Ensuring the safety of cosmetics

Consumer safety underpins all aspects of the formulation, manufacture and sale of cosmetic and personal care products in Europe. Responsibility for product safety lies first and foremost with industry.

The EU Cosmetic Products Regulation (CPR) governs how cosmetics and personal care products are made and placed on the market. It is one of the most comprehensive sets of laws for the industry in the world. The CPR dictates that cosmetics must be safe for human health when applied in normal or reasonably foreseeable conditions.

To meet its obligations under the Regulation, manufacturers must fulfil the following duties before placing a product on the market:

  1. Run a comprehensive safety assessment
  2. Provide detailed product information
  3. Comply with ingredient and labelling rules

Understanding hazard and risk

The words hazard and risk are often used interchangeably, although they mean different things. A hazard is the intrinsic property of a substance, thing or situation to cause harm. Risk is the likelihood that harm will actually occur.

Many substances have a toxic property (hazard), but are not necessarily poisonous in the way we use them. For example, salt is toxic in large quantities, but a certain amount is essential for health and safe at those levels. A risk assessment is used to establish whether a hazard presents an unacceptable risk or not. We all make risk assessments every day without realising it – for example every time we cross a road.

Scientists formulating cosmetic products make sure that exposure to ingredients and the way they are used within the product are safe. A qualified safety assessor also carries out a safety assessment on every product before it goes on sale.

These processes ensure that cosmetics are safe for use, even if some of the individual ingredients could have hazardous properties under different circumstances.

How safety assessments are conducted

All cosmetic products undergo a rigorous safety assessment before they are placed on the market. This must be carried out by an appropriately qualified professional. The assessment is complemented by a safety report, the contents of which are defined in an annex to the Cosmetic Products Regulation.

The safety assessor must be competent in analysing, evaluating and interpreting toxicological data. They must have access to the toxicological and analytical information relevant to the assessment. Their assessment must be based on a thorough analysis of all available data and conditions of exposure. Having completed the assessment, they will reach one of the following conclusions:

  1. The product is safe for the proposed use without restrictions
  2. The product is safe with restrictions and may need specific warnings or precautions (risk reduction measures)
  3. The product is not safe and must not be placed on the market

For certain ingredients, such as preservatives, UV filters or colorants, or substances that have raised a safety concern,  the Scientific Committee on Consumer Safety (SCCS), a group of independent experts, can be mandated by the European Commission to provide scientific advice and produce an independent safety evaluation. Evaluations carried out by the SCCS form the basis for ingredient restrictions in the Annexes of the Cosmetic Products Regulation. For more information on the risk assessment of cosmetic ingredients as set out in the CPR, please refer to the SCCS Notes of Guidance for the testing of cosmetic ingredients.

Once a product has been assessed and gone on sale, it is monitored to ensure it continues to be safe. Any adverse reactions (referred to as ‘undesirable effects’ in the CPR) must be recorded and evaluated. If the effect is considered serious, the competent authorities must be informed and further action may be taken. This can include withdrawing the product. The fact that this is extremely rare demonstrates that the system for assessing safety is very effective.

Safety assessments are carried out without testing either the ingredients or the finished product on animals. Animal testing and the marketing of products containing ingredients tested on animals are subject to strict bans in the EU, as laid out in the CPR.

Full details of the safety assessment procedure are available from the European Commission’s website.

Cosmetic products and allergies

An allergy is defined as an excessive immune reaction to substances in the environment that are harmless to the majority of people. Allergies affect one in three people at some point in their lives. For instance, up to 20% of people suffer from hay fever, while more than one in ten are allergic to the nickel in coins.

Almost any substance, natural or man-made, has the potential to trigger an allergic reaction. That does not mean it is unsafe. The body can simply react to it differently, and the reaction can vary from person to person.

Safety assessments for cosmetic products include an evaluation of the risk of skin allergies caused by the ingredients. These assessments greatly minimise the risk of products causing adverse reactions.

If a higher risk of allergy has been identified, such as with some hair dyes, the product will carry a warning label. Users will also be advised to carry out an allergy alert test before using the product.