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RASFFReference 2020.1899

PRESENCE OF PHARMACOLOGICALLY ACTIVE SUBSTANCE (MELATONIN) IN FOOD SUPPLEMENT (MIRACLE SLEEP PILLS)

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

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RASFF

Identification and classification

Reference
2020.1899
Notification ID
428742
Classification
alert notification
Risk decision
serious
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
food supplement Miracle Sleep
Distribution status
Description
product traded online
Notification ID
228
Notification ID
2228067
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    2228138
    productAspect
    60-pill bottle
    temperature
    Description
    ambient
    Notification ID
    27368

RASFF

Risk and analytical results

hazardObserved
The following adverse effects may occur with the consumption of melatonin: irritability, nervousness, restlessness, insomnia, strange dreams, migraine, lethargy, psychomotor hyperactivity, dizziness, drowsiness, hypertension, stomach pain, dyspepsia, mouth ulcers, dry mouth, hyperbilirubinemia, dermatitis, night sweats, itching, rashes, dry skin, pain in the extremities, menopausal symptoms, asthenia, chest pain, glycosuria, proteinuria, altered liver function tests and weight gain.
Notification ID
37139

RASFF

Measures

  1. Action taken
    Description
    withdrawal from the market
    Notification ID
    18837
    Notification ID
    2228205
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain
    url
    http://www.aecosan.msssi.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/miracle.htm
  2. Action taken
    Description
    Re-dispatch
    Notification ID
    18702
    Notification ID
    2228534
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain

RASFF

Origin, notification and distribution

Origin
Poland
Notifying country or territory
Spain
Published distribution
Spain
Affected territories
Spain

RASFF

Published territorial roles

  1. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      428742
    2. Role
      ORIGIN
      notificationId
      428742
    3. Role
      OPERATOR
      notificationId
      428742
    Organisation
    code
    PL
    countryNetworkOrganizationId
    5028
    Description
    Poland
    Notification ID
    31
  2. Roles
    1. Role
      NOTIFYING
      notificationId
      428742
    2. Role
      NOTIFYING
      notificationId
      429177
    3. Role
      FOR_FOLLOW_UP
      notificationId
      429177
    4. Role
      NOTIFYING
      notificationId
      429672
    5. Role
      DISTRIBUTION
      notificationId
      429672
    6. Role
      NOTIFYING
      notificationId
      428742
    7. Role
      OPERATOR
      notificationId
      428742
    Organisation
    code
    ES
    countryNetworkOrganizationId
    5010
    Description
    Spain
    Notification ID
    2

RASFF

Follow-ups

  1. fupDate
    11-05-2020 12:54:44
    fupId
    429177
    fupNumber
    1
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    31
    organizationCode
    PL
    organizationDescription
    Poland
  2. fupDate
    15-05-2020 10:47:31
    fupId
    429672
    fupNumber
    2
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    31
    organizationCode
    PL
    organizationDescription
    Poland
  3. fupDate
    18-05-2020 14:07:46
    fupId
    429839
    fupNumber
    3
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    31
    organizationCode
    PL
    organizationDescription
    Poland
  4. fupDate
    19-06-2020 10:34:36
    fupId
    432799
    fupNumber
    4
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    2
    organizationCode
    ES
    organizationDescription
    Spain
  5. fupDate
    19-06-2020 16:46:07
    fupId
    432888
    fupNumber
    5
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  6. fupDate
    08-10-2020 09:26:01
    fupId
    444285
    fupNumber
    6
    fupType
    Description
    outcome of investigations and measures taken
    Notification ID
    27659
    networkOrganizationId
    2
    organizationCode
    ES
    organizationDescription
    Spain

RASFF

5010
  1. countryNetworkOrganizationId
    5010
    Notification ID
    35
    link
    http://aplicaciones.magrama.es/silum/web/novedades/novedades.jsp
  2. countryNetworkOrganizationId
    5010
    Notification ID
    36
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.