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RASFFReference 2021.3507

unauthorised substance melatonin in food supplement offered online for sale

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

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RASFF

Identification and classification

Reference
2021.3507
Notification ID
485893
Classification
alert notification
Risk decision
undecided
Product type
food
Notification basis
consumer complaint
Status
ec_validated

RASFF

Product

Description
food supplement
Distribution status
Description
product traded online
Notification ID
228
Notification ID
6047626
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    6047861
    productAspect
    bottle/60 caps
    temperature
    Description
    ambient
    Notification ID
    27368

RASFF

Risk and analytical results

hazardObserved
The product, it contains the pharmacologically active substance melatonin in a dose of 3 mg per tablet, which confers it the status of medicinal product. Besides, the above mentioned product has not been subject to evaluation and pre-marketing authorisation.
Notification ID
50367

RASFF

Measures

  1. Action taken
    Description
    withdrawal from the market
    Notification ID
    18837
    Notification ID
    6047990
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain
  2. Action taken
    Description
    informing recipient(s)
    Notification ID
    18383
    Notification ID
    6161962
    takenBy
    Notification ID
    5026
    isoCode
    NL
    organizationName
    Netherlands
  3. Action taken
    Description
    withdrawal from the market
    Notification ID
    18837
    Notification ID
    6162034
    takenBy
    Notification ID
    5026
    isoCode
    NL
    organizationName
    Netherlands
  4. Action taken
    Description
    return to consignor
    Notification ID
    18835
    Notification ID
    21736882
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain
  5. Action taken
    Description
    prohibition to trade - sales ban
    Notification ID
    18953
    Notification ID
    21736946
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain

RASFF

Origin, notification and distribution

Origin
United States
Notifying country or territory
Spain
Published distribution
Netherlands, Spain
Affected territories
Netherlands · Spain

RASFF

Published territorial roles

  1. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      485893
    2. Role
      DISTRIBUTION
      notificationId
      485893
    3. Role
      OPERATOR
      notificationId
      485893
    Organisation
    code
    NL
    countryNetworkOrganizationId
    5026
    Description
    Netherlands
    Notification ID
    38
  2. Roles
    1. Role
      NOTIFYING
      notificationId
      485893
    2. Role
      NOTIFYING
      notificationId
      487439
    3. Role
      FOR_FOLLOW_UP
      notificationId
      487439
    4. Role
      NOTIFYING
      notificationId
      485893
    5. Role
      DISTRIBUTION
      notificationId
      485893
    Organisation
    code
    ES
    countryNetworkOrganizationId
    5010
    Description
    Spain
    Notification ID
    2
  3. Roles
    1. Role
      ORIGIN
      notificationId
      485893
    2. Role
      OPERATOR
      notificationId
      485893
    Organisation
    code
    US
    countryNetworkOrganizationId
    5230
    Description
    United States
    Notification ID
    10225

RASFF

Follow-ups

  1. fupDate
    02-07-2021 16:25:39
    fupId
    485974
    fupNumber
    1
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  2. fupDate
    16-07-2021 16:56:19
    fupId
    487439
    fupNumber
    2
    fupType
    Description
    outcome of investigations and measures taken
    Notification ID
    27659
    networkOrganizationId
    38
    organizationCode
    NL
    organizationDescription
    Netherlands
  3. fupDate
    12-09-2023 15:01:55
    fupId
    632566
    fupNumber
    3
    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

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.