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).
– 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 (GMP)
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:
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:
The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.
On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties.
The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Changes in Annexes III and VI to Regulation are expected, regarding the ingredients: BHT; Acid Yellow 3; Resorcinol; HAA299; and Homosalate.
The European Commission has published the Commission Implementing Decision (EU) 2022/677, which updates the Glossary of common ingredient names for use in the labelling of cosmetic products.
Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.
On July 8th, the European Commission published the Commission Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009. This amendment lowers the current threshold for labelling formaldehyde from 500 ppm to 10 ppm.
