Rapex

RAPEX is the acronym for "Rapid Alert System for Dangerous Non-food Products", a database maintained and published weekly by the European Commission as a rapid alert system for consumers on dangerous consumer products (including cosmetics causing undesirable side effects).

RAPEX is used to exchange information from Member States on dangerous or potentially dangerous consumer products (excluding food and pharmaceutical products and medicines). These include products such as clothing, shoes, cosmetics, jewellery or children's toys with components or properties that are harmful to health, or products with technical defects.

RAPEX enables rapid EU-wide exchange of information on measures such as recall or withdrawal operations, whether they are measures taken by national authorities or voluntary measures by producers and distributors. To monitor the measures, appropriate delivery lists are sent throughout Europe to the locally and factually responsible authorities, such as the food control authorities.

The basis for the establishment of RAPEX is the Product Safety Directive 2001/95/EC (GPSD), an EC Directive on general product safety, which came into force on 15 January 2004.

The European Commission's Directorate-General for Health and Consumers publishes a weekly report on current RAPEX alerts.

The RAPEX database is thus an important source of information on cosmetics that pose a risk to health in the EU member states. Knowledge of this data is of great importance for dermatological advice to patients regarding the use of cosmetics.

In the period 2005-2017, 157 dangerous cosmetic products were reported to the RAPEX database (P. Elser et al 2017). The most frequently reported products were:

• Bleaching and whitening products (24.2%): Hazardous ingredients were: hydroquinone, kojic acid, mercury, clobetasol, betamethasone
• Creams/lotions/gels (10.8%) Sources of danger were the ingredients with excessive concentrations of formaldehyde, 5-chloro-2-methyl-isothiazol-3(2H9-one and 2-methyl-isothiazol-3(2H)-one.
• Nail adhesives (8.9%): Sources of danger were the ingredients methyl methacrylate
• Henna dyes (11.7%): Sources of danger were the ingredients p-phenyldiamine (up to 10.9%); phenol, N-nitrosodiethanolamine. The latter is classified as human carcinoma.
• Shower Bath Gel
• Hair conditioning agents
• Hair dyes
• Makeups
• Shampoos
• Some products contained unauthorised dyes.
• One eyelash mascara (eye-lash-extensions) contained the synthetic prostamide F2alpha analogue Bimatoprost (pharmaceutical approved for the treatment of open angle glaucoma).
• Powder preparations with very small particle size can cause health problems when inhaled, especially by children.

1. Elsner P et al (2017) Dangerous cosmetic product in Germany. Dermatologist 68: 885-889
2. Rapid Alert System Weekly Nortification Rports: https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.listNotifications
3. eur-lex.europa: http://eur-lex.europa.eu/legal content/DE/TXT/?uri=celex%3A32010D0015