A growing number of cosmetic brands are choosing to develop or manufacture their products outside the European Union, particularly in Asia (China, India, South Korea), Morocco or Turkey. This approach is often part of a strategy aimed at reducing production costs, seeking greater industrial flexibility or accessing raw materials that are more readily available in these regions.
While these regions offer undeniable economic advantages and competitive manufacturing capacity, they also raise significant challenges regarding regulatory compliance when brands aim to place their products on the European market.
The standards applied locally in terms of formulation, quality and safety are often not aligned with the requirements of the European Cosmetic Regulation (EC) No. 1223/2009.
As a result, a product considered compliant in its country of manufacture may prove unusable as-is within the European Union due to non-compliance with EU regulatory criteria, whether in terms of authorised ingredients, labelling, toxicology or mandatory regulatory documentation.
Cosmetics manufactured outside the EU: underestimated regulatory risks
As a French laboratory specialising in the bespoke formulation and manufacturing of cosmetic and dermo-cosmetic products, we are observing a clear market trend. Increasingly, brands seek the expertise of Laboratoire Orescience after outsourcing the development or production of their formulas to non-EU countries, with the aim of marketing them in Europe.
However, in most cases, these products do not meet the European regulatory requirements or the quality standards expected for compliant industrial transposition. The information provided is often insufficient or even non-existent. In the best-case scenario, brands possess a sample of the finished product along with a partial or imprecise INCI list.
Essential components for regulatory compliance are generally missing. There is no Product Information File (PIF), no traceability of raw materials, no certificates of analysis, and no information regarding suppliers or the origin of active ingredients.
Under these conditions, reproducing the original formula identically becomes difficult or even unfeasible from both a regulatory and a technical-industrial perspective. This prevents any attempt at compliant industrial transposition and often requires a full redevelopment of the formula within a secure, documented and regulatory-compliant framework.
Understanding industrial transposition in cosmetics
Industrial transposition refers to the process of adapting a formula developed at laboratory scale to ensure it can be reproduced under industrial manufacturing conditions, while preserving the product’s original characteristics: texture, stability, efficacy, sensorial profile, pH and viscosity. This step requires precise control of manufacturing processes, in-depth knowledge of raw material interactions and the ability to anticipate necessary adjustments depending on the industrial equipment used.
However, this transposition is only possible if the original formula is fully documented, traceable and compliant with regulatory standards. In cases where products have been developed in countries with standards significantly different from those in the EU, the necessary foundation for transposition is often absent or unusable.
Gaps between local regulations and European requirements
Regulation (EC) No. 1223/2009 is the legal framework governing the placing of cosmetic products on the EU market. It sets out strict requirements to ensure consumer safety, product quality and transparency of information. Key obligations include the creation of a complete Product Information File (PIF), toxicological assessment, full traceability of ingredients, stability testing, packaging compatibility tests and regulatory notification via the Cosmetic Product Notification Portal (CPNP).
These requirements are systematic and non-negotiable for any product sold in Europe. However, they are not always incorporated into the development or manufacturing processes carried out outside the EU. In some production areas, local regulations may be more lenient, incomplete or lacking altogether in fundamental aspects such as toxicological evaluation, allergen management, preservative control or microbiological safety.
As a result, a formula developed and approved outside the EU, although technically viable in its original context, may be completely unusable on the European market. This often leads to significant financial losses for the brand, which may be forced to restart the formulation and compliance process from scratch, sometimes without being able to capitalise on the initial investment.
Why prioritise reformulation over identical reproduction?
In the majority of the projects we receive, attempts at industrial transposition from a product developed outside the European Union encounter clear limitations: incomplete formulation, lack of technical data, use of raw materials not authorised in Europe, or absence of clear supplier identification and information on ingredient quality. These shortcomings make faithful reproduction not only uncertain but fundamentally incompatible with the requirements of the European market.
In this context, our approach is based on complete reformulation, developed using only the available elements: the finished product sample and the provided INCI list. This method, both rigorous and secure, enables us to offer our clients a compliant, traceable and industrially reproducible formula that fully meets the European Cosmetic Regulation (EC) No. 1223/2009.
The reformulation process includes analysis of the initial product’s sensorial and functional characteristics (texture, fragrance, colour, perceived stability), identification and substitution of actives with authorised and traceable alternatives, rigorous sourcing of raw materials compliant with EU standards, and execution of all mandatory regulatory tests. At the end of this phase, we compile the full Product Information File (PIF), ensuring regulatory compliance, consumer safety and the industrial viability of the formula.
Cosmetic formulation and industrial transposition: the regulatory expertise of Laboratoire Orescience
For over 25 years, Laboratoire Orescience has supported both European and international cosmetic brands in the development, formulation and industrialisation of their products, ensuring strict compliance with European Cosmetic Regulation (EC) No. 1223/2009.
Our expertise lies in mastering formulation according to EU regulations, ensuring rigour in industrial transposition and providing integrated contract manufacturing solutions. From the initial stages of development, we develops formulas that are transposable to industrial scale, with a clear objective: to guarantee performance, stability and compliance with European standards.
Our support covers the entire cosmetic development chain, from bespoke formulation to market launch. We handle the technical and regulatory selection of raw materials, stability and packaging compatibility testing, regulatory oversight according to the target markets, claims substantiation in line with the brand’s marketing positioning, preparation of the Product Information File (PIF) and notification on the CPNP portal.
Beyond formulation, we act as a strategic partner, securing every stage of development to ensure the industrial viability, regulatory compliance and commercial success of each cosmetic project.
