Complying with UK cosmetic regulations
Introduction
For international beauty brands looking to enter the UK market, it is crucial to understand the regulatory requirements that they must comply with. The UK regulatory landscape for cosmetics is governed by various pieces of legislation, and it depends on whether you are selling in Great Britain (England, Scotland and Wales) or the United Kingdom of Great Britain and Northern Ireland (England, Scotland, Wales and Northern Ireland). Here are some key requirements that international brands should take into consideration.
UK Responsible Person
First and foremost, each cosmetic product must be assigned a Responsible Person (RP). The RP is the party responsible of safety and compliance of the cosmetic product whilst on the market. It is much more than just an address on the back of pack. Your RP provider should be part of your team, and understand your unique goals and objectives. If you’re based outside of the UK you can appoint a third-party RP provider such as COSMESURE. If you plan to sell cosmetic products in Northern Ireland then you’ll need to nominate an EU RP based in either the EU or Northern Ireland - COSMESURE also offers this service.
Product Safety & Formulation
Cosmetic products must be safe for consumers to use. The UK controls the presence and concentration of specific ingredients within cosmetic products. Regulations require that cosmetic products undergo a safety assessment by a qualified professional, which includes an evaluation of the ingredients, their concentrations, and the intended use of the product. This assessment must be conducted for each product and should be updated as necessary if any changes are made to the formulation. Our recommendation is that all cosmetic products are assessed before ordering and manufacturing takes place.
Technical Dossier
Each cosmetic product placed on the market in the UK must be accompanied by a Product Information File (PIF). The PIF is a dossier of core information that controls the manufacture, production, storage and all technical aspects of the product. The national competent authority can request a PIF at any time - so it’’s important to ensure that all PIFs are accurately maintained and routinely audited for accuracy and compliance.
Product Labelling
In addition to ensuring product safety, cosmetic brands must also comply with strict labeling requirements. Multiple regulations control cosmetic product labeling. All cosmetic products placed on the UK market should be labeled with English language pack - so translations may be required. There are also mandatory components of a product label, everything from font size to symbols and warnings are all dictated by regulations.
Claims Substantiation
Cosmetic brands are not allowed to make claims about their products that are not supported by scientific evidence. Claims such as "anti-aging" or "reduces wrinkles" must be backed up by clinical studies or other scientific evidence. Failure to substantiate claims can result in fines or even legal action against the brand. The Responsible Person is required to hold scientific and technical substantiation for each and every single claim, whether communicated on pack, listed on a website, or via TikTok.
Notification
Before placing a cosmetic product on the market, brands must notify the regulatory authorities in the UK. This notification includes information about the product's ingredients, the safety assessment, and labeling. The notification must be made by a Responsible Person, who is a legal requirement in the UK, and must be completed before the product can be sold. There are penalties for selling cosmetic products that are not registered with the authorities.
Cosmetovigilance
The responsibilities don’t end after the launch of the product. It is a requirement to operate a cosmetovigilance system to ensure that all product safety information is recorded, interpreted, analysed and trended. Trends should be used for EPD purposes. In some cases, it may be required to generate a case report and inform the national competent authority of a Serious Undesired Event (SUE).
Summary
Complying with UK regulatory requirements can be a complex and time-consuming process for international cosmetic brands. However, failure to comply with these regulations can result in fines, legal action, and damage to the brand's reputation. Working with am in market service provider such as COSMESURE can help international brands navigate the regulatory landscape and ensure that their products are safe, compliant, and ready for sale in the UK market.
Contact us at info@cosmesure.uk to find out how we can support you.