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RASFFReference 2021.2265

Side effects related to consumption of diatary supplement products from NL

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

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RASFF

Identification and classification

Reference
2021.2265
Notification ID
477110
Classification
alert notification
Risk decision
undecided
Product type
food
Notification basis
consumer complaint
Status
ec_validated

RASFF

Product

Description
Two diatary supplement products
Distribution status
Description
product traded online
Notification ID
228
Notification ID
5365779
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    5366028
  2. Notification ID
    5366065

RASFF

Risk and analytical results

hazardObserved
Bioactive Complete B-complex in addition to vitamins B1 and B2 also contains Niacin (vitamin B3, added as nicotinamide and nicotinic acid), Vitamin B6, folate, vitamin B12, biotin, pantothenic acid, inositol and PABA. Of these, it is especially the addition of Niacin to the 100 mg such as nicotinamide and nicotinic acid that stands out. The two people may have ingested a potentially high dose of nicotinic acid, as there is niacin in both supplements with an unknown content of nicotinic acid, and the nicotinic acid may thus be the cause of the anaphylactic reaction.
Notification ID
46858
numberOfPersonsAffected
2
typeOfIllness
Two Danish patient's (mother and daughter) has experienced anaphylaxis with redness, burning and difficulty breathing within half an hour after consumption of the diatary products Bioactive Complete B Complex and Vitamin B Niacin 500 mg from the same company in the Netherlands. This is the first time that the patients have consumted these products. Each patient consumpted one unit of each product before the symptoms began half an hour later.

RASFF

Measures

  1. Action taken
    Description
    informing authorities
    Notification ID
    18380
    Notification ID
    5366176
    takenBy
    Notification ID
    5008
    isoCode
    DK
    organizationName
    Denmark

RASFF

Origin, notification and distribution

Origin
Netherlands
Notifying country or territory
Denmark
Published distribution
Denmark
Affected territories
Denmark

RASFF

Published territorial roles

  1. Roles
    1. Role
      NOTIFYING
      notificationId
      477110
    2. Role
      NOTIFYING
      notificationId
      477110
    3. Role
      DISTRIBUTION
      notificationId
      477110
    Organisation
    code
    DK
    countryNetworkOrganizationId
    5008
    Description
    Denmark
    Notification ID
    53
  2. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      477110
    2. Role
      ORIGIN
      notificationId
      477110
    3. Role
      OPERATOR
      notificationId
      477110
    Organisation
    code
    NL
    countryNetworkOrganizationId
    5026
    Description
    Netherlands
    Notification ID
    38

RASFF

Follow-ups

  1. fupDate
    25-05-2021 14:32:43
    fupId
    479790
    fupNumber
    1
    fupType
    Description
    notification upgrade
    Notification ID
    27667
    networkOrganizationId
    53
    organizationCode
    DK
    organizationDescription
    Denmark

RASFF

5008
  1. countryNetworkOrganizationId
    5008
    Notification ID
    10

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.