CPSR for Imported Cosmetics - Products Made Outside the UK or EU Into Compliance

Importing a finished cosmetic looks simpler than making one: the product exists, it sells in its home market, and the manufacturer says it is fully tested. The law sees it differently. Under Regulation (EC) No 1223/2009 and its UK equivalent enforced through the Cosmetic Products Enforcement Regulations 2013, the person who places a cosmetic on the market from outside the UK or EU is the importer and, unless another established person is designated, the Responsible Person, with every obligation that carries: the CPSR, the Product Information File, notification, the label and cosmetovigilance. The Office for Product Safety and Standards and its EU counterparts hold the importer, not the overseas factory, to account.

This guide explains what changes when you import: why the origin assessment is not enough, how ingredient rules differ between markets, what you must obtain from the manufacturer, how the UK or EU CPSR is built, what happens to the label, the notification and Responsible Person requirements, and the contractual steps that make all of this possible.

Why you become the Responsible Person

The regulation requires a Responsible Person established in the market for every cosmetic placed on it. A manufacturer in Seoul, Los Angeles or Guangzhou is not established in the UK or EU and cannot be the Responsible Person for products sold there. The default rule is that the importer is the Responsible Person for each product they place on the market, unless they designate, by written mandate, another person established in the market who accepts the role. Either way, someone in the UK or EU takes legal responsibility for compliance, and if you are the importer and have not designated anyone, that someone is you.

Importers who do not want to hold the role themselves can appoint a service such as Phoenix's UK and EU Responsible Person, but the CPSR, PIF and notification must still be built.

Why the origin assessment is rarely enough

Manufacturers usually offer some form of safety documentation, and it is often genuinely good work. It still falls short for four reasons. First, the ingredient rules differ: the UK and EU annexes of prohibited, restricted and permitted substances are among the strictest in the world, and formulas legal at origin regularly contain ingredients that are banned, capped at lower levels or restricted to different uses here. Second, the format differs: Annex I requires a specific two part structure that other jurisdictions do not use. Third, the assessor requirement differs: Part B must be signed by a person with the qualifications the regulation specifies, which an overseas assessor may not hold or may not be able to evidence. Fourth, the exposure and allergen methods differ: UK and EU assessments use the scientific committee's exposure values and the expanded fragrance allergen labelling list. A good origin dossier is valuable input to a UK or EU CPSR; it is not one.

What you must obtain from the manufacturer

• The full quantitative formula. Every ingredient with its exact percentage. Without this no UK or EU CPSR can be written; a percentage range or an ingredient list without quantities is not enough.
• Raw material documentation. Safety Data Sheets and specifications for each ingredient, and the IFRA certificate and allergen statement for each fragrance.
• Manufacturing and GMP information. The method, a GMP statement, and batch records or the ability to obtain them, for section three of the PIF.
• Any existing safety, stability or microbiological data. Useful inputs to Part A even where they do not satisfy Annex I.
• Animal testing information. A statement covering the product and ingredients, essential for the PIF and for the marketing ban on animal tested products.
• Claims evidence. For any claims you intend to carry over.

Formula confidentiality. Manufacturers are often reluctant to disclose full formulas. The common solutions are a non disclosure agreement, disclosure directly to your safety assessor under confidentiality rather than to you, or a mandate under which the manufacturer supplies the assessor's requirements without the importer seeing them. Any of these can work; what cannot work is an assessment without the formula. Put the disclosure mechanism in the supply contract before you commit to stock.

Building the UK or EU CPSR

With the formula and documents in hand, the assessor screens every ingredient against the UK and EU annexes, identifies any that are prohibited, restricted or capped, converts names to INCI, expands fragrances to constituent level for sensitisation and allergen assessment, applies the scientific committee's exposure values for the product type, compiles sourced toxicological profiles, assesses preservation and stability on the evidence, and writes Part B with its conclusion, warnings and conditions for the UK or EU market. Where an ingredient fails the screen, the assessor will say so and the product will need reformulation by the manufacturer or exclusion from the range. The process is otherwise the same as for a domestically made product, and our guides to preparing for a CPSR and to dual market reports apply in full.

The label

Imported labels almost always need work. The ingredient list must use INCI nomenclature in the required order; US style names and some origin conventions differ. Fragrance allergens above the thresholds must be named, which most origin labels do not do. The warnings and instructions required by Part B must appear. The Responsible Person's name and address in the UK or EU must be added, replacing or supplementing the manufacturer's. The nominal quantity, batch code, period after opening or best before date, country of origin and function must all be present, and for EU sales the mandatory information must be in the language of the country of sale. Overstickering is permitted where it is legible and durable, but it must be done to every unit before sale, and the stickered artwork belongs in the PIF.

Notification and the PIF

The importer as Responsible Person notifies each product through SCPN for Great Britain and CPNP for the EU before it is placed on the market, and builds and holds the Product Information File for ten years after the last batch. The PIF for an imported product has the same five sections as any other, and the hardest to fill are usually manufacturing and GMP, which depend on the manufacturer's cooperation, and animal testing, which depends on an honest statement about the product's history. An importer who cannot obtain these has a product they cannot lawfully hold a PIF for.

Great Britain, the EU and Northern Ireland

Imports destined for both Great Britain and the EU need a dual market assessment, a Responsible Person in each, two notifications and a label satisfying both regimes, and imports into Northern Ireland follow EU rules. Importers who bring goods into Great Britain and then move some to the EU are placing them on a second market and take on the EU obligations as well.

Claims that do not travel

Imported products often carry claims that are lawful at origin and problematic here. Korean functional cosmetics may claim whitening, anti wrinkle or UV protection effects under a domestic category that does not exist in the UK or EU. US products may carry acne, dandruff or sun protection claims that make them drugs there and would make them medicines here. Chinese products may carry efficacy claims from their special cosmetics category. Under the UK and EU regime, claims must meet the common criteria of legality, truthfulness, evidential support, honesty, fairness and informed decision making, and anything implying treatment or prevention of disease takes the product outside cosmetics altogether. Review every claim on the origin pack and website before importing, remove or reword those that do not travel, and keep the evidence for the ones you keep in the PIF.

Sunscreens, whitening and other products that often cannot be imported as cosmetics

Some categories deserve particular caution. Sunscreens are cosmetics in the UK and EU but must use only the UV filters in Annex VI at permitted levels, and many US and Asian filters are not on it; a sunscreen that fails this screen cannot be relabelled into compliance. Skin lightening products frequently contain substances prohibited in the UK and EU. Products with hormone like actives, certain hair dyes, and products containing preservatives no longer permitted here are further examples. The screen against the annexes before ordering is what identifies these, and an importer who skips it can find a container of stock that has no lawful route to market.

Putting it in the contract

• Formula disclosure mechanism. To you or directly to your assessor, under confidentiality.
• Document supply obligation. SDS, specifications, IFRA and allergen documents, GMP statement, batch records, animal testing statement.
• Change notification. The manufacturer must tell you before changing any ingredient or supplier, because it invalidates your CPSR.
• Reformulation cooperation. Where the screen finds a non compliant ingredient.
• Labelling responsibility. Who applies the UK or EU label and who approves the artwork.
• Liability and insurance. Reflecting that you carry the Responsible Person's exposure.

A compliance sequence for importers

• Before ordering stock. Obtain the ingredient list and screen it against both annexes; exclude products that fail.
• Agree the contract. With disclosure, documents and change control.
• Commission the CPSR. Dual market if needed.
• Design the label. From Part B and the labelling rules; plan overstickering if required.
• Build the PIF and notify. Before the first unit is sold.
• Establish cosmetovigilance. A channel for reactions and a procedure for reporting serious ones.
• Diarise review. Annual, and on any change at the manufacturer or in the annexes.

A consultation before you place an order will tell you which products in a range can be imported as they are, which need relabelling only, and which need reformulation, and the all in one compliance pack then builds the CPSR, PIF and notification together.

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)