COSMETIC REGULATIONS

Cosmetic Products Enforcement Regulations 2013

The EU Regulation (EC) No 1223/2009 and Cosmetic Products Enforcement Regulations 2013 lays down the rules for cosmetic products in the UK.

Before you can sell your cosmetic on the UK or EU market, including products that are given away, free samples, they needs to comply with these regulations.

The guidance supports the understanding of Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.

What is a cosmetic product?

The definition according to EU cosmetic Directive:

‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’.

Cosmetic products available to consumers in GB must be safe for human health. The Product Information File (PIF) contains information on how safe a cosmetic product is for human health. This is why it must be kept up to date. The PIF supports cosmetic product safety by providing:

a safety assessment, which confirms a cosmetic product is safe and gives the scientific evidence to support this
details on good manufacturing practice, which includes what has been done when manufacturing a cosmetic product to make sure it is safe

Making cosmetic products safe for users also covers how a cosmetic product is presented. It must:

not be mistaken for food
have clear labelling
have instructions on use and disposal

How to get a cosmetic product safety assessed

The product safety assessment is carried out by a qualified professional, who has a university degree in pharmacy, toxicology, medicine, or a similar discipline. It is the responsibility of the Responsible Person to ensure the safety assessment is carried out by a suitably qualified safety assessor.

All cosmetic products available to consumers must have a ‘Responsible Person who makes sure safety measures are followed and legal obligations are met. A Responsible Person can be a business or an individual (including sole traders). A Responsible Person must have a UK-established address to make cosmetic products available in GB. A UK-established address does not include mail forwarding or PO box addresses.

A responsible person can be either:

the manufacturer
the importer
the distributor, if they label the product as their own (for example, using their brand name)
an appointed company or person (who is named by the manufacturer or the importer)

The cosmetic product safety report

Before making a cosmetic product available to consumers, its safety must be checked by a qualified safety assessor. The cosmetic product safety report forms part of the PIF.

The two parts of the cosmetic 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) provides all the details needed to perform a safety assessment on a cosmetic product. It may be necessary to carry out or organise testing of a cosmetic product to complete this section. Part A includes information on:

the ingredients, their concentrations, chemical names and toxicological properties
the physical and chemical properties of ingredients and the final cosmetic product
the product stability
any microbial contaminants in ingredients or the final 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 quantities of the ingredients and final product the user could be exposed to

The cosmetic product safety assessment (Part B) is the safety assessor’s conclusion to part A. It includes:

an assessment of the product’s safety
any necessary warnings or instructions for the product
the scientific reasoning for the conclusions of the safety assessment
details of the safety assessor, including name, address, and proof of qualifications

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