PRIMS cosmetics

Moving away from a linear sequential process to a continuously updated digital eco-system

Specification management

Smart algorithms

Regulatory and toxicology data

For each specification (raw material, formula, packaging component, product, multi-product kit) data and documents are managed as "one item only".
All related specifications of all levels are linked to each-other. This ensures full real-time traceability for the finished product (SKU) down to the raw material and individual substances (INCI) level and back.
Each user has a named user account with a specific user rights profile. All activities are logged and can be traced back in time.
Each individual specification is processed through its own lifecycle (development, provisional, active, superseded, discontinued). New versions are created to develop and replace the active version. Previous versions including all links to underlying specifications can always be pulled up to go "back in time".
The cloning function enables easy creation of variations of a product, for example a range of 6 shower gels with the same base formula with different colours and/or fragrances. All relevant product details, documents and links are included in cloning, and can easily be adjusted to create the product variations in a matter of minutes.

The regulatory and toxicology data for thecosmetic ingredients (INCIs) are continuously managed, validated and updated byTRC and available to all users.
Regulatory data includes all amendments whenever it becomes available with or without transitional period. Regulatory data is timely and continuously updated, and immediately feeds into the compliance status of the full product portfolio in PRIMS.
Toxicology data includes toxicological thresholds for cosmetic ingredients for the relevant endpoints, and when relevant, other information sources are included based on the weight of evidence approach e.g. data by CIR, EFSA, WHO, OECD.
PRIMS algorithms are in line with the latest approach for safety assessment of cosmetic products. If no toxicological data is available for an ingredient, a read-across in case of Quantitative Structure Activity Relationship (QSAR) or Toxicological Thresholds of Concern (TTC) may be applied as alternative. In the future, in line with the latest developments on Next Generation Risk Assessment (NGRA), PRIMS will integrate the new alternative methodologies and PoDs as they become available.
Additional (unpublished) toxicology data can be shared with TRC to be included in PRIMS after thorough evaluation at all times.

Specification management

Smart algorithms

Regulatory and toxicology data

Specification management

Smart algorithms

Regulatory and toxicology data

The smart algorithms alert on missing PIF data and documents, produce cumulative formula compositions, highlight non-compliance and safety concerns, and provide guidance on mandatory label content.
Product compliance and safety status are shown colour-coded in the dashboard, 24/7 and in real-time, based on the system integrated regulatory and toxicology databases
Users can drill down from product to individual substance compliance and view substance specific regulatory and toxicology data
Regulatory compliance is not just indicating whether a regulatory threshold applies, like in many other available compliance software solutions. It is the result of an assessment against exact thresholds that apply specifically to the chosen product category. Where applicable, the algorithms combine the sum of multiple substances for evaluation against both their individual and their combined group-thresholds.
Product safety is automatically assessed based on the toxicology threshold data, the product category specific exposure scenario and individual substance share in the product formula
REACH compliance is easily managed through the REACH compliance dashboard where only relevant raw materials are shown and are directly managed by clicking through to an individual raw material