Labelling

The label must correspond with the labelling and the indications on the authorisation certificate.

Classification and labelling in accordance with Regulation (EC) No. 1272/2008 (CLP)

Download a document with an overview of the above-mentioned details.

Other indications

  • Standard phrases for special risks (RSh phrases) and Standard phrases for safety precautions (SP phrases) in accordance with Regulation (EC) No. 547/2011
  • National indications

The proposal for the label in the application dossier for a new authorisation must already contain a proposal for labelling, in accordance with the results of the studies provided. It should be noted that Belgium does not accept in-vivo animal studies that are conducted later than June 2011, except if the outcome would provide a labelling that would trigger a more severe classification when compared to the CLP calculation rules. Any projected in-vivo assay should be replaced by validated in-vitro alternatives according to the current data requirements.

You can find several documents and guides below which can help in the drafting of CLP labelling:

Period for adapting the label following modification of the labelling on the authorisation certificate

Unless otherwise indicated on the accompanying letter with the modified authorisation certificate, the following periods apply for the modification of the label:

  • Plant protection products for professional use:
    The labels of the products on the market must correspond with the authorisation certificate no later than 18 months after 31 December of the calendar year in which the modification of the certificate was made. For example, a modification made to the certificate in July 2015 must be applied to the label by 1/07/2017.
  • Plant protection products for non-professional use:
    The labels of the products on the market must correspond with the authorisation certificate no later than 3 years after 31 December of the calendar year in which the modification of the certificate was made. For example, a modification made to the certificate in July 2015 must be applied to the label by 1/01/2019.

If the labels must be modified more quickly, e.g., due to deadlines imposed by the EU, or urgent reasons, the periods will be communicated in the accompanying letter.

List of reference data

Download here a list of reference data for labelling.