Sector

Cosmetics

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)
  • Cosmetic Product Safety Report (CPSR)
    • Hazard & Exposure
    • Safety Assessments

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.

Since 2013, the Cosmetic Products Regulation (EC) No. 1223/2009 has established standards ensuring that all cosmetic products placed on the European Economic Area (EEA) market are safe for human health. Under the Regulation, ‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the 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 odours.

 

Cosmetic products may include liquids, creams, emulsions, lotions, lacquers, gels, oils, pastes, powders, salts, and foams in the following categories; Hair and Scalp Products, Nail and Cuticle Products, Oral Hygiene Products, and Skin Products.

 

The Cosmetics Regulation applies to the EEA - the 27 EU Member States, plus Iceland, Liechtenstein and Norway - and imposes significant obligations on companies placing cosmetics on the EEA market.

 

Cosmetics companies are required to have a designated legal or natural ‘Responsible Person’ (RP) within the EEA if they wish to place products on the EEA market. This person is charged with ensuring compliance of products with all the requirements of the Cosmetics Regulation. CSI offers a RP service to companies seeking to delegate this key role to a trusted third party.

 

CSI prepares a Product Information File (PIF) for each cosmetic product in our client’s portfolio. The PIF must contain a description of the cosmetic product, a detailed Cosmetic Product Safety Report (CPSR), a description of the method of manufacturing, proof of effect(s) claimed for the product, and data on any animal testing. A PIF for each cosmetic product must be retained (and made available to Member State Competent Authorities on request by the RP.

 

The two-part CPSR is composed of Part A, which includes hazard and exposure information, and Part B, which contains a safety assessment of the product. This assessment must be performed by suitably qualified safety professionals. All of CSI’s Cosmetic Safety Assessors meet the strict qualifications requirements stated in the Regulation.

 

Information on cosmetic products placed on the EEA market must be provided through notification via the Cosmetic Products Notification Portal (CPNP). CSI notifies cosmetic products on behalf of our clients.

Cosmetic products may include liquids, creams, emulsions, lotions, lacquers, gels, oils, pastes, powders, salts, and foams in the following categories; Hair and Scalp Products, Nail and Cuticle Products, Oral Hygiene Products, and Skin Products.

 

The Cosmetics Regulation applies to the EEA - the 27 EU Member States, plus Iceland, Liechtenstein and Norway - and imposes significant obligations on companies placing cosmetics on the EEA market.

 

Cosmetics companies are required to have a designated legal or natural ‘Responsible Person’ (RP) within the EEA if they wish to place products on the EEA market. This person is charged with ensuring compliance of products with all the requirements of the Cosmetics Regulation. CSI offers a RP service to companies seeking to delegate this key role to a trusted third party.

 

Although the UK left the EU on 31st January 2020, the Cosmetic Products Regulation (EC) No. 1223/2009 was transposed into UK law almost unchanged, so the provisions of the Regulation apply in full in the UK.

 

CSI prepares a Product Information File (PIF) for each cosmetic product in our client’s portfolio. The PIF must contain a description of the cosmetic product, a detailed Cosmetic Product Safety Report (CPSR), a description of the method of manufacturing, proof of effect(s) claimed for the product, and data on any animal testing. A PIF for each cosmetic product must be retained (and made available to Member State Competent Authorities on request by the RP.

 

The two-part CPSR is composed of Part A, which includes hazard and exposure information, and Part B, which contains a safety assessment of the product. This assessment must be performed by suitably qualified safety professionals. All of CSI’s Cosmetic Safety Assessors meet the strict qualifications requirements stated in the Regulation.

 

Information on cosmetic products placed on the EEA market must be provided through notification via the Cosmetic Products Notification Portal (CPNP). CSI notifies cosmetic products on behalf of our clients.

 

CSI provides a UK Responsible Person (UK RP) service for companies wishing to place products on the UK market, and submits the required product notifications on the UK Office for Product Safety and Standards (OPSS) database.   

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.

Cosmetics Contacts

Warren Scott's Picture

Warren Scott

Principal Consultant

Scotland

Jeremy Wilson's Picture

Jeremy Wilson

Business Development

Oregon

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Warren Scott
Principal Business Development Consultant

Expertise: Business Development & Regulatory Consulting

Warren shares a direct consulting role for Industrial Chemicals (REACH), Biocides and Cosmetics, with a Business Development remit for CSI’s European office.

Warren has over 30 years’ experience in laboratory contract research, business development for contract research organizations, and the consulting sector. His experience encompasses projects in various business sectors including plant protection, chemical, biocidal and cosmetic products. Warren qualified as a Soil Scientist and prior to joining CSI held scientific and business development positions at Inveresk Research and Wildlife International.

EDUCATION
BSc (Hons) Soil Science, University of Aberdeen.

Jeremy Wilson
Business Development

Expertise: Business Development & Marketing

Jeremy leads marketing and business development efforts in North America and Latin America. He represents CSI at various industry trade associations and professional societies.

Jeremy has over 23 years of experience in regulatory affairs and product registration compliance with Federal, State, and International chemical regulations. His experience includes government agency interactions and determination of appropriate regulatory pathways to meet product registration objectives. He has prepared numerous registration submissions, placed and monitored necessary Good Laboratory Practice (GLP) studies to develop data and documentation, and served as the primary agency liaison for the registration process. Jeremy has expertise with biorational/biopesticide registration and Latin America regulatory requirements.

EDUCATION
BS, Environmental Science; Minor in Biology, Washington State University.