cosmetics compliance software

Compliance and Safety

Extend coverage to 55+ countries with the 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 (EC Reg. No. 1223/2009) data plus USA (FDA) eCFR Title 21 inc. California Prop 65 and FDA Inactive Ingredients Database (oral and topical uses).

The full Compliance Pack includes:

ASEAN (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. 1 Observer – Papua New Guinea)
Canada Hotlist
China IECIC 2021, STSC 2015
EU CosIng (1223/2009), REACH Annex XVII
Mercosur (Argentina, Brazil, Paraguay, Uruguay and Venezuela (suspended 2016)), and associate members: Bolivia, Chile, Peru, Colombia, Ecuador, Guyana and Suriname), and two observers: Mexico and New Zealand.
USA (FDA) eCFR Title 21 inc. California Prop 65 and FDA Inactive Ingredients Database (oral and topical uses)

Please note: From 1st January 2022 compliance data is updated bi-annually.

The Product Manager Compliance Package includes all currently available compliance data. Click here for the current Product Manager plans and prices.

Including the 27 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 (and STSC) or US FDA. Compliance data is updated bi-annually. 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.

Ingredients Watch

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.

Compliance Checker

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

Advisory Lists

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”.

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.

PIF/Product Dossier

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.

CPSR

Our newest feature fully integrates Cosmetic Product Safety Reports (CPSRs) into the PIFs/Product Dossiers generated within the Cosmetri platform. Admins can designate users as Safety Assessors and verify their status by uploading their credentials directly in the system. Once logged into Product Manager, verified Safety Assessors can then easily complete parts A and B of the CPSR using pre-populated formulation data and sign off on the CPSR once completed. They can even use snippets to store common phrases and clone completed CPSRs as needed to finalize the reports more efficiently than ever.

Product Labels

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.

Batch Traceability

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.

Compliance Included
Manage harmonized compliance +
Formulate using only allowed ingredients (by Compliance and Advisory List(s)) +
Detailed compliance status and reporting for any/all products +
Color-coded compliance warnings (banned, restricted, listed, not listed) +
Add custom compliance zones/countries for manual checking +
Add custom URLs for own research lookups +
Compliance notes to assist team in resolving issues +
Compliance Checker scan and % level of compliance score +
Compliance Checker auto tasks +
Compliance Checker custom tasks +
Search/filter ingredients banned, restricted, not listed, by selected compliance zones +
Search/filter ingredients by advisory list, include or exclude +
Ingredients Watch monitors formulas and alerts for possible regulatory changes +
Build own ingredient advisory lists for custom policies +
Associate ingredient advisory list with compliance zone +
Perfume allergen calculations +
Manage actives, incidentals and allergenics +
PIF / dossier (EU and ASEAN format) +
Product batch traceability +
SCCS Opinions +
Ingredients Watch Included
Auto monitoring of formulas and raw materials for changes to ingredients +
Ingredient changes detected for EU (CosIng) data + all subscribed compliance zones +
Set reporting period by start/end date or no. of days back. Settings are user-specific. +
Ingredients Watch alerts displayed also in Formula level +
Count of no. of raw materials containing the alerted ingredient. View report including min. and max. %w/w concentration +
Count of no. of formulas containing the alerted ingredient. View report including min. and max. %w/w concentration +
Set approval status for alerted ingredients +
Approval log (user, date and time stamp) +
Approval auto unset in ingredient subsequently updated +
SCCS Opinions +
Ingredients / Chemical Management Included
Database of 31,000+ ingredients +
Request custom ingredient, if not found (subject to approval by Cosmetri chemists) +
Organize ingredients for own policies such as nano- and paraben-free, halal, etc +
Manage banned ingredients +
Search by CAS, INCI, CI, IUPAC etc +
Manage safety data, including GHS, safety and risk phrases, hazard statements +
Direct link to ECHA for lookup of additional GHS/CLP data for ingredient +
Annex VI CLP data (EU) +
Toxicity, LD50 values (3,216 ingredients) +
Chemical properties, inc. MF, MW, RI, solubility, etc (10,844 ingredients) +
Export all safety data for formula to .xls +
Search/filter by ingredient cosmetic function +
US and international INCIs +
Search/filter ingredients by advisory list, include/exclude +
Manage common/alternative names +
Build ingredients advisory lists +
Associate advisory list with customer/brand product group +
Associate advisory list with compliance zone +
Perfume/fragrance allergens management +
SCCS Opinions for ingredients +
Manage own ingredients notes +
‘Where used’ ingredient in formulas report, inc %w/w +
‘Where used’ ingredient in raw materials report, inc %w/w +
Export INCI lists with configurable templates +
Create task for ingredient +
Labels Included
Manage all required content for inclusion on product label +
Upload additional files/artwork (max. 5Mb) +
PAO symbol generated +
Labels reports (.pdf, .doc and .xls) +
Export labels dossier .zip with all content, artwork and symbols +
Adjust position of ingredients <1%w/w +
Option for ingredients @ exactly 1%w/w +
Perfume allergens correctly declared (if listing is required) +
Manage additional shades/colors, including international format for listing by color index (CI) +
Include standard symbols +
Enter and display common or alternative ingredient names +
Fine-tuning and formatting of label of ingredients – add additional nomenclature, warnings, etc +
International, US, Chinese and Japanese INCIs +
Search/filter ingredients by advisory list, include/exclude +
Manage common/alternative names +
Build ingredients advisory lists +
Associate advisory list with customer/brand product group +
Associate advisory list with compliance zone +
Perfume allergens +
SCCS Opinions for ingredients +
Manage own ingredients notes +
‘Where used’ ingredient in formulas report, inc %w/w +
‘Where used’ ingredient in raw materials report, inc %w/w +
Create task for ingredient +
Manage multi-language LOI versions +
LOI snippets for additional warnings, such as impurities and allergenics +
LOI settings by country/compliance zone +
Safety Included
SED calculated +
MoS calculated +
Max. daily amount (g) calculated +
Manage NO(A)EL values +
SCCS lookup table for calculated relative daily exposure +
Export all results and safety data to .xls +
ISO 16128 natural and organic content +
Calculate toxicity levels and report trace elements +
Filter raw materials by safety, toxicity and ISO 16128 +
Advanced reporting module for ingredients and raw materials +