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Chemical,REACH,Restriction,Phthalates,Substance,Assessment

Under the requirements of Article 69(2) of REACH Regulation, ECHA is required to consider whether the use of 10 phthalates should be restricted. After gathering information from various sources, ECHA has prepared a report with the view that the use of the above substances have been largely phased out in EU.

Among the ten phthalates, the first seven entries in Annex XIV (33-39) of REACH have passed their sunset date of 4 July 2020 and the remaining three entries (44-46) have passed their latest application date of 27 August 2021. ECHA has not received any applications for authorisations for these substances.

Submissions for the presence of the substances in articles to fulfil obligations under the Waste Framework Directive (SCIP database) indicate that nine out of the ten phthalates (i.e., excluding n-pentyl-isopentylphthalate) are contained in imported articles only, likely in volumes of less than one tonne of the substances per importer. Besides, ECHA did not identify any new uses of the substances in articles placed on the EU market during public consultation period which took place between 8 December 2021 and 26 January 2022.

However, following an assessment of the available evidence, ECHA still holds the view that further examination of the risks from the use of the ten phthalates in articles should be considered as part of a larger investigation to address risks of ortho-phthalates, with suspected similar concerns to human health, as well as to the environment. Ortho-phthalates (with a backbone C4-C6) are listed in the Restriction Roadmap (expected to be published by the EU Commission soon), restriction proposal to be initiated by the European Commission under the Chemical Strategy for Sustainability.

The ten phthalates includes:

Annex XIV #	Substance Name	EC No.	CAS No.
33	Diisopentylphthalate	210-088-4	605-50-5
34	1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich	276-158-1	71888-89-6
35	1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters	271-084-6	68515-42-4
36	1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear	284-032-2	84777-06-0
37	Bis(2-methoxyethyl) phthalate	204-212-6	117-82-8
38	Dipentyl phthalate	205-017-9	131-18-0
39	n-pentyl-isopentylphthalate	933-378-9	776297-69-9
44	1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear	271-093-5	68515-50-4
45	Dihexyl phthalate	201-559-5	84-75-3
46	1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters or mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (201-559-5)	272-013-1 271-094-0	68648-93-1 68515-51-5

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ECHA Believes the Uses of Ten Phthalates have been Largely Phased Out in EU