Skip to content
Official alerts and notifications portal
Menu
RASFFReference 2022.5812

Too high content of monacolin K in food supplements from Germany

Official information organised for easier consultation. The source publication remains authoritative.

Open official publication ↗

RASFF

Identification and classification

Reference
2022.5812
Notification ID
573497
Classification
alert notification
Risk decision
serious
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
Red rice extract
Distribution status
Description
distribution to other member countries
Notification ID
219
Notification ID
17388576
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    17389942
    labelling
    vegan-glutenfrei-laktosefrei, hochdosiert mit 4,5 mg Monacolin K /// unofficial translation: vegan-gluten-free-lactose-free, high-dose with 4.5 mg monacolin K
    productAspect
    Kunststoffdose 120 Kapseln, Transparente Steckkapseln, gefüllt mit rosarotem Pulver /// unofficial translation: plastic box 120 capsules, transparent plug-in capsules, filled with pink powder
    temperature
    Description
    ambient
    Notification ID
    27368
    weight
    120.0
    weightUnit
    Description
    units
    Notification ID
    20003
  2. Notification ID
    17395998
    labelling
    600 mg fermentierter Roter Reis ///600 mg fermented red rice
    productAspect
    Kunststoffdose 600mg, 120 Kapseln, Transparente Steckkapseln, gefüllt mit rosarotem Pulver /// unofficial translation: plastic box 600mg, 120 capsules, transparent plug-in capsules, filled with pink powder
    temperature
    Description
    ambient
    Notification ID
    27368
    weight
    120.0
    weightUnit
    Description
    units
    Notification ID
    20003

RASFF

Risk and analytical results

hazardObserved
Der in der vorliegenden Probe gemessene Gehalt an Monacolinen übersteigt mit 4,53 mg pro Tagesdosis deutlich den zulässigen Höchstgehalt gemäß Anhang III Teil B der VO (EG) 1925/2006, laut dem Einzelportionen des Erzeugnisses für den täglichen Verzehr weniger als 3 mg Monacoline aus Rotschimmelreis enthalten müssen. ///unofficial translation: The content of monacolins measured in the present sample with 4.53 mg per daily dose clearly exceeds the maximum permitted content according to Annex III Part B of Regulation (EC) 1925/2006, according to which individual portions of the product for daily consumption must contain less than 3 mg of monacolins from red mold rice.
Notification ID
73378

RASFF

Hazards

  1. analyticalResult
    4.53
    Hazard category
    Description
    composition
    Notification ID
    17533638
    maxPermittedLvl
    3 mg
    maxPermittedLvlQuantities
    3
    maxPermittedLvlUnit
    mg
    Name
    monacolin K - too high intake - - composition
    samplingDate
    23-08-2022 00:00:00
    unit
    mg

RASFF

Measures

  1. Action taken
    Description
    detained by operator
    Notification ID
    18822
    Notification ID
    17396240
    takenBy
    Notification ID
    5007
    isoCode
    DE
    organizationName
    Germany
  2. Action taken
    Description
    product (to be) redispatched or destroyed
    Notification ID
    18954
    Notification ID
    17396243
    takenBy
    Notification ID
    5007
    isoCode
    DE
    organizationName
    Germany
  3. Action taken
    Description
    withdrawal from recipient(s)
    Notification ID
    18844
    Notification ID
    17862128
    takenBy
    Notification ID
    5007
    isoCode
    DE
    organizationName
    Germany

RASFF

Origin, notification and distribution

Origin
Germany
Notifying country or territory
Germany
Published distribution
Austria, Cyprus, Czechia, Germany, Poland
Affected territories
Austria · Cyprus · Czechia · Germany · Poland

RASFF

Published territorial roles

  1. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      576856
    2. Role
      DISTRIBUTION
      notificationId
      576856
    Organisation
    code
    AT
    countryNetworkOrganizationId
    5001
    Description
    Austria
    Notification ID
    5
  2. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      573497
    2. Role
      DISTRIBUTION
      notificationId
      573497
    3. Role
      OPERATOR
      notificationId
      573497
    Organisation
    code
    CY
    countryNetworkOrganizationId
    5005
    Description
    Cyprus
    Notification ID
    12
  3. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      575629
    2. Role
      DISTRIBUTION
      notificationId
      575629
    Organisation
    code
    CZ
    countryNetworkOrganizationId
    5006
    Description
    Czechia
    Notification ID
    37
  4. Roles
    1. Role
      NOTIFYING
      notificationId
      573497
    2. Role
      NOTIFYING
      notificationId
      575629
    3. Role
      FOR_FOLLOW_UP
      notificationId
      575629
    4. Role
      NOTIFYING
      notificationId
      574374
    5. Role
      FOR_ATTENTION
      notificationId
      574374
    6. Role
      NOTIFYING
      notificationId
      575629
    7. Role
      FOR_ATTENTION
      notificationId
      575629
    8. Role
      NOTIFYING
      notificationId
      573497
    9. Role
      ORIGIN
      notificationId
      573497
    10. Role
      NOTIFYING
      notificationId
      575629
    11. Role
      DISTRIBUTION
      notificationId
      575629
    12. Role
      NOTIFYING
      notificationId
      573497
    13. Role
      DISTRIBUTION
      notificationId
      573497
    14. Role
      NOTIFYING
      notificationId
      576856
    15. Role
      DISTRIBUTION
      notificationId
      576856
    16. Role
      NOTIFYING
      notificationId
      573497
    17. Role
      OPERATOR
      notificationId
      573497
    18. Role
      NOTIFYING
      notificationId
      576856
    19. Role
      OPERATOR
      notificationId
      576856
    Organisation
    code
    DE
    countryNetworkOrganizationId
    5007
    Description
    Germany
    Notification ID
    3
  5. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      574447
    2. Role
      DISTRIBUTION
      notificationId
      575629
    3. Role
      OPERATOR
      notificationId
      575629
    Organisation
    code
    PL
    countryNetworkOrganizationId
    5028
    Description
    Poland
    Notification ID
    31

RASFF

Follow-ups

  1. fupDate
    10-10-2022 12:33:42
    fupId
    574374
    fupNumber
    1
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  2. fupDate
    12-10-2022 12:45:57
    fupId
    574809
    fupNumber
    2
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    520
    organizationCode
    CY
    organizationDescription
    Public Health Services
  3. fupDate
    14-10-2022 07:23:34
    fupId
    574447
    fupNumber
    3
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    87
    organizationCode
    DE
    organizationDescription
    Sachsen-Anhalt
  4. fupDate
    18-10-2022 10:31:29
    fupId
    575629
    fupNumber
    4
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    31
    organizationCode
    PL
    organizationDescription
    Poland
  5. fupDate
    18-10-2022 14:58:30
    fupId
    575713
    fupNumber
    5
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  6. fupDate
    19-10-2022 15:01:39
    fupId
    575643
    fupNumber
    6
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    31
    organizationCode
    PL
    organizationDescription
    Poland
  7. fupDate
    27-10-2022 15:08:34
    fupId
    576856
    fupNumber
    7
    fupType
    Description
    outcome of investigations and measures taken
    Notification ID
    27659
    networkOrganizationId
    76
    organizationCode
    DE
    organizationDescription
    Bayern
  8. fupDate
    02-11-2022 09:30:34
    fupId
    577955
    fupNumber
    8
    fupType
    Description
    outcome of investigations and measures taken
    Notification ID
    27659
    networkOrganizationId
    5
    organizationCode
    AT
    organizationDescription
    Austria
  9. fupDate
    02-11-2022 15:13:33
    fupId
    578089
    fupNumber
    9
    fupType
    Description
    outcome of investigations and measures taken
    Notification ID
    27659
    networkOrganizationId
    37
    organizationCode
    CZ
    organizationDescription
    Czechia

RASFF

5001
  1. countryNetworkOrganizationId
    5001
    Notification ID
    1
    link
    http://www.ages.at/ages/produktwarnungen/
5005
  1. countryNetworkOrganizationId
    5005
    Notification ID
    6
    link
    http://www.moa.gov.cy/moa/vs/vs.nsf/vs49_gr/vs49_gr?OpenDocument
  2. countryNetworkOrganizationId
    5005
    Notification ID
    7
  3. countryNetworkOrganizationId
    5005
    Notification ID
    8
    link
    http://www.moh.gov.cy/moh/mphs/phs.nsf/DMLannouncements_gr/DMLannouncements_gr?OpenDocument
5006
  1. countryNetworkOrganizationId
    5006
    Notification ID
    9
5007
  1. countryNetworkOrganizationId
    5007
    Notification ID
    16
    link
    http://www.lebensmittelwarnung.de
5028
  1. countryNetworkOrganizationId
    5028
    Notification ID
    32

Provenance and context

NagameAlert organises public RASFF data while preserving official values and keeping notification classification separate from the risk decision. The official record remains authoritative and should be checked for follow-ups and current status.