Registration Dossier

Manufacture, use & exposure

Formulation

Documentsopen allclose all

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
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 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category formulated:
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
PC 21: Laboratory chemicals
PC 29: Pharmaceuticals
PC 32: Polymer preparations and compounds
Substance supplied to that use in form of:
in a mixture

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 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 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 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 15: Use as laboratory reagent
Product category formulated:
PC 9a: Coatings and paints, thinners, paint removes
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
PC 39: Cosmetics, personal care products
Substance supplied to that use in form of:
as such

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workers
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
PROC 15: Use as laboratory reagent
Product category formulated:
PC 21: Laboratory chemicals
Substance supplied to that use in form of:
as such
in a mixture

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
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 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 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 15: Use as laboratory reagent
Product category formulated:
PC 9a: Coatings and paints, thinners, paint removes
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
PC 39: Cosmetics, personal care products
Substance supplied to that use in form of:
as such

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
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 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 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 15: Use as laboratory reagent
Substance supplied to that use in form of:
as such

Formulation

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Reference
Name:
Trometamol
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
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 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 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 15: Use as laboratory reagent
Product category formulated:
PC 21: Laboratory chemicals
PC 29: Pharmaceuticals
PC 39: Cosmetics, personal care products
Substance supplied to that use in form of:
as such

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category formulated:
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
PC 21: Laboratory chemicals
Substance supplied to that use in form of:
as such
in a mixture

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
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 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
PROC 10: Roller application or brushing
PROC 13: Treatment of articles by dipping and pouring
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 15: Use as laboratory reagent
PROC 20: Use of functional fluids in small devices
PROC 21: Low energy manipulation of substances bound in materials and/or articles
Product category formulated:
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
PC 21: Laboratory chemicals
PC 30: Photo-chemicals
PC 32: Polymer preparations and compounds
PC 40: Extraction agents

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 workers
Process category (PROC):
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

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
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 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 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 15: Use as laboratory reagent
Substance supplied to that use in form of:
as such

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
Name of activity / technique:
Formulation into a mixture
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workers
Name of activity / technique:
Formulation into a mixture
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 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)
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 15: Use as laboratory reagent
Product category formulated:
PC 28: Perfumes, fragrances
PC 32: Polymer preparations and compounds
PC 39: Cosmetics, personal care products
Substance supplied to that use in form of:
as such

Formulation

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported <10tonnes/year per registrant
Reference
Name:
trometamol
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Contributing activity / technique for the environment
Name of activity / technique:
Formulation into a mixture
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workers
Name of activity / technique:
Formulation into a mixture
Process category (PROC):
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)
PROC 15: Use as laboratory reagent
PROC 19: Hand-mixing with intimate contact and only PPE available.
Product category formulated:
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
PC 21: Laboratory chemicals
PC 0: Other: Constituent of Microbiological culture media
Substance supplied to that use in form of:
as such

Formulation

Reference
Name:
TROMETAMOL
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Contributing activity / technique for workers
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 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 formulated:
PC 29: Pharmaceuticals
PC 0: Other: Synthesis intermediate
Substance supplied to that use in form of:
as such

Formulation

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC2: Formulation into mixture
Environmental release category (ERC):
ERC3: Formulation into solid matrix
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 5: Mixing or blending in batch processes
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 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category formulated:
PC 21: Laboratory chemicals
PC 39: Cosmetics, personal care products
Substance supplied to that use in form of:
as such
in a mixture

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
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 15: Use as laboratory reagent
Product category formulated:
PC 19: Intermediate
PC 21: Laboratory chemicals
PC 0: Other: General processing aid
Substance supplied to that use in form of:
as such
Related assessment:
use assessed in a joint 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 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 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 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 15: Use as laboratory reagent
Product category formulated:
PC 9a: Coatings and paints, thinners, paint removes
PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents
PC 39: Cosmetics, personal care products
Substance supplied to that use in form of:
as such
Related assessment:
use not assessed