Registration Dossier

Manufacture, use & exposure

Manufacture

Documentsopen allclose all

Manufacture

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:
Manufacture of alpha-amylase
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Use in closed batch process
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:
Use in batch process where opportunity for exposure arises
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Transfer of substance/mixture from/to containers at non-dedicated facilities
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Transfer of substance/mixture from/to containers at dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Use as a laboratory agent
Process category (PROC):
PROC 15: Use as laboratory reagent
Related assessment:
use assessed in an own CSR

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Amounts used, frequency and duration of use (or from service life)

Other conditions

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
municipal biological STP
Other conditions of use

Conditions and measures related to external treatment of waste (including article waste)

Particular considerations on the waste treatment operations:
no

Other conditions affecting environmental exposure

Releases to waste and the environment

Release to the environment

ReleaseEnvirRepopen allclose all
Release from the site to::
wastewater
Release estimation method:
ERC
Release from the site to::
ambient air
Release estimation method:
estimated release factor
Remarks:
0
Release from the site to::
non-agricultural soil
Release estimation method:
estimated release factor
Remarks:
0

Exposure of the environment

PECopen allclose all
Exposed compartment:
freshwater
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (freshwater)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
marine water
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sewage treatment plant
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
air
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
agricultural soil
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
ContribScenWorkersRepopen allclose all

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all
Effectiveness
Route affected:
inhalation

Conditions and measures related to personal protection, hygiene and health evaluation

Other conditions affecting workers exposure

Place of use:
indoor

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Closed batch process (PROC3)

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Batch process where opportunity for exposure arises

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Transfer of enzyme products from/to vessels at non-dedicated facilities

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Transfer of enzyme products from/to vessels at dedicated facilities

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Use as Laboratory reagent

Manufacture

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:
Manufacture of alpha-amylase
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Use in closed batch process
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:
Use in batch process where opportunity for exposure arises
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Transfer of substance/mixture from/to containers at non-dedicated facilities
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Transfer of substance/mixture from/to containers at dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Use as a laboratory agent
Process category (PROC):
PROC 15: Use as laboratory reagent
Related assessment:
use assessed in an own CSR

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Amounts used, frequency and duration of use (or from service life)

Other conditions

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
municipal biological STP
Other conditions of use

Conditions and measures related to external treatment of waste (including article waste)

Particular considerations on the waste treatment operations:
no

Other conditions affecting environmental exposure

Releases to waste and the environment

Release to the environment

ReleaseEnvirRepopen allclose all
Release from the site to::
wastewater
Release estimation method:
ERC
Release from the site to::
ambient air
Release estimation method:
estimated release factor
Remarks:
0
Release from the site to::
non-agricultural soil
Release estimation method:
estimated release factor
Remarks:
0

Exposure of the environment

PECopen allclose all
Exposed compartment:
freshwater
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (freshwater)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
marine water
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sewage treatment plant
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
air
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
agricultural soil
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
ContribScenWorkersRepopen allclose all

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all
Effectiveness
Route affected:
inhalation

Conditions and measures related to personal protection, hygiene and health evaluation

Other conditions affecting workers exposure

Place of use:
indoor

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Closed batch process (PROC3)

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Batch process where opportunity for exposure arises

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Transfer of enzyme products from/to vessels at non-dedicated facilities

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Transfer of enzyme products from/to vessels at dedicated facilities

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Use as Laboratory reagent

Manufacture

Contributing activity / technique for the environment
Name of activity / technique:
Manufacture of alpha-amylase
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Name of activity / technique:

Manufacture of alpha-amylase
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 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
Name of activity / technique:

Use in closed batch process
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:

Use in batch process where opportunity for exposure arises
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:

Transfer of substance/mixture from/to containers at non-dedicated facilities
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:

Transfer of substance/mixture from/to containers at dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:

Transfer of substance/mixture into small containers
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:

Use as a laboratory agent
Process category (PROC):
PROC 15: Use as laboratory reagent

Manufacture

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC1: Manufacture of the substance
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 4: Chemical production where opportunity for exposure arises
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

Manufacture

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:
Manufacture of substance
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Handle substance within a closed system.
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:
Handle substance within a closed system.; With sample collection
Process category (PROC):
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
Name of activity / technique:
Transfer of substance or mixture (charging/discharging) at dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Use of the substance within laboratory settings, including material transfers and equipment cleaning
Process category (PROC):
PROC 15: Use as laboratory reagent
Related assessment:
use assessed in an own CSR

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
site specific biological STP
Application of site specific biological STP sludge on agricultural soil:
yes

Conditions and measures related to external treatment of waste (including article waste)

Particular considerations on the waste treatment operations:
no

Other conditions affecting environmental exposure

Releases to waste and the environment

Release to the environment

ReleaseEnvirRepopen allclose all
Release from the site to::
wastewater
Release estimation method:
estimated release factor
Remarks:
2.5
Release from the site to::
ambient air
Release estimation method:
estimated release factor
Remarks:
0
Release from the site to::
non-agricultural soil
Release estimation method:
estimated release factor
Remarks:
0

Exposure of the environment

PECopen allclose all
Exposed compartment:
freshwater
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (freshwater)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
marine water
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sewage treatment plant
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
agricultural soil
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
ContribScenWorkersRepopen allclose all

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Physical form of the used product:
liquid

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

PPERepopen allclose all
Effectiveness
Route affected:
dermal

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Handle substance within a closed system.

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Physical form of the used product:
liquid

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

PPERepopen allclose all
Effectiveness
Route affected:
dermal

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Handle substance within a closed system.

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Physical form of the used product:
liquid

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

PPERepopen allclose all
Effectiveness
Route affected:
dermal

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Transfer of substance or mixture (charging/discharging) at dedicated facilities

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Physical form of the used product:
liquid

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

TechCondRepopen allclose all

Conditions and measures related to personal protection, hygiene and health evaluation

PPERepopen allclose all
Effectiveness
Route affected:
dermal

Exposure of workers

Exposure estimation
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
measured data
Exposure estimation tool name:
other: Use of the substance within laboratory settings, including material transfers and equipment cleaning

Manufacture

Contributing activity / technique for the environment
Name of activity / technique:
Manufacture of substance
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Handle substance within a closed system.
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:

Handle substance within a closed system.; With sample collection
Process category (PROC):
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
Name of activity / technique:

Use of the substance within laboratory settings, including material transfers and equipment cleaning
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:

Transfer of substance or mixture (charging/discharging) at dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities