03/06/08 | Better regulation

Cosmetics safety rules to be rejuvenated

Cosmetics products, alongside food and drink, come into closer contact with our bodies than any others. We trust that using shampoo will not cause our hair to fall out, that toothpaste will not damage our teeth, that perfume will make us smell more attractive not turn our skin bright red. And whilst we may wish to believe that a miracle cream will make us look younger, we certainly do not expect it to harm our skin. Giving priority to safety means the number of incidents in Europe in which consumers suffer serious adverse reactions to cosmetic products is tiny.

For more than three decades, EU regulation in the sector has been directly responsible for high uniform safety requirements across all Member States. Thanks to this harmonisation, cosmetics manufacturers have been able to offer their products throughout the internal market without the need to clear regulatory hurdles in each country. "The system has worked well, contributing to a strong cosmetics industry in Europe and giving consumers high levels of protection," says Barbara Mentré, policy officer in the Cosmetics and Medical Devices Unit in the Enterprise and Industry DG. "Indeed the EU's model has been adapted for regulation in other parts of the world, facilitating global trade in cosmetics products."

Getting up to date

However, the common rules date from the 1976 Cosmetics Directive, when there were just nine Member States in the then European Economic Community, a third the size of today's EU. Moreover, the rules have been amended over 50 times since 1976 in order to follow technical developments. Keeping up with the resulting tangle of legislation, with as many as three or four amendments in some years, represents a major cost for business in the sector. EU firms are reckoned to spend as much as 1% of their turnover on ensuring they are on top of the rules. Moreover, because the original rules were enacted as a Directive - which has to be transposed into national law, as does each amendment to it - there may be slight differences in their application between Member States.

In February 2008, the Commission launched a proposal which essentially pursues two aims: ensuring a high level of safety of cosmetic products by strengthening manufacturer responsibility and in-market control aspects, while cutting unnecessary administrative burdens. "We are not proposing to change the approach to cosmetic products safety, but to make the rules easier to understand and comply with," emphasises Mentré. The Commission proposes to replace the existing set of Directives with a single Regulation, which will apply directly throughout the Union. To make it easier for stakeholders to understand, a set of definitions - missing from the Directive - will be added. Another improvement will simplify the process of updating the list of 'ingredient names'. This consists of around 15,000 substances used in cosmetics products, and needs to be updated frequently as firms try out new product 'recipes'.

More effective market surveillance

One key feature of the revised rules will be simpler notification procedures. Under the existing rules, companies placing a new cosmetic product on the market in the EU have to provide information on their product to national authorities and to a group of anti-poison centres throughout Europe. Often there are slight variations in the procedure and in the format of information to be supplied. The new Regulation will create a single central notification procedure, so that enterprises need only follow one process covering the whole Union.

National authorities will be able to redeploy their resources to spend more time checking that products on the market are safe, rather than processing information. The Commission will facilitate co-operation and sharing of information between national authorities. This means that when problems with a given product are identified, national authorities will be able to react more quickly to protect consumers. Moreover, manufacturers will now be obliged to notify the authorities should they become aware of any serious undesirable effects related to any of their products.

Another key feature of the proposed Regulation is the setting up of minimum requirements for the safety assessment of cosmetic products carried out by the manufacturer. The introduction of more precise rules on product safety assessment will clarify the obligations of manufacturers and provide Member States with suitable tools to verify that an appropriate safety assessment has been carried out before the cosmetic product was placed on the market.

The text only of the articles can be republished as long as the source of the article is quoted: Enterprise & Industry magazine (http://ec.europa.eu/enterprise/magazine/index_en.htm), © European Union, 2008 - 2012