Short answer
Every complaint about a perfume — a leaking pump, a different smell, a rash — should be logged, investigated and closed, and the few that describe a serious reaction must be reported to the authorities on a deadline. In the US, MoCRA requires the responsible person to report a serious adverse event to the FDA within 15 business days, with a copy of the label. In Great Britain, a reaction that stops the user carrying out their usual day-to-day tasks must be reported to the Office for Product Safety and Standards immediately; in the EU, serious undesirable effects go to the national authority without delay. A simple complaint log, linked to batch codes and retained samples, is what makes those deadlines possible.
Complaint, adverse event, serious adverse event
| Type | Examples | What it triggers |
|---|---|---|
| Quality complaint | Leaking or blocked sprayer, cloudy juice, wrong color, smells different from the last bottle | Log, investigate, answer the customer; check the batch |
| Adverse event (non-serious) | Mild redness, itching, irritation that settles | Log and investigate; tell your safety assessor; look for a pattern |
| Serious adverse event | Hospitalization, significant disfigurement, a reaction that stops the person working normally | Mandatory report to the authority within the market's deadline, plus everything above |
United States: MoCRA
Under the Modernization of Cosmetics Regulation Act, an adverse event is any health-related event associated with the use of a cosmetic that is adverse. A serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement — including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance — other than as intended; or one that requires medical or surgical intervention to prevent such an outcome.
- The responsible person must report serious adverse events to the FDA within 15 business days of receiving the information, with a copy of the label.
- New medical or other information received within a year of the report must be sent within 15 business days.
- The FDA can see adverse event records during an inspection.
- The label must carry a US contact through which adverse events can be reported; see MoCRA requirements for fragrance brands.
Small-business exemptions under MoCRA do not remove the duty to report serious adverse events.
Great Britain and the European Union
- Great Britain. GOV.UK guidance says a reaction that leaves the user temporarily or permanently unable to carry out their usual day-to-day tasks must be reported to OPSS immediately as a serious undesirable effect, with details of the Responsible Person, the effects, the product name and batch number, and any corrective measures. Reactions that do not prevent day-to-day tasks — allergic reactions, irritation, cosmetic acne — do not need reporting. See selling perfume in the UK.
- European Union. Article 23 of the Cosmetics Regulation requires the responsible person and distributors to notify serious undesirable effects without delay to the competent authority of the member state where the effect occurred; see selling perfume in the EU.
In both, undesirable effects — serious or not — also belong in the product's safety report and information file, which your safety assessor updates.
The complaint log
One log for all complaints, kept as a spreadsheet or in your quality records, with these fields:
- Date received, and how (email, phone, retailer).
- Product, size and batch code; where and when bought.
- What the person reports, in their words; for a reaction, where on the body, when it started, how long it lasted, any medical care.
- Classification: quality complaint, adverse event, serious adverse event — and who decided.
- Investigation: retained sample checked, batch record reviewed, other complaints on the same batch.
- Report to an authority: which, when, reference number.
- Answer to the customer; corrective action; date closed.
Personal and health details are sensitive data in most markets; keep the log secure and only as long as your retention policy says (how long to keep formula records).
Investigating
- Find the batch. The batch code on the bottle leads to the batch record and the material lots used; see batch numbers and lot codes.
- Compare the retained sample with the customer's bottle if you can get it back, and with a standard.
- Look for a pattern: several complaints on one batch point to that batch; several on one formula across batches point to the formula or a material.
- For reactions, give your safety assessor the formula version and the allergen and restriction checks; ask whether the safety assessment needs revisiting.
- Decide the action: none, a corrected process, a reformulation under change control (formula change control), or a withdrawal or recall (perfume product recall).
Written procedures for complaint handling are part of cosmetic good manufacturing practice; see cosmetic GMP and ISO 22716 and perfume lab SOPs. The wider market rules are in perfume regulations by market.
Sources
- US FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA): definitions of adverse event and serious adverse event; reporting within 15 business days; read October 11, 2026.
- GOV.UK — Making cosmetic products available to consumers in Great Britain, "Adverse reactions to cosmetic products"; read October 11, 2026.
- EUR-Lex — Regulation (EC) No 1223/2009, Article 23 (link format).
Frequently asked questions
A customer says the perfume gave her a rash. Do I have to report it?
Log and investigate it in every case. Whether it is reportable depends on severity and the market: in the US, a serious and persistent rash can be a serious adverse event; in Great Britain, a rash that does not stop day-to-day activities does not need reporting to OPSS. If in doubt, ask your safety assessor or regulatory adviser promptly — the deadlines are short.
Who is the "responsible person"?
In the US, the manufacturer, packer or distributor whose name appears on the label. In the EU and GB, the Responsible Person designated for the product, established in that market.
Do complaints about the smell count?
Yes, as quality complaints. Several on one batch may reveal a weighing error, a contaminated material or a supplier change.
Written and reviewed by the RUŌOD Lab team. This article is general education about perfume formulation and record-keeping; it is not legal, regulatory or safety advice, and the examples are illustrations, not validated commercial formulas. How we write and check these guides.