Safety of cosmetic products

This article has been translated from Finnish to English by Semantix. You can find the original article at the web adress

The legislation on cosmetic products requires that the products must be safe to use for their initial function. Despite this, safety of cosmetic products is discussed from time to time and is sometimes unduly criticised. Many of these discussion might not take place if people knew the legislation on cosmetic products, which specifically aims at strengthening the safety of the products.

In Finland, the cosmetic products are regulated by the EU Regulation(EC) No 1223/2009 on Cosmetic Products. This Regulation is applied throughout the EU area. In its entirety, the Regulation on Cosmetic Products aims to strengthen the safety of the products. 

Safety assessment is at the heart of the Regulation

The Regulation requires the cosmetic product manufacturers to carry out an extensive safety assessment for their products before placing them on the market. The safety assessment cannot be carried out by anyone, and the Regulation sets strict requirements for the qualifications of the safety assessor. 

The safety assessment evaluates both the safety of all ingredients that the products contain and the finished products. The assessment must be carried out to all cosmetic products from regular soap to eye cream. The enterprise responsible for the products must have the product information, including the results of the safety assessment. If necessary, this information must be made readily available to the surveillance authorities for purposes of surveillance. In Finland, the Finnish Safety and Chemicals Agency (Tukes) and the Finnish Customs supervise the safety of cosmetic products. 

In practise, the safety assessment carried out by a qualified assessor is a scientific risk assessment, which takes into account the hazardous properties of substances, their amount and use, the physical and chemical properties and microbiological quality of the finished products. The safety assessment pays particular attention to products used on mucous membranes and products for special groups, such as for children under three years of age. The Cosmetics Regulation sets out the requirements for the safety assessment. The Regulation requires that the safety assessment must be regularly updated as new information comes out. 

In order to ensure safety, the Regulation also sets out responsibilities for each operator in the product supply chain. To minimise risks, responsibilities have been assigned to each operator from the manufacturer to the surveillance authorities. This strengthens the safety of the products and minimises any harm that the product may cause to the consumer. 

No more animal testing

Animal testing is not allowed in the safety assessment of cosmetic products, and the sale of products or products whose ingredients have been tested on animals after the ban came into force, is prohibited in the EU. Animal testing of the finished cosmetic products was prohibited in the EU already in 2004. Testing cosmetic ingredients on animals was completely banned in the EU in 2009 (testing ban), and so was the marketing of cosmetic products whose ingredients were tested on animals after the ban had come into force (marketing ban). The EU set the longest transition period, until the beginning of 2013, for the complex tests covered by the marketing ban. After that, no animal testing has been allowed for the purposes of meeting the requirements of the European legislation on cosmetic products. 

Which ingredients are allowed in cosmetics?

The Regulation on Cosmetic Products regulates the ingredients allowed in cosmetics. The Regulation includes lists of certain ingredients, their use and maximum concentration and possible warnings regarding the use of the finished products. These ingredients include colorants, preservatives and UV filters. In addition, the Regulation includes a variety of ingredients for several purposes whose use is allowed with restrictions, such as the allowed hair colorants. The Scientific Committee for Consumer Safety (SCCS) has carried out the safety assessment of these substances. The enterprise responsible for the products is responsible for the safety of the substances used in the product when they contain substances whose use is not separately regulated by law. 

If any new information obtained requires more detailed safety assessment or re-assessment, the SCCS will take care of it. The opinions of the SCCS are public, and the law is amended as necessary based on their views. The Regulation also includes a list of prohibited substances. These include medicaments, among others. In addition, the prohibited substances include substances which are classified as carcinogenic, mutagenic or toxic to reproduction in the Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances (CLP legislation). 

How can you find the right product for you?

Despite the safety requirements stipulated in the legislation, the safety of the ingredients allowed in cosmetic products is sometimes being questioned in public discussions. Many of these discussions are emotionally motivated or they originate out of ignorance. The EU Regulation on Cosmetic Products is considered to be one of the strictest in the world, and therefore it is very powerful. Consumers or professionals using cosmetic products do not need to worry about the safety assessment, which is the responsibility of the manufacturer, but the products should always be used according to their instructions. 

Having a common European legislation is beneficial to the consumer as products that must meet the same safety requirements are sold in other EU countries as well. For the safety of consumers, the legislation stipulates what information must be made available on the packaging of the cosmetic products. This makes it easier for the consumers to choose suitable products for them and to use them correctly. However, products purchased in different countries may have the packaging information in different languages due to the language requirements. In Finland, all labelling in the packaging must be in Finnish and Swedish. The European legislation has, however, harmonised the label information so that it is the same in all languages. For example, the ingredients should be presented with their international INCI names in all countries, so that the consumers across Europe can easily know what ingredients the products contain. 

The consumers should be aware that if they buy cosmetic products outside of the EU, for example, from the United States or Asia, they may not meet with the requirements of the European legislation. The products may contain, for example, substances that are not allowed in the EU or the labelling may be incomplete. In these cases, the consumer takes the responsibility for any adverse effect caused by such product. The same applies to products purchased from online stores outside the EU. Instead, if the consumer experiences any adverse event caused by a product purchased in the EU, they may contact the enterprise responsible for the product. 

Even if the enterprises ensure the safety of the products, it does not eliminate the possibility for an individual consumer to be allergic to some ingredient in the product. If the consumer notices that they are sensitised to a product or get skin symptoms after using it, they should consult a dermatologist and make the necessary allergy tests to find out the cause of the symptoms. It is not possible to diagnose an allergy on your own. Once the substance that causes allergy has been identified, reading the products’ list of ingredients helps to avoid products that contain the substance. 

Most common fragrances that cause allergic reactions. If a product contains fragrance, it is marked in the list of ingredients with the word ‘parfum’. In addition, the legislation provides that the 26 most common fragrances that cause allergic contact dermatitis must be indicated in the list of ingredients with their proper names, together with the word ‘parfum’, if their concentration in a rinse-off product (e.g. shampoo) exceeds 0.01% and in products intended to be applied on the skin (e.g. moisturizer) 0.001%. These 26 substances must always be indicated in the list of ingredients if those concentrations are exceeded, even if the substances would have been used for a purpose other than scenting (e.g. as an ingredient of a plant-based oil). However, a person with fragrance allergy should be careful. The word ‘parfum’ does not need to be included on the labelling if, for example, a fragrance is part of a plant extract and the plant extract has not been added to the product as a fragrance but for another purpose. 

Hair colorants may also cause allergic reactions. If a hair dye causes you an allergic reaction, you should find out the cause of the reaction before dyeing your hair again. If you are diagnosed with an allergy to a hair colorant, you should no longer dye your hair with a product that contains the allergen or its derivatives, as it may cause you a severe allergic reaction. 

If you have not had any allergic reaction from cosmetic products, then there is no need to avoid them. You will find the best products for you by testing them – remember that a product that works well for you might not be suitable for someone else. 

Eeva-Mari Karine, M.Sc.Eng. Expert (cosmetics)
The Finnish Cosmetic and Hygiene Industry Association

Ritva Kurimo, M.Sc. (chemist)
TMI Ritva Kurimo