Regulatory specialists play a crucial role in the cosmetics industry, ensuring that products comply with the ever-changing legal requirements and international standards. Their work demands precision, up-to-date regulatory knowledge, and efficient documentation management. CosmetoSAFE Assist was specifically developed to address these challenges by automating key regulatory processes, minimizing risks, and allowing specialists to focus on strategic aspects of their work. Below is an in-depth explanation of how this tool supports regulatory departments.
Automation of Product Information File (PIF) creation
Under Regulation (EC) No 1223/2009, every cosmetic product introduced to the EU market must have a Product Information File (PIF). This file must include:
- Product composition (INCI compliance),
- Safety assessments,
- Efficacy studies (when related to marketing claims),
- Manufacturing information.
Challenge: Creating PIFs manually is time-consuming and prone to errors, especially for complex formulations or intricate production processes.
CosmetoSAFE Assist automates the PIF creation process by integrating data from various sources, such as ingredient databases, safety assessments, and technical documentation from suppliers. The tool ensures that PIFs comply with the latest regulatory requirements, significantly reducing the risk of errors during regulatory audits.
Monitoring regulatory changes
Cosmetic regulations evolve rapidly, and staying informed about these changes is essential for launching safe and compliant products.
Examples include:
- Bans on specific ingredients (e.g., restrictions on microplastics in the EU).
- Updates to maximum allowable levels for substances (e.g., preservatives).
- New guidelines on eco-labeling.
Challenge: Regulatory specialists often manually monitor updates across multiple databases (e.g., COSING, ECHA) and analyze their impact on existing products.
CosmetoSAFE Assist Solution:
The tool integrates with key regulatory databases, including COSING and ECHA, providing real-time updates on regulatory changes. Specialists are automatically alerted to ingredient status changes or new restrictions, enabling quick adjustments to formulations or documentation.
Example: If an ingredient used in a product becomes restricted or banned, CosmetoSAFE Assist flags it and suggests corrective actions, such as identifying alternative ingredients or adjusting concentrations.
Compliance with marketing claims
Regulation (EC) No 655/2013 establishes detailed requirements for cosmetic product marketing claims. All claims must be:
- Truthful: They cannot mislead consumers.
- Substantiated: Product efficacy must be supported by evidence.
- Clear: Information must be easy for consumers to understand.
Challenge: Preparing documentation to substantiate marketing claims requires significant effort and collaboration across departments.
CosmetoSAFE Assist Solution:
The tool evaluates marketing claims against current regulations, verifying compliance with claims such as “natural,” “hypoallergenic,” or “preservative-free.” It ensures claims are supported by appropriate evidence or studies.
Example: A claim like “paraben-free” must be backed by full documentation of the formula. CosmetoSAFE Assist automatically generates a report confirming the absence of parabens, aligned with regulatory standards.
Ingredient and INCI Management
Every cosmetic product sold in the EU must feature labeling that adheres to International Nomenclature of Cosmetic Ingredients (INCI) standards. Additionally, allergens and restricted ingredients must be listed on the label if their concentration exceeds specified thresholds.
Challenge: Manually generating INCI lists and ensuring compliance with labeling requirements can lead to errors, particularly for complex formulations.
CosmetoSAFE Assist Solution:
The tool automates INCI list generation and labeling processes, incorporating the latest legal requirements. It also flags potential issues, such as missing allergen disclosures or non-compliant ingredients.
Example: For formulations containing allergens, CosmetoSAFE Assist calculates their concentration and, if limits are exceeded, ensures the required disclosures are included on the product label.
Audit and inspection preparedness
Regulatory specialists are often responsible for preparing documentation for audits and inspections. Any inconsistencies in documentation can result in sanctions, including product recalls.
Challenge: Manually compiling documentation for audits is time-intensive and error-prone.
CosmetoSAFE Assist Solution:
The tool generates comprehensive compliance reports, including PIFs, ingredient compliance declarations, and safety assessment reports, all ready for submission during inspections.
Example: CosmetoSAFE Assist automatically produces a report demonstrating product compliance with Regulation (EC) No 1223/2009, which can be presented during audits with confidence.
CosmetoSAFE Assist was specifically developed to meet the unique demands of regulatory specialists in the cosmetics industry. By automating critical processes such as documentation creation, regulatory monitoring, and marketing claim validation, the tool saves time, eliminates errors, and enhances efficiency. With CosmetoSAFE Assist, regulatory teams can confidently ensure that their products are fully compliant with legal requirements, enabling companies to maintain a competitive edge in the market.
