Frequently asked questions

At Oxford Biosciences the standard Cosmetic Product Safety Report is £220, covering a single product of up to 20 ingredients. A single-ingredient product is £70, and a variation in essential oil or pigment that requires a full additional report is £40. Portfolio pricing applies to batches, from £875 for five products. All fees are exclusive of VAT. Timelines run from receipt of the full documentation set: standard turnaround is then typically 2 to 3 working days, with a 48-hour service at a 50 per cent premium and a 24-hour service at a 100 per cent premium where the complete set is supplied at the point of order.

A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.

Article 10(2) of Regulation (EC) No 1223/2009 requires that the Part B safety assessment be carried out by a person holding a diploma in pharmacy, toxicology, medicine or a similar discipline. At Oxford Biosciences every assessment is conducted and signed by a Clinical Pharmacologist who holds an MSc from the University of Oxford. The assessor's credentials and approval form part of Part B and are the basis on which a competent authority evaluates the report.

A MoCRA Toxicological Risk Assessment is the safety substantiation the Modernization of Cosmetics Regulation Act 2022 requires a US responsible person to hold. Oxford Biosciences prepares it as a fixed-fee engagement, covering the federal requirement together with the state-level provisions that apply in California (Proposition 65, the Safe Cosmetics Act and the Toxic-Free Cosmetics Act), Washington, New York and Minnesota. It is prepared and signed by the same Clinical Pharmacologist who signs our EU and UK CPSRs, and can be produced in multiple languages.

MoCRA, the Modernization of Cosmetics Regulation Act 2022, is the first comprehensive federal cosmetics law in the United States. It amended the Federal Food, Drug, and Cosmetic Act to require registration of manufacturing facilities with the FDA, product listing, adequate substantiation of product safety, adverse event recordkeeping and reporting, and a named responsible person. Oxford Biosciences prepares the MoCRA-compliant Toxicological Risk Assessment that substantiates safety, with the relevant US state provisions addressed alongside it.

Not always. The evidence has to be proportionate to the claim. A quantified claim such as a percentage reduction in wrinkle depth needs instrumental measurement on a panel, while a softer appearance claim can often rest on expert grading or validated self-assessment.

A clinical efficacy study starts from £5,000 plus VAT, with panel sizes scoped to the claim being substantiated, and the 60-subject panel the benchmark for broadcast advertising. The cost sits in the fixed study infrastructure rather than the per-subject rate, so it does not fall in proportion to panel size.

Plan for three to five months end to end. The timeline is driven by the in-use observation period, typically 8 to 12 weeks for wrinkle, pigmentation and brightening endpoints, with protocol design, ethics and recruitment before it and analysis and reporting after.

Cosmetic claims are regulated as statements of fact, not marketing copy. Article 20 of Regulation (EC) No 1223/2009 and Commission Regulation (EU) No 655/2013 establish six Common Criteria that every claim must meet: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. Evidence must exist before a claim is published and remain on file. Oxford Biosciences reviews claims individually against the six Common Criteria and prepares formal Claims Substantiation Dossiers suitable for the Product Information File and for production to a competent authority or the Advertising Standards Authority.

Article 19 of Regulation (EC) No 1223/2009 sets out the mandatory particulars: the Responsible Person's name and address, the nominal content, the date of minimum durability or the period-after-opening (PAO) symbol, precautions for use, the batch number, the product function, and the list of ingredients in INCI nomenclature. In Great Britain the same requirements apply through the Cosmetic Products Enforcement Regulations 2013, and since 1 January 2026 the UK Responsible Person's details must appear on the label of products sold in GB. Oxford Biosciences reviews packaging artwork against these requirements as a fixed-fee engagement, quoted on request.

A Preservative Efficacy Test, also called a challenge test, demonstrates that a product's preservative system controls microbial growth across its life. Oxford Biosciences performs it to ISO 11930: the product is inoculated with the five specified challenge organisms (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus brasiliensis), and viable counts are enumerated over a 28-day window against the Criterion A or B log-reduction thresholds. Typical turnaround is six weeks, reflecting the protocol duration plus enumeration and reporting.

Oxford Biosciences operates three in-house laboratories supporting Annex I, sections 3 to 5 of Regulation (EC) No 1223/2009. Services include microbiology (Preservative Efficacy Test to ISO 11930, Microbial Content Test to ISO 17516:2014), real-time and accelerated stability and packaging compatibility, photoprotection testing (in vitro and in vivo SPF and UVA-PF under the current ISO series), and analytical work including heavy metals by ICP-MS, antioxidant capacity by the DPPH assay, and GC/MS constituent analysis of essential oils, hydrolats and perfumes. Analytical work is not contracted out.

EU rules. Under the Windsor Framework, cosmetics placed on the Northern Ireland market follow the EU Cosmetics Regulation, while Great Britain follows the assimilated UK regime, so a product sold across the whole UK may need to meet two diverging sets of requirements.

Selling cosmetics on Amazon UK carries the same legal requirements as any Great Britain sale: a valid Cosmetic Product Safety Report, a UK-established Responsible Person, SCPN notification to the Office for Product Safety and Standards, and compliant labelling, including the UK Responsible Person's details on the label since 1 January 2026. Marketplaces increasingly ask sellers to evidence this documentation. Oxford Biosciences provides the CPSR, acts as your UK Responsible Person, and manages the SCPN notification so your listings meet the requirement.

SI 2026/23 bans the UV filter 4-MBC from 15 July 2026, adds sixteen CMR-classified substances to the prohibited list from 15 August 2026, and lowers the labelling threshold for formaldehyde-releasing substances to 0.001 per cent. Northern Ireland is unaffected, as it follows the EU regime.

A UK Cosmetic Product Safety Report from Oxford Biosciences is £220 for a single product of up to 20 ingredients, the same report that serves the EU market under Annex I of Regulation (EC) No 1223/2009. A single-ingredient product is £70, variants are £40, and batch pricing applies from £875 for five products. Once the full documentation set is supplied, turnaround is typically 2 to 3 working days, with 48-hour and 24-hour expedited service available. All fees are exclusive of VAT.

To sell a cosmetic product in Great Britain you must appoint a UK Responsible Person established in the UK, who takes legal responsibility for compliance, holds the Product Information File, and notifies the product through the SCPN service to the Office for Product Safety and Standards. Since 1 January 2026 the UK Responsible Person's name and address must appear on the product label for goods placed on the GB market. Oxford Biosciences acts as UK Responsible Person through Oxford Biosciences Ltd, and as EU Responsible Person through our Irish-registered entity, under a single quality management system.

SCPN, the Submit Cosmetic Product Notification service, is the UK government system through which cosmetic products are notified before being placed on the Great Britain market. It replaced reliance on the EU's CPNP for GB after Brexit. Notification is made by the UK Responsible Person and is overseen by the Office for Product Safety and Standards (OPSS). A product should be notified only once it has been assessed as safe. Oxford Biosciences manages SCPN notification as part of its UK Responsible Person service.

No. Cosmetics do not carry CE or UKCA marks. Those conformity marks apply to other product groups such as electronics, toys, machinery, personal protective equipment and medical devices, not to cosmetics. In the EU a cosmetic demonstrates compliance through a Cosmetic Product Safety Report under Regulation (EC) No 1223/2009, notification on the CPNP, and an EU Responsible Person. In Great Britain it is the same evidence under the UK Cosmetics Regulation, notified through the SCPN with a UK-based Responsible Person. If a supplier or manufacturer tells you a cosmetic needs a CE or UKCA mark, they have confused cosmetics with a different product category. Oxford Biosciences prepares the safety report, notification and Responsible Person designation that actually establish cosmetic compliance.

An apostille is a single certificate that authenticates a document for any country party to the 1961 Hague Apostille Convention. For countries outside the convention, full consular legalisation through the destination's embassy is needed instead, often after notarisation and government legalisation.

A Certificate of Free Sale confirms that a product is freely and legally sold in its country of origin. Many importing authorities require one before they will register or admit an imported cosmetic, often legalised or apostilled, and sometimes with a sworn translation.

The underlying safety science can be reused, but the filing cannot. A single master evidence base supports many markets, yet each needs its own assessment format, registration or notification, and usually its own local representative, with the formulation re-checked against that market's ingredient lists.

In the EU and UK, to child-specific exposure factors in the SCCS Notes of Guidance, using a child's body weight, surface area and use patterns rather than an adult's, with a higher margin of safety expected. Products for children under three require a specific assessment of suitability under Annex I.

In the EU and UK, several ingredients carry child-specific limits or warnings, including triclosan and triclocarban (warnings against use for young children), fluoride (child-supervision guidance), and ingredients such as camphor, menthol and certain essential oils treated with caution. Fragrance-allergen content is minimised and hypoallergenic claims must be evidenced.

Yes. Since 1 January 2021 Great Britain and the EU run separate cosmetic regimes. A product sold in both needs a Responsible Person in each, a notification in each (SCPN and CPNP), market-specific labelling, and checking against both sets of annexes, which are now diverging.

The safety assessment can be shared, but it must be checked against both regimes. A single CPSR can underpin GB and EU sales, signed against both, yet the formulation has to be assessed against each regime's annexes, which now differ, so a product can be compliant in one and not the other.

Yes, if you sell in both. The Responsible Person must be established in the market it covers, so a UK-established RP is needed for Great Britain and an EU-established RP for the EU. One address cannot serve both, and the easement that allowed an EU address on GB packs has been winding down.

In the EU and UK, it depends on the source. Cannabidiol prepared as an extract or tincture of cannabis is prohibited under Annex II entry 306, but synthetically produced CBD and CBD isolate outside that prohibition are permitted. The product must also stay within THC and controlled-cannabinoid limits and make no medicinal claims.

In the EU and UK, yes: Cannabis sativa seed oil and other seed- and stem-derived ingredients are permitted in cosmetics because they come from the seeds and stems rather than the prohibited flowering tops, provided the THC content stays within the hemp limit of 0.2%.

Yes, for general cosmetics. China exempts imported general cosmetics from mandatory animal testing where the applicant supplies a safety assessment and a GMP certificate from the manufacturing country's competent authority, and the UK issues such certificates.

Yes. Under Article 6 of the CSAR, a company based outside China must appoint a China-established domestic responsible person, who signs the dossier, responds to NMPA audits, keeps import records, and carries the adverse-reaction reporting duty.

Yes. The simplified transitional report has been withdrawn and a full product safety assessment report is now required. Special cosmetics, infant and children's products, and products containing a monitored new ingredient always need the full report.

Special cosmetics (hair dyes, perming products, sunscreens, freckle and whitening products, anti-hair-loss products, and any new-function product) require NMPA registration with a five-year certificate. General cosmetics require only notification, which does not expire.

Through the NMPA, by registration for higher-risk new ingredients or notification for lower-risk ones, followed by a three-year safety-monitoring period before the ingredient is added to the Inventory of Existing Cosmetic Ingredients in China (IECIC).

In the EU, yes: under Article 16 of Regulation 1223/2009 a cosmetic containing a nanomaterial must be notified to the European Commission six months before being placed on the market, in addition to the standard CPNP notification, with safety data specific to the nano form.

In the EU and UK, a toxicological dossier built to the SCCS Notes of Guidance (12th revision, SCCS/1647/22): the core endpoints including genotoxicity, skin sensitisation, repeated-dose toxicity and dermal absorption, generated by non-animal methods, with a margin of safety calculated from the exposure.

In the EU and UK, usually not: the manufacturer supplies the formula, manufacturing method, GMP statement and quality data; the Responsible Person, normally the brand or an appointed party, holds the CPSR, PIF and notification and carries the legal duty. A manufacturer is the RP only if it has expressly agreed to be.

In the EU and UK, cosmetic good manufacturing practice is the set of production, quality-control and documentation standards a cosmetic must be made to. ISO 22716 is the recognised GMP standard for cosmetics, and compliance gives a presumption of conformity. A GMP statement and manufacturing method form part of the Product Information File.

In the EU and UK, aerosol cosmetics such as hairsprays, dry shampoos and spray deodorants fall under the Aerosol Dispensers Directive 75/324/EEC (and the GB Aerosol Dispensers Regulations 2009) as well as the Cosmetics Regulation, adding flammability classification, pressure requirements and aerosol labelling, plus control of propellant impurities.

In the EU and UK, only substances on the hair-dye entries of Annex III to Regulation 1223/2009 may be used as oxidative colourants, each at a set maximum concentration and condition. The label must carry the prescribed allergy warning, advise against use on eyebrows and eyelashes, and recommend an allergy-alert test.

In the EU and UK, a product-by-product audit of whether the CPSRs are valid and properly signed, Responsible Persons are in place and transferable, PIFs complete, notifications current, claims substantiated and labels compliant, plus the portfolio's exposure to recent and forthcoming ingredient bans, delivered as a costed report.

In the EU and UK, only colorants listed in Annex IV to Regulation 1223/2009 may be used, each with its permitted field of application, maximum concentration and purity criteria. Some are not allowed near the eyes and some not on the lips or mucous membranes, so colorants must be checked against where the product is used.

In the EU, under Regulation (EU) 2023/2055, loose plastic glitter and rinse-off microbeads were banned from 17 October 2023. Rinse-off cosmetics must be reformulated by October 2027, leave-on by October 2029, and make-up, lip and nail products by October 2035, with a microplastics label required from October 2031.

ISO 16128 provides a method for calculating the natural, naturally derived and organic content of ingredients and products, but it is not a certification or safety standard. COSMOS (through Ecocert, the Soil Association, Cosmebio and others) and NATRUE are the recognised certification schemes with audited thresholds.

In the EU and UK, there is no legal definition of natural or organic in EU or UK cosmetics law, so the claim must be substantiated under the Common Criteria and the Commission's Technical Document. Voluntary standards such as ISO 16128, COSMOS and NATRUE provide a recognised basis, but certification does not exempt the claim from the law.

In the EU and UK, preservatives may only be used if listed in Annex V, within its limits. Methylisothiazolinone is prohibited in leave-on products and limited to 0.0015% in rinse-off; several parabens are banned and the rest capped; phenoxyethanol is limited to 1%. The system must also be proven effective by challenge testing.

A deodorant that masks odour is a cosmetic. An antiperspirant reduces sweating, a physiological effect, which makes it an over-the-counter drug in the United States, while in the EU and UK aluminium-salt antiperspirants remain cosmetics. The SCCS has concluded aluminium in antiperspirants is safe at typical use levels.

In the EU and UK, hydroquinone is prohibited in cosmetics. Alpha-arbutin, arbutin and kojic acid are permitted within limits set by Regulation (EU) 2024/996 because they can release or behave like hydroquinone: alpha-arbutin to 2% in face creams and 0.5% in body lotions, arbutin to 7% in face creams, and kojic acid to 1% in face and hand products.

In the EU, Commission Regulation (EU) 2024/996 caps retinol, retinyl acetate and retinyl palmitate at 0.05% retinol equivalent in body lotion and 0.3% retinol equivalent in other leave-on and rinse-off products, with a mandatory vitamin A warning. The limits applied from 1 November 2025, with sell-through to 1 May 2027.

Before sale in the UK or EU a cosmetic needs a CPSR signed by a qualified assessor, a Responsible Person established in the market, a Product Information File, a notification (SCPN for GB or CPNP for the EU) and a compliant label. All must be in place before the first sale, and no UKCA or CE mark is required.

In the EU and UK, yes: where it acts mainly by physical means rather than by a cosmetic action. Some barrier, mechanically exfoliating and dermal-filler products fall under the EU Medical Devices Regulation 2017/745 or the UK Medical Devices Regulations, a separate and more onerous regime than cosmetics.

In the EU and UK, a cosmetic is defined by Article 2 of Regulation 1223/2009. A product becomes a medicinal product under Directive 2001/83/EC either by presentation (its claims) or by function (a pharmacological, immunological or metabolic action), and where it could be both, the medicines regime takes precedence.

Sunscreens, anti-dandruff shampoos, anticavity (fluoride) toothpastes, antiperspirants, acne treatments and skin protectants are over-the-counter drugs in the US, regulated under FDA monographs rather than as cosmetics, so they fall outside the cosmetic MoCRA pathway.

In the EU and UK, animal testing of cosmetics is already banned under Article 18 of Regulation 1223/2009, so 'not tested on animals' is the baseline for every product and cannot fairly be presented as a special virtue. A 'cruelty-free' claim is best supported by an auditable certification such as Leaping Bunny, and the brand's China route should be checked.

Vegan means no animal-derived ingredients, such as beeswax, lanolin, carmine, honey or collagen. There is no legal definition, so the claim is substantiated through the full formulation and often a scheme such as The Vegan Society, and it must meet the Common Criteria like any other claim.

In the EU and UK, yes: decanting a bulk product into sample or travel sizes, or repackaging it, creates a product that needs its own label and safety coverage. The original CPSR and label do not automatically carry over, because the packaging, exposure and label have changed.

In the EU and UK, every product in the box needs a Responsible Person, CPSR, notification and compliant label for its market. Sourcing products from abroad can make the curator the importer and Responsible Person, and multi-brand boxes need per-item documentation and batch traceability for recalls.

In the EU and UK, Regulation (EU) No 655/2013 requires every claim to be truthful and supported by evidence. 'Dermatologically tested' needs at least one dermatological study on the finished product, ROAT or HRIPT. 'Hypoallergenic', 'non-sensitising' or 'suitable for sensitive skin' needs an HRIPT, and usually both tests.

No. A skin compatibility study on a finished cosmetic product administers a cosmetic, not a medicinal product, so it is not a clinical trial within Article 2(2) of Regulation (EU) No 536/2014 in the EU or the Medicines for Human Use (Clinical Trials) Regulations 2004 in the UK, and does not require Research Ethics Committee approval. It is still conducted under the Declaration of Helsinki with informed consent, adverse event reporting and GDPR-compliant data handling.

No. The SCCS has been consistent in its Notes of Guidance that human testing is not an acceptable means of identifying a sensitisation hazard. The HRIPT is a confirmatory study on a finished product that the safety assessment has already found to present a low sensitisation risk.

Induction: a patch of the product is applied to the same site on the back for 24 hours, read, and reapplied three times a week for three weeks, nine applications in total. Rest: 10 to 14 days with no product. Challenge: a single patch on a naive site, read at 24, 48 and 72 hours. A reaction at the naive site that appears or intensifies at 48 to 72 hours indicates sensitisation.

The MCII is the average, across all subjects, of each subject's total erythema and oedema scores divided by the number of readings. Below 0.25 is non-irritating; 0.25 to 0.50 very slightly irritating; 0.50 to 1.00 slightly irritating; 1.00 to 2.00 moderately irritating; 2.00 and above irritating. The maximum possible value is 6.

2 g of undiluted product is applied to the antecubital fossa daily for 5 days, with deionised water on the other arm as control. A trained assessor scores erythema and oedema on a 0 to 3 scale at 30 minutes, 24 hours and then daily under standardised light. A Cumulative Irritation Index is calculated per subject and averaged across the panel.

A ROAT (Repeated Open Application Test) applies the product openly to the inner elbow daily for 5 days on 10 subjects and measures irritation. An HRIPT (Human Repeat Insult Patch Test) applies nine patches over three weeks, rests, then re-challenges a naive site on 50 or more subjects to detect sensitisation. Irritation and sensitisation are different mechanisms and need different tests.

Under Article 6 of Regulation 1223/2009 and the retained GB duties, a distributor must check the label carries the Responsible Person, batch and durability details and meets language rules, not supply products it should presume non-compliant, protect compliance in storage and transport, keep traceability, and cooperate in any recall.

In the EU and UK, for each supplier and line confirm a Responsible Person exists, the product has been notified (SCPN or CPNP) and the label is compliant, and hold that documentation. For own-brand or imported lines the retailer is itself the Responsible Person and needs the full compliance set.

DPPH is a nitrogen-centred radical whose unpaired electron is delocalised across two phenyl rings and a picryl group, which makes it stable and violet. An antioxidant donates a hydrogen atom, or an electron followed by a proton, pairing the electron and converting the radical to the pale yellow hydrazine DPPH-H.

The sample is diluted or extracted into methanol at a series of concentrations and mixed in triplicate with a fresh DPPH solution of about 60 to 100 µmol/L. The reaction runs in the dark at 25 °C and absorbance at 517 nm is followed until it plateaus. Each run includes a DPPH-only control, sample blanks for coloured samples, a Trolox calibration series and a positive control.

Percentage inhibition is the fraction of DPPH radicals scavenged at a given sample concentration. IC50 is the concentration at which 50 percent are scavenged; lower means more potent. Trolox equivalents express the sample's capacity relative to Trolox, a water-soluble vitamin E analogue, in µmol TE per gram, and are the most useful figure for comparing products and batches.

DPPH is a synthetic radical that does not occur in skin, is soluble only in organic solvents, and is affected by solvent, pH, steric hindrance and coloured compounds. It measures a property of the product, not an effect on the consumer, so it substantiates 'contains antioxidants' but not 'protects skin from free radical damage'.

A DPPH result substantiates claims about a property of the product: 'contains antioxidants', 'with antioxidant [ingredient]', 'antioxidant activity', and comparisons between the brand's own formulations. It does not on its own substantiate claims about an effect on the consumer, such as protection of the skin from free radical damage, oxidative stress, pollution or ageing.

The DPPH assay measures how effectively a product, extract or ingredient neutralises a stable free radical, 2,2-diphenyl-1-picrylhydrazyl, in solution. The radical is violet and absorbs at 517 nm; as antioxidants reduce it the colour fades, and the fall in absorbance is proportional to radical scavenging capacity.

10 g of finished product or 5 g of extract, oil or raw material, from a single batch, in amber glass or opaque packaging protected from light, with the formulation so the antioxidant of interest can be identified. Results are reported within 5 working days.

No. East Asia has no mutual recognition between markets. China, Japan, South Korea and Taiwan each run their own regime, and each requires its own filing and a locally established entity.

Through a framework engagement with a named assessor who holds the portfolio's data, keeps the safety reports current as the annexes change, coordinates Responsible Person roles and notifications across markets, and monitors regulatory change so affected products are flagged before an audit.

In the EU, two amendments to Regulation 1223/2009 took effect in 2026: Omnibus VIII (Regulation (EU) 2026/78), in force 1 May 2026, prohibiting newly classified CMR substances; and the second ingredient Omnibus (Regulation (EU) 2026/909), in force 18 May 2026, revising restrictions on Citral, Benzyl Salicylate, water-soluble zinc salts and the UV filter DHHB.

In the EU, only UV filters listed in Annex VI may be used, at set limits. Homosalate is now restricted to face products at 7.34% (Regulation 2022/2195), and benzophenone-3 and octocrylene were cut by Regulation 2022/1176 (BP-3 to 6% face / 2.2% body). 4-MBC is banned. Nanoform filters need Article 16 notification.

In the EU and UK, SPF is measured in vivo to ISO 24444 and UVA protection in vitro to ISO 24443, with water resistance by its own method. EU Recommendation 2006/647/EC requires UVA protection of at least a third of the labelled SPF, shown by the UVA-in-a-circle symbol, with SPF communicated in categories from low to very high.

In the EU and UK, a cosmetic toothpaste may contain up to 0.15% fluoride (1500 ppm) under Annex III, and fluoride toothpastes must carry the prescribed child-supervision warning. Above that, high-fluoride toothpastes (2800 or 5000 ppm) are medicines, not cosmetics, and in the US fluoride toothpaste is an over-the-counter drug.

In the EU and UK, under Annex III a product containing or releasing up to 0.1% hydrogen peroxide can be sold to consumers as a cosmetic. Between more than 0.1% and 6% it may only be supplied through a dental practitioner and not used on under-18s. At 6% or more it is not permitted as a cosmetic.

Free formaldehyde is the amount present on the day of testing. Released formaldehyde is the total available after the releaser has been driven to complete hydrolysis, and it is the figure the labelling decision rests on, because a product with 5 ppm free formaldehyde a week after manufacture may contain 60 ppm at the end of its shelf life.

In the EU and UK, yes. Formaldehyde is classified as a category 1B carcinogen under CLP and was added to Annex II of Regulation (EC) No 1223/2009 at entry 1577 by Regulation (EU) 2019/831, which also removed its former uses as a preservative at 0.2 percent and as a nail hardener at 5 percent. Preservatives that release formaldehyde remain permitted under Annex V with a labelling requirement.

In the EU and Northern Ireland, when the total formaldehyde released in the finished product exceeds 0.001 percent (10 ppm), under Regulation (EU) 2022/1181, which applied to products placed on the market from 31 July 2024 and to all products made available from 31 July 2026. In Great Britain the retained threshold remains 0.05 percent (500 ppm) with the warning 'contains formaldehyde'.

DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea, sodium hydroxymethylglycinate, bronopol (2-bromo-2-nitropropane-1,3-diol), 5-bromo-5-nitro-1,3-dioxane, benzylhemiformal, methenamine and tris(hydroxymethyl)nitromethane, all permitted under Annex V with individual maximum concentrations. Quaternium-15 was prohibited in the EU from 1 March 2022.

For the EU market, either label the product 'releases formaldehyde' or reformulate to a non-releasing preservative system. Most brands reformulate. The report identifies which ingredient is contributing and by how much, so the change targets the right one, and a repeat analysis on the new formulation is the evidence that the warning is no longer required.

The product is dispersed in water, formaldehyde is converted to a stable UV-absorbing derivative with 2,4-dinitrophenylhydrazine (DNPH), and the derivative is separated from those of other aldehydes and ketones by reversed-phase HPLC and detected at 360 nm. The limit of quantification is around 1 mg/kg, a tenth of the EU labelling threshold.

In the EU, Regulation (EU) 2023/1545 expanded the list to over 80 fragrance allergens that must be named individually in the ingredient list when present above 0.001% in leave-on or 0.01% in rinse-off products. Compliance is required for products placed on the EU market from 31 July 2026, with sell-through to 31 July 2028. The UK has not adopted the expanded list.

In the EU and UK, several fragrance materials are prohibited (including HICC, atranol, chloroatranol and Lilial), oxidation-prone terpenes such as limonene and linalool carry a peroxide-value limit, and phototoxic citrus furocoumarins are restricted. IFRA standards set further industry usage limits alongside the law.

Yes. Dilution with carrier oil or solvents appears as foreign peaks; synthetic linalool and linalyl acetate added to lavender are revealed by the absence of the minor natural constituents and, where needed, by chiral analysis; extension with cheaper related oils and reconstitution from isolates show as profiles that do not match the ISO specification.

In the EU, Regulation (EU) 2023/1545 extended the Annex III allergen list from 26 to more than 80 substances, adding common essential oil constituents such as alpha- and beta-pinene, camphor, carvone, terpineol, menthol, vanillin, methyl salicylate and beta-caryophyllene. Labelling is required above 0.001 percent in leave-on and 0.01 percent in rinse-off products. Products placed on the EU market from 31 July 2026 must comply; making available continues until 31 July 2028.

The diluted oil is injected into a gas chromatograph, where a capillary column separates the constituents by volatility and polarity over about an hour. Each compound then enters a mass spectrometer that fragments it into a reproducible ion pattern. Identification uses two criteria together: a library match of the mass spectrum and a retention index calculated against a series of n-alkanes.

Yes. Hydrolats are extracted first because their volatile fraction is usually below 0.1 percent, and results are reported both as a percentage of that fraction and as mg/L. Absolutes are diluted further and filtered to remove waxes. A blend is analysed as one sample and reported as one constituent list, which is what the CPSR needs since labelling thresholds apply to the finished product.

Methyl eugenol (Annex III/102, from 0.01 percent in fine fragrance down to 0.0002 percent in other leave-on products), safrole (Annex II, no more than 100 ppm as a natural constituent), furocoumarins in citrus oils (Annex III/358, 1 mg/kg in sun and bronzing products), and constituents assessed on margin of safety such as estragole, pulegone, thujone and menthofuran.

5 mL of oil, absolute or perfume compound, or 50 mL of hydrolat, in an amber glass vial with a PTFE-lined cap, from the batch that will go into the product. State the intended percentage of the oil in each product and whether each product is leave-on or rinse-off, so the allergen contribution can be calculated in the report.

An essential oil is a mixture of dozens to hundreds of compounds whose proportions vary with species, chemotype, origin and batch. The safety assessor must assess each constituent at its actual concentration against its own limit, and identify every regulated allergen for labelling. Only the constituent profile of the batch in use provides that.

Beyond the EU and UK, Oxford Biosciences prepares the United States MoCRA Toxicological Risk Assessment, the Canadian Health Canada Cosmetic Notification, the Australian AICIS Compliance Statement, the New Zealand EPA Group Standard Compliance Statement, and the ASEAN Cosmetic Directive Documentation Package, each quoted per product, with GCC and Latin American markets (Brazil, Mexico, Argentina and Chile) quoted on application. Where markets share an evidence base, a single Product Information File carries the jurisdiction-specific annexes rather than requiring a separate dossier for each.

In the EU and UK, HEMA and Di-HEMA Trimethylhexyl Dicarbamate are not banned but are restricted to professional use only, with mandatory warnings, under Regulation (EU) 2020/1683. They are potent contact sensitisers when uncured product reaches the skin, and a methacrylate allergy is lifelong.

TPO (trimethylbenzoyl diphenylphosphine oxide), a photoinitiator used to cure gels, was classified as a CMR 1B substance, which prohibits it in EU cosmetics from 1 September 2025 even at trace levels. Great Britain follows on its own timeline through SI 2026/23. The industry has moved to alternatives such as TPO-L and BAPO.

The full domestic set regardless of Korean compliance: a CPSR, a Responsible Person, an SCPN or CPNP notification, and an Article 19 label in the correct language. The importer is the Responsible Person unless another established party holds the role, and the formula must be checked against the EU and UK ingredient lists.

Korea operates its own ingredient lists, administered by the Ministry of Food and Drug Safety, that do not match the EU's. Some UV filters, colorants and actives permitted in Korea are not on the EU positive lists, and concentration limits differ, so a popular Korean product can fail an EU check on a single ingredient.

In the EU and UK, intimate washes and similar products are cosmetics, because the Cosmetics Regulation covers the external mucous membranes, but mucosal application demands attention to pH, osmolality, irritation and microbiology, and the line with medicines is sharp: treating an infection such as thrush is medicinal, not cosmetic.

In the EU and UK, men's grooming is mostly assessed as ordinary cosmetics, but watch the recurring issues: high-alcohol aftershaves applied to freshly shaved skin, the deodorant-versus-antiperspirant split, and shaving or hair-regrowth claims that can cross into the medicines regime.

ICP-MS measures total chromium and cannot distinguish chromium(III), present in the permitted green pigments chromium oxide (CI 77288) and chromium hydroxide (CI 77289), from chromium(VI), which is prohibited, carcinogenic and a potent sensitiser. The Annex IV purity criteria for the green pigments require freedom from chromate, which only a speciation method can demonstrate.

A weighed portion of product is digested in nitric acid under microwave heating in a sealed vessel to destroy the organic matrix and dissolve the metals. The solution is sprayed into an argon plasma at 6,000 to 10,000 K, which ionises every element, and a quadrupole mass spectrometer separates and counts the ions of each metal by mass. Calibration against certified standards gives the concentration in mg/kg.

Neither Regulation 1223/2009 nor the SCCS sets numerical limits, but market surveillance authorities do. The strictest are the German BVL technically avoidable limits: lead 2 mg/kg, arsenic 0.5, cadmium 0.1, mercury 0.1, antimony 0.5. Health Canada applies 10, 3, 3, 3 and 5 mg/kg respectively; the FDA applies 10 mg/kg lead in lip and external products and 1 mg/kg mercury; ASEAN applies 20 mg/kg lead, 5 arsenic and 1 mercury; China applies 10 lead, 2 arsenic, 1 mercury and 5 cadmium.

The report identifies the likely source by comparing the finished product result with the raw material certificates and the concentrations of mineral ingredients, analysing the raw material itself where necessary. A trace of lead in a lipstick is usually a pigment lot problem resolved by changing lot or supplier, not by reformulation.

Products containing mineral pigments and fillers (iron oxides, ultramarines, chromium oxides, mica, talc, titanium dioxide, zinc oxide, kaolin), clays, charcoal, seaweed and algae, rice-derived ingredients, cocoa, herbal powders, henna and other plant dyes, kohl and kajal, and any lip, oral or children's product containing them. A product made entirely from pharmaceutical-grade synthetic ingredients has no plausible route for a trace and does not need testing.

Lead, arsenic, cadmium, mercury and antimony are prohibited under Annex II of Regulation (EC) No 1223/2009, but they occur as impurities in mined, harvested and extracted raw materials. Article 17 permits a technically unavoidable trace provided the product is still safe, and demonstrating that requires measuring the trace.

Criteria A requires a 3-log reduction in bacteria by day 7 and a 1-log reduction in yeast by day 7 with no subsequent regrowth. Criteria B allows until day 14 to reach the same reductions and is acceptable only where a documented risk assessment shows that packaging, use pattern or product properties reduce the microbiological risk.

The test itself runs 28 days from inoculation. With the baseline microbial content test, neutraliser validation beforehand and the final plate incubation afterwards, a report is typically issued 5 to 6 weeks after the sample arrives.

ISO 11930:2019 is the international standard for evaluating the antimicrobial protection of a cosmetic product. It specifies the five test organisms, inoculum levels, sampling days, neutraliser validation and the Criteria A and B log-reduction thresholds that define a pass.

When a sample of inoculated product is plated to count survivors, the preservative comes with it and can keep killing organisms on the agar, making the product appear to pass. Neutraliser validation proves that the counting medium stops the preservative acting without being toxic to the organisms itself.

A Preservative Efficacy Test deliberately contaminates a product with five reference organisms and measures over 28 days whether the preservative system kills them. Annex I of Regulation (EC) No 1223/2009 requires the result for any product that can support microbial growth.

Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans and Aspergillus brasiliensis, as reference strains. Together they cover Gram-negative and Gram-positive bacteria, yeast and mould.

Products that cannot support microbial growth under ISO 29621: anhydrous products with no free water, products with water activity below 0.60, pH at or below 3 or at or above 10, ethanol at or above 20 percent, or packaging that prevents any contact between product and user during use.

Regulation (EU) 2024/2462 added entry 79 to REACH Annex XVII, restricting PFHxA, its salts and PFHxA-related substances. Cosmetic products placed on the EU market from 10 October 2026 may not contain PFHxA and its salts at 25 ppb or more, or PFHxA-related substances at 1,000 ppb or more. The POPs Regulation separately prohibits PFOA, PFOS and PFHxS at 0.025 mg/kg, and a universal restriction of PFAS as a class is under consideration.

A formulation review showing no fluorinated ingredient, a total organic fluorine screen showing no measurable fluorine, and, where the claim needs to survive a challenge, targeted analysis showing the named compounds below quantification. In the EU and UK the claim must meet the Common Criteria of Regulation (EU) No 655/2013.

In three stages. First, every ingredient is reviewed against the OECD definition and each applicable state law. Second, a total organic fluorine screen by combustion ion chromatography detects fluorinated polymers such as PTFE that targeted analysis cannot see. Third, targeted LC-MS/MS quantifies individual PFAS including PFHxA, PFOA, PFOS and PFHxS at limits of 1 to 5 ng/g, below every regulatory limit.

Bans on cosmetics containing intentionally added PFAS took effect on 1 January 2025 in California, Colorado, Maryland, Minnesota and Washington, and on 1 January 2026 in Maine and Vermont. Connecticut requires notification and labelling from 1 July 2026 ahead of a full prohibition. Oregon's ban applies from 1 January 2027 and New Mexico's from 2028.

PFAS are per- and polyfluoroalkyl substances, defined by the OECD as any substance containing at least one fully fluorinated methyl or methylene carbon. In cosmetics that includes PTFE, perfluorononyl dimethicone and other fluorinated silicones, C9-15 fluoroalcohol phosphate, perfluorooctyl triethoxysilane, perfluorodecalin, perfluorohexane and polyperfluoromethylisopropyl ether.

20 g of product in its final packaging from a single batch, a second sample in glass or polypropylene if the pack is a fluorinated or unknown plastic, 5 g of any suspect raw material, the full formulation with CAS numbers and supplier specifications, and a list of every market and US state the product is sold in.

In the EU and UK, the brand placing the product on the market under its own name, not the manufacturer. A private-label brand needs its own CPSR coverage, Responsible Person and label; a CPSR issued to the manufacturer or another brand does not transfer to it.

In the EU and UK, it marks a cosmetic for a trained professional, not a consumer, and that status permits certain ingredients and higher concentrations barred from consumer products, such as professional hair dyes, HEMA in nails and 0.1 to 6% hydrogen peroxide tooth whitening. The labelling is the condition for those uses, and the product is still a full cosmetic.

Cosmetic ingredients are chemical substances and fall under REACH independently of the Cosmetics Regulation. Anyone manufacturing or importing a substance into the EU or GB at one tonne or more a year must register it, regardless of its cosmetic use, with the two laws running in parallel.

Usually your suppliers register, as most brands are downstream users. But if you import raw materials or mixtures from outside the EU or GB at one tonne or more a year, the registration or notification duty can fall on you, which post-Brexit supply routes make easy to acquire unknowingly.

The transitional registration deadlines have been extended to October 2029, 2030 and 2031, phased by tonnage and hazard, having previously been October 2026, 2028 and 2030. The extension allows time for the Alternative Transitional Registration model (ATRm) to be finalised.

They are now two separate regimes with the same structure but no mutual recognition. EU REACH (Regulation 1907/2006) is administered by ECHA; UK REACH applies in Great Britain and is administered by the HSE. Northern Ireland remains under EU REACH through the Windsor Framework.

Yes. Products can be added at any time and are pro-rated to the enrolment anniversary. Products can be removed at the end of their current twelve-month period. A discontinued product can be removed immediately on written confirmation.

One CPSR is one enrolment. Where a CPSR covers a shade range, every shade's colourant entries are checked under that enrolment, because the colourants are what differ between shades. Regulatory Watch checks each colourant against EU Annex IV, UK Schedule 34 Part 4, US 21 CFR Parts 73 and 74, and the ASEAN, Chinese and Japanese positive lists, and flags changes to permitted fields of application, purity criteria and concentration limits.

Regulatory Watch, priced per product per year and quoted on request, is a small fraction of what the assessment cost. There is no minimum number of products and no additional charge per market.

No. Regulatory Watch identifies the change and states the recommended action. Where that action is a CPSR update, label review or reformulation, it is quoted separately at the published rate, and the quotation is included in the alert.

No. If Oxford Biosciences holds your CPSR, the formulation is already on file and enrolment takes two working days. If your CPSR was issued elsewhere, the formulation is taken under NDA and enrolled in the same way.

Yes. In the EU, Regulation (EU) 2023/1545 expanded the list of individually declarable fragrance allergens from 26 to over 80. The placing-on-the-market date of 31 July 2026 has passed; the live date is 31 July 2028, after which non-compliant stock may no longer be made available. The UK has not adopted this measure. Regulatory Watch checks each enrolled product's fragrance disclosure against the list and states which market and date apply.

Each published change is broken down into the ingredient identity, restriction type, product categories and compliance dates, then run against the INCI list and concentrations held in the product's CPSR. Only products whose formulation is actually affected generate an alert.

Yes. Enrolment is per product. Many brands enrol fragranced products, colour cosmetics and products sold in more than one market first, then extend coverage to the rest of the range.

Regulatory Watch covers cosmetic ingredient law as it applies to the enrolled formula in each chosen market: prohibitions, concentration limits, conditions of use, labelling triggers, and nanomaterial and CMR status. It does not cover regulation outside the formulation, such as MoCRA facility registration and product listing, general product safety filings, customs, VAT, advertising codes or certification schemes.

In the EU and UK, most restrictions carry two dates. The placing-on-the-market date is the last day a product may first be supplied into that market. The making-available date is the last day existing stock may be sold at any point in the chain. Regulatory Watch alerts state both dates separately.

A newsletter tells you a rule has changed. Regulatory Watch tells you whether it affects a named product of yours, at what concentration, in which market, by which date, and what to do. The matching to your formulation is the service.

Regulatory Watch is a subscription service from Oxford Biosciences that monitors changes to cosmetic ingredient law in every market an enrolled product is sold in, checks each change against the product's actual formulation, and sends a plain-language alert stating whether the product is over the new line, the compliance dates and the recommended action.

Regulatory Watch covers every market in which an enrolled product is sold, including the UK, EU, USA, Canada, Australia, New Zealand, the GCC, ASEAN, China, Japan, Korea, Brazil, Mexico, India, Switzerland, Norway, Türkiye and South Africa. There is no additional fee per market.

Responsible Person designation is priced per product per year, with a lower rate for a single jurisdiction (GB or EU only) than for dual UK and EU designation, and a reduced rate from Year 2 onwards. Every new engagement begins with a Regulatory Due Diligence Review, the fee for which is credited against your first year. Request a quote for current rates for your product range. All fees are exclusive of VAT.

Every cosmetic product placed on the EU or UK market must have a Responsible Person established within that jurisdiction. Under Articles 4 and 5 of Regulation (EC) No 1223/2009, the Responsible Person is the legal entity that holds the regulatory obligation for the product: it maintains the Product Information File, makes the CPNP or SCPN notification, oversees labelling, and handles cosmetovigilance and contact with the competent authority. It is not simply a postal address. Oxford Biosciences acts as Responsible Person in both the UK and the EU under a single quality management system.

The same as offline, plus attention to where you sell and how you fulfil. The destination market sets the rules, marketplaces require valid documentation and Responsible Person details, online claims are regulated like on-pack claims, and importing stock to fulfil orders can make you the Responsible Person.

Accelerated testing stores the product at elevated temperature, typically 40 °C or 45 °C for 12 weeks, to predict what will happen over 12 to 30 months at ambient. Real-time testing stores it at ambient for the full claimed period. Accelerated data support a durability claim; real-time data prove it.

Both are quick stress tests run at the start of a stability study. Centrifugation at 3,000 rpm for 30 minutes predicts emulsion separation; freeze-thaw cycling between -10 °C and 45 °C simulates transport extremes and finds emulsions that break on freezing and gels that lose structure on thawing.

The product is stored in its final pack alongside an inert glass control, and any difference between the two at each time point is a packaging interaction: weight loss through permeation, absorption of fragrance or preservative into plastic, migration of pack components into the product, corrosion of metal parts, or deformation of the pack.

If the product is stable for less than 30 months unopened, it carries a date of minimum durability. If it is stable for more than 30 months, it carries a period after opening, which is a judgement combining the stability data, the challenge test result, the pack type and the use pattern, documented in the CPSR.

The report states what failed, when, and the likely cause. Most failures are emulsion instability, pH drift, oxidation of oils or a packaging interaction, and each has a formulation or packaging fix. Our formulation team can correct the product and the corrected version is retested.

At each time point and condition: appearance, colour, odour, pH, viscosity with the spindle and speed recorded, density, pack weight, and for emulsions the droplet size under the microscope. Where a product carries a quantified active, its content is assayed at the start and end of the study.

In the EU and UK, yes. Annex I of Regulation (EC) No 1223/2009 requires the physical and chemical characteristics of the product and its stability under reasonably foreseeable storage conditions, and Article 19(1)(c) requires either a date of minimum durability or a period after opening, both of which rest on stability data.