— Check what you need to do to sell cosmetic products in Great Britain — Published on the 4th of October 2021 by GOV.UK
- What is a Responsible Person, and what is it’s role?
- How to making cosmetic products safe for users.
- Labelling cosmetic products.
- The notification procedure at the Office for Product Safety and Standards for cosmetic products.
- What to do to keeping users of cosmetic products safe.
On October 4, 2021, the UK government published general guidance that deals with the marketing of cosmetic products in the UK. These products must meet conditions set by the government. This includes all cosmetic products that are available to both professional users and the public. Not only the goods purchased by consumers, but also those received by consumers (e.g. free samples).
However, this guide does not cover Northern Ireland regulations. Separate technical guidelines apply to that. Also, in that case the responsible person will have to be based in Northern Ireland itself, or in the EU.
All cosmetic products available to consumers must have a "responsible person". This person will ensure that safety measures are adhered to and that legal obligations are met. This can be a company or an individual (including sole traders). A responsible person must have a UK-based address to offer cosmetic products in GB. Mail forwarding or PO Box addresses are not accepted.
A responsible person may be
- the manufacturer;
- the importer;
- the distributor, if he labels the product as his own (for example, by using his brand name);
- a designated company or person (named by the manufacturer or importer).
What does a responsible person do?
Who ensures that the cosmetic products he makes available are safe. This means that the responsible person:
- knows what ingredients are used in their cosmetic product, including harmful ingredients or nano-materials;
- is aware of the restrictions on what can be used in cosmetic products;
- has an updated document keeping information about the cosmetic product (called the "Product Information File" or "PIF");
- clearly displays all information on the cosmetic product's packaging, labeling and instructions for use;
- notifies the Office of Product Safety and Standards (OPSS) of the cosmetic product (called notification) before it is offered to the consumer;
- notifies the OPSS of any serious adverse effects reported about the cosmetic product;
- can demonstrate that the claims made at the time of marketing the product are accurate.
Looking for a Responsible Person? Alura Group can help.
The Product Information File
Cosmetic products must be safe for human health. The Product Information File (PIF) contains information about the safety of a cosmetic product to human health.
The PIF supports the safety of cosmetic products by providing
- a safety assessment, which confirms that a cosmetic product is safe and provides the scientific evidence that confirms this;
- details of good manufacturing practices, which indicate what has been done in the production of a cosmetic product to ensure that it is safe;
Making cosmetic products safe for users also relates to how a cosmetic product is presented. It should
- not be confused with food;
- have clear labeling;
- contain instructions for use and disposal;
- the Product Information File (PIF).
The responsible person must maintain a PIF in English for all their cosmetic products. The PIF contains
- a description of the cosmetic product;
- the product safety report;
- how good manufacturing practices were followed;
- evidence of how the cosmetic product works;
- the PIF must be kept for ten years after the last batch of the cosmetic product was made available.
The Product Safety Report.
Before a cosmetic product reaches the consumer, its safety must be verified by an independent safety assessor. The Product Safety Report consists of 2 parts and is part of the PIF.
The two parts of the product safety report are:
- The cosmetic product safety information (Part A). This is provided by the responsible person.
- The cosmetic product safety assessment (Part B). This is provided by the safety assessor.
The cosmetic product safety information (Part A)
The cosmetic product safety information (Part A) contains all the data necessary to perform a cosmetic product safety assessment. It may be necessary to conduct or organize tests on a cosmetic product to complete this section. Part A contains information about:
- the ingredients, their concentrations, chemical names and toxicological properties;
- the physical and chemical properties of the ingredients and the finished cosmetic product;
- the stability of the product;
- any microbial contaminants in the ingredients or in the finished product;
- how preservatives prevent microbial contamination of the product;
- any impurities;
- what has been used to package the product;
- how the cosmetic product is likely to be used;
- the amounts of ingredients and finished product to which the user could be exposed.
The cosmetic product safety information (Part B)
The cosmetic product safety assessment (Part B) are the conclusions of the safety assessor in relation to Part A. They include
- an assessment of the safety of the product;
- any necessary warnings or instructions for the product;
- the scientific justification for the conclusions of the safety assessment;
- the safety assessor's details, including name, address and proof of qualifications.
How do you have the safety of a cosmetic product assessed?
The product safety assessment is conducted by a qualified professional. This is someone who has a university degree in pharmacy, toxicology, medicine or a similar discipline. It is the responsibility of the responsible person to ensure that the safety assessment is performed by a qualified safety assessor.
Good manufacturing practices for cosmetic products
"Good manufacturing practices" must be observed in the production of cosmetic products. This involves how the reproducibility and quality of a cosmetic product is ensured when it is made. Good manufacturing practices can be demonstrated by complying with the relevant designated standard ISO 22716. Good manufacturing practices for cosmetic products are different from good manufacturing practices for pharmaceutical products.
How can good manufacturing practices be met?
ISO 22716 describes practical things that can be done to implement good manufacturing practices. It is not the only way to demonstrate that good manufacturing practices are being applied. ISO 22716 says that the company that manufactures cosmetic products:
- Ensure that all employees know their roles and responsibilities with respect to the production, control, storage and shipping of cosmetic products;
- ensure that personnel have the appropriate training and skills for the production of cosmetic products;
- ensure that the place where cosmetic products are manufactured is regularly maintained and cleaned;
- Ensure that the place where the cosmetic products are manufactured is arranged in such a way as to reduce the risk of mixing of products and raw materials;
- ensure that the equipment used for manufacture is regularly maintained and prevented from contaminating cosmetic products;
- have comprehensive information on raw material supply chains so that any problems can be traced;
- ensure that all water used in the manufacture of cosmetic products is adequately treated and routinely tested for microbes and impurities;
- have detailed information on how the cosmetic product was produced;
- know where in the production process the quality of cosmetic products should be tested;
- give a cosmetic product a batch number and label;
- check all equipment and the place where the cosmetic product is manufactured before manufacturing to minimize contamination;
- ensure that the quality of the product is maintained during storage, shipment and return;
- record and account for changes in the manufacturing process;
- use quality control as a means of verifying whether a cosmetic product, its raw materials, or the items used for packaging change unexpectedly;
- know and define the different types of waste generated during manufacturing;
- identify waste and dispose of it in a controlled and hygienic manner;
- investigate any complaints or problems with a cosmetic product. (What measures should be taken to prevent recurrence of problems?);
- Conduct internal audits to ensure that these steps (defined in ISO 22716) are being performed correctly;
- ensure that up-to-date documentation is in place to demonstrate what happens during the manufacturing, quality control, storage and shipping of cosmetic products.
What can and cannot be put in cosmetic products
If colorants, preservatives or UV filters are used, the applicable restrictions or prohibitions must be followed. This is a positive list, meaning that only substances from Annex 4, 5 or 6 may be used.
Carcinogenic, mutagenic or reprotoxic substances (CMR substances)
The use of CMR substances in cosmetic products is prohibited. For CMRs of category 2, exemption can be requested by industry. Category 2 CMRs are evaluated by a scientific advisory group and if found to be safe, may be used. Category 1A and 1B CMRs are evaluated by a Scientific Advisory Group only if the criteria of Article 15 are met.
Further information can be found on the Health and Safety Executive's (HSE) chemical classification page. This page contains the GB Mandatory Classification and Labelling List, which provides information on the CMR classification of chemicals.
New ingredients used as dyes, UV filters or preservatives
For all new ingredients used as dyes, UV filters or preservatives, and thus not listed in Annex 4, 5 or 6, a safety dossier must be submitted to OPSS for a safety assessment. This also applies to nano-materials.
There are technical guidelines on what must be submitted in a safety dossier for nano-materials. Also, there is an at must submit a safety dossier for all other ingredients. There is also a checklist of the information that must be included in a safety dossier.
Safety dossiers should be submitted to the OPSS Safety Assessment inbox: [firstname.lastname@example.org](https://email@example.com).
How to notify OPSS about nano-materials?
A notification of nano-materials are made for cosmetic products containing nano-materials not listed in Annex 4, 5 or 6 that are used for a purpose other than as a preservative, UV filter or colorant. This is done through the cosmetic products notification submission service.
For cosmetic products containing nano-materials listed in Annex 4, 5 or 6 and used in accordance with the restrictions, further information is required as part of the cosmetic product notification.
The following cosmetic product notification service guidelines explain how to submit notifications of products containing nano-materials.
Labeling of cosmetic products
The labeling of cosmetic products must be easily legible. The container and any packaging must indicate the following
- the name and address of the responsible person;
- the country of origin if the product is imported into the UK;
- the weight or volume;
- the date until which the cosmetic product can be used;
- any precautions for use;
- an identification number (e.g. lot number);
- what the cosmetic product does;
- the ingredients – these can only be listed on the packaging. Note: ingredients of nano-materials must be followed by "(nano)";
- In some cases, the date of use and the weight or volume are not required, for example when the content is less than 5 grams or 5 milliliters. This may apply to free samples and single-use packages;
- If there is no space on the package to list precautions and ingredients, it is important that this information be stated otherwise, such as in a package insert. A symbol should be used to indicate where this information is located;
- The labeling and advertising of cosmetic products should not give the impression that they have characteristics or functions that they do not.
Making claims about what a cosmetic product does
The labelling and advertising of cosmetic products must not imply they have characteristics or functions which they do not have.
Notifying the Office for Product Safety and Standards about a cosmetic product
Before a cosmetic product is made available in GB, the Responsible Person must submit information on the cosmetic product to OPSS. This process is called notification.
How to notify OPSS about a cosmetic product
Notifying OPSS about a cosmetic product can be done using the Submit cosmetic product notifications service. Further information, including access to the service, can be found on the Submit a cosmetic product notification guidance page.
Keeping users of cosmetic products safe
Adverse reactions to cosmetic products
If a user of a cosmetic product has a reaction which results in them being temporarily or permanently unable to carry out their usual day-to-day tasks this must be reported to OPSS immediately as a serious undesirable effect (SUE). Examples of the effect that must be reported include disability, hospitalisation, congenital abnormalities, risk to life, and death.
Forms to fill out for SUEs can be found on the Cosmetic products: reporting SUEs page. Further details must be provided on:
- the Responsible Person
- all serious effects the user experiences
- the name and batch number of the cosmetic product
- any corrective measures taken
All SUE forms must be submitted to firstname.lastname@example.org.
Effects on users that do not prevent them from doing their day-to-day tasks do not need to be reported. For example, allergic reactions, irritation, and cosmetic acne.
Safety concerns about substances in cosmetic products
There may be situations where there are serious concerns about the safety of substances in cosmetic products. If this is the case the Responsible Person may be asked by OPSS to provide:
- the cosmetic products containing this substance
- the concentrations of this substance in associated cosmetic products
Making information accessible to the public
If requested by a member of public, the Responsible Person must provide:
- the list of ingredients of the product – this is sometimes called the qualitative composition
- information on amounts per unit weight or volume for any hazardous ingredients such as CMRs – this is sometimes called the quantitative composition
- data on undesirable effects and serious undesirable effects (SUEs)
The information provided must maintain commercial secrecy and intellectual property.
Based on the information provided by the UK Government. Source: www.gov.uk for further information, subscription-forms and government links .
What Do You Need To Do To Sell Cosmetic Products In Great Britain