Keeping Your CPSR Current: The Review Cycle When Regulations, Ingredients and Suppliers Change

Article 10 of Regulation (EC) No 1223/2009 does not just require a Cosmetic Product Safety Report before a product is sold; it requires the Responsible Person to keep the report up to date in the light of additional relevant information generated after the product is placed on the market. The same duty applies in Great Britain under the Cosmetic Products Enforcement Regulations 2013. Relevant information includes changes to the law, and the law changes constantly: the annexes are amended through regular omnibus regulations implementing opinions of the Scientific Committee on Consumer Safety in the EU, and through Great Britain's own process, with advice from its Scientific Advisory Group on Chemical Safety, on a different timetable.

This guide sets out how to keep a CPSR current: what triggers a review, how to run an annual check, what a regulatory watch looks like for a small brand, how addenda work and when a new report is needed instead, how to handle supplier and packaging changes, and how to record all of it so that the file shows the report has been maintained.

The review triggers

Makers often ask whether a CPSR expires. It does not carry an expiry date, and there is no rule that it must be renewed every so many years. But it is valid only for the product it assessed, made as assessed, with the ingredients from the suppliers assessed, in the packaging assessed, for the use and users assessed, with the claims assessed, under the regulation as it stood on the date of assessment. Every one of those things can change without the maker noticing, and when one does, the report no longer covers the product as sold. The practical question is not whether the report has expired but whether it is still current, and the only way to know is to check.

Expiry versus currency

What changes in the law, and how often

The EU amends the annexes of the Cosmetics Regulation several times a year. Recent years have brought new prohibitions of substances classified as carcinogenic, mutagenic or reproductively toxic, new restrictions and lowered maxima for preservatives and fragrance materials following SCCS opinions, new conditions for UV filters and nanomaterials, and a substantial expansion of the fragrance allergens that must be declared on labels with staged transition dates. Great Britain has adopted some of these changes later, some differently, and some not at all, while adding its own. A brand selling in both markets is therefore tracking two moving targets. None of these changes arrives with a personal notification to the maker; they are published in the official journals and picked up by those who are watching.

Setting up a regulatory watch

• Subscribe to the sources. EU Official Journal alerts for amendments to Regulation 1223/2009, SCCS opinion publications, OPSS cosmetics updates and GB legislation alerts.
• Maintain an ingredient register. Every ingredient across your range, by INCI and CAS number, so an amendment can be matched to your products in minutes.
• Ask your assessor to watch for you. Many offer a monitoring service that flags amendments affecting your ingredients and issues addenda.
• Follow your trade body. Industry associations summarise changes for members.
• Check supplier bulletins. Fragrance and ingredient suppliers announce reformulations and regulatory updates.

The annual review: a procedure

• Confirm the formula. The current batch record matches the formula in Part A exactly.
• Confirm the suppliers. Every ingredient still comes from the supplier named, and every SDS, specification, IFRA certificate and allergen statement is the current version.
• Screen the formula against both current annexes. Or have the assessor do it.
• Confirm packaging, use and claims. Nothing has changed on the pack, the website or in the product's positioning.
• Review undesirable effects. Any reports since the last review, and whether they change the assessment.
• Confirm the market. No new countries or Northern Ireland sales without the corresponding assessment.
• Record the review. In the PIF change log, with the date, what was checked and the outcome, even when nothing changed.

Addendum or new report?

An addendum is a dated, signed document from the assessor amending specific parts of the existing report: a new supplier's documents reviewed and accepted, an annex amendment screened with the conclusion that the product remains compliant or that a level must change, a new variant assessed, a new allergen declaration, a new market. It references the original report and sits with it in the PIF. A new report is warranted when the change is substantial enough that the original no longer serves as the foundation: a materially different formula, a new product type, a change of assessor, or an original report that is old, thin or undocumented. Most changes in a well run brand are handled by addenda at modest cost; the discipline is to ask for them rather than to assume.

Supplier changes: the silent invalidator

The change that most often goes unrecorded is a supplier substitution. A fragrance house discontinues a scent and offers a close match; a wholesaler switches its shea butter source; a botanical extract is bought from a new vendor because the old one was out of stock. In each case the composition, purity, constituent profile or allergen content may differ, and the report assessed the original. Fragrances and essential oils are the highest risk because their allergen profiles vary most, followed by botanical extracts and blended raw materials. Build a rule into purchasing: no new supplier for any ingredient without the assessor reviewing the new documents first, and log every change.

A worked example: an allergen rule change

A brand sells a lavender body butter assessed two years ago. The EU expands the list of fragrance allergens that must be named on labels, with a transition period for products placed on the market after a set date and a further period for products already on shelves. The brand's annual review, or its assessor's monitoring, flags that the lavender oil contains a newly listed constituent above the labelling threshold. The assessor issues an addendum stating the additional allergen to be declared for the EU market, the brand revises the EU label at the next print run within the transition period, the PIF change log records the amendment, the addendum and the new artwork version, and superseded artwork is archived. Great Britain has not adopted the same change on the same date, so the GB label is unaffected for now and the addendum says so. The product never left the shelf. Had nobody been watching, the brand would have discovered the change from a marketplace suspension or a customer complaint after the transition period expired.

Inherited and old reports

Brands that have been trading for years, or that acquire products from another business, often hold reports written under an earlier state of the law by an assessor they no longer work with. Such a report is not invalid by age, but it is unlikely to be current: allergen rules, annex restrictions and exposure guidance have all moved, and supplier documents will have been superseded. The efficient approach is to have a current assessor review the inherited report against today's annexes and today's supplier documents, issue an addendum where the report holds and a replacement where it does not, and start a change log from that point. A report that cannot be traced to a named qualified assessor, or whose supporting documents are missing, should be replaced rather than extended.

Building review into the business, not the calendar alone

• Purchasing. No new supplier for any ingredient without assessor review.
• Product development. Every new variant, claim or format goes through the assessor before launch.
• Marketing. Website and social copy changes checked against the assessed claims.
• Customer service. Every reaction logged and periodically reviewed with the assessor.
• Sales. New markets, including Northern Ireland and EU marketplaces, flagged before the first order ships.
• Management. An annual compliance review on the calendar with the assessor, and a register of every product's CPSR status.

Recording it in the PIF

The Product Information File's change log is where currency is demonstrated. Each entry records the date, what changed or was reviewed, why, what the assessor issued, and which sections of the file and which label versions were updated. Superseded documents are retained and marked. An inspector opening a file with a change log showing annual reviews and addenda for every change sees a maintained product; a file with a report dated years ago and nothing since sees the opposite, regardless of whether the product actually changed. Our PIF template includes the log structure.

When the review finds a problem

Sometimes the annual screen finds that an ingredient in a product already on sale has been restricted below the level used, or newly prohibited. The response depends on the amendment's transition dates, which usually allow a period for products to be brought into compliance and a further period for stock already on the market. The assessor will advise what the dates mean for your product, whether reformulation is needed, and how to handle existing stock. Acting promptly on a finding is the difference between an orderly reformulation and a withdrawal. Our article on Part B conditions covers the response options.

Phoenix offers regulatory monitoring and addenda for the reports it prepares, and a consultation can bring an older or inherited report up to date.

Official sources and legislation

• Regulation (EC) No 1223/2009 on cosmetic products
• Cosmetic Products Enforcement Regulations 2013
• OPSS guidance on cosmetic products regulations
• Office for Product Safety and Standards
• Scientific Committee on Consumer Safety (SCCS)

Disclaimer: This article is general information, not legal advice. Regulations change and product decisions depend on your exact formulation, claims and market. Have your product assessed by a qualified professional before sale.