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Report Adverse Effects and Health Hazards Associated with Cosmetics

When you use cosmetic products, so-called adverse effects may occur in rare cases, such as allergic reactions, skin irritation, or other intolerances:

  • scalp burning
  • Itching
  • redness
  • skin rash
  • Swelling of body parts

Every report of an adverse reaction helps to better protect consumers in the future, for example through:

  • targeted inspections
  • Product warnings
  • Product recalls
  • Formulation adjustments
  • labeling changes

Reporting as a consumer:

If, as a consumer, you notice such an adverse effect on your health after using cosmetic products, you can notify the Federal Office for Consumer Protection and Food Safety (BVL).

Alternatively, you can also contact the following entities directly:

  • the manufacturer or importer listed on the packaging
  • the retail store where you purchased the product
  • the relevant authorities, typically the food safety agency in your county or city

The following individuals can report information about adverse effects:

  • You yourself or someone you authorize, such as a family member or legal representative
    • If you are under 16 years of age, you must be represented in all cases
  • healthcare professionals such as doctors, pharmacists, or nurses
  • Employees of, for example, hair salons, beauty salons, and massage studios

Reporting as a business:

If you are a company that manufactures, imports, or sells cosmetics and become aware of adverse effects, you must:

  • determine whether the event constitutes a serious undesirable effect (SUE) according to the criteria of the EU Cosmetics Regulation.
    • SUEs generally require a medical evaluation and, in most cases, treatment as well. Examples include:
      • a doctor’s note due to swollen hands
      • a hospital stay for further examination
      • anaphylactic shock (i.e., allergic shock)
  • If this is an SUE, you are required to notify the appropriate authority.

  • When using cosmetics, the following may occur:
    • adverse effects, such as a rash or itching
    • serious side effects that may require, for example, sick leave or hospitalization
  • Consumers should be sure to report any adverse effects
    • report them to the manufacturer, the importer—see packaging—or the retailer, or
    • file a report with the relevant local authorities or the Federal Office for Consumer Protection and Food Safety (BVL)
  • Reports can be made informally or through third parties such as doctors’ offices, pharmacies, or hair salons
  • Without reports of adverse effects, authorities or companies will not be made aware of these cases
  • Manufacturers, importers, and retailers
    • must review reports
    • are required to report serious adverse effects to the competent authority
  • For companies, there is the mandatory Form A for reporting serious adverse events
  • Competent authorities coordinate measures as necessary, such as product inspections or product recalls

For consumers:

  • When you submit a report, it should include the following information:
    • Your initials (name)
    • Your year of birth
    • Your symptoms
    • the time of onset
    • The nature of the effects
    • the name of the cosmetic product in question

For companies:

  • Reporting Form A

There are no costs to you.

As a consumer, you can file your report in several ways:

  • Notify the BVL directly online, by mail, or by email
    • Online procedure:
      • The online form guides you step by step through the information required by the agency.
    • Email or mail:
      • Download the checklist from the BVL’s website and fill it out directly.
      • You may remain anonymous when submitting the report; however, one person should be identifiable in case of follow-up questions, for example: a doctor, a hairstylist, or a family member
      • Send the completed checklist to the BVL via email or as a printed copy by mail.
      • You can also submit the report informally via email or mail, but it must then include various required pieces of information (see the online form or checklist).
    • Once you have notified the BVL, the information will be forwarded to the appropriate authority.
  • Submit an informal written report to the manufacturer or importer listed on the packaging, the retailer, or the competent authority.
    • If the manufacturer, importer, or retailer classifies the case as a serious adverse event, they must forward the report to the competent authority.
  • Notification to the competent authority
    • If the information is provided informally via email or mail, it should still include various required details (see online form or checklist).
    • Companies and authorities coordinate with one another to classify the adverse effects and coordinate measures.

As a manufacturer, importer, or trading company based in Germany, you can submit your report on serious adverse effects to the competent authority via email or mail using Report Form A:

  • Download Reporting Form A from the BVL website.
  • You can fill out the form directly or print it out.
  • Send the completed form by email or mail to the supervisory authority responsible for your business.

As a manufacturer, importer, or trading company based abroad, you can submit your report on serious adverse effects to the BVL via the online procedure, by email, or by mail:

  • Online procedure:
    • Only companies based abroad may use the online form.
    • It guides you step by step through the required information and provides a link to upload Report Form A, which is also available in English.
    • You do not need a user account for the online procedure or for reporting from abroad.
  • Email or Mail:
    • Download Registration Form A.
    • You can fill out the form directly or print it out.
    • Send the completed form to the BVL by email or mail.

Processing time: 20 Working days
The Federal Office for Consumer Protection and Food Safety forwards the report within 20 business days.

Retailers, manufacturers, or importers must immediately report serious adverse effects of cosmetics to the competent supervisory authority, no later than 20 days after becoming aware of them.

You cannot file an appeal.

Federal Office for Consumer Protection and Food Safety (BVL)


Redirect Service: Deep link to the original portal

The text was automatically translated based on the German content.

Source: Serviceportal Saarland