Cosmetic Products Regulations
- A cosmetic product is any substance or mixture intended to be in contact with various external parts of the human body or with the teeth and the mucous membranes of the oral cavity (Article 2, (EC) No 1223/2009).
- The external parts include: the outer layer of the skin, hair system, nails, lips and external genital organs.
- Cosmetic products are made with the view of mainly cleaning, perfuming, changing appearance, correcting body odour, protecting and maintaining external body parts.
- A product intended to be used for treatment or as a medicine is not a cosmetic.
- However, a product can be both a drug and a cosmetic. Example: A shampoo is cosmetic because it is intended for cleansing the hair, but an anti dandruff shampoo, is both a cosmetic and a drug.
- If a product has both cosmetic and medicinal functions, it is termed as a borderline product. MHRA will apply the tests set out in Directive 2001/83/EC but the product will be classified as a medicinal product.
- A cosmetic product may have a preventive purpose but not curative.
UK Cosmetic Products Regulations
The main changes and amendments to the EC Regulation No (1223/2009) on Cosmetic Products covers the following:
1. Placing on the market
Now means making a cosmetic product available (the supply) on the market in Great Britain after the end of the transition period, 31 December 2020. This includes England, Wales and Scotland and the amended regulations are concerned with organising the supply and safe usage of cosmetic products within these markets.
2. Who a Responsible Person is and the duties expected?
- The manufacturer or distributor of a cosmetic product can be the responsible person for the cosmetic product, however, a third party can be designated to be the responsible for such a product.
- A written mandate and agreement is required to permit a third-party act as a responsible person and such must be based in the UK.
- A Responsible is required to ensure that the cosmetic product is safe for usage and conforms entirely with the Cosmetic Products Regulations.
- UK Responsible Persons will need to notify existing products (previously available In the UK, EU or EEA and notified to CPNP) by 31 March 2021 to the Secretary of State.
- New products to be placed on the GB market after 31 December 2020 should be notified using the UK’s Submit Cosmetic Product Notification Service.
3. Product Information File
This is an up to date file of the details of a cosmetic product which is made available to market surveillance and enforcement authorities when requested. It should contain:
- The product description; its function and intended area of application, also foreseeable use and warnings on undesirable effects should be inputted.
- CPSR (Cosmetic Product Safety Report) – provided by a qualified assessor
- Method of Manufacture- Tests and Good manufacturing practice compliance, if involved, animal testing referenced in the course of manufacturing.
- Nature and proof of effect of product.
- All information contained within the Product Information File must be maintained in English.
A 2-year transition period from 31 December 2020 has been given before businesses have to include the UK Responsible Person details on product labels (i.e. by 31 December 2022). The EU responsible person details should be included for existing products.
The Label should hold information that explains the contents and best usage of the cosmetic product to enable the public or user make the best judgement. Examples are shown below:
5. UK Submit Cosmetic Product Notification (UK SCPN)
- The UK SCPN has been introduced to replace the EU’s Cosmetics Products Notification Portal (CPNP) in Great Britain. Notifications would be made via UK SCPN service to the Secretary of State and competent authorities before Cosmetic products are placed on the GB market.
- Products with nano materials not used as colourant, preservative or UV-filters that had not been notified to the commission prior to the end of the transition period, should be notified to the Secretary of State via the UK’s SCPN portal by the Responsible Person, 6 months to it being placed on the GB market.
Important information to submit Cosmetic Product Notification (UK SCPN)
- The category and name of the Cosmetic Product
- The name of the responsible person
- Where the PIF (Product Information File) is kept
- Details of a named contact for urgent Enquiries
- Details of any nanomaterials the cosmetic product contains
- Details of any carcinogenic, mutagenic, or toxic for reproduction (CMR) substances the cosmetic product contains
- A summary of the ingredients
- An image of the product’s label
- A photograph of the cosmetic Product packaging
6. Serious Undesirable Effects (SUEs)
The Cosmetic Regulation defines an Undesirable Effect (UE) as an “adverse reaction to human health attributable to the normal use of cosmetic products”. Such occurrence should be notified on the new UK SUE form. Information on any SUE should be notified similarly as previously – thought for the UK only.
Beginning from 1 January 2021, UK businesses who bring in products from an EU Member State will become importers. An importer of a cosmetic product becomes a Responsible person by default. However, they can appoint an agent based in the UK to act as a Responsible Person for them.
8. Unfettered Access for Northern Ireland Cosmetic Products
Access has been granted by the government to qualify Northern Ireland goods to be sold to the rest of the UK market with no additional approvals as long as the products are in accordance with the European Union Regulation (EC) No 1223/2009 on Cosmetic Products.
- Cosmetic products made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use.
- Where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent authority, giving details, in particular, of the non-compliance and of the corrective measures taken.
- Responsible persons shall cooperate with competent authorities, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall provide all the information and documentation necessary to demonstrate the conformity of specific aspects of the product and Good Manufacturing Practice.
How OMC Medical can assist you with the process
- Act as your UK Responsible Person in the UK
- Notify your cosmetic products in the UK Submit Cosmetic Product Notification (UK SCPN)
- Keep you up to date with the UK Cosmetic regulatory requirement.
- Help you with the Labelling & Placing the product on the market
Why Choose Us
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory Affairs solutions
Contact us for free consultation: [email protected].