The lack of distinction between the bulk form and the nano form
The REACH regulation does not distinguish between the usual form, called “bulk” in English, and the “nano” form of chemical substances. This means that the information on the substance in nanometric form is in the same registration dossier in “bulk” form.
For Olivier Depallens from the Swiss Federal Office of Health (Bundesamt für Gesundheit's - BAG), “it is never very clear which form was tested, and the manufacturer's statement attesting that the substance in nano form has the same toxicological properties as the “bulk” form is subject to long discussions”.
For this reason, the BAG wants to revise Swiss laws concerning the notification of nanomaterials, which will include a “specific notification for the substance in “nano” form.
The project to review Swiss regulations
The decisions that allowed this project
The current revision of the regulations, called CheMo (Swiss Chemical Products Ordinance) is based on two decisions of the Swiss Federal Council:
- December 2014 : extension of the implementation phase of the action plan concerning nanomaterials until 2019.
- September 2015 : “modernization” of national chemical regulations
These decisions led the BAG to realize the need to change regulatory requirements for nanomaterials. This awareness took the form of an assessment of the impact of nanomaterials in Switzerland from November 2015 to April 2016, then negotiations were initiated with the parties concerned by these regulations.
The BAG project
ChemO will regulate:
- Notification of new substances
- The identification of SVHCs
- Classification, labelling and safety data sheets for substances and mixtures
According to Olivier Depallens, CheMo will make it possible to make a separate notification for substances in nano form. After the adaptations of the REACH Annexes with regard to nanomaterials, the registration dossier for substances should be the same as for substances in bulk form.
This revision in two phases must still be presented to the Swiss Federal Council:
- 2017 : Some elements of revision including the communication of all substances in nano form present on the Swiss market
- 2019-2020 : implementation of notification requirements for nanomaterials as well as for substances not registered at the end of REACH 2018 (substances on the Swiss market in quantities greater than or equal to one ton per year).
These new requirements will correspond to a REACH registration, with the difference that each dossier “will have to be evaluated by the authorities.” This verification does not in fact always take place under the REACH regulation.
The missing information for the project
Information about REACH
For Olivier Depallens, the Swiss Federal Office is awaiting the decision of the European Union with regard to the information specific to nanomaterials to be included in the REACH registration and the revisions of the Annexes to the regulations.
In addition, the Federal Office wishes to use the deadline set by REACH 2018 in order to clarify the number of unregistered substances circulating on the Swiss market (in quantities greater than or equal to one ton per year) and which could be subject to the new notification conditions set by CheMo.
Information provided by ECHA
The BAG hopes that ECHA will publish a list of all substances that have been registered in accordance with the REACH Regulation, as well as the annexes introducing information specific to nanomaterials in the second half of 2018.
Olivier Depallens declared this information necessary “to prepare the second phase of the [legislative] review at the end of 2018”.
Do you want to know more?
EcoMundo can help you with all stages of the REACH registration process. Do not hesitate to contact our experts.
The lack of distinction between the bulk form and the nano form
The REACH regulation does not distinguish between the usual form, called “bulk” in English, and the “nano” form of chemical substances. This means that the information on the substance in nanometric form is in the same registration dossier in “bulk” form.
For Olivier Depallens from the Swiss Federal Office of Health (Bundesamt für Gesundheit's - BAG), “it is never very clear which form was tested, and the manufacturer's statement attesting that the substance in nano form has the same toxicological properties as the “bulk” form is subject to long discussions”.
For this reason, the BAG wants to revise Swiss laws concerning the notification of nanomaterials, which will include a “specific notification for the substance in “nano” form.
The project to review Swiss regulations
The decisions that allowed this project
The current revision of the regulations, called CheMo (Swiss Chemical Products Ordinance) is based on two decisions of the Swiss Federal Council:
- December 2014 : extension of the implementation phase of the action plan concerning nanomaterials until 2019.
- September 2015 : “modernization” of national chemical regulations
These decisions led the BAG to realize the need to change regulatory requirements for nanomaterials. This awareness took the form of an assessment of the impact of nanomaterials in Switzerland from November 2015 to April 2016, then negotiations were initiated with the parties concerned by these regulations.
The BAG project
ChemO will regulate:
- Notification of new substances
- The identification of SVHCs
- Classification, labelling and safety data sheets for substances and mixtures
According to Olivier Depallens, CheMo will make it possible to make a separate notification for substances in nano form. After the adaptations of the REACH Annexes with regard to nanomaterials, the registration dossier for substances should be the same as for substances in bulk form.
This revision in two phases must still be presented to the Swiss Federal Council:
- 2017 : Some elements of revision including the communication of all substances in nano form present on the Swiss market
- 2019-2020 : implementation of notification requirements for nanomaterials as well as for substances not registered at the end of REACH 2018 (substances on the Swiss market in quantities greater than or equal to one ton per year).
These new requirements will correspond to a REACH registration, with the difference that each dossier “will have to be evaluated by the authorities.” This verification does not in fact always take place under the REACH regulation.
The missing information for the project
Information about REACH
For Olivier Depallens, the Swiss Federal Office is awaiting the decision of the European Union with regard to the information specific to nanomaterials to be included in the REACH registration and the revisions of the Annexes to the regulations.
In addition, the Federal Office wishes to use the deadline set by REACH 2018 in order to clarify the number of unregistered substances circulating on the Swiss market (in quantities greater than or equal to one ton per year) and which could be subject to the new notification conditions set by CheMo.
Information provided by ECHA
The BAG hopes that ECHA will publish a list of all substances that have been registered in accordance with the REACH Regulation, as well as the annexes introducing information specific to nanomaterials in the second half of 2018.
Olivier Depallens declared this information necessary “to prepare the second phase of the [legislative] review at the end of 2018”.
Do you want to know more?
EcoMundo can help you with all stages of the REACH registration process. Do not hesitate to contact our experts.
