EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
Commission Delegated Regulation (EU) 2020/... of XXX  
supplementing Regulation (EU) 2019/2144 of the European Parliament and of the 
Council by laying down detailed rules concerning the specific test procedures and 
technical requirements for the type -approval of motor vehicles with regard to the driver 
drowsin ess and attention warning systems and amending Annex II to that Regulation 
and Annex II to Regulation (EU) 2018/858 of the European Parliament and of the 
Council   EN 1  EN ANNEX I 
 
PART 1  
Technical requirements for the driver drowsiness  and attention warning (DDAW) 
system s 
 
1. Definitions  
For the purposes of this Annex , the following definitions apply : 
1.1. ‘trigger behaviour ’ means the vehicle action for which the driver drowsiness and 
attention warning (DDAW ) system monitors and provide s a warning  to the driver 
once this action happens ; 
1.2. ‘drowsiness  threshold’  is a quantification  of the level  of driver  drowsiness,  at or 
before  which  the DDAW  system  shall  provide  a drowsiness  warning  to the driver . 
2. General technical requirements  
2.1. A driver drowsiness and attention warning  (DDAW ) system shall monitor a 
driver’s level of drowsiness and alert the driver through the vehicle human 
machine interface ( HMI). 
2.2. The DDAW  system  shall  be designed  to avoid  or minimise  the system  error  rate 
under  real driving  conditions.  
2.3. Privacy  and data protection  
2.3.1. The DDAW  system  shall  function  in normal  operation  mode  without  the use of 
biometric  information,  including  facial  recognition,  of any vehicle  occupants.  
2.3.2. The DDAW  system  shall  be designed  in such a way that it shall  only continuously  
record  and retain  data necessary  for the system  to function  and operate  within  a 
closed -loop system.  
2.3.3. Any processing  of personal  data shall  be carried  out in accordance  with Union  data 
protection  law. 
3. Specific  technical  requirements.  
3.1. DDAW  system  control  
3.1.1. It shall  not be possible  for the driver  to manually  deactivate  the DDAW  system.  
It may however  be possible  for the driver  to manually  deactivate  the DDAW  
system  HMI  warnings.  Following  manual  deactivation  of the DDAW  System  HMI  
warnings,  it shall  be possible  for the driver  to re-activate  the system  HMI  warnings  
by taking  no more  than the same  number  of actions  as were  required  to deactivate  
it. 
3.1.2. The DDAW  system  shall  be automatically  deactivated  in the situations  pre-defined  
by the manufacturer.  Such  situations  include,  for instance,  the deactivation  of the 
warnings  by the driver  (point 3.1.1.). The DDAW  system  shall  be automatically  
reactivated  as soon  as the conditions  that led to its automatic  deactivation  are no EN 2  EN longer  present.  
3.1.3. The DDAW  system , including  HMI warnings,  shall  be automatically  reinstated  to 
normal  operation  mode  upon  each activation  of the vehicle  master  control  switch.  
The vehicle  manufacturer  can choose  to add a condition  to such automatic  
reinstatement : upon  the driver’s  door having  been  opened  or the vehicle  being  
switched  off for a minimum  period  of 15 minutes. 
3.1.4. The DDAW  system  shall  be automatically  activ ated above  the speed  of 70 km/h.  
3.1.5. Once  activated,  DDAW  system  shall  operate  nominally  within  the speed  range  of 
65 km/h  to 130 km/h  or the vehicle’s  maximum  allowed  speed,  whichever  is lower.  
The DDAW  system  shall  not be automatic ally deactivate d at a speed  of above  
130 km/h  (although  the system’s  behaviour  can be adapted  to the degraded  
situation) . 
3.1.6. There  shall  be a less than 5-minute  delay  between  the vehicle  meeting  the 
activation  criteria  set out in points  3.1.4., and the DDAW  system  beginning  to 
actively  monitor  driver  drowsiness.  
3.1.7.  When the DDAW  system  has a learning  phase  allowing  for calibration  of system  
parameters  to best fit driver’s  behaviour  and driving  pattern,  it shall  not provide  a 
warning  during  that phase.  If such warning  is provided,  the learning  phase  is 
considered  over.   
The learning  phase  activation  time shall  start once all the condition  for the 
activation  of the DDAW  system  referred  to in points  3.1. and 3.2. are met.  
3.2. Environmental  conditions  
3.2.1. The DDAW  syste m shall  operate  effectively  during  the day and night.  
3.2.2. The DDAW  system  shall  operate  in absence  of weather  conditions  limiting  the 
system's  operation.  
3.2.3. At a minimum,  the DDAW  system  shall  work  effectively  on a multi -lane divided  
road,  with or without  a central  divide , when  lane markings  are visible  on both sides  
of the lane.  
3.3 Monitoring  driver  drowsiness  
3.3.1. The DDAW  system  shall  provide  a warning  to the driver  at a level  of drowsiness  
which  is equivalent  to 8 or above  on the reference sleepiness scale set out in the 
Appendix (Karolinska Sleepiness Scale , hereinafter referred to as “ KSS”). 
The DDAW  system  may provide  a warning  to the driver  at a level  of drowsiness  
which  is equivalent  to level  7 on KSS.  
In addition,  manufacturer  may implement  an information  strategy  on the HMI  prior  
to the warni ng. 
Detailed  requirements  for the validation  of the DDAW  system  by the manufacturer  
are set out in Part 2. 
3.3.2. The DDAW  system  shall  analyse  other  vehicle systems  for detection  of drowsy  EN 3  EN driving  indicator s. Such  driving  indicator s may include  but are not limited  to the 
following : 
(a) a reduction  in the number  of micro -corrections  within  driver  steering,  paired  
with an increase  in the number  of large  and fast corrections ;  
(b) an increase  in the variability  of a vehicle’s  lateral  lane position . 
It is recommended  that the DDAW  system  analyse s other  vehicle  systems  to detect  
drowsy  driving  indicators  by monitoring  lane position , namely  the position of the 
vehicle relative to the lateral lane markings , or a steering  input , namely  a 
quantification of the way the driver manipulates the steering wheel , e.g. steering  
wheel  reversal  rate, yaw rate, standard  deviation  of lane position , etc. 
An alternative  manner of measuring driver performance through vehicle systems 
analysis  (‘metrics’)  may be used,  provided  that it is an accurate  and robust  measure  
of driver  drowsiness.  
It is possible  to use one or more  secondary  metrics  in addition  to the 
recommendation  stated  in the second  subparagraph  of point  3.3.2.  to aid the 
reliability  and robustness  of the system.  Examples  of such metrics  include:  
additional  vehicle  metrics,  temporal  metrics  (a temporal measurement directly 
related to the driver’s operation of the vehicle ), physiological  metrics  and vehicle  
control  metrics.  
3.4. Human  Machine interface  requirements  
3.4.1. Warning  nature   
3.4.1.1.  Visual , audit ory and any other  warning  used by the DDAW  system  to alert the 
driver  shall  be presented  as soon  as possible  after occurrence  of the trigger  
behaviour  and may cascade  and intensify  until acknowledgement  thereof  by the 
driver.  
Can be accepted  as acknowledgement  by the driver:  an improvement  of the driving  
behaviour  based  on the input  used for the DDAW  system  (strategy  to be described  
in the documentation  provided  by the manufacturer).  
3.4.2. Visual  Warning  
3.4.2.1.  The visual  warning  shall  be located  so as to be readily  visible  and recognisable  in 
daylight  and at night-time by the driver  and distinguishable  from  other  alerts.  
3.4.2.2. The visual  warning  shall  be a steady  or flashing  indication  (e.g. tell-tale, pop-up 
message,  etc.). 
3.4.2.3.  Any new symbols  developed  for the purpose  of a DDAW  visual  warning  are 
recommended  to be constructed  using  similar  elements  to and keeping  coherence  
with ISO 2575:2010+A7:2017  K.21  and/or  ISO 2575:2010+A7:2017  K.24 . 
3.4.2. 4. The contrast  of the symbol  with the background  in sun light,  twilight  and night  
conditions  are recommended  to be in accordance  with ISO 15008:2017 . 
3.4.2.5.  The following  visual  alert and background  colour  combinations  should  not be 
used:  red/gre en; yellow/blue;  yellow/red;  red/violet.  EN 4  EN 3.4.3. Audible  warning  
3.4.3.1. The audible  warning  shall  be easily  recogni sed by the driver.  
3.4.3.2.  A majority  of the audible  warning  shall  fall within  the frequency  spectrum  of 200-
8000  Hz and amplitude  range  of 50-90 dB. 
3.4.3.3.  If speech  alerts  are utilised,  the vocabulary  used shall  be consistent  with any text 
used as part of the visual alert.  
3.4.3.4.  The audible  portion  of the alert shall last for at least the duration  that allow s the 
driver  to understand  it. 
3.5. DDAW  failure  warning  
3.5.1. A constant  visual  failure  warning  signal  (e.g. warning  reflecting  the relevant  
Diagnostic  Trouble  Codes  (DTC)  for the system,  tell-tale, pop-up message,  etc.) 
shall  be provided  when  there  is a failure  detected  in the DDAW  system  as a result  
of which  the DDAW  system  does not meet  the requirements  of this Annex . 
Temporary  visual  failure  warning  signal  can be used as complimentary  infor mation  
to the constant  optical  failure  warning  signal  
3.5.2. There  shall  not be an appreciable  time interval  between  each DDAW  self-check,  
and subsequently  there  shall  not be a delay  in displaying  the failure  warning  signal,  
in the case of an electrically  detectable  failure.  
3.5.3. Upon  detection  of a non-electrical  failure  condition  (e.g. sensor  obscuration , 
excluding  temporary  obscuration  such as caused  by sun glare) , the failure  warning  
signal  as laid down  in point 3.5.1. shall  be displayed . 
3.5.4. Failures  that activate  the warning  signal  mentioned  in point  3.5.1. , but which  are 
not detected  under  static  conditions,  shall  be retained  upon  detection  and continue  
to be displayed  from  start-up of the vehicle  after each activation  of the vehicle  
master  control  switch,  for as long as the failure  or defect  persists.  
3.6. Provisions  for periodic  roadworthiness  tests.  
3.6.1. For the purpose  of periodic  roadworthiness  tests,  it shall  be possible  to confirm  the 
correct  operational  status  of the DDAW  system  by either  (a) or (a) and (b) below:  
(a) A visible  observation  of the failure  warning  signal  status  following  the 
activation  of the vehicle  master  control  switch  and any bulb check.  Where  the 
failure  warning  signal  is displayed  in a common  space  (the area on which  two or 
more  information  functions/  symbols  may be displayed,  but not simultaneously),  it 
must  be checked  first that the common  space  is functional  prior  to the failure  
warning  signal  status  check;  
(b) The use of an electronic  vehicle  interface,  such as the one laid down  in point  
I.(14)  of Annex  III of Directive  2014/45/EU1. Where  the functionality  and 
operational  status  of the DDAW  system  can be checked using  an electronic  vehicle  
                                                 
1 Directive 2014/45/EU of the European Parliament and of the Council of 3 April  2014  on p eriodic 
roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC  (OJ L 
127, 29.4.2014, p. 51)  EN 5  EN interface,  manufacturers  shall  ensure  to make  available  the technical  information  
for the use of the electronic  vehicle  interface  in accordance  with Article  6 of 
Regulation  (EU)  2019/6212. 
3.6.2. At the time of type-approval,  the means  to protect  against  simple  unauthorised  
modification  of the operation  of the failure  warning  signal  chosen  by the 
manufacturer  shall  be confidentially  outlined  in the assessment  of the technical  
documentation  under  Part 3. Alternatively,  this protection  requirement  is fulfilled  
when  a secondary  means  of checking  the correct  operational  status  of the DDAW  
system  is available.   
 
 
Appendix  to Part 1  
 
Reference sleepiness scale for DDAW system  
(Karolinska Sleepiness Scale) 
 Rating  Verbal  Description  
1 Extremely  alert  
2 Very  alert  
3 Alert  
4 Rather  Alert  
5 Neither  alert nor sleepy  
6 Some  signs  of sleepiness  
7 Sleepy,  no effort  to keep  awake  
8 Sleepy,  some  effort  to keep  awake  
9 Very  sleepy,  great  effort  to keep  awake,  fighting  sleep  
 
 
  
                                                 
2 Commission Implementing Regulation (EU) 2019/621 of 17 April 201 9 on the technical information 
necessary for roadworthiness testing of the items to be tested, on the use of the recommended test 
methods, and establishing detailed rules concerning the data format and the procedures for accessing the 
relevant technical in formation  (OJ L 108, 23.4.2019, p. 5)  EN 6  EN PART 2  
 
Test procedures for validation of driver drowsiness and attention warning (DDAW) 
systems  
 
1. Validation  testing  by the manufacturer  
1.1. General  requirements  
1.1.1. Manufacturer s shall  carry  out validation  testing  to ensure  that DDAW  systems  are 
able to monitor  driver  drowsiness  in a manner  which  is accurate,  robust  and 
scientifically  valid.  
1.1.2. The validation  testing  of the DDAW  shall  meet  the requirements  set out in points  2 
to 8. The manufacturer  shall  document  the validation  process  in the  documentation  
package  to be provided  by the manufacturer  in accordance  with Part 3. 
2. Testing  requirements  
2.1. Validation  testing  shall  take place  using  human  participants . Alternatively  the data 
used for the validation  shall  derive  from  behaviour  data collected  with human  
participants.  
2.2. Any validation  testing  that includes  a human  participant  operating  a motor  vehicle  
in a real-world,  non-simulated  road environment , shall  have  a safety  backup .  
The safety  backup  shall  intervene  if the driver  become s drowsy , so that he or she 
can no longer  safely  control  the motor  vehicle.  
If the safety  backup  intervenes , the participant  shall  not be permitted  to drive  any 
further  as part of the testing.  
If the safety  backup  is a backup  driver,  double  pedals  shall  be required.  
Once  the safety  backup  intervene s, the safety  strategy  prepared  for this test shall  
apply.  For example:  another  non-drowsy  driver  takes primary  control  of the vehicle  
and the drowsy  driver  shall  not be allowed  to continue  to drive.  
2.3. If validation  testing  is performed  in a simulator , the manufacturer  shall  document  
its limitation s with regard  to real-world  open  road testing  for the purpose  of testing  
the DDAW  system.  Such  documentation  will include comparison  of primary  input  
data,  used for the DDAW  system , from  the simulator  and primary  input data from  
the vehicle  in real conditions  and analysis  of the validity  of the simulated  
validation’s  results.  
3. Test sample  
3.1. Each  test participant  shall  generate  at least 1 true positive  or 1 false  negative  event.  
The total number,  obtained  by the sum of true positive  events  and false  negative  
events, shall  be equal  to or higher  than 10. The minimum  sample  size of 
participants  shall  be 10 participants.  It is allowed  to run more  than one test per 
participant  in order  to acquire  more  data for a given  participant.  EN 7  EN The sensitivity  per participant  shall  be calculated  first for each participant,  then the 
average  sensitivit y and its standard  deviation  shall  be calculated  from  the values  of 
sensitivity  per participant.  
It is explicitly  allowed  to provide  results  from  a subgroup  of participants  of a larger  
test to include  only participants  fitting  the description  above.  
3.2. All the results  from  participants  fitting  the requirements  of point  3.1. shall  be 
accounted  for the validation.  Excluding  results  from  participants  with at least 1 true 
positive  or 1 false  negative  is not allowed.  
3.3. The participants  shall  correspond  to the targeted  demography  for the vehicle  (for 
example,  participants  with a valid  license  to drive  the vehicle  on which  the DDAW  
system  is installed) . 
3.4. None  of the 10 participants  of the minimum  sample  size shall  be involved  in the 
development  of DDAW  system.  One of the acceptance  criteri a, of point  8, shall  be 
met with and without  results  from  participants  involved  in the DDAW  system  
development.  
4. Environmental  conditions  
4.1. At a minimu m, the system  shall  be tested  in the day and night  conditions  from  
point  4.1.1.  and 4.1.2.,  and record  at least a true positive  event  in each conditions  
(overall,  not for each participant  tested  in the condition).  
It is not necessary  for each participants  to test both conditions.  
Systems  not affected  by light do not need  to meet  the minimum  number  of true 
positive  event  in each condi tions  indicated  above.  
4.1.1. For open  road testing:  
(a) Day:  testing  shall  start after sunrise  and before  sunset ; 
(b) Night:  testing  shall  start after sunset  and before  sunrise.  
4.1.2. For simulator  testing:  
(a) Day:  cond itions  diffuse  with ambient  light (ISO  15008:  2017) ; 
(b) Night:  condition  of low ambient  illumination  under  which  the adaptation  level  
of the driver  is mainly  influenced  by the portion  of the road ahead  covered  by the 
vehicle’s  own headlights  and surrounding  street  lights, and display  and instrument  
brightness  (ISO  15008:  2017).  
5. Measuring  drowsiness  
5.1. Application  of KSS 
5.1.1. The participant’s  level  of drowsiness  shall  be measured  using  the KSS.  
5.1.1.1.  Participants  shall  be trained  on the KSS before  they apply  it as part of the DDAW  
system  validation  testing . 
The training  process  shall  be the same  for all participants . 
The training  process  shall  be clearly  documented  in the evidence  dossier  supplied  
to the technical  service  in accordance  with Part 3. EN 8  EN 5.1.1.2.  The standardised  wording  in the Appendix  to Part 1 shall  be used and all levels  of 
the KSS shall  be labelled . 
5.1.2. Measurements  shall  be obtained  during  the testing  at intervals  of approximately  5 
minutes,  where  each measurement  obtained  shall  be assumed  to cover  the previous  
5 minutes.  
The recommended  intervals  does not apply  before  the participant  provide  a first 
self-asses sment  rating  at level  6 or above  on the KSS.  
5.1.3.  During  the validation  tests,  it is recommended  to mute  the warning  from  the 
DDAW  system,  to prevent  changes  of the status  of the participant  before  the next 
self-assessm ent. The time at which  the warning  from  the DDAW  is provided  
(muted  or not) shall  be recorded  to clearly  establish  if it is a true positive  event.  
5.1.4. If there  is a gap of more  than one KSS level  between  participant ’s subsequent  KSS 
ratings , with one of the two subsequent  values  being  a reported  KSS level  at 7 or 
above,  any DDAW  system ’s warning  shall  be treated  as a true positive  event.  
5.1.5. If a partic ipant ’s self-assessment  rating  of drowsiness  is at a KSS level  below  8 and 
the subsequent  self-assessment  rating  is at a KSS level  above  or equal  to 8 (the 
required  drowsiness  threshold  in point  3.3.1 . of Part 1): 
The DDAW  system  either  provide s a warning  and it shall  be treated  as a true 
positive,  or the DDAW  system  does not provide  a warning  and it shall  be treated  as 
a false  negative,  unless  the testing  continue s for at least an extra  testing  interval  
and the follo wing  rating  corresponds  to one of the three  statement s below:  
(a) During  the extra  testing  interval,  if the participant s provide  a self-
assessment  above  or equal  to the drowsiness  threshold  again,  the reading  
shall  be treated  as a false  negative  (e.g. sequence  of rating  can be 7-8-8, 7-
9-9 or 7-9-8); 
(b) During  the extra  testing  interval , if the partici pants provide  a self-
assessment  at the KSS level  7, the data point  shall  be treated  as an outlier.  
All outliers  shall  be documented  in the documentation  package ; 
(c) During  the extra  testing  interval , if the participant s provide  a self-
assessment  below  the KSS level  of 7, their data shall be excluded  from  the 
testing  as their drowsiness  ratings  are likely  unreliable  (e.g. sequence  of 
rating  can be 7-8-6 or 6-8-6). 
5.2. Alternative  measurement (s) 
5.2.1. Manufacturers  may use an alternative  measurement(s)  to validate  a DDAW  system  
under  the following  conditions : 
(a) If the alternative  method  directly  monitor s the participants’  state, such as 
Electroencephalogram  (EEG ) or PERCLOS  (percentage  of eyelid  closure ). 
(b) If the alternative  method  fit the measurement  described  in the point  5.1. except  
for the drowsiness  scale  used and/or  the time interval  used;  
(c) If the measurement  is performed  by sleep  video  analysis  performed  by at least 3 
raters  (sleep  experts),  who do not interact  with the participant  and each other  
before  the rating  process  is finalised.  The time interval  of this method  shall  not 
exceed  5 minutes . 
5.2.2. Where  alternative  measurements  to KSS are used to determine  the participant’s  
level  of drowsiness,  the manufacturer  shall  provide  evidence  that the chosen  EN 9  EN measurement  is a valid  and accurate  means  to assess  driver  drowsiness,  and that 
the drowsiness  threshold  used in the validation  testing  is equivalent  to a KSS level  
referred  to in point  3.3.1. of Part 1  
For the sleep  video  analysis,  expected  evidence  concerns  the quality  of the video  
used,  the visibility  of the setup  for the participant,  the correspondence  between  the 
rating  scale  and KSS,  the training  of the raters  (in addition  a minimal  performance  
level  of “concordance  rate”  superior  or equal  to 0.70 is required),  information  of 
independence  of the raters  to the DDAW  development  and description  on how the 
final rating  is calculated  based  on the input  from  the sleep  experts.  
 
‘Concordance  rate’ is a score  calculated  from  the rating  of a sleep  expert  on a 
facial  training  video   
𝐶𝑜𝑛𝑐𝑜𝑟𝑑𝑎𝑛𝑐𝑒  𝑟𝑎𝑡𝑒  =෍ሾ1−ሺȁ𝐴𝑖−𝐵𝑖ȁሻ𝐷Τሿ𝑛Τ𝑛
𝑖=1  
A: “True”  Drowsiness  rating  value  of the training  video  
B: Evaluated  drowsiness  level  by the sleep  expert  
D: Maximum  of drowsiness  level  occurring  during  the training  video  
n: number  of data point  to rate during  the training  video  
5.2.3. If the alternative  measurement  uses a different  time interval  than the one specified  
in point  5.1.2, point  5.1.5. shall  apply , where  the intervals  of assessment  are equal  
to or shorter  than 15 minutes  and above  or equal  to 5 minutes .  
If the time interval  is shorter  than 5 minutes,  the interpretation  of point  5.1.5. shall  
not apply.  Instead,  a false  negative  event  occurs  only if the DDAW  does not 
provide  a warning  during  the 10 minutes  following  the last rating  below  the 
drowsine ss threshold.  If during  5 minutes  or more  the ratings  are above  the 
drowsiness  threshold  then it is followed  by a rating  below  the drowsiness  
threshold,  the data point  shall  be treated  as an outlier.  All outliers  shall  be 
documented  in the documentation  package ; 
5.2.4. If the time intervals  are longer  than 15 minutes,  the technical  services  may consider  
raising  the requirements  from  point 8.1(a) and point 8.1(b)  by the amount  set out in 
point 8.1(c) to better  allow  for a correct  assess ment  of the driver’s  drowsiness.  
5.3. Compl ementary  measurements  
 
Manufacturers  may use complementary  measurement (s) to KSS or the alternative  
measurement(s)  to validate  a DDAW  system , which shall  be duly documented  in 
the documentation  package  under  Part 3. 
 
Where  sleep  expert  video  analysis  are used as a compl ementary  measurement,  at a 
minimum  two raters  and an inter-rater reliability  test shall  be conducted,  and the 
results  shall  be included  in the documentation  package.  The facial  cues and body  
movements/behaviours  for each level  of drowsiness  on the KSS shall  be 
demonstrated  (usually  it is a confidential  document) . 
 
6. Alternative  drowsiness  threshold  
6.1. If alternative  measurements  to KSS are used to validate  a DDAW  system,  the 
manufacture  shall  state the threshold  being  used and provide  evidence  detailing  the EN 10  EN equivalency  between  the threshold  and a KSS level  of 8.  
If the alternative  measurement  uses a scale  which  has fewer  descriptive  level s than 
the KSS,  the equivalence  between  the alternative  scale  and the KSS shall  refer  to 
the lowest  corresponding  level  when  compared  to the KSS. The only exception  is 
for the level  of the alternative  scale  that includes the equivalenc y to a KSS level  of 
8, in which  case it shall  refer  to the highest  corresponding  level  when  compared  to 
the KSS. 
For example,  if the alternative  scale  level  “4” correspond s to a range  between  “6 
and 7” on the KSS,  a “4” on the alternative  scale  shall  be considered  a “6” on the 
KSS.  
If an alternative  scale  level  “A” corresponds  to a range  between  “6,5 and 8,5” on 
the KSS,  an “A” on the alternative  scale  shall  be considered  an “8” on the KSS.  
6.2. If a compl ementary  measurement  is used in addition  to KSS or to an alternative  
measurement  to validate  a DDAW  system,  the manufacturer  shall  state the 
threshold  being  used and provide  evidence  detailing  the equivalency  between  the 
threshold  and a KSS level  of 8. 
7. Test results  
7.1. Test data shall  only be discarded  by the manufacturer  before  any statistical  analysis  
is conducted  in any of the following  cases : 
(a) there is an error  in carrying  out the testing  procedure ; 
(b) the participant’s  KSS ratings  are deemed  unreliable ;  
(c) insufficient  data is collected  for a participant  (e.g. length  of trial was too short  
or participant  did not generate  at least 1 true positive  event  or 1 false  negative  
event ). 
7.2. The manufacturer  shall  document  any errors  that occur  during  testing  shall  be 
documented  as part of the evidence  in the documentation  package,  separate  from  
the test results,  along  with the erroneous  data and, if applicable,  the reason  for 
excluding  a participants’  data from the statistical  analysis.  
8. Acceptance  criteri a 
8.1 A DDAW  system shall  be deemed  effective  by the technical  services  if the 
following  requirement  (a) or (b) is satisfied  as modified , if necessary , by 
requirements  (c) for tests using  interval  time above  15 minutes  and (d) for tests 
performed  in a simulated  environment : 
 
(a) the average  sensitivity  is above  40% (Sensitivity  calculated  from  the average  of 
the sensitivity  of all participants)  
(b) the lower  bound  from the 90% confidence  interval  of the sensitiv ity results  
shall  be above  20%.  It means  that 95% of the participants  statisticall y have  more  
than 20% average  sensitivity,  this is verified  by satisfying  the equation:  
𝐴𝑣𝑒𝑟𝑎𝑔𝑒  ሺ𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣𝑖𝑡𝑦 ሻ−1.645 ×ඨ𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑  𝐷𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛  ሺ𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣𝑖𝑡𝑦 ሻ
𝑁𝑢𝑚𝑏𝑒𝑟  𝑜𝑓 𝑝𝑎𝑟𝑡𝑖𝑐𝑖𝑝𝑎𝑛𝑡𝑠≥20%  
(c) the requirement  listed  in sub-point  (a) is increased  by 5% and the requirement  
listed  in sub-point  (b) is increased  by 2,5% if the testing  method  does not use an 
interval  time equal  to or shorter  than the 15 minutes  possible  in point 5.2.3 (upper  EN 11  EN bound  possible  between  the recommended  measurement  the alternative  
measurement) . 
(d) the requirement  listed  in sub-point  (a) is lowered  by 5% and the requirement  
listed  in sub-point  (b) is lowered  by 2,5% if the testing  method  is performed  on an 
open  road.  
 
For example,  the average  sensitivity  required  for an open  road test using  an interval  
time equal  to or shorter  than 15 minutes  will be ≥ 35% and the average  sensitivity  
required  for a simulation  test with interval  time of more  than 15 minutes  will be ≥ 
45%. 
 Performance  metric  calculation  
The performance  metrics  shall  be calculated  as: 
 
Sensitivity  value  of a participant:  
𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣𝑖𝑡𝑦 = 𝑛ሺ𝑇𝑃ሻ
𝑛ሺ𝑇𝑃ሻ+𝑛ሺ𝐹𝑁ሻ×100%  
 
Average  sensitivity  for all participants:  
𝐴𝑣𝑒𝑟𝑎𝑔𝑒 ሺ𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣𝑖𝑡𝑦 ሻ= σ𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣 𝑖𝑡𝑦
𝑁𝑢𝑚𝑏𝑒𝑟  𝑜𝑓𝑝𝑎𝑟𝑡𝑖𝑐𝑖𝑝𝑎𝑛𝑡𝑠 
 
Standard  Deviation  (Sensitivity):  
𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑  𝐷𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛 ሺ𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣𝑖𝑡𝑦 ሻ= ඨσ൫𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣𝑖𝑡𝑦 −𝐴𝑣𝑒𝑟𝑎𝑔𝑒 ሺ𝑆𝑒𝑛𝑠𝑖𝑡𝑖𝑣𝑖𝑡𝑦 ሻ൯2
𝑁𝑢𝑚𝑏𝑒𝑟  𝑜𝑓𝑝𝑎𝑟𝑡𝑖𝑐𝑖𝑝𝑎𝑛𝑡𝑠 
 
where:  
n(TP) is the total number  of events  in which  the system  and driver  both correctly  
identify  as drowsy ; 
n(FN) is the total number  of events  in which  the system  predicts  that the driver  is 
not drowsy,  but when  the driver  is in fact drowsy ; 
n(FP) is the total number  of events  in which  the system  predicts  that the driver  is 
drowsy,  but the driver  is not drowsy ; 
n(TN) is the total number  of events  in which  the system  and driver  both correctly  
identify  as not being  drowsy ; 
 
Σ is the sum over all the participants . 
 
Note:  The distribution  of the results  is approximated  by a Gaussian  distribution.  
8.2. If the DDAW  system  requires  a learning  phase,  the acceptance  criteria  listed  in 
point  8.1. shall  exclude  results  obtained  during  the learning  phase  or for 30 minutes  
after the condition  for activation  of the DDAW  are fulfilled , whichever  is shorter.  
  EN 12  EN PART 3  
 
Procedures for assessment of technical document ation  and verification testing by the 
approval authorities and technical services  
 
1. Documentation  package  
 
The manufacturer  shall  provide  to the approval  authorities  and technical  services  a 
documentation  package  containing  evidence  of the effectiveness  of the system.  The 
documentation  package  shall cover  both,  the system  functionality  and the system  
validation . 
1.1. System  functionality  
The documentation  package  detailing  how the system  functions  shall  include:   
(a) a list of all the system  inputs  containing  the primary  and secondary  metrics ; 
(b) a description  of how the metrics  function  and monitor  driving  behaviour ; 
(c) a description  of the trigger  behaviour  being  monitored  by the system ; 
(d) evidence  on the relationship  between  drowsy  driving  and/or  steering  behaviour  
and the chosen  trigger  behaviour ; 
(e) the system’s  drowsiness  threshold ; 
(f) the vehicle  speed at which  the system  is activated ; 
(g) an explanation  of the systems  activation,  reactivation  and deactivation  
functions ; 
(h) a document  detailing  the functionality  of the system’s  HMI.  This includes  
evidence  of compliance  with the DDAW  HMI  requirements  (point 3.4. of Part 1), 
and justifications  if the manufacturer  choose  not to follow  the recommendations  
listed  in the points  3.4.2.3.,  3.4.2.4.  and 3.4.2.5.  of Part 1. 
(i) a document  providing  at least one test protocol  to be tested  by the Technical  
Service,  for which  the DDAW  system  shall  deliver  a warning  when  performed.  
The list of system  inputs  shall  only be provided  to the approval  authority  or the 
technical  service  for the purpose  of verifying  the DDAW  system  for the type-
approval . The list of any secondary  metrics  will not be passed  on from  the 
technical  service  to the approval  authorit y. 
1.2. System  validation  
Evidence  on the effectiveness  of the system  document  shall  include:   
(a) the information  on the number  and demographics  of the test participants  
assessed .  
(b) the description  of the test conditions  assessed ; 
(c) evidence  that the system  works  effectively  in weather  conditions  not limiting  
the system’s  operati on. The evidence  shall  indicate  the known  or logical  limitation s 
due to weather  conditions,  the technical  challenge  and the strategy  for the system  
behaviour  in these  given  weather  condition s (for example  strong  rain, snow,  high 
temperature  etc.). 
(d) a description  of full test methodology  used to assess  the effectiveness  of the 
system  and the rationale  behind , includ ing any alternative  or complementary  
measurements  and alternative  drowsiness  threshold  (referred  to in point  5.2., point  
5.3. and point  6. of Part 2 respectively ); 
(e) a description  of the statistical  analysis  technique  used.  If a statistical  analysis  
method  that diffe rs from  that set out in point 8.1. is used, evidence  on the statistical  EN 13  EN analysis  technique  and level  of significance  used shall  be provided ; 
(f) an analysis  and description  of the results ; 
(g) evidence  that the system  alerts  a driver  at the time of or before  reaching  the 
KSS level  set out in point  3.3.1. of Part 1; 
(h) the data of each participant  for statistical  anomaly  assessment . 
 
The information  on demographics  of the test participants  referred  to in sub-point  
(a) shall include:  
(i) inclusionary  or exclusionary  criteria  that were  used when  selecting  
participants,  and 
(ii) a statement  on the adequacy  of the participants  in respect  of the targeted  
demography  for the vehicle  set out in point  3.3. of Part 2. 
 
The information  on full test methodology  referred  to in sub-point  (d) shall include:   
(i) provide  evidence  that the compl ementary  measurement(s)  or the 
combination  of the primary  (KSS  or alternative  measure)  and 
compl ementary  measurements  are a valid  and accurate  means  to assess  
driver  drowsiness ; 
(ii) provid e information  on how the data of the primary  and compl ementary  
measurements  were  analysed  and collated  to assess  the effectiveness  of 
the DDAW  system ; 
(iii) provide  evidence  that the drowsiness  threshold  being  used in the 
validation  testing  is equivalent  to a KSS level  referred  to in point  3.3.1 of 
Part 1. 
 
1.2.1.  If the validation  was performed  on another  vehicle,  the documentation  shall  
contain  information  linking the validation  process  to the type-approval  
requirements  for the vehicle.  
e.g. Provide  documents  demonstrating  the technical  similarities  or the adaptation  
required  to enable  the DDAW  system to the vehicle  presented  for type-approval.  
The requirements  on the participants  shall  also be similar  (demography,  
involvement  of professional  driver).  
1.2.2.  If the validation  was performed  as part of a research  to establish  compliance  with 
the technical  requirements  for the DDAW  system,  the documentation  shall  contain  
information  linking the validation  testing  to the respective  approval  requirements  
for the motor  vehicle  concerned . 
e.g. Provide  an additional  link between  what  is enabled  in the version  of the 
DDAW  system  installed  in the motor  vehicle  and a recal culat ion of the equivalent  
sensitivity  values  from  the data produced  during  the research  phase.  
2. Assessment  by the technical  service  of the DDAW  system  documentation  package  
and test report  
2.1 The technical  service  shall  check  that the manufacturer  has proved  on the basis  of 
the tests performed  in accordance  with this Annex  that the DDAW  meets  the 
technical  criteria  laid down  in Part 1 and the validation  criteria  laid down  in Part 2. 
The following  actions  are expected:  
(a) check  that the reported  performance  levels  meet  the required  minimum  
thresholds  referred  to in point 3.3.1. of Part 1; 
(b) review  the test report  to verify  whether  the underlying  methodology  EN 14  EN presented  in the test report  meets  the requirements  set out in Part 2; 
(c) perform  an assessment  of the test report  from  the validation  testing  carried  
out by the manufacturer . 
 
The assessment  of the test report  shall  verify  whether  the underlying  evidence  on 
the tests performed  correspond  with the reported  test results  to a level  of overall  
effect  such that the performance  declaration  is confirmed  as being  adequate.  This 
includes  assessing  the participant  data for statistical  anomalies  such as the number  
of outliers.  
 
The technical  service  may use means  at its discretion  for the assessment  of the test 
report . Such  means  may include  a review  of the full raw data sets from  a selection  
of test drives  chosen  by the technical  service  (including  any data that was excluded  
from  the analysis)  and re-running  parts  of the validation  testing based  on collected  
data (may  only be possible  for limited  validation  methods,  such as sleep  video  
analysis) . 
2.2 The technical  service  shall  assess  the possibility  of the test protocol , proposed  by 
the manufacturer,  to reflect  a drowsy  driving  event,  taking  into account  the 
information  on the system  functionality  provided  under  point  1.1. The technical  
service  shall  also perform  the test based  on the proposed  protocol . 
2.2.1.  The test shall  be accounted  as passed  as soon  as the DDAW  system  provides  a 
warning  for a drowsy driver . 
2.2.2. If the test fails to provide  a warning  for a drowsy  driver, the technical  service  may 
repeat  it up to two times.   
2.2.3. The root cause  of any failed  test run shall  be analy sed by the technical  service  and 
the analysis  shall  be annexed  to the test report.  If the root cause  cannot  be linked  to 
a deviation  in the test setup,  the technical  service  may test any variation  of 
parameter  within  parameter’s  range  defined  in the test protocol  provided  by the 
manufacturer.  
2.2.4.  A reference  to the code  of the respective  test protocol , which  has been  run by the 
technical  service, shall  be included  in the “Remarks ” section  of the Type -Approval  
Certificate  in order  to allow  competent  authorities,  when  performing  for instance  
market  surveillance  activities,  to request  the test protocol  from  the technical  service  
that carried  out the test. EN 15  EN ANNEX  II 
Amendment to Regulation (EU) 2019/2144  
 
In Annex  II to Regulation  (EU)  2019/2144  the row for requirement E2  is replaced by the 
following:  
Subject  Regulatory acts  Additional 
specific 
technical 
provisions  M1 M2 M3 N1 N2 N3 O1 O2 O3 O4 STU  Component  
‘E2 Driver 
drowsiness and 
attention warning  ‘Commission  
Regulation  (EU) 
2020/ …*+ 
  B B B B B B       
 
*    Regulation (EU) 2020/… of … supplementing Regulation (EU) 2019/2144 of the European Parliament and 
of the Council by laying down detailed rules concerning the specific test procedures and technical requirements 
for the type -approval of motor vehicles with regard to the driver drowsiness and attention warning  and amending 
that Reg ulation (OJ L …, … p. …).’  
  
                                                 
+ OJ: Please insert in the text the number of this Regulation and insert the number, date, title and OJ reference of 
this Regulation in the footnote.  EN 16  EN ANNEX III  
 
Amendments to Annex II to Regulation (EU) 2018/858  
 
Appendix 1 of Part I of Annex II to Regulation (EU) 2018/ 858 is amended as follows:  
(1) in Table 1 the following entry 74 is added : 
‘74 E2 Driver 
drowsiness and 
attention 
warning  Regulation (EU) 
2019/ 2144 of the 
European Parliament 
and of the Council  (*) 
Commission Delegated 
Regulation (EU) 
2021 /[…(**) - number  
to be added before 
publication.]  Vehicles based on a 
vehicle type covered 
by a EU type -
approval of vehic les 
produced in unlimited 
series  X 
   Vehicles with more 
than 2 seating 
positions  X’ 
________________________________  
(*) Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type -
approval requirements for motor vehicles and their trailers, and  systems, components and separate technical units 
intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable 
road users, amending Regulation (EU) 2018/858 of the Europ ean Parliament and of the Council and repealing 
Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the 
Council and Commission Regulations (EC) No 631/2010, (EU) No 406/2010, (EU) No 672/2010, (EU) No 
1003/20 10, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, 
(EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) 347/2012, (EU) No 351/2012, (EU) No 1230/2012 
and (EU) 2015/166  
(**) Commission Delegated Regulation ( EU) 2021/[… - number and full title/OJ reference to be added before 
publication.]’  
(2) in Table 2 the following entry 74 is added : 
‘74 E2 Driver 
drowsiness and 
attention 
warning  Regulation 
(EU) 
2019/ 2144  
Regulation 
(EU) 
2021/[…  - 
number  to 
be added 
before 
publication.]  Vehicles based on a 
vehicle type covered by a 
EU type -approval of 
vehicles produced in 
unlimited series  X 
   Vehicles with more than 
2 seating positions  X’ EN 17  EN