Reporting a side effect (or adverse reaction) to a cosmetic product

What are some examples of side effects to cosmetic products?

A side effect is an undesirable effect or adverse reaction to a cosmetic product (e.g. make-up or beauty products) under normal conditions of use. Side effects to cosmetics can include:

  • Irritation
  • Allergic reaction
  • Sensitivity to light
  • Itching.

What is considered a serious side effect?

A serious side effect (or serious undesirable effect- SUE) for a cosmetic is one that leads to:

  • Temporary or permanent functional incapacity
  • Disability
  • Hospitalisation
  • Congenital anomalies
  • An immediate vital risk
  • Death

All serious side effects must be reported to us by the company who put that product on the market.

Why report a serious side effect or adverse reaction to a cosmetic product?

These reports help us understand if there are any bigger public health problems linked to a cosmetic. They also help spot potential trends or issues with products people are using. 

Unfortunately, some people can have reactions to certain ingredients in cosmetic products. If this happens, a specialist doctor may need to do more tests or exposures to find out what caused the allergy or intolerance.

How do I report any side effects to cosmetics such as make-up or beauty products?

How you report a side effect (or undesirable effect) will depend on if you are a consumer or a member of the cosmetics industry. You can find information about these specific reporting requirements below.

Consumer reporting of side effects

Consumers can report an undesirable effect using our online report form. We may need to contact you to for more information once you have submitted the form. All information relating to you is confidential.

Alternatively, you can report a risk associated with a cosmetic product by emailing the Cosmetics section. Please see the Contact Us page.

Cosmetic industry members (e.g. Responsible Person, manufacturers, importers, distributors & retailers) side effect reporting

If you are a member of the cosmetics industry, you must report Serious Undesirable Effects- SUEs (or serious side effects) to the HPRA. This is in line with Article 23 of Regulation 1223/2009.

There is a unified system for reporting Serious Undesirable Effects (or serious side effects)  across the European Economic Area (EEA). This system is explained on the European Commission's website in its  SUE Reporting Guidelines.

The person responsible for the product on the market must fill out  SUE Form A as soon as they learn about a Serious Undesirable Effect (serious side effect). Once it's filled out, the form should be sent to the relevant authority in the country where the SUE happened. You can find instructions on how to complete the form on the European Commission's website.

If a SUE (or side effect) happened in Ireland, please report it to us by sending your completed SUE Form A to our Cosmetics section of the HPRA.