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Cosmetics: Report undesirable effects and damage to health


Notification as a consumer

If you as a consumer notice a negative effect on your health after using cosmetic products, you can inform the Federal Office of Consumer Protection and Food Safety (BVL) by completing 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 bodies directly:

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

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

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

Adverse effects can be caused by allergic reactions, skin irritation or other intolerances.
The following persons can pass on information about adverse effects:

  • You or a representative of the person concerned, for example relatives or legal representatives,
  • Healthcare professionals such as a doctor, pharmacist, nurse or nurse practitioner, or
  • Service providers such as employees of hairdressing salons, beauty and massage studios.

Registration as a company

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

  • check whether it is a serious undesirable effect (SAE) according to the criteria of the EU Cosmetics Regulation.
    • Serious adverse reactions generally require medical evaluation and usually also treatment. This includes, for example
      • a sick note because the hands are swollen,
      • hospitalization for further examination or
      • an anaphylactic, i.e. allergic shock.
  • If it is a serious adverse reaction, it is your duty to inform the competent authority.

Your notification enables the competent authorities and companies to be informed quickly in order to protect consumers, for example through measures such as

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

to protect them.

Process flow

As a consumer, you can submit 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 making a report, but a person should be identifiable for queries, for example:
    • Doctor
    • Hairdresser
    • Relatives
  • If you wish to inform the BVL directly, you can do so via the online procedure, by post or e-mail.
    • Online procedure:
      • The online form guides you step by step through the required information.
    • E-mail or post:
      • Download the SUE checklist from the BVL website and complete it directly.
      • Send the completed checklist to the BVL by e-mail or post.
      • The notification can also be sent informally by e-mail or post. It is important to note that a minimum amount of information is required in order to be able to evaluate and process the case accordingly.
  • Have you contacted the person responsible at the manufacturer, importer or dealer directly? Then your report will be assessed there.
    • If this person classifies the case as a serious undesirable effect, they 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 consult with each other when classifying adverse effects and coordinating 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 concerned
  • If you have informed the BVL, the information will be forwarded to the competent authority.

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 from the BVL website.
  • You can fill in the form directly or print it out.
  • Send the completed form by e-mail or by post to the supervisory authority responsible for you.

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

  • Online procedure:
    • 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 or for notifications from abroad.
  • E-mail or post:
    • Download the notification form A.
    • You can fill in the form directly or print it out.
    • Send the completed form to the BVL by e-mail or post.

You can find the authority responsible 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 you have any questions. 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.

Requirements

You do not have to fulfill any special requirements to report any adverse effects and damage to health caused by cosmetics.

Which documents are required?

You do not need to submit any further documents.

What are the fees?

There are no costs for you.

What deadlines do I have to pay attention to?

Retailers, manufacturers or importers must immediately report serious adverse effects of cosmetics to the competent monitoring authority, at the latest within 20 days of becoming aware of them.

Processing duration

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

Applications / forms

Forms: yes

Online procedure possible: yes

Written form required: no

Personal appearance required: no

Confidence level: low

Online reporting of undesirable and serious undesirable effects of cosmetics (for consumers and retailers, manufacturers or importers based abroad) (available soon)

Appeal

You cannot lodge an appeal.

Technically approved by

Federal Ministry of Food and Agriculture

Professionally released on

11.11.2021

Author

The text was automatically translated based on the German content.

Source: Serviceportal Niedersachsen (Portalverbund des Bundes und der Länder)