A directive in need of a makeover

Two MEPs discuss cosmetics.

Dagmar Roth-Behrendt

As the European Parliament’s rapporteur, I negotiated the last two of seven revisions of the European cosmetics directive.

The Parliament took a strong stance on public health, the phasing-out of animal testing and improving consumer information. But the scope for influence was rather limited until the last revision in 2000-03, known as the 7th amendment, when the co-decision procedure was introduced by the Treaties of Maastricht and Amsterdam.

After three legislative readings, the outcome of the 7th amendment was a great success for Parliament as an institution and for the citizens we are representing. I have a lively memory of the final conciliation meeting in November 2002 when, at four o’clock in the morning and after more than twelve hours of negotiation, a compromise with the Council of Ministers was reached. Among the most controversial elements were the phasing-out of animal testing, the ban on substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) and improved labelling information for consumers.

The implementation of these achievements is taking place in a step-wise fashion. Since September 2004, the labels of cosmetic products indicate allergenic ingredients. The labelling of the storage life, symbolised by an open cream jar, has been compulsory since March 2005.

The ban on substances which are identified as CMR has applied since September 2004. But the procedures for the classification of substances as CMR lack transparency. I am convinced that it would be highly irresponsible, and clearly against the interest of consumers and industry, if regulators failed to act or delayed decisions on individual substances without providing watertight evidence that there was no risk for public health. Surely the enforcement of the CMR ban needs thorough scrutiny.

With regard to the phasing-out of animal testing, important challenges are still ahead of us. The testing of finished cosmetic products became illegal in EU member states in September 2004. Additionally, a testing ban on ingredients will apply as soon as alternative methods are validated and adopted, but with the definite cut-off date of 11 March 2009. In 2006, the Commission adopted guidelines for manufacturers to declare products free of animal testing in order to allow consumers an informed choice.

From 11 March 2009, a general ban on marketing cosmetic products and ingredients that have been tested on animals will enter into force for imported and EU-made products. For three specific human health effects, ie, repeated-dose toxicity, reproductive toxicity, and toxico-kinetics, the deadline is 11 March 2013 as it was anticipated that the work on alternatives for these tests will extend beyond 2009.

These deadlines for phasing out animal tests are not disposable. Attempts to annul the provision have been declared inadmissible by the European Court of Justice. Only jointly could Parliament and Council change the law. I doubt that anybody would dare to make such an attempt, as Parliament would furiously oppose it.

I appreciate the Commission‘s commitment to meet the targets which is visible through an number of initiatives such as the foundation of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the conference ‘Europe Goes Alternative’, which will take place in Brussels for a third time on 5 November 2007.

Nevertheless, efforts have to be made in order to safeguard public health without animal testing. To that end the European Centre for the Validation of Alternative Methods needs proper financial backing and credit for its valuable work. In addition, I can also only call on the cosmetics industry to continue to join forces for the development of alternative approaches - as it has done under the roof of the EPAA.

The upcoming 8th revision of the cosmetics legislation should focus on introducing a robust safety assessment and a surveillance and communication system for undesired effects of cosmetic products. It also makes sense to merge the seven revisions and more than 50 technical adaptations into the legal form of a regulation. But, under no circumstances should the achievements of the last revision be weakened.

• German centre-left MEP Dagmar Roth-Behrendt is a member of the Parliament’s committee on environment, public health and food safety and rapporteur on revisions to the EU’s cosmetics directive.

Françoise Grossetête

The European Parliament has been working on the successive revisions to the cosmetics directive, mainly linked to health and safety, for some time.

The cosmetics directive is a messy patchwork of more than 50 amendments. The law, made up of amendments introduced over the course of the past thirty years, lacks a clear set of consistent terminology and overarching definitions.

The directive is in need of a makeover. The bulk of its provisions are unclear or, because of changes introduced over the years, simply out of context. The resulting legal uncertainty places unnecessary burdens, financial and otherwise, on businesses struggling with its application.

Context and clarity are needed. The market is enjoying a period of global growth. European companies, especially those from France, are leading the field. The European market for cosmetics is worth around €65 billion. Europe boasts more than 3,000 cosmetics manufacturers, many of which are small- and medium-sized enterprises employing directly and indirectly more than 350,000 Europeans.

This is no time, however, for the industry to be resting on its laurels. While the EU’s rate of economic growth has remained relatively modest, emerging markets are growing at a rapid pace. More modern and effective regulation would allow European companies to maintain their leading position on the world market.

The regulatory frameworks governing the sector in different parts of the world vary significantly. European companies have to absorb rising costs with no guarantees that the safety of products will necessarily be improved. Moreover, the transposition of extremely detailed legal provisions in the EU’s 27 member states, not to mention the European Commission’s follow-up procedures, places heavy and costly burdens on business without bringing any added value. A regulation would be preferable to a directive.

This simplification would not be aimed at changing rules relating to animal testing, which were added to the cosmetics directive in 2003. The ban on animal testing for finished cosmetics products has been in place since 11 September 2004. The ban on animal testing for single ingredients or for combinations of ingredients will be applied gradually as and when alternative methods are validated in the run-up to a final ban in 2009.

If we want our industry to become more responsible we should be careful not to discourage research and development. Ways of guaranteeing optimum safety of products for the consumer need to be found. Safety remains a prime concern.

Survival of the cosmetics industry relies on trust. We need systematically to research ways of eliminating and replacing chemical products. Currently, we do not have a complete set of replacement methods.

Finally, and this point is of great importance, information exchange between dermatologists, industry and regulators on reactions to defective products need to be strengthened. We call this ‘cosmétovigilance’.

This is especially important with allergic reactions to ingredients, as any increases in vulnerability are only likely to be detected after lengthy observation of the general population.

The idea of creating a network of watchdogs for the cosmetics industry at EU rather than national level seems to be an interesting idea. It would be more effective to establish a single notification structure for defective products at EU level.

The EU’s product safety network, Rapex, could be used as a model for the cosmetics sector. Rapex sends out rapid alerts on all dangerous consumer products, with the exception of foodstuffs, pharmaceutical products and medical devices. It allows member states and the Commission rapidly to exchange information on measures taken to restrict or ban the sale or use of products which endanger public health and safety.

• French centre-right (EPP-ED) MEP Françoise Grossetête is shadow rapporteur on revisions to the EU’s cosmetics directive.

Two MEPs discuss cosmetics.