Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Manufacture, use & exposure

Formulation

Documentsopen allclose all

Formulation

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Fume hoods are used when possible. Packaging and transfers of larger quantities of the substance and mixtures are done under open system conditions within a controlled secluded area. Mixing is done under closed batch conditions, but mixing systems are in some cases temporarily opened during mixing for sampling purposes.
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
PROC 4: Chemical production where opportunity for exposure arises
PROC 5: Mixing or blending in batch processes
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Granulation is important in mixture processing.
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Name of activity / technique:
Cleaning of industrial equipment is always done manually before repairs and occasional maintenance.
Process category (PROC):
PROC28: Manual maintenance (cleaning and repair) of machinery
Product category formulated:
PC 0: Other: Use in nicotine bitartrate dihydrate containing mixtures
Substance supplied to that use in form of:
as such
Related assessment:
use assessed in an own CSR

Formulation

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Contributing activity / technique for the environmentopen allclose all
Name of activity / technique:
Formulation into mixture
Environmental release category (ERC):
ERC2: Formulation into mixture
Name of activity / technique:
Formulation into solid matrix
Environmental release category (ERC):
ERC3: Formulation into solid matrix
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions - solid 100%
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Name of activity / technique:
Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions - liquid 2%
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Name of activity / technique:
Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions - solid 2%
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Name of activity / technique:
Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions - liquid 2%
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Name of activity / technique:
Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment condition - solid 2%
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Name of activity / technique:
Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment condition - liquid 2%
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Name of activity / technique:
Chemical production where opportunity for exposure arises - solid 2%
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Chemical production where opportunity for exposure arises - liquid 2%
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Mixing or blending in batch processes - solid 2%
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Name of activity / technique:
Mixing or blending in batch processes - liquid 2%
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Name of activity / technique:
Transfer of substance or mixture (charging and discharging) at non-dedicated facilities - solid 100%
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Transfer of substance or mixture (charging and discharging) at non-dedicated facilities - solid 2%
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Transfer of substance or mixture (charging and discharging) at non-dedicated facilities - liquid 2%
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Transfer of substance or mixture (charging and discharging) at dedicated facilities - solid 100%
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Transfer of substance or mixture (charging and discharging) at dedicated facilities - solid 2%
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Transfer of substance or mixture (charging and discharging) at dedicated facilities - liquid 2%
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Transfer of substance or mixture into small containers (dedicated filling line, including weighing) - solid 100%
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Transfer of substance or mixture into small containers (dedicated filling line, including weighing) - solid 2%
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Transfer of substance or mixture into small containers (dedicated filling line, including weighing) - liquid 2%
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Use as laboratory reagent - solid 100%
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
Use as laboratory reagent - liquid 2%
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
Manual maintenance (cleaning and repair) of machinery - solid 100%
Process category (PROC):
PROC28: Manual maintenance (cleaning and repair) of machinery
Name of activity / technique:
Manual maintenance (cleaning and repair) of machinery - liquid 2%
Process category (PROC):
PROC28: Manual maintenance (cleaning and repair) of machinery
Product category formulated:
PC 0: Other: nicotine containing products
Related assessment:
use assessed in an own CSR

Formulation

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Fume hoods are used when possible. Packaging and transfers of larger quantities of the substance and mixtures are done under open system conditions within a controlled secluded area. Mixing is done under closed batch conditions, but mixing systems are in some cases temporarily opened during mixing for sampling purposes.
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
PROC 4: Chemical production where opportunity for exposure arises
PROC 5: Mixing or blending in batch processes
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Granulation is important in mixture processing.
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Name of activity / technique:
Cleaning of industrial equipment is always done manually before repairs and occasional maintenance.
Process category (PROC):
PROC28: Manual maintenance (cleaning and repair) of machinery
Product category formulated:
PC 0: Other: Use in nicotine bitartrate dihydrate containing mixtures
Substance supplied to that use in form of:
as such
Related assessment:
use assessed in an own CSR
Insignificant exposure via the following route:
oral
Pattern of exposure:
occasional