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||Review of authorisations
1. Authorisations granted in accordance with Article 60
shall be regarded as valid until the Commission decides to amend or withdraw the authorisation
in the context of a review, provided that the holder of the authorisation
submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting
all elements of the original application for the current authorisation
, the holder of an authorisation
may submit only the number of the current authorisation
, subject to the second, third and fourth subparagraphs.
A holder of an authorisation
granted in accordance with Article 60
shall submit an update of the analysis of alternatives referred to in Article 62
(4)(e), including information about any relevant research and development
activities by the applicant, if appropriate, and any substitution plan submitted under Article 62
(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account
the elements in Article 60
(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot
demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic
analysis contained in the original application.
If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.
If any other elements of the original application have changed, he shall also submit updates of these element(s).
When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation
in the context of the review shall be taken in accordance with the procedure referred to in Article 64
applied mutatis mutandis.
2. Authorisations may be reviewed at any time if:
(a) the circumstances of the original authorisation
have changed so as to affect the risk to human health or the environment, or the socio-economic
(b) new information on possible substitutes becomes available.
The Commission shall set a reasonable deadline by which the holder(s) of the authorisation
may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article
3. In its review decision the Commission may, if circumstances have changed and taking into account the principle of proportionality,
amend or withdraw the authorisation
, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article
(5) become available. In the latter case the Commission shall require the holder of the authorisation
to present a substitution plan if he has not already done so as part of his application or update.
In cases where there is a serious and immediate risk for human health or the environment, the Commission may suspend the authorisation
pending the review, taking into account the principle of proportionality.
4. If an environmental quality standard referred to in Directive 96/61/EC is not met, the authorisations granted for the use
of the substance concerned may be reviewed.
5. If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations
granted for the use of the substance concerned in the relevant river basin may be reviewed.
6. If a use of a substance is subsequently prohibited or otherwise restricted in Regulation (EC) No 850/2004 of the European
Parliament and of the Council of 29 April 2004 on persistent
organic pollutants (51)
, the Commission shall withdraw the authorisation
for that use.