As a subject matter expert in regulatory compliance for the cosmetics industry, I have a deep understanding of the intricacies involved in the European Union's (EU) regulations concerning cosmetic products. My role often involves staying abreast of the latest legislative changes and advising companies on how to ensure their products are compliant with these regulations. One of the key areas of focus in recent years has been the use of certain preservatives, specifically parabens, in cosmetic formulations.

Parabens are a class of widely used preservatives that have been a subject of debate due to potential health concerns. The European Union, in response to these concerns, has enacted specific legislation to regulate their use in the cosmetic industry.

**Regulation 1223/2009 on Cosmetic Products** is a comprehensive regulatory framework designed to ensure the safety and efficacy of cosmetics while safeguarding consumers. Within this regulation, there are specific provisions that address the use of preservatives, including parabens.

Under this regulation, companies using parabens in their cosmetic products must adhere to certain criteria:


1. Cosmetic Product Safety Report (CPSR): Companies must compile a detailed CPSR that includes a safety assessment and relevant data, demonstrating the safety of the product before it enters the market.


2. Maximum Concentrations: The regulation sets maximum allowable concentrations for certain parabens in cosmetic products to minimize potential health risks. For instance, propylparaben and butylparaben are limited to 0.8% individually and 1.0% when used in combination.


3. Labelling Requirements: Manufacturers are required to list parabens and other ingredients on product labels, enhancing transparency and allowing consumers to make informed choices.

It's important to note that while some parabens are allowed in certain quantities, the use of the claim "PARABEN FREE" on labels is no longer permitted, as it can create a misleading impression about the safety of these ingredients.

Furthermore, the European Commission guidance specifies that the maximum total concentration of parabens allowed in cosmetic products is 8g per kilogram of the product, with no single paraben exceeding 4g/kg. However, for longer chain parabens such as propyl- and butyl paraben, the Scientific Committee on Consumer Safety (SCCS) recommends a lower limit of 1.9 g/kg.

In addition, the use of isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, and pentylparaben in cosmetics formulations is banned in the EU, as outlined in fragment 4 of the provided search result.

The EU also took a precautionary approach in 2011, when the Danish government decided to ban the use of certain parabens in personal care products intended for children up to three years old. This decision was based on the potential increased sensitivity of young children to hormone-like effects, as mentioned in fragment 5.

The SCCS has reviewed the potential risks to children and concluded that the general use of paraben-containing cosmetic products is not a health concern for children of any age group. However, for very young children under six months, there might be a risk when cosmetics are applied to areas where the skin can be irritated and broken.

Scientific research on parabens continues, and the EU closely monitors emerging evidence, ready to adjust regulatory measures to ensure the continued protection of consumer health, as stated in fragment 6.

In conclusion, while not all parabens are banned in the EU, their use is heavily regulated, and certain types are prohibited. The EU's approach reflects a careful balance between allowing the use of substances that have a long history of safe use in the industry and protecting public health by restricting or banning substances that may pose a risk.

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EU bans five parabens, restricts triclosan in cosmetics. The European Commission has amended Annex II of the EU cosmetic Regulation, adding five parabens to the list of substances prohibited in cosmetic products.Apr 10, 2014read more >>