Cosmetic Regulations under EMA: Health Authority Directives

Cosmetic Regulations under EMA: Health Authority Directives

The European Medicines Agency (EMA) is responsible for regulating cosmetic products in the European Union (EU). In this essay, we will discuss the EMA cosmetic regulations that govern the manufacturing, distribution, and sale of cosmetic products in the EU.

Definition of Cosmetics

The EMA defines cosmetics as products intended to be applicable on the external parts of the human body, including the skin, hair, nails, lips, and external genital organs, or teeth and the mucous membranes of the oral cavity. These products are functionally direct to cleanse, perfume, protect, change the appearance, correct body odors, or maintain good condition.

Cosmetic Products Safety

Cosmetic products are subject to strict safety requirements in the EU. The EMA requires cosmetic products to be safe for human health when used under normal or reasonably foreseeable conditions of use. Cosmetics must not cause harm to human health, and manufacturers must ensure that the products are free from harmful substances.


Cosmetic products must have a list of ingredients on their packaging. The ingredients must be  in descending order of weight. Ingredients that make up less than 1% of the product can be listed in any order after the ingredients that make up more than 1%.

Prohibited Ingredients according Cosmetic Regulations

The EMA prohibits the use of certain ingredients in cosmetic products. These include substances that are carcinogenic, mutagenic, or toxic to reproduction. The use of certain fragrances, colorants, preservatives, and UV filters is also restricted.

Animal Testing

The EMA prohibits animal testing for cosmetic products and their ingredients. This ban applies to all cosmetic products that are in marketing within the EU, regardless of where they are manufacture. Companies must use alternative methods to test the safety of their products.

Claims in Cosmetic Regulations

Cosmetic products are subject to strict advertising and labeling regulations in the EU. Manufacturers must ensure that the claims they make about their products are truthful, not misleading, and supported by scientific evidence. Claims such as “anti-aging,” “hypoallergenic,” or “dermatologically tested” must substantiate by evidence.

Registration of Cosmetic Products

Before a cosmetic product can be placed on the market in the EU, it must be registered with the relevant authorities. The registration process involves providing information on the product’s ingredients, function, and safety. Manufacturers must also ensure that their products comply with all relevant regulations before they are placed on the market.

The EMA cosmetic regulations play a crucial role in ensuring the safety of cosmetic products in the EU. These regulations help to protect consumers from harmful substances and false claims while promoting the free movement of safe and compliant cosmetic products across the EU. Manufacturers must ensure that their products comply with all relevant regulations before they are on the market. Consumers can be confident in the safety and efficacy of cosmetic products that have been through registering process with the relevant authorities and comply with EMA cosmetic regulations.

Value Add

  • With a fine understanding of the increased importance of the new regulation, Templarpharma has successfully enabled major cosmetic players to meet the deadline for the regulation.
  • The assessments provided by Templarpharma’s duly qualified professionals include several hundreds of products, ranging from simple formulations to complex aerosols and moisturizers, and are in themselves a certification of the safety of the products, within the intended application and its compliance to the various annexes of the cosmetics regulation.
  • After completing the highly complicated retrospective assessments for the existing products, Templarpharma’s experts provide cosmetics companies with end-to-end scientific and regulatory support to ensure compliance with the with Regulation (EC) no. 1223/2009.

Expertise in Cosmetic Regulations

Templarpharma’s end-to-end Cosmetic Regulation Compliance Services encompass the following:

Cosmetic Safety Assessments

  • Cosmetics Ingredient Profiles
  • Product Information Files (PIFs)
  • Cosmetic Product Safety Reports (CPSR)
  • Part A Cosmetic Product Safety Information
  • Part B Full Safety Assessment
  • General Toxicological reports for ingredients