Cosmetic Products

Here are some guidance notes for Traders on The Cosmetic Products (Safety) Regulations 2003. This is advice to businesses to help them comply with the law.

1. Introduction
These Regulations exist to ensure that cosmetic products are safe to use. They do this by controlling the composition of such products and by requiring certain markings, or labelling, to be used.

They apply to all businesses that deal with such products, including retailers, wholesalers, importers and manufacturers.

Businesses dealing in skin lighteners, and certain soap products, should be particularly careful as these are the products that have often caused problems in the past. Further details about these are included in section 8 of this leaflet.

2. What are cosmetic products?
Cosmetic products are any substances or preparations intended to be placed in contact with any part of the external surfaces of the human body or mucus membranes, for example;

• Products for use on the skin, lips, nails and hair
• Products for use on the teeth and gums

And whose use is wholly, or mainly, for the following purposes;

• cleaning,
• perfuming, or combating body odour,
• protecting, or keeping them in good condition or
• Changing their appearance

If the cosmetic product is only used for the purpose of treating, or preventing diseases the Regulations do not apply. Separate controls exist for such products.

3. Main legal requirements

General requirements
Cosmetic products shall not be liable to cause damage to human health, when applied under normal conditions of use or under reasonably foreseeable conditions of use. It is an offence for UK manufacturers and importers to supply cosmetic products, which do not comply with these requirements.

Particular requirements
Cosmetic products must comply with detailed compositional and labelling requirements and it is an offence for any type of business to supply cosmetic products, which do not comply with these requirements.

The term 'supply' includes all of the following; offer to supply, agree to supply, expose for supply or possess for supply.

4. What are the labelling and marking requirements?
The following information must be clearly and permanently marked in English. It may also be in other languages as well;

• The functions of the product unless this is clear from its presentation.
• The name and address of the manufacturer or supplier. This address must be one based within the EC. If a product is manufactured in the USA and displays an American address it is not sufficient. The address of the importer, or other supplier, within the EC should also be given.
• A 'batch number', or other reference, by which the date and place of manufacture can be identified.
• Relevant precautions and instructions or information for use.
• A list preceded by the word 'ingredients' stating the ingredients in descending order of weight.
• A 'best before' date. This is only required If the life expectancy of the product is less than 30 months. The date shown should include the month, and then the year, after which the product should not be used.
• Any reference to testing on animals in the labelling or advertising of a product must clearly state whether the tests carried out involved the product itself or the ingredients.

5. Where should these markings be?
In general these marking requirements apply to both the product container and any outer packaging, for example a tube of toothpaste packaged in a box will have to be marked both on the tube and on the box. Further details follow;

Batch number
In certain cases, it will be sufficient if this only appears on the product packaging.

Precautions and instructions or information for use
If it is impractical for these to appear on the container and packaging they shall appear on a leaflet etc. enclosed with the product, but if so the packaging and container should refer the consumer to this by means of abbreviated information or the prescribed symbol (shown below).

Ingredients list
This need only appear on the product packaging or, where this is impractical, on the container. If neither of these is practical the list shall appear on a separate leaflet etc. which is enclosed with the product. The packaging should refer the consumer to this by means of abbreviated information or the prescribed symbol (shown below). If the leaflet cannot be enclosed with the product it should be attached to the product. If the product has no individual packaging or container the list shall appear on the container in which the product is exposed for supply or on a notice nearby.

For soap, bathballs and other small products, where it is not practical for the ingredients list to be on a separate leaflet enclosed with, or attached to, the product it shall appear on a notice in immediate proximity to the container in which the product is exposed for supply.

6. Prohibited & restricted substances
Over 700 substances are prohibited from being used in cosmetic products. For example, chlorine, cyanides iodine, mercury and mercury compounds.

In addition over 50 substances can only be used in cosmetic products subject to certain restrictions. These restrictions may only allow a maximum amount of a substance or require additional warning or precautionary markings.

For example, hair dyes containing over 0.3% hydroquinone are prohibited and, if hydroquinone is contained, the product must be marked with certain warnings.

Skin lightening creams contain hydroquinone have been banned - further details are contained in section 8.

7. Restrictions for colouring agents, preservatives and ultra violet filters.
Cosmetic products must not contain some colouring agents, except with certain restrictions, such as, on which part of the body they are applied and levels of concentrations.

Some preservatives must not be contained, except with certain restrictions, such as, maximum concentration, by whom used and additional warnings for usage.

Some ultra violet filters must not be contained, except with certain restrictions, such as, maximum concentration and additional warnings for usage.

It is therefore very important to check and follow the manufacturer's instructions, which are given with cosmetic products.

8. What products have previously caused problems?

Skin lighteners & toning creams
Complexion, beauty and skin creams, sometimes called skin toners often contain hydroquinone. This has now been banned for use in such products. Hydroquinone is a bleaching agent, which bleaches, or lightens, the skin. However, this action is reversed by exposure of the skin to strong sunlight. Excessive use of products containing hydroquinone can lead to permanent damage of the skin pigment. This can result in a patchy uneven lightening of the skin, or the appearance of dark patches.

In the past we have found products that were intended to be sold outside the EC for sale in the borough or cosmetics that people have personally brought in from African countries. These have often proved to be counterfeit or to contain excessive amounts of the banned ingredient.

Soaps
Certain brand name soaps have previously been found to contain mercury.

Mercury and its compounds are extremely toxic and can be absorbed through the skin with serious side effects like skin blisters and irreversible skin damage, depression, vomiting, headaches, mental disturbances and kidney damage.

Medicines used as cosmetic skin lighteners
Shops have been found to be selling steroid based medicines as skin lighteners. These particular medicines are prescription only medicines the supply of which is regulated by the Medicines Act 1968.

Medicines which are marked on the container, or packaging, with the symbol 'POM' are prescription only medicines available only from a chemist on prescription. Supplies elsewhere, even with a prescription, are illegal.

 

Hair dyes and straighteners
Hair dyes and straighteners intended for professional use may contain hydrogen peroxide. The maximum permitted limit is 12% and the following precautions and instructions should be present 'Wear suitable gloves. Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them'.

Hair dyes for general and professional use may also contain hydroquinone but the permitted levels have been reduced from 2% to 0.3%. The following warnings should be present on general use products 'Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them'.

9. What other requirements are there?
The Regulations specify that 'responsible persons' must keep certain product information available. However, this requirement is unlikely to affect retailers unless they are personally importing the cosmetic products into the UK from outside the EC. There is also a requirement for UK based manufacturers and UK based importers into the EC to notify the local 'competent authority' about each type of cosmetic product before its first supply in the EC.

Responsible persons
A 'responsible person' is; a manufacturer, a manufacturer's agent, a person to whose order a cosmetic product is manufactured (where these are all established within the EC) or, where there is no such establishment within the EC, or the manufacture's agent is not the supplier, the person who first supplies the cosmetic product in the EC.

Information to be kept
The information to be kept is extensive and includes details of product safety assessments, manufacturing methods and proof of the effect claimed for the product. Further details are available on request.

The information must be kept at the address stated on the product container or packaging as detailed in section 4.

Competent authority
The Regulations cite the Secretary of State as the UK competent authority and that he may appoint or substitute other persons, such as local authority trading standards services, as he sees fit to act as the said authority. Further details are available on request.

10. What steps can I take to make sure the cosmetic products I sell comply?
If a business if found to have breached the Regulations the law provides a defence if it can be shown that the business has taken 'all reasonable steps and exercised all due diligence' in order to avoid committing an offence.

The steps that businesses should take are dependent upon a number of things, such as, the size of the business and whether it is a manufacturer, importer, wholesaler or a retailer.

For example, a small retailer may need to carry out physical checks on the stock such as checking the markings, whilst an importer or wholesaler may need to do additional checks including having samples analysed for compliance.

Previously problems have arisen where businesses have purchased their stock from travelling salespersons or direct from non-EC countries. It is recommended that you should only deal with reputable and established suppliers. In addition you should always obtain receipts for any cosmetic products purchased.

11. What happens if my cosmetic products don't comply with the Regulations?
These Regulations are made under the Consumer Protection Act 1987. Failure to comply could result in goods being seized and prosecution. On conviction the Courts may impose a fine of up to £5000 or up to 6 months imprisonment or both.

12. Further information
If you require further assistance on the Regulations, or would like additional information leaflets, please contact us at the address given.