WRITTEN QUESTION E-0501/02

by Anneli Hulthén (PSE) to the Commission

(22 February 2002)

Subject: Chemicals in cleansing wipes

It is a well-known fact that children, and in particular babies, are very sensitive to chemicals and other contaminants. Because they have thin skin, their bodies absorb more chemicals than adults' bodies do.

The use of baby wipes is increasing sharply year by year. In Sweden, for instance, use has doubled over the past three years. Unfortunately, the number of additives, e.g. strong preservatives, is also increasing. Many wipes may contain over 30 additives, many of which damage both the environment and people's health. Some firms, for instance, use the preservative bromonitropropandiol in their wipes. Several reports have shown that this substance has a medium toxicity if it comes into contact with skin and that it can cause allergies. The firms concerned argue that it has been approved by the relevant EU scientific committee.

Since January 1999, manufacturers have been required under EU law to declare all hygiene product ingredients in descending order by quantity, but this is clearly not enough to protect our children's health and the environment.

Does the Commission not take the view that the precautionary principle should apply with regard to these products, as they are intended for use on children, who are in fact more sensitive than anyone else?

Answer given by Mr Byrne on behalf of the Commission

(2 April 2002)

The Commission shares the opinion of the Honourable Member on the need to ensure the prevention of any harmful effects of chemicals on the health and well being of small children and infants.

The risks manifested by various chemicals are a function of their inherent toxic properties (hazard) and of human exposure to them. In general, chemicals are managed at Community level on the basis of risk assessment (hazard + exposure). This is because for many of the toxic properties of chemicals, it is possible to define a level of exposure that it is considered to be safe.

The chemicals used in baby wipes are subject to the provisions of the Cosmetics Directive, Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1). Accordingly, the manufacturers of cosmetic products are under the obligation to assess the safety of their products and their ingredients in order to ensure that only safe products are made available to consumers. When new ingredients are to be used or new questions arise on existing materials, the opinion of the Scientific Committee on Cosmetics and Non Food Products (SCCNFP) is requested.

In the specific case of preservatives, like bromo-nitro-propane-diol (also known as Bronopol), the Cosmetics Directive operates with an authorisation scheme so that only materials that have been approved by the SCCNFP are allowed to be used under conditions (concentration limits, purity requirements etc) that are specified by the SCCNFP. Bromo-nitro-propane-diol has been evaluated by the SCCNFP, and is allowed to be used in cosmetic products (listed in Annex IV of the Directive) up to a level of 0,1 %.

Concerning the higher sensitivity of the skin of small children, the Commission is not aware of any scientific evidence that baby skin is more sensitive or that it allows more chemicals to pass through than the skin of adults. In fact, there is ample published scientific evidence showing that new-born skin rapidly matures in the first days to weeks after birth to become as

impermeable to chemicals as adult skin. The difference between infants and adults is that the infant skin surface area relative to the infant body weight is higher than that of adults. This results in a theoretical potential for increased exposure of infants to chemicals being applied to their skin by a factor of 2-3 versus the exposure of adults. This difference however, is taken into account in the risk assessment process.

The Commission wishes to reassure the Honourable Member of its commitment to ensure a high level of health and safety. In doing so the Commission intends to continue monitoring and incorporating new evidence in the risk assessment process, making use of independent scientific advice, and using the appropriate instruments including the precautionary principle to manage the risk of chemicals.

(1) OJ L 262, 27.9.1976.