Since 1st of May 2015, there is an obligation for mixtures’ suppliers (incl. plant protection products authorisation holders) to classify and label all plant protection and additives entering the Czech market according to the Regulation (ES) 1272/2008 in its most updated version. Temporary transition period (for mixtures produced before this date) has ended. Often, updated classification of an active substance or a coformulant results from the amendment of Annex IV of the CLP. These amendments stem out of a newly formed RAC opinion or new scientific/technical findings (see CLP, Article 15).  

New/updated classification of a substance may lead to the change in classification of the plant protection product (PPP) and consequently, to the change in the risk mitigation measures on the label of the product. Next, it is necessary to amend/change a safety sheet according to Annex II of REACH Regulation ((EU) 2015/830) in all respective parts of the safety sheet.

Following documents/information (in an electronic form) are required by NIPH in order to assess eventual changes in classification and/or labelling:

a) classification summary (i.e. classification of individual components of a product including the percentage ratio within the product) together with a proposition of a new/updated classification for individual hazard-classes,

b) proposition of a new classification and labelling of the mixture (e.i. plant protection product), including the reasoning behind this classification and relevant resource of information which lead to the classification,

c) proposition of a label of the PPP with an updated labelling according to CLP Regulation (EU) 547/2011) and consequently, Decree No 132/2018 Coll., together with an updated risk mitigation measures (to protect operators, workers, bystanders and general public),

d) safety sheet of PPP according to Regulation (EU) 2015/830,

e) eventually, safety sheets of individual components of the PPP according to Regulation (EU) 2015/830 with an updated classification,

f) proposed changes within the registration report (usually part A, part B3/B6 (toxicology) and part C including detailed PPP’s composition),

g) eventual summaries of scientific studies in case the applicant refers to them.

In order to assess the (eventual) change in classification and labelling of additives within PPPs, NIPH requires documentation in an e-form (see above-listed points) except for the registration report. However, it is obliged to support the documentation with a complete composition of the additive.

NIPH’s workflow after receiving an application

Substance/component of a PPP which is the reason for the change in classification bears a harmonised classification (i.e. it is listed within Annex IV of CLP)

• The applicant proposes an update of the hazard class according to the updated Annex IV; in this case, NIPH will carry out the change after the change enters in force.
• The applicant proposes an update of the hazard class not listed within the update of Annex IV of CLP but was proposed by the applicant in the past or is newly proposed; in this case, NIPH will consider how to proceed further reflecting upon eventual ECHA RAC opinions and new findings regarding said substances/components. The applicant is free to carry out this step themselves, alternatively.

CAUTION: In case the substance/component bears a harmonised classification, it is not possible to change a hazard class (or omit a hazard class) listed within Annex IV of CLP based on RAC opinion solely.

Substance/component of a PPP which is the reason for the change in classification does not bear a harmonised classification (i.e. it is NOT listed within Annex IV of CLP)

• There is an officially formed RAC Opinion - NIPH will consider all the (new) information including RAC Opinion(s).
• There is no RAC Opinion regarding the substance/component – NIPH will consider all the new information and proceed according to CLP criteria.

NIPH accepts RAC ECHA Opinion(s).

Posted by: M. Hornychová, Z. Trávníčková (version - October 2019)