CONFIDENTIAL.
HIGH QUALITY.
SAFE.
HIGH QUALITY.
SAFE.
Ensuring that your cosmetic products comply with EU and UK cosmetic regulations is not just a best practice—it is a legal requirement before they can be placed on the market. One of the most essential obligations under Regulation (EC) No. 1223/2009 in the EU and the UK Cosmetic Regulation 2019 is the appointment of a Responsible Person (RP). This role is critical in overseeing compliance, product safety assessments, and regulatory documentation, ensuring that every product meets the necessary legal standards.
Without a designated Responsible Person, your cosmetic products cannot be legally sold in the EU or UK markets. Choosing a professional RP service ensures full regulatory compliance, protects your brand, and prevents potential legal and financial risks.
A Responsible Person (RP) is a legal entity or an individual who ensures that a cosmetic product complies with all safety, regulatory, and labeling requirements before being placed on the market. The EU Responsible Person must be located in one of the EU member states, whereas the UK Responsible Person must be based in the UK. The RP acts as the official contact point for regulatory authorities and ensures that all necessary documentation is maintained.
Additionally, the RP acts as the primary point of contact for regulatory bodies, facilitating compliance audits, regulatory inquiries, and managing product recalls if necessary. A major responsibility of the RP is handling product notification processes, ensuring that all cosmetics are properly registered through the CPNP (Cosmetic Product Notification Portal) for the EU and the SCPN (Submit Cosmetic Product Notification) system for the UK. Without these registrations, products cannot be lawfully distributed.
Beyond compliance, the RP oversees documentation and safety compliance by compiling and maintaining essential regulatory documents. These include the Product Information File (PIF) and the Cosmetic Product Safety Report (CPSR), both of which contain critical safety data and product assessments required for market approval.
The RP ensures that every product meets regulatory compliance standards before entering the market. This includes verifying that all aspects of safety, labeling, and marketing claims are in accordance with EU and UK laws.
A Cosmetic Product Safety Report (CPSR) is a legally required safety document for all cosmetics sold in the EU and UK. This report comprises a toxicological profile of ingredients, safety evaluations, and expert assessments from a qualified toxicologist. Without a CPSR, a cosmetic product cannot legally be sold. The RP ensures that the CPSR is correctly prepared and included in the mandatory Product Information File (PIF).
To legally market cosmetics, the RP must register products in the CPNP portal (EU) and the SCPN system (UK). These registrations are essential regulatory steps that ensure authorities have full visibility into product compliance before they enter the market.
All cosmetic products must comply with strict EU and UK cosmetic labeling standards, which require ingredient listings (INCI), batch traceability, manufacturer details, and product safety warnings. Additionally, any marketing claims—such as “dermatologically tested,” “hypoallergenic,” or “anti-aging”—must be backed by valid scientific evidence to avoid misleading consumers and regulatory violations.
A Responsible Person can be:
A manufacturer based in the EU or UK.
A brand owner or distributor, provided the manufacturer is located outside the EU or UK.
A third-party regulatory consultant, such as DR. Burstein & Waymore, specializing in full compliance support.
At Burstein & Waymore, we offer comprehensive Responsible Person services in both the EU and UK, ensuring full compliance with cosmetic regulations. Our services include:
Cosmetic Product Safety Reports (CPSR) & Safety Assessments
PIF Compilation & Documentation Compliance
CPNP & SCPN Product Notifications
Regulatory Labeling & Claims Substantiation
Ongoing Market Surveillance & Compliance Support
Useful links:
Short lead time
Support for you
Experienced team
Good value for you
Cosmetic products made available on the market must be safe for human health under normal or reasonably foreseeable conditions of use.
The responsible person is obliged to ensure that the manufacture of cosmetic products complies with good manufacturing practice.
Before placing a cosmetic product on the EU market, the responsible person must ensure that the product undergoes a safety assessment based on relevant information and that a cosmetic product safety report is prepared in accordance with Annex I of Regulation 1223/2009.
The responsible person must keep the product information file at the address indicated on the label for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
Ensure that sampling and analysis of products are conducted in a reliable and reproducible manner.
Oversee the sampling and analysis of products in a reliable and reproducible manner. Before introducing the cosmetic product to the market, electronically submit the required information to the Commission through the Cosmetic Product Notification Portal (CPNP).
Ensure that the cosmetic product does not contain:
If the product includes substances classified as CMR substances, ensure that those substances fall into category 2, allowing use in cosmetic products only if evaluated and found safe by the SCCS.
In cases where a cosmetic product contains nanomaterials, notify the Commission electronically six months before placing it on the market.
Minimize the level of traces of prohibited substances. However, the unintentional presence of a small quantity of a prohibited substance, technically unavoidable in good manufacturing practice, is permitted as long as it does not affect the product’s safety.
Ensure no products, where the final formulation and cosmetic ingredients were tested on animals, will be placed on the EU market due to the ban on animal testing.
Cosmetic products should only be made available on the market if the container and packaging meet the requirements of Regulation 1223/2009.
Revise product claims on the label to ensure they do not imply characteristics or functions that the products do not have.
Grant the public certain access to information meant for the general public.
In the event of serious undesirable effects, the responsible person and distributors must promptly notify the competent authority of the Member State where the serious undesirable effect occurred and cooperate with the authority.
In the event of serious doubt regarding the safety of any substance in cosmetic products, the competent authority of the Member State where a product containing such a substance is made available on the market may, by reasoned request, require the responsible person to submit a list of all cosmetic products for which they are responsible and that contain this substance. The list shall indicate the concentration of this substance in the cosmetic products.
Don’t hesitate, white us today.