Sector

Cosmetic

Regulatory Consulting Support for Cosmetics in North America, Europe, China, and Taiwan

We provide extensive regulatory support and advice to bring cosmetic products to market. In addition to the regulatory assistance, we provide support and recommendations for testing, safety, claims, and labeling. We work with your product development teams and R&D staff to improve speed to market and compliance with all applicable regulations.

Experienced Support For:

US / Canada

US Food & Drug Administration (FDA)
Health Canada

China / Taiwan

China State Food & Drug Administration (SFDA)
Taiwan Department of Health

European Economic Area (EEA) & UK

Responsible Person (RP & UK RP)
Product Information File (PIF)
Notifications:
- Cosmetic Products Notification Portal (CPNP)
- Office for Product Safety & Standards (UK OPSS)
Classification, Labelling, and Packaging (CLP)
Cosmetic Product Safety Report (CPSR)
- Hazard & Exposure
- Safety Assessments

Cosmetic Support in North America

Cosmetics and personal care products are regulated by the US FDA and Health Canada. While there is no formal approval process by either agency, cosmetic products sold in North America must follow the regulations carefully and meet all the legal requirements to be sold in either country.

Cosmetic Support in Europe (EU/EEA)

Since 2013, the Cosmetic Products Regulation (EC) No. 1223/2009 has established requirements to ensure that all cosmetic products placed on the European Economic Area (EEA) market are safe for human health. The Regulation applies across the EEA (the 27 EU Member States plus Iceland, Liechtenstein and Norway) and sets out clear obligations for companies placing cosmetic products on the market.

Under the Regulation, a ‘cosmetic product’ is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (such as the skin, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odours.

Cosmetic products include a wide range of formulations such as liquids, creams, emulsions, lotions, gels, oils and powders used across categories including hair and scalp, nail and cuticle, oral hygiene, and skin care.

Companies must appoint a designated ‘Responsible Person’ (RP) established within the EEA. The RP is legally responsible for ensuring that each product complies with all requirements of the Regulation. CSI supports clients by acting as a trusted EU Responsible Person and managing these obligations on their behalf.

For each cosmetic product, a Product Information File (PIF) must be prepared and maintained by or on behalf of the Responsible Person. The PIF must include:

A description of the cosmetic product
A Cosmetic Product Safety Report (CPSR)
Details of the method of manufacturing and compliance with good manufacturing practice
Evidence supporting any product claims
Information relating to animal testing

The CPSR is a two-part document comprising:

Part A: hazard identification and exposure assessment
Part B: the safety assessment of the finished product

This assessment must be carried out by suitably qualified safety professionals.

CSI works closely with clients and third-party safety assessors to ensure that the PIF and CPSR meet regulatory requirements and are maintained in a format suitable for inspection by competent authorities.

Cosmetic products placed on the EEA market must be notified via the Cosmetic Products Notification Portal (CPNP). CSI prepares and submits product notifications on behalf of clients as part of our Responsible Person service.

Cosmetic Support in the UK

The UK Cosmetics Regulation, based on Regulation (EC) No. 1223/2009 as retained in UK law, sets out the requirements to ensure that cosmetic products placed on the Great Britain market are safe for human health.

Under UK legislation, a ‘cosmetic product’ is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (such as the skin, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odours.

The UK Cosmetics Regulation applies in Great Britain and imposes clear obligations on companies placing cosmetic products on the market.

Companies must appoint a designated ‘Responsible Person’ (UK RP) established in Great Britain. The UK Responsible Person is legally responsible for ensuring that each product complies with all applicable regulatory requirements. CSI supports clients by acting as a trusted UK Responsible Person and managing these obligations on their behalf.

For each cosmetic product, a Product Information File (PIF) must be prepared and maintained. The PIF must include:

A description of the cosmetic product
A Cosmetic Product Safety Report (CPSR)
Details of the method of manufacturing and compliance with good manufacturing practice
Evidence supporting any product claims
Information relating to animal testing

The CPSR is a two-part document comprising:

Part A: hazard identification and exposure assessment
Part B: the safety assessment of the finished product

This assessment must be carried out by suitably qualified safety professionals.

CSI works closely with clients and third-party safety assessors to ensure that the PIF and CPSR meet UK regulatory requirements and are maintained in a format suitable for inspection by the Office for Product Safety and Standards (OPSS).

Cosmetic products placed on the Great Britain market must be notified via the UK Submit Cosmetic Product Notification (SCPN) system. CSI prepares and submits product notifications on behalf of clients as part of our UK Responsible Person service.

Cosmetic Support in China/Taiwan

Cosmetics and personal care products are regulated by the China State Food and Drug Administration (SFDA). Under this agency, CSI provides regulatory consulting support for food, drug, cosmetics, food additives, and dietary supplements. In Taiwan, cosmetics and personal care products are regulated by the Taiwan Department of Health.