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RASFFReference 2025.8945

Incorrectly declared allergens in food supplement from the USA

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

RASFF

Identification and classification

Reference
2025.8945
Notification ID
802445
Classification
information notification for attention
Risk decision
potential risk
Product type
food
Notification basis
surveillance programme / monitoring sample
Status
ec_validated

RASFF

Product

Description
Food supplement
Distribution status
Description
no distribution from notifying country
Notification ID
222
Notification ID
30094986
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    30095032
    labelling
    240 Fish Gelatin Softgels; Batch number: UC250156; Expiry date: 04/2028
    temperature
    Description
    ambient
    Notification ID
    27368
  2. Notification ID
    30095046
    labelling
    100 Fish Gelatin Softgels; Batch number: UC250195; Expiry date: 06/2028
    temperature
    Description
    ambient
    Notification ID
    27368

RASFF

Risk and analytical results

hazardObserved
Regulation (EU) 1169/2011– Art. 21 & Annex II: Must clearly indicate allergens listed in Annex II (typically through bold text). This product contains the food allergen “fish”. The product says ‘contain: Fish (see below)’ separately from the ingredient list but the ingredient has not been emphasised in ingredient list. Directive 2002/46/EC – Art. 2 (a): Must include the term “food supplement”. This term was not present. Directive 2002/46/EC – Art. 2 (d): Must include the warning statement “Do not exceed the recommended daily dose”. This statement was not present. Directive 2002/46/EC – Art. 2 (e): Must include the warning statement “food supplements should not be used as substitute for a varied and balanced diet and a healthy lifestyle”. This statement is not present. Regulation (EU) 1169/2011– Art. 9 (1) (h): Must include name and address of food business operator responsible business within EU. No EU food business operator present.
Notification ID
126574

RASFF

Measures

  1. Action taken
    Description
    return to consignor
    Notification ID
    18835
    Notification ID
    30095140
    takenBy
    Notification ID
    5018
    isoCode
    IE
    organizationName
    Ireland

RASFF

Origin, notification and distribution

Origin
United States
Notifying country or territory
Ireland
Published distribution
no distribution from notifying country

RASFF

Published territorial roles

  1. Roles
    1. Role
      FOR_ATTENTION
      notificationId
      802445
    Organisation
    code
    INFO
    countryNetworkOrganizationId
    5680
    Description
    INFOSAN
    Notification ID
    10340
  2. Roles
    1. Role
      NOTIFYING
      notificationId
      802445
    Organisation
    code
    IE
    countryNetworkOrganizationId
    5018
    Description
    Ireland
    Notification ID
    57
  3. Roles
    1. Role
      ORIGIN
      notificationId
      802445
    2. Role
      OPERATOR
      notificationId
      802445
    Organisation
    code
    US
    countryNetworkOrganizationId
    5230
    Description
    United States
    Notification ID
    10225

RASFF

5018
  1. countryNetworkOrganizationId
    5018
    Notification ID
    23
    link
    http://www.fsai.ie/news_centre/food_alerts.html
  2. countryNetworkOrganizationId
    5018
    Notification ID
    24
    link
    http://www.fsai.ie/news_centre/allergen_alerts.html

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.