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RASFFReference 2023.1333

unauthorised substances sildenafil (> 17096 mg/kg - ppm) and tadalafil (> 6.25 mg/kg - ppm) in food supplement from Croatia, with raw material from China, dispatched from Hong Kong

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RASFF

Identification and classification

Reference
2023.1333
Notification ID
596719
Classification
information notification for attention
Risk decision
serious
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
EpiMen Plus, capsules, food supplement
Distribution status
Description
distribution restricted to notifying country
Notification ID
220
Notification ID
19075162
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    19075600
    productAspect
    packaging of two capsules in 450mg
    weight
    0.9
    weightUnit
    Description
    g
    Notification ID
    18974

RASFF

Risk and analytical results

hazardObserved
(active components of medicine drugs in food supplement products)
Notification ID
80701

RASFF

Hazards

  1. analyticalResult
    97093, 75385, 82710, 133550, 174593, 161993, 190611, 141808, 143968, 128780, 124863, 89725, 88628, 69392, 80163, 87522, 106725, 137448, 17096, 135000, 97921, 133550, 80163, 253908, 126762
    Hazard category
    Description
    composition
    Notification ID
    19168481
    Name
    sildenafil - unauthorised substance - composition
    samplingDate
    23-11-2022 00:00:00
    unit
    mg/kg - ppm
  2. analyticalResult
    4122.1, 5115.2, 1799.1, 67.1, 54.2, 1949, 5305, 25.4, 9330, 4305, 76.8, 6.8, 7.1, 166.2, 27.9, , 6.25, 59.9, 20.63
    Hazard category
    Description
    composition
    Notification ID
    19168507
    Name
    tadalafil - unauthorised substance - composition
    samplingDate
    23-11-2022 00:00:00
    unit
    mg/kg - ppm

RASFF

Measures

  1. Action taken
    Description
    recall from consumer
    Notification ID
    18836
    Notification ID
    19076264
    takenBy
    Notification ID
    5016
    isoCode
    HR
    organizationName
    Croatia

RASFF

Origin, notification and distribution

Origin
China
Notifying country or territory
Croatia
Published distribution
Croatia
Affected territories
Croatia

RASFF

Published territorial roles

  1. Roles
    1. Role
      ORIGIN
      notificationId
      596719
    Organisation
    code
    CN
    countryNetworkOrganizationId
    5075
    Description
    China
    Notification ID
    10070
  2. Roles
    1. Role
      NOTIFYING
      notificationId
      596719
    2. Role
      NOTIFYING
      notificationId
      597799
    3. Role
      DISTRIBUTION
      notificationId
      597799
    4. Role
      NOTIFYING
      notificationId
      596719
    5. Role
      OPERATOR
      notificationId
      596719
    6. Role
      NOTIFYING
      notificationId
      597799
    7. Role
      OPERATOR
      notificationId
      597799
    Organisation
    code
    HR
    countryNetworkOrganizationId
    5016
    Description
    Croatia
    Notification ID
    36
  3. Roles
    1. Role
      OPERATOR
      notificationId
      597799
    Organisation
    code
    HK
    countryNetworkOrganizationId
    5117
    Description
    Hong Kong
    Notification ID
    10112
  4. Roles
    1. Role
      FOR_ATTENTION
      notificationId
      598202
    Organisation
    code
    INFO
    countryNetworkOrganizationId
    5680
    Description
    INFOSAN
    Notification ID
    10340

RASFF

Follow-ups

  1. fupDate
    23-02-2023 18:28:08
    fupId
    597799
    fupNumber
    1
    fupType
    Description
    accompanying documents
    Notification ID
    27662
    networkOrganizationId
    36
    organizationCode
    HR
    organizationDescription
    Croatia
  2. fupDate
    23-02-2023 18:30:32
    fupId
    597952
    fupNumber
    2
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  3. fupDate
    24-02-2023 15:34:04
    fupId
    598202
    fupNumber
    3
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  4. fupDate
    03-03-2023 15:06:01
    fupId
    599513
    fupNumber
    4
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  5. fupDate
    23-03-2023 11:17:39
    fupId
    602896
    fupNumber
    5
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  6. fupDate
    14-04-2023 16:47:42
    fupId
    606701
    fupNumber
    6
    fupType
    Description
    follow-up from non-member country
    Notification ID
    27671
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  7. fupDate
    13-06-2023 10:14:02
    fupId
    616683
    fupNumber
    7
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    36
    organizationCode
    HR
    organizationDescription
    Croatia

RASFF

5016
  1. countryNetworkOrganizationId
    5016
    Notification ID
    5

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.