The Cosmetics Regulation (EC) No 1223/2009 is the primary regulation governing the safety and efficacy of cosmetic products in the European Union. It was enacted to ensure a high level of protection for human health and to harmonize the regulations across EU member states. Here are the key provisions and elements of this regulation:

Scope and Definitions

1. Scope: The regulation covers all cosmetic products placed on the market within the EU.
2. Definitions: It provides precise definitions for cosmetics, ingredients, and other related terms to ensure clarity.

Safety Assessment and Product Information File (PIF)

1. Safety Assessment: All cosmetic products must undergo a thorough safety assessment by a qualified person before being placed on the market.
2. Product Information File (PIF): Each cosmetic product must have a PIF that includes detailed information such as the product description, Cosmetic Product Safety Report (CPSR), manufacturing methods, and proof of the claimed effects.

Notification

1. Cosmetic Product Notification Portal (CPNP): Before a cosmetic product is placed on the market, the responsible person must notify it through the CPNP. This includes information on the product's composition and the person responsible for it.

Responsible Person

1. Responsible Person: Each cosmetic product must have a designated responsible person within the EU who ensures compliance with the regulation. This person must be easily identifiable and accessible.

Labelling

1. Labelling Requirements: Cosmetic products must be labelled with specific information, including the name and address of the responsible person, the country of origin (if imported), nominal content, expiry date, precautions, batch number, function, and the list of ingredients.

Claims and Advertising

1. Claims: Any claims made about a cosmetic product must be substantiated, and it must not mislead consumers. This includes efficacy and marketing claims.
2. Advertising: All advertising must be truthful and not mislead consumers about the product’s characteristics or functions.

Prohibited and Restricted Substances

1. Prohibited Substances: The regulation lists substances that cannot be used in cosmetic products.
2. Restricted Substances: It also lists substances that can only be used under certain conditions or within specified limits.

Animal Testing

1. Animal Testing Ban: The regulation prohibits the testing of cosmetic products and their ingredients on animals within the EU and bans the marketing of cosmetics tested on animals outside the EU after specific deadlines.

Good Manufacturing Practices (GMP)

1. GMP Compliance: Cosmetic products must be manufactured in accordance with Good Manufacturing Practices, ensuring products are consistently produced and controlled.

Market Surveillance

1. Market Surveillance: Member states must conduct market surveillance to ensure compliance with the regulation. Non-compliant products can be withdrawn from the market.

Serious Undesirable Effects (SUE)

1. SUE Reporting: Any serious undesirable effects from cosmetic products must be reported by the responsible person to the competent authorities.

Amendments and Updates

1. Updates: The regulation can be amended to include new scientific findings and update the lists of prohibited and restricted substances.

These provisions aim to ensure that cosmetic products sold in the EU are safe for human use, properly labelled, and marketed honestly. Compliance with these regulations is mandatory for all cosmetic products placed on the EU market.

Some colorants are advised to be avoided due to potential health risks or allergic reactions. A few examples:

• Tartrazine (E102). A yellow dye that can cause allergic reactions in some people and has been linked to hyperactivity in children.
• Allura Red AC (E129). Can cause allergic reactions and hyperactivity; banned in some countries.
• Ponceau 4R (E124). A red dye that can cause allergic reactions and hyperactivity.
• Amaranth (E123). A red dye associated with allergic reactions and potential carcinogenic effects.
• Brilliant Blue FCF (E133). Can cause allergic reactions in sensitive individuals.
• Black PN (E151). A black dye that can cause allergic reactions in some people.
• Patent Blue V (E131). Another dye that can cause allergic reactions.
• Green S (E142). Can cause allergic reactions and hyperactivity in some individuals.

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Studies

There is a growing warning regarding the toxicity of synthetic colorants that are widely used by the pharmaceutical, food and cosmetics industries due to their low cost, high stability and to improve the sensory and organoleptic characteristics of the product, which may change during processing. While these colorants  improve the appearance of a product, they can also pose a potential risk to human health with undesirable side effects especially when used continuously as they are absorbed through the skin or mucous membranes. For this reason, over the course of time, many of the colorants  that were regularly placed on the commercial circuit with regular authorisation by the control authorities have subsequently been banned and withdrawn from the market following more in-depth examinations of their hazardousness to human health. For example, azo dyes, which are among the most widely used, have been shown to produce carcinogenic aromatic amines in the intestine via enzymes or bacteria in the body (1). 

The FDA (Food and Drug Administration), which is the body responsible for regulating artificial food colourings in the United States, has required food manufacturers to declare the acceptable daily intake (ADI) for those colourings that may pose a health risk. Now, this is an acceptable and generally agreeable decision, but the problem arises with so-called 'cumulation', i.e. the repeated and continuous consumption of the same product or another product containing the same colouring agent. The same problem arises in cosmetics and pharmaceuticals. In a recent study (2), the FDA came to the conclusion that the ADI is regularly exceeded by a certain part of the population in most of the cases examined.

Bibliografia_____________________________________________________________________

(1) Feng J, Cerniglia CE, Chen H. Toxicological significance of azo dye metabolism by human intestinal microbiota. Front Biosci (Elite Ed). 2012 Jan 1;4(2):568-86. doi: 10.2741/e400. 

(2) Bradman A, Castorina R, Thilakaratne R, Gillan M, Pattabhiraman T, Nirula A, Marty M, Miller MD. Dietary Exposure to United States Food and Drug Administration-Approved Synthetic Food Colors in Children, Pregnant Women, and Women of Childbearing Age Living in the United States. Int J Environ Res Public Health. 2022 Aug 5;19(15):9661. doi: 10.3390/ijerph19159661.