SVHC updates!

17 July, 2019

Update of the candidate list on July 16th

ECHA added four new substances to the candidate list. Generally, there is nothing special about it, since the list is updated twice a year. This time however a substance was added for the first time due to its persistent and mobile properties. The concept of considering substances that fulfill the criteria for being persistent, mobile and toxic (PMT) was introduced by the German Environmental Agency and is discussed in Europe.

In the latest update of the candidate list “2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof)”, further denoted as HFPO-DA, was added based on article 57f, which means the substance(s) was identified to raise equivalent level of concern having probable serious effects to man and/or the environment.

The substance(s) is persistent and mobile and amongst other potential effects the SVHC support document states “the high potential for causing serious effects even though those would not be observed in standard tests” and “potential for inter-generational effects”. The main target organs identified in rodent studies include liver, kidneys, haematologic system and the immune system.

The combination of the intrinsic properties justified the inclusion in the candidate list.

For companies using this substance, its salts or acyl halides this triggers some actions: For the substance itself the Safety Data Sheets need to be updated, for mixtures containing the product in concentrations > 0.1% it might become necessary to update or generate corresponding Safety Data Sheets. The intentional use of the substance in articles is unlikely.

 

Endocrine disrupting properties to be added to the phthalates DEHP, BBP, DBP and DIBP

ECHA has submitted a recommendation to the Commission to amend Annex XIV to include endocrine disrupting properties for four phthalates. In the recommendation the latest application and sunset dates were recommended for uses that were so far exempted from authorization.

Therefore, with this amendment coming into effect, mixtures may not contain the four phthalates in concentrations above 0.1% without authorization (instead of 0.3% so far). For DEHP some uses will no longer fall under the generic exemptions since now it is also identified as a hazard to the environment. Further ECHA has recommended to remove the exemption for uses of DEHP in immediate packaging of medicinal products.

Companies currently using these phthalates in these exempted uses need to keep an eye on further developments and react as soon as the actual amendments come into effect.

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Dr. Thomas Berbner Business Development
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