Registration Dossier

Manufacture, use & exposure

Uses at industrial sites

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Uses at industrial sites

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported <10tonnes/year per registrant
Regulatory status:
other: use in pharmaceutical production
Contributing activity / technique for the environment
Name of activity / technique:
Use for pharmaceutical production.
Environmental release category (ERC):
ERC5: Use at industrial site leading to inclusion into/onto article
Contributing activity / technique for workers
Name of activity / technique:
Loading
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Subsequent service life relevant for this use:
no
Insignificant exposure via the following route:
oral
dermal
eye
inhalatory
Insignificant release via the following route:
water
air
soil
waste
Pattern of exposure:
accidental / infrequent

Uses at industrial sites

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6a: Use of intermediate
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
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
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no

Uses at industrial sites

Reference
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6c: Use of monomer in polymerisation processes at industrial site (inclusion or not into/onto article)
Contributing activity / technique for workers
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
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 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)
Product category used:
PC 32: Polymer preparations and compounds
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no

Uses at industrial sites

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
Name of activity / technique:
Use of the substance as a catalyst
Environmental release category (ERC):
ERC6b: Use of reactive processing aid at industrial site (no inclusion into or onto article)
Contributing activity / technique for workers
Name of activity / technique:
Use of the substance as a catalyst
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 15: Use as laboratory reagent
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no

Uses at industrial sites

Reference
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6b: Use of reactive processing aid at industrial site (no inclusion into or onto article)
Contributing activity / technique for workers
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 15: Use as laboratory reagent
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no

Uses at industrial sites

Registration/ Notification status for the use:
use registered according to REACH Article 17/18
Contributing activity / technique for workers
Name of activity / technique:
Use of benzenesulfonic acid to produse amlodipine besilate
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
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)
PROC 15: Use as laboratory reagent
Sector of end use:
SU 0: Other: Pharmaceuticals
Substance supplied to that use in form of:
as such

Uses at industrial sites

Reference
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6b: Use of reactive processing aid at industrial site (no inclusion into or onto article)
Contributing activity / technique for workers
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
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 6: Calendering operations
PROC 7: Industrial spraying
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)
PROC 10: Roller application or brushing
PROC 12: Use of blowing agents in manufacture of foam
PROC 13: Treatment of articles by dipping and pouring
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Product category used:
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
Sector of end use:
SU 8: Manufacture of bulk, large scale chemicals (including petroleum products)
Substance supplied to that use in form of:
as such
in a mixture
Subsequent service life relevant for this use:
no

Uses at industrial sites

Reference
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC5: Use at industrial site leading to inclusion into/onto article
Contributing activity / technique for workers
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
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)
PROC 15: Use as laboratory reagent
Product category used:
PC 29: Pharmaceuticals
Sector of end use:
SU 0: Other: Pharmaceuticals
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no

Uses at industrial sites

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6b: Use of reactive processing aid at industrial site (no inclusion into or onto article)
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
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
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 6: Calendering operations
Process category (PROC):
PROC 7: Industrial spraying
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 10: Roller application or brushing
Process category (PROC):
PROC 12: Use of blowing agents in manufacture of foam
Process category (PROC):
PROC 13: Treatment of articles by dipping and pouring
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Substance supplied to that use in form of:
as such
in a mixture
Subsequent service life relevant for this use:
no

Uses at industrial sites

Reference
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6a: Use of intermediate
Contributing activity / technique for workers
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
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 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)
Product category used:
PC 0: Other: Intermediate
Sector of end use:
SU 9: Manufacture of fine chemicals
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no

Uses at industrial sites

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6c: Use of monomer in polymerisation processes at industrial site (inclusion or not into/onto article)
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
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
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no