Επιστροφή στη διαδικτυακή πύλη Europarl

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Parliamentary questions
25 May 2009
E-0674/2009
Answer given by Mr Dimas on behalf of the Commission

Within the framework of Council Regulation (EEC) No 793/93(1), a voluntary risk assessment has been performed by industry on lead and lead compounds. The risk assessment concludes that there is a need for limiting the risk for specific situations concerning consumers, workers and the environment.

The Scientific Committee on Health and Environmental Risks (SCHER) adopted an opinion on the risk assessment on 13 January 2009. The SCHER supports the conclusions in as far as human health is concerned, but is of the opinion that uncertainties remain for the environmental part of the risk assessment and that the voluntary risk assessment for the environmental compartment should be considered as a work in progress.

However, it should be noted that in the meantime Council Regulation (EEC) No 793/93 was repealed and replaced by the REACH Regulation(2).

As lead and lead compounds have not been identified as priority substances under Council Regulation (EEC) No 793/93, the transitional measures applying to such ‘priority substances’ , based on Article 136 of REACH, do not apply. This means notably that the Member State who was in charge of reviewing the voluntary risk assessment conducted under the previous regulation is not obliged to submit a transitional dossier to finalise the risk assessment and in this particular case, the strategy for limiting the risk.

REACH is based on the principle that manufacturers, importers and downstream users shall ensure that the manufacture, placing on the market and use of substances shall not adversely affect human health or the environment. As part of the registration procedure, the registrant is required to document that substances can be used in a safe manner, with regard to human health and the environment. The deadline for the registration of substances like lead and lead compounds, which are manufactured in or imported into the EU in quantities above 1 000 tonnes per year and per manufacturer or importer, or which are carcinogen, mutagen or toxic to reproduction (CMRs) manufactured in or imported into the EU in quantities above 1 tonne, is 30 November 2010. Thus, industry will need to document by this date that the production, placing on the market and use of lead is adequately controlled as part of their registration dossiers, implementing measures to address the risks identified in the voluntary risk assessment and considering taking measures to account for the risks for the environmental compartment not yet fully identified.

If a Member State or the Commission considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled, a restrictions dossier in accordance with Annex XV of REACH can be prepared.

Currently lead and lead compounds, as assessed in the voluntary risk assessment, are not listed in the registry of intentions, which is published on the website of the European Chemicals Agency (ECHA) and which allows interested parties to be informed of the substances for which the authorities intend to submit restrictions dossiers.

Under REACH also the Commission can ask the ECHA to develop a restrictions dossier with the aim to introduce further restrictions on the manufacturing, importing or placing on the market of lead. It is also possible for the Commission to nominate lead as a substance of very high concern and hence as a candidate for authorisation. Which of the two routes, if any of them is needed, is the most appropriate for this particular substance at stake will be assessed by the Commission in 2011 on the basis of the registration dossiers.

(1)Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances, OJ L 84, 5.4.1993.
(2)Regulation (EC) No 1907/2006 of the Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 396, 30.12.2006.

OJ C 189, 13/07/2010
Τελευταία ενημέρωση: 12 Ιουνίου 2009Ανακοίνωση νομικού περιεχομένου