/ EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Safety of the food chain
E.3 - Pesticides and Biocides

62ndmeeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products

Subject:Harmonised classification of in situ generated active substances

  1. Purpose of the note

On the occasion of the review of an in situ generated active substance, a question has been raised on (a) the consideration of the exclusion and substitution criteria for insitu generated active substancesand (b) the requirement for a harmonised classification and labelling.

The objective of this note is to clarify the matter.

  1. Background and issues for discussion

Over the past months, progress has been made on the management of in situ generated active substances. It has been agreed that the decision on the approval would refer to the in situ generated active substance together with the supported precursor(s) from which the active substance is generated, including when relevant the generation method[1].

A redefinition of in situ generated active substances currently supported in the review programme has been madeaccordingly[2].

The harmonised classification and labelling of active substancesis of major importance in the approval process, as the classification isa criterion for concluding whether or not an active substance meets the exclusion or substitution criteria, or whether it is eligible to be listed into Annex I to the BPR. In addition, the classification of biocidal products is important to define whether it can be made available on the market for use by the general public in accordance with Article 19(4) of the BPR.

In the context of in situ generation, several substances are in play: the in situ generated active substance and the precursor(s). In addition, while many in situ generated active substances are reactive and unstable, some of themcan be more stable and therefore placed on the market ina stable form.

It is therefore necessary to clarify:

  1. Which substances are taken into account to conclude whether the exclusion criteria, the substitution criteria and the criteria for listing into Annex I to the BPR are met.
  2. If and when a harmonised classification is needed on the insitu generated active substance and its precursor(s).
  1. Way forward
  2. Consideration of the exclusion, substitution and Annex I listing criteria

The approval conditions set out under the BPR relates to the active substance. In the context of insitu generation, precursors generating the active substance are considered as the biocidal product.

Considering the above, only the properties of the in situ generated active substance areconsidered to define whetherthe exclusion, substitution and Annex I listing criteria are met.

The precursors are managed through the BPR and where relevant, through other chemical legislation for other uses. In particular, most of the substances made available on the market without any indication that they can be used as precursors for the in situ generation of an active substance are covered by REACH Regulation (EU) No 1907/2006. Precursors supported under the BPR, by (1) being named, for example, in the active substance description in the Review Programme, the published Article 95 list and / or an Active Substance Approval Decision and (2) by being supplied in compliance with the requirements of Article 95 of the BPR, benefit from the same exemptions under REACH, in particular Articles 15(2), 16 and 56(4)(b), as biocidal active substances.

3.2.Harmonised classification

The harmonised classification plays a key role in the approval process, in particular in relation with the exclusion or substitution criteria. In that respect, it is proposed that:

(1)For the active substance:

  1. A harmonised classification is proposed by the eCA on the in situ generated active substancefor all the endpoints for which it is possible to perform the related phys/chem, tox and ecotox tests. For instance, a harmonised classification has been proposed for peracetic acid[3]which can be generated in situ.
  2. The related CLH dossier to establish or amend the harmonised classification must be submitted in due time as for any other active substance. The same principles as for any other active substance apply regarding the management of the dossier (i.e. the RAC opinion must be delivered before the submission of the draft CAR if the harmonised classification concerns exclusion criteria,etc.).

(2)For the precursor(s):

  1. The submission of a CLH dossier for the precursor(s) is not an element taken into account for the acceptability of the submission of the draft CAR to ECHA.
  2. When the eCA considers having appropriate information onthe precursor(s), the eCA may also submit a CLH dossier for the precursor(s) to ECHA to establish or amend the harmonised C&L. This canlater facilitate the product authorisation stage, andcould be important for product authorisation: for instance, where the related classification would prevent the making available on the market of these precursors for use by the general public. As well, the harmonised C&L can help to manage the concerned substance(s) in an appropriate manner under REACH and other chemical legislations (e.g. if aprecursor is a CMR, it might afterwards be proposed to be listed in the candidate list for inclusion in Annex XIV of REACH via the related procedures).

1

[1]The definitions and concepts related to in situ generation as defined indocument "CA-March15-Doc.5.1 - Final - Substances generated in situ.doc" are applicable to this note.

[2]

[3]