— Cosmetics Regulatory Compliance & safety

All-in regulatory compliance and safety services for cosmetics

Clear solutions for cosmetics manufacturers, brands and consultants, throughout the entire product lifecycle.

Managed by dedicated senior experts and powered by our PRIMS Compliance Software. Work with us in 5 steps to compliance with confidence!

15+

Years of expertise in cosmetics regulation & safety

5000+

Products managed and monitored by TRC experts

24/7

Automated compliance and future forecasting

100%

In-house services, assessments and RP/Agent services

150+

Brands supported internationally

— Services

Access key cosmetics markets with clarity and confidence.

High quality regulatory, safety and documentation support for cosmetic products across the EU, UK, USA and Canada.

All services you need ranging from Product Information Files (PIF), Cosmetic Product Safety Reports (CPSR) and product notifications, to Responsible Person and USA and Canada Agent services to launch and maintain compliant and safe products.

full service packages
European Union

Cosmetics Regulation EC 1223/2009

All-in safety and compliance services:

  • EU Responsible Person
  • PIF compilation & management
  • Safety Assessment / CPSR
  • Label and claim review
  • CPNP notification
  • Adverse event management
  • Continuous compliance monitoring
  • REACH registration compliance
United Kingdom

UK Cosmetics Regulation 2019

All-in safety and compliance services:

  • UK Responsible Person
  • PIF compilation & management
  • Safety Assessment / CPSR
  • Label and claim review
  • SCPN notification
  • Adverse event management
  • Continuous compliance monitoring
  • REACH registration compliance
United States

MoCRA (federal) & state level Regs.

Full-service compliance and safety solutions

  • US Agent services (facilities and brand owners, importers, packers)
  • PIF compilation & management
  • Safety Assessment / CPSR
  • Label and claim review
  • FDA (federal) product listing
  • Adverse event management
  • Continuous compliance monitoring
Canada

Canada Cosmetics Regulation

All-in compliance and safety solutions:

  • Canada Responsible Person
  • PIF compilation & management
  • Safety Assessment / CPSR
  • Label and claim review
  • Health Canada notification
  • Adverse events management
  • Continuous compliance monitoring
individual services
Safety & Compliance Assessment (CPSR)

Full cosmetic compliance and safety assessments and reports (CPSR part A and part B) by qualified in-house toxicologists, continuously updated.

Training, Consulting & Outsourcing

Regulatory training, strategic consultancy and outsourced regulatory affairs support for your team.

REACH / CLP (EU, UK)

REACH and CLP compliance reviews, supplier verification and substance assessments on product or portfolio level.

PPWR (EU)

Integrated centralised product and packaging compliance service powered by PRIMS Compliance Software

— The TRC method

Compliant in 5 steps.

Our structured compliance process removes complexity and creates a clear, easy pathway to market – in every jurisdiction, powered by PRIMS Compliance and Safety Software in every step.

The process aligns with the requirements of the regulations and includes all the prerequisite services needed for compliance and safety as needed for your portfolio:

1

Prescan

Initial assessment of your formulations, product label and marketing requirements, discuss your product dossiers.

2

PIF Building

Compilation and structuring of a complete PIF, including all required technical documentation and records.

3

CPSR

Safety Assessment and Cosmetic Product Safety Report (CPSR) by qualified in-house toxicologists and safety assessors.

4

Label & Claim Review

Regulatory review of product labelling, INCI ingredient listings and marketing claims prior to market launch.

5

Notification / Listing

Submission of product notifications and listings through CPNP (EU), SCPN (UK), FDA systems (USA) or Health Canada.

— Our Expertise

Human expertise powered by state of the art software.

Since 2018, TRC has brought together regulatory and toxicological expertise, many years of combined experience in the cosmetics industry, software technology, and extensive vetted regulatory and toxicology databases to deliver real value, greater operational efficiency and continuous compliance oversight.

♙
In-house Toxicologists

In-house qualified safety assessors and toxicologists delivering CPSRs, safety assessments and ingredient reviews.

□
Regulatory Expertise

Work with one dedicated expert who understands your brand, products and priorities to cover all your needs.

↯
PRIMS-Powered Workflows

Managing non-linear processes and change in the supply chain, formulations and regulations through connected digital processes to stay in control.

⌁
Continuous Monitoring

Active regulatory monitoring as legislation evolves across markets to timely sell out existing stock and adjust and reformulate.

— Client perspectives

Trusted by brands that cannot afford compliance uncertainty.

Manufacturer

“Product compliance and product safety are key. With TRC as our compliance partner, and PRIMS cloud solution as a very easy to use, high quality and value adding tool, we feel very confident that the highest level of compliance and safety of our products will be maintained. Now, and in the future, as regulations continue to evolve.”

Codibel testimonial

Susan Knops | Jethro Schiansky Quality Assurance Manager | Legal & RA Advisor (3rd party manufacturer)

Consultant

“TRC feels like a team outside my own team. Combined with PRIMS, I have expert support, reliable regulatory and toxicology data, and continuous insight into product compliance. It saves me time and helps me manage more products with confidence.”

Skinsafe Testimonial

Triin Truu | Consultant, Safety Assessor

Brand Owner

“PRIMS is well designed and user friendly, offering fast access to specifications and product compliance under EU and UK Cosmetics Regulations. It's a valuable tool for tracking raw material details and managing REACH compliance. We found it especially useful for ingredient evaluation in response to the Chemical Strategy for Sustainability (CSS) under the EU Green Deal.”

Amway testimonial

Katelijn Ramakers | Amway Regulatory Affairs & QA - Europe/SA/ANZ & Russia/KAZ

Brand Owner

“We eliminated endless back-and-forth via email. Now everyone works in the same environment, in real time. We have a system that understands the unique position of importers like us; accountable for safety, but often one step removed from product development. If you are an importer navigating the complexity of EU compliance for global products - PRIMS/ TRC is the partner you need.”

Forever testimonial

Niels Hommel | Managing Director | Forever Living

— PRIMS Compliance and Safety Software

The technology behind faster, reliable compliance and safety.

Control and clarity across your product portfolio. PRIMS is developed in-house, continuously improved, and used daily by TRC Regulatory Specialists and Safety Assessors to deliver faster high quality operations, reliable documentation, traceability and continuous compliance oversight — seamlessly across your target markets. Also available on a license basis.

  • Centralised documentation and PIF management

  • Compliance and safety tracking, 24/7, real-time

  • Current & future compliance status and alerts

  • Secure client access and dedicated contact

  • Automated label content generation

  • Product & portfolio-wide analysis & reporting

— Insights

Regulatory intelligence.

TRC actively contributes to the cosmetics industry through collaboration with authorities, conference presentations and educational webinars. Explore our latest insights, expert resources and practical guidance.

Insights
Natural and organic product claims
Insights
PPWR: Packaging Compliance is becoming Product Compliance
Insights
The ECHA/EU proposed ban of products containing microplastics
Insights
EU General Product Safety Regulation (GPSR) – the impact on cosmetics
Insights
Hand sanitiser/cleanser – cosmetic or biocide?
Insights
MoCRA, 10 steps to efficiently manage cosmetics compliance and safety in practice in the US
Events
The Regulatory Company at Tones of Beauty UK: making cosmetics compliance & safety part of market readiness
Insights
Assessment of CBD for use in cosmetics
With The Regulatory Company & PRIMS, in good company
— Careers

Join the TRC team.

We are a growing team of regulatory specialists, toxicologists and software developers working at the intersection of science, regulation and technology. If you are passionate about cosmetics compliance and product safety, we would love to hear from you.

There are no vacancies at the moment, but feel free to send your resume including motivation to jobs@theregcom.com.

 

— FAQ

Need help, any questions?

Your obligations and responsibilities depend on your role in the production, distribution and/or the sales of cosmetics products and where you are located. The safety and regulatory compliance of each cosmetic product on the EU market shall be ensured by the “Responsible Person”.

EU manufacturer
For a cosmetic product manufactured within the EU, and not subsequently exported and imported back into the EU, the EU manufacturer is the Responsible Person.

Any manufacturer
All manufacturers located inside or outside the EU shall ensure that the manufacturing of a cosmetic product complies with good manufacturing practices (GMP).

EU importer
For an imported cosmetic product, each individual EU importer shall be the Responsible Person for the specific cosmetic product he makes available on the market. A single cosmetic product can be imported by multiple EU importers where each individual EU importer is considered a Responsible Person for the quantities of the cosmetic product it imports.

EU distributor
In the context of their activities, shall act with due care in relation to the applicable requirements. A distributor shall verify labelling information, language and the minimum durability date specified on the product. In addition, he shall act on suspicions of non-compliance and non-safe products ensuring products will not be placed on the market and/or eliminate the risks of products already on the market.

3rd party Responsible Person
EU manufacturers and EU importers may designate, by written mandate, a legal entity or person established within the EU as the Responsible Person who has to accept this mandate in writing.

The obligations of the Responsible Person are many and are all geared to ensuring compliance and safety of the cosmetic product. The RP shall cooperate at all times with the authorities providing all data deemed necessary in a language easily understood by the authority.

Obligations
The role of Responsible Person (RP) may automatically fall to you depending on your company activities and/or the location of your company (within/outside) the EU, or can be assigned to a 3rd party service provider such as The Regulatory Company.
Responsible Person obligations are:

  1. Ensuring safety for human health under normal and reasonably foreseeable conditions of use (including labelling, instructions and warnings).
  2. Compliance with good manufacturing practice
  3. Performance and continuous updating of the safety assessment
  4. Building and maintaining a product information file
  5. Sampling and analysis of a cosmetic product
  6. CPNP notification prior to placing a cosmetic product on the market
  7. Product composition in accordance with the annexes II-VI of the Cosmetics Regulation and updates thereof
  8. Product composition not to contain CMR substances
  9. Proper evaluation and notification of a cosmetic product containing nanomaterials
  10. Product safety with regards to the non-intended and technically unavoidable presence of prohibited substances under GMP
  11. Compliance with non-animal testing requirements
  12. Compliant product labelling
  13. Public access to product composition data, specifically regarding hazardous substances, and the history of (seriously) undesirable effects
  14. Product claims in line and limited to the characteristics and functions of a cosmetic product
  15. Timely communication and adequate handling in the event of a serious undesirable effect (also applies to distributors)
  16. Traceability of raw materials and substances in all cosmetic products under the RP’s responsibility

Your obligations and responsibilities depend on your role in the production, distribution and/or the sales of cosmetics products and where you are located. The safety and regulatory compliance of each cosmetic product on the EU market shall be ensured by the “Responsible Person”.

EU manufacturer
For a cosmetic product manufactured within the EU, and not subsequently exported and imported back into the EU, the EU manufacturer is the Responsible Person.

Any manufacturer
All manufacturers located inside or outside the EU shall ensure that the manufacturing of a cosmetic product complies with good manufacturing practices (GMP).

EU importer
For an imported cosmetic product, each individual EU importer shall be the Responsible Person for the specific cosmetic product he makes available on the market. A single cosmetic product can be imported by multiple EU importers where each individual EU importer is considered a Responsible Person for the quantities of the cosmetic product it imports.

EU distributor
In the context of their activities, shall act with due care in relation to the applicable requirements. A distributor shall verify labelling information, language and the minimum durability date specified on the product. In addition, he shall act on suspicions of non-compliance and non-safe products ensuring products will not be placed on the market and/or eliminate the risks of products already on the market.

3rd party Responsible Person
EU manufacturers and EU importers may designate, by written mandate, a legal entity or person established within the EU as the Responsible Person who has to accept this mandate in writing.

The obligations of the Responsible Person are many and are all geared to ensuring compliance and safety of the cosmetic product. The RP shall cooperate at all times with the authorities providing all data deemed necessary in a language easily understood by the authority.

Obligations
The role of Responsible Person (RP) may automatically fall to you depending on your company activities and/or the location of your company (within/outside) the EU, or can be assigned to a 3rd party service provider such as The Regulatory Company.
Responsible Person obligations are:

  1. Ensuring safety for human health under normal and reasonably foreseeable conditions of use (including labelling, instructions and warnings).
  2. Compliance with good manufacturing practice
  3. Performance and continuous updating of the safety assessment
  4. Building and maintaining a product information file
  5. Sampling and analysis of a cosmetic product
  6. CPNP notification prior to placing a cosmetic product on the market
  7. Product composition in accordance with the annexes II-VI of the Cosmetics Regulation and updates thereof
  8. Product composition not to contain CMR substances
  9. Proper evaluation and notification of a cosmetic product containing nanomaterials
  10. Product safety with regards to the non-intended and technically unavoidable presence of prohibited substances under GMP
  11. Compliance with non-animal testing requirements
  12. Compliant product labelling
  13. Public access to product composition data, specifically regarding hazardous substances, and the history of (seriously) undesirable effects
  14. Product claims in line and limited to the characteristics and functions of a cosmetic product
  15. Timely communication and adequate handling in the event of a serious undesirable effect (also applies to distributors)
  16. Traceability of raw materials and substances in all cosmetic products under the RP’s responsibility

Your obligations and responsibilities depend on your role in the production, distribution and/or the sales of cosmetics products and where you are located. The safety and regulatory compliance of each cosmetic product on the EU market shall be ensured by the “Responsible Person”.

EU manufacturer
For a cosmetic product manufactured within the EU, and not subsequently exported and imported back into the EU, the EU manufacturer is the Responsible Person.

Any manufacturer
All manufacturers located inside or outside the EU shall ensure that the manufacturing of a cosmetic product complies with good manufacturing practices (GMP).

EU importer
For an imported cosmetic product, each individual EU importer shall be the Responsible Person for the specific cosmetic product he makes available on the market. A single cosmetic product can be imported by multiple EU importers where each individual EU importer is considered a Responsible Person for the quantities of the cosmetic product it imports.

EU distributor
In the context of their activities, shall act with due care in relation to the applicable requirements. A distributor shall verify labelling information, language and the minimum durability date specified on the product. In addition, he shall act on suspicions of non-compliance and non-safe products ensuring products will not be placed on the market and/or eliminate the risks of products already on the market.

3rd party Responsible Person
EU manufacturers and EU importers may designate, by written mandate, a legal entity or person established within the EU as the Responsible Person who has to accept this mandate in writing.

The obligations of the Responsible Person are many and are all geared to ensuring compliance and safety of the cosmetic product. The RP shall cooperate at all times with the authorities providing all data deemed necessary in a language easily understood by the authority.

Obligations
The role of Responsible Person (RP) may automatically fall to you depending on your company activities and/or the location of your company (within/outside) the EU, or can be assigned to a 3rd party service provider such as The Regulatory Company.
Responsible Person obligations are:

  1. Ensuring safety for human health under normal and reasonably foreseeable conditions of use (including labelling, instructions and warnings).
  2. Compliance with good manufacturing practice
  3. Performance and continuous updating of the safety assessment
  4. Building and maintaining a product information file
  5. Sampling and analysis of a cosmetic product
  6. CPNP notification prior to placing a cosmetic product on the market
  7. Product composition in accordance with the annexes II-VI of the Cosmetics Regulation and updates thereof
  8. Product composition not to contain CMR substances
  9. Proper evaluation and notification of a cosmetic product containing nanomaterials
  10. Product safety with regards to the non-intended and technically unavoidable presence of prohibited substances under GMP
  11. Compliance with non-animal testing requirements
  12. Compliant product labelling
  13. Public access to product composition data, specifically regarding hazardous substances, and the history of (seriously) undesirable effects
  14. Product claims in line and limited to the characteristics and functions of a cosmetic product
  15. Timely communication and adequate handling in the event of a serious undesirable effect (also applies to distributors)
  16. Traceability of raw materials and substances in all cosmetic products under the RP’s responsibility
— Get in touch —

Take your next step towards cosmetics compliance

Speak with one of our experts to discuss the compliance requirements in your target market and how to get started. Schedule a free discovery call.