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Brussels, 10 July 2007
The European Commission today confirmed reception of a formal notification from the Spanish Authorities relating to a decision to withdraw from the Spanish market two brands of toothpaste of Chinese origin because of a risk to public health. The formal notification is part of the EU wide Rapid Alert System for non-food dangerous products (RAPEX), that alerts and co-ordinates an EU wide response to dangerous consumer goods found in the Single Market. The notification relates to two brands of toothpaste: Spearmint and Trileaf Spearmint. Spanish laboratory tests have detected the presence of DEG (diethylene glycol) a substance used in antifreeze and as a solvent. The measures adopted are compulsory – a withdrawal from the Spanish Market. The notification has been entered into the Commission's RAPEX system today, alerting other Member States to the hazard. Once a formal "notification" is made by a Member State, there is a legal obligation for other Member States to take follow up actions on their market and to inform the Commission about the measures taken.
Speaking today following the alert, EU Consumer Commissioner Meglena Kuneva, said, "It is important to underline that, according to available evidence, the products found pose only a moderate immediate risk for the health and safety of consumers. To date, there are no known reports of human poisonings or adverse clinical effects caused by this toothpaste. However, even this is an unacceptable risk. Also, in the light of the global scale of the issue, we are working closely with national authorities to address any potential risk seriously and in depth. The Commission urges consumers to not buy counterfeit products and to contact authorities in case of doubts. The EU RAPEX alert system has demonstrated its value in this case and has paved the way for a rapid EU-wide safety response prompted by the vigilance of the Spanish authorities".
On 29 May the European Commission had warned the authorities of the 30 European countries participating in the RAPEX rapid alert system on non-food dangerous products of the presence of diethylene glycol (DEG) – a substance used in antifreeze and as a solvent – replacing glycerine in toothpaste found in a number of Central American countries. The exchange of information worked well and the Spanish authorities immediately informed the Commission on 5 July of the presence of DEG in samples of toothpaste of Chinese origin found in Spain. These concerned samples of toothpaste included in toilet bags given to patients in hospitals, and possibly clients in hotels and passengers on airplanes.
The Commission immediately informed the authorities in the Member States of this, again asking them to report any developments on this issue in their territory.
The Spanish Agency for medicines and health products (AEMPS) has clarified that the health risk posed by the presence of DEG in the toothpaste found in Spain is minimal, since the product is toxic only if ingested - usually not the case with toothpaste. The most likely danger would be from children or individuals with kidney or liver disease ingesting significant amounts of toothpaste.
The Commission confirmed that the European alert and information exchange system has worked well, informing all Member States well ahead of the first finding of samples of toothpaste containing DEG in Europe and allowing for an immediate exchange of updated information on the development of the situation.
On 7 July, following the information issued by the Spanish authorities, the Italian Health Ministry ordered the seizure of 20,000 tubes of toothpaste in several Italian cities.
The Italian laboratory analyses which will allow establishing whether the seized samples are contaminated with bacteria or contain toxic substances such as DEG are ongoing and the results will be known in a few days. The Portuguese authorities have also made market checks.
The Spanish authorities have now completed the risk assessments of the products seized last week. This has resulted in formal restrictive measures and their notification through the RAPEX system today.
In the framework of the ongoing dialogue with the Chinese government, the European Commissioner for Consumer Protection, Meglena Kuneva, will travel to China on July 21-26 to discuss a range of issues with the Chinese authorities - in particular issues relating to product safety.
Chinese Toothpaste outside the EU market
The issue became prominent in late May, when Chinese toothpaste containing DEG was found in Panama, the Dominican Republic and subsequently in other American countries. It seems that a Chinese chemical maker had sold the industrial-grade chemical as glycerine, which is often used as a moistener/sweetener in products from toothpaste to soap and cosmetics. The alert has spread to the US, where the FDA found DEG-containing toothpaste. Other countries where toothpaste of Chinese origin was found include Japan and Canada. On 1 June the FDA " warned consumers to avoid using tubes of toothpaste labeled as made in China, and issued an import alert to prevent toothpaste containing the poisonous chemical diethylene glycol (DEG) from entering the United States". The Commission raised the issue with the Member States market surveillance on 29 May, asking them to report any developments. The Spanish case is the first occurrence of this in Europe.
What is RAPEX
RAPEX is an EU-wide rapid alert system for non-food dangerous products, coordinated by the Commission and linking market surveillance authorities in 30 European countries. When authorities take restrictive measures (ban on sale, withdrawal from the market, recall from consumers, ...) concerning a product posing a serious risk for the health and safety of consumers, they must notify the Commission which validates the notifications, translates it and distributes it to the authorities in all other MS – there is then a formal obligation on Member State Authorities to take follow up measures on their national markets and to inform the Commission.