authorisation requirement. We think exemptions are not advisable, because (i) compounds with SVHC properties should not be released into the environment due to precautionary principle, (ii) there is evidence for anti-androgenic mixture effects (dose addition) of phthalates and (iii) imported goods are already exempted from authorisation. The proof of internal exposure in humans by human biomonitoring data underlines the need for stricter limitations of potential exposure sources.	Thank you for your opinion.	
		3439_HBM4EU_OpenConsultation_Phthalates_Attachment.docx
		
3446
2018/08/06	European Plasticisers,
Industry or trade association,
Belgium	Please see comments on bis(2-ethylhexyl) phthalate (DEHP) (reference number b8807f04-79c5-4a2f-9975-b8f46ea30292) in attachment	Please see references to responses in section I	
				
3462
2019/03/12	Cefic - European Plasticisers,
Industry or trade association,
Belgium	I refer to comments made by European Plasticisers to DEHP via the attachment	Please see references to responses in section I	

III - Comments on uses for which review periods should be included in Annex XIV, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3446
2018/08/06	European Plasticisers,
Industry or trade association,
Belgium	Please see comments on bis(2-ethylhexyl) phthalate (DEHP) (reference number b8807f04-79c5-4a2f-9975-b8f46ea30292) in attachment	Please see references to responses in section I	
				
3462
2019/03/12	Cefic - European Plasticisers,
Industry or trade association,
Belgium	I refer to comments made by European Plasticisers to DEHP via the attachment	Please see references to responses in section I