UK Cosmetic Product Safety Report
Q.01
What is a CPSR for cosmetics in the UK?
A.01
A Cosmetic Product Safety Report (CPSR) is the documented safety assessment that has to exist for every cosmetic product before it is placed on the GB market. Under the UK Cosmetics Regulation (Regulation (EC) No 1223/2009 as retained in GB), Article 10 says the responsible person shall, before placing the product on the market, make sure it "has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I" [1]. Its purpose is to show that the product meets Article 3: it must be safe for human health under normal or reasonably foreseeable conditions of use, taking account of presentation, labelling, instructions for use and disposal [2].
Approach: I read Articles 2, 3, 4, 10 and 11 and Annex I of the GB-retained Cosmetics Regulation in its current revised text on legislation.gov.uk.
Who is responsible
- The responsible person must be established in the UK. Depending on the supply route, that is the UK manufacturer, the importer, a person they appoint by written mandate, or a distributor who sells the product under its own name or modifies it [3].
- The responsible person shall make sure the assessment takes into account the intended use and the expected systemic exposure to each ingredient, uses a weight-of-evidence approach across all existing data, and that the CPSR "is kept up to date" with new information after launch [1].
Who can sign it
- The Part B assessment "shall be carried out" by someone holding a university diploma, or other formal qualification from a university course of theoretical and practical study, in pharmacy, toxicology, medicine or a similar discipline. A course the Secretary of State recognises as equivalent also counts [1].
- Non-clinical safety studies done after 30 June 1988 for the assessment must comply with the Good Laboratory Practice Regulations 1999, or with international standards the Secretary of State recognises as equivalent [1].
Minimum content (Annex I)
Part A, Cosmetic product safety information [4][5]
- Qualitative and quantitative composition: chemical identity of each substance (chemical name, INCI, CAS, EINECS/ELINCS where possible) and its function. For perfumes, the composition's name, code number and supplier.
- Physical and chemical characteristics, and stability under reasonably foreseeable storage conditions.
- Microbiological quality, including preservation challenge test results. Extra attention applies to products used around the eyes, on mucous membranes or damaged skin, on children under three, on elderly people and on people with weakened immune responses.
- Impurities and traces (including evidence that traces of prohibited substances are technically unavoidable), and the purity and stability of the packaging material.
- Normal and reasonably foreseeable use, justified against the warnings on the label.
- Exposure to the product: site and surface area of application, amount applied, how long and how often it is used, exposure routes, and the population exposed. Secondary exposure (for example inhaling spray) and the effect of particle size are also considered.
- Exposure to each substance for the relevant toxicological endpoints.
- Toxicological profile of each substance. The focus is on skin and eye irritation, skin sensitisation and, where the substance absorbs UV, photo-induced toxicity. A margin of safety (MoS) based on a NOAEL "shall be calculated", and leaving it out must be justified. Nanomaterials, impurities and interactions between substances must be considered, and any read-across must be substantiated.
- All available data on undesirable effects and serious undesirable effects, including statistical data.
- Other relevant information, such as studies in human volunteers.
Part B, Cosmetic product safety assessment [5]
- The conclusion: a statement on the product's safety in relation to Article 3.
- Whether particular warnings and instructions for use need to go on the label (Article 19(1)(d)).
- The scientific reasoning behind the conclusion, based on Part A. This must include a specific assessment for products meant for children under three and for products meant only for external intimate hygiene, plus interactions between substances and the effect of stability on safety.
- The assessor's name, address, proof of qualification, date and signature.
Where it sits
- The CPSR is one part of the Product Information File (PIF), under Article 11(2)(b). The PIF also holds a product description, the manufacturing method and a statement of compliance with good manufacturing practice, proof of claimed effects where justified, and any animal-testing data [6].
- The PIF shall be kept for ten years after the last batch is placed on the market. It must be readily accessible to the competent authority at the address notified under Article 13, and it must be in English [6].
On scope: these definitions apply to the market of Great Britain [7]. I did not research the Northern Ireland position separately.
Q.02
Who can sign the safety assessment?
A.02
In GB, the Part B safety assessment of the CPSR "shall be carried out" by a person holding a diploma or other evidence of formal qualifications awarded at the end of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course the Secretary of State recognises as equivalent [1].
Approach: I read Article 10 and Annex I Part B of the GB-retained Cosmetics Regulation (Regulation (EC) No 1223/2009 as it applies in Great Britain).
What the rule covers
- Only Part B needs the qualified assessor. Article 10(2) applies the qualification to "the cosmetic product safety assessment, as set out in Part B of Annex I" [1]. Part B holds the safety conclusion, the statement on label warnings, and the scientific reasoning [5]. The text sets no assessor qualification for putting together the Part A safety information.
- The assessor signs and dates Part B. Section 4 of Part B, "Assessor's credentials and approval of part B", requires the safety assessor's name and address, proof of their qualification, and their date and signature [5].
- The responsible person is a separate role. The responsible person "shall" make sure the product has had a safety assessment and that a CPSR is set up under Annex I before the product is placed on the market. They also keep the report up to date after launch [1]. They are not required to sign the assessment themselves unless they hold the qualification.
Points to note
- The text names three disciplines and then says "or a similar discipline". It gives no list of what counts as similar.
- The equivalence route runs through recognition by the Secretary of State, not by an EU body [1]. I did not find a published list of recognised equivalent courses in the GB text I read.
- Article 10(2) sets no requirement on where the assessor lives or is based. The UK-establishment requirement applies to the responsible person, not the assessor.
Q.03
What does the report need to contain?
A.03
In GB, Annex I of the Cosmetics Regulation says the CPSR "shall, as a minimum, contain" two parts. Part A is the safety information (10 sections), and Part B is the qualified assessor's safety assessment (4 sections) [4].
Approach: I read Annex I of the GB-retained Cosmetics Regulation (Regulation (EC) No 1223/2009 as it applies in Great Britain), as published on legislation.gov.uk.
Part A: Cosmetic product safety information [4][5]
| # | Section | What it must cover |
|---|---|---|
| 1 | Quantitative and qualitative composition | The chemical identity of each substance (chemical name, INCI, CAS, EINECS/ELINCS where possible) and its intended function. For perfume and aromatic compositions: the composition's name and code number, and who supplies it. |
| 2 | Physical/chemical characteristics and stability | The physical and chemical characteristics of the substances or mixtures and of the finished product, and the product's stability under reasonably foreseeable storage conditions. |
| 3 | Microbiological quality | Microbiological specifications of the raw materials and of the product, and the results of the preservation challenge test. "Particular attention shall be paid" to products used around the eyes, on mucous membranes, on damaged skin, on children under three, on elderly people and on people with compromised immune responses. |
| 4 | Impurities, traces, packaging | Purity of the substances and mixtures. Where traces of prohibited substances are present, evidence that they are technically unavoidable. The relevant characteristics of the packaging material, in particular its purity and stability. |
| 5 | Normal and reasonably foreseeable use | The reasoning "shall be justified", in particular against the warnings and other explanations on the label. |
| 6 | Exposure to the product | Site(s) and surface area(s) of application, amount applied, duration and frequency of use, exposure route(s), and the target or exposed population(s), including any specific population. Exposure is calculated in a way that fits the toxicological effects being considered (for example per unit area of skin or per kg body weight). Secondary exposure, such as inhaling sprays or swallowing lip products, should be considered. "Particular consideration shall be given" to how particle size affects exposure. |
| 7 | Exposure to the substances | Exposure to each substance for the relevant toxicological endpoints, using the Section 6 data. |
| 8 | Toxicological profile of the substances | All relevant endpoints, with a particular focus on skin and eye irritation, skin sensitisation and, where the substance absorbs UV, photo-induced toxicity. The section must consider all significant absorption routes and systemic effects, and a margin of safety (MoS) based on a NOAEL "shall be calculated". If any of this is left out, the omission "shall be duly justified". It must also consider particle size (including nanomaterials), impurities in substances and raw materials, and interactions between substances. Any read-across shall be substantiated and justified, and sources shall be clearly identified. This applies without prejudice to Article 18. |
| 9 | Undesirable effects and serious undesirable effects | All available data, including statistical data, for this product or, where relevant, other cosmetic products. |
| 10 | Information on the cosmetic product | Other relevant information, for example existing studies in human volunteers, or confirmed findings of risk assessments done in other relevant areas. |
Part B: Cosmetic product safety assessment [5]
- Assessment conclusion: a statement on whether the product is safe in relation to Article 3.
- Labelled warnings and instructions of use: a statement on whether particular warnings or instructions need to go on the label under Article 19(1)(d).
- Reasoning: the scientific reasoning behind the conclusion and the labelling statement, based on Part A. It must include:
- an assessment and discussion of margins of safety, where relevant;
- a specific assessment for products meant for children under three, and for products meant only for external intimate hygiene;
- an assessment of possible interactions between the substances;
- a justification for which toxicological profiles were or were not considered;
- "due" consideration of how the product's stability affects its safety.
- Assessor's credentials and approval: the safety assessor's name and address, proof of their qualification, and the date and their signature.
The annex sets a minimum. It does not prescribe a format, and you can add more than it lists.
Q.04