ADD TEXT: Overview EU Cosmetic regulation, 1223/2009, step for registration (bullet point)

ADD TEXT: Overview UK Cosmetic regulation, BREXIT, step for registration (bullet point)

Exporting to EU

The cosmetics market in the European Union (EU) is one of the largest and most developed in the world. According to data from the European Cosmetics Association (Cosmetics Europe), the EU’s cosmetics market was valued at  €80 billion at retail sales price in 2021, making it the largest cosmetics market in the world. The European Union (EU) Cosmetic Regulation 1223/2009 establishes the regulatory framework for the manufacture, import, and sale of cosmetic products within the EU. Here are the general 5 steps for registration of cosmetic products under this regulation:

Step 1: Formula Review

The formula review is a meticulous process that ensures the safety and regulatory compliance of a cosmetic product, including the establishment of the INCI list and confirmation of mandatory lab tests, before the preparation of CPSR and verification of product label.

Step 2: Cosmetic Product Safety Report (CPSR) (link to CPSR)

The CPSR (Cosmetic Product Safety Report) is a comprehensive document produced by a qualified toxicologist that includes two distinct sections, Part A containing all data needed for the evaluation of the cosmetic product and Part B providing an assessment of the product’s safety and conclusions, which is essential to certify the effectiveness and safety of a product before it can be placed on the EU market.

Step 3: Product Information File (PIF) and CPNP Notification

A Product Information File (PIF) is a complete regulatory dossier that includes the formula, CPSR A&B, and labels of a cosmetic product, and once completed, the product can be notified in the EU via the CPNP (Cosmetic Product Notification Portal) to obtain a unique CPNP number, and while the EU does not require pre-approval of cosmetic products, the selection of a competent Responsible Person is crucial for post-launch verification by competent authorities.

Step 4: Labels and Claims Review

Complying with EU cosmetic labelling rules can be confusing and costly for cosmetic brand owners, as certain elements may need to be translated into different languages depending on the country, and distributors have the right to refuse non-compliant products, making a Label Review by a recognized and experienced company like Influentive  is essential for ensuring clear and compliant labels that are easily accessible, readable, and understandable by consumers at the time of purchase.

Step 5: Responsible Person

The Responsible Person is the legal representative for cosmetic products in Europe and is responsible for ensuring compliance with EU regulations, as well as being the contact point for authorities and consumers in case of issues or concerns regarding the product.

UK Cosmetics Regulatory Compliance | Biorius

Exporting to UK

The global cosmetic products market values the United Kingdom as an important player, with retail sales valued at €9.9 billion in 2021. In Western Europe, the UK ranks third among the leading cosmetic markets, following Germany and France, and preceding Italy. It is also the world’s eighth-largest cosmetic industry, trailing behind the USA, China, Japan, India, Brazil, Germany, and France. Industry projections indicate a 25% growth rate for the global cosmetics market by 2027, with the UK predicted to experience the most substantial expansion in Western Europe in the coming years.

Step 1: Formula Review:

The focus is on ensuring regulatory and safety compliance of ingredients (INCI) in cosmetic products. This involves a thorough examination of the composition and raw materials documentation to ensure safety for the intended use and target population. The creation of a CPSR and verification of the product label are dependent on this step.

Step 2: Cosmetic Product Safety Report (CPSR)

The Cosmetic Product Safety Report (CPSR) is a crucial and complex document required by UK Cosmetics Regulation. It confirms the safe use of a cosmetic product and is produced by a qualified toxicologist who considers various information. CPSR has two sections, Part A for product evaluation and Part B for assessing safety and effectiveness. It must be signed by recognized UK and EU toxicologists and failure to provide a high-quality CPSR can result in penalties and harm to the brand’s reputation.

Step 3: A Product Information File (PIF) and SCPN Notification

The PIF is a detailed dossier with all necessary information about a cosmetic product. It must be completed and notified on the SCPN before sale in the UK. After Brexit, PIFs must be updated with names and addresses of EU and UK Responsible Persons for products sold in both territories. All cosmetic products must be re-notified in the new SCPN system for sale in the UK, and all existing products had to be re-notified within 90 days from March 31st, 2021.

Step 4: Labels and Claims review

UK cosmetic labels must comply with regulations, and a Label Review by a regulatory expert can ensure compliance, including the inclusion of country of origin and UK Responsible Person’s contact details.

Step5: Responsible Person

The UK requires a local Responsible Person for cosmetic products sold there, and brands selling in both the UK and EU need a Responsible Person in each area. The Responsible Person ensures ongoing compliance and is accountable in case of non-compliance. It’s best to find a Responsible Person with offices in both regions to represent products, and Influentive offers services in both areas.