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The Eu’S Role In Cosmetics: Ec 1223/2009 Regulation

Europe is a global leader in the cosmetics sector and major cosmetics exporter. The industry is very advanced and offers noteworthy employment to Europeans. The EU’s participation primarily concerns the legal and regulatory agenda for international trade relations and market access. These primary concerns ensure the uppermost level of consumer safety is adhered to.

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The European regulatory bodies are also in contact with stakeholders of cosmetic companies and this cooperation permits the interchange of essential data and boosts the smoother implementation of EU policies in this industry. Let’s take a look at some of these regulations:

Understanding EC 1223/2009 Regulation:

The EC 1223/2009 regulation was passed in 2009 and succeeds the previous cosmetics regulation- 76/768/EEC. With the new cosmetics regulation, product safety has been strengthened, taking into consideration the recent ground breaking developments, plus the planned use of nanomaterials. Below are the most significant changes introduced by the EC 1223/2009:

CPSR Cosmetics Product Safety Report.

A more thorough CPSR cosmetics safety assessment.A new and more wide-ranging set of documents known as the PIF (Product Information File) to reinforce safety requirements.CPSR cosmetics reports are created so that manufacturers can follow certain processes in the development of a product safety report before putting the product on the market.

Part A: Cosmetic product safety informatio

Exposure to substances

Information on the cosmetic product

Normal and reasonably foreseeable use

Traces, Impurities, information about packaging material

Quantitative and qualitative composition

Microbiological quality

Toxicological profile of the substances

Undesirable effects and serious undesirable effects

Stability, physical and chemical characteristics of the cosmetic product

Exposure to cosmetic product

Part B: Cosmetic product safety assessment

Labelling warnings and instructions of use

Assessor’s credentials and approval of Part B

Assessment conclusion



Redefining the Roles and Responsibilities of “Responsible Person”

Only cosmetic products that is classified within the EU as a “responsible person” can be released into the market. The new regulation allows for the exact identification of the responsible person and lists out their obligations.

Notification of all New Products Put on the EU Market

A central notification system through the CPNP (Cosmetic Product Notification Portal) All producers of cosmetics will have to notify the EU once through the CPNP.

Serious Undesirable Effects (SUE) Notification

A responsible person is obligated to notify the national authorities about any serious undesirable effects. The authorities will after collecting information, is obliged to share it with other EU countries.

Rules for using Nanomaterials in Cosmetic Products

New policies about using substances classified as mutagenic, carcinogenic, preservatives, UV-filters, or toxic CMR substances Colorants, including all nanomaterials, must be authorised. Products comprising of other nanomaterials that are not restricted by the regulation will be the subject of a thorough safety assessment.

These new cosmetics regulation also describes new requirements for Good Manufacturing Practice (GMP).