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RASFFReference 2023.5778

suplement diety ze względu na skład spełnia kryterium definicji dla produktu leczniczego/// a food supplement due to its composition meets the definition criterion for a medicinal product

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RASFF

Identification and classification

Reference
2023.5778
Notification ID
629547
Classification
information notification for attention
Risk decision
potential risk
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
PAC-on Calm
Distribution status
Description
distribution to non-member countries only
Notification ID
225
Notification ID
21585340
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    21585651
    productAspect
    zawartość: 60 kapsułek, nr partii: 26AP220301, data minimalnej trwałości: 03.2024, producent: AronPharma Sp. z o.o., ul. Trzy Lipy 3, 80-172 Gdańsk/// content: 60 capsules, batch number: 26AP220301, date of minimum durability: 03.2024, producer: AronPharma Sp. z o.o., ul. Trzy Lipy 3, 80-172 Gdańsk.
    temperature
    Description
    ambient
    Notification ID
    27368
    weight
    47.0
    weightUnit
    Description
    g
    Notification ID
    18974

RASFF

Risk and analytical results

hazardObserved
The questioned food supplement due to the above-mentioned composition does not meet the definition of a food, including a food supplement. According to the opinion of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB), this product meets the definition criterion for a medicinal product - within the meaning of the Act of September 6, 2001. The questioned product contains in the recommended daily dose (1 capsule): - 250 mg of valerian root extract (Valeriana officinalis L.), standardized to 0.8% valeric acid, DER 8:1, - 100 mg of lemon balm leaf extract (Melissa officinalis L.), standardized to 5% rosemary acid, DER 5:1, - 100 mg of passion flower extract (Passiflora incarnata L.), standardized to 2% vitexin, DER 3:1, - 50 mg of hops extract (Humulus lupulus L), DER 4:1.
Notification ID
89525

RASFF

Measures

  1. Action taken
    Description
    informing authorities
    Notification ID
    18380
    Notification ID
    21586272
    takenBy
    Notification ID
    5028
    isoCode
    PL
    organizationName
    Poland
  2. Action taken
    Description
    informing authorities
    Notification ID
    18380
    Notification ID
    21586284
    takenBy
    Notification ID
    5028
    isoCode
    PL
    organizationName
    Poland
  3. Action taken
    Description
    informing authorities
    Notification ID
    18380
    Notification ID
    21586288
    takenBy
    Notification ID
    5028
    isoCode
    PL
    organizationName
    Poland
  4. Action taken
    Description
    withdrawal from recipient(s)
    Notification ID
    18844
    Notification ID
    21589575
    takenBy
    Notification ID
    5028
    isoCode
    PL
    organizationName
    Poland

RASFF

Origin, notification and distribution

Origin
Poland
Notifying country or territory
Poland
Published distribution
Poland, United Kingdom
Affected territories
Poland · United Kingdom

RASFF

Published territorial roles

  1. Roles
    1. Role
      NOTIFYING
      notificationId
      629547
    2. Role
      NOTIFYING
      notificationId
      629547
    3. Role
      ORIGIN
      notificationId
      629547
    4. Role
      NOTIFYING
      notificationId
      629741
    5. Role
      DISTRIBUTION
      notificationId
      629741
    6. Role
      NOTIFYING
      notificationId
      629547
    7. Role
      DISTRIBUTION
      notificationId
      629547
    8. Role
      NOTIFYING
      notificationId
      629547
    9. Role
      OPERATOR
      notificationId
      629547
    Organisation
    code
    PL
    countryNetworkOrganizationId
    5028
    Description
    Poland
    Notification ID
    31
  2. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      631524
    2. Role
      DISTRIBUTION
      notificationId
      629741
    Organisation
    code
    GB
    countryNetworkOrganizationId
    5014
    Description
    United Kingdom
    Notification ID
    17

RASFF

Follow-ups

  1. fupDate
    25-08-2023 16:01:30
    fupId
    629741
    fupNumber
    1
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    777
    organizationCode
    PL
    organizationDescription
    WSSE w Gdańsku
  2. fupDate
    25-08-2023 16:01:41
    fupId
    629827
    fupNumber
    2
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    777
    organizationCode
    PL
    organizationDescription
    WSSE w Gdańsku
  3. fupDate
    05-09-2023 16:56:24
    fupId
    631524
    fupNumber
    3
    fupType
    Description
    follow-up from non-member country
    Notification ID
    27671
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  4. fupDate
    28-09-2023 15:16:23
    fupId
    635605
    fupNumber
    4
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission

RASFF

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.