Cosmetics: Reporting undesirable effects and damage to health
Reporting as a consumer
If, as a consumer, you 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 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 offices directly:
- the manufacturing or importing company indicated on the packaging;
- the 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 adverse effects (AE) of cosmetics can be, for example:
- burning scalp
- Itch
- Redness
- Rash
- Swelling of body parts
Undesirable effects can be triggered by allergic reactions, skin irritations or other intolerances, among other things.
Information about the adverse effects may be passed on to the following persons:
- You or a representative of the data subject, such as relatives or legal representatives,
- Healthcare professionals such as a doctor, pharmacists, nurses or
- Service providers such as employees of hairdressing salons, beauty salons and massage studios.
Reporting as a company
If you are a company that manufactures, imports or trades cosmetics, if you become aware of adverse effects, you must:
- check whether it is a serious adverse reaction (SUE) according to the criteria of the EU Cosmetics Regulation.
- Serious adverse effects usually require medical evaluation and usually treatment. These include, for example:
- a sick note because the hands are swollen,
- hospitalization for further examination, or
- anaphylactic, i.e. allergic shock.
- Serious adverse effects usually require medical evaluation and usually treatment. These include, for example:
- if it is a serious undesirable effect, it is your duty to inform the competent authority.
Their notification makes it possible to inform the competent authorities and companies quickly, in order to protect consumers under certain circumstances, for example through measures such as
- targeted controls,
- product warnings,
- product recalls,
- Adaptation of the recipe or
- Customization of the labeling
to protect.
Process flow
As a consumer, you can report your report in different ways:
- Submit your informal notification in writing to the manufacturer or importer – which can be found on the packaging –, the trade or the competent authority.
- Use the checklist on the BVL website to submit your report. This will give you indications of the information you need to process and follow up on your case.
- You can remain anonymous when reporting, but a person should be identifiable for queries, for example:
- Doctor
- Hairdresser or hairdresser
- Member
- If you would like to inform the BVL directly, you can do so via online procedure, by post or e-mail.
- Online procedure:
- The online form will guide you step by step through the information you need.
- E-mail or post:
- Download the SUE checklist from the BVL website and fill it out directly.
- You can send the completed checklist to the BVL by e-mail or by post.
- The notification can also be made informally by e-mail or post. It is important that minimum information is required in order to be able to evaluate and process the case accordingly.
- Online procedure:
- Have you contacted the responsible person at the manufacturer, importer or distributor directly? Then your report will be evaluated there.
- If that person classifies the case as a serious adverse effect, he or she must forward the report to the competent authority.
- If you have directly informed the competent authority, they will contact the manufacturer or importer.
- In the classification of undesirable effects and the coordination of measures, companies and authorities coordinate with each other.
- In any case, you should provide the following important minimum information:
- Your initials
- Your year of birth
- Your symptoms
- the time of occurrence
- the nature of the consequences
- the name of the cosmetic product concerned
- Once 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 in writing by e-mail or post to the competent authority using the notification form A:
- Download the registration form A from the BVL website.
- You can fill out the form directly or print it out.
- You can 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 report of serious adverse effects to the BVL via online procedure, by e-mail or 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 reporting form A.
- You do not need a user account for the online procedure and the notification from abroad.
- E-mail or post:
- Download the Notification Form A.
- You can fill out the form directly or print it out.
- Please 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.
If necessary, the competent authority will contact you for any queries. If necessary, the Federal Office of Consumer Protection and Food Safety informs the authorities in the other EU member states in order to protect consumers throughout Europe.
Requirements
You do not have to meet any special requirements to report any adverse effects and health damage that have occurred from cosmetics.
Which documents are required?
You do not need to submit any other documents.
What are the fees?
There is no cost to 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 supervisory authority, at the latest within 20 days of becoming aware of them.
Processing duration
The Federal Office of Consumer Protection and Food Safety forwards the report within 20 working days.
Applications / forms
Forms: yes
Online procedure possible: yes
Written form required: no
Personal appearance required: no
Confidence level: low
Report undesirable and serious adverse effects of cosmetics online (for consumers as well as retailers, manufacturers or importers based abroad) (coming soon)
Appeal
You will not be able to 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.
