Whilst things have changed a little since Great Britain left the EU, the requirements for bringing cosmetic products to market in the UK are largely the same.
There is no doubt that things were simpler when the UK was part of the EU, if only the fact that you now have to do everything twice!, well, nearly!
Don't be put off by the unknown
Many customers who contact us talk about being "putting things off", as they are daunted by the prospect of what they are facing in terms of comply with legislation.
All I can say is "don't be"..., yes there area few things you need to do, but it's not that bad, although it's also not free! So, if you are serious about creating a new range of products and you have the funds to pay for safety testing, microbiological testing and also some time needed to register your products on the UK Market place, then go for it.
So, what is a cosmetic product?
Some products may seem obvious, especially the ones you find in the cosmetics section of the department store, others are left obvious. The easiest thing to do is refer to the law. The law states that a cosmetic comprises of three parts: a function, field of application, and product composition. All parts of the definition need to be satisfied.
Function: Six functions in relation to external parts of the human body for products that may be cosmetic products, namely:
to change the appearance;
to keep in good condition; or
to correct body odours.
Field of application: The field of application of cosmetics is to the external parts of the human body; that is one or more of the following sites:
the hair system;
the external genital organs;
the teeth; or
the mucous membranes of the oral cavity
Product composition: A cosmetic product may be a substance or mixture of a number of substances, and it may come in one or more than one part to be combined by the user.
There may be some products that remain border-line, but the above combination should give a pretty good indication as to whether your product may be deemed 'cosmetic' or not. As an example, Aromatherapy products supplied on the marketplace may fall within the scope of the General Product Safety Regulations 2005.
Products that are intended to be ingested, inhaled, injected or implanted are not classified as cosmetic products.
What hoops need to be jumped through?
What you need to do, does depend a little on product(s) you are going to sell.
Here are the 10 key elements:
Physical, chemical and microbiological testing
Challenge Testing (PET or Preservative Efficacy Testing)
Stability and compatibility testing
Cosmetic Product Safety Report (CPSR)
Good Manufacturing Practice (GMP)
Product Information File (PIF)
1. Physical, chemical and microbiological testing
The purpose of this element of the assessment is to determine the characteristics of the product...those elements of the product which make it unique from any other product. Physical, chemical and microbiological testing are likely to consider the following ten points:
quantitative & qualitative composition;
physical/chemical characteristics and stability;
impurities, traces and the packaging material;
normal and reasonably foreseeable use;
exposure to the product;
exposure to the substances;
toxicological profile of the substances;
undesirable effects and seriously undesirable effects; and
other relevant information on the product.
2. Challenge Testing (PET or Preservative Efficacy Testing)
It is important to understand how the product will perform over a long period of time, given the range of situations that the cosmetic product is likely to be exposed to, over time. All cosmetic products, which under normal storage and conditions for use, may deteriorate or form a risk to consumers, have to undergo cosmetics challenge test.
Preservatives are often used to prolong the shelf-life of cosmetic product. The type of preservative used will depend on the product ingredients, i.e. a water-based product is likely to use completely different preservative than an oil based product.
Other than the needs of the manufacturer to have confidence in their product shelf-life, the manufacturer (or Responsible Person) has a duty towards the consumer, to protect them from any possible health risks that may be associated with the use of a cosmetic product.
The purpose of challenge testing is to test whether microorganism introduced during normal and reasonably foreseeable use will not negatively affect the quality or safety of the product.
The Safety Assessor will be able to provide guidance on the choice of preservative.
Some products represent a very low risk of microbiological contamination and microbial growth due to their characteristics. These include the product formulation, production conditions, packaging or a combination of these factors, which create a hostile environment for microbial survival and growth.
3. Stability and compatibility testing
Stability testing is used to confirm that the product will remain in a safe and useable condition for its specified shelf-life or period after opening (PAO) timescale. In addition to the physical stability of the product formulation, compatibility between the formulation and the primary packaging is also checked during stability testing.
Stability testing involves exposing the product to various conditions such as changing temperatures, humidity, UV light and mechanical stress. From these tests it is possible to predict conditions, which a product may be subjected to during its shelf life and see if these conditions have a negative impact on the product’s quality and safety.
Packaging is another factor that can affect the finished product stability, e.g. leaching of substances of the packaging into the product formulation.
If your product uses different types of packaging then ear package should be tested. There are two types of stability tests – real-time and accelerated test.
Real-time stability testing: monitors the product throughout its shelf life (if you want to claim a one-year shelf life, you would need to monitor the product for at least one year).
Accelerated testing: is done under accelerated conditions, such as elevated temperatures. Consequently, the testing period is shortened, and such tests usually take 3 months.
4. Safety Assessment
A safety assessment is required to be completed on a cosmetic product before being placed on the UK. The purpose of the safety assessment is to demonstrate that the product 'is safe for human health when used under normal or reasonably foreseeable circumstances'. The cosmetic product safety assessment should indicate if the product is either safe for use or safe for use with restrictions.
The safety assessor should determine which 'warnings' or 'instructions of use' are mandatory for labelling.
A specific safety assessment is required for cosmetic products intended for use on children under the age of three, and for cosmetic products intended exclusively for use in external intimate hygiene.
5. Cosmetic Product Safety Report (CPSR)
The Cosmetic Product Safety Report (CPSR), signed by a qualified safety assessor is the document produced by the safety assessor and provided to the Responsible Person. It provides the evidence of how the product is safe for its intended cosmetic use and takes account of reasonably foreseeable use.
6. Responsible Person
A cosmetic product cannot be placed on the UK market unless there is a 'Responsible Person' established in the UK in respect of that cosmetic product. This includes if you are a Northern Ireland business placing a cosmetic product on the UK market under unfettered access.
For the purpose of the law, the Manufacturer or Importer is considered to be the Responsible Person.
7. Good Manufacturing Practice (GMP)
Manufacturing of cosmetic products should be carried out to cosmetic Good Manufacturing Practice (GMP). GMP requires that every batch of cosmetic products is tested for microbiological, physical and chemical properties in order to ensure safety and quality of each batch - this is usually achieved through accelerated testing.
ISO Standard 22716 covers GMP, but there are other ways and guidance documents are available from trade associations.
All cosmetic products must comply with labelling requirements. The Regulation requires all cosmetic products (except where specific exceptions apply – see below) to have clearly and indelibly marked on their container and packaging the following information:
Name and address of the Responsible Person
Country of origin for imported products
Nominal quantity of contents