Compliance & Safety

Aether provides comprehensive compliance tools to help you meet regulatory requirements for cosmetics and aromatics products.

Overview

The cosmetics industry is heavily regulated, with different requirements in different markets. Aether helps you:

• Generate required documentation automatically
• Track compliance status for all ingredients
• Surface potential issues before they become problems
• Maintain audit trails for regulatory inspections

Safety Data Sheets (SDS)

SDS documents provide critical safety information about your products.

Automatic Generation

Aether generates SDS documents from your product formulations, including:

• Hazard Identification - Classification based on ingredient properties
• Composition Information - Complete ingredient breakdown with percentages
• First Aid Measures - Recommended actions for exposure scenarios
• Firefighting Measures - Special procedures for emergency responders
• Accidental Release Measures - Spill and leak response procedures
• Handling and Storage - Safe handling guidelines and storage requirements
• Exposure Controls - Personal protective equipment (PPE) recommendations
• Ecological Information - Environmental impact data
• Disposal Considerations - Proper disposal methods

SDS Generation Process

1. Formulate your Product - Complete all ingredient and mixture specifications
2. Review Composition - Ensure all components have complete safety data
3. Generate SDS - Aether compiles the document automatically
4. Review & Customize - Add any product-specific information
5. Export - Download as PDF or share digitally

Managing SDS

• Version History - Track changes to SDS documents over time
• Multi-language Support - Generate in multiple languages for international markets
• Batch Generation - Create SDS for multiple products at once
• Template Customization - Use your company’s letterhead and formatting

Allergen Sheets

Allergen sheets document the allergenic substances in your products.

Automatic Detection

Aether automatically identifies allergens based on:

• INCI Ingredient Data - Known allergen classifications from regulatory databases
• EU Annex III - List of substances requiring allergen labeling
• FDA Requirements - US allergen labeling standards
• Custom Allergen Lists - Your own allergen classifications

Allergen Sheet Content

Each allergen sheet includes:

• Allergen Identification - List of all allergens present
• Concentration Levels - Percentage of each allergen in the final product
• Regulatory Status - Compliance with EU, US, and other standards
• Warning Statements - Required disclaimers for each market
• Safe Usage Guidelines - Recommendations for consumers with allergies

Allergen Categories

Aether tracks allergens across multiple categories:

Ingredient List Generation

Automatic generation of ingredient lists for product labels.

Formatting Rules

Different markets have different requirements for ingredient labeling:

EU Standards

• Descending Concentration Order - Ingredients listed from highest to lowest percentage
• INCI Names Required - International Nomenclature of Cosmetic Ingredients
• Components Below 1% - Can be listed in any order after ingredients ≥ 1%
• Colorants - Can be grouped as “CI XXXXX” or listed individually
• Perfume/Parfum - Can be listed as “Parfum” (with separate allergen disclosure)

US Standards (FDA)

• Descending Concentration Order - Similar to EU but with different thresholds
• Common Names - Can use common names alongside INCI names
• Flavor/Perfume - Can be listed as “Fragrance” or “Flavor”
• Botanical Names - Must use standard botanical nomenclature

International Standards

• INCI Required - Most countries accept or require INCI names
• Local Language - Many countries require dual labeling (INCI + local language)
• Regional Variations - Some countries have additional requirements

Automatic Generation

Aether automatically generates ingredient lists based on:

1. Product Formulation - All ingredients and mixtures in the product
2. Recursive Resolution - Expands mixtures to show all underlying ingredients
3. Target Market - Formats according to selected regulatory standards
4. Concentration Calculation - Computes percentages for proper ordering

Customization Options

• Group Similar Ingredients - Combine related items (e.g., all essential oils)
• Hide Trade Secrets - Mask proprietary formulations
• Add Disclaimers - Include required legal text
• Multi-format Export - Plain text, RTF, PDF

IFRA Limits

International Fragrance Association (IFRA) usage limits enforcement.

What is IFRA?

IFRA is the global representative body of the fragrance industry. They establish:

• Usage Categories - Different product types have different limits
• Standards - Maximum safe usage percentages for fragrance materials
• Prohibition List - Substances that cannot be used in fragrances
• Restriction List - Substances with usage limits

IFRA Enforcement in Aether

Aether helps you stay compliant with IFRA standards:

1. Ingredient Flagging - All fragrance ingredients are flagged with their IFRA status
2. Real-time Validation - Checks as you add ingredients to mixtures and products
3. Warning System - Alerts when you approach IFRA limits
4. Category-Specific Limits - Different limits for different product types

Usage Category Examples

Limit Checking

When you add a fragrance ingredient to a mixture or product:

1. Aether identifies the IFRA category of the final product
2. Checks the IFRA standard for that ingredient in that category
3. Calculates the actual percentage in the final product
4. Blocks the save if the limit would be exceeded
5. Shows a warning if you’re approaching the limit (configurable threshold)

Regulatory Export

Export data in formats required by regulatory bodies.

EU Cosmetics Regulation (CPNP)

• Dossier Preparation - Complete product information dossiers
• Safety Assessments - Cosmetic Product Safety Reports (CPSR)
• Notification - CPNP notification file generation
• Responsible Person - Track your EU responsible person information

US FDA Requirements

• Registration - Facility and product registration assistance
• Labeling Compliance - FDA-compliant label generation
• Adverse Event Reporting - Track and report adverse events
• Establishment Registration - FDA establishment registration

Other Regulatory Frameworks

• Health Canada - Canadian cosmetics regulations
• ASEAN - Association of Southeast Asian Nations standards
• Australia/NZ - Therapeutic Goods Administration (TGA) requirements
• Custom Frameworks - Support for additional regulatory requirements

Compliance Dashboard

A centralized view of your compliance status across all products.

Dashboard Features

• Overall Compliance Score - Percentage of products passing all checks
• Per-Product Status - Individual compliance status for each product
• Issue Tracking - List of all compliance issues with severity levels
• Regulatory Calendar - Upcoming compliance deadlines and renewal dates
• Audit Trail - Complete history of all compliance checks and actions

Compliance Checks

Aether automatically runs these checks:

Batch Tracking & GMP Compliance

Good Manufacturing Practices (GMP) require complete traceability.

Batch Records

• Complete Documentation - Full history for each batch
• Raw Material Traceability - Link ingredients to specific lots
• Process Documentation - Manufacturing steps and parameters
• Testing Results - Quality control test results
• Distribution Tracking - Where each batch was sent

Supply Chain Transparency

• Supplier Audits - Track supplier compliance and certifications
• Material Certificates - Store and manage COAs (Certificates of Analysis)
• Chain of Custody - Document the journey from raw material to finished product

Next Steps

• Set up Inventory Tracking for supply chain transparency
• Configure Ecommerce Integration for marketplace compliance
• Review Platform Concepts for multi-workspace considerations