Why reporting adverse effects associated with cosmetics is important?


Cosmetic products are used in everyday life. The cosmetic market is one of the largest industries in the world and as much as they are a necessity, cosmetic products can cause some harmful adverse events. Reports of adverse events associated with cosmetics and personal care products has almost doubled over the last decade, especially since cosmetovigilance was implemented in Europe in July 2013. Regulation (EC) N° 1223/2009 reinforces product safety compliance requirements, introducing to manufacturers the term “responsible person” and the obligation of reporting serious undesirable effects (SUE). A designated responsible person by the manufacturer is required to report and notify any serious undesirable effects to national authorities. Each cosmetic product marketed in Europe must comply with GMP (Good Manufacturing Practices) to ensure product safety. Cosmetovigilance ensures that prohibited hazardous substances are not used in cosmetics and that potential ones are easily detected. In addition, any adverse events which can highlight the future of a product are collected to provide further information on how to ensure better safety of cosmetic products.

Harmful sulfates in cosmetics

Products that were most commonly reported to national authorities were hair care, skin care and products intended for the use in children. Hair products like shampoos, conditioners, hair colours and styling aids contain certain chemicals that can cause alopecia, scalp irritation and burning sensation. For example, the most common active ingredients in shampoos are Sodium Lauryl Sulfate (SLS) and Sodium Laureth Sulfate (SLES). They are used as foaming agents in shampoos, toothpastes and shower gels. Not only were there research studies performed that have shown how SLS and SLES can cause irritation to the skin, eyes and the respiratory tract, but there have also been reported adverse events pertaining to that. There are also studies that show contamination of SLS with the carcinogen 1,4-dioxane.

Most common parabens and why they are not good for human health

Paraben is a class of preservatives that are widely used in cosmetics and personal care products. They are used most commonly because they extend “shelf life” of products, but also keep bacterial growth from collecting in product containers. So why are they bad? Well, because they can easily perforate the skin and enter the bloodstream. There are studies that show they can easily interact and mimic oestrogen, and have also been found in human breast tissue, suggesting a possible connection to breast cancer. One of the most commonly used parabens in the fragrance and sunscreen industry is methylparaben, which has scientifically been proven to cause skin damage and increase skin ageing.

Hair colours and dyes

Labels on hair colouring products often contain “Warning” signs that highlight potential eye irritation and other allergic reactions. One of the most problematic ingredients in hair colour products is p‑Phenylenediamine. This substance is not only used in hair colours, but also in tattoos and textile dyes. It has been proven to potentially cause dermatitis, cancer and reproductive toxicity. Most of the reported adverse events in connection to hair colour products are hair loss, scalp redness, rash and allergic reactions like swelling and difficulty breathing.

Sunscreen has one of the most toxic ingredients

Oxybenzone is a chemical filter used mostly in sunscreen products due to its ability to absorb UV light. Unfortunately, it has been reported by EWG (grade 8 on their toxicity rating scale) that due to its risks like hormone disruption (lower thyroid and oestrogen levels) and capability to damage cells it can also lead to skin cancer. There have been adverse events related to sunscreen products containing this substance that caused severe allergic reactions and low testosterone level in men.

Acne products

Even though benzoyl peroxide is forbidden for use in over-the-counter (OTC) products in the EU, it is available online due to FDA’s approval for OTC cosmetics. Unfortunately, this substance causes a lot of adverse effects (redness, irritation, scars, swelling and hospitalisation) and is therefore under close monitoring. However, there are other alternatives on the market, e.g. salicylic acid. This substance is available in most OTC products across Europe but it too can cause possible side effects. Even though it has benefits in treating acne temporarily, in some people salicylic acid can cause irritation, dry skin, increase in breakouts and thinning of the skin.

We all have to use personal care products. However, we can be cautious in choosing them and report an undesirable effect if it occurs. Doctors and pharmacists can help us choose the best products for our body and there are also other supportive tools available, such as internet reviews and articles. There is also cosmetovigilance, a very important and vital tool that aids the risk management process, records adverse events and helps track the active substances used daily in cosmetic products.

If you are in the cosmetics industry and need help with cosmetic compliance, feel free to contact us.

Iva Mandić, AS /  Senior Pharmacovigilance Associate

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Marti Farm Ltd.
Planinska ulica 13, HR 10000 Zagreb
Planinska ulica 13, HR 10000 Zagreb
a limited liability company
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Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Planinska ulica 13, HR 10000 Zagreb
Office: Planinska ulica 13, HR 10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
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Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)

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