Authorised plant protection products might be subject to changes in the classification of the hazardous substances they contain as active substances or as co-formulants. Therefore, producers and authorisation holders are under a duty to notify the BVL immediately of any changes in active substances or in co-formulants contained in their plant protection products. The BVL presents in the notification 11/02/09 of 26 May 2011 how changes in classification and labelling of authorised plant protection products can be approached. This notification appeared in the German Federal Gazette ("Bundesanzeiger") on 01 June 2011 (issue 84, page 2022). The text is reproduced below.

Notification concerning the procedure for the hazardous substance classification and labelling of plant protection products if the hazardous substance classification of active substances or co-formulants contained therein changes (BVL 11/02/09) of 26 May 2011

The manufacturer or the authorisation holder is principally responsible for the hazardous substance classification and labelling of a plant protection product. This is in accordance with the legal provisions concerning the classification and labelling of hazardous substances under Regulation (EC) No 1272/2008. The provisions of the second subparagraph of Article 31 (2) of Regulation (EC) No 1107/2009 are not in contradiction to this.

According to the second subparagraph of Article 31 (2) of Regulation (EC) No 1107/2009, the authorisation of a plant protection product also includes the classification of the plant protection product within the meaning of Directive 1999/45/EC. During the authorisation procedure, the Federal Office of Consumer Protection and Food Safety (BVL) reviews in cooperation with the assessment authorities the proposals of the applicant concerning the hazardous substance classification and labelling, adjusting it where necessary. After granting authorisation, new evidence can lead to reviewing the hazardous substance classification of a component contained in a plant protection product. The hazardous substance classification of the plant protection product must therefore be adapted where necessary, this might lead to changes in operator exposure and whether it is considered approvable e.g. for use in amateur gardening. In the event of a change in the hazardous substance classification of active substances or co-formulants of their plant protection product, authorisation holders can be informed relatively quickly and easily by their supplier chain. According to the second subparagraph of Article 31 (2) of Regulation (EC) No 1107/2009, the authorisation holder must immediately notify the BVL of this change. After notification by the authorisation holder, the BVL assesses in collaboration with the assessment authorities whether the protection of man and the environment remains guaranteed. The BVL uses indications of change in the hazardous substance classification and labelling of an active substance or co-formulant as a reason to re-examine other plant protection products containing the same active substance or co-formulant. If necessary, the concerned authorisations will be adapted accordingly.

The approach outlined here applies from 14 June 2011.

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