Introduction

Every cosmetic and personal-care product sold in the UK or EU — moisturisers, serums, shampoos, conditioners, lip products, foundation, deodorant, sunscreen and every other leave-on or rinse-off cosmetic — requires a formal safety assessment before it can legally reach the market. This is set out in Article 3 and Annex I of Regulation (EC) No 1223/2009, and applies identically in Great Britain under the retained version of the Regulation enforced by the Office for Product Safety and Standards (OPSS). There is no exemption for small businesses, low sales volumes, or handmade/artisan production.

Spectra prepares a full CPSR for your single-formulation beauty product, confirming every ingredient is compliant with the relevant Annexes and that the product is safe for its intended use, backed by a signed conclusion from an assessor holding a recognised qualification in toxicology, pharmacy, medicine or an equivalent discipline.

What a Beauty CPSR Covers

Because beauty and personal-care formulations vary enormously from a simple single-oil serum to a complex multi-phase emulsion with active ingredients, preservatives, UV filters and fragrance the assessment scope adapts to your specific product type, but always covers the same core areas required under Annex I.

What's Included

• Ingredient-by-ingredient toxicological evaluation, screened against:
• Annex II — substances prohibited in cosmetic products
• Annex III — substances subject to restrictions (maximum concentration, product type, warnings required)
• Annex IV — permitted colourants
• Annex V — permitted preservatives
• Annex VI — permitted UV filters
  
  
• Margin of Safety (MoS) calculation using NOAEL data and a realistic exposure assessment based on your product's application method, frequency and retention
• Physico-chemical and stability assessment, including formulation type, expected shelf stability and packaging material compatibility
• Microbiological quality review, relevant to preservation efficacy and product type (particularly for water-based, rinse-off or eye-area products)
• Allergen and fragrance screening, where a fragrance component is present, against Annex III declaration thresholds
• Signed safety conclusion, including any conditions of use, warnings or age restrictions that must appear on your label
• PIF-ready documentation, structured to Annex I Part A and Part B for direct inclusion in your Product Information File

Legal & Regulatory Framework

• Article 3, Regulation (EC) No 1223/2009 — general safety obligation
• Annex I, Regulation (EC) No 1223/2009 — CPSR content and structure requirements
• Schedule 34, Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/696) — UK retained legislation, in force since 1 January 2021
• Cosmetic Products Enforcement Regulations 2013 (SI 2013/1478) — enforcement powers and offences under UK law
• SCCS Notes of Guidance — safety assessment and exposure methodology
• Annexes II–VI — substance-specific restrictions and permitted use lists

Under this framework, your Responsible Person must keep the signed CPSR within the Product Information File, retained for 10 years after the last batch of the product is placed on the market, held in English, and made available to enforcement authorities such as Trading Standards on request. The CPSR must also be kept up to date a reformulation, a new supplier, or newly published safety data on an ingredient can all trigger the need for a review.

Who Needs This Service

• New skincare, haircare, makeup and personal care brands preparing for their first UK or EU launch
• Established brands launching a new product outside their existing certified range
• Contract manufacturers and private-label producers preparing documentation on behalf of a brand client
• Handmade and small-batch producers — there is no size-based exemption from the CPSR requirement
• Brands reformulating an existing product where the change affects safety-relevant properties

Process & Turnaround

1. Information collection — you provide your full INCI formulation with percentages, raw-material SDS, and label artwork.
2. Ingredient screening — every material is checked against the relevant Annexes and current SCCS guidance.
3. Toxicological assessment — NOAEL data and your product's specific exposure scenario determine the MoS calculation.
4. Drafting — Annex I Parts A and B are compiled into a first draft.
5. Review and sign-off — the report is checked and formally signed by a qualified assessor.
6. Delivery — your completed CPSR and PIF integration notes are delivered.

Deliverables

• Signed CPSR (Parts A & B), formatted to Annex I
• Ingredient compliance summary against Annexes II–VI
• Conditions-of-use and labelling guidance
• PIF-ready documentation package

Why Choose Spectra

Formulations differ hugely between product categories, and a generic template report is one of the most common reasons a CPSR is challenged at inspection. Spectra's assessors tailor the scope of review to your specific product type a rinse-off shampoo is assessed differently to a leave-on eye cream while keeping the documentation structured exactly as OPSS and EU competent authorities expect to see it.

FAQs

Is a CPSR legally required for every beauty product, no matter how small the brand? Yes. There is no exemption based on business size, sales volume, or handmade production status. Without a valid CPSR, a cosmetic product cannot lawfully be placed on the UK or EU market.

Who is legally permitted to prepare a CPSR?
Only a person holding a recognised qualification in toxicology, pharmacy, medicine or an equivalent discipline recognised by the relevant authority. Spectra's assessors meet this requirement.

What happens if my product formulation changes after the CPSR is issued? Regulation (EC) No 1223/2009 requires the CPSR to be kept up to date in view of any new relevant information. A change to ingredients, concentrations, packaging or intended use should trigger a review of the existing report in some cases, a new CPSR.

How long must the CPSR be kept on file? Your Responsible Person must retain it within the Product Information File for 10 years after the last batch of the product is placed on the market.

Can this CPSR support both a UK and EU launch?
Yes it's prepared against the shared underlying Regulation both jurisdictions apply, and feeds into either SCPN (UK) or CPNP (EU) notification.

What do you need from me if I don't have formal lab documentation yet?
At minimum, your complete formulation with percentages and raw material safety data sheets from your suppliers. We can advise on what additional data (e.g. stability or preservative efficacy testing) may be needed for your specific product type.