Cosmetic Safety Obligations are important in keeping consumers, the environment and the general population safe. In this series, we will delve into the safety obligations across the globe.
Safety obligations of Cosmetic Products Series
To learn more about the differences in safety obligations across regional regulations, explore our safety obligations of cosmetic products series:
The Industrial Chemicals Act Safety Obligations
The Industrial Chemicals Act 2019 is the primary legislation governing the introduction and use of chemicals in cosmetics in Australia. It is enforced by the Australian Industrial Chemicals Introduction Scheme (AICIS), which replaced the former National Industrial Chemicals Notification and Assessment Scheme (NICNAS) in 2020.
AICIS ensures that all industrial chemicals used in cosmetics are assessed for safety and environmental impact before being introduced to the Australian market.
AICIS oversees the registration, notification, and risk assessment of chemicals used in cosmetics. Under the Industrial Chemicals Act 2019, any business that imports or manufactures industrial chemicals (including cosmetic ingredients) must:
- Register with AICIS before importing or manufacturing chemicals in Australia.
- Categorize chemical introductions based on risk levels to determine compliance requirements.
- Maintain records and report on chemical use for regulatory monitoring.
Failure to comply with AICIS safety obligations can result in penalties, fines, or removal of products from the market.
Mandatory Business Registration for Chemical Introductions
Before importing or manufacturing cosmetics containing industrial chemicals, businesses must register with AICIS and obtain a registration number. Registration tiers are based on annual importation/manufacturing volume, and businesses must renew their registration each year by June 30.
Categorization of Chemical Introductions
AICIS assesses cosmetic ingredients based on their risk to human health and the environment. Chemical introductions are classified into five categories, each with specific regulatory obligations:
Listed Introductions (Pre-Approved Chemicals – Lowest Risk)
- These chemicals are already assessed and appear on the AICIS Inventory.
- No additional risk assessment is required.
- Businesses only need to confirm compliance with usage conditions.
Exempted Introductions (Minimal Risk – No Notification Required)
- Very low-risk substances that meet strict safety criteria (e.g., naturally occurring chemicals like plant extracts).
- Businesses do not need to notify AICIS but must keep records for at least 5 years to prove compliance.
Reported Introductions (Low Risk – Annual Reporting Required)
- Applies to chemicals that are low risk but not listed on the AICIS Inventory.
- Businesses must submit an annual report to AICIS detailing the chemical’s introduction and use.
Assessed Introductions (Higher Risk – Pre-Market Assessment Required)
- These chemicals require a detailed safety assessment by AICIS before introduction.
- Examples include new synthetic chemicals or substances with potential toxicity concerns.
- Businesses must submit toxicity data, safety studies, and environmental impact assessments.
Commercial Evaluation Introductions (Limited Testing for New Chemicals)
- Allows businesses to test a new chemical in limited quantities before full-scale introduction.
- Requires a special AICIS permit and compliance with safety conditions.
Prohibited and Restricted Ingredients in Cosmetics
Certain chemicals are either completely banned or subject to strict concentration limits under AICIS regulations.
Prohibited Ingredients
AICIS enforces chemical bans based on health risks such as carcinogenicity, reproductive toxicity, or environmental harm. Examples include:
- Mercury compounds (highly toxic, bioaccumulative).
- Chloroform (potential carcinogen).
- Certain lead-containing ingredients (neurotoxic effects).
Restricted Ingredients
Some ingredients are allowed in cosmetics but must comply with strict usage limits to prevent adverse health effects.
Examples include:
- Formaldehyde – Permitted in nail hardeners at a maximum concentration of 5%.
- Hydroquinone – Restricted to prescription-only skin-lightening treatments.
- Parabens – Allowed but subject to maximum concentration limits due to potential endocrine-disrupting effects.
AICIS works closely with the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) to maintain up-to-date lists of restricted and prohibited ingredients.
Monitoring Chemical Safety in Cosmetics
AICIS conducts regular compliance checks to ensure businesses follow safety obligations. Regulatory enforcement includes:
- Random inspections and audits of imported and manufactured cosmetic ingredients.
- Mandatory record-keeping (businesses must maintain ingredient safety data for at least 5 years).
- Penalties for non-compliance, including product recalls and financial penalties.
Environmental Considerations Under AICIS
Beyond consumer safety, AICIS evaluates the environmental impact of cosmetic chemicals. Businesses must:
- Assess potential risks of chemical pollution.
- Follow safe disposal guidelines for cosmetic waste.
- Avoid using substances that could contaminate water supplies or harm wildlife.
The Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act) also regulates the environmental impact of chemicals in cosmetics.
Consumer Goods (Cosmetics) Information Standard 2020 Safety Obligations
The Consumer Goods (Cosmetics) Information Standard 2020 is a key regulation in Australia that ensures cosmetic products are labeled accurately and transparently to enhance consumer safety and informed decision-making. This standard, enforced by the Australian Competition and Consumer Commission (ACCC) under the Australian Consumer Law (ACL), mandates that cosmetic products list all ingredients to help consumers identify potential allergens and harmful substances.
By enforcing ingredient disclosure, accurate labeling, and consumer transparency, the Consumer Goods (Cosmetics) Information Standard 2020 plays a critical role in reducing health risks associated with cosmetic products.
Mandatory Ingredient Listing for Consumer Safety
The primary objective of the Consumer Goods (Cosmetics) Information Standard 2020 is to ensure full disclosure of cosmetic ingredients so consumers can make informed choices, particularly if they have allergies, sensitivities, or health concerns.
Requirement to Disclose All Ingredients
All cosmetic products sold in Australia must list every ingredient used in their formulation.
The ingredient list must be:
- Clearly visible on the packaging.
- Written in English (though additional languages are allowed).
- Accurate and not misleading to prevent deceptive marketing.
Standardized Ingredient Naming Using INCI System
Ingredients must be identified using the International Nomenclature of Cosmetic Ingredients (INCI), a globally recognized naming system. This ensures consistency across international markets and helps consumers identify specific chemicals regardless of brand or region.
Listing Order Based on Concentration
Ingredients must be listed in descending order of concentration, starting with the most abundant ingredient. Ingredients present at less than 1% concentration can be listed in any order after the main ingredients. This hierarchy ensures greater transparency about the formulation of a product.
Preventing Misleading Claims
The Consumer Goods (Cosmetics) Information Standard 2020 works alongside the Australian Consumer Law (ACL) to prevent misleading product claims that could deceive consumers or create false expectations about a product’s benefits or safety.
No False or Misleading Ingredient Claims
A product cannot claim to be “chemical-free” if it contains synthetic compounds, as all cosmetics are made of chemical substances.
Terms such as “organic” or “natural” must be accurate and verifiable—a product cannot claim to be 100% natural if it contains synthetic preservatives or fragrances.
Products must not claim medical or therapeutic benefits unless approved under the Therapeutic Goods Administration (TGA).
Greenwashing and Sustainability Claims
If a product is marketed as “eco-friendly” or “biodegradable,” the manufacturer must provide scientific evidence supporting this claim.
False environmental claims can lead to legal action from the ACCC under consumer protection laws.
Compliance, Penalties, and Enforcement by ACCC
The Australian Competition and Consumer Commission (ACCC) is responsible for enforcing compliance with the Consumer Goods (Cosmetics) Information Standard 2020.
The ACCC regularly audits cosmetic products to ensure ingredient disclosure requirements are met. Non-compliant companies may be investigated, fined, or forced to recall mislabeled products.
Businesses failing to comply with the ingredient labeling requirements may face:
- Fines up to $10 million AUD for corporations.
- Fines up to $500,000 AUD for individuals.
- Mandatory product recalls or withdrawal from the market.
SUSMP Safety Obligations
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), also known as the Poison Standard, plays a crucial role in regulating and restricting the use of certain chemicals in cosmetic products in Australia. The Therapeutic Goods Administration (TGA) enforces these regulations, ensuring that hazardous substances are either banned outright or restricted to safe concentration limits to prevent health risks.
The SUSMP categorizes chemicals into schedules (categories) based on their toxicity, potential for misuse, and required level of control. Cosmetics must comply with these scheduling restrictions to ensure consumer safety and avoid legal penalties.
Scheduling System Under the SUSMP
The SUSMP classifies chemicals into different schedules to determine how they can be used, sold, or banned in Australia. The most relevant schedules for cosmetic ingredients include:
Schedule | Regulation Impact on Cosmetics |
Schedule 2 (Pharmacy Medicine) | Some mild medicinal ingredients allowed in over-the-counter cosmetics (e.g., some topical antiseptics). |
Schedule 4 (Prescription Only Medicine) | Ingredients requiring prescription from a healthcare professional (e.g., higher-strength retinoids). |
Schedule 5 (Caution Substances) | Low-hazard chemicals that require clear labeling and warnings in cosmetics. |
Schedule 6 (Poisonous Substances) | Chemicals with high toxicity, severe skin irritation risk, or long-term health effects—restricted in cosmetics. |
Schedule 7 (Dangerous Poisons) | Prohibited in cosmetics due to their high risk of toxicity and potential harm. |
The higher the schedule number, the more hazardous the substance and the greater the restrictions on its use in consumer products.
Prohibited Ingredients in Cosmetics (Schedule 7 & Above)
- Mercury compounds – Extremely toxic, causing neurological and kidney damage (banned under international treaties).
- Chloroform – Known carcinogen, formerly used as a solvent in beauty products.
- Lead acetate – Historically used in hair dyes but now banned due to neurotoxic effects.
- Hydroquinone (except in prescription use) – A skin-lightening agent with potential cancer and skin damage risks.
- Bithionol – Previously used in perfumes, banned due to photoallergic reactions.
- Vinyl chloride – Found in aerosol beauty products, banned due to cancer risks.
- Nitrosamines (certain forms) – Banned in cosmetics due to high carcinogenic potential.
Products found to contain these prohibited ingredients are subject to immediate recall and potential legal action by the Australian Competition and Consumer Commission (ACCC) and TGA.
Restricted Ingredients in Cosmetics (Schedules 5 & 6)
Formaldehyde
- Permitted up to 5% in nail hardeners (with a warning label).
- Limited to 0.2% in general cosmetics due to its carcinogenic potential.
- Must include clear warning labels about potential skin and eye irritation risks.
Parabens
- Permitted in low concentrations (≤0.8% for individual parabens, ≤1.5% for mixtures).
- Certain long-chain parabens (e.g., isopropylparaben, isobutylparaben) are banned or highly restricted due to hormonal disruption concerns.
Phthalates
- Diethyl phthalate (DEP) is permitted in cosmetics but other phthalates like DBP and DEHP are banned due to their potential reproductive toxicity.
Retinol and Retinoic Acid
- Low concentrations of retinol (Vitamin A derivatives) are permitted.
- Higher-strength formulations (>0.3%) require TGA approval and prescription due to their skin irritation potential.
Hydrogen Peroxide
- Over-the-counter cosmetic teeth whiteners must contain ≤6% hydrogen peroxide.
- Professional-use products can contain up to 35% but require regulation under dental guidelines.
Essential Oils and Natural Extracts
- Tea tree oil – Must be diluted properly to prevent skin irritation and allergic reactions.
- Citrus extracts (limonene, linalool) – Require allergen disclosure on labels.
Heavy Metals
Cosmetic products must not contain excessive levels of heavy metals, as these can accumulate in the body and cause long-term health issues.
Heavy Metal | Maximum Permitted Level |
Lead | ≤10 ppm |
Mercury | Prohibited except for trace amounts (≤1 ppm in eye products) |
Arsenic | ≤2 ppm |
Cadmium | ≤5 ppm |
Chromium | ≤10 ppm |
Enforcement and Compliance Actions for Banned/Restricted Ingredients
The TGA, ACCC, and AICIS enforce compliance with SUSMP ingredient regulations through:
- Routine product testing to detect banned or excessive levels of restricted substances.
- Consumer complaint investigations into harmful reactions caused by cosmetics.
- Mandatory recalls and fines for companies violating ingredient restrictions
Examples:
- Mercury-containing skin whitening creams were seized in 2023, leading to heavy fines and product bans.
- A hair dye containing excessive lead acetate was recalled after testing revealed unsafe levels.
- Several low-cost imported lipsticks were withdrawn from the market after testing showed arsenic contamination.
