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Regulatory Information

BASF is a key player in the chemical industry with extraordinary expertise. For our Industrial Petrochemicals Unit, we have a dedicated team for regulatory affairs and advocacy topics, located in Ludwigshafen am Rhein, Germany.

These colleagues are always aware of the latest and upcoming developments in the regulatory area of plasticizers and prepared to support customers in this regard.

To stay informed about the latest regulatory developments with regards to Hexamoll® DINCH, take a look at our News section and below you find a summary of the current situation.

>> Click here to learn more about Hexamoll® DINCH’s approvals and certificates.

>> Click here to enter the website of European Plasticizers, who have a comprehensive regulatory summary on their website.

Dr. Rainer Otter, Vice President of Regulatory Affairs / Advocacy, BASF SE already commented on the revised chapters on plasticized PVC material in the European Pharmacopoeia in 2017.

2019

DEHP (DOP) in medical devices: usage is more and more restricted, alternative plasticizers such as Hexamoll® DINCH are needed and were added to the European Pharmacopoeia (Ph. Eur.) in 2018 (see below).

According to the Medical Device Regulation (EU) 2017/745: medical devices need a specific justification if containing substances above 0.1% with the following properties, which both apply to DEHP (DOP):

  - CMR Cat 1A or 1B (carcinogenic, mutagenic or toxic to reproduction)

  - endocrine disrupting properties with scientific evidence of serious effects to human health

Based on the final version of SCHEER’s (Scientific Committee on Health, Environmental and Emerging Risks) ”Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices“, justification documents for medical devices containing DEHP (DOP) need to be provided as of May 26, 2021. These documents need to show the intended purpose and context of the use of the device including available alternative substances and alternative materials, designs or medical treatments.

So far, DEHP (DOP) was exempt from authorisation (REACH Annex XIV) in medical devices as only classified for human health, which is regulated in Medical Device Regulation (EU) 2017/745. Since December 2014, DEHP (DOP) is on the candidate list for authorisation due to endocrine disrupting properties (Article 57f – environment (new) and human health). On July 10, 2019, ECHA recommended to amend Annex XIV: all exempted should need authorisation, which means medical devices containing DEHP (DOP) will need authorisation. Final decision pending.

2018

The European Pharmacopoeia (Ph. Eur.) introduced four alternative plasticizers that can be added to PVC for the manufacturing of medical devices. Hexamoll® DINCH is listed in the European Pharmacopoeia as Additive 24 for uses like e.g. blood bags and medical tubing.1 Of the four newly added plasticizers, only for DEHTP (bis-(2-ethylhexyl) terephthalate and Hexamoll® DINCH (cyclohexane 1,2-dicarboxylic acid, diisononyl ester), a Regulatory Management Option Analysis (RMOA) was performed.
The RMOA for Hexamoll® DINCH was undertaken by France and published on the ECHA website. The conclusion is “No need to initiate further regulatory risk management action at this time” (published by ECHA in Jan 2016) – this is the best possible result.2

The US Consumer Product Safety Commission (US CPSC)  issued a final phthalates rule (16 CFR part 1307), implementing a prohibition of children’s toys that can be placed in a child’s mouth and child care articles that contain concentrations of more than 0.1 percent of DINP. Previously, permanent prohibitions of toys/ childcare articles containing concentrations of more than 0.1 percent of DEHP, DBP, BBP, DIBP, DPENP, DHEXP and DCHP were already implemented.Hexamoll® DINCH as an alternative plasticizer is currently being evaluated by the University of Cincinnati by the order of US CPSC.

Arabian Restriction Notification to World Trade Organization (WTO):

(i.e. Bahhrain, Kuwait, Oman, Qatar, Saudia Arabia, United Arab Emirates, Yemen)

- max. permissible concentration (in weight) of DEHP (DOP), BBP, DBP, DIBP: 0.1%

- will apply to medical devices, incl. in vitro and monitoring and control instruments incl. those for industry, as of July 22, 2021 onwards

Other

French Law No. 2012-1442 (2012) Article 3, Chapter IV:

"Article L 5214-1 as of July 1, 2015, the use of tubes containing di (2-ethylhexyl)phthalate (DEHP/ DOP) is banned in pediatrics, neonatoloy and maternity."

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