Cosmetic Product Safety Report (CPSR)

The Cosmetic Product Safety Report (CPSR) is the document on which the right to place a cosmetic product on the EU or UK market depends. It is the safety assessor’s reasoned legal opinion that the product, as formulated and labelled, is safe in normal and reasonably foreseeable use. It is the pivotal scientific document within the Product Information File (PIF), though not the only condition of lawful supply: the complete PIF, the notification, the labelling, and the Responsible Person obligations must each be satisfied before a product reaches the market.

The requirement is set out in Article 10 of Regulation (EC) No 1223/2009. The form and content of the report are prescribed in Annex I to the Regulation and elaborated by Commission Implementing Decision 2013/674/EU. Where a product is also placed on the UK market, the report additionally complies with the Cosmetic Products Enforcement Regulations 2013.

The CPSR within the Product Information File

Article 11 requires the Responsible Person to keep a PIF for every product placed on the market. The file comprises a description of the cosmetic product, the CPSR set out in Annex I, a description of the method of manufacture accompanied by a statement of compliance with Good Manufacturing Practice (the harmonised standard is ISO 22716:2007), proof of the effect claimed where the nature of the claim justifies it, and data on any animal testing carried out. The CPSR draws on every other element of the file and must remain consistent with it. A change to the formulation, the method of manufacture, or the supplier of a raw material can require the assessment to be revised and reissued.

Structure of the report: Annex I, Parts A and B

Annex I divides the report into two parts with distinct functions.

Part A, the cosmetic product safety information, sets out the evidence base for the assessment: the quantitative and qualitative composition; the physical, chemical and microbiological characteristics and the stability of the product; impurities, traces and information on the packaging material; normal and reasonably foreseeable use; exposure to the product; exposure to the substances; the toxicological profile of each substance; and undesirable and serious undesirable effects (Annex I, Part A, points 1 to 9).

Part B, the cosmetic product safety assessment, records the assessor’s conclusion as to the safety of the product, any warnings and instructions for use that must appear on the label, and the reasoning that supports the conclusion, with citation to SCCS opinions, CIR Expert Panel conclusions and the toxicological literature, together with the assessor’s credentials and approval (Annex I, Part B, points 1 to 4).

The Margin of Safety

The substance of Part B is a quantitative evaluation of systemic exposure against established toxicological thresholds. For each substance of concern, the Margin of Safety (MoS) is derived as the ratio of the No Observed Adverse Effect Level (NOAEL) to the Systemic Exposure Dose (SED). A Margin of Safety of at least 100 is ordinarily required, corresponding to the standard factors of 10 for interspecies and 10 for intraspecies variation. The exposure inputs, dermal absorption assumptions, and toxicological endpoints follow the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation (12th Revision, SCCS/1647/22). Under Article 10(2) the Part B assessment must be carried out by a person holding a recognised qualification in pharmacy, toxicology, medicine or a similar discipline. Our assessments are conducted and signed by a Clinical Pharmacologist who holds an MSc from the University of Oxford.

United Kingdom and European Union: common structure, diverging annexes

The Annex I structure is identical in both jurisdictions. In Great Britain the Regulation has effect as assimilated law, amended by Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 and enforced under the Cosmetic Products Enforcement Regulations 2013. The Office for Product Safety and Standards (OPSS) is the competent authority, and notification is made through the Submit Cosmetic Product Notification (SCPN) service. In the European Union, notification is made through the CPNP.

The substance annexes have begun to diverge. In the EU, Commission Regulation (EU) 2026/909, the second Omnibus act, entered into force in May 2026 and revised Annexes II, III, V and VI, introducing restrictions on fragrance allergens including benzyl salicylate and the citral group, the UV filter DHHB, certain hair dyes, and aluminium, with most provisions applying from 2027. In Great Britain, SI 2026/23 introduced a separate set of CMR restrictions and reduced the formaldehyde-release labelling threshold, on a timetable that does not align with the EU. Since 1 January 2026 the name and address of the UK Responsible Person must appear on the label of products placed on the GB market; the transitional reliance on Article 19(1)(a) of the EU Regulation ended on 31 December 2025. A formulation that is compliant in one market may consequently require separate assessment for the other.

Turnaround

Timelines run from the point at which the full documentation set is supplied. In practice most of the delay arises before that point, in assembling formulae, specifications and supplier records. Once the complete set is in hand, standard turnaround is typically 2 to 3 working days. For deadline-driven engagements, including products held at a port of entry, a 48-hour service is available at a 50 per cent premium and a 24-hour service at a 100 per cent premium, where the full documentation set is supplied at the point of order.

Fees

The standard Cosmetic Product Safety Report is £220, covering a single product of up to 20 ingredients, with both Part A and Part B as required by Annex I. A single-ingredient product, such as a pure essential oil or a single-component carrier, is £70. Formulations above 20 ingredients carry a graduated additional charge. A variation in essential oil or pigment that requires a full additional report is assessed as a variant at £40. Portfolio pricing applies where products share an evidence base or formulation family, from £875 for a batch of five. All fees are exclusive of VAT and are reviewed annually.

Reports prepared by Oxford Biosciences are issued to the brand owner alone. They are not released to, or through, third-party Responsible Person services; the terms governing use, ownership and onward disclosure are set out in our Non-Disclosure and Intellectual Property Protection Agreement, executed at the point of engagement. To open an assessment, provide the full quantitative formula, the method of manufacture, and the intended markets.