1. Regulatory Authority & Framework

Unlike most countries (ASEAN, GCC, LATAM), Australia does NOT register cosmetic products with a health authority.

Cosmetics are regulated under:

• AICIS (Australian Industrial Chemicals Introduction Scheme) – chemical-level compliance
• Therapeutic Goods Act 1989 – for borderline products
• Mandatory Standards via ACCC (labeling/safety)
• AS/NZS standards (if applicable)
• Consumer Law enforcement by ACCC

There is no cosmetic pre-market “registration” or “notification” —
BUT companies must ensure chemical compliance + safety + labeling.

2. Definition of Cosmetic (Australia)

Cosmetics are defined as products applied to the body for:

• Cleansing
• Perfuming
• Beautifying
• Maintaining/improving appearance

Borderline rules:
If a product claims to treat acne, grow hair, treat eczema, heal skin, lighten melasma, SPF protection, it becomes a therapeutic good (TGA) and must be registered under ARTG, not AICIS.

Common examples reclassified into TGA:

• Sunscreens (SPF)
• Anti-acne (benzoyl peroxide, SA > 2%)
• Anti-dandruff
• Melasma treatment
• Hair loss therapy
• Skin-lightening with medical claims

3. Australia’s Cosmetic Compliance = AICIS Chemical Introduction Rules

Australia focuses on ingredient-level regulation.

Every manufacturer/importer must:

3.1 Register Business with AICIS

• Annual registration fee (AUD ~$1,500+ depending on revenue)
• Required if you import or manufacture ANY cosmetic or ingredient
• Retailers/resellers don’t need AICIS registration

3.2 Categorize Each Ingredient (6 Introduction Categories)

AICIS categories:

1. Exempted
2. Reported
3. Assessed
4. Commercial Evaluation
5. Listed
6. Internationally Assessed

Most cosmetic ingredients fall under Exempted or Reported.

3.3 Maintain Records for 5–7 Years

• Ingredient concentrations
• Safety data
• Supplier documentation
• Risk assessment
• Evidence for category justification

3.4 Ensure All Ingredients Are Permitted

No banned or restricted ingredients per AICIS or ACCC regulations.

4. Cosmetic Labeling Requirements (Mandatory)

Australia follows ACCC mandatory standards + AICIS rules.

Labels must include:

• Product name and function
• Full ingredient list (INCI)
• Batch/lot number
• Country of origin
• Net weight/volume
• Warnings (if applicable, e.g., AHA, hair dyes)
• Manufacturer/importer details
• Usage instructions

Note:

• INCI format is mandatory
• English is required on the label
• Allergens must be declared

No “Notification Number” is issued, unlike ASEAN or GCC markets.

5. Ingredient Compliance Requirements

AICIS checks chemical identity, not the finished product.

Australia prohibits/restricts:

• Mercury
• Hydroquinone
• Prescription-only actives (retinoids, steroids)
• Drug-level salicylic acid
• High-level peroxides
• Unapproved preservatives
• Certain nanomaterials (case-by-case review)
• SPF claims (must go to TGA)

Regulatory alignment is closer to EU Cosing than to ASEAN.

6. GMP & Safety Requirements

Cosmetic manufacturers must maintain:

• GMP (ISO 22716 recommended)
• Safety substantiation (toxicology review, micro test, stability)
• Claims substantiation (ACCC can challenge misleading claims)
• Records for all ingredients introduced (AICIS-compliant)

7. Fees & Timelines

Fees

• AICIS Annual Registration Fee:
  • Category A (small business): ~AUD 1,500
  • Category B: AUD 6,000+
• No product registration fee
• No approval or notification fee

Timeline

• AICIS business registration: 1–5 working days
• Ingredient categorization: depends on complexity
• No pre-market waiting period → cosmetic can be sold once AICIS + label compliance completed

Australia is one of the fastest entry markets globally.

8. Importation Requirements

To import cosmetics into Australia:

• Importer must be registered with AICIS
• Ensure ingredients fall into permitted categories
• Provide SDS/ingredient certificates
• Comply with labeling laws
• Customs may check for restricted ingredients (especially whitening products)

No CFS required.

9. Post-Market Surveillance (PMS)

Monitored by:

• ACCC (labeling, consumer safety, misleading claims)
• AICIS (chemical compliance & record-keeping)
• TGA (if product is borderline therapeutic)

Authorities conduct:

• Random sampling
• Online monitoring
• Audits
• Recalls (voluntary or mandatory)

10. Borderline Products (Cosmetic vs Therapeutic Good)

11. Consulting Notes for Your Portfolio

12. Advantages of the Australian Cosmetic Market

• No product registration needed → fastest entry globally
• No fees per product
• AICIS is transparent, online, science-based
• High consumer trust
• Strong demand for Asian skincare (K-beauty, J-beauty, C-beauty)
• Ideal for cross-border & influencer-driven brands