Cosmetic Products
Cosmetic products are a category of consumer products intended for use by the user on the skin surface. Cosmetics include a broad range of products, from oral hygiene products such as mouthwash through to skincare products like sunscreen.
Cosmetic products differ from medicines in that their primary function is not to treat or prevent disease, and they do not contain ingredients which are regulated as medicines. Though medicines and cosmetic products may be similar in their use, their regulatory requirements are different. If you aren’t sure whether your product is cosmetic or medicine, please refer to our FAQ.
Regulatory requirements
EU
Within the 27 EU Member States, cosmetic products are primarily under regulation EC No 1223/2009, however, additional directives and regulations may also be applicable to products, such as:
- Chemical Label & Packaging Regulations (CLP) (EC) No 1907/2006
- Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH) (EC) No 1272/2008
- Claims made on cosmetic products are governed by Commission Regulation 655/2013 on Cosmetic Claims
Great Britain
All cosmetic products sold in Great Britain must be submitted to the Office for Product Safety and Standards (OPSS) through the UK Cosmetics Notification Portal and will require a Responsible Person based in the UK to maintain and provide a physical address for your Product Information File, have a good understanding of the UK cosmetic product regulations to ensure that your product and labelling is compliant, and be able to assist you when engaging with regulatory authorities
In Great Britain, the Product Safety and Metrology, etc. (Amendment, etc.) (EU Exit) Regulations 2019 S.I. 2009 No.696 governs the placing on the market of cosmetic products.
Any cosmetics products being sold in Northern Ireland will remain covered by the EU regulations.
Why work with us?
Inter Scientific offers a turnkey solution to cosmetic brand owners, saving you time and money. Once we understand your specific needs, we will create a tailored solution to ensure your products are safe and legal.
We offer Responsible Person services to our clients selling products in both the UK and throughout Europe.
With over a decade of experience in the regulatory industry and a strategic approach to regulation and product testing, you’re in safe hands with us.
Our cosmetic product services
- Product Information File (PIF)
- Responsible Person (RP)
- Cosmetovigilance (CV)
- Cosmetic Product Safety Reports (CPSR)
- Safety assessment
- Non-clinical safety studies
- Notification submission
- Shelf-life studies
- Microbiological testing
- AMES testing
- Durability testing
- Quality Management System (QMS) for manufacturing
- Manufacturing audit
Frequently asked questions
Products which contain CBD and are intended for use on the skin or lips will likely be considered as cosmetic products in the UK and EU. Products which are vaped or intended for human consumption would not usually be classed as cosmetics.
Hand sanitiser generally falls under one of two regulatory frameworks: cosmetic or medicinal products/medical devices. If a claim is made on a product such as ‘kills coronavirus’, then the product would ordinarily be deemed a medicinal product and not as a cosmetic product.
A PIF contains the following information:
- Description of the cosmetic product
- Cosmetic Product Safety Report (CPSR)
- Description of the method of manufacture and a statement on compliance with Good Manufacturing Practice (GMP)
- Proof of the effect claimed for the cosmetic product
- Data on animal testing
A Responsible Person is responsible for ensuring cosmetic product compliance for products sold in the EU and UK. They must be indicated on the product labelling and they are responsible for the PIF.
The RP may be responsible for the Cosmetic Product Safety Report (CPSR), which is contained in the PIF, provided the RP is qualified in pharmacy, toxicology, medicine, biochemistry, pharmacology or similar.
Yes. In order to place products in the market in the EU or UK, a RP is required, unless the manufacturer is based in the jurisdiction where the products are to be sold and they themselves adopt the responsibility of the RP.
The Responsible Person is responsible for ensuring that cosmetic products are compliant on the market and shall have the power to make corrective actions to ensure regulatory compliance. Details of the RP should also be included on the product for identification purposes. The RP is responsible for the PIF and provides this to the competent authority if requested.
For a cosmetic product manufactured within EU 27 or the UK, the manufacturer may designate a third party as the RP. For a cosmetic product imported into EU 27 or the UK, the importer may designate a RP within EU 27 or the UK respectively. This RP must be within the EU 27 for cosmetic products sold in the EU, while the RP must be in the UK for cosmetic products sold in the UK, i.e. the RP must be based in the jurisdiction where the products are to be sold. The designation of a third party as RP should be conducted by written mandate, as should the acceptance by the RP.
Claims on cosmetic products are tightly regulated by Commission Regulation 655/2013 on Cosmetic Claims. Claims pertaining to medical benefits are prohibited on Cosmetic Products.
A safety assessment is required prior to placing a cosmetic product on the market, according to Directive 76/768/EEC. This is the responsibility of the RP.
To conduct a safety assessment, the RP must assess the intended product use, the systemic exposure from the individual ingredients in the final formulation, a weight-of-evidence approach when reviewing data, non-clinical safety studies and keeping the CPSR up to date.
The CSPR can only be carried out by a person who has formal qualifications upon completion of a university course in relevant fields including toxicology, medicine, pharmacy or a similar discipline.
Good Manufacturing Practice or GMP is a set of standards intended to ensure that cosmetic products are manufactured consistently and to high quality. An international standard for GMP for Cosmetic Products (ISO 22716) is generally adhered to by cosmetic product manufacturers in order to comply with regulatory requirements.
Animal testing of cosmetic products has been prohibited in the EU since September 11, 2004. Alternative, ethical testing methods are required for cosmetic products.
Contact us today
We provide regulatory consultancy and lab testing under one roof so you don’t need to outsource to multiple companies – our process is smooth, simple and you’ll be assigned your own project manager who will keep your application on track and update you every step of the way.
To discover more about how we can support you to sell your cosmetic products safely and legally, complete the contact form below or email cosmetics@inter-scientific.com and let’s get to work.
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In May 2016, the Food and Drug Administration finalised its “deeming” rule, subjecting nicotine products to scrutiny under the Federal Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. Products marketed after February 2007 must submit a Premarket Tobacco Product Application (PMTA) before the product can be sold in the US.
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