The calculation of safety parameters, such as the Estimated Daily Dose (SED) and the Margin of Safety (MOS), is carried out with extreme precision for different toxicological endpoints. Cosmoware is the software on the market that allows the greatest variety of selection for the types of cosmetic products, the target population of consumers, divided by age groups, sex, professional use and even an evaluation path for the safety of products during pregnancy, breastfeeding or accidental or repeated contact.

Our selection process takes into account the most varied conditions of use and categories of users, including particularly vulnerable subjects and the most sensitive and susceptible parts of the body.

Our industry-leading calculation engine ensures that each product meets the highest safety standards, complying with the most stringent regulations and fully protecting consumer health.

The theoretical estimation of the Period After Opening (PAO) is carried out through an in-depth analysis of the characteristics of the cosmetic product, the raw materials used and the expected conditions of use. This process allows to determine a precise and reliable indication of the safety duration of the product once opened, in compliance with current regulations and ensuring the protection of consumer health.

The Ingredient Report is issued in accordance with the regulations in force for both the European Union (INCI EU) and the United States (INCI-CTFA), ensuring the correct naming of ingredients according to international standards. At the same time, a complete report on labeling compliance is drawn up, verifying that all the information reported complies with the regulatory provisions applicable in the reference markets. This service ensures that products are presented with accurate, clear and compliant labels, helping to strengthen consumer confidence and reduce the risk of non-compliance.

Ranged formula generation is designed to facilitate and speed up the mandatory notification process for cosmetic products in major regulated markets. Formulas are carefully crafted to ensure that all required details are available in a format compatible with notification portals, such as CPNP for the European Union, NPIS for the United Kingdom and COSMETICDIRECT for the United States. This system significantly simplifies the submission of notifications, ensuring rapid regulatory compliance and minimising any delays or issues in launching products to the market.

Separate management of cosmetic lines and custom customers allows you to effectively organize formulations and projects for different product lines or specific customers. This approach allows you to maintain a clear distinction between the different needs and characteristics of the products, ensuring a highly personalized service. Each line or customer can be managed individually, with dedicated data and tailor-made solutions, optimizing production and improving operational efficiency.

The raw materials documentation archive is a fundamental organizational tool that allows you to store and manage in a structured way all the technical and regulatory information related to the ingredients used. It includes technical sheets, certifications, safety data sheets (SDS) and other documents necessary to ensure the cosmetics compliance of the various materials. This archive ensures rapid and centralized access to information, simplifying the quality control, compliance verification and regulatory audit processes.

The management of unwanted adverse events is a structured process that allows collecting, analyzing and monitoring reports of adverse reactions related to the use of cosmetic products, in compliance with the regulations in force in the EU and USA. This system guarantees the traceability of reports, the evaluation of the associated risk and the implementation of any corrective or preventive actions. It also ensures compliance with regulatory requirements, providing essential support for the protection of consumer safety and for the maintenance of quality standards.

Production management involves the coordination and optimization of all production phases, ensuring an efficient workflow that complies with quality standards. It includes the planning and monitoring of production launches, ensuring that processes are started and completed on time. Material rotation is managed to minimize waste and ensure optimal use of resources, respecting expiration dates and FIFO (First In, First Out) principles. Lot traceability allows complete control over the origin and path of each product, making it easy to trace raw materials and production processes when necessary, thus ensuring complete traceability at all stages of manufacturing.

Regular remote updates ensure that the system and processes always remain aligned with the latest technical and regulatory innovations in the cosmetics sector. Adaptation to technical progress and cosmetic regulations ensures continuous compliance with legal requirements in global markets. Updating available toxicological data allows for the constant integration of new scientific information, improving the accuracy of safety assessments. Furthermore, updating INCI names keeps product formulations and labels fully compliant with international standards, facilitating transparent communication with consumers and regulatory authorities.

To facilitate companies, Cosmoware offers a specialized service that automates the creation of the PIF, ensuring a high quality standard in content and formats, fully compliant with the regulations of the EU, UK and US markets.

Cosmoware is the only software for drafting PIFs that also supports third parties with the drafting of PIFs dedicated to bulk and semi-finished products, providing detailed or range formulations, depending on the specific needs to preserve the right to confidentiality of the data provided. The only software on the market that also offers an integration mode for those who purchase bulk from third party suppliers and must draft the PIF only for the packaging part.

In addition, we prepare PIF abstracts for the management of Access Points at the Responsible Person's premises, making access to the necessary data immediate. This service simplifies consultation and ensures continuous alignment with evolving regulations, offering companies complete support for the safe and effective management of their cosmetic products.

Our PIFs are regularly peer reviewed by external and independent industry experts and have been judged to be top-tier among PIF preparation software available on the international market.

For this reason we are also happy to have some multinational companies in the cosmetics sector among the users of our Cosmo-ware software.

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The generation of regulatory reports allows for immediate verification of the compliance of cosmetic formulas with current regulations. These reports provide a detailed and accurate analysis, identifying any critical issues or non-compliance, and allow for timely changes to ensure compliance with industry rules. This tool is essential to ensure that each formula is ready for marketing without the risk of irregularities.

Comoware has developed some calculation and verification tools for the main corporate policies. In this way the regulatory technician can verify very quickly and efficiently if the products comply with the characteristics and standards most requested by customers.

For example, the calculation of the Natural Index, carried out according to the criteria defined by the ISO 16128 standard, allows to determine the percentage of natural ingredients, of natural origin and organic farming present in cosmetic products, providing a clear indication for the correct communication of natural and organic claims and the verification of the certification for the main specifications of organic cosmetics.

The vegan status policy is calculated through a detailed analysis of the origin of the various components of the formula, verifying the absence of ingredients of animal origin or ingredients tested on animals, in line with the needs of vegan consumers and the ethical standards required by the Vegan specifications.

A shared database for the search of NOAELs (No Observed Adverse Effect Levels) and skin absorption data (DAA and DAC) represents an essential tool to support the chemical risk assessment of cosmetic products. This software-managed system allows users to quickly access updated and scientifically validated information, facilitating the calculation of safety parameters such as SED and MOS. Thanks to data sharing, the database allows to optimize search times, ensure greater accuracy in assessments and ensure compliance with international regulatory requirements.

The labelling comment archive is a tool dedicated to collecting and organizing comments, checks and reports collected by the safety assessor and related to the information reported on product labels. This archive allows you to monitor the compliance of labels with current regulations, track any changes or updates requested and ensure that products fully meet regulatory and consumer transparency requirements.

Supplier management includes the organization and monitoring of all information relating to suppliers of raw materials and packaging materials. The system allows you to separate the name given by the various suppliers to the same raw material, so that you can manage any secondary suppliers validated together with the main supplier. This process includes recording personal details and controlling the quality of supplies. Effective supplier management allows you to maintain high production standards, optimize costs and ensure continuity in the supply chain.

The archive of safety tests and stability tests of formulations is an organized collection that allows you to store all the data and results relating to the evaluation of the safety and stability of the various cosmetic products in the list. This archive collects the reports on the tests conducted, such as skin tolerability analyses (patch tests), preservative system endurance studies (Challenge tests) and accelerated aging tests of the formulations to guarantee the shelf life of the products. Thanks to this structure, it is possible to quickly access the necessary information, supporting quality control activities and ensuring compliance with regulatory standards.

Quality control is an essential process to ensure that each stage of production meets the required standards. It includes the issuance of certificates of analysis for production batches, documents that certify the conformity of finished products with technical and regulatory specifications. In addition, the control of incoming materials ensures that raw materials and components meet established quality requirements, through rigorous inspections and tests. This integrated approach guarantees the quality and safety of products throughout the entire production chain.