06 Health

Introducing our regulatory services for cosmetic products – the ultimate solution for businesses looking to comply with local and international regulations. Our team of experts has years of experience in the cosmetic industry and is well-versed in the latest regulatory requirements. We provide a comprehensive range of services, including regulatory strategy development, product safety and efficacy assessment, labeling and claims review, and registration support.

In the European Economic Area (EEA) cosmetic products and associated efficiency claims are regulated by two major regulations: Regulation (EC) No 1223/2009 (cosmetic products) and Regulation (EU) No 655/2013 (criteria for the justification of cosmetic product claims). In addition, the ingredients used in the product formulation and the packaging are subject to other regulations such as Regulation (EC) 1907/2006 (REACH), Regulation (EU) 2019/1021 (POP) and Directive 94/62/EC (Packaging and Packaging Waste).

Regulatory Services
Registration on Cosmetics Products Notification Portal (CPNP)

The Cosmetic Products Notification Portal (CPNP) is an online notification platform used to submit technical information related to cosmetic products to be marketed in the European Union (EU). We undertake the process starting from the creation of your company’s account on the European platform until the integral notification of your Cosmetic Products.

Preparation of Cosmetic Product Safety Assessment (CPSR)

Our team of experts can assist you with authoring of the Cosmetic Product Safety Report (CPSR) parts A and B, reviewing the safety of cosmetic ingredients and determining the level of exposure consumers can safely have to these ingredients. According to Regulation 1223/2009, cosmetic products must have a Safety Assessment Report by a specialized Safety Assessor before placing them on the European market.

Preparation of Product Information File (PIF)

SustChem’s team experts undertake to prepare PIFs for your cosmetic products through personalised, flexible services. We undertake the collection of the required PIF information through direct contact with manufacturers or subcontractors, the verification of the relevance of the information received, setting up of the required tests if necessary and the creation of the cosmetic product’s PIF.

Cosmetic Testing services

Personal care product testing serves as a valuable resource for cosmetic manufacturers, aiding them in both mandatory and promotional endeavors. In a more comprehensive context, it aids in the evaluation of the analytical and clinical effectiveness aspects of cosmetic production. This evaluation process is instrumental in the creation of cosmetics that are not only safe for consumers but also in ensuring overall consumer safety. SustChem S.A. can support you in either mandatory or promotional testing for cosmetics in collaborating laboratories.

  1. a) Stability test
  2. b) Preservative Efficacy Testing (Challenge test)
  3. c) Microbiological analysis
  4. d) Human Repeated Insult Patch Test (HRIPT) for “Hypoallergenic Product” claim
  5. e) Testing for special claims (SPF, UVA, Sensitive Skin, Hydration, Antiwrinkle etc.)
  6. f) Testing for “Ophthalmologically Tested” claim
Review of label & claims

Claims made on cosmetic products should not mislead consumers or imply that the cosmetic product has a feature or function that it does not. Regulation 655/2013 and relevant directives were developed to provide further clarity on the criteria that claims must meet in order to be considered admissible under Regulation (EC) No. 1223/2009. We provide services on reviewing and substantiating product claims, such as efficacy and safety claims and that the product label complies with all relevant regulations and includes all required information such as ingredient list, warnings, and claims.


SustChem S.A. provides a comprehensive and customizable set of services to assist cosmetics companies in complying with the regulatory directives. Our services include establishing a cosmetovigilance system, collection and assessment of undesirable events, handling of Serious Undesirable Effects (SUE), including expedited reporting to Competent Authorities and training of personnel on cosmetovigilance, as legally required.

International Compliance Services for the importation or exportation of cosmetic products

It’s crucial to approach importing or exporting cosmetic products with a comprehensive understanding of the regulatory landscape in the target country. We understand that navigating global cosmetic product regulations can be challenging. Our comprehensive services aim to simplify this process, allowing you to confidently expand your cosmetic business across international borders while ensuring full compliance with legislative requirements.

Training in Cosmetics Regulation & processes

Our team designs and conducts specialized training seminars in Regulation (EU) 1223/2009, tailored to the specific needs and obligations of the participants. Trainees gain deeper understanding of the basic concepts and the processes, in order to develop a solid regulatory strategy for continuous compliance with the Regulation.

Consulting services

Our team undertake liaison with Competent Authorities such as the National Medicines Agency and provide consulting services, regarding all requirements and obligations to both concerning both the cosmetic company and the cosmetic product. Specifically, we conduct review of product formulation to ensure compliance with regulatory requirements, such as prohibited or restricted ingredients or anything else that may arise due to changes in the regulatory framework.

Cosmetics Production Licensing & Standards Supporting
Practice for Cosmetics Production Licensing

In collaboration with the Management Systems Dpt. we support companies to obtain permit to manufacture cosmetics by the competent authority (National Organization For Medicines) and license to operate a cosmetics laboratory.

Good Manufacturing Practices (GMP) & Quality Management System ISO 22716

In collaboration with the Management Systems Dpt. we support companies comply with GMP requirements, which are designed to ensure consistent product quality and safety.  Our team also support the acquisition of ISO 22716 for cosmetic products.

Standards Supporting – Ecolabel / Cosmos

Many companies in the field of cosmetics have certified their products with the Cosmos Organic or Cosmos Natural labels. These externally verified claims, certify that the products have been produced using organic and natural materials from sustainable agricultures and with regard to people safety and environmental impact minimization. In collaboration with the Sustainability Dpt. we support companies in their effort to certify their products with Standards (Cosmos Organic , Cosmos Natural labels, EU Ecolabel, Blue Angel, Nordic Swan).  Further details can be found in Sustainability Section.