EU overrules a Danish national ban of four phthalates

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In 2011 Denmark submitted a proposal for the EU regulation of four phthalates, and in the same time a Danish ban was decided for the placing on the market of articles intended for use indoors and articles that may come into direct contact with the skin or mucous membranes containing one or more of the four phthalates in a concentration greater than 0.1 % by weight of any plasticised material.

The four phthalates were all reported to affect testicular functions and to have adverse effects on sexual differentiation during the developmental process. They were furthermore found to be endocrine disruptors by exerting anti-androgenic effects.

The names and structures of these phthalates:

DBP

Dibutyl phthalate (DBP), CAS no. 84-74-2, EC no. 201-557-4

DIBP

Diisobutyl phthalate (DIBP), CAS no. 84-69-5, EC no. 201-553-2 

DEHP

Di(2-ethylhexyl) phthalate (DEHP), CAS no. 117-81-7, EC no. 204-211-0

BBP

Benzyl butyl phthalate (BBP), CAS no. 85-68-7, EC no. 201-622-7

This ban should have been in force from December 2015 but a decision of the European Court from 2013 implied that the Danish Environment Minister on July 1, 2014, announced that Denmark would remove the ban and wait for the normal procedures and decisions of the European Chemicals Agency (ECHA), that is currently assessing, whether there is basis for a EU-wide ban.

Already in 2012 Denmark submitted a large ANNEX XV RESTRICTION REPORT with the scientific background for the restriction proposal. That report has been evaluated by the ECHA Committees for Risk Assessment (RAC) and for Socio-economic Analysis (SEAC), who both concluded that the proposed restrictions were not justified, because the available data did not indicate that currently (2012) there was a risk from combined exposure to the four phthalates.

Denmark is the leading edge in EU regarding regulation of phthalates. A Status on phthalates was published in 2003, and a “Phthalate strategy” was developed in 2013. Since 2009 there has been a Danish national ban on all phthalates in toys and articles for children 0-3 years.

There has been a EU-wide ban since 2007 regards three phthalates (DEHP, DBP, and BBP) in toys and articles for children aged 0-14 years. In addition, DINP (diisononyl phthalate), DIDP (diisodecyl phthalate) og DNOP (di-n-octyl phthalate) are banned in these products, if these articles could be placed in the mouth.

In the same time Denmark cancelled its national ban on the four phthalates, these substances have been added to the REACH Registry of SVHC Intentions. This is very curious, because the list of substances of very high concern (SVHC) is the basis for the Candidate list (now 155 chemicals) and Annex XIV substances, and these same four phthalates are already on the candidate and authorisation lists. It seems that the internal communication and management in ECHA are insufficient!

Furthermore, the four phthalates are presently in the Authorisation process and has to be banned in 2015, if no company gets authorisation for further use. In this respect ECHA’s Committees for Risk Assessment and Socio-economic Analysis have recently adopted positive opinions on an application for authorisation from Roxel (UK Rocket Motors) Ltd. This application concerned i) the industrial use of bis(2-ethylhexyl) phthalate (DEHP) and ii) dibutyl phthalate (DBP) in the manufacture of solid propellants and motor charges for rockets and tactical missiles and iii) on the industrial use of dibutyl phthalate (DBP) within a specialty paint in the manufacture of motors for rockets and tactical missiles. The Committees concluded that the applicant had demonstrated adequate control and proposed to review the authorisation in four years, in line with the requested review period. The European Commission will make the final decision on the application, based on ECHA’s opinions.

Finally, The Candidate List contains following other phthalates, sometimes named as 1,2-benzenedicarboxylic acid dialkylesters:

  • Dipentyl phthalate (DPP)
  • Diisopentyl phthalate (DIPP)
  • Pentyl isopentyl phthalate (PIPP)
  • 1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear (overlaps with the prevoius three dipentyl esters)
  • Dihexyl phthalate (DHxP)
  • 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear (overlaps with previous – see also the News Blog from  June 19)
  • Bis(2-methoxyethyl) phthalate
  • 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (mixtures of variable composition)
  • 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters (mixtures of variable composition).

I have previously,  June 19, in the News Blog mentioned that ECHA makes many inconsistencies and mistakes concerning their applied chemical nomenclature.

For instance, ECHA uses the names bis(2-ethylhexyl) phthalate and bis(2-methoxyethyl) phthalate in stead of the correct ones: di(2-ethylhexyl) phthalate and di(2-methoxyethyl) phthalate. “Bis” is only allowed, if the two similar alkyl groups are connected to the same atom as e.g. in bis(chloromethyl) ether but that is not the case for DEHP and other phthalates – and for other phthalates “di” i correctly used. Also the use of both “phthalates” and 1,2-benzendicarboxylic (phthalic) acid dialkyl esters are also confusing but may be the bureaucrates in Helsinki don’t know, what they are dealing with?

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