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Parliamentary questions
12 September 2008
E-4469/2008
Answer given by Mr Verheugen on behalf of the Commission

Thimerosal, also known as thiomersal, is a chemical substance which may be used either in the early stages of manufacturing or as preservative in some vaccines, as an antimicrobial and antifungal agent. Reference is made to the response to Written Question E‑1065/07 by Ms Sinnott(1), where the Commission provided information on the use of thimerosal in vaccines.

In addition, the following information is provided on the specific questions raised by the Honourable Member:

1. Vaccines used in the EU are authorised by the Commission following a Community wide procedure or by Member States following a national procedure.

The following vaccines containing thiomersal are authorised by the Commission:

VaccineThiomersal specification in finished product
Daronrix50mg/dose(0.5 ml)
Fendrix< 2mg/dose (0.5ml)
Focetria50mg/dose(0.5 ml)
Infanrix Hexa < 40ng/dose (0.5 ml)
Infanrix Penta < 40ng/dose (0.5 ml)
Pandemrix5mg/dose(0.5 ml)
Prepandrix5mg/dose(0.5 ml)
Quintanrix6mg/dose (0.5 ml)
Tritanrix HepB6mg/dose (0.5 ml)

Four of these vaccines (Daronrix, Focetria, Pandemrix and Prepandrix) are pre-pandemic or pandemic influenza vaccines and have not been used so far in the EU.

The Commission does not have a comprehensive test of nationally authorised medicinal products.

The Commission does not have an overview on sales and market share of Community and nationally-authorised vaccines containing thiomersal. The percentage is expected to vary across Member States due to differences in vaccine markets. According to the information available to the Commission, national immunisation programs in the Member States are now using in most cases thiomersal-free vaccines, at least in the case of paediatric vaccines.

2. The Commission is not aware of any decision from Member States to ban thiomersal in vaccines. As stated in the response to Written Question E‑1065/07, the European Medicines Agency (EMEA) concluded in 2004 that immunisation with vaccines containing thiomersal continues to offer benefits to the general population, including infants, which far outweigh the risks, if any, of exposure to thiomersal. The EMEA also acknowledged that, during some manufacturing processes, the use of organic mercury compounds is necessary and that in such cases, residual levels might be present in the final product.

3. Since 2004, various publications have appeared in the scientific literature, many of them being reviews of existing data, opinions or comments on previous articles. The conclusions by the EMEA were reiterated by its Safety Working Party in May 2005 and in a Position Paper published by the EMEA's Committee of Medicinal Products for Human Use in February 2006(2). The EMEA and the Commission have not received evidence on the risk of the development of autism in children linked to thiomersal.

4. In May 2005, the EMEA's Safety Working Party stated that, in general, vaccinations are not recommended during pregnancy but it may be unavoidable in certain cases.

5. The EU mercury strategy is driven by concerns about the toxicity of mercury and methylmercury. In line with this strategy, the development of vaccines without thiomersal and other mercury containing preservatives, or with the lowest possible levels, should continue to be promoted. Several vaccines authorised in the EU in recent years have had thiomersal removed or the levels thereof reduced.

However, there may be situations where thiomersal is needed during the manufacturing process of vaccines, or where it is needed as preservative in multi-dose products, such as pandemic vaccines. In these situations it is in the interest of public health to allow the use of thiomersal if the benefit-risk balance of the product concerned is considered positive, in particular in the absence of clear evidence regarding an association with autism and neurodevelopmental disorders. In such circumstances, a ban on the use in medicinal products could lead to the unavailability of certain vaccines.

6. The debate on thiomersal has promoted the search for alternative preservatives for vaccines and has led to the authorisation by Member States of new vaccines without thiomersal. The Commission does not currently fund research projects on this topic. It does not feature among the priorities derived from the Health research part of the Specific Programme ‘Cooperation’. At this stage, in the absence of clear evidence regarding an association with autism and neurodevelopmental disorders, no specific EU research action in this direction is intended.

(1)http://www.europarl.europa.eu/QP-WEB/home.jsp
(2)http://www.emea.europa.eu/pdfs/human/press/pp/261299en.pdf

OJ C 999, 01/01/2009
Ultimo aggiornamento: 19 settembre 2008Avviso legale