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

In the UK and EU, cosmetic claims are covered by Article 20 of the UK Cosmetics Regulation (EC) No. 1223/2009 (UKCR) and the EU Cosmetic Products Regulation (EC) No. 1223/2009 (CPR), respectively.  Cosmetics claims are also covered by Regulation (EU) No. 655/2013 - Common Criteria for Cosmetic Claims, which is applicable in both the UK and EU.

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.

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.

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.  This Regulation continues to apply also in the UK, as it is referred to under Article 20 of the UK Cosmetics Regulation (EC) No. 1223/2009 (UKCR).

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 and the UK. See FAQ - 'What is the common criteria for cosmetic products?' for further details.

For more information on 'free from' claims please see the following guidance:

CTPA Help Note on 'Free From' Claims

CTPA Position Paper on the use of ’Free From’ Claims

The UK Cosmetics Regulation states that any claims made for cosmetic products must be accurate and fully substantiated.  It refers to the EU Common Criteria on Cosmetic Claims (No 655/2013) which provides six common criteria to which all cosmetic claims must adhere – truthfulness, honesty, legal compliance, fairness, evidential support and informed decision making.  Under the ‘truthfulness’ criteria, claims such as ‘fragrance-free’, ‘perfume-free’, ‘unscented’ or similar should not be made if the product contains fragrance compounds with the purpose to fragrance the finished cosmetic product.

In addition, the EU Commission issued a Technical Document on Cosmetic Claims to further expand on the Common Criteria and provide some examples.  This document is not legally-binding but it is industry best practice across the UK and EU and CTPA fully supports this document.  The document says that “the claim 'free from perfume' should not be used when a product contains an ingredient which exerts a perfuming function in the product, regardless of its other possible functions in the product.”

Fragrance allergens listed on an ingredient list may also be present in ingredients which don’t have a perfuming function; for example, essential oils or other natural extracts.  In order to justify the use of the claim ‘fragrance-free’ for a cosmetic product that is clearly not without smell, the manufacturer must be able to demonstrate that all the ingredients in the product have a main function other than fragrance.  Therefore, the ability to make any claim relating to fragrance is not because of the presence (or not) of ingredients such as essential oils, but what function and properties those ingredients have.  This is why it is so important that allergic consumers check the ingredients list so that they can avoid the substances to which they are allergic. 

If the product contains ingredients intended to perfume, and therefore declaring ‘parfum’ on the ingredients list, it should not be labelled as fragrance-free or any claim which could be understood in the same way. 

Some products may be labelled as unscented, indicating the absence of a characteristic odour, but may contain small quantities of fragrance ingredients used to mask or cover possible unpleasant smell from the ingredients and raw materials. In these cases, the products will still indicate the presence of a fragrance and any declarable allergens.  

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.

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 the CTPA Guide to Advertising Claims 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 and EU. Selling cosmetic products tested on animals or containing ingredients tested on animals is also banned.

Article 20 of the UK and EU Cosmetics Regulations 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 products in 2004 and for ingredients in 2009, and this ban has been replicated under the UK Cosmetics Regulation, 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. Since the ban on animal testing applies equally to all cosmetic products on the UK and 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 borderline into medicinal regulation 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.

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 UK and EU Cosmetics Regulations and certification in relation to these claims is not a legal requirement. However, any claims 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. 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 UK and EU Cosmetics Regulations 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 and UK Cosmetics Regulations is mandatory.

PPD is a widely used ingredient in permanent hair colorants.  Although it is not always present in hair colouring products, PPD or related ingredients such as PTD, MePPD or other derivatives will be present in darker colouring shades. 

As well as having to be listed in the ingredients list on pack, when a hair colorant contains PPD, or a related hair dye, by law the product also has to be labelled with “Contains phenylenediamines” or “Contains phenylenediamines (toluenediamines)” to alert users with a PPD allergy that the product is unsuitable for them.  These warnings exist because of the risk that a person allergic to PPD may also react to related ingredients.  PTD, MePPD or other derivatives can produce a similar type of reaction in people with the potential to become sensitised, and there may be cross-reactivity to both hair dyes.  In other words, someone allergic to PPD is likely to react to PTD, MePPD and other derivatives, even if they have not used them before. 

 Therefore, a hair dye containing PPD, PTD or other PPD-related ingredients must not claim ‘PPD-free’.  While it may be accurate that the product does not contain the ingredient, this claim is still misleading and may put consumers at risk.  People with a known allergy to PPD are likely to assume that the product is suitable for them, and consequently experience an allergic reaction which could be severe.

Compliance with third country legislation is not enough to be able to place cosmetic products on the market in the UK and EU.

In the UK and EU, the manufacture and supply of all cosmetic products is governed by the to UK Cosmetics Regulation (EC) No. 1223/2009 (UKCR) and the EU Cosmetics Regulation (No. 1223/2009) (CPR) and its amendments, respectively. The UKCR applies to cosmetics marketed in Great Britain (England, Wales and Scotland).  The CPR and its amendments are directly applicable in all 27 EU countries and all cosmetic products need to comply with the above regulations before they are placed on the EU market. The EU Regulation also applies to cosmetics marketed in Northern Ireland.  This is in accordance with the terms of the Northern Ireland Protocol to the UK/EU Withdrawal Agreement.

CTPA provides guidance documents covering what companies need to know for supplying cosmetic products on the UK market (‘Supplying Cosmetic Products on the GB Market' and 'Supplying Cosmetic Products on the EU and NI Markets' , including formula composition rules, labelling requirements, safety assessment and product information file.

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 UK Responsible Person* that products comply with:

• UK Cosmetics Regulation (EC) No. 1223/2009 (UKCR) for cosmetic products marketed in Great Britain (GB), which includes England, Wales and Scotland; and/or

• the EU Cosmetic Products Regulation (EC) No. 1223/2009 (CPR) for cosmetics marketed in Northern Ireland (NI).  This is in accordance with the terms of the Northern Ireland Protocol within the UK/EU Withdrawal Agreement.

and may be freely sold across:

• GB; and/or
• NI.

A CFS is also regarded as a 'Certificate of Manufacture' or a 'Health Certificate' or 'Safety Certificate' by certain countries.

*Article 5A of the UK Cosmetics Regulation, which was introduced by the latest amendment Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020, gives the conditions for an NI-based importer or RP to be recognised also in the UK.

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

It is important to understand the rules for cosmetic products and the documentation required when exporting to any country outside the UK. Many countries have their own laws on cosmetics to which imported cosmetic products must comply.  In some cases, compliance with the EU Cosmetics Regulation may be sufficient to meet the product safety obligations of some markets but will usually require compliance with local requirements.  

The UK Government Department for Business and Trade (DBT) has a number of export guides for UK businesses who are interested in selling overseas.  DBT (previously known as Department for International Trade – DIT) has also published a step-by-step guide to help businesses understand how to move goods from the UK to international destinations, including the EU. 

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, the Regulatory Handbook, including a UK & EU/EEA Section and an International Section.  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 Membership Services page. 

Imports from the EU 

The UK/EU Trade and Cooperation Agreement (TCA) sets 0% tariffs for UK/EU trade, for goods originating in either parties. 

To benefit from the 0% tariff obtained within the TCA, the goods will need to qualify within the relevant rules of origin at the time of import. Proof of origin will be requested to the importer, and the UK company can offer the relevant supplier declarations. Templates of these declarations can be found in the relevant annexes of the TCA. For goods that are not of a UK origin or do not count with sufficient UK originating materials (please note that cumulation can apply with EU materials), then the goods in question would not be able to benefit from the lack of tariffs and therefore, the EU Common Tariff Schedule would apply. 

Imports from other third countries 

Cosmetics imported from other third countries, which are not EU countries, will be subject to the UK Global Tariffs plan, unless there is a Free Trade Agreement between the UK and that third country. 

Further information can be found on the UK Government website. 

EU countries are part of the EU Single Market and Customs Unions.  Goods moving between EU countries are free to circulate without any tariffs or customs procedures.

As a general rule, cosmetic products sold online need to be compliant with the cosmetic legislation wherever you are directing your sales.  Regulations on product safety cover products sold both physically in shops, and through online stores, including online retailers or direct to consumer sales, unless there are specific legislations or provisions in the regulatory framework that state otherwise.

If you are targeting consumers in a specific country, full compliance including any notification or registration obligations, labelling requirements, and the need for a local responsible person for the country might be expected.  If you are unsure whether a product is being directed or targeted at consumers in a specific country, examples include making the product available for purchase in the local currency, promoting the delivery information for that particular country, or making the information available on the website in a particular language.

For example, outside of the UK, countries such as Australia and the USA have been clear that compliance with national laws is required if a citizen buys a product from a UK-based website.  However, the situation may not be as clear for some other countries and a case-by-case analysis of the national law may be required.  Infrequently, countries may have specific legislation covering access from consumers in the country to products sold via e-commerce platforms, setting out the requirements for compliance there, for example in China. 

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 UK and EU Cosmetics Regulations 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.

The labelling requirements for cosmetic products are detailed under Article 19 of the UK and EU Cosmetics Regulations, depending on whether products are placed on the GB market or the EU/NI markets respectively.

These are:

• name and address of the UK Responsible Person (for the GB market) or the EU Responsible Person (for the EU and NI markets);
• 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 any other consumer facing packaging, if applicable. 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 container, 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.

The below advice is valid under both the UK and the EU Cosmetics Regulations.

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.

There are a number of fragrance allergens which require labelling in the ingredient list if they are present over a certain threshold concentration.

Article 19 of both the UK and EU Cosmetics Regulations requires products containing fragrances to label the word “parfum” within the ingredients list.  All fragrance allergens present in a cosmetic product must also be labelled if they are present within the product above 0.01% (for rinse-off products) or 0.001% (for leave-on products).  Fragrance allergens are regulated under Annex III of both the UK and EU Cosmetics Regulations.

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 UK and EU Cosmetics Regulations 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, for products placed on the EU and NI markets, or within GB, for products placed on the GB market. If more than one EU or GB 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 any additional 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.

Apart from the net content, there is no text size requirement for the obligatory labelling required under the UK and EU Cosmetics Regulations. 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 UK or 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 European Commission has a dedicated webpage on sunscreen products. CTPA also provides a guidance note on durability claims for sunscreens.

It is CTPA understanding that the EU Commission recommendation for labelling and testing sun products remains applicable in the UK.

Making cosmetic products in a work-space at home is permissible, as long as the products follow the UK and the EU Cosmetics Regulations, which includes being made according to Good Manufacturing Practice (GMP). GMP is a legal requirement of the UK and the EU Cosmetics Regulations. 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.  If  producing cosmetic products in areas of the home (such as a kitchen), GMP must be demonstrated and details must also be provided to the safety assessor, who will take the manufacturing process into account when compiling the Cosmetic Product Safety Report (CPSR) in particular in regard to the microbiological quality of the product.

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 UK and the EU Cosmetics Regulations 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 certification or system 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 Cosmetic Products Regulation 1223/2009 and the UK Cosmetics Regulation control what may or may not be put in a cosmetic in the EU and the UK respectively. Both Regulations contain 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 specific 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.  It is important to highlight that these Annexes are regularly updated by the Competent Authorities, with new ingredients being banned, or restricted or added to the positive lists.  It is important for formulations to be checked and, if needed, updated according to new requirements.

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  not classified as a Carcinogenic, Mutagenic or Reprotoxic (CMR) substance by the  EU and GB  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 Business and Trade (DBT) (formerly BEIS), 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 and the UK cosmetics legislation and used in accordance with any restrictions set out in the Annex entry.

The below advice is applicable under both the UK and the EU Cosmetics Regulations.

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, compatibility 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.

The below advice is applicable under both the UK and the EU Cosmetics Regulations.

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 microbiological specifications and quality 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).

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 UK and the EU Cosmetics Regulations. 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.

Good Manufacturning Practice (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 UK and the EU Cosmetics Regulations. 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).

One major consideration is that the compatibility 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 clear  instructions can be classed as a finished cosmetic product, as long as it has a primary cosmetic function, and therefore needs to comply fully with the UK and EU Cosmetics Regulations 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 (for GB), REACH Regulation and the Classification, Labelling and Packaging Regulations applicable to the EU and GB respectively (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 and UK Cosmetics Regulations and the Toy Safety Regulations.

The new cosmetic ingredient must comply with all applicable laws.  CTPA issued this flowchart to explain the process to make a new cosmtic ingredient available on the UK and EU markets.  This guidance only refers to the following chemicals legislation: Cosmetics Regulation; Classification, Labelling and Packaging (CLP) Regulation; Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation.  However, companies need to review whether there are any other pieces of legislation; for example, environmental, sourcing, licensing, or others, which apply to the new ingredient.

To fall under the scope of the UK and EU Cosmetics Regulations, 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.

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 do not comply with the definition given in the UK and EU Cosmetics Regulations. 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. 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.

No. False eyelashes are not substances or mixtures but are considered articles. They therefore do not fall under the scope of the UK and EU Cosmetics Regulations. 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.

The UK and EU Cosmetic Regulations control what may or may not be put in a cosmetic product.  There is a list of substances that must not be present (list of banned substances, Annex II) and a list of substances that may be used as ingredients subject to particular restrictions (Annex III); there are also positive lists of allowed colorants, preservatives and UV filters (Annexes IV, V and VI respectively).  Hydroquinone is banned from use in cosmetic products as per Annex II entry 1339, with the exception of the specific use as per entry 14 in Annex III.  Under Annex III, hydroquinone is only allowed to be used in artificial nail systems at a specific concentration and with mandatory warnings as specified in the Annex entry.

However, there are other products that do not fulfil the definition of Article 2 of the UK and EU Cosmetic Regulations that companies should consider.

An example is eyelash adhesives, which 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.

After discussions with the UK Competent Authorities, CTPA would like to reiterate that such adhesives should not contain hydroquinone.

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.

Article 2 of the UK Cosmetics Regulation and EU Cosmetic Products 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."

As pet products are not intended to be used on the human body, they are not classified as cosmetics and therefore are not subject to the legislation.

If the purpose of the product is just to clean the pet such as straightforward shampoos and conditioners, then they will likely be classed as a ‘general product’.  This means that in the UK they will have to comply with the General Product Safety Regulations 2005 (GPSR).  Further information on GPSR is available here. 

If the purpose of the product is to kill fleas or other parasites it could be classified as a biocide.  For more information see the EU Commission's guidance on borderlines between the Biocidal Products Directive (98/8/EC) and the Veterinary Medicinal Products Directive 2001/82/EC.  

If the purpose of the product is to treat a disease or adverse condition of the animal, then it could be a veterinary medicine.  There is a Veterinary Medicine Guidance Note on the Defra website which makes it clear that such products can also fall into the category of medicine depending on the claims being made and/or the ingredients being used. 

Advice and further information on requirements and best practice may be available from the Pet Industry Federation.

A biocidal product must comply with the EU Biocidal Products Regulation.  This is out of the remit of CTPA, but more information is available from the HSE (Health & Safety Executive) website. 

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 strict safety legislation, which carries responsibilities to all significant actors on the supply chain.

In particular:

• UK Cosmetics Regulation (EC) No. 1223/2009 (UKCR) for cosmetics marketed in Great Britain (England, Wales and Scotland);
• EU Cosmetic Products Regulation (EC) No. 1223/200 (CPR) for cosmetics marketed in Northern Ireland. This is in accordance with the terms of the Northern Ireland Protocol to the UK/EU Withdrawal Agreement.

The EU Cosmetics Regulation is also directly applicable in all Member States of the European Union. Respecting the area where the product is placed on the market, all cosmetic products need to comply with the requirements before being supplied.

Both Regulations lay 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 on Supplying a Cosmetic Product on the UK Market and Supplying Cosmetic Products on the EU/NI Markets Guide.

The UK Cosmetics Regulation is enforced in GB via the UK Cosmetic Products Enforcement Regulations 2013 which specifies the role of the authorities, the penalties and the enforcement process. UK authorities enforce the EU Cosmetics Regulation in Northern Ireland through the same enforcement regulations.  The UK Government Department for Business and Trade (DBT) and the Office for Product Safety and Standards (OPSS) are the UK Competent Authority for implementing the legislation for cosmetic products.

In the UK, enforcement activities can be carried out by OPSS and 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, which may include inspections. They are also available to give help and advice to companies who are just starting out or seeking to understand how to comply with the current legislation..

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 UK and EU Cosmetics Regulations apply 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 UK and EU Cosmetics Regulations 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.  Each EU Member States have their penalties set out in local legislation.

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 UK and EU Cosmetics Regulations are met, if cosmetics are sold in the GB market or the EU/NI markets respectively.

The RP may be an individual (a natural person) or a company (a legal person), must be located in GB (for cosmetics sold in the GB market) or within the EU/EEA or NI (for cosmetics sold in the EU and NI markets) 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 GB or the EU (depending on which Regulation applies); or
• a person or a company established within GB or EU mandated to act as the RP by the manufacturer/brand owner/importer. 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.

The below advice is applicable under both the UK and the EU Cosmetics Regulations.

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 (CPSR);
• 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.

The UK and EU Cosmetics Regulations operate a system of notification and in-market surveillance. To ensure traceability of all cosmetic products, before placing a new cosmetic product on the UK or EU markets, the Responsible Person must notify their details and specific information about the product to the Office for Product Safety and Standards (OPSS – for products placed on the GB market) or the EU Commission (for products placed on the EU and NI markets). This is done electronically through a centralised website called Submit Cosmetic Products Notifications (SCPN) portal for Great Britain, or the Cosmetic Products Notification Portal (CPNP) for the EU and Northern Ireland. 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 SCPN or CPNP (depending on the area of placing on the market). To use either of the systems, you must first set up users (staff carrying out the notification) and organisations to which users are attached.

For CPNP, 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)
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 CPNP portal is available on the European Commission's website.

For SCPN there is only the main portal’s website. 

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.  The same definition applies under the UK Cosmetics Regulation, referring to the GB market.

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

In addition to the UK and EU Cosmetics Regulations, 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 other UK and EU legislations (depending on the area of placing on the market) and guidance documents for example purposes is available from our 'Other Laws' page.

The primary purpose of the UK and the EU Cosmetics Regulations is to protect human safety. The manufacturer or supplier of the cosmetic product (the Responsible Person) is responsible for ensuring it is safe. In order to demonstrate this, the EU and the UK Cosmetics Regulations require that each cosmetic product must undergo a full safety assessment and that a Cosmetic Product Safety Report (CPSR) is compiled by a properly qualified safety assessor before the product is placed on the market. These documents may be inspected at any time by the enforcement authorities, usually Trading Standards in the UK.

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.

The safety assessment is required to be performed in line with the requirements of Article 10 of the UK and the EU Cosmetics Regulations by a specifically qualified expert (the 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; 
• the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended; and
• any impurities, traces, as well as the packaging material.

Annex I of both the EU and UK Cosmetics Regulations gives the structure of the CPSR and therefore what needs to be covered by the safety assessor and reported into the CPSR.

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 fragrance 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 (PIF).

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 UK and the EU Cosmetics Regulations, 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 Cosmetic Products Regulation in respect of the Cosmetic Product Safety Report, which are available on the European Commission's website. 

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 UK and the EU Cosmetics Regulations:

"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 (EU) / by the Secretary of State (UK)."

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.

In order to ensure that your chosen safety assessor is duly qualified and experienced in cosmetic safety assessment and CPSRs, you may want to ensure that he/she will ask you for this information about your product and its ingredients. 

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 and therefore products only containing natural ingredients must also be safety assessed.

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 and the UK Cosmetics Regulations include many natural materials, as well as many man-made materials, that are prohibited or restricted from use in cosmetics for reasons of safety.  It is also important to keep in mind that many natural extracts or essential oils contain a number of allergens and impurities that must be considered for the safety of the finished product.

While all cosmetic products need to be assessed as safe for use, the UK and the EU Cosmetics Regulations also require 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 UK and the EU Cosmetics Regulations.

The below advice is applicable under both the UK and the EU Cosmetics Regulations.

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. However, the formula usually undergoes stability, compatibility and challenge testing, the results of which will used by the safety assessor in formulating the safety assessment.

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.  You can access these infographics, which explain in a concise and simple way what is cosmetovigilance and give a step-by-step overview of what to do.

The UK and the EU Cosmetics Regulations require 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.

Article 2 of both the Regulations 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'.

Reporting

UK (including Northern Ireland)

On 1 January 2021, the Office for Product Safety and Standards (OPSS), the Competent Authority for cosmetics in the UK, published the new UK Serious Undesirable Effects (SUE) reporting form 1.  This form allows the UK Responsible Person (RP) to notify SUEs to the Competent Authority. 

Under this new system, RPs and/or distributors should send SUE reports received from UK consumers directly to OPSS via the email address [email protected]. This replaces the previous process by which SUE reports were sent to Trading Standards. 

EU

The RP or a distributor should complete SUE report Form A to transmit the information on the SUE to the Competent Authority of the 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.

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. Although the reporting aspect of the SUE reporting guidelines by the European Commission is not relevant to the UK, the causality assessment process is the same in the UK and EU. 

The below advice is applicable under both the UK and the EU Cosmetics Regulations.

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.

However, the safety assessor may require SDSs, Certificates of Analysis and any other relevant information for the ingredients that are included in the finished product in order to compile the CPSR and carry out the safety assessment of the finished product. 

Annex I of the UK and EU Cosmetics Regulations provides the requirements for compiling the Cosmetic Product Safety Report (CPSR).  A simplification of this is listed below:

• quantitative and qualitative composition of the cosmetic product;
• physical/chemical characteristics and stability of the cosmetic product;
• microbiological quality;
• impurities, traces, information about the packaging material;
• normal and reasonably foreseeable use;
• exposure to the cosmetic product;
• exposure to the substances;
• toxicological profile of the substances;
• undesirable effects and serious undesirable effects;
• any additional relevant information on the cosmetic product;
• conclusion on the safety assessment (labelled warnings and instructions of use, reasoning of the conclusion, assessor's credentials and qualifications).

Make sure that the CPSR you receive carefully considers all the above mandatory sections.

In order to carry out a comprehensive safety assessment, the safety assessor should be asking for the following information from the RP:

• product formulation (list of intentionally added ingredients and their concentrations, totalling to 100%);
• thorough supplier documentation: compositional information of each ingredient should include presence of impurities (if any), that are technically unavoidable as they need to be assessed for safety;
• Safety Data Sheets (SDS), Certificate of Analysis (CoA) and other relevant documentation related to each cosmetic ingredient in the finished product;
• for fragrance materials: the IFRA Conformity Certificate (if the fragrance supplier is a member of IFRA), list of fragrance allergens with concentrations and any preservatives or other stabilisers;
• results from preservative challenge test, stability/compatibility and microbiological test reports;
• information about the Good Manufacturing Practice (GMP) system that you use (GMP can be demonstrated through compliance with the ISO standard ISO22716);
• information about the packaging, its material composition, and any other relevant technical information available from the packaging supplier;
• how the product is used (leave-on/rinse-off, site of application, amount of product per use, use frequency, as examples);
• any clinical studies, if available;
• if the product has got cosmetovigilance data (for example, history of Undesirable Effects or Serious Undesirable Effects); this may be asked by the safety assessor prior to, or after, the product is placed on the market. This can provide supporting evidence to the overall risk profile of the product.

The qualifications of the safety assessor are stated in the UK Regulation. 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.

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 Membership Services 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 Office for Product Safety and Standards (OPSS), 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.  Citizens Advice can also be contacted by calling 0800 144 8848.