The EU Cosmetics Regulation is Regulation (EC) No 1223/2009 of the European Parliament and of the Council, the single piece of legislation governing how cosmetic products are developed, manufactured, documented, claimed, labeled, and sold across the 27 EU member states and the European Economic Area.
That sounds like a lot for one regulation.
It is, and that is the point.
Before 1223/2009 took effect on July 11, 2013, cosmetics in Europe were regulated through a patchwork of member-state laws built on an older 1976 directive. The current regulation replaced that with a single framework.
After 30 years in the hair and beauty sector, most recently in private label cosmetics, the EU is the regulatory environment I know most deeply. It is where our 14+ manufacturers across Europe operate and where most first-time founders launch.
For the broader multi-market picture, the global cosmetics regulations guide covers how the EU compares to the US, UK, and beyond.
Important disclaimer: I am not a lawyer or regulatory affairs professional. This is practical industry perspective, not legal advice. For specific questions, work with a qualified safety assessor and Responsible Person.
This guide covers how 1223/2009 is structured, the actors and documents it requires, ingredient control and claims, enforcement, and what is changing in 2026.
The compliance mechanics make more sense once you know the shape of the regulation itself.
Regulation 1223/2009 is organized around ten chapters and ten annexes. Annexes I to VIII are the operative ones: Annex IX lists the repealed Directive and Annex X is the correlation table.
The chapters set out definitions, the responsibilities of the Responsible Person and of distributors, good manufacturing practice, safety assessment requirements, sampling and analysis, notification obligations, restrictions on substances, the animal testing ban, labeling, claims, market surveillance, and administrative provisions like delegated acts and penalties.
The annexes are the operational lists that formulators and regulatory specialists consult constantly. Annex I sets out what a Cosmetic Product Safety Report must contain. Annex II lists substances prohibited in cosmetic products. Annex III lists substances restricted with specific conditions of use, concentration limits, warnings, or target populations. Annex IV lists permitted colorants. Annex V lists permitted preservatives. Annex VI lists permitted UV filters. Annex VII sets out the symbols used on packaging and containers, and Annex VIII lists the validated alternative methods to animal testing. Sampling and analysis are handled by Article 12, which points to harmonised standards, not by an annex.
If you have ever wondered why some ingredients appear on product labels with "warnings for use" language and others do not, the answer is inside these annexes.
Three ideas sit underneath it.
Uniform rules across the single market. A cosmetic product placed on the market in Germany is, by law, equally compliant in Italy, France, or Poland. You do not need twenty-seven separate national filings. One CPNP notification covers the whole bloc.
Pre-market safety, not pre-market approval. Unlike pharmaceuticals, cosmetics do not require authority approval before sale. But they do require that the Responsible Person completes a safety assessment and compiles the supporting file before the product reaches a shelf. The burden of proof sits with the brand.
Continuous scientific update. The Commission issues amending regulations regularly. In the twelve months to April 2026 alone, Commission Regulation (EU) 2025/877 of May 12, 2025 updated Annexes II and III on CMR substances, and Commission Regulation (EU) 2026/78 (Omnibus VIII), applicable from May 1, 2026, adds fifteen newly classified CMR substances to the Annex II prohibition list. Compliance here is maintenance work.
Alongside 1223/2009 itself, several companion instruments come up frequently.
Commission Implementing Decision 2013/674/EU publishes the official guidelines on Annex I, the content of the safety report.
If a safety assessor references "the Annex I guidelines," this is the document.
Commission Regulation (EU) No 655/2013 lays down the common criteria for justifying product claims.
Any claim made on a cosmetic label or advertisement must meet these criteria.
Commission Implementing Decision (EU) 2025/1175 of June 16, 2025 updated the glossary of common ingredient names (INCI references) for use in labeling.
Regulation (EC) No 1272/2008 on the classification, labeling, and packaging of substances (CLP) is the external trigger for many cosmetic ingredient bans.
When a substance is classified as CMR (carcinogenic, mutagenic, or toxic for reproduction) under CLP, Article 15 of the Cosmetics Regulation prohibits its use in cosmetics. The prohibition does admit derogations: a substance in category 2 may be used where the SCCS has evaluated it and found it safe for use in cosmetic products, and substances in category 1A or 1B may be used by way of exception where four conditions are fulfilled together, among them no suitable alternative substances available, as documented in an analysis of alternatives, and a favorable SCCS evaluation.
That automatic link is the EU’s precautionary principle at work.
The regulation names specific roles.
Confusing them is one of the most common mistakes I see in first-time founders.
The Responsible Person is the named legal or natural person, established inside the EU, who is accountable for ensuring the cosmetic product complies with the regulation before it is placed on the market. Article 4(1) says "a legal or natural person", so a sole trader established in the Union can hold the role personally and does not need to incorporate to do it.
Who can be the Responsible Person. Under Article 4, the Responsible Person is by default the manufacturer established in the Community, but the article attaches a condition that is easy to miss: it applies to a product manufactured there “and not subsequently exported and imported back into the Community”. Send your own production outside the Union and bring it back, and you are the importer for that batch, not the manufacturer. For a product imported into the EU, the importer is the Responsible Person for the product he places on the market. Either can designate a third party through written mandate. For non-EU brands selling into the EU, appointing a third-party Responsible Person based in a member state is the standard path.
What the Responsible Person actually does. They ensure the PIF is complete and kept up to date, they submit the CPNP notification, they are named on the product label, they are the authorities' first point of contact for any safety or compliance query, and they handle cosmetovigilance (the collection and reporting of undesirable effects).
They carry legal liability for the product’s compliance status.
Cost profile. For a brand that has no natural EU legal entity, contracting a Responsible Person service typically costs 500 to 2,000 EUR/USD per year for a small catalog. (All cost figures in this article are indicative estimates that vary by manufacturer, region, and project scope.)
Prices scale with portfolio complexity.
The Responsible Person is the person a market surveillance authority calls when something appears on Safety Gate with your product name on it. You want that person to be competent, reachable, and familiar with your catalog, not a service that filed the paperwork twelve months ago and has not looked at your products since.
That experience should drive how you evaluate Responsible Person providers. Ask how many brands they actively manage, how they handle cosmetovigilance reports, and what happens when an authority calls on a Friday afternoon. The answers vary more than the flat price tags would suggest.
The Safety Assessor is the qualified professional who signs the Cosmetic Product Safety Report.
Under Article 10(2) of the regulation, the assessment must be carried out by a person holding a diploma or other evidence of formal qualifications from a university course in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a member state. The two routes are alternatives, not cumulative requirements.
What a member state decides is narrower than it sounds: Article 10(2) already fixes the qualification itself, and what is left to the member states is recognising a course as equivalent to the university one. So the bar is European and the equivalence is national, which is why an assessor accepted in one country is not automatically accepted in another.
The safety assessor is not the same person as the Responsible Person. Some Responsible Person service providers offer both functions under the same contract. Others do not. The signature on the CPSR is the one that matters from a liability perspective.
The Product Information File (PIF) is the master dossier for each cosmetic product sold on the EU market.
Article 11 of the regulation and Annex I of the same text set out precisely what the PIF must contain: a description of the cosmetic product allowing a clear link between the product and the PIF, the Cosmetic Product Safety Report (next section), a description of the manufacturing method and a statement of compliance with Good Manufacturing Practice (GMP), evidence of claimed effects when the nature or effect of the product justifies it, and data on animal testing related to the product and its ingredients.
The PIF must be held at the address of the Responsible Person indicated on the product label, in an electronic or other format that allows it to be readily accessible to authorities upon request, for a period of ten years following the date on which the last batch was placed on the market.
Cost profile. A first-time PIF for a single product typically runs 500 to 1,800 euros, depending on formula complexity, the testing that accompanies it, and whether claims substantiation is already complete.
The Cosmetic Product Safety Report (CPSR) is the core of the PIF.
It is split into two parts by Annex I of the regulation.
Part A, safety information. The quantitative and qualitative composition of the product, physical and chemical characteristics and stability data, microbiological quality, impurities, traces, and information on packaging material, normal and reasonably foreseeable use, exposure to the cosmetic product, exposure to the substances it contains, toxicological profile of the substances, undesirable effects and serious undesirable effects data, and any other relevant information.
Part B, safety assessment. The assessor’s reasoned conclusion on the safety of the product, the labeled warnings and instructions for use justified by the assessment, the assessor’s credentials, and the assessor’s signature and date.
Cost profile. The CPSR itself, when priced separately, typically runs 300 to 800 euros per product. In practice, most regulatory consultancies bundle it inside the full PIF fee.
The Cosmetic Products Notification Portal (CPNP) is the EU’s online notification system.
Before a cosmetic product is placed on the market, the Responsible Person must submit a notification through the portal.
What the notification contains. The category of the cosmetic product and its name, the identity of the Responsible Person and the address at which the PIF is made readily available, the country of origin for imported products, the member state in which the product is to be placed on the market, the contact details of a physical person to contact in case of necessity, the presence of substances in nanomaterial form with specific data, the name and CAS or EC number of substances classified as CMR of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, and the frame formulation allowing prompt and appropriate medical treatment in case of difficulties.
Cost profile. The CPNP notification itself is free. What costs is everything that must exist before you can file it.
A single CPNP notification covers the entire EU market. The notification generates a reference number used for traceability and market surveillance.
The part of the regulation that moves fastest, and catches founders most often, is substance control.
The update cycle follows a recognizable pattern.
The Scientific Committee on Consumer Safety (SCCS) issues a scientific opinion on an ingredient’s safety, typically in response to a Commission mandate or new toxicological evidence. SCCS opinions are public, with a consultation period for stakeholder comments before finalization.
Recent examples from 2025 and 2026: SCCS final opinion SCCS/1685/25 on Cannabidiol (CBD), adopted March 26, 2026 and published April 24, concluding CBD is safe up to 0.19 percent in dermal and oral cosmetic products, with THC impurities safe up to 0.00025 percent. The preliminary version of November 19, 2025 carried the same 0.19 percent figure. SCCS preliminary opinion SCCS/1686/25 of November 19, 2025 on Thiomersal and Phenylmercuric salts, concluding these are not considered safe at current permitted concentrations. SCCS/1682/25 final version of March 26, 2026 on Butylated Hydroxyanisole (BHA) as a potential endocrine disruptor.
The Commission then issues a Commission Regulation amending the relevant Annexes. The amendment publishes in the Official Journal with an application date and often a transitional period for existing products.
The transitional period is the window during which products containing the restricted substance may still be placed on the market or, more commonly, may still be made available on the market if already placed before the restriction took effect.
Commission Regulation (EU) 2025/877 of May 12, 2025 updated Annexes II and III regarding CMR substances. Products must comply with specific deadlines detailed in the regulation.
The Omnibus amendment applicable from May 1, 2026 adds fifteen newly classified CMR substances to the Annex II prohibition list (Commission Regulation (EU) 2026/78). That regulation carries no transitional provision and no sell-through window: it applies from May 1, 2026, and stock already placed on the market is covered from the same date.
Commission Regulation (EU) 2023/1545 of July 26, 2023 widened the set of fragrance allergens that Annex III requires to be named individually in the ingredient list. Immediately before that amendment there were 24 of them, in Annex III entries 45 and 67 to 92, and the Scientific Committee on Consumer Safety had identified 56 more. In the text consolidated at May 1, 2026, 81 Annex III entries carry that individual disclosure condition. Read that as a count of entries at a stated date rather than a count of substances: one entry can cover more than one, as entry 70 declares geranial and neral together as "Citral". The transition runs on two dates and in one direction only: a product that does not meet the new entries could be placed on the Union market until July 31, 2026, and stock already placed may still be made available on the Union market until July 31, 2028.
The practical implication for a brand developing formulations in 2026: your fragrance supplier needs to provide full allergen data per the expanded list, your label design has to accommodate longer ingredient declarations, and the allergen documentation inside your PIF needs updating.
This change will come round again.
Claims regulation in the EU sits at the intersection of Article 20 of 1223/2009 and Commission Regulation (EU) No 655/2013 on common criteria for cosmetic claims.
The six common criteria that every cosmetic claim must meet are: legal compliance (no claim of authorization that does not exist), truthfulness (no false attributes), evidential support (claims must be backed by evidence proportionate to the claim), honesty (no exaggeration beyond what the product actually does), fairness (no denigration of competitors, and none of ingredients that are legally used), and informed decision-making (enabling the consumer to make a choice).
Enforcement on those criteria is strict.
"Free from" claims are the ones brands get wrong most often, and the reason is that absence is not the test. A "paraben-free" claim can be perfectly true and still fail. The agreed Technical Document on cosmetic claims puts it under the fairness criterion and says the claim should not be accepted, because certain parabens are authorised under Annex V and the claim denigrates the whole group. Phenoxyethanol and triclosan are treated the same way. A prohibited ingredient fails for the opposite reason: nobody may claim to be "free from corticosteroids", because nobody is allowed to use them and the absence is not a merit. That document is best practice agreed with the member states rather than law, it applies from 1 July 2019, and it is what national authorities go by.
"Hypoallergenic" claims require specific evidence under the guidelines. Brands cannot use the term simply because they believe the formula is gentle.
Claims of approval by an authority are prohibited. You cannot say "approved by the EU Cosmetic Regulation" or similar.
Comparative claims must be accurate, substantiated, and not denigrate competitor products.
For a complete list of banned and restricted claim formats, the Commission Technical Document on Cosmetic Claims (most recent version) sets out detailed examples. Your Responsible Person or safety assessor will review every claim against this document before the label is printed.
Article 19 of Regulation 1223/2009 sets out the mandatory information on cosmetic product labels.
The non-negotiable label elements. The name or registered name and the address of the Responsible Person. The nominal content at the time of packaging. The date of minimum durability for products with a minimum durability of thirty months or less, or the Period After Opening (PAO) symbol for products with a minimum durability of more than thirty months, except where durability after opening is not a relevant concept. Precautions to be observed in use. Batch number or other identification. Function of the product if not clear from its presentation. List of ingredients in descending order of weight above 1 percent, in any order below 1 percent, using INCI (International Nomenclature of Cosmetic Ingredients) names.
Allergen disclosure. Fragrance allergens listed in Annex III, when present above 0.001 percent in leave-on products or 0.01 percent in rinse-off products, must be declared separately in the ingredient list.
Language. Member states specify the language requirements for labeling in their territory. Article 19(5) reaches the nominal content, the date of minimum durability, the precautions of use and the function of the product, plus the information covered by paragraphs 2, 3 and 4, and the language of those particulars is determined by the law of the member state in which the product is made available to the end user.
For a full comparison of label requirements across EU, US, and Great Britain, the dedicated guide covers the details.
A compliance system without enforcement is theater. The EU enforces.
Safety Gate is the EU’s rapid alert system for dangerous non-food products.
It was previously known as RAPEX.
National market surveillance authorities across thirty countries (the 27 EU member states plus Iceland, Liechtenstein, and Norway) use Safety Gate to share alerts on products posing a risk. When an authority in one country identifies a non-compliant cosmetic, the alert appears across all national authorities within days, triggering parallel market checks across Europe.
The Safety Gate annual report for 2025 recorded 4,671 alerts validated across all product categories, the highest number since the system started in 2003 and a 13 percent increase on the 4,137 alerts of 2024. Cosmetics were the single most frequently notified category for the third consecutive year, at 36 percent of all alerts, ahead of toys at 16 percent and electrical appliances and equipment at 11 percent.
Five years ago that ranking looked different.
Italy notified more dangerous products than any other member state in 2025, with 1,193 alerts across all categories, up from 1,089 the year before. It sits on both sides of the ledger: a major notifier, and also a significant EU country of origin for goods that fail compliance checks.
From the public 2025 Safety Gate data, the pattern is consistent and instructive.
Chemical risk is the dominant failure mode. It accounted for 53 percent of all Safety Gate notifications in 2025 across every product category, and inside cosmetics it is the reason behind the large majority of alerts. That covers products containing prohibited substances, substances above permitted concentration limits, or CMR substances newly added to the restrictions.
The most frequently detected prohibited substance in 2025 was BMHCA (Butylphenyl Methylpropional, also known as Lilial), prohibited in cosmetics from March 2022 under Commission Regulation (EU) 2021/1902 following its CMR classification. It alone generated 1,278 notifications during the year, and it was behind 77 percent of the cosmetics alerts that flagged a chemical risk. HICC (hydroxyisohexyl 3-cyclohexene carboxaldehyde, Lyral), prohibited since August 2019, keeps turning up in the same alerts, often in the same products.
Microbiological risk is the second most common failure type, covering products that fail preservative efficacy or contamination testing. Second is a long way behind, though. Run the report’s own numbers and chemical risk accounts for almost every cosmetics alert there is: 1,278 BMHCA alerts are 77 percent of the cosmetics alerts flagging a chemical risk, which puts chemical risk at roughly 1,660 of the 1,680 or so cosmetics alerts that 36 percent of 4,671 comes to. Everything else, microbiological and labeling together, fits in what is left.
Labeling non-compliance generates alerts as well, especially missing batch codes, incorrect INCI order, and unsubstantiated claims.
The authorities act with speed. The Safety Gate 2025 report notes that member states began issuing alerts on nail polish containing TPO (a photoinitiator) within weeks of its prohibition taking effect in September 2025: 60 notifications in the last four months of the year alone.
The enforcement actions available to authorities escalate based on risk.
Voluntary recall is the first step for products with identified non-compliance but limited consumer risk. The Responsible Person withdraws the product, notifies retailers, and destroys or reformulates the inventory.
Mandatory withdrawal follows if the Responsible Person does not act quickly enough. The authority orders the product off the market, usually with a specific deadline.
Product destruction or reformulation comes next, for any inventory already in the distribution chain. For a small brand, this is often the most expensive component.
Financial penalties are set at member state level. In Italy, for example, Legislative Decree 204/2015 implements 1223/2009 and sets an administrative fine of 500 to 4,000 euros for non-compliant labeling (Article 13 of the decree), while placing a product on the market without a safety assessment, or in breach of the PIF rules, carries a criminal fine of 10,000 to 100,000 euros (Article 8). Every member state writes its own figures under Article 37, so they are not interchangeable.
Safety Gate publication. A public alert that names the product, the brand, and the risk. This is the reputational component that often hurts more than the direct financial cost.
A single Safety Gate alert can end a young brand. Retailers pull the listing, marketplaces suspend the account, distributors block reorders, and the brand must relaunch from scratch. I have watched promising operations disappear from this exact sequence. Compliance is the business.
The structural lesson is that the EU system rewards brands that invest in the compliance layer properly and punishes those that treat it as a last-minute box-tick. The cost differential between "done properly" and "done minimally" is typically 1,500 to 3,000 euros per product. Between "done minimally" and "done wrong", it can be the whole brand.
Cosmetovigilance is the ongoing obligation of the Responsible Person to monitor undesirable effects reported after the product is on the market.
Under Article 23 of 1223/2009, serious undesirable effects (defined as effects that result in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, immediate vital risk, or death) must be notified by the Responsible Person and by distributors to the competent authority of the member state in which the serious effect occurred, without delay.
Non-serious undesirable effects are monitored and kept on file, subject to authority access. They also inform the safety assessor’s periodic review of the CPSR.
In practical terms, this means the Responsible Person must operate a simple but disciplined system: collect complaints from customers and retailers, categorize them by severity, investigate where appropriate, and report serious events upward. A brand without this system in place is technically non-compliant even if no serious event has yet occurred.
EU cosmetic rules are moving unusually fast in 2026. Brands launching this year face more simultaneous changes than at any point since the introduction of 1223/2009.
May 1, 2026: Commission Regulation (EU) 2026/78 (Omnibus VIII), adding fifteen newly classified CMR substances to the Annex II prohibition list, took effect. Brands using any of the affected substances had to have reformulated before that date.
July 31, 2026: the end of the tolerance for placing on the market products that do not carry the expanded fragrance allergen disclosures under Commission Regulation (EU) 2023/1545. Stock already placed may still be made available on the Union market until July 31, 2028.
August 15, 2026: a Great Britain CMR amendment applies. This is a Great Britain, not EU, instrument, and Northern Ireland stays on the EU text, but it affects dual-market brands.
Ongoing: SCCS opinions on BHA, parabens (butylparaben children’s exposure), thiomersal, phenylmercuric salts, and multiple UV filters are moving through the review process. Expect Commission amendments in the second half of 2026 that incorporate these opinions.
France’s Law No. 2025-188 of February 27, 2025, implemented by Decree 2025-1376 published in December 2025, entered into force January 1, 2026. It prohibits the manufacture, import, export, and sale in France of cosmetic products containing PFAS (per- and polyfluoroalkyl substances) above thresholds specified in the decree, with a twelve-month transition period for pre-existing stock manufactured before January 1, 2026.
France is the first EU member state to ban PFAS in cosmetics.
The European Chemicals Agency is running a consultation on a bloc-wide PFAS restriction. A harmonized EU position is expected, but no specific timeline has been confirmed as of April 2026.
Practical implication: brands with any France distribution must confirm PFAS-free formulations now. Brands with broader EU distribution should plan reformulation, because the EU-wide extension is widely expected to follow within the next 12 to 24 months.
The European Commission launched an initiative in late 2023 to assess the effectiveness of Regulation 1223/2009.
This evaluation is a preliminary step that typically feeds into a longer horizon "recast" of the regulation.
The evaluation is ongoing. No text of a recast has been published. Industry commentary suggests that any recast will focus on digital labeling provisions, enhanced nanomaterial controls, and tighter online marketplace enforcement, but brands should not assume specific outcomes until the Commission publishes a proposal.
The relevant posture for brands in 2026 is to monitor the evaluation process, not to over-react to speculation about future text.
Founders cannot track every SCCS opinion and every Commission regulation. Neither can I.
The practical approach has three components.
One: a Responsible Person who tracks amendments against your specific portfolio. The quality of the Responsible Person service becomes visible here. A good service flags you when a new amendment touches one of your formulations, before you think to ask. A bad service only reacts when you call.
Two: a trusted industry news feed. Cosmetics Europe publishes member alerts. COSlaw, Cosmetics Business, and specialized regulatory consultancies publish summary briefs. Subscribing to two or three of these is sufficient for most brands.
Three: a review cadence. Every six months, a scheduled review of your portfolio against current Annex lists, current SCCS opinions in consultation, and pending Commission regulations. Thirty minutes twice a year, with your Responsible Person or consultant, prevents expensive surprises.
For brands approaching a new product development cycle, the review cadence should also include a forward-looking check: if an SCCS opinion is likely to restrict an ingredient you plan to use in the next 18 months, substitute now rather than reformulate after launch.
Is the EU Cosmetics Regulation the same across all 27 member states?
Yes. Regulation (EC) No 1223/2009 is directly applicable in all 27 EU member states plus the EEA countries (Iceland, Liechtenstein, and Norway), which have adopted the regulation through the EEA agreement. A product compliant with 1223/2009 can be sold across the entire single market with a single CPNP notification. However, member states retain limited national competence in specific areas such as language requirements on labels, national enforcement penalties, and some specific national rules (for example, France’s national PFAS ban of January 2026). A brand selling across multiple member states needs one set of compliance documentation but must still check member-state-specific labeling language requirements and any national-level restrictions.
What documents do I need to sell a cosmetic product in the EU?
You need a complete Product Information File (PIF) held at the address of your Responsible Person, a Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor inside the PIF, a completed CPNP notification submitted through the portal, and label compliance with Article 19 requirements including INCI ingredient list, Responsible Person name and address, batch code, nominal content, and Period After Opening symbol or minimum durability date. You also need evidence of Good Manufacturing Practice compliance at the manufacturing facility, typically in the form of ISO 22716 certification. For a line of three to five products, plan 3,000 to 5,000 euros in regulatory costs and 4 to 9 months from brief to launch.
Do I really need a Responsible Person even for a small brand?
Yes. Article 4 of 1223/2009 makes this non-negotiable. Every cosmetic product placed on the EU market must have a designated Responsible Person established in the EU. For a brand with no establishment in the EU, this means contracting a Responsible Person service, typically costing 500 to 2,000 euros per year for a small catalog. The role cannot be waived, and it cannot be delegated to the manufacturer without a written mandate. One case needs no mandate at all: for an imported product, Article 4(5) makes each importer the Responsible Person for the product he places on the market, by operation of law. Placing a product without a valid Responsible Person is an immediate compliance breach, subject to withdrawal and penalties.
How do I know if one of my ingredients is prohibited or restricted?
The definitive source is the consolidated version of Regulation 1223/2009, including its annexes, available on EUR-Lex. Annex II lists prohibited substances, and Annex III lists restricted substances with their specific conditions of use. The CosIng database maintained by the European Commission is the searchable tool cross-referencing these annexes by INCI name. In practice, your safety assessor and Responsible Person check every ingredient in your formulation against the current annexes before the CPSR is finalized, and your manufacturer should do the same before supplying raw materials. For ongoing monitoring, the cosmetics industry tracks SCCS opinions and upcoming Commission amendments, which signal what will move onto the prohibited or restricted lists in the near future.
What claims am I allowed to make on a cosmetic product?
Any claim you make must meet the six common criteria established in Commission Regulation (EU) No 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. Practical implications: claims of authority approval are prohibited, "free from" claims are restricted when they imply a safety benefit without evidence, "hypoallergenic" requires specific evidence, comparative claims must be accurate and non-denigrating, and all performance claims must be backed by proportionate evidence (clinical, instrumental, consumer testing, or scientific literature, depending on the claim). Your Responsible Person and safety assessor will review every claim against the criteria before the label is printed. The Commission’s Technical Document on Cosmetic Claims provides detailed examples of acceptable and unacceptable claim formats.
What happens if my cosmetic product is flagged on Safety Gate?
A Safety Gate alert initiates a parallel response across all EU and EEA national market surveillance authorities. In practice: your distributors in the flagged country will pull the product, major retailers and online marketplaces will suspend the listing, other national authorities will begin market checks in their own territories, and the public Safety Gate entry will be visible to consumers and media. The immediate response from your Responsible Person involves identifying the root cause (prohibited substance, contamination, labeling, claims), issuing a voluntary recall and reformulation plan, documenting corrective action to the notifying authority, and monitoring for further cross-border alerts. The financial impact is rarely limited to the direct inventory loss; retailer relationships, marketplace account status, and brand trust take materially longer to recover.
What is likely to change in EU cosmetic regulation over the next 12 months?
Two of this year’s changes have already landed: the May 1 Omnibus amendment adding CMR substances to Annex II took effect, and the July 31 tolerance for placing on the Union market products that do not carry the expanded fragrance allergen disclosures ran out. Still ahead: new Commission amendments incorporating the autumn 2025 SCCS opinions on CBD, Thiomersal, Phenylmercuric salts, and BHA, continued consultation on PFAS at EU level following France’s national ban, and ongoing SCCS review of UV filters, parabens, and several preservatives. Brands should not over-react to speculation about a possible Regulation 1223/2009 recast, which is in early-stage evaluation rather than proposed text. The relevant posture is to maintain an active review cadence with the Responsible Person and to substitute ingredients flagged in SCCS opinions early rather than waiting for the Commission amendment to become binding.
Keep reading
Complete independent guide to cosmetics import/export documentation in 2026. EU, USA, and Great Britain customs requirements, HS codes, certificates of free sale, IOSS changes, MoCRA obligations, and the operational traps that cost founders the most. From 30 years in the industry.
Complete independent guide to cosmetic brand trademark protection in 2026. EUIPO, USPTO, UKIPO, and the Madrid System compared, Nice classes 3 and 5 explained, costs and timelines. From 30 years in the industry. Not legal advice.
Complete independent comparison of cosmetic label requirements across the EU, USA, and Great Britain in 2026. Mandatory elements, symbols, language rules, printing technique constraints, and a pre-production checklist. From 30 years in the industry.
