Extend coverage to 50+ countries with the new Compliance Package
cosmetri Product Manager includes powerful yet easy-to-use tools and the regulatory data for achieving compliance of your cosmetics and personal care products. All currently available Product Manager plans include EU CosIng data, plus one of the following available compliance countries/zones:
- ASEAN (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. 1 Observer – Papua New Guinea)
- Mercosur (Argentina, Brazil, Paraguay, Venezuela, Bolivia and Uruguay and associate members: Chile, Peru, Colombia, Ecuador, Guiana and Suriname)
- US (FDA) eCFR Title 21 inc. California Prop 65 and FDA Inactive Ingredients Database
Including the 28 countries of the European Union plus Iceland, Norway and Liechtenstein and the countries associated with the above regulatory frameworks means that Product Manager can be used for checking compliance of your products in 50+ countries, representing approximately 65% of world GDP. In addition, several countries either base their regulations largely upon the EC Regulation 1223/2009 and FDA or abide to Mutual Recognition Agreements (MRA).
Product Manager integrates with the official regulatory data sources, such as the Chinese IECIC or US FDA. Compliance data is updated quarterly, or sooner. EU CosIng data is updated daily. Unlike some of our competitors, we do not rely on peer reviewing of regulatory data or data provided by intermediary/third-party data providers.
Product Manager monitors your formulas, saving you hours of time in routine checking. You’ll be alerted to any regulatory changes as soon as the official regulatory date source is updated in Product Manager. Click to approve any ingredients reported by Ingredients Watch as updated across your selected time frame. A user log records all approval status changes. If the same ingredient is subsequently updated, the approval is reset, ensuring that you'll be notified. View a ‘where used’ report to see which formulas and raw materials contain the affected ingredient and the %w/w. When checking compliance for an ingredient in your formula, you’ll also see the date the regulatory data was last updated by the authority and the date it was added to Product Manager.
Product Manager’s Compliance Checker scans your product, formula and raw materials for any missing compliance data or documents, providing you with a completion level ‘score’, based on over 100 checks. Add your own custom compliance tasks that are factored into the score calculation. In the ‘Tasks’ tab of your formula you can view a task for each action required – such as uploading a missing CoA or SDS. View the level of completion of each of your products and keep compliance data up-to-date for the entire product lifecycle.
Custom Compliance Zones and Policies
Create unlimited countries or zones for manual compliance checking. Set any of these as default and all formulas you create in Product Manager will be associated with these. You’ll receive a warning in Compliance Checker if any ingredient has not been checked as ‘approved’ for any country or zone. Create custom policies, such as a formula requiring to be organic, fair trade or free of nanomaterials.
In addition to your adherence to any regulatory frameworks, you can build your own advisory lists of ingredients and view warnings if any ingredients in your formula are affected. For example, quickly build a ‘parabens’ list and either associate this with all formulas, or with a combination of countries and/or customers e.g. for “paraben-free formulations for customer X in China and ASEAN countries”.
As well as the approx. 30,000 ingredients that are searchable by INCI (US and international), CAS, function, compliance status (prohibited, regulated and unlisted) and advisory list status, Product Manager has detailed ingredient property and safety data for several thousand of these ingredients, available in all plans. View CLP, toxicity and GHS data, including warning symbols and link directly to the ECHA website for additional information.
Custom Research Tools
When managing your formula’s compliance, you can conduct further research and manage compliance-related tasks across your compliance team. In the ‘References’ column you’ll see any SCCS Opinions and bookmarks that you can set for any country, enabling you to click to specific websites where further information can be found. Enter any compliance notes to assist in resolving any issues with an ingredient’s compliance and create a custom task for an ingredient in your formula. For example, if a member of your team is responsible for compliance of your formula in China, you can send that person a task related to an ingredient in the formula and send them a note or reminder.
Export a PIF or product dossier, either in EU or ASEAN formats. All referenced files are bundled into the same zipped folder, along with the PDF report. View the cloud version of any document by clicking in the report while logged into Product Manager, or use the exported folder as a portable, off-line version.
Easily manage the content, artwork, symbols and list of ingredients that must appear on your product labels and packaging. Fine-tune the label of ingredients, with options for international and US-only formats. Additional pigments to define any shades/colors will be correctly declared with their CI code and any perfume allergens will be listed as per the associated regulation. Any required PAO symbol is generated by the software. Export all data and files, including a full report in .pdf, .xls and .doc formats.
Manage your product batches using Product Manager and you’ll maintain a complete history of your production. A batch protocol is generated for each product batch, including the generated batch ticket, dispense list and all raw material batch data and documents. View details of any past manufacturing order, along with any associated test data and approval logs. The formula used for production is locked from editing and auto-updated to the current raw materials batches dispensed for production. The Compliance Checker scans these batches for any missing compliance data or documents, ensuring that you can view the revised score from batch-to-batch and correct any issues. Your PIF/product dossier will always be kept up-to-date and you’ll fulfil a key GMP requirement for maintaining batch traceability of your products and raw materials used.