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"Mr President, ladies and gentlemen, the debate in plenary on the safety of toys in the European Union could not have come at a better time than this year, especially in the light of the recent events that have seen countries such as Belgium withdraw various types of puzzle mat from the market because the concentration of formamide, a chemical substance classified as carcinogenic, mutagenic and toxic for reproduction, was high enough to be deemed a risk to children’s health, and other countries, such as France, accordingly step up their market surveillance of these same products. That being said, the directive already lays down migration limits for some chemical substances for which scientific information is available and permits, again via the committee procedure, the future introduction of migration limits should further scientific data be made available for other new substances. Mrs Rühle, as regards compounds and polycyclic aromatic hydrocarbons, these substances can be found in various consumer goods and not just in toys. Hence, the possibility of adopting specific measures has now been tested within the framework of the REACH Regulation, which has a broader scope, and this appears to be the most consistent and effective method. Toys intended for use by children under three years of age are subject to stricter rules. Children below that age are more vulnerable and require greater protection. Should there be any doubt about the age group for which a toy is intended, the manufacturer must apply the most rigorous standards. However, there does not appear to be any justification for making all toys subject to the same restrictions as toys intended for babies. The exposure to risk and the way in which those toys are used are not, in fact, the same. Furthermore, certain categories of toys that are intended for older children and for which no risks or accidents have been recorded would end up simply being banned. This method would be disproportionate and would contradict the objective of better regulation. The new directive also prohibits the use of chemicals classified as carcinogenic, mutagenic or toxic for reproduction, but this Parliament itself decided that an outright ban without any possibility of derogation would have been neither justifiable nor realistic. However, if a substance presents no health risks, because it is inaccessible, say, then it may not be prohibited. Assessments must be carried out on a case by case basis using the scientific information available for each substance. Stricter limits may be adopted under the committee procedure to ensure an adequate level of safety. The Commission will propose this whenever a genuine risk and specific data deem it necessary. As you know, the new directive will apply to economic operators from July 2011. The obligations relating to chemical substances will apply from July 2013. Ensuring that all those concerned – Member States and economic operators – apply the new rules and integrating the necessary adaptations to scientific progress is a priority for the Commission. In particular, the Member States have already met twice to discuss the changes in certain chemical substance-related obligations, in October 2009 and in September of this year. A further meeting is planned in April 2011 to conclude the work. An expert group on chemicals has also been set up to give the Commission guidance. The group already held a meeting in November, which produced good results with regard to defining the issues to be addressed and the options to be suggested. A further meeting is scheduled for January 2011. Mr Harbour, with regard to market surveillance, I shall have an opportunity to answer your questions at a later date. At the moment, we are awaiting notification of the measures taken by the national authorities, and then we will see to it that the data provided are analysed immediately by our scientific committees. If it is confirmed as a result of these tests, as a result of scientific data, that such concentrations of formamide do indeed present a risk to children’s health, then acting under the committee procedure, we will take all the measures necessary to amend the provisions of the directive accordingly. The directive – and here I wish to reassure Mr Harbour – does indeed provide for this mechanism, which means that it can be constantly updated to reflect the latest available scientific data. As Mrs Weisgerber mentioned, the Commission, for example, has already made these amendments for certain chemical substances, such as lead and cadmium, so that their values are in line with the latest scientific data. These amendments will be scrutinised in accordance with the regulatory procedure; hence, Parliament will be fully involved in this work. However, over and above the mechanisms provided for by the committee procedure – and I am addressing Mrs Rühle here – I personally undertake to keep you constantly informed of the progress of the work on these two substances. With regard to the other specific issues raised in the question tabled, I would like to start with the Scientific Committee on Health and Environmental Risks, which refers to a study conducted by the Joint Research Centre to analyse the methodology used in laboratories to identify traces of heavy metals such as lead in toys. These analyses were carried out in accordance with the EN 71-3 standard. According to the study, 40 laboratories took part in the analysis, 15 of which are bodies notified by the Member States as being qualified to assess the conformity of toys within the meaning of the directive. Only three out of 40 laboratories misinterpreted the results of the analyses. The Commission has sent the results of these studies to the Member States that notified the names of the laboratories and to the laboratories themselves, inviting them to take the appropriate measures. The study in question has also been sent to the European Committee for Standardisation so that it can be incorporated in the review of the EN 71-3 standard, which is currently under way. The aim of the review is to establish a new standard by the deadline set, namely 2013, for applying the new provisions on chemical substances. As regards the new directive on toys, adopted in May 2009, it is based on a new legislative framework for the marketing of products and it provides for greater market surveillance. The Member States are bound to provide the instruments necessary to ensure that only safe products are accessible to European consumers. They have an obligation both to strengthen border controls and to ensure that their inspectorates monitor effectively products that have already been placed on the European market. Lastly, should the Member States discover any irregularities in toys, they must immediately notify the other countries of this information via RAPEX, the EU rapid alert system for dangerous consumer products. Mr Harbour, the Commission is cooperating very closely with the Chinese authorities, in particular, with regard to the safety of toys. European and Chinese experts on the subject meet regularly to exchange information on applicable legislation and standards, and on administrative practices, too. The Chinese authorities’ inspectors are receiving training with a view to improving the quality control of products. As regards chemical substance limits, Mr Buşoi, it is true that a migration-based method is preferable from a scientific point of view, because it is based on the real risk to which children are exposed. However, setting migration limits means assessing the risk and the exposure to risk, as well as permitting acceptable daily intakes in order to calculate those limits. Given the large number of chemical substances – more than 1 000 – and the lack of sufficient information on all of them, we cannot implement this method with the scientific knowledge we currently possess."@en1
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