Nail product

Product definition

A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. (Regulation No.1223/2009)

This factsheet applies to the following groups of cosmetic products:

• Hair product: A cosmetic product which is intended to be applied on the hair of head or face, except eye lashes, e.g. hair mousse, balm, hair conditioner, shampoo, hair spray, etc.
• Skin product: A cosmetic product which is intended to be applied on the skin, e.g. body cream, moisturing cream, deodorant, etc.
• Lip product: A cosmetic product which is intended to be applied on the lips, e.g. lip stick, lip balm, lip gloss, etc.
• Face product: A cosmetic product which is intended to be applied on the skin of the face, e.g. rouge, make-up, aftershave lotion, shaving foam, etc.
• Nail product: A cosmetic product which is intended to be applied on nails, e.g. colour or conditioner.
• Oral product: A cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity, e.g. tooth paste.
• Eye product: A cosmetic product which is intended to be applied in the vicinity of the eyes, e.g. eyeliners, eye shadow, etc.
• Perfume: Cosmetic products applied to the body to perfume it.

Common risks of cosmetics

The most common risks identified in this product sector are set out below.
1. Chemical risks

• Hazardous substances and their route of exposure can cause short- and long-term adverse health effects if they exceed allowed limits.

2. Hygiene risks:

• Microbiological or other contamination of ingredients from which the cosmetic product is made of can cause irritation and infections.

This is a list of examples of common risks. However, the manufacturer or the responsible person has to carry out a safety assessment of the cosmetic product that covers all relevant risks that may be associated with it and actions must be taken to mitigate these risks where possible. A general definition of risk and its relationship to hazards can be found in the factsheet one Risk management. 

Examples of dangerous products

Specific examples of measures taken against dangerous cosmetic products offered for sale in the European Union are available on the Safety Gate website. Type the group of cosmetics (e.g. cream, teeth whitener, nail polish, or wet wipe) into the free text search box and select the ‘cosmetic’ Product Category to view notified examples.

The vast majority of cosmetics that have been notified in the Safety Gate contain substances which have been banned or restricted from use in cosmetics. A better understanding of reasons behind a qualification of a product as dangerous can help avoid their repetition.

Main applicable legislation

The applicable legislation for cosmetic products is the Cosmetic Products Regulation 1223/2009. It lays down the requirements that all cosmetics must meet before they can be marketed in the EU. All cosmetic products placed on the EU market must be safe. The manufacturer or importer are responsible for the safety of their products and must ensure that they undergo an expert scientific safety assessment before they are sold. If the manufacturer is established outside the EU, it had to appoint a responsible person established in the EU. A special database with information on cosmetic substances and ingredients, called CosIng, enables easy access to data on these substances, including legal requirements and restrictions.

The use of certain substances is prohibited in cosmetics (Annex II to Regulation No 1223/2009) and others can be used only under certain conditions (Annex III to Regulation No 1223/2009). Colorants, preservatives and UV filters can only be used in cosmetic products if they are listed in the respective Annexes IV to VI to the Cosmetics Regulation.

The main regulatory requirements are established in the Cosmetics Regulation (Regulation (EC) No 1223/2009), further information on the requirements relating to cosmetics can be found here. In addition to this, scientific and technical guidance is available here. Easy access to information on certain cosmetic ingredients and their permitted concentrations is provided at the Cosmetic Ingredients database.

The EU level cosmetics legislation requires also that all cosmetic products before they are placed on the EU must be registered in the cosmetic products notification portal (CPNP). Cosmetics that contain new ingredients in nano form must be notified at least 6 months before the products are placed on the market. More specific details can be found here:

• Cosmetics legislation
• Commission Implementing Decision 2013/674/EU of 25 November 2013 on guidelines on annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (guidelines on the cosmetic products safety report)
• Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products
• Technical document on cosmetic claims
• Report from the Commission to the European Parliament and the Council on product claims made based on common criteria in the field of cosmetics
• Animal testing is banned (under the EU Cosmetic Products Regulation, Regulation (EC) No 1223/2009).

Applicable standards

The Cosmetics Regulation requires that the manufacturing of cosmetic products complies with good manufacturing practice of cosmetic products. The manufacturer can presume that the manufacturing process is in conformity with the requirements in the cosmetics regulation (EU) 1223/2009 if he follows the harmonised standard ISO 22716:2007. This standard provides guidance for good manufacturing practice of cosmetic products.

Note: The following site of CEN (the European standardisation organisation) provides links to the national standardisation bodies’ websites. In addition, the China Standards Information Services Network can be used to access European standards.

In addition to this, the Council of Europe has published ‘Guidelines on Good Manufacturing Practice of Cosmetic Products (GMPC) and this can be purchased from here.

Other legislation of relevance:

While manufacturers need to familiarise themselves with all the laws which apply to their specific products, the following summarises some further key applicable laws:

• The REACH regulation restricts chemical substances in goods. REACH stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals”, and it places responsibility on the industry to manage the risks from chemicals and to provide safety information on the substances. The European Chemicals Agency (ECHA) maintains a list of substances of very high concern (the “SVHC list”). According to article 56(1) of the Regulation, manufacturers shall not place products containing any of the substances on this list on the market. The updated list of substances of very high concern can be found on ECHA’s website.
• The Urban Waste Water Treatment Directive (UWWTD) aims at protecting human health and the environment from the effects of untreated urban wastewater.
• The Green Claims Directive aims to make green claims reliable, comparable and verifiable across the EU to protect consumers from greenwashing, to contribute to creating a circular and green EU economy by enabling consumers to make informed purchasing decisions and to help establish a level playing field when it comes to environmental performance of products.
• The Ecodesign for Sustainable Products Regulation, ESPR is part of a package of measures that are central to achieving the aims of the 2020 Circular Economy Action Plan and fostering the transition to a circular, sustainable, and competitive economy. It contains inter alia rules to address destruction of unsold consumer products.
• The Packaging and Packaging Waste Regulation, PPWR regulate what kind of packaging can be placed on the EU market, as well as packaging waste management and prevention measures. All packaging must comply with essential requirements related to its manufacturing, composition, and reusable or recoverable nature.
• The Regulation on Deforestation-free Products aims to avoid that the listed products Europeans buy, use and consume contribute to deforestation and forest degradation in the EU and globally reduce carbon emissions caused by EU consumption and production of the relevant commodities. Moreover, it addresses all deforestation driven by agricultural expansion to produce the commodities in the scope of the regulation, as well as forest degradation.

Please note that every product must be safe for the consumers, whether it is a cosmetic product or not. If a cosmetic product is unsafe, and that particular aspect is not regulated by the Cosmetics Regulation (EU) 1223/2009, then the General Product Safety Regulation (GPSR) of the EU applies.

Mandatory labelling and warnings

The following are obligatory:

• Description of the product
• Product ingredients
• Responsible person’s name and address
• Nominal content
• Best before use or symbol
• Precautions (if applicable)
• Batch number
• Function
• List of ingredients. These need to be Internationally recognisable – INCI (International Nomenclature Cosmetic Ingredient). Further information can be found here.

If claims are made these need to be substantiated (proof of the effect claimed). According to Article 20 of Regulation No 1223/2009, in the labelling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.

Warnings and instructions for use need to draw the attention of users and supervisors to the inherent hazards and associated risks and how to avoid injury. They must be adequate and non-misleading.

Product Information File

All cosmetic products must be accompanied by their Product Information File (PIF). This will include:

• A description of the cosmetic product,
• The cosmetic product safety report,
• a description of the method of manufacturing and a statement on compliance with good manufacturing practices,
• proof of the effect claimed for the cosmetic product (if justified),

Notification to the Cosmetic Products Notification Portal (CPNP) is mandatory before placing on the market

Ownership of the PIF remains with the responsible person (RP) established within the EU. This person shall ensure that the product they are responsible for complies with the obligations set out in EU Cosmetics Regulation.

General safety requirements

Please refer to respective sections of the SPEAC FINDER regarding:

• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate/RAPEX
• Selling online
• Technical documentation
• Testing
• Using a third party