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Critical Catalyst ensures your company meets all the regulatory requirements posed by the EU Cosmetics Regulation 1223/2009. Within the shortest time, we can make your products go through the whole registration process and allow them to be sold in the 31 countries of the European Economic Area (EU + EFTA).

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FREQUENTLY ASKED QUESTIONS

Since July 11th, 2013, cosmetics are regulated in the European Union by Regulation (EC) No 1223/2009.

The Cosmetics Regulation No. 1223/2009/EC aims at the free movement of cosmetic products within the EEA market but also at ensuring the safety of the users of cosmetic products in Europe.

According to the Cosmetics Regulation (EC) No. 1223/2009, “cosmetic product” means any substance or mixture intended to be placed in contact with 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 odors.

The assessment of whether a product is a cosmetic product has to be made on a case-by-case assessment, taking into account all characteristics of the product, its intended purpose and label.

Since products have to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity, any product intended to be ingested, inhaled, injected or implanted into the human body would also not be considered a cosmetic product in the EU.

A Responsible Person (RP) is an EU based cosmetic product manufacturer, importer, distributor, or another person established within the EU who has to accept this role in writing. A RP must be designated for each cosmetic product placed on the EU market, which bears its name and address on the label.

The role of the RP is to ensure that the cosmetic products placed on the EU market are safe for use and compliant with the EU Cosmetics Regulation.

One of the requirements of EU Cosmetics Regulation is that prior to placing the product on the market a safety assessment is carried out. The Regulation specifies that this safety assessment should be in the form of a Cosmetic Product Safety Report.

It is the responsibility of the Responsible Person to ensure that the product undergoes a safety assessment and that a cosmetic product safety report is produced and maintained up-to-date.

The Cosmetic Product Safety Report is the Safety Assessor’s opinion that the product is safe in normal and foreseeable conditions of use and complies with the requirements on safety of the EU Cosmetics Regulation.

The Cosmetic Product Safety Report is composed of two parts:

  • Part A – Cosmetic product safety information (gather all the data necessary for the safety assessment)
  • Part B – Cosmetic product safety assessment (cosmetic Safety Assessor’s opinion on the safety of the product)

 

The Cosmetic Product Safety Report must be prepared and signed by a qualified Safety Assessor, a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.

The Cosmetic Products Notification Portal (CPNP) is an online notification platform used to submit technical information related to cosmetic products to be marketed in the European Union (EU).

From July 11, 2013 the notification of cosmetics in the CPNP portal became mandatory for all brand owners wishing to legally make their products available on the EU Market.

When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.

The CPNP is accessible to the following entities:

  • Health Authorities
  • European Poison Centers
  • EU Responsible Persons for Cosmetic Products
  • EU Cosmetic Product Distributors
INDUSTRY NEWS & UPDATES

May Butylphenyl Methylpropional be used in Cosmetic Products?

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. According to an amendment to the CLP Regulation, the use of Butylphenyl Methylpropional will be prohibited in cosmetic products from 1st March 2022.

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How are Cosmetic Products Regulated in the United Arab Emirates?

The United Arab Emirates (UAE) are an emerging market for the beauty industry. Cosmetics and personal care products supplied or sold in the UAE must comply with the health and safety requirements set out in UAE legislation. Overall, the process for importing a cosmetic product into the UAE market from the European Union can be quite straightforward since the UAE has aligned several of its requirements with the European Cosmetic Regulation.

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European Commission Report on Nanomaterials – 2021

The European Commission is required to submit to the European Parliament and the Council an annual status report on the use of nanomaterials in cosmetic products and to review the provisions concerning nanomaterials in the European Regulation (EC) No 1223/2009 on cosmetic products. In July 2021, the Commission has issued its latest annual report on this subject.

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New Labelling Requirements for Cosmetic Products in China

The new Cosmetics Supervision and Administration Regulation (CSAR) was enacted in China. The National Medical Products Administration (NMPA) has released standards for the testing of cosmetic products’ safety profile and efficacy claims. The NMPA has also published the Administrative Measures on Cosmetics Labelling, an updated set of requirements for the label of cosmetic products made available in the Chinese market.

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50th Amendment to the IFRA Code of Practice

On June 30, IFRA announced the notification of the 50th Amendment to the IFRA Standards. The Standards form the basis for the globally accepted and recognized risk management system for the safe use of fragrance ingredients and are part of the IFRA Code of Practice. The amendment introduced one update to the Standards and one new prohibited substance – Mintlacton.

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How are Cosmetic Products Regulated in India?

The different expectations and needs of consumers are continually changing and therefore the cosmetic industry needs to be gradually evolve to meet the new consumer’s demand. In this regard, India has recently introduced some regulatory updates to ensure that cosmetics placed on the market are safer for all consumers.

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