Cosmetics; reporting of adverse effects and health damage

In rare cases, cosmetics can cause undesirable effects such as skin irritation. Manufacturers or retailers must report effects with serious health consequences to the authorities.

Description

Notification as a consumer

If you as a consumer notice an adverse effect on your health after using cosmetic products, you can inform the Federal Office of Consumer Protection and Food Safety (BVL) by filling out this form.

The form asks for the relevant information step by step in order to assess the case in the best possible way.

In addition to reporting via the federal portal, you can also contact the following directly:

  • The manufacturing or importing company indicated on the packaging,
  • the retail store where you purchased the product,
  • the competent authorities, usually the food inspectorate in your county or city, or
  • the Federal Office of Consumer Protection and Food Safety (BVL).

So-called undesirable effects (AE) of cosmetics can be, for example:

  • burning scalp
  • itching
  • redness
  • skin rash
  • swelling of body parts

Adverse effects may be caused by, among other things, allergic reactions, skin irritations or other intolerances.
Information about the adverse effects can be shared by the following people:

  • Yourself or a representative of the affected person, for example, relatives or legal representatives,
  • healthcare professionals such as a doctor, pharmacist, nurse, or
  • Service providers such as employees of hair salons, cosmetic and massage studios.

Notification as a company

If you, as a company that manufactures, imports or trades cosmetics, learn of adverse effects, you must:

  • check whether it is a serious undesirable effect (SUE) according to the criteria of the EU Cosmetics Regulation.
    • Serious adverse effects usually require medical evaluation and usually treatment. This includes, for example:
      • a sick leave because the hands are swollen,
      • a hospital stay for further examination or
      • anaphylactic shock, i.e. allergic shock.
  • if it is a serious adverse reaction, it is your duty to inform the competent authority.

Your notification makes it possible to inform the competent authorities and companies quickly so that, under certain circumstances, consumers can be protected by measures such as

  • targeted controls,
  • product warnings,
  • product recalls,
  • adaptation of the formulation or
  • adjustment of the labeling

protection.

Prerequisites

You do not have to meet any special requirements to report adverse effects and health damage of cosmetics that have occurred.

Procedure

As a consumer, you can report your notification in different ways:

  • Send your informal notification in writing to the manufacturer or importer - to be found on the packaging -, the retailer or the competent authority.
  • Use the checklist on the BVL website for your notification. This will provide you with the information you need to process and follow up your case.
  • You can remain anonymous when reporting, however, one person should be identifiable for queries, for example:
    • Physician
    • Hairdresser
    • Relative
  • If you want to inform the BVL directly, you can do so via online procedure, mail or e-mail.
    • Online procedure: (available soon)
      • The online form will guide you step by step through the information you need.
    • Email or Mail:
      • Download the SUE checklist from the BVL website and fill it out directly.
      • Send the completed checklist to the BVL by e-mail or by mail.
      • The notification can also be sent informally by e-mail or post. It is important here that minimum information is required in order to be able to evaluate and process the case accordingly.
  • You have contacted the responsible person at the manufacturer, importer or distributor directly? Then your report will be evaluated there.
    • If this person classifies the case as a serious undesirable effect, he must forward the report to the competent authority.
  • If you have informed the competent authority directly, they will contact the manufacturer or importer.
    • Companies and authorities coordinate with each other in the classification of adverse effects and the coordination of measures.
  • In any case, you should provide the following important minimum information:
    • Your initials
    • Your year of birth
    • your symptoms
    • the time of onset
    • the nature of the consequences
    • the name of the cosmetic product involved
  • If you have informed the BVL, the information will be forwarded to the competent authority accordingly.

As a manufacturer, importer or trading company based in Germany, you can submit your notification of serious adverse effects to the competent authority in writing by e-mail or post using notification form A:

  • Download the notification form A on the BVL website.
  • You can fill out the form directly or print it out.
  • Send the completed form by e-mail or by mail to the monitoring authority responsible for you.

As a manufacturer, importer or trading company based abroad, you can submit your notification of serious adverse effects to the BVL using the online procedure, by e-mail or by post:

  • Online procedure: (available soon)
    • Only companies based abroad can use the online form.
    • It guides you step by step through the necessary information and provides an upload for the notification form A.
    • You do not need a user account for the online procedure and the notification from abroad.
  • E-mail or mail:
    • Download the reporting form A.
    • You can fill out the form directly or print it out.
    • Send the completed form to the BVL by e-mail or by post.

You can find the competent authority for cosmetics in your area on the website of the Federal Office of Consumer Protection and Food Safety.
The competent authority will contact you if necessary for further inquiries. If necessary, the Federal Office of Consumer Protection and Food Safety will inform the authorities in the other EU member states in order to protect consumers throughout Europe.

Deadlines

Retailers, manufacturers or importers must report serious adverse effects of cosmetics to the competent surveillance authority without delay, at the latest within 20 days of becoming aware of them.

Processing time

The Federal Office of Consumer Protection and Food Safety forwards the notification within 20 working days.

Required documents

  • Required Documents

    You do not need to submit any additional documentation.

Forms

Fees

  • There are no costs for you.

Legal bases

Remedy

You will not be able to appeal.

Links to more information

Status:03.03.2023

Responsible for editing:Bundesministerium für Ernährung und Landwirtschaft

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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