Legislation concerning cosmetic products in the main markets worldwide, such as the
European Union (EU), the Unites States (US) and Japan, demand the assurance of three
very important features, namely safety, efficacy and quality of cosmetic products, as is the
case for pharmaceuticals or foods.
General aspects of current legislation on safety and efficacy in the different countries,
including label information requirements were dealt with in Section 1.1.
As indicated in Section 1.1, manufacturers must have enough data available to assure
cosmetic product safety under the normal conditions of use. Data can be obtained either
specifically on the finished products or be deduced from the properties of their ingredients.
Moreover, data can be obtained through different studies (toxicology, sensitivity, allergic
reactions, etc.), some of which are commented in Section 9.1. Sometimes, surveillance of
cosmetics in use can be requested to detect possible side effects.
Likewise, as mentioned in Section 1.1, manufacturers must have enough data available
to demonstrate cosmetic efficacy (fulfilling that claimed on the label). These can be
obtained through different studies (moisturized state, elasticity, etc.), some of which are
commented in Section 9.2.
Both safety and efficacy have to be considered under the following conditions:
– The final product must accord with the composition designed by the manufacturer
and be in a perfect state.
– The cosmetic has to be applied by the user under the normal given conditions.
Another very important feature of cosmetic products is their quality and this requires thorough
control.
Sometimes it is not easy to differentiate between quality and safety problems. Both could
cause adverse effects on users, however the origin is different. Experience shows that quality
problems affect specific batches which have to be withdrawn from the market, whereas if
there is a safety problem it affects all the batches. This is because in the latter case, productuse has proven to have toxicological effects on users, thus it is a design failure of the product
in question, which must then be completely withdrawn from the market.
Often, quality failures are so evident (like, for example, separation of phases, rarefaction
of the fat phases, etc.) that users will realise that they should not apply the product. On the
other hand, some quality failures do not cause adverse effects on users. For example, an
error in the label does not usually cause adverse effects, although it may in certain cases;
like for instance the wrong sun protection factor labelled on a sunscreen product could give
rise to solar erythema in users who would trustingly overexpose themselves to the sun.
Difference between quality and safety failures are shown in Figure 1.2.1 with the following
example: Let us suppose that some dermatological infections have occurred and
the authorities are searching for the origin. Several cases could be given that could have
caused adverse effects on the user, but the origin is different
Case 1: The amount of anti-microbial preservatives in the cosmetic formulation has not
been calculated properly in the product design, and the cosmetic is not preserved well
enough. This is an example of a safety problem; the manufacturer must modify the formulation,
and all the batches that were put onto the market will have to be withdrawn.
Case 2: The product should contain a specific amount of anti-microbial preservatives
(according to its formulation), but due to a production failure several batches were
produced without the correct dose. This is an example of a quality problem; the cosmetic
product is well formulated but the operator in charge made a mistake and added
an insufficient amount of preservatives in several batches. Only the affected batches
will have to be withdrawn from the market.
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