COSMETIC FORMULATION SUPPORT

Regulatory Review and Expert Support During Cosmetic Formulation Development

Developing a cosmetic product involves more than selecting ingredients and achieving the desired formula characteristics. Regulatory requirements, restrictions on certain substances and the conditions that a product must meet in its intended market should also be considered from the earliest stages of development.

CosmeticsPIF provides expert support to cosmetic manufacturers and brands in formulation development, review and regulatory compliance, with a particular focus on European Union requirements and the regulatory requirements of other agreed target markets.

Reviewing regulatory requirements early in development can help identify potential issues before a formulation is finalised, reducing the need for later changes, repeated work and additional costs.

How Can We Support Your Project?

New Formulation Development

Regulatory support with ingredient selection, concentration planning and proposed changes during cosmetic product development.

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Existing Formulation Review

Review of the composition, regulatory status of ingredients and relevant restrictions before manufacturing or placing a product on the market.

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Changes and Reformulation

Expert support with ingredient substitution, supplier changes, compliance with updated regulations and improvements to existing formulations.

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Regulatory Support During Cosmetic Product Development

Regulatory requirements are best considered from the ingredient selection and formulation planning stages.

We provide expert support during the development of new formulations, including the review of ingredient acceptability, concentrations and proposed changes against the requirements of the intended market.

Support may include:
  • Checking the regulatory status of ingredients before they are included in a formulation.
  • Reviewing permitted concentrations and specific conditions of use.
  • Identifying potential regulatory obstacles during development.
  • Reviewing proposed formulation changes.
  • Providing expert recommendations on necessary regulatory adjustments.

The scope of support is tailored to the stage of product development and the specific questions faced by the manufacturer.

Regulatory Review of Existing Cosmetic Formulations

Once a formulation has been developed, it is important to check whether its composition meets the applicable regulatory requirements of the intended market.

Based on the qualitative and quantitative composition provided, we review ingredient identity, regulatory status, concentrations and applicable restrictions.

Where relevant, the review covers:
  • INCI names and ingredient identification details, including CAS and EC numbers.
  • Prohibited and restricted substances.
  • Maximum permitted concentrations and specific conditions of use.
  • Regulatory acceptability of the formulation for the agreed target market.

The client receives a summary of identified non-compliances and the corrections required.

This service is particularly useful before manufacturing begins, when obtaining a formulation from a contract manufacturer, or when preparing a product for a new market.

Important: A regulatory formulation review is not the same as a safety assessment of the finished cosmetic product and does not replace a Cosmetic Product Safety Report (CPSR).

Formulation Compliance for the EU and International Markets

A formulation marketed in one country does not necessarily meet the requirements of another. Differences between regulatory frameworks and amendments to legislation can also affect products already on the market.

CosmeticsPIF provides support in identifying regulatory non-compliances and considering the formulation changes needed to meet the requirements of the EU or another agreed target market.

This support can be particularly valuable for manufacturers planning international expansion, brands working with overseas suppliers and companies adapting existing products to changing regulatory requirements.

Ingredient Substitution and Reformulation Support

Regulatory changes, raw material shortages, changes of supplier or plans to improve a product may require adjustments to an existing formulation.

Replacing an ingredient is not always straightforward. In addition to the regulatory acceptability of the proposed alternative, its intended function, concentration and potential effects on product characteristics and existing documentation need to be considered.

We provide expert support in reviewing proposed alternative ingredients and assessing the regulatory implications of formulation changes.

Depending on the nature of the change, we can also identify the need for additional stability, packaging compatibility or microbiological testing, or for reassessment of relevant aspects of product safety.

Expert Support for Cosmetic Formulation Development and Improvement

Alongside regulatory services, CosmeticsPIF offers expert formulation support informed by extensive practical experience in cosmetic product development.

This experience allows us to consider formulations not only from a regulatory perspective, but also in terms of ingredient functions, interactions, technical characteristics and opportunities for product improvement.

Depending on the project, support may include:
  • Reviewing the concept and proposed composition of a new cosmetic product.
  • Expert recommendations on ingredient selection and combinations.
  • Assessing existing formulations and opportunities for improvement.
  • Considering alternative ingredients and formulation approaches.
  • Providing expert support with formulation questions arising during development.

Clients can therefore benefit from support that combines hands-on formulation experience with knowledge of regulatory requirements.

Formulation support is a separate service, with the scope agreed for each project. Laboratory sample preparation, testing and manufacturing are not included unless expressly agreed otherwise.

Specific Regulatory Requirements for Cosmetic Ingredients

Certain ingredient categories require particular attention because of concentration limits, product type or additional conditions of use.

These include:
  • Preservatives – permitted substances, concentrations and conditions of use.
  • UV filters and colourants – permitted use in relevant product categories.
  • Fragrance ingredients and allergens – regulatory restrictions and relevant labelling requirements.
  • CMR substances – applicable prohibitions, restrictions and any legally permitted exemptions.
  • Microplastics and other specially regulated ingredients – requirements, exemptions and relevant transitional periods.

Each review takes into account the product's composition, intended purpose, foreseeable use and the regulations applicable in the agreed target market.

For ingredient declarations, we also provide INCI list preparation and verification services.

Raw Material Documentation and Preparation for CPSR and PIF

Trade names alone are not sufficient for a cosmetic product safety assessment. Appropriate information on raw material composition, identity and other characteristics relevant to the formulation is also required.

We help identify the necessary manufacturer and supplier documentation, along with any gaps that should be addressed before further regulatory work can proceed.

Depending on the project, this support may also include recommendations on appropriate product testing.

Once the formulation has been finalised and the required documentation assembled, the project may proceed to separately agreed services covering safety assessment, CPSR preparation and compilation of the Product Information File (PIF).

Who Are Our Services For?

Cosmetic Manufacturers

Developing new products or improving existing formulations.

Cosmetic Brands

Working with contract manufacturers and seeking an independent expert formulation review.

Companies Entering the EU Market

Requiring a regulatory review or formulation adjustments before placing products on the EU market.

Product Development Teams

Seeking additional expertise on ingredient selection and regulatory considerations during formulation changes.

Companies Changing Ingredients or Suppliers

Needing to review the regulatory implications of those changes.

Cosmetic Importers and Distributors

Seeking expert regulatory review of products sourced from overseas manufacturers before market entry.

How We Work Together

Collaboration begins with a brief description of the product, its development stage and the type of support required.

Following initial contact and confidentiality arrangements, we review the available information and define the scope of work. Depending on the agreed service, clients may receive written regulatory findings, a summary of non-compliances, recommendations for necessary corrections or expert support during further product development.

The scope of work, required documentation and terms of engagement are confirmed before work begins.

Need Expert Support With a Cosmetic Formulation?

Whether you are developing a new product, reviewing an existing formulation or considering ingredient substitutions, CosmeticsPIF can help you address relevant formulation and regulatory questions at an early stage.

Send us a brief description of your product and the support you require so that we can assess the potential scope of collaboration.

You do not need to provide your full formulation or confidential documentation in your initial enquiry. Such information can be shared once the appropriate arrangements have been made and a non-disclosure agreement (NDA) has been signed.

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