SDS, CoA and PIF: The Compliance Documents Your Skincare Brand Needs

A Safety Data Sheet (SDS) explains a product's hazards and safe handling, a Certificate of Analysis (CoA) shows a batch passed its tests, and a Product Information File (PIF) is the safety dossier required for every cosmetic in the EU, the UK and ASEAN markets. Australia has no PIF requirement, and only hazardous chemicals legally need an SDS, but stockists, couriers and overseas partners ask for them all.

The documents at a glance

Document	What it shows	Who asks	Required by law?
SDS	Hazards, handling, transport	Couriers, marketplaces, salons	AU: hazardous chemicals only. EU, UK, US: not for retail cosmetics.
CoA	One batch's test results	Retailers, distributors, importers	Not named in cosmetic law
Certificate of Conformity	Manufacturer's declaration of compliance	Importers, distributors, retail buyers	Not named in cosmetic law
PIF	Safety report, GMP statement, claim support	Responsible Persons, regulators	EU, UK, ASEAN: yes. AU, US: no.
Stability and challenge tests	Shelf life and preservation	Safety assessors, retailers	EU/UK: in the safety report

Safety Data Sheet (SDS)

What it is: a 16-section document covering hazards, composition, first aid, handling, storage and transport.

Who asks: couriers checking for dangerous goods (Australia Post lists nail polish and perfume as examples of flammable liquids that may be prohibited from the post), marketplaces, salons and clinics.

Is it required by law?

• Australia: under the model Work Health and Safety (WHS) Regulations, manufacturers and importers must prepare an SDS for each hazardous chemical and review it at least every five years. Each state and territory enforces its own WHS laws, so check with your regulator. Cosmetics packaged for consumers are exempt from WHS labelling.
• EU and UK: REACH's SDS rules don't apply to finished cosmetics intended for the final user.
• US: OSHA's Hazard Communication Standard doesn't apply to cosmetics packaged for retail sale to consumers.

Certificate of Analysis (CoA) and Certificate of Conformity

A CoA reports one batch's test results against its specification, typically appearance, odour, pH and microbiological results. Its batch code should match the product's; we print ours on the base of every bottle.

A Certificate of Conformity is the manufacturer's signed declaration that a product meets its specification and the regulations it names. Ours covers the EU, AICIS and FDA.

Who asks: retailers, distributors, importers and overseas buyers.

Is it required by law? No cosmetic rule we checked names either, and a Certificate of Conformity is a declaration, not a government approval. The TGA doesn't approve cosmetics, so "TGA approved" on a cosmetic is a red flag.

Product Information File (PIF) and safety report

What it is: Article 11 of the EU Cosmetics Regulation (EC) No 1223/2009 requires a PIF for every cosmetic placed on the market. Great Britain applies an amended version of the same regulation, and Northern Ireland follows the EU rules. The PIF holds a product description, the Cosmetic Product Safety Report (CPSR), the manufacturing method with a good manufacturing practice (GMP) statement, proof of claimed effects where justified, and any animal testing data.

The CPSR has two parts: safety information (Part A) and the safety assessment (Part B), by someone with a university qualification in pharmacy, toxicology, medicine or a similar discipline.

Who holds it: the Responsible Person, at the address on the label, for 10 years after the last batch goes on sale. In the EU they must be established there, such as your importer. In Great Britain they need a UK address (not a PO box), and the PIF must be in English.

Is it required by law?

• EU and UK: yes, plus notification before sale (to the European Commission or Great Britain's Office for Product Safety and Standards).
• ASEAN markets such as Singapore: yes. The company placing the product on that market keeps the PIF at the address on the label.
• Australia: no. Cosmetics are regulated through AICIS, the ACCC and the Poisons Standard, and none requires a PIF.
• US: no PIF, but MoCRA requires safety substantiation records.

In Australia, claims about treating acne, healing or repairing damaged skin, or antibacterial activity would likely make a product a therapeutic good unless a specific exclusion applies. See cosmetic or therapeutic?

Stability and challenge test results

Stability testing checks that a product keeps its appearance, texture, scent and pH over its shelf life. Preservative efficacy (challenge) testing adds known microbes and counts them over about four weeks to show the preservative controls them. See cosmetic preservatives.

Is it required by law? The EU and UK CPSR must cover stability and include challenge test results. The FDA says US law doesn't require specific safety tests, and Australian cosmetic rules name none.

Which documents do you need?

Selling in Australia only

Get your label right (see cosmetic labelling requirements), check whether you need AICIS registration if you import or make products yourself, and keep each product's SDS and batch CoAs on file.

Amazon and other marketplaces

Some marketplaces review products that may be dangerous goods, such as aerosols and flammable liquids, and may ask for an SDS. Rules change, so check your seller account before sending stock.

Salons, clinics and retailers

If you use products at work, keep an SDS for any hazardous product in your hazardous chemicals register; unopened stock you'll sell as consumer products, and consumer products used in household quantities and in a household way, are exceptions. Decanting from bulk? Keep its SDS and label each unit you fill with the original batch code. Bulk cosmetics for repackaging aren't covered by the consumer packaging exemption, so a bulk product classed as hazardous needs a WHS label. See bulk skincare to fill yourself.

Exporting to the EU, UK or ASEAN

For the EU or UK you need a local Responsible Person, whose name and address go on the label, a PIF with a CPSR signed off by a qualified safety assessor, and notification before sale. In ASEAN markets, the local company placing the product on sale keeps the PIF. See our regulatory guide by market.

Selling in the US

• Responsible person (the manufacturer, packer or distributor named on the label): keeps safety substantiation records, lists each product and its ingredients with the FDA (updated annually), and reports serious adverse events within 15 business days.
• Facility registration: each facility that manufactures or processes the product for US sale, including facilities outside the US, registers with the FDA and renews every two years. Registration isn't FDA approval.

What Cellular Cosmetics supplies

• Documents: an SDS, CoA and PIF for each product. SDS, CoA and Certificate of Conformity downloads are in our document library; PIFs on request under an NDA. For EU or UK sale, your Responsible Person holds the PIF for your labelled product, and a qualified safety assessor signs off its CPSR.
• Testing: we run stability and preservative efficacy (challenge) testing, and every product is microbiologically tested before release. Ask us which test reports come with your order. See certifications and testing.
• Manufacturing: on the Gold Coast. We operate to ISO 22716 GMP principles, and everything we make is a cosmetic.

See our guide to starting a skincare brand in Australia.

Frequently asked questions

Is an SDS legally required for skincare in Australia?

Only if the product is classified as a hazardous chemical, which depends on its formula.

Do I need a Product Information File to sell cosmetics in Australia?

No. Australian law doesn't require one. The EU and UK require a PIF, and so does the ASEAN Cosmetic Directive (for example in Singapore), so you'll need one if you export to those markets.

What's the difference between a CoA and a Certificate of Conformity?

A CoA reports one batch's test results. A Certificate of Conformity is the manufacturer's declaration that the product meets its specification and named regulations.

Who keeps the PIF when I sell in the EU or UK?

The Responsible Person, at the address on the label, for 10 years after the last batch goes on sale.

What is ISO 11930?

The international standard for evaluating a cosmetic's antimicrobial protection, using a challenge test and a risk-based procedure.

This article is general information, not legal advice.

Sources: Safe Work Australia, Preparing safety data sheets; Safe Work Australia, Using safety data sheets; Safe Work Australia, Hazardous chemicals that are exempt from labelling under WHS Regulations; AICIS, Labelling, SDS and packaging; AICIS, Personal care, skincare, make-up and other cosmetic products (updated 7 February 2025); Therapeutic Goods Administration, Determining if your product is a cosmetic or therapeutic good (updated 3 July 2026); EUR-Lex, Regulation (EC) No 1223/2009 on cosmetic products; EUR-Lex, Regulation (EC) No 1907/2006 (REACH), consolidated text (23 June 2025); legislation.gov.uk, REACH Article 2, as it applies in Great Britain; GOV.UK, Making cosmetic products available to consumers in Great Britain (published 4 October 2021); ASEAN Cosmetic Directive, Guidelines for Product Information File (PIF); US FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (current as of 29 October 2026); US FDA, Registration and Listing of Cosmetic Product Facilities and Products (current as of 9 September 2026); OSHA, 29 CFR 1910.1200 Hazard Communication; ISO, ISO 11930:2019; Australia Post, Prohibited and restricted items.

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