General Review of Official Methods of

Analysis for Cosmetics in Different Countries

L. Gagliardi,

1*

D. De Orsi

and S. Dorato

Department of Drug Research and Evaluation, Istituto Superiore di Sanità,

Viale Regina Elena 299, 00161, Roma, Italy

Department of Pharmaceutical Sciences, Facoltà di Farmacia,

Università di Genova, Italy

GENERAL OVERVIEW OF COSMETIC REGULATIONS

As described in Section 1.1, three main regulatory systems exist at a global level in the

domain of cosmetics: those of the European Union (EU), the United States (US) and

Japan. These regulatory models have been used by many other countries or communities

to prepare their own cosmetic legislation.

Since cosmetics are widely used consumer goods, all regulations concerning them have,

as their prime and principal purpose, the guaranteeing of consumer safety. Thus, Article 2 of

the European Union Cosmetics Directive 76/768/EEC expressly states: “A cosmetic product

put on the market within the Community must not cause damage to human health under normal or
reasonably foreseeable conditions of use (…)”. Article 3 states that “Member States

shall take all necessary measures to ensure that only cosmetic products which conform to the

45

Corresponding author. E-mail: luigi.gagliardi@iss.it

Analysis of Cosmetic Products

Amparo Salvador and Alberto Chisvert

Copyright © 2007 by Elsevier B.V.

All rights of reproduction in any form reserved

provisions of this Directive and its annexes may be put on the market”. Thus, it is the responsibility of
national authorities to verify the conformity of cosmetic products sold in their

respective countries.

Another concern of the responsible authorities, especially in the numerous countries

where legislation forbids misleading advertising, is to verify the veracity of claims and the

efficacy of products. Efficacy and claims may be linked to the presence of an ingredient

in the finished product, whose presence and/or content must be verified, if necessary.

As described in Section 1.1, depending on the local regulatory system, the tests are performed before
and/or after placing the cosmetic products on the market. The regulations

applicable to cosmetics can, indeed, be classed in two main categories: regulations imposing

an obligation to submit a registration dossier to the authorities prior to placing the finished

product on the market (pre-market approval), and those which impose responsibility on the

manufacturer selling the product, without the need for prior approval from the authorities,

but with control, if necessary, once the product is on the market (in-market control).

Whether applying a pre-market or an in-market control system, the authorities need official analysis
methods to verify the regulatory compliance of cosmetics vis-à-visthe requirements applicable to
substances which may be included in the formulations undergoing

testing. Thus, the competent authorities can verify whether the qualitative–quantitative

formula submitted by the manufacturer does, in fact, correspond to the analysis of the finished
cosmetic. The possible presence of banned substances in the finished product may

also be tested. Similarly, the authorities responsible for in-market control may verify

whether the cosmetic complies with the concentration restrictions applicable to certain

ingredients, or whether they contain substances other than those listed on the ingredient

label (see Section 1.2 for a detailed explanation on ingredients labelling).

It should be noted that physical/chemical tests performed on the finished product prior to sale

do not prevent a second round of testing once the product is placed on the market. The authorities
will then check whether the information supplied at the time of registration corresponds to

the product sampled at random when on the market, by controlling, for example, whether the

stated concentrations vary over time. This type of control is performed mostly in countries

where a shelf life or expiry date is required on the finished product label. In such cases the

authorities can check whether the quantity of active substances remains within the permitted

limits throughout the shelf life, during that time the product is assumed to remain effective.
For their part, manufacturers must, at all times, be able to guarantee their products conform

to legislation through a quality-control system (see Section 1.2). The analytical methods used

by manufacturers must enable them to control the manufacturing process and the conformity

of each batch of raw materials it intends to use, and also, the final cosmetics before sale.

SUBSTANCES SUBJECT TO BE CONTROLLED BY THE AUTHORITIES

As illustrated in Section 1.1, most cosmetic regulations control the use of cosmetics ingredients by
publishing three types of substance lists:

(a) Substances banned in cosmetics:

These substances must not be found in the finished product, except as traces.

Indeed, according to the Article 4.2 of the EU Cosmetics Directive, the presence of

46 2. General Overview on Analytical Methods for Cosmetic Ingredients

traces of a banned substance (i.e. those listed in Annex II of the EU Cosmetics

Directive) is allowed provided that such presence is technically unavoidable when

using good manufacturing practice and if they do not pose any risk to consumer

health.

(b) Substances restricted in cosmetics:

These substances may not be used in cosmetic products, except subject to the restrictions and
conditions laid down by the different legislations (e.g. EU Cosmetics

Directive Annex III). The restrictions may concern maximum concentrations, pH limits in the finished
product, warning labels or purity criteria, depending on the product

in which they are formulated. For example, see Table 2.1.1 for the restrictions specific

to thioglycolic acid and its salts in the EU Cosmetics Directive Annex III.

A specific case concerns the 26 potentially allergenic fragrance ingredients listed in

EU Cosmetics Directive Annex III: these substances must be shown on the ingredient

list on the label if their content in the final product exceeds 0.001% in leave-on cosmetics and 0.01%
in rinse-off cosmetics.

The authorities may verify whether a restricted ingredient is contained in a cosmetic product at a
concentration higher than that permitted for the field of application

under consideration.

(c) Substances subjected to positive listing:

These substances are used in cosmetics for specific functions: for example cosmetic

colouring agents, preservatives or UV filters for skin protection in the EU and in many

other countries. In the context of cosmetic regulations, China has also published a list
of hair dyes.

However, the positive lists may also concern functions which are considered to

correspond to a cosmetic in the EU, but whose ingredients are considered as active

ingredients of over-the-counter (OTC) drugs in the US, quasi-drugs in Japan, functional cosmetics in
Korea or medicated products in Taiwan (see Section 1.1). Only

substances included on a specific positive list are allowed for the function concerned

in the country issuing the list. However, a substance that is not included in a specific

positive list (e.g. a preservative not listed in EU Cosmetics Directive Annex VI) may

nevertheless be used in a cosmetic insofar as it is used for a function other than that

taken into account in the positive list concerned (preservation in this example).

These substances are also, in most cases, subject to concentration limits, and the

authorities will make every effort to verify they are not used at concentrations higher

than those authorized.

In contrast, the authorities may also control substances that are not necessarily regulated

in cosmetic products:

(a) Substances that are claimed to be present in the final product or for which an exact

concentration is claimed.

These tests are performed by the authorities responsible for advertising control, for

example the Direction Générale de la Consommation, de la Concurrence et de la

Répression des Fraudes (DGCCRF) in France. In fact, these tests are generally performed with a view
to control fraud and misleading advertising.