The UK Government provides useful general information for setting up a business.  You will need to ensure compliance with all relevant legislation, so please explore our website for information about other laws that may be applicable, such as Weights & Measures, Advertising, Trade Marks.

In the UK, the manufacture and supply of all cosmetic products is governed by the EU Cosmetics Regulation ((EC) No. 1223/2009) and its amendments.  These are directly applicable in all Member States and all cosmetic products need to comply with the requirements before they are placed on the UK/EU market. 

The Regulation lays down rules for product safety, roles and responsibilities, good manufacturing practice (GMP), documentation, notification, ingredients and prohibited substances, animal testing, labelling, claims, reporting and the provision of information.

For more detail on the Regulation requirements see the CTPA Guide to Supplying Cosmetic Products on the UK Market

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For information on the UK regulatory framework for cosmetics after the UK leaves the EU, and how to prepare for a ‘no deal’ scenario, see our Brexit ‘No Deal’ Help section.

The EU Cosmetics Regulation is enforced in the UK via the UK Cosmetic Products Enforcement Regulations 2013 which specifies the role of the authorities, the penalties and the enforcement process.  The UK Government Department for Business, Energy and Industrial Strategy (BEIS) is the UK Competent Authority for implementing the legislation for cosmetic products. 

The enforcement authority in the UK is Trading Standards.  Trading Standards Officers (TSOs) operate out of each Local Authority and have the power to carry out market surveillance on any aspect of the Cosmetics Regulation.  They are also available to give help and advice to companies who are just starting out and looking to comply.

For information on entering into a Primary Authority Partnership (PAP) You will need to contact the Trading Standards office located in your region.  Contact details are found by visiting the Chartered Trading Standards Institute.

The EU Cosmetics Regulation 1223/2009 applies regardless of the quantities you are selling or how you are selling your products including those for use in the professional setting and free samples.

Not complying with the requirements of the EU Cosmetics Regulation can lead to enforcement action and to sanctions, which may include a fine and/or imprisonment. The UK Cosmetic Products Enforcement Regulations 2013 sets out these penalties.

Only cosmetic products with a designated Responsible Person (RP) can be placed on the market. The RP is the one that must ensure all the relevant obligations set out in the EU Cosmetics Regulation are met. 

The RP may be an individual (a natural person) or a company (a legal person), must be located within the EU/EEA and should have access to the Product Information File (PIF).  The name and address of the RP is required on the product packaging. 

The Responsible Person may be:

• the manufacturer or a brand owner marketing a cosmetic product under their name or trademark; or
• the importer who is importing a cosmetic product from outside the EU; or
• a person or a company established within the Community mandated to act as the RP by the RP. In this situation, a mandate should exist and there should be acceptance from the designated person in writing.

For more information see the guidance from Cosmetics Europe, the European personal care association; Compliance with regulation 1223/2009 on cosmetic products roles responsibilities along the supply chain.

Each cosmetic product must have its own Product Information File (PIF) containing information about the product. This is a legal requirement and the files are open to inspection by the enforcement authority where the PIF is located (Trading Standards Officers in the UK).  The Responsible Person (RP) is the one that should guarantee that the product is safe and makes the PIF accessible to the enforcement authority. 

The PIF must include the following:

• the product description;
• the Cosmetic Product Safety Report;
• details of methods of manufacture in accordance with GMP;
• proof of the effect claimed for the cosmetic product, where justified by the nature or the effect of the cosmetic product; and
• data on animal testing.

Detailed guidance on what is required in the PIF is available from Cosmetics Europe, the European personal care association; Guidelines on Product Information File (PIF) Requirement.

There is no requirement to register cosmetic products in the EU. Instead the EU Cosmetics Regulation operates a system of notification and in-market surveillance. To ensure traceability of all cosmetic products, before placing a new cosmetic product on the EU market the Responsible Person must notify their details and specific information about the product to the EU Commission.  This is done electronically through a centralised website called the Cosmetic Products Notification Portal (CPNP). The Enforcement authorities responsible for checking that cosmetics comply with the Regulation (Trading Standards Officers in the UK) have access to this portal. 

Before notifying cosmetic products, the Responsible Person has to set up an account on the CPNP. To use the CPNP you must first set up users (staff carrying out the notification) and organisations to which users are attached. There are three websites that you must use in order to register users, register the organisation and notify products.  

These must be used in the correct sequence:

1. Usernames and passwords are registered using the ECAS (European Commission Authentication Service) system.
2. A second website, the SAAS (DG Sanco Authentication Authorisation System) website, allows organisations to register as responsible persons or distributors. 
3. Finally, once organisations and users have been registered and permitted to access the system, notifications can be made via the CPNP.

Further guidance on notifying to the portal is available on the European Commission’s website.

For information on the UK regulatory framework for cosmetics after the UK leaves the EU, and how to prepare for a ‘no deal’ scenario, see our Brexit ‘No Deal’ Help section.

A distributor is “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community Market”. This includes wholesalers, retailers, shops, beauty or hair salons, telesales, outlets and internet selling.

Distributors have specific obligations established under Article 6 of the EU Cosmetics Regulation. These obligations are outlined in the CTPA Guide to Supplying Cosmetic Products on the UK Market. Further detail can also be found in the CTPA Distributor Guidance.

In addition to the EU Cosmetics Regulation, other legislation affecting cosmetic products includes the Weights and Measures Act, Trade Descriptions Act, the Consumer Protection Act, legislation on alcohol, legislation on aerosols, legislation on Registration, Evaluation and Authorisation of Chemicals (REACH) and the Health and Safety at Work Act.  A list of UK legislation and guidance documents for example purposes is available from our ‘Other Laws’ page.

CTPA is the UK trade association representing all types of companies making, supplying and selling cosmetic and personal care products.  The Association’s role is to advise member companies about the strict legal framework for cosmetics, to represent industry views to UK Government and external stakeholders and provide the science behind cosmetic products and their safety to the media.  

CTPA is a members’ organisation.  We offer a membership service that includes one-to-one advice on the regulatory framework for cosmetics and personal care products and access to our member-only website and other resources.  More information about the benefits of membership and downloadable enquiry forms are available on our “Why Join?” page.

We also provide top-level guidance to non-members, including SMEs and start-up companies through information on this website and a CTPA guide ‘Supplying Cosmetic Products on the UK Market? A CTPA Guide to What you Need to Know’ which outlines the EU Cosmetics Regulation. The guide has been specifically written to help small entrepreneurial companies understand their obligations under the legal requirements. 

CTPA does not manufacture or sell cosmetic products, nor can we provide consultancy services, including claims and analytical assessment, or pack copy checking.  Whilst our scientific, technical and regulatory staff have a wealth of industry knowledge, we are not safety assessors and cannot provide such services.

While CTPA cannot recommend specific companies, there is a full list of our members and the services they provide here on our website.  Using the interactive key, you will be able to filter companies by the service you require or by membership type.  Links will then take you to the company websites.

CTPA has a consumer website, www.thefactsabout.co.uk which has comprehensive information on the laws governing cosmetic products in the UK/EU.  The site also provides in-depth advice on specific product types as well as commonly used ingredients and terms. 

CTPA is not the UK Competent Authority for cosmetics; this is the UK Government Department for Business, Energy and Industrial Strategy, together with Trading Standards.

CTPA cannot comment on individual products, nor is it the enforcement body.  If you believe cosmetic products on the UK market are not compliant with the legislation, we strongly advise you to contact Trading Standards, who are responsible for enforcement in the UK, via the Citizens’ Advice Consumer Helpline.This is the network of call centres run by Citizens’ Advice on behalf of Trading Standards to provide first line consumer advice and support to consumers.  The number to call is 03454 04 05 06, which we understand is charged at local call rate.  An explanation of how it works is given on the Citizens’ Advice web page.

To fall under the scope of the EU Cosmetics Regulation 1223/2009, a product needs to fulfil the definition of a cosmetic product. Article 2 of the Regulation defines a cosmetic product as:

“…any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.” 

A product must therefore be a substance or mixture and have both a site of application and a function that falls within this definition in order to be classed as a cosmetic.  Cosmetic claims and overall presentation of the product may also define its classification.

For more information see the CTPA Guide to Supplying Cosmetic Products on the UK Market.

No.  A product is either a cosmetic or a medicine and cannot be both at the same time. When marketing a product as a cosmetic, care should be taken that it is not presented (by ingredient, claims or presentation) as treating or preventing an adverse condition and so does not cross the medicines borderline where the regulatory situation will differ. 

Please remember that a claim does not have to be written; the term covers any text, names, trademarks, pictures and figurative or other signs. It can be implied by ingredients, labelling, advertising and presentation including any on-line marketing and text such as reviews or testimonials.

The MHRA is the authority that ultimately decides whether a product needs to be marketed as a medicine and requires a licence. More information on borderline products, including the MHRA position on adverse skin conditions and a link to MHRA guidance, is available on our Cosmetic Product Borderlines page.

Personal lubricants are not classed as cosmetic products as their site of application and function does not comply with the definition given in the EU Cosmetics Regulation. Instead a lubricant may be considered a medical device depending on the nature of the product, its intended use and the claims that are made with it. If the product is not classed as a medical device then the product could be covered by the General Product Safety Regulations.

For more information on medical devices, general products and their respective legislation, please see our Cosmetic Product Borderlines page. Guidance for businesses on general product safety is also available on the gov.uk website here.

Eyelash adhesives do not have a cosmetic function and so are not cosmetic products. They are general products and so are covered by the General Product Safety Regulations 2005 under which they are required to be safe in normal or reasonably foreseeable use. Guidance for businesses on general product safety is available on the gov.uk website here.

CTPA advises that for general products that are applied to the skin, they should contain ingredients that are allowed for use in cosmetic products and should be subject to a safety assessment. 

The EU Cosmetics Regulation controls what may or may not be put in a cosmetic product. Hydroquinone is banned from use in topical cosmetic creams and may only be used according to specific uses as restricted in Annex III of the EU Cosmetics Regulation.  Under Annex III, hydroquinone is restricted to artificial nail systems (with a warning to ‘avoid skin contact’) and to help develop colour in hair colorants (with a warning ‘do not use to dye eyelashes or eyebrows’) where it is not in contact with large areas of the skin for any length of time.  CTPA’s advice is to apply the same rules when looking into marketing General Products that are applied to the skin.

After discussions with the UK Competent Authorities, CTPA would like to reiterate that such adhesives should not contain hydroquinone and CTPA has been advised that if such products containing hydroquinone were identified by Market Surveillance Officers, they would be removed from the market and appropriate action taken.

Pet products are not classed as cosmetics. The definition of a cosmetic from the EU Cosmetics Regulation does not cover any product intended for animals, stating that a cosmetic product is applied to the human body.

If the pet products are straightforward shampoos, conditioners or fragrances etc., they will have to comply with the General Product Safety Regulation.  

The Legal Controls on Veterinary Medicine guidance provided by the Veterinary Medicines Directorate on the gov.uk website references shampoos and ‘cosmetic’ products under “specific topics”, stating that such products can also fall into the category of medicine depending on the claims being made and/or the ingredients being used. 

False eyelashes are not substances or mixtures but are considered articles. They therefore do not fall under the scope of the EU Cosmetics Regulation. Make-up brushes similarly do not fall under the definition of a cosmetic.

Instead, products of this type are general products and are regulated under the General Product Safety Regulations 2005. Under the GPSR companies have an obligation to ensure the product is safe in normal or reasonably foreseeable use. Guidance for businesses on general product safety is available on the gov.uk website here.

Making cosmetic products in a work space at home is permissible, as long as the products follow the EU Cosmetics Regulation, which includes being made according to Good Manufacturing Practice (GMP). See FAQ - 'What is GMP and why is it important?' for further explanation. GMP is a legal requirement of the EU Cosmetic Regulation.  The person making the cosmetics at home must make sure that work areas are clean, that there is no possible contamination, that there is suitable separation of ingredients and finished products and that microbial contamination is monitored.

GMP (Good Manufacturing Practice) means having procedures in place to ensure that products are prepared in a clean environment and that the products do not become contaminated in production. Microbial contamination can be quite common as many micro-organisms live freely in the atmosphere around us.  Contamination of products can lead to degradation and, in severe cases, could cause harm to the consumer.

For further guidance, the CTPA ‘GMP - A Practical Guide for the Cosmetic Industry 2015’ is available for non-members to purchase from our publications page.

Companies are presumed compliant with the EU Cosmetics Regulation requirement to manufacture in accordance with GMP if they abide by the International Standard Organisation (ISO) Guidelines on Good Manufacturing Practices ISO 22716 (available to purchase from the British Standards Institute (BSI) website). Following ISO 22716 is not a legal requirement: companies are free to use whatever GMP they wish.  However, they would be required to demonstrate their own system achieved the same objective as that of the ISO 22716 Guidelines.

The EU Cosmetics Regulation 1223/2009 controls what may or may not be put in a cosmetic. The Regulation contains a list of substances that a product must not contain (Annex II) and a list of substances that may be used as ingredients subject to certain restrictions (Annex III).  In addition, certain classes of ingredients such as colours (Annex IV), preservatives (Annex V) and UV filters (Annex VI) are part of positive lists, so only ingredients pre-approved and listed in these Annexes are allowed for those purposes.  

If an ingredient is not prohibited, restricted and does not have a use requiring pre-approval (colour, preservative or UV filter), it may be used without restriction provided it is is not classified as a Carcinogenic, Mutagenic or Reprotoxic (CMR) substance by the Classification, Labelling and Packaging Regulation (CLP) and that the final product is safe.

For more information about CMR substances see the CTPA Guide to Supplying Cosmetic Products on the UK Market.

Depending on the presence of any controlled substances and the part of the plant used as the source material, it may be possible for some cannabis ingredients and extracts to be used legally in cosmetics in the UK, providing specific criteria and exemptions are met.

Following consultation with the Home Office and BEIS (Department for Business, Energy and Industrial Strategy) CTPA has produced a position paper containing further information and advice to help determine whether a particular material is permitted for use in cosmetics.

Glitter is often used for visual effects in cosmetic products.  Some glitter is made by fixing colours between thin layers of plastic and these would be classed as a plastic.  If these types of glitters are used in rinse-off cosmetic products they will be covered by the UK ban on plastic microbeads which came into force in 2018.  Not all substances that provide a glittery effect are based on plastic.  Some glittering effects are provided by coloured mica, which is a naturally mined mineral.  Other glitters are minerals based on silica (a constituent of sand) mixed or coated with colours. 

It is CTPA’s advice that any colours used in glitters should be listed in Annex IV to the EU cosmetics legislation and used in accordance with any restrictions set out in the Annex entry. 

Cosmetic Product Safety information that contributes to the safety assessment includes, amongst other things;

• Physical/chemical characteristics and the stability of the cosmetics product under reasonably foreseeable storage conditions (sometimes referred to as stability testing).
• The microbiological specifications of the substance or mixture and the cosmetic product and results of preservation challenge testing.
• The relevant characteristics of packaging material, in particular purity and stability (sometimes referred to as compatibility testing).
• Any claims made by a cosmetic product must be substantiated, therefore you may need to perform studies to back up your claims. 

The results from the stability, compatability and challenge tests will be used to help inform a decision on the shelf-life of the product and will also be considered by the safety assessor as part of the Cosmetic Product Safety Report (CPSR)

There are no specific guidelines for stability testing so it is for each company to decide what is appropriate for the product in question.  It is desirable to perform such tests both in an inert container to test the formulation alone and also to test within the actual packaging to check for any compatibility issues. 

There is an ISO document that is a guideline on stability testing for cosmetic products (ISO/TR 18811:2018). 

Cosmetics Europe has Guidance on Stability Testing of Cosmetics which is available free of charge on its website:

Please also find a link to a monograph from the International Federation of the Societies of Cosmetic Chemists (IFSCC) which also outlines the Fundamentals of Stability Testing.  The information in the document is still valid.

See FAQ - 'What is a CPSR?' for further details.

The aim of a challenge test, sometimes referred to as a ‘preservative efficacy test’, is to test the robustness of the preservative system in the product and packaging during use by the consumer, as proof of its efficacy.  Whereas microbiological testing forms part of the continual quality assurance system and is used to confirm whether the product meets the required specification prior to its release to the consumer.

Data from challenge testing should be supplied to the safety assessor for them to consider as part of the Cosmetic Product Safety Report (CPSR). See FAQ - 'What is a CPSR?' for further details.

Cosmetics Europe, the European personal care association, provides Guidelines on Microbial Quality Management on its website. In addition ISO 11930:2019 covers Evaluation of the Antimicrobial Protection of a Cosmetic Product. 

CTPA provides guidance on Microbial Quality Management which you can find in our Publications section.

Cosmetic products refilled in store that are sold to consumers must fully comply with the EU Cosmetics Regulation.  The action of refilling introduces microbiological risks that need to be managed so that the product remains safe.  At present there are no specific standards nor set procedures for product refills. However, we recommend at least the following points are considered:

Cleaning and sanitisation - a key consideration is whether the old consumer packaging will be cleaned and sanitised prior to re-use or whether residue from the previous batch could still be present. CTPA strongly recommends consulting a microbiologist with experience in the field of cosmetics to ensure any risks are adequately managed.

GMP/Filling instructions - it is recommended that the process the retailer will use for refilling is fully defined and documented for ensuring both hygiene and that the correct fill weight is delivered.

Labelling for the consumer - refilled products must also comply with the labelling requirements of the EU Cosmetics Regulation. This includes being able to provide a ‘Best Before End’ date (BBE) or the Period After Opening (PAO) when relevant.

Labelling of bulk - the product in the dispenser is not a finished cosmetic product and so should be labelled according to the requirements of the Classification, Labelling and Packaging (CLP) Regulations. Safety Data Sheets (SDS) will be needed to aid in safe handling of the bulk product.

Safety assessment - the safety assessor will consider how the containers will be cleaned and filled, as well as other potential variables, when compiling the Cosmetic Product Safety Report (CPSR). See FAQ - 'What is a CPSR?' for further details.

One major consideration is that the compatability of the product and preservative performance in a different container will not have been assessed which could present a future risk for consumer safety.

A kit that is intended to be used to make a specific cosmetic formulation and is accompanied by the recipe and instructions is a finished cosmetic product and needs to comply fully with the EU Cosmetics Regulation requirements.

If there are no instructions or indications as to how the components are expected to be used, the kit would fall under the scope of the General Product Safety Regulation, REACH Regulation and the CLP Regulation (for more information on these regulations see our ‘Other Laws’ page). In this case it is the responsibility of the company to make sure the raw materials will be safe whichever use is made of them by the end consumer. As they are to be applied to the skin, it would be advisable to ensure a cosmetics safety assessor has assessed the potential foreseeable uses for the raw materials.

You will need to be sure that the instructions cover any eventualities when the consumer is mixing or processing the ingredients to make a cosmetic product and the safety assessment should, in our opinion, extend to covering serious mistakes by the consumer when making the product (for example, making mistakes in quantities weighed or used). 

Cosmetics kits intended for use by children in play, with instructions, are both cosmetics and toys and will need to comply with both the EU Cosmetics Regulation and the Toy Safety Regulations.

The primary purpose of the EU Cosmetics Regulation is to protect human safety.  The manufacturer or supplier of the cosmetic product is responsible for ensuring it is safe. In order to demonstrate this, the EU Cosmetics Regulation requires that each cosmetic product must undergo a full safety assessment and that a Cosmetic Product Safety Report (CPSR) is compiled before the product is placed on the market.  See FAQ - 'What is a CPSR?' for further details. These documents may be inspected at any time by the enforcement authorities, usually Trading Standards in the UK.

The safety assessment is required to be performed in line with the requirements of Article 10 of the EU Cosmetics Regulation by a specifically qualified expert (safety assessor).

The safety assessor will consider all supporting information such as:

• the general toxicological profile of each ingredient used; 
• the chemical structure of each ingredient; 
• the level of exposure of each ingredient; 
• the specific exposure characteristics of the areas on which the cosmetic product will be applied; and 
• the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended.

In the case of perfumery raw materials, the composition may not be known because of confidentiality. If so, it is necessary to obtain a relevant safety assessment from the supplier.

The CPSR (Cosmetic Product Safety Report) is a dossier containing all the information required to demonstrate that a particular cosmetic product is safe. It will form part of the Product Information File. See FAQ - 'What is a Product Information File (PIF) and what goes in it?' for further details.

While there is no set format as to how the CPSR should look, it must follow the minimum requirements detailed in Annex I to the EU Cosmetics Regulation, under each of the headings of Part A and Part B.

Part A is a collection of all the cosmetic product safety information necessary for the safety assessment of the product, while Part B provides the safety assessment conclusion with the assessors reasoning, any labelling/warnings required, and the safety assessor’s credentials.

The European Commission has published guidelines on Annex I to the EU Cosmetics Regulation in respect of the Cosmetic Product Safety Report, which are available on the European Commission’s Cosmetics Sector Webpage.

Safety assessments may only be carried out by Safety Assessors who are specifically qualified and have appropriate experience to make the assessment. The qualifications are stated in Article 10 of the EU Cosmetics Regulation:

“The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.”

The safety assessment can be performed in-house if the appropriate personnel are available. If this is not the case, the safety assessment must be performed by an appropriately qualified third party.

There is no register of approved cosmetic safety assessors. A list of safety assessors who are also CTPA members can be found on our Members List page by selecting ‘Safety Assessment’ (F) in the key reference.  It is recommended to contact a variety of safety assessors to ascertain whether you feel confident in their qualifications and their abilities.

A safety assessment is required for all cosmetic products, regardless of the origin of the materials they contain. It does not matter whether a cosmetic product is made up of all natural or all synthetic ingredients - the legislation does not distinguish between the source of an ingredient.

Whether an ingredient is synthetic/man-made or ‘natural’ has no bearing on whether an ingredient is safe to use. The Annexes of the EU Cosmetics Regulation include many natural materials, as well as many man-made materials, that are prohibited from use in cosmetics for reasons of safety.

While all cosmetic products need to be assessed as safe for use, the EU Cosmetics Regulation also requires a specific safety assessment for cosmetic products that are intended for use on children under three years of age;

‘There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.’ [Annex I Part B (3)].

Additionally, there are some ingredients that are not allowed for usage on particular age groups, or some may require specific warnings/labelling requirements. These will be indicated in any corresponding Annex entry to the EU Cosmetics Regulation.

There is no requirement to test finished cosmetic products for safety in a laboratory prior to placing them on the market. All products must instead undergo a safety assessment based upon data on the finished product and its ingredients. This assessment is the most appropriate way of demonstrating a product’s safety. The formula usually undergoes stability, compatability and challenge testing, the results of which will used by the safety assessor in formulating the safety assessment. See FAQs - 'What is Stability testing and why is it needed?' and 'What is the difference between micro and challenge testing?' for further details. 

However, microbiological testing forms part of the continual quality assurance system and is required to confirm whether the product meets the required specification prior to its release to the consumer.  This testing can be conducted within a company if the appropriately qualified persons are employed but is often outsourced to microbiological testing houses. See FAQ - 'What is the difference between challenge testing and microbiological testing?' for further details.

CTPA members can be found on our Members List page by selecting ‘Microbiological Services’ (D) in the key reference.

Cosmetovigilance is the process of collecting, evaluating and monitoring reports of undesirable events following normal or reasonably foreseeable use of a cosmetic product.

The EU Cosmetics Regulation requires that any adverse effects attributable to a cosmetic product are recorded in the Product Information File (PIF).  Additionally, the Responsible Person and Distributors must report a Serious Undesirable Effect (SUE) to the Competent Authority of the EU Member State where the SUE has occurred.  When an SUE is reported to a Competent Authority, the authority then has to alert the authorities in all other EU Member States.  A report can also come from a consumer or a healthcare professional.

 
Article 2 of the Regulation provides definitions of both undesirable effects and serious undesirable effects.

Undesirable Effect

'an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product'.

Serious Undesirable Effect

'an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death’.

SUE reporting guidelines and reporting forms are available on the European Commission’s Market Surveillance webpage.

Any undesirable effect (UE), whether it is deemed to be ‘serious’ or not, does need to be investigated to make sure it is attributable to the cosmetic product in question.  In order to determine this, it is important that a causality assessment is performed.  The guidelines also cover the causality assessment. 

In the event of an SUE occurring in the UK, the Responsible Person (or Distributor, depending on who has the duty to report under the Regulation) should in the first instance contact their local Trading Standards department and share the information on Form A.  The Trading Standards Officer will make a record of the dialogue with the RP/Distributor, complete a Form B and forward the forms to the Department for Business, Energy and Industrial Strategy (BEIS). 

No.  Finished cosmetic products are exempt from the legislation requiring the provision of a 16-point Safety Data Sheet (SDS), sometimes referred to as Material Safety Data Sheets (MSDS).  However, it must be recognised that there are legal requirements under Health and Safety legislation to provide a certain amount of information for some products regarding transport and safe handling.

CTPA has issued an Information Note on this issue explaining the legal requirements and providing examples of how information may be provided to distributors, retail outlets, beauty salons etc.

There is no approved list of cosmetic product claims in the UK/EU, nor is there a process of claims authorisation.

In the UK/EU, cosmetic claims are covered by Article 20 of the Cosmetic Products Regulation (EC) No. 1223/2009 and Regulation (EU) No. 655/2013 - Common Criteria for Cosmetic Claims.

It is the responsibility of the manufacturer or supplier to ensure that all claims made about a cosmetic product do not imply a characteristic it does not have. Claims must be substantiated and not mislead or misinform the consumer, and must comply with the Common Criteria for Cosmetic Claims.

Please remember that a claim does not have to be written; the term covers any text, names, trademarks, pictures and figurative or other signs. It can be implied by ingredients, labelling, advertising and presentation including any on-line marketing and text such as reviews or testimonials.

More guidance on making cosmetic claims is available in the CTPA guide Confidence in Cosmetic Claims. See FAQ - 'What is the common criteria for cosmetic claims?' for further details.

Regulation (EU) No. 655/2013, laying down common criteria for the justification of claims used in relation to cosmetic products (Common Criteria for Cosmetic Claims), was published in July 2013.

The objective of the Common Criteria is to protect consumers from misleading claims whilst also ensuring better convergence of actions of Member State Competent Authorities.  It is not aimed at defining and specifying the wording that can be used for cosmetic product claims.

The six Common Criteria for claims are;

• Legal Compliance,
• Truthfulness,
• Evidential Support,
• Honesty,
• Fairness,
• Informed Decision-Making.

More information about the common criteria is available in the CTPA guide Confidence in Cosmetic Claims.

The European Commission has also published a Technical Document on Cosmetic Claims as guidance to enforcement authorities in the Member States for the case-by-case application of the Common Criteria. 

Annexes I and II (published in 2013) are already being applied; Annex I provides a detailed description of the common criteria, including illustrative and non-exhaustive examples of claims.  Annex II provides for best practices specifically related to the type of evidential support used for the justification of cosmetic claims.

Annexes III and IV brought new elements which applied as of 1 July 2019.  Annex III looks at how the six Common Criteria apply to ‘free-from’ claims; Annex IV gives guidance on ‘hypoallergenic’ claims.  This document is also work in progress and subject to modifications.

Many ‘free from’ claims perpetuate myths on safe and legally allowed ingredients, fostering a negative perception around the safety and uses of cosmetic ingredients, which in turn has led to safe and effective ingredients no longer being used.  The damage to the trust and reputation such action has on the industry should not be underestimated.

Annex III of the Technical Document on Cosmetic Claims is a guidance that provides an interpretation by the European Commission of how the Common Criteria apply to ‘free from’ claims.  The guidance is not legally-binding, however the Common Criteria are.  Companies would therefore be expected to provide different and robust interpretation if they want to continue to make ‘free from’ claims in the EU. See FAQ - 'What is the common criteria for cosmetic products?' for further details.

For more information on “free from” claims, including a CTPA Help Note and ‘Call to Action’ to companies, please see the following two public news items:

CTPA Help Note on 'Free From' Claims

Cosmetic Claims – Focus on ‘Free From’ Claims

The Responsible Person has a duty to ensure that the wording of any message communicated about a cosmetic product is in compliance with the Common Criteria for Cosmetic Claims and is consistent with the documentation in their possession for supporting the claim. See FAQs - 'What is the Responsible Person?' and 'What is the common criteria for cosmetic claims?' for further details.

According to the Common Criteria, all claims need appropriate evidential support.  The only exception are hyperbolic claims which an average consumer would not be expected to take literally.

Annex II to the Technical Document on Cosmetic Claims provides best practices specifically related to the type of evidential support used for the justification of cosmetic claims.

More guidance on claims support is available in the CTPA guide Confidence in Cosmetic Claims.

CTPA has also written an Advertising Claims Guide to help advertisers understand more clearly the framework in which cosmetic claims appear and the way in which cosmetic claims may be substantiated.  The Guide has been endorsed by both the Advertising Standards Authority and Clearcast, the broadcast clearance body.

Animal testing of cosmetic products and cosmetic ingredients is banned in the UK/EU. Selling cosmetic products tested on animals or containing ingredients tested on animals is also banned. 

Article 20 of the EU Cosmetics Regulation is very clear and states that 'cruelty free' and 'not tested on animals' claims are only allowed when companies can demonstrate that no animal testing has ever happened in the past.  While animal testing has been banned in the EU for cosmetic product in 2004 and for ingredients in 2009, cosmetic ingredients are likely to have been tested on animals at some point in the past. Some competent authorities have taken enforcement action because companies could not demonstrate that all of the ingredients in the products in question had never been tested on animals.

Furthermore, the Common Criteria for Cosmetic Claims prohibits claims that are no more than claiming compliance with legal requirements. See FAQ - 'What is the common criteria for cosmetic claims?' for further details. Since the ban on animal testing applies equally to all cosmetic products on the UK/EU market, it would appear that claims relating to avoidance of animal testing would not be permitted.  Moreover, the presence of ‘not testing on animals’ claims potentially denigrates products which do not make the claim, as the assumption may be made by the consumer that products not making the claim are tested on animals, which is not true.

However, explicit statements relating to a company’s philosophy regarding animal testing ought to remain acceptable under the Common Criteria.

For products intended to be marketed as cosmetics, care should be taken that the product is not presented (by ingredient, claims or presentation) as treating or preventing an adverse condition and so does not cross the medicines borderline where the regulatory situation will differ.  The Medicines and Healthcare products Regulatory Agency (MHRA) is the authority that ultimately decides whether a product needs to be marketed as a medicine and requires a licence in the UK. 

Please remember that a claim does not have to be written; the term covers any text, names, trademarks, pictures and figurative or other signs. It can be implied by ingredients, labelling, advertising and presentation including any online marketing and text such as reviews or testimonials.

More information on borderline products, including the MHRA position on adverse skin conditions and a link to MHRA guidance, is available on our Cosmetic Product Borderlines page.

The terms 'natural' and ‘organic’ are not specifically defined under the EU Cosmetics Regulation and certification in relation to these claims is not a legal requirement.  However, any claim made by a cosmetic product is covered by the legislation and claim must be capable of substantiation, must not mislead or misinform the consumer and all claims must comply with the Common Criteria. See FAQ - 'What is the common criteria for cosmetic claims?' for further details.  Such claims should not imply that this type of product is safer than other cosmetics just because they are making ‘natural’ or ‘organic’ claims.

If companies are seeking organic certification of the finished product by a commercial organisation, we urge them to remember that such certification is optional, while compliance with the EU Cosmetics Regulation is mandatory.

For more information on natural and organic claims and standards from non-mandatory certification bodies and organisations, please refer to the CTPA Guide to Supplying Cosmetic Products on the UK Market.

There is no legal definition of a vegan cosmetic product.  Manufacturers may include claims that the product does not contain any animal-derived ingredients or is ‘suitable for vegans’.  Such claims are acceptable, but it is a legal requirement that all claims can be substantiated and are not misleading to the consumer  It should therefore be clear to the consumer what criteria are being applied.

Societies representing vegan or vegetarian interests may have further information on their websites and in their literature. They may also offer certain logos to be used for labelling should the product meet their criteria.  It must be remembered that certification by a commercial organisation of either ingredients and/or a final cosmetic product is optional, while compliance with the EU Cosmetics Regulation is mandatory.

The labelling requirements for cosmetic products are detailed under Article 19 of the EU Cosmetics Regulation.

These are:

• name and EU address of the Responsible Person;
• declaration of quantity of contents;
• Period after Opening or date of minimum durability where relevant;
• warning statements and precautionary information;
• batch code;
• product function;
• declaration of ingredients;
• country of origin for imported products.

All legally required information must be in indelible, easily legible and visible lettering.

All of the legally required information must be visible on the container as well as the packaging if there is any. The only exception is the declaration of ingredients which needs only to be on the packaging or outside of the pack depending on what is initially seen by the consumer.

Systems such as hang tags, re-peelable labels etc., were introduced by industry in response to size and shape challenges. All effort should be made to have the legally required information on the primary packaging, with any inclusions being the exception and, as the information is obligatory, presented with the product.

Every effort should be made, by following good industry standards, to ensure that the products are packaged correctly with all the required information.

A table summarising the requirements, as well as other guidance on labelling, is available in the CTPA Guide to Supplying Cosmetic Products on the UK Market.

Guidance on ingredient labelling is also available on our Cosmetic Product Ingredient Labelling page.

Ingredient labelling of cosmetics was introduced to help people to make informed choices about what they buy, particularly if they have a diagnosed allergy to a specific ingredient. Such labelling will also support dermatologists trying to identify the cause of a patient’s reaction.   

An ingredient means any substance or mixture intentionally used in the cosmetic product during the process of manufacturing.

The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. The ingredient list should start with the word ‘INGREDIENTS’ in upper or lower case and then follow with each ingredient in descending order of weight. However, ingredients of less than 1% may be listed in any order after those of 1% or more.  Colouring agents, other than colorants intended to colour the hair, may be listed in any order after the other ingredients using their Colour Index (CI) number.

Many essential oils naturally contain some of the 26 fragrance allergens identified in the Cosmetics Regulation and these must also be labelled separately if present above a certain level irrespective of their source; your suppliers should be supplying you with the information to fulfil your labelling obligations.

INCI stands for the International Nomenclature for Cosmetic Ingredients, which is the nomenclature for use in the ingredient declaration.  Standardised INCI names mean that in whatever EU country, and in many other parts of the world, a cosmetic product is bought, the ingredient names will be the same. This helps users to identify products with ingredients to which they know they are allergic.

The INCI names for cosmetic ingredients can be found in the European Glossary of Common Ingredient Names (Commission Decision (EU) 2019/701), which is available online.

Companies can get advice on the most appropriate INCI names for their ingredients from their raw material suppliers.

In the absence of an INCI name, companies can use an alternative as listed below:

• the International Cosmetic Ingredient Dictionary and Handbook published by the Personal Care Product Council (PCPC);
• chemical name;
• European Pharmacopoeia name;
• international non-proprietary name as recommended by the World Health Organisation; or
• EINECS, IUPAC or CAS identification reference.

Guidance on ingredient labelling is available on our Cosmetic Product Ingredient Labelling page and in the CTPA Guide to Supplying Cosmetic Products on the UK Market.

Cosmetic products placed on the UK and EU market do not have expiry dates.

Paragraph (1)(c) of Article 19 of the EU Cosmetics Regulation contains specific requirements for indicating a date of minimum durability (‘best before’) or indication of Period After Opening (PAO).

Products that remain durable for 30 months or less are required to be labelled with a date of minimum durability.

A product that remains durable for more than 30 months may be required to be labelled with a PAO if, after its opening, the deterioration of the product may lead to harm to the consumer.

It is important to note that some products may not require either to be indicated.  Also, no product can be required to indicate both, as the two are mutually exclusive.

More information about ‘best before’ and PAO labelling is available in in the CTPA Guide to Supplying Cosmetic Products on the UK Market.

Cosmetic Products are required to be labelled with the name and address of the Responsible Person within the EU. If more than one address is indicated on-pack, the address at which the PIF is made available should be underlined.  This information must be on both the container and its packaging.

A physical address is required - an email address is not sufficient.  Normally it is a business address, which will often be a head office but it might be a manufacturing site.  What is important is that it is a recognised address connected with the Responsible Person.

The address given may be abbreviated but must be sufficient for the normal postal service to deliver a letter to that address.  For an address within the UK, Trading Standards Officers usually accept as minimum abbreviation the full postcode.  To make this meaningful to those who live outside the UK, ‘UK’ or other words must be added to identify the country.

For information on the UK regulatory framework for cosmetics after the UK leaves the EU, and how to prepare for a ‘no deal’ scenario, see our Brexit ‘No Deal’ Help section.

Apart from the net content, there is no text size requirement for the obligatory labelling required under the EU Cosmetics Regulation.  The only requirement is that the text must be indelible, legible and visible. Contrasting colours and durability should therefore be considered with care.

The definition of easily legible is open to wide interpretation but observed sensibly it means that the labelling should be of sufficient size that it can be read by a person with normal vision at a distance of about 30cm without having to resort to aids such as magnification.

The UK Weights and Measures (Packaged Goods) Regulations 2006 specifies a minimum height for the figures used when declaring content on pack, depending on the net contents:

There is no requirement for labelling to be reviewed or approved by a third party. However, as mistakes can be costly to rectify and can have a reputational impact, it is recommended that artwork/pack copy is checked by at least another person who is experienced with the EU Cosmetics Regulation.

In 2006 the European Commission issued a Recommendation on the efficacy of sunscreen products and the claims made relating thereto .

The Recommendation sets out:

• claims which should not be made in relation to sunscreen products;
• precautions to be observed including application instructions;
• the minimum efficacy standard for sunscreen products in order to ensure a high level of protection of public health;
• simple, understandable labelling to assist in choosing the appropriate product.

The Recommendation only covers sunscreen products whose primary function is sun protection i.e. ‘beach .

The European Commission also has a dedicated webpage on sunscreen products.

The United Kingdom is currently in the process of leaving the European Union. This is commonly referred to as ‘Brexit’.

Brexit will have impacts on the cosmetics industry.  When the UK leaves the EU, it also leaves the European Economic Area (EEA), the Customs Union and the Free Trade Agreements that Europe has in place with third countries.  This will have consequences on customs, tariffs, movement of people and regulations.

If a withdrawal agreement (‘deal’) is not reached then there is a possibility of a ‘no deal’ Brexit and contingency plans are being put in place for this eventuality - CTPA is strongly recommending that companies prepare for a ‘no deal’ Brexit.

For more information on Brexit and how to prepare now for a ‘no deal’ scenario see our BREXIT - 'No Deal' Help page.

The UK is still currently a full member of the European Union and all cosmetic products on the market in the UK must still comply with the EU Cosmetics Regulation.

Whether the EU Regulation will continue to apply to products on the UK market after the date the UK leaves the EU will depend on whether a Withdrawal Agreement is in place.

If a Withdrawal Agreement is in place by the time the UK leaves the EU, EU law will continue to apply for at least until the end of any transition period.  The regulatory framework that will apply at the end of the transition period will depend on further negotiations and the terms of regulatory cooperation between the UK and the EU.

If the UK leaves the EU with ‘no deal’, both EU law will cease to apply and a UK cosmetic law will begin to apply on day 1 of Exit (i.e. there will be no transition period). This law will be the UK Cosmetics Regulation Statutory Instrument (SI), which is part of the Product Safety & Metrology etc (Amendment etc) (EU Exit) Regulations 2019 (Schedule 34).

The requirements of the EU and new UK cosmetics legislation are closely aligned. However, there are some differences, the main differences being that products on the UK market will require a UK Responsible Person, the Product Information File to be available to UK Authorities and notification of cosmetic products on the UK notification database is required.  

Going forward, CTPA will call on the UK Government and the EU to maintain this regulatory alignment by:

• implementing similar and compatible rules;
• sharing mutual access to regulatory databases;
• exchanging information; and
• establishing administrative co-operation on in-market control post the EU Exit.

For more information on Brexit and how to prepare now for a ‘no deal’ scenario see our BREXIT - 'No Deal' Help page.

Companies will also have to continue to comply with the EU Cosmetics Regulation for their products on the EU 27 Market.

If the UK leaves the EU with a withdrawal agreement in place, products on the UK market will continue to be notified to the EU CPNP until at least the end of any transition period.

In the event of the UK leaving the EU without a deal, on day 1 of Exit in a ‘no deal’ scenario the UK Cosmetics Regulation Statutory Instrument (SI), which is part of the Product Safety & Metrology etc (Amendment etc) (EU Exit) Regulations 2019, will begin to apply.

Under this new UK Cosmetics Regulation, companies will need to notify cosmetic products on the UK market to a new UK cosmetic product notification database.

In order to prepare to notify on the UK CPNP if there is ‘no deal’, we advise companies to download their notifications from the EU CPNP in the form of .xml files, which will be compatible for upload into the UK notification database (if and when it will be needed). 

For more information on Brexit and how to prepare now for a ‘no deal’ scenario see our BREXIT - 'No Deal' Help page.

The European Commission published a specific technical notice on cosmetics to inform companies how to prepare for a 'no deal' Brexit.  The technical notice clearly states that UK companies who want to continue selling cosmetic products in the EU will need to comply with the EU Cosmetics Regulation after the UK leaves the EU.

As per the European Commission Q&A on industrial products, goods placed on the EU market before Exit day can be sold through even if they are not correctly labelled with the new EU RP address.  This provision does not provide for a time limit, therefore it is CTPA’s understanding that products placed on the market before Exit day can be sold through.  However, products placed on the EU market after Exit day must comply with the EU Cosmetics Regulation from day one of Exit.

The UK Government has published additional guidance for businesses who are placing manufactured goods on the UK or EU markets in the event of a ‘no deal’ Brexit. This guidance explains the different arrangements for goods placed on the market before Exit day and goods placed on the market after Exit day.

For more information on Brexit and how to prepare now for a ‘no deal’ scenario see our BREXIT - 'No Deal' Help page.

In the UK/EU, the manufacture and supply of all cosmetic products is governed by the EU Cosmetics Regulation (No. 1223/2009) and its amendments.  This Regulation and its amendments are directly applicable in all 28 EU countries and all cosmetic products need to comply with the above regulations before they are placed on the UK/EU market. Compliance with third country legislation is not acceptable as a substitute for the EU Cosmetics Regulation.

CTPA provides a guide covering what companies need to know for supplying cosmetic products on the UK market, including formula composition rules, labelling requirements, safety assessment and product information file.

It is important to understand the rules for cosmetic products and the documentation required when exporting to any country outside the EU.

In some cases, compliance with the EU Cosmetics Regulations will be sufficient to meet the product safety obligations of some markets, however may countries have their own laws on cosmetics to which imported cosmetic products must comply.

The UK Government Department for International Trade (DIT) has a number of export guides for UK businesses who are interested in selling overseas.

The European Commission’s Market Access Database provides information on import conditions in third country markets.

CTPA can also provide help to members. CTPA specialises in the UK and EU legislation, however, we do gather and share information on international regulations with our members. CTPA members may also subscribe to an additional online regulatory resource consisting of two reference manuals: the UK & EU/EEA Manual and the International Manual. The latter provides information on the regulatory frameworks in key international markets, including registration and labelling requirements for cosmetic products. More information about CTPA membership can be found on our ‘Why Join’ page.

When exporting to third countries, companies are often asked to provide a Certificate of Free Sale (CFS) as part of their export dossier.  A CFS is an attestation made by the EU Responsible Person that the product complies with the EU Cosmetic Products Regulation (EC) No. 1223/2009 and may be freely sold across the EU.  A CFS is also regarded as a 'Certificate of Manufacture' or a 'Health' or 'Safety Certificate' by certain non-EU countries. 

More information about who can issue a Certificate of Free Sale is available from our Certificates of Free Sale for Export page.

The UK Government website provides advice on importing and exporting products into and out of the EU.

https://www.gov.uk/starting-to-import/importing-from-noneu-countries

https://www.gov.uk/starting-to-export/outside-eu

The UK Government website provides advice on moving goods within the EU:

https://www.gov.uk/starting-to-export/within-eu

https://www.gov.uk/starting-to-import/moving-goods-from-eu-countries

In general, a company selling to other countries outside of the EU will need to comply with that specific country’s legislation. 

Some countries such as Australia and the USA have been very clear that compliance with national laws is required if a citizen buys a product from a UK-based website. The situation may not be as clear for some other countries and a case-by-case analysis of the national law may be required.

It is therefore advisable for companies to seek legal advice if intending to offer products for sale via the internet to overseas customers.

Article 19 of the Cosmetics Regulation calls only for a list of ingredients to be visible on the packaging of the product, and there is no obligation to provide a list of ingredients on a website.

If the list of ingredients is not available online, then it is advisable that the returns policy should ensure that returns be accepted based on the consumer not being able to use the product because they may be allergic to some of the ingredients and did not have the information available when purchasing online.