top of page
Regulamento cosmético no Reino Unido

Regulation

UK Cosmetics

How to start selling cosmetics in the UK?

The United Kingdom formally left the European Union on 31 January 2020, but the UK Cosmetics Regulation originates from the EU Cosmetics Regulation 1223/2009. Cosmetics companies had until 31 December 2020 (transition period) to comply with the requirements of "The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34", the so-called "UK Cosmetics Regulation". Over the years, much legislation has been enacted to better protect consumers, animals and the environment, to better inform end users and to better harmonize national laws. As such, all cosmetic products available on the UK market, whether paid or free, must comply with a long list of legal requirements.
A company that markets or intends to market cosmetic products in the United Kingdom must be represented by a Responsible Person based in the United Kingdom and comply with the requirements set out below.
Before launching your brand in the UK, make sure you have made the right decisions, as these could affect your long-term success. Our recommendation is that you select a qualified partner who will support your development on both sides of the Channel. Pharmilab ensures its presence in both the EU and the United Kingdom, certifying that its products are compliant in both territories!

STEP 1

This is the first step in the entire process, and an essential moment where the Regulatory and safety compliance of the ingredients is assessed (some ingredients are restricted/banned), the list of ingredients is established and the mandatory laboratory tests are carried out. This step is a prerequisite for preparing the CPSR (Cosmetic Product Safety Report) and checking the product label. Formula review is a meticulous review of the formula of your cosmetics to ensure that all ingredients are safe for the intended use and comply with UK cosmetics regulations. Thus, the composition is entirely reconstructed from its raw materials. Raw material documentation is reviewed to verify regulatory compliance and the impurity profile is assessed. Preliminary calculations and investigations are carried out to ensure that each ingredient and impurity is safe, taking into account the cosmetic product, its intended use and the target population.

Formulation review
STEP 2

The CPSR (Cosmetic Product Safety Report) is a long and complex dossier in accordance with the UK cosmetics regulations. The CPSR is an exhaustive document prepared by a qualified toxicologist (in accordance with number 2 of article 10 of regulation 1223/2009). This safety report aims to support and confirm the safe use of the cosmetic product, taking into account all available information, such as toxicological profiles of each ingredient and impurity, test results, certificates, declarations, raw material documentation, etc. . The introduction of a cosmetic product onto the EU market without a high-quality RPCS is a serious infringement leading to market withdrawal, significant financial sanctions and serious damage to the cosmetic brand's reputation. The CPSR is made up of two distinct sections, Part A and Part B. Part A: Information on the Safety of Cosmetic Products. This part of the report contains all the data necessary to evaluate the cosmetic product. Part B: Cosmetic Product Safety Assessment. This part of the report includes an assessment of the cosmetic product's safety and conclusions. Part B is essential as it certifies the efficacy and safety of a product before it is placed on the EU market.

Security Assessment Report (CPSR)
STEP 3

A PIF (Product Information File) is a cosmetic regulatory dossier that contains: Qualitative and quantitative product formula Microbiological and physicochemical specifications Packaging information Label CPSR Manufacturing method Declaration of GMP and non-testing on animals Proof of claimed effects A Product Information File is a large, highly structured dossier that contains all information related to a particular cosmetic product. Some of the data comes from product manufacturers, some data comes from independent laboratories, and some data comes from a suitably qualified safety assessor. Once the preparation of the PIF has been completed, the cosmetic product can be notified electronically on the British SCPN (Submit Cosmetic Product Notification) portal and is assigned a unique SCPN number. This number can be requested from the importer and the Responsible Person at any time, particularly by customs officials. In other words, a notification consists of announcing to the United Kingdom that a product is going to be sold in the United Kingdom. Technically, cosmetic products are not registered in the UK; are notified. Unlike other countries and regions that require pre-approval of products by competent authorities, the UK requires notification before the product can be launched on its market. This means that verification by the competent authorities is carried out after the product has been released onto the UK market. For this reason, the selection of a qualified and competent Responsible Person is especially important. After Brexit, product information files must be updated to indicate the names of EU and UK responsible persons. Furthermore: Cosmetic products sold in both markets must be notified to both the CPNP and SCPN to allow them to be sold in both territories The names and addresses of EU and UK responsible persons must be included on the label if the product is sold in both territories. Each product must be re-notified in a new notification system before it can be authorized for sale in the UK. No automatic transfer has been developed between the EU CPNP (Cosmetic Product Notification Portal) and this new British notification portal (SCPN: Submit Cosmetic Product Notification). The British system became available on January 1, 2021 and is relatively similar to the CPNP. All cosmetic products currently on sale on the UK market had to be re-notified within 90 days of the end of the transition period (i.e. 31 March 2021).

Product Information File (PIF) and notification in SCPN
STEP 4

The UK rules on cosmetics labeling can seem very confusing, and although they are the responsibility of distributors (in accordance with Article 6 of the EU Cosmetics Regulation), developing and publishing labels and packaging is continue to be a costly task for cosmetics brand owners. Some elements will, in fact, have to be translated into all official languages of the countries where the products are sold, and distributors must ensure that this information is properly translated. In fact, labels in English alone are not always sufficient. Labels (or certain parts of labels) must be translated into the country's language, but this largely depends on each EU country, which considering its 27 countries, with their 24 different languages, may not be an easy task. Distributors naturally have every right to refuse products that do not meet these requirements. A clear label is important to help consumers with their purchases and to protect their health. All important information must always be easily accessible, legible and understandable to the consumer at the time of purchase. The rule is quite simple: the end consumer must understand exactly what they are buying when they check the product. A Label Review is a complete compliance of packaging and labels, which checks claims, PAO (Period After Opening), INCI list, etc. Therefore, a review of labels and support on specific claims or topics that the brand wants to promote as marketing text (by a specialized team like Pharmilab) is essential.

Review of Labels and Claims
STEP 5

Legal representation for cosmetics in the UK is called the UK Responsible Person. Since 1 January 2021, a Responsible Person in the UK is required to sell cosmetic products in the country. A cosmetics brand selling in both the EU and the UK needs a local Responsible Person for each economic area. The Responsible Person has many responsibilities and will be held accountable in the event of a non-compliance issue. A simple and easy way to explain the Responsible Person is: Who should the UK authorities (OPSS - Office Product Safety & Standards) call if they want to control your cosmetic product? Who should a consumer call if they have an unusual reaction to their cosmetic product? In the SCPN, a Responsible Person is designated for each notified product. Among other important functions, this Responsible Person will ensure the compliance of cosmetic products on an ongoing basis and update the PIF whenever necessary. In short, being a Responsible Person entails many responsibilities and is an important and delicate matter that should not be taken lightly. Cosmetics brands should really invest time in this crucial step. See the best way to choose your Responsible Person Find out more about Responsible Persons and their obligations Among other recommendations, a cosmetics brand should try to find a Responsible Person with offices in both the EU and the UK who can therefore represent the products in both regions. A new Responsible Person will normally audit cosmetic product dossiers to ensure that they comply with legislation and to avoid taking excessive risks. This audit involves additional costs and takes time. For this reason, working with just one Responsible Person is the most economical option for cosmetics brands. Pharmilab has offices in both the EU and the UK, allowing us to act as a Responsible Person in both areas. A simple and easy way to explain the Responsible Person is: Who do European countries have to contact if they want to control their cosmetic product? Who should a consumer contact if they have an unusual reaction to their cosmetic product? In the CPNP, a Responsible Person is designated for each notified product. Among other important functions, this Responsible Person will ensure compliance of cosmetic products on an ongoing basis and update the PIF when necessary. In short, choosing the Responsible Person is extremely important, as it involves many responsibilities. Working with an experienced company like Pharmilab is the best choice for the success of the cosmetic brand in the European market.

Responsible Person in the UK
Design sem nome (7).png

Clarify your doubts about European Union and United Kingdom Cosmetic Regulations with our FAQ.

Need help or have any questions?

+351 239 090 867

bottom of page