HAIR CARE
make-up
skin care
fragances & perfumes
Nail care

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).

 

  • Formula Review and Change Control
  • Product Information File (PIF)
  • Cosmetic Product Safety Report (CPSR)
  • Notification to EU authorities (Cosmetic Product Notification Portal – CPNP)
  • Labelling compliance and translation (artwork and proofreading services)
  • Period After Opening (PAO) assessment
  • Cosmetic claims substantiation
  • Cosmetovigilance (post-market surveillance)

 

 

Compliance with Good Manufacturing Practices is a must for the Cosmetics Industry.

To help your company face this challenge, we provide:

  • ​Gap analysis of existing Good Manufacturing Practices (GMP) procedures;
  • Design and implementation of Quality Management System for cosmetics manufacturing according to ISO 22716;
  • Support to ISO 22716 certification and audits;
  • In-house training.

 

 

  • Global importation/exportation support;
  • Placing cosmetics in North America, Latin America, Asia and Middle East.
  • Region-specific requirements compliance (e-COSMA; Health Canada; FDA VCRP; e-Philippines);
  • Custom clearance and transportation, Free Sale Certificate, Certificate of Origin, Certificate of Conformity;
  • Material Safety Data Sheets (MSDS) for transportation;
  • Certification support (Natural, Organic, Fair trade, Eco-friendly, Vegan).

 

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

Butylphenyl Methylpropional to be prohibited in cosmetics placed in the EU market

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 (Commission Delegated Regulation No. 2020/1182), Butylphenyl Methylpropional is now classified as toxic to reproduction (Repr. 1B – CMR 1B) and it shall be prohibited in cosmetic products from 1st March 2022.

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China Bans Microbeads In Cosmetics

On 16th January 2020, China’s National Development and Reform Commission (NDRC) issued the Notice [2020] No. 80, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. More detailed information was given in the Notice [2020] No. 1146, issued by the NDRC on 10th July 2020.

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RAPEX System 2019 Report

Every week, the RAPEX system publishes notifications of urgent measures taken by EU Member-States to prevent, restrict or impose conditions on the marketing of products due to the serious and immediate danger they pose to the health and safety of consumers.

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Cosmetic Packaging in European Union

Packaging material is defined as the container (or primary packaging) that is in direct contact with the formulation. According to the European Cosmetic Regulation No. 1223/2009, packaging evaluation is mandatory to guarantee cosmetic product safety. To meet this Regulation requirements, the European Commission issued the Decision 2013/674/EU, establishing guidelines on the practical application of such requirements and identifying information that should be collected on the packaging materials and the potential migration of substances from packaging.

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“Anti-pollution” claims in cosmetic products

Nowadays, it is possible to find in the market several cosmetic products with claims like “anti-pollution protection”, “pollution shield”, “against pollution damage” and similar ones. But how can a company test and prove this type of allegations?

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UK Product Safety and Metrology EU Exit Regulations

The fact that the United Kingdom (UK) has left the European Union (EU) is not news for anyone. This means that the UK will no longer be considered a Member-State of the EU and will be considered a third country, implying that all the EU rules and regulations will no longer apply.

On July 3rd, the UK government has released the last version of the Product Safety and Metrology EU Exit Regulations, which includes the UK Cosmetic Regulation within Schedule 34.

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