Meet Cosmetics Industry Standards with Confidence

Cosmetics and personal care manufacturers face increasing regulatory scrutiny across global markets. Whether you're meeting EU Cosmetics Regulation requirements for European sales, ISO 22716 GMP for international recognition, UK Cosmetics Regulation for British markets, or FDA requirements for US distribution, comprehensive digital traceability is essential for compliance and consumer safety.

Trace Swift provides complete lot-level traceability designed specifically for cosmetics and personal care manufacturers. Our platform automates batch tracking, ingredient sourcing records, and compliance records so you can focus on formulation innovation and production rather than paperwork.

Regulatory Standards We Support

The Cost of Poor Traceability

When a quality or safety issue emerges in cosmetics manufacturing, the consequences extend beyond regulatory penalties to brand reputation and consumer trust. Inadequate traceability systems can result in:

• Expanded recalls: Without precise batch tracking, recalls may need to include far more product than necessary, multiplying costs and market disruption
• Regulatory action: EU competent authorities, FDA, and MHRA can suspend sales, require product withdrawal, or impose penalties for traceability failures
• Retailer delisting: Major retailers (Boots, Superdrug, Sephora, Ulta, Target) require robust traceability from suppliers. Compliance failures mean lost shelf space
• Consumer injury claims: Without complete batch records, defending against product liability claims becomes extremely difficult
• Brand damage: Public recalls and safety alerts can permanently damage consumer trust in beauty brands
• EU market exclusion: Non-compliance with EU Cosmetics Regulation can result in products being barred from the European market
• Responsible Person liability: The Responsible Person faces personal liability for non-compliant products in EU and UK markets

What Cosmetics Regulations Require

Product Information File (PIF)

EU and UK regulations require a comprehensive Product Information File for each cosmetic product, including:

• Product description: Clear identification of the cosmetic product
• Safety report: Cosmetic Product Safety Report (CPSR) by a qualified assessor
• Manufacturing method: Description of production process and GMP compliance
• Proof of claimed effects: Substantiation for marketing claims
• Animal testing data: Confirmation of compliance with testing bans

Good Manufacturing Practice (ISO 22716)

ISO 22716 is the recognised GMP standard for cosmetics, required or referenced by most regulations:

• Personnel: Training and hygiene requirements
• Premises: Facility design and maintenance
• Equipment: Qualification and cleaning procedures
• Raw materials: Supplier qualification and incoming inspection
• Production: Batch documentation and in-process controls
• Finished products: Testing, release, and storage
• Quality control: Laboratory procedures and specifications
• Documentation: Records and traceability

Traceability Requirements

All major cosmetics regulations require traceability:

• Ingredient traceability: Track all raw materials from supplier to finished product
• Batch identification: Unique batch numbers for all production
• Forward traceability: Know which finished products contain each ingredient lot
• Backward traceability: Know which ingredients went into each finished product batch

How Trace Swift Supports Compliance

EU Cosmetics Regulation 1223/2009 Compliance

The EU Cosmetics Regulation establishes comprehensive requirements for cosmetic products placed on the European market. Trace Swift supports the traceability and documentation requirements throughout the regulation.

Article 8 - Good Manufacturing Practice

The regulation requires manufacturing in accordance with GMP (ISO 22716). Trace Swift supports:

• Production documentation: Batch records showing ingredients used, quantities, and procedures followed
• Quality checks: Recording of goods receipt inspection and production quality checkpoints
• Traceability: Complete lot-level tracking from raw materials to finished products
• Production notes: Documentation of observations and any departures from standard procedures

Article 10 - Product Information File

The PIF must include manufacturing documentation. Trace Swift provides:

• Manufacturing method description: Documented formulas and procedures
• Batch records: Production documentation for each manufactured batch
• GMP compliance evidence: Records demonstrating adherence to ISO 22716

Article 23 - Serious Undesirable Effects

When serious adverse events occur, traceability is critical:

• Rapid batch identification: Quickly identify affected batches
• Ingredient source tracking: Trace potential causes to specific ingredient lots
• Batch records: Production documentation to support investigations

ISO 22716 GMP Compliance

ISO 22716:2007 is the international standard for cosmetics GMP, referenced by EU, UK, and many other regulations. Trace Swift supports the documentation and traceability requirements throughout the standard.

Section 9 - Production

ISO 22716 requires documented production operations:

• 9.1 Production operations: Batch records documenting actual production
• 9.2 Bulk product operations: Tracking of ingredients through manufacturing
• 9.3 Packaging operations: Documentation of filling and packaging
• 9.4 Storage: Batch tracking and expiry date management

Section 13 - Deviations

Trace Swift supports deviation documentation:

• Record observations and deviations in batch notes
• Link notes to specific batches
• Document corrective actions in production records

Section 17 - Documentation

ISO 22716 Section 17 requires comprehensive documentation that Trace Swift provides:

• 17.3 Specifications: Documented ingredient and product specifications
• 17.4 Formulae: Manufacturing formulae with ingredients and quantities
• 17.5 Batch documentation: Records for each production batch
• 17.6 Record retention: Maintained for required periods

Purpose-Built for Cosmetics Manufacturing

Trace Swift understands the unique requirements of cosmetics and personal care manufacturing. Our platform supports manufacturers producing skincare, haircare, colour cosmetics, fragrances, and other beauty products.

Cosmetics Manufacturing Scenarios

Ingredient Categories We Support

Trace Swift handles the full range of cosmetic ingredients:

• Actives: Track active ingredients like retinol, vitamin C, hyaluronic acid with lot and supplier tracking
• Emollients & Oils: Manage oils, butters, and emollients with batch tracking
• Emulsifiers & Thickeners: Track rheology modifiers and emulsification systems
• Preservatives: Manage preservative systems with lot tracking
• Fragrances: Track fragrance compounds and essential oils with lot traceability
• Colorants: Manage pigments and dyes with lot tracking
• Packaging: Track primary and secondary packaging components

Allergen and Restricted Substance Tracking

EU and UK regulations require particular attention to allergens and restricted substances. Trace Swift helps you maintain compliance:

Beyond Compliance: Business Benefits

While regulatory compliance drives the need for traceability, Trace Swift delivers additional value to cosmetics manufacturing operations:

Accurate Cost Calculation

Know the true cost of every product you manufacture. Trace Swift tracks actual ingredient costs at the batch level. When raw material prices change, see immediately how your margins are affected. Essential for competitive pricing in the beauty market.

Formula Cost Optimisation

Compare ingredient costs across suppliers. Identify opportunities to optimise formulations without compromising quality or efficacy. Cost cascade calculations show how ingredient changes affect finished product costs across your entire portfolio.

Inventory Control

Track inventory by lot and expiry date. First-expired, first-out (FEFO) management prevents waste of expensive active ingredients. Real-time stock visibility helps optimise purchasing and reduce carrying costs.

Production Efficiency

Digital production capture eliminates manual data entry and transcription errors. Barcode scanning speeds batch recording. Preparation summaries help plan production runs and warehouse picking.

Implementation in Days, Not Months

Unlike complex ERP systems requiring lengthy implementations and expensive consultants, Trace Swift is designed for rapid deployment:

1. Day 1-2: Setup - Create your account, set up ingredients, suppliers, and product formulas
2. Day 3-5: Go-Live - Start recording production batches in actual manufacturing
3. Ongoing: Support - UK-based email support helps you optimise your processes

Most cosmetics manufacturers achieve full traceability compliance within their first week. No consultants required. No lengthy configuration. Just practical software that works.

Transparent, Affordable Pricing

Cosmetics manufacturing software shouldn't require enterprise budgets. Trace Swift pricing starts at £90/month with no long-term contracts or hidden fees.

• All features included in every plan
• Unlimited ingredients, formulas, and batches
• Full ISO 22716 compliance capabilities
• Regular software updates and improvements
• Email support during UK business hours

Your Formulas Stay Confidential

Your cosmetic formulations represent significant R&D investment and competitive advantage. Trace Swift treats them with the confidentiality they deserve:

• Strict multi-tenant architecture ensures complete data isolation
• Your formulas are never shared, analysed, or accessed by other users
• Hosted on secure AWS infrastructure
• Encrypted data transmission and storage
• You retain full ownership of your data
• Follows GDPR principles for EU data protection

Frequently Asked Questions

Does Trace Swift work for small cosmetics manufacturers?

Yes. Trace Swift is designed for small to medium cosmetics manufacturers. Our pricing and functionality are tailored for businesses that need professional ISO 22716 compliance without enterprise complexity or cost. Whether you're producing 30 batches per month or 300, Trace Swift scales with you.

Will this help me meet EU Cosmetics Regulation requirements?

Trace Swift supports the traceability and GMP documentation requirements of EU Cosmetics Regulation 1223/2009. We provide batch records, ingredient traceability, and production documentation that form part of your Product Information File and GMP compliance evidence.

Can Trace Swift support ISO 22716 certification?

Yes. Trace Swift provides the documentation and traceability system required for ISO 22716 compliance. Our batch records, ingredient tracking, and production documentation support the standard's requirements for Sections 9 (Production), 13 (Deviations), and 17 (Documentation).

How does Trace Swift handle fragrance allergen tracking?

You can record allergen information for fragrance ingredients in your input records. During production capture, you record actual quantities used, maintaining the data needed to calculate allergen concentrations in finished products for labelling compliance.

What about stability and expiry date management?

Trace Swift tracks expiry dates for both raw materials and finished products. FEFO (First Expired, First Out) inventory views help you use materials before expiration. Finished product batch records include expiry date and PAO (Period After Opening) assignment.

Can I manage contract manufacturing for multiple brands?

Yes. Trace Swift supports multiple product lines and can maintain separate formulas for different customers or brands. Each batch is tracked independently with its own lot codes and traceability, while you maintain oversight of all production in one system. Client confidentiality is maintained through data isolation.

How long does a traceability trace take?

Most traces complete in under 5 minutes. You can identify all products containing a specific ingredient lot, or all ingredients in a specific product batch, essentially instantly. This supports rapid response in recall situations and makes audit responses straightforward.

What if I have questions during implementation?

We provide email support during UK business hours (Monday-Friday, 9:00-17:00 GMT). Most support queries receive responses within 24 hours. Our support team understands cosmetics manufacturing and can help you configure the system for your specific production processes.