If DEHP is a low phthalate of very high concern, shouldn’t it be banned in medical applications?
DEHP has been registered under the EU’s Chemicals Legislation REACH. It is classified as a Substance of Very High Concern (SVHC), therefore its uses are subject to Authorisation since 2015. The use of DEHP in some medical applications is still in Europe, but upon an evaluation of possible alternatives, four new plasticisers have been added to the European Pharmacopoeia: DINCH (cyclohexane-1,2-dicarboxylic acid, diisononyl ester) BTHC (butyryl tri-n-hexyl citrate) TOTM (tris(2-ethylhexyl) trimellitate) DEHT (bis(2-ethylhexyl) terephthalate) These plasticisers can be used for containers and tubing used in human blood and blood components and empty sterile containers of plasticised PVC for human blood and blood components. In addition, these plasticisers are used for the manufacture of tubes in sets for transfusion of blood and blood components. [They are also used in the manufacture of plasticised poly(vinyl chloride) tubes for sterile containers for human blood containing anticoagulant solution.. [1] Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Link
European Plasticisers comments on ECHA’s recommendation to amend authorisation list for DEHP, BBP, DBP and DIBP
ECHA has recommended that the European Commission should amend the REACH authorisation list to include endocrine disrupting properties for four phthalates: DEHP, BBP, DBP, and DIBP. If these changes are brought about, some previously exempted uses will require authorisation. These include the use of DEHP in food contact materials or medical devices. Further recommendations from ECHA are that the exemption for DEHP in medicinal product packaging be removed and that authorisation should be required for any of the four phthalates present in mixtures at concentration above or equal to 0.1% by weight. Consistent with better regulation, and in the interests of the circular economy, European Plasticisers calls on the European Commission not to adopt this recommendation from ECHA. It should be noted that DEHP, DBP, BBP and DIBP are already listed on Annex XIV due to Category 1B reproductive effects, and further listings as endocrine disruptors are based on these same adverse effects. Since the substances have already been extensively regulated and phased out by this first listing on Annex XIV (and the Candidate List), the added value of second and third listings is very questionable given the limited benefits. We therefore question the efficiency and potential of this amendment […]
Final SEAC and RAC opinions support the restriction of DEHP, DBP, BBP and DiBP
Brussels, 29 June – On 20 June, ECHA announced that the Socio-Economic Assessment Committee (SEAC) adopted a final opinion on the restriction of four low molecular weight phthalates. Based on socio-economic arguments, SEAC opinion confirms the position expressed in March by ECHA’s Risk Assessment Committee (RAC) supporting the restriction of the use of DEHP, DBP, BBP and DiBP in articles either imported or manufactured in Europe. European Plasticisers welcomes the establishment of a level playing field for the European industry versus importers of articles manufactured outside the EU. Nevertheless, the very broad scope of the restriction may undermine the Authorisation of DEHP which is still pending after two and a half years from the Sunset date and despite the favourable opinion of both ECHA committees on Authorisation. Manufacturing of articles from recycled flexible PVC will also be affected by the restrictions decision with implications for the circular economy. The final opinions of RAC and SEAC diverge from the position expressed in 2012 when they concluded in a similar proposal that, based on existing data and given the significant decrease in use and replacement by other plasticisers, restriction of DEHP, DBP, DiBP and BBP is not warranted. The opinion of the […]
DEHP, BBP, DBP and DiBP on the Candidate list for equivalent level of concern (Art. 57(f)) for human health
Brussels, 20 February 2017 – On 16th February 2017, the European Commission’s REACH committee voted by qualified majority to include the four phthalates DEHP, BBP, DBP and DiBP in the REACH Candidate List as Substances of Very High Concern (SVHC), on the grounds of endocrine disruption for human health.
The European plasticiser industry regrets the European Parliament objection to the Authorisation of recycled soft PVC containing DEHP
The European Council for Plasticisers and Intermediates – ECPI – is disappointed by the European Parliament’s plenary vote against the Commission proposal to authorise the recycling of soft PVC containing DEHP. The final decision will be taken by the European Commission which is not obligated to follow the European Parliament’s opinion. Although the European Commission proposal to grant the Authorisation of flexible PVC recycling containing DEHP fully respects REACH, today’s plenary vote challenges this process. “ECPI respects the right of the European Parliament to oversee an implementing measures but it is essential to underline that the Commission has been strictly adhering to its mandate under REACH. This is a highly complex and technical process based on thorough scientific and socio-economic impact assessments”, commented Stéphane Content, General Manager of ECPI. In September 2014, ECHA’s Risk Assessment Committee (RAC) and Socioeconomic Analysis Committee (SEAC), based on an extensive evaluation of all available data, recommended the Authorisation of DEHP for use in specific applications including recycled soft PVC containing DEHP. “We call on the European Commission to respect the scientific conclusions of both RAC and SEAC. We hope for a positive confirmation to be finally given to the Authorisation for the continued recycling […]