Cosmetic Notification Renewal and Variation (2-Year Validity)

A cosmetic notification is not a one-and-done affair — its validity period is 2 years, it must be renewed before expiry, and when there is a substantive change to the product a variation must also be handled. Many brands put a lot of care into the moment of launch but forget that a notification is a "state that must be maintained": continuing to sell after the notification has expired, or changing the formula while still using the old notification number, are both common violations found during inspection. This article makes the timing, triggering conditions and common mistakes of renewal and variation clear. (For the full overview, see the Malaysia Cosmetic Regulations and Labelling Guide.)

Why is the notification only valid for 2 years?

Cosmetics use a notification system where responsibility rests with the operator, and the authority uses "periodic renewal" to have every product re-confirm, at intervals, that the formula has not been secretly changed, the holder information is still correct, and the safety assessment still holds. The 2-year validity is this mechanism of periodic re-checking. Think of it as the product's "compliance freshness date" — once it passes, you cannot keep selling and must renew first to refresh the status.

Renewal

• After approval, the notification is valid for 2 years.
• Renewal must be handled within 1 month before expiry; once expired without renewal, the product may not be sold.
• Renewal is not just pressing a button: you should ensure the underlying PIF and safety assessment are still valid and consistent with the current situation (see Cosmetic PIF and Safety Assessment).

In practice, it is advisable to set reminders early and treat "1 month before expiry" as the final deadline rather than the starting line, leaving time to cross-check ingredients, labels and holder information so you are not scrambling on the expiry day.

Variation

Changing any of the following items usually requires re-notification / handling a variation:

The core principle is: the original notification number does not apply to a "substantively different" product. As long as a change makes the product inconsistent with the original notification in ingredients, identity or safety information, you cannot keep using the old number and must handle a variation or re-notify. If the change involves a restricted-ingredient concentration or a warning, do not forget to check the label in step (see Cosmetic Restricted Ingredients and Concentration Limits).

Renewal vs variation: don't mix them up

• Renewal deals with "time is up" — the content has not changed, you are just extending the 2-year validity.
• Variation deals with "the content has changed" — no matter how much validity remains, any substantive change must be handled.

The two can happen at the same time: for example, if you take the chance to change the formula during renewal, you must handle both renewal and variation together, rather than hiding the formula change inside the renewal to slip it through.

Why can even a "small change" require a variation?

What brands most often underestimate is "it's just a small swap, it shouldn't matter". But whether a variation is needed is judged not by the size of the change but by whether the change makes the product inconsistent with the identity or safety information of the original notification. Switching a preservative supplier, fine-tuning an ingredient's concentration, changing the product name from "Brightening Essence" to "Clarifying Essence", or tweaking the wording of a warning — these are small matters in marketing's eyes, but in compliance they may have changed the ingredients, identity or safety claim. The safe approach is: for any change, ask yourself three questions first — have the ingredients changed? Has the name / identity changed? Has it affected safety or statutory information? If even one answer is "yes", do not keep using the old notification number — handle a variation first.

Common mistakes

• The notification has expired without renewal but the product is still on sale.
• The formula was changed but the old notification number is still used, so it does not match when spot-checked.
• The notification holder (CNH) was changed without handling a variation (see Imported Cosmetics: CNH Holder and Responsibilities).
• Not going back to confirm at renewal whether the PIF is still consistent with the current situation.

Post-market maintenance self-check checklist

• [ ] The notification expiry date of each SKU is recorded and reminders are set.
• [ ] Renewal is completed within 1 month before expiry.
• [ ] Any change of formula, name or CNH has been handled as a variation.
• [ ] Packaging or labelling changes affecting safety / compliance have been re-notified.
• [ ] After renewal / variation, the PIF and safety assessment are updated in step.

Frequently asked questions (FAQ)

Q: Does a change of packaging design require re-notification? If it is only a visual design adjustment and the statutory information is unchanged, usually no; but once it involves ingredients, name or safety information, a variation must be handled.

Q: Does renewal require redoing the safety assessment? You should ensure the PIF and safety assessment remain valid and consistent with the current situation; if there have been changes in the interim, the corresponding data must be updated.

Q: If I only discover it has expired after the fact, can it be remedied? Once expired without renewal, the product may not be sold; you should stop selling first, re-handle the notification status as required, and then re-list.

Q: For multiple shades / scents in the same range, are renewal and variation counted separately? Generally they are managed per individual notification, so renewal and variation must correspond one by one — you cannot use a single number to cover substantively different products.

Conclusion

The maintenance formula for a cosmetic notification: 2-year validity + renewal within 1 month before expiry + re-notification for substantive changes. Treat it as a status that needs periodic re-checking, not a one-off procedure. Want to check whether your product status and label are still compliant? Run a free label check now.

This article is compiled from official NPRA guidelines and is for reference only; actual compliance is subject to the latest official text and review by the competent authority.