What requirements must Cosmetics Meet?


Cosmetics are part of everyday life and their safety is important. Safety regulations concerning cosmetics apply to toothpaste, soap, shampoo and other skin-care and hygiene products as well as make-up.

What are cosmetics?

Cosmetic products are intended to be placed in contact with the external parts of the human body such as the skin, hair, nails, lips and external genital organs or with the teeth and the mucous membranes of the oral cavity with a view to
- cleaning them
- perfuming them
- changing their appearance
- keeping them in good condition
- protecting them
- correcting body odours.

What requirements must cosmetics meet?

Around 10,000 ingredients are used in cosmetics. It is important to ensure that ingredients do not damage consumers' health or property.
In Finland cosmetics are subject to the provisions in the Cosmetics Decree (189/96) and the Ministry of Trade and Industry's Decision on Cosmetic Products (190/96), which were issued under the Product Safety Act (914/86). The European Union has had a Cosmetics Directive since 1976.
Regulations set maximum concentrations for certain ingredients together with other limitations. Rules concerning colourings and preservatives are particularly strict. The use of over 400 substances is forbidden. This includes most pharmaceuticals as well as pesticides and many organic solvents.
Regulations also cover labels on containers and packaging. Not including ingredients on labels is just as much an infringement of safety regulations as using forbidden substances.
The Product Safety Act also covers consumer services. Product safety requirements also apply to beauticians and hairdressers.
Cosmetic products must be labelled to indicate at least the following:

the name or trade name and address or registered office of the manufacturer or of the person responsible for marketing the cosmetic product within the European Economic Area (EEA).
the nominal contents (by weight or by volume)
instructions and precautions which are necessary for safe use
indications necessary for safe use which are prescribed in the Ministry of Trade and Industry's Decision on Cosmetic Products (such as "do not use on irritated skin" or "contains formaldehyde")
the minimum storage period if it does not exceed 30 months
the batch number
the purpose of the product if it is not obvious
a list of ingredients
As a rule labels must be on both packaging and containers. In Finland labels must be in Finnish and Swedish.

The Consumer Ombudsman has issued a statement on the use of expressions referring to allergy safety. The term "allergy tested", for example, should not be used on packaging or in advertising unless information is provided concerning what, why and how products have been tested and what results were obtained.

List of ingredients

A list of ingredients must appear on the container and/or packaging.
The list of ingredients must be indicated by the word ingredients in Finnish and Swedish.
Ingredients must be listed in descending order of weight. Thus the ingredient which has been used in the largest quantity should appear first on the list. Ingredients in concentrations of less than 1% may be listed in any order at the end of the list.
INCI (International Nomenclature of Cosmetic Ingredients) names must be used in the list of ingredients. This ensures that substances are identified by the same names in all the member states and makes it easier for consumers to tell if a product contains a substance which they should avoid, regardless of what country they buy a product in. Perfume and aromatic raw materials are referred to by the words "perfume" or "flavour".
INCI names are posted on the Internet in English at http://pharmacos.eudra.org/F3/inci/index.htm.
Product-specific safety information

A cosmetics company in the European Economic Area must keep the following information readily accessible to the competent authorities at the address specified on the label:

the composition of the product
specifications of the raw materials and the finished product
the method of manufacture
an assessment of the safety for human health of the finished product
the name and address of the qualified person or persons responsible for the assessment
data concerning undesirable effects on human health resulting from use of the product
proof of the effect claimed for the cosmetic product
Product-specific information must be available both for new products and for products already on the market. This also applies to products which are intended for professional use. The information supplied to authorities must be treated as confidential.

Registration of cosmetics companies

The company responsible for placing a cosmetic product on the market in the European Economic Area (the EU plus Norway, Iceland and Liechtenstein) must be registered by the competent authority at the national level. In Finland this authority is the Consumer Agency.
In Finland a domestic manufacturer or supplier or a domestic company responsible for placing imported cosmetic products on the market in the European Economic Area must be registered.
A company marketing cosmetic products which have been registered in some other EEA country does not need to be registered in Finland.
Who is responsible for the safety of cosmetics?

Traders are responsible for seeing that the products which they manufacture, market and sell are safe. This includes manufacturers, importers, distributors and sellers.

Traders must show due care to prevent risks and dangerous situations. Traders must voluntarily report any risk observed in products which they have produced or sold.

Who monitors cosmetics?

The Consumer Agency, the state provincial offices and municipal health inspectors are responsible for monitoring that products are safe and properly labelled.

The monitoring authorities conduct market surveillance and have products tested. They investigate reports from consumers concerning products which cause allergies or other health problems. This includes finding out the composition of the product from the manufacturer or importer and testing the product if necessary.

Since the Product Safety Act also covers services, consumers can report risks observed in services provided by beauticians and hairdressers to the Consumer Agency. If the Consumer Agency receives numerous complaints about the same person, it investigates complaints and asks for an explanation.

What happens if a product is found to present a risk?

If a cosmetic product presents a risk to consumers' health or property, the Consumer Agency can ban the sale of the product or service on the basis of the Product Safety Act. A sales ban is usually backed by a conditional fine. The manufacturer or importer can also withdraw the product voluntarily.
In addition to a sales ban the Consumer Agency can require a trader to recall products which have already been sold and provide consumers with a replacement or refund.
The obligation to recall a dangerous product concerns manufacturers, importers, distributors and sellers.
If a product presents a risk, it is defective and the consumer is entitled to a replacement or refund under the Consumer Protection Act.

What are cosmetics?

In current usage, a cosmetic (toiletry) is any preparation which is applied to the skin, eyes, mouth, hair or nails for the purpose of cleansing, enhancing appearance, giving a pleasant smell or giving protection. Within the definition of a cosmetic may be included:

Soaps, shampoos, toothpaste, and cleansing and moisturising creams for regular care
Colour cosmetics such as eyeshadows, lipsticks and nail varnishes
Hair colorants and styling agents
Fragrance products such as deodorants, aftershaves and perfumes
Ultraviolet light (UV light) screening preparations.

There is vast population exposure to cosmetics and their use is life long. Many thousands of substances are used by the cosmetic industry. An inventory of these is published by the European Commission and is searchable by the public (WWW). Important groups of these substances include preservatives, antioxidants, colours and UV filters. Specific lists of such substances are given in the Cosmetics Directive 76/768/EEC (WWW) These have been exhaustively evaluated for safety by an independent scientific committee which advises the Commission (WWW). Many of these ingredients are used also in household, occupational and the inactive bases of topical medicinal products. Most of the ingredients listed as being used by the cosmetics industry are innocuous to the skin.

All cosmetic products sold in the EU must have full ingredient labelling on the package. The terminology used must, by law, comply with that published in the Inventory (WWW). Therefore, all consumers in all member states can readily obtain the same information on cosmetic formulations should they need it. With minor differences the terms used are the same as those used for labelling in the US and other important countries.

Cosmetic products and their ingredients must be safe for use. This implies that tests have been performed on the ingredients to ensure that this is so. Guidelines for the Safety Evaluation of Cosmetic Ingredients (WWW) are published by the Commission and are regularly updated. The Cosmetics Directive requires that non-animal tests are used when validated. The 7th Amendment of the Directive focuses on this in particular.

Marvellous claims are often made for cosmetic products. Other than UV-filters which do protect from the hazards of excessive sunlight exposure including premature ageing of the skin, there is no evidence that cosmetic products are able to produce any other long term benefits. The Cosmetics Directive does require that when a claim for efficacy is made for a cosmetic product, full substantiation for the claim should be available.

Despite the intrinsic safety of cosmetic products, consumers may experience reactions to them.

What types of adverse reactions occur to cosmetic products?

The adverse reactions which can occur from the use of cosmetic products can be identical or very similar to those which can be caused by the topical application of other chemical substances and mixtures onto the skin. The two main types of such reactions are irritant and allergic contact reactions both of which can manifest as an obvious inflammatory response causing an eczematous (dermatitic) picture.

Irritant reactions to cosmetic products are the most common. All members of the population will experience an irritant contact reaction at some time. Those individuals with a constitutional tendency to eczema ('atopics' account for 20% of the population; they are those with a history of flexural eczema, asthma, hay fever), and light skinned subjects may be more susceptible to the development of the more minor degrees of reaction. 'Chapping' of the hands is an example of such a mild reaction which is well recognised.

In an irritant contact reaction 'damage' to the skin or impairment of its physiological integrity is caused by one or several chemical or physical factors which affect one or a number of 'target' sites in the skin. There are many possible mechanisms by which such changes can occur. In normal life our skin is being constantly subjected to potential irritant factors and it has evolved to be an efficient barrier to cope with the challenge. Minor and subclinical damage is repaired rapidly.

Substances with a low intrinsic potential to cause irritant damage need to be applied repeatedly so that a stepwise increase in minimal (and not clinically obvious) damage occurs before repair has taken place. At a certain point a 'threshold' is breached above which there is clinical evidence of an eczematous reaction. In general, irritant reactions are minor problems which resolve rapidly once the offending agent(s) has been removed from contact with the skin.

An irritant contact reaction may occur following a single exposure to a substance but is more common after repeated exposure to the same or different agents over a period of time. The inflammatory reaction occurs at the site of application with no obvious tendency to 'spread' elsewhere.

How do irritant reactions present?

Scaling or redness sometimes associated with an itch following the repeated use of a cosmetic can be an irritant effect. Clearance of the problem rapidly after stopping use of the product is the norm. Irritant reactions are more easily induced where the stratum corneum (the outer layer of the epidermis) is thinnest (it is the stratum corneum which forms the most important barrier component of the skin), or where there is occlusion. On the hands an irritant contact dermatitis will tend to occur in the finger webs, under rings and over the back of the hands. The eyelids are more easily affected on the face.

Severe or acute irritant reactions occur rarely. They can be seen following certain hairdressing procedures where very alkaline or caustic substances are allowed inappropriate contact with the skin. At the very worse a 'chemical burn' can be produced.

A slight stinging of the skin immediately following the use of a cosmetic may be caused be the effects of certain cosmetic ingredients on the skin of some individuals. These individuals are known as 'stingers'. The stinging effect is trivial and of no medical consequence but is an important cause of cosmetic intolerance. Deodorants are a common cause of stinging. Certain chemicals are well known to be able to cause stinging but remain widely used in cosmetic and dermatological preparations because of particular desired qualities. As examples are propylene glycol, alpha hydroxy acids and some fragrance chemicals. Individuals with a susceptibility to experience stinging can be selected by the application of substances to the nasolabial fold area. Additionally, individuals with a dry or eczematous skin type may be more prone to experience such a phenomenon. In these individuals the barrier function of the skin may be impaired. Most people who experience stinging simply cease to use the offending product.

Allergic contact reactions are less common than irritant reactions. It is known that about 10% of individuals investigated for eczematous skin conditions are allergic to fragrance substances and approximately 8% to preservatives. The prevalence of hypersensitivity in the unselected general population is unknown but there is some evidence that up to 2% of the population may be allergic to one or more of the common cosmetic ingredients.

What is contact allergy?

Contact allergy is a manifestation of a type 1V delayed hypersensitivity (cell mediated) immune response. There are two phases to the presentation of an allergic contact reaction - induction during which the state of hypersensitivity to a molecule is acquired, and elicitation whereby an eczematous reaction follows from subsequent exposure to the substance. Even with potent experimental allergens there is a minimum period of about 10 days from first exposure to the immunological acquisition of hypersensitivity. An allergic contact dermatitis is a consequence of previous exposure.

The probability of developing hypersensitivity depends on the sensitising capacity of the chemical and exposure to it. Most potential allergens on the consumer and industrial market have a low intrinsic potential for sensitisation, an important exception being some preservatives.

An allergic contact dermatitis will occur at the site of skin contact with the allergen to which previous exposure has induced the state of hypersensitivity. Secondary spread may occur. Contaminated hands may spread the allergen to 'non-exposed' sites. Trivial or occult contact with an allergen may result in a persistence of a dermatitis; some allergens are 'ubiquitous' e.g., formaldehyde and other preservatives.

Contact allergens tend to be low molecular weight (

How is contact allergy acquired?

Contact allergy is not innate, it is acquired through exposure. Exposure to a particular allergen may be from a single cosmetic product, many cosmetic products as well as from non-cosmetics. Many of the most common cosmetic allergens are widely used in household and industrial products. The induction of the state of specific hypersensitivity to a substance requires an 'incubation' of at least 10 days from first exposure but generally there will have been exposure, either continuous or intermittent, over a very much longer period and often years. Once allergy is acquired, a suitable subsequent threshold dose will elicit an allergic contact reaction. This elicitation may be observed in 6-48 hours. Top

An individual may experience an allergic contact dermatitis after using a cosmetic product for the first time Such a reaction must have occurred on the skin of a previously sensitised individual. The acquisition of hypersensitivity may have been years previously. Therefore, although the eliciting exposure may be apparent, the inducing exposure may not be identifiable.

What other types of reaction occur to cosmetics?
Contact urticaria is occasionally observed and can be a desirable feature of some cosmetics. A transient redness may occur after the application of a perfume to the skin. The expected 'tingling freshness' in the mouth after using some toothpastes is a manifestation of a contact urticaria.

Pigmentary anomalies often occur on the pigmented skin after it has been inflamed. So-called post inflammatory hyperpigmentation is the most common and consists of increased pigmentation at the sites of previous inflammation. Colour returns to normal with time. Melasma is a patchy increased pigmentation on the face of women caused by hormonal and sunlight influences. Melasma does not follow contact reactions and may be erroneously blamed on self-tanning products. Berloque dermatitis is no longer of importance. This condition was caused by the phototoxic effects of psoralens present in some fragrances.

In general acne is not aggravated or precipitated by the use of cosmetics. The rare entity of cosmetic acne may occur from the excessive use of greasy products and pomade acne occurs on the foreheads of Afro-Caribbeans.

How are cosmetic reactions investigated?

Diagnostic patch testing remains the mainstay in the proper evaluation of an adverse reaction to a cosmetic. It is a hospital based procedure carried out by a dermatologist properly trained to be able to provide an appropriately comprehensive screen, know what to test, know what to dilute for testing, can competently read any reactions and can give authoritative advice after interpreting any reactions. Anyone can patch test, but few do it well. Patch testing is an objective test. With it one can demonstrate the presence or absence of contact allergy. There is no ordinary clinical test for irritancy; its presence is subjective.

All individuals undergoing patch testing will be tested to a 'standard series' of allergens consisting of those substances which are 'common' or important causes of contact allergy. When investigating a possible cosmetic reaction the standard series will be supplemented by other relevant cosmetic allergens and the individuals own skin care products. Patch testing chambers are applied to the upper back and remain in place for 2 days. Readings are made at 2 and 4 days after the occlusive application.

The interpretation of reactions can be very difficult. False negative and false positive reactions occur. The latter is a reaction interpreted as allergic when it is really irritant. Patch testing is a test designed to determine allergy not irritancy. A neat shampoo will always cause a false positive reaction. Many moisturising products also cause false positive reactions and are recognised as such by the competent assessor.

Allergic reactions to cosmetics are generally caused by one of the well characterised allergens which are present in the standard and cosmetic series used during diagnostic patch testing. Now that cosmetic products have full ingredient labelling, appropriate advice can be provided on preventing future exposure through cosmetics although exposure may still occur from non-cosmetic uses.

If there are no reactions to the well recognised allergens but a reaction occurs to a cosmetic product which is interpreted as allergic in nature then further investigations are undertaken. The first is a ROAT (repeated open application test). This consists of the rubbing in of the product several time daily for several days to the skin of the upper arm or forearm. If there is no reaction then the patch test was probably a false positive reaction and no further action is necessary. If there is a reaction, often consisting of erythematous papules, then further investigation may be required. Samples of the individual ingredients used by the cosmetic manufacturer may be requested and tested on the individual. Rare or not previously described allergens may be detected. Compound allergy is the very rare phenomenon whereby a genuine allergic reaction is observed to a finished product but not to the individual ingredients; it is believed that chemical modification may occur within the product. Some cosmetic ingredients are not 'pure' and reactions may occur to 'impurities' present in some batches of a substance.

How do cosmetic reactions present?

All cosmetic products will cause an adverse reaction on the skin of somebody at sometime if sufficient members of the population use it.

Certain product types may be more likely to cause adverse reactions than others. Deodorants may be slightly irritant to some skins for a variety of reasons and allergy to perfumed products may occur. Hair dyes are an important cause of cosmetic allergy and the reactions can be severe; an appropriate warning is carried on the product label.

Reactions which are immediate or occur over a few hours are irritant in nature (although allergic contact urticaria can cause an 'immediate reaction', it is very rare). Allergic reactions are delayed and develop over many hours. On morphology (appearance) it is not possible to clinically discriminate between an irritant and allergic contact dermatitis. However, irritant reactions tend to cause mild discomfort with perhaps some redness and then scaling. Allergic reactions can present similarly but the features may be more persistent and sometimes severe.

Should there be warnings on cosmetic labels indicating that use of the product may elicit an allergic reaction?

Cosmetics products are inherently 'safe'. In general warnings are provided only because of regulatory requirements and cover 'high risk' cosmetics such as hair dyes. The general population accepts that perfume allergy occurs; the market contains many fragrance free products and warnings are not provided. Up to 10% of normal women are allergic to metallic nickel present in costume jewellery and other items. It is common knowledge that nickel allergy occurs and most women, having experienced an elicitation reaction, will recognise the cause of their problem and change their use of offending items.

Should 'sensitivity testing' be encouraged before using a cosmetic?

There used to be a requirement that the packaging of hair dyes should carry such a recommendation. However, the testing procedures recommended were never standardised and although true allergic reactions could be detected by such tests the proportion of false negatives was not established. Patch testing, properly performed, is a standardised procedure and is not suitable for domestic use. Despite the recommendations, it was known that individuals often carried out the sensitivity test before first use of a dye (although allergy could not be present because of the absence of previous exposure), a false sense of security then developed and the tests were not repeated on subsequent use when allergy could have developed. Because of these problems the legal requirement to encourage testing was removed.

Why are chemicals known to be able to cause contact allergy used in cosmetics?

The most potent potential allergens in cosmetics are some of the preservatives which are needed to protect the cosmetic from bacterial and fungal growth. The very good preservatives are usually good allergens. A cosmetic not properly preserved may be unsafe. UV -filters are important cosmetic ingredients in reducing sun damage to the skin. Although modern UV filters are uncommon causes of contact allergy, it does occur.

Is it the fault of a cosmetic when an individual acquires and then develops an allergic contact reaction?

Usually not although there have been some examples where ingredients previously considered to have a low sensitising potential have caused problems from their inclusion in particular formulations. These problems have been caused by increased skin penetration because of enhanced 'delivery function', because of a higher level of the substance than usual or because of cross reactions occurring with similar chemicals which may have a greater sensitising potential. There was no 'prediction' that such events would occur.

What is meant by 'hypoallergenic'?

'Hypo-' means 'less than' or 'decreased'. The incidence of contact allergy to certain chemical substances has been unacceptably high in the past. Modifications to their use have resulted in no single cosmetic ingredient currently having an unacceptable incidence of causing contact allergy. Even the most potent potential allergens can be used safely.

As fragrances are an important cause of contact allergy, most 'hypoallergenic' cosmetics are fragrance free. Lanolin is a rare cosmetic allergen. Lanolin sensitive individuals can use some lanolin fractions which are, therefore, 'hypoallergenic'.

In popular usage the term 'hypoallergenic' is broadened to include reference to a reduced potential to cause adverse reactions of any type.

The use of the term 'hypoallergenic' to describe a cosmetic product is being discouraged by the European Commission because there is a requirement that all cosmetic formulations should be as safe as practicably possible.

What is meant by 'suitable for sensitive skin'?

Some 20-30% of the population consider themselves to have a 'sensitive skin'. The phrase is difficult to define but is usually referred to those individuals who are likely to experience a non-specific irritant reaction. These reactions include the common responses to the alcohols, fragrances, propylene glycol and other ingredients frequently used in cosmetics as well as the transient effect experienced by 'stingers'. A manufacturer may test its products on 'at risk' volunteer consumers before marketing to confirm an increased tolerance by those with a history of a 'sensitive skin'.

Can permanent damage be caused from an adverse reaction to a cosmetic?

With the exception of chemical burns from caustics used in hair relaxers the answer is NO. Following an inflammatory reaction the skin may be more 'sensitive' for a limited period.

What frequency of reports of adverse reactions is acceptable?

Having accepted that all cosmetics will cause an adverse reaction at some time there must be a limit on the ratio of units of use of a particular cosmetic to the reports of reactions. As most adverse reactions are transient and trivial it is unlikely that the consumer will notify the manufacturer. Reactions are more likely to be notified if they are severe, were caused by an expensive product or the manufacturer (supplier) actively encourages reporting. An uninvestigated report is not a demonstration of cause and effect.

The maxim for consideration is that a cosmetic should cause no excess of adverse reactions of an irritant or allergic nature under intended or reasonably foreseeable conditions of use over those to be expected from a product of the type.

Can misuse of a cosmetic cause skin damage?

There have been examples of deliberate misuse of cosmetics for the purpose of compensation. Spraying an aerosol close to the skin can cause a freezing burn. The application of a detergent based cleanser with failure to rinse off will cause an irritant dermatitis.