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The Cosmetic Products (Safety) Regulations 2008 (as amended) consolidate previous cosmetic regulations and implement current European Directives.

Main provisions

• It is an offence to supply cosmetic products which may cause damage to human health when applied under normal or reasonably foreseeable conditions of use.
• The use of certain substances in cosmetic products is prohibited.
• The use of certain substances is restricted - e.g. some fragrances, colouring agents, preservatives and UV filters.
• The use of 'specified risk material' (e.g. products derived from certain animals that may carry a risk of BSE) as an ingredient is prohibited.
• Specific labelling is required.
• Certain information is required to be held by the 'responsible person'.

What is a cosmetic product?

The Regulations define a 'cosmetic product' as being:

"any substance or mixture intended to be placed in contact with the various 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, correcting body odours, protecting them or keeping them in good condition, except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease".

The last part of this definition means that products used solely as medicines are not covered by these Regulations.

The Regulations further define 'cosmetic product intended to come into contact with the mucous membranes' as:

''cosmetic product intended to be applied in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, and does not include any cosmetic product which is intended to come only into brief contact with the skin.'

Aromatherapy products

These can be medicines, cosmetic products or neither of these, depending on their intended use. If they are not medicines or cosmetic products, then they are controlled by the General Product Safety Regulations 2005. Please ask your local Trading Standards Service if you require more guidance on aromatherapy products.

Rules on animal testing

It is an offence to test a finished cosmetic product on an animal in order that the product might comply with the requirements of the Regulations.

The Regulations also restrict the supply of cosmetic products whose final formulation, or any ingredient or combination of ingredients, have been tested on animals. There are also similar restrictions on carrying out any such tests. These restrictions apply where there are authorised alternative methods of test (from 11 March 2013 where the tests involve repeated dose toxicity, reproductive toxicity or toxicokinetics).

Where a claim is made that a cosmetic product has not been tested on animals, this must be correct. In particular, the manufacturer or supplier must not have tested or commissioned tests on animals of the finished product or its prototype or any of their ingredients. The cosmetic product must also not contain any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products.

Composition

The rules on what may or may not be used as an ingredient, and the rules on restricted use and special precautions, are too detailed to be summarised in a leaflet like this, therefore reference will need to be made to the lists in the Schedules to the Regulations.

Labelling requirements:

1. Name and address of manufacturer/supplier

This should be the name or style and address or registered office address of the manufacturer or supplier established within the European Economic Area (EEA). This information may be abbreviated as long as it is generally possible to identify the manufacturer/supplier. The address must be sufficient for the normal postal service to deliver a letter to that address.

Where the product is manufactured outside the EEA, the county of origin must also be stated.

2. Ingredients

A list of its cosmetic ingredients (headed by the word "INGREDIENTS") in descending order of weight is required. This weight is determined at the time the ingredients are added to the product.

An ingredient must be identified by its common name, as listed in the International Nomenclature of Cosmetic Ingredients (INCI). This list can be obtained from the Stationery Office or online at the Europa Website

In the absence of an INCI name, any of the following may be used:

• Chemical name
• European Pharmacopoeia name
• International Non-proprietary name (INN)as recommended by the World Health Organisation
• EINECS, IUPAC or CAS identification reference; or
• Colour index number.

Where ingredients constitute less than 1% of the product, they may be listed in any order after those that constitute 1% or more.

Certain fragrance compounds have been found to be allergens that can produce allergic reactions to individuals sensitive to these compounds. The presence of any of these listed fragrances exceeding 0.001% (leave-on products) or 0.01% (rinse-off products) must be declared in the main part of the ingredients list. (eg. the presence of linalool in lavender.)

Colouring agents can be listed in any order after the other ingredients.

What does not have to be listed as an ingredient

Some items are not regarded as cosmetic ingredients, e.g. impurities, solvents, carriers (but the latter two only if used in quantities that are strictly necessary for their purpose), and these do not have to be listed.

3. Durability

Any precautions required to keep the product in a satisfactory condition need to be stated (e.g. store in a cool dry place).

Less than 30 month period

If the product is likely to either become unsafe or not fulfil its intended purpose within 30 months of manufacture, it should carry the words "Best used before the end of ..." followed by day/month/year or month/year format on which it is likely to cease to perform satisfactorily.

More than 30 month period

If the product is likely to either become unsafe or not fulfil its intended purpose more than 30 months after manufacture, it must carry the 'open container' symbol (FIGURE 1) as specified in Schedule 8 (Part 2) of the 2008 Regulations.

FIGURE 1

'Open Container'

Symbol

An indication of the 'Period After Opening' (PAO) when the above conditions will occur should also be stated, followed by month or month/year format. The use of 'M' to represent months is acceptable.

4. Precautions

Any relevant information contained in the Schedules to the Regulations regarding certain restricted ingredients needs to be included in the labelling. Any particular precautions for cosmetics for professional use (especially in hairdressing products) must be stated.

5. Batch number/Lot code

An indication of the batch/date and place of manufacture is required. This is to allow sufficient identification and traceability.

6. Product function

If it is not obvious from the presentation of the product, its function needs to be stated (e.g. "conditioning shampoo").

Language

The date of minimum durability, particular precautions to be observed in use and the function of the product should be in English.

Where Should the Labelling Appear?

The cosmetic product container and packaging requires the above information in indeliable, easily legible and visible lettering.

There are exceptions for cosmetic products sold loose, and for products where it is impossible for the information to appear where it should (e.g. if the item is too small). In this case, the following applies:

• The information can appear on a leaflet, label, tag, tape or card enclosed with or attached to the product (in which case the packaging should refer to where the information can be found, either using an abbreviation or the 'Hand and Book' symbol (FIGURE 2) as specified in Schedule 8 (Part 1) of the 2008 Regulations).

• If the ingredients list can fit onto the container instead of the above, and still be easily legible, they should be on the container.

• Name and address of the manufacturer/supplier and best before date must appear on the container and packaging.

• Batch number/lot code should appear on the packaging, if it is not possible to appear on the container.

FIGURE 2

'Hand and Book'

Symbol

Information to be kept by manufacturers, agents or importers

The manufacturer, manufacturer's agent, person for whom the manufacturer is making the product, or the first importer of the product into the EEA is known as the 'responsible person'. Where the responsible person is the manufacturer or first importer, they must possess an appropriate level of experience or relevant professional qualification(s). The responsible person must keep, readily accessible to nominated authorities, (usually the 'Home Authority' Trading Standards Service), a Product Information Package (PIP) for every cosmetic product.

The information must be in English or other language easily understood by nominated authorities.

The PIP must include the following

• The full formulation of the product including all ingredients and concentrations (except for perfumes, where the name and code number and identity of the perfume supplier is sufficient).
• The physio-chemical and microbiological specifications of the raw materials and the finished product, and the purity and microbiological control criteria of the cosmetic product.
• The method of manufacture, including an overview of the manufacturing process. This should be in accordance with good manufacturing practice.
• A health assessment.
• A specific health assessment in respect of cosmetic products intended for use on children under three years old or exclusively for use in external intimate hygiene.
• The name and address of the qualified person making the health assessment.
• Note: health assessments can only be undertaken by certain persons as listed in the Regulations.
• Existing data on undesirable effects on human health resulting from use of the cosmetic product. This should document consumer complaints including medically substantiated adverse reactions.
• Proof of any effect claimed on the cosmetic product, packaging or associated literature.
• Data on any animal testing performance in relation to the development or safety evaluation of the product or ingredients.

The EEA name and address of where the PIP can be readily accessible must be specified on the cosmetic product.

The responsible person must notify the Department for Business Innovation and Skills (BIS) of the place where each type of product is manufactured or imported.

email cosmeticnotification@bis.gsi.gov.uk

Trade secrecy

If the responsible person does not wish to list all the ingredients of a product, so that it's full composition remains a secret, they can make a request for confidentiality to BIS. The responsible person may be allowed to omit certain ingredients from the list. These omitted ingredient(s) can be listed as a registration number instead of a name.

For more detailed advice on the manufacture and supply of cosmetic products, please contact your local Trading Standards Service.

European Cosmetics Regulation 1223/2009

This new Regulation takes full effect in July 2013.

• New labelling rules for cosmetics and the product information file

Cosmetic Products Notification Portal (CPNP)

A significant new duty on importers and manufacturers of cosmetic products, brought in by this new Regulation, is the duty to notify the Commission in detail about all the products marketed by the responsible business.

This requires economic operators to first register with the European Commission Authentication Service (ECAS) to obtain a unique login. Then to notify details of all products via the CPNP, including images of the packaging and details of labelling and formulations.

The basic premise of the new notification duty is that poison centres across Europe should have access to details of cosmetic products on the EU market in the event of poisoning and medical incidents involving cosmetic products.

• Official Commission guide to the CPNP

The Cosmetic, Toiletry and Perfumery Association (CTPA)

You may wish to consider joining the The Cosmetic, Toiletry and Perfumery Association. The CTPA represents members worldwide through its wide network of contacts within government, national associations, European and International organisations.