Regulation of Cosmetics in the European Union
Regulation of Cosmetics in the European Union
On 22 December 2009, the new Cosmetics Regulation - EC No 1223/2009 - was officially published by the EU and its 27 member states must enforce the regulation by their respective competent authorities. In addition, the EU Cosmetics Regulation does not contain any penalty clauses or provisions for administrative offence. These must be stipulated individually by the Member States. Therefore, there may be different penalties in each Member State for the same offence.
Laws that EU Enforces for Cosmetics:
Related amendments
The European Commission amends the EU Cosmetics Regulation (EC) 1223/2009 several times a year, mainly in relation to the prohibited, restricted and permitted substances in Appendices II, III, IV, V and VI. In the 2019 amendments, for example, Amendment (EU) 2019/1966 amended the provisions on salicylic acid (SA) in Appendices III and V to prohibit the use of SA in oral products, in aerosol products that may cause lung exposure to the user by inhalation, and in all products for use by children under 3 years of age. Amendment (EU) 2019/1858 adds Hydroxyethoxyphenylbutanone to the list of permitted preservatives for cosmetics.
Definition of "Cosmetic Product"
The definition of cosmetics is common to all EU member states (Article 2 of the Cosmetics Regulations). Cosmetics are "substances or mixtures intended to contact human surface parts (epidermis, hair and capillary system, nails, lips and external genitalia) or teeth and oral mucosa, with the sole or main purpose of cleaning, flavoring, changing appearance, protecting, maintaining good condition or correcting body odor".
Cosmetics classification
The EU definition of cosmetics is based primarily on the application site and intended function of the product, and each product may cover a range of pharmaceutical products, germicide and medical devices, but it can only fall into one category.
For example, soap, lipstick, sunscreen, anti-caries toothpaste, antiperspirants, hair dyes and anti-dandruff shampoos are all cosmetic products, but anti-acne lotions are pharmaceutical products.
Regulatory process
- Pre-market Approval and Notification of Products: In the EU, no government approval is required before a cosmetic product can be placed on the market. The EU has a filing system for cosmetic products, which means that the person responsible for a cosmetic product should submit information about it to the European Commission via the Cosmetic Products Notification Portal (CPNP) before it is placed on the market.
In the EU, the manufacturer or importer is usually appointed as the Product Responsible Person (RP) for cosmetic products. To ensure the safety of a cosmetic product prior to marketing, the RP is required to commission a Safety Assessor (SA) to carry out a cosmetic safety assessment and write a Cosmetic Product Safety Report (CPSR).
In addition, some nanometre materials are more strictly regulated in the EU. According to Article 16 of the EU Regulation (EC) No 1223/2009, cosmetic companies using new nanometre materials, with the exception of partially compliant nanometre materials, are required to inform the European Commission six months prior to the marketing of their products, who will task the European Scientific Committee on Consumer Safety (SCCS) with conducting a safety assessment.
- Post-market surveillance: The competent authorities of the EU member states are responsible for the post-market surveillance of cosmetics to ensure the safety of cosmetics produced or imported into the EU. In order to ensure coordination and cooperation in the cosmetic surveillance process, to build a unified EU cosmetic market order and to better protect the health and rights of consumers, the Platform of European Market Surveillance Authorities for Cosmetics (PEMSAC) has been jointly established by the competent authorities of the EU member states. Cosmetics (PEMSAC).
Raw materials management
The EU regulation of cosmetics is based on the safety risk assessment of cosmetic ingredients. The Scientific Committee on Consumer Safety (SCCS) regularly revises and updates the Guidelines for the Testing and Safety Assessment of Cosmetic Ingredients, which contain a series of cosmetic toxicity testing procedures to provide guidance to government authorities and cosmetic manufacturers in ensuring the safety of cosmetics.
In EC No 1223/2009, the EU has established a list of banned substances (Appendix II) and restricted substances (Appendix III) for cosmetics, and three lists of permitted ingredients (Appendices IV, V and VI) for colorants, preservatives and UV sunscreens (ultraviolet filters). In this regard, the SCCS and cosmetic manufacturers are responsible for testing the safety of ingredients and products respectively.
Cosmetic labels and claims
In accordance with Article 19 of the EC (EC) 1223/2009, the labels of cosmetic products should indicate the relevant information in clear and understandable language or labeling. In addition, cosmetic packaging is subject to other regulations such as the EU Packaging Directive (94/62/EC), the EU Food Contact Materials Regulation (EC) 1935/2004 and the EU Regulation (EU) No 10/2011 on plastic FCM products. The name of the product, the manufacturer, the address of the company, the nominal content, the current content, the list of ingredients, the composition of the ingredients, the minimum expiry date and the precautions for use must appear on the packaging and containers of cosmetic products.
The General Standard for Cosmetic Claims (EU) 655/2013 and the EU Cosmetics Regulation (EC) 1223/2009 set out the requirements that must be met for cosmetic claims. Scientifically undetermined effects are prohibited in the advertising of cosmetic products. Intentionally misleading advertising is prohibited. Cosmetics may not be advertised as "heavy metal free". It is also prohibited to claim that they are "free from allergens".
For R&D and Further Manufacturing ONLY.
