Frequently asked questions

The questions we are asked most, answered plainly. If yours is not here, ask us.

CPSR

How much does a CPSR cost and how long does it take?

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.

What is a CPSR?

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.

Who is qualified to sign a CPSR?

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.

MoCRA

What is a MoCRA Toxicological Risk Assessment?

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 for £395, 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.

What is MoCRA?

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.

Labelling & Claims

Do I need a clinical study to make a cosmetic claim?

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.

How much does cosmetic claims testing cost?

A clinical efficacy study starts from £5,000 plus VAT for a 15-subject panel, £8,500 for 30 subjects and £14,500 for 60 subjects. The cost sits in the fixed study infrastructure rather than the per-subject rate, so it does not fall in proportion to panel size.

How long does a cosmetic efficacy study take?

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.

How are cosmetic claims regulated?

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 per claim (£125, minimum five) and prepares formal Claims Substantiation Dossiers suitable for the Product Information File and for production to a competent authority or the Advertising Standards Authority.

What must appear on a cosmetic label?

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 for £195.

Testing

What is a Preservative Efficacy Test (challenge test)?

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 for £165: 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.

What testing does Oxford Biosciences provide?

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.

UK

Do cosmetics sold in Northern Ireland follow UK or EU rules?

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.

What do I need to sell cosmetics on Amazon UK?

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.

What is changing for cosmetics in Great Britain in 2026?

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.

How much does a UK CPSR cost?

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.

What are the UK Responsible Person requirements?

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.

What is SCPN?

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.

General

Do cosmetics need a CE or UKCA mark?

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.

export

What is the difference between an apostille and legalisation for export documents?

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.

What is a Certificate of Free Sale and when do I need one?

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.

Can one safety assessment be used to sell a cosmetic in several countries?

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.

baby-children

How is the safety of a baby or children's cosmetic assessed?

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.

Which ingredients are restricted in children's cosmetics?

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.

brexit

Do I need separate compliance for Great Britain and the EU after Brexit?

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.

Does one CPSR cover both the UK and the EU?

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.

Do I need a Responsible Person in both the UK and the EU?

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.

cbd-hemp

Is CBD legal in cosmetics in the EU and UK?

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.

Is hemp seed oil allowed in cosmetics?

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%.

china

Can a UK-made cosmetic be sold in China without animal testing?

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.

Do I need a domestic responsible person to sell cosmetics in China?

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.

Does China require a full cosmetic safety assessment?

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.

What is the difference between special and general cosmetics in China?

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.

novel-ingredients

How is a new cosmetic ingredient registered in China?

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).

Do nanomaterials in cosmetics need a separate notification in the EU?

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.

What safety data does a new cosmetic ingredient need?

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.

contract-manufacturing

Is the contract manufacturer the Responsible Person?

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.

What is cosmetic GMP and ISO 22716?

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.

hair-care

What extra rules apply to aerosol cosmetics?

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.

How are hair dyes regulated in cosmetics?

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.

due-diligence

What does regulatory due diligence on a cosmetic brand cover?

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.

colour-cosmetics

Which colorants are allowed in cosmetics?

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.

Are glitter and microplastics banned in cosmetics?

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.

natural-organic

What standards define natural and organic cosmetics?

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.

Can I call my cosmetic natural or organic?

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.

body-care

What are the rules on preservatives like MIT and parabens?

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.

Is an antiperspirant a cosmetic or a drug?

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.

skincare

Are skin-lightening ingredients allowed in cosmetics?

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.

What are the EU limits on retinol in cosmetics?

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.

startup

What do I need to sell a cosmetic for the first time?

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.

borderline

Can a cosmetic be classified as a medical device?

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.

When is a product a cosmetic and when is it a medicine in the EU and UK?

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.

Which cosmetics are regulated as OTC drugs in the United States?

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.

cruelty-free

Can I claim my cosmetic is cruelty-free in the EU and UK?

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.

What does a vegan claim on a cosmetic require?

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.

subscription

Does decanting or repackaging a cosmetic need its own compliance?

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.

What compliance does a beauty subscription box need?

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.

retail

What are a distributor's obligations for cosmetics?

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.

What due diligence should a retailer do on the cosmetics it stocks?

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.

east-asia

If my product is approved in China, can I sell it in Japan, Korea and Taiwan too?

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.

business

How do you manage compliance for a large product portfolio?

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.

eu

What are the EU cosmetics Omnibus changes in 2026?

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.

sun-protection

What are the EU restrictions on sunscreen UV filters?

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.

How is a sunscreen's SPF and UVA protection tested?

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.

oral-care

What is the fluoride limit in toothpaste?

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.

What are the rules on hydrogen peroxide in tooth-whitening products?

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.

fragrances

Which fragrance allergens must be labelled on cosmetics?

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.

Are some fragrance ingredients banned or restricted?

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.

international

Which international markets does Oxford Biosciences cover?

Beyond the EU and UK, Oxford Biosciences prepares the United States MoCRA Toxicological Risk Assessment (£395), the Canadian Health Canada Cosmetic Notification (£395), the Australian AICIS Compliance Statement (£149), the New Zealand EPA Group Standard Compliance Statement (£179), and the ASEAN Cosmetic Directive Documentation Package (£249), 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.

nail-care

Is HEMA banned in nail products?

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.

Why has TPO been banned in gel nail products?

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.

kbeauty

What is needed to import Korean (K-beauty) cosmetics into the UK or EU?

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.

Why might a K-beauty product not be compliant in the EU?

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.

intimate-care

How are intimate care products regulated as cosmetics?

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.

mens-grooming

Do men's grooming products have special compliance rules?

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.

private-label

Who is responsible for compliance on a private-label cosmetic?

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.

professional

What does 'for professional use only' mean on a cosmetic?

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.

reach

How does REACH apply to cosmetic ingredients?

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.

Do I need to register my cosmetic ingredients under REACH?

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.

What are the UK REACH registration deadlines?

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.

What is the difference between UK REACH and EU REACH?

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.

responsible-person

How much do Responsible Person services cost?

Dual UK and EU Responsible Person designation is £299 per product in Year 1, reducing to £149 net of the £150 Regulatory Due Diligence credit applied to every new engagement, and £169 per product per year thereafter. A single jurisdiction, GB or EU only, is £199 in Year 1, £49 net of the credit, and £119 per year thereafter. Every new engagement is preceded by a Regulatory Due Diligence Review. All fees are exclusive of VAT.

What is a Responsible Person?

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.

ecommerce

What compliance do I need to sell cosmetics online?

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.

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