Statistics from the National Register of Adverse Effects from Cosmetic Products
Between 2008 and 2014, the Register received a total of 442 notifications. Women reported adverse effects most frequently (figure 1). The majority of notifications were from people in the 30-59 year age group. Among health personnel, pharmacists submitted the most reports to the register, accounting for 82 per cent of all notifications.
Moisturisers (cream, gel, serum, oil), sunscreens and skin cleansers were the most frequently reported products (table 1). For consumers who are 20 years or older, moisturisers accounted for more than 50 per cent of all the reported products, while for children aged 0-9 years, sunscreens were the most frequently reported product type (51 per cent).
The reported products came from a total of 77 manufacturers or suppliers.
Moisturisers (cream, gel, serum, oil)
Sun protection (sunscreen, self-browning cream, solarium products)
Hair dye, bleach, permanent wave
Various soap products (e.g. soap, wipes, scrub)
Hair care products (shampoo, conditioner, styling products)
Nail products (varnish, remover, hardener, products for artificial nails)
Hair removal products
Adverse effects reported to the register vary from mild irritation to severe reactions. From 2008-2014, the most frequently reported effects were skin reactions in the form of eczema / rash, redness, itching, stinging and swelling (Table 2). The group "Other" included burning, pain, dizziness, nausea and blood pressure drop, and other skin symptoms than those listed in the table.
Around 26 per cent of consumers have previously experienced reactions to the same or similar products.
Type of adverse effect
Eczema + burning, oedema or blistering
Watery eyes / runny nose
About the National Register of Adverse Effects from Cosmetic Products
The register was established in 2008 as a partnership between the Norwegian Institute of Public Health (NIPH) and the Norwegian Food Safety Authority. The aim is to learn more about how many people react to cosmetic products, the type of effects that occur and which products are responsible.
In the first years, the register only received notifications from health professionals such as doctors, dentists, pharmacists and nurses, according to the Cosmetics Act and the regulations concerning the notification duty. In spring 2015, a consumer-based reporting system was established where consumers can submit their own notifications.
What can be reported to the register?
Products defined as cosmetic products which can be reported to the register are:
- Cosmetics and personal care products
Products that come into contact with the body surface (skin, hair, nails, lips and external genitals), teeth or mucous membranes of the nose and mouth which are used to protect, preserve or affect the appearance, or to affect body odour, to clean or to scent
- Healthcare products
Products that come into contact with the body surface, teeth or mucous membranes of the nasal and oral cavity which aim to alleviate, cure or prevent health problems that are not caused by disease
- Tattoo products
Substances introduced into the skin to achieve permanent or long-lasting marking (includes permanent makeup and tattoo liquid)
- Injection products
Substances that are inserted into the skin to change its appearance in ways other than those mentioned above
How to report adverse effects
Via health personnel
Consumers must consult health care personell such as a pharmacist, doctor, dentist or nurse who will complete the appropriate form for the consumer and send this to the NIPH. A consent form is sent with the notification form.
Via the internet
Consumers can report adverse effects using the notification form found by logging in to the Altinn service with a Norwegian personal identity number. Although login is required to register a notification, any personal information will be removed before the notification is entered into the register. The notification can therefore not be traced back to the consumer.
What information is collected?
A minimum of details about the product and any adverse effects are needed to process a notification, including:
- Product information, e.g. name and type of product
- Usage patterns, e.g. start and end dates, how many times the product was used
- Type of adverse effects, their course and severity
- Other relevant information such as skin condition before application and health conditions that may be present.
What happens to the notifications?
The causal relationship between product use and reported effects are assessed for each notification received at the NIPH.
These assessments are collected in reports which are submitted to the Norwegian Food Safety Authority. If there are many notifications about a particular product, the Food Safety Authority will contact the supplier or manufacturer.