Brussels, 10 May 2012
Cefic comments on document CA-March12-Doc.6.2a
Draft guidance on active substances generated in situ
Cefic thanks the Commission for its appreciation expressed during the 45thCA meeting on the work performed by Cefic on the “Note for guidance on in-situ generated active substances”.
During this CA meeting, the Commission proposed a new version of the guidance document on in-situ generated active substances (CA-March12-Doc.6.2.a), including additional changes in order to facilitate the transition to the new BPR on the “in-situ” subject.After the evaluation of this version, Cefic agrees with most of the proposed changes, but wants to oppose strongly to the newly introduced concepts on Annex I entry. Due to the complexity of available in-situ generation applications and their chemistry, Cefic proposes to consider the wording of the Annex I entry of in-situ dossiers on a case-by-case basis, of course looking out forconsistency between comparable dossiers.
Section 5. Annex I entry, last paragraph-first part states the following:
“Additional cases may occur as the review of submitted dossiers progresses. As a general rule, the Annex I or IA entry should indicate the in-situ generated active substance and, as the case may be, list the different precursors supplied with a biocidal claim which have been assessed and found acceptable.”(emphasis added)
Cefic maintainsits view that the appropriateness of mentioning boththe ‘in-situ generated active substance’ and ‘precursor substance’/‘precursor substances’in the Annex I inclusion needs to be considered on a case-by-case basis - the phrase “as the case may be” should not only apply to the precursors.
The suggestionof linking in all casesthe different possible precursor substances to the in-situ generated active substance in the same and thus one single Annex I entry is not defensible.The appropriateness of combining different precursors and the in-situ generated active substance in a single Annex I inclusion can of course be considered, but this should not be the default approach.
For example, in the case of the formaldehyde releasers, this would mean that there would be one single Annex I inclusion for “formaldehyde” linked to an extensive list of “releasers”, being the precursors.Industry has originally proposed that different formaldehyde releasers should have separate Annex I inclusions and sees no justification for this change.
Also, aluminium phosphide and magnesium phosphide, both releasing phosphine, have already obtained separate Annex I inclusions. This was the correct approach in our view.
Section 5. Annex I entry, last paragraph-second partstates the following:
“Active substances that can be placed on the market either directly as biocidal product or indirectly via in-situ generation should have one single Annex I-entry, which should also list the different precursors supplied with a biocidal claim which have been assessed and found acceptable.”
Cefic opposes the idea for one single Annex I entry for the same active substance that a) can be placed on the market as such and can be applied directly, and b) can be used ‘indirectly’ through in-situ generation.
For example, this would mean that for peracetic acid (PAA), one single Annex I entry would exist for “equilibrium PAA” and “in-situ generated PAA”;or that the substances chlorine, sodium hypochlorite, calcium hypochlorite and active chlorine are combined in one single Annex I entry, since they all transform to hypochlorous acid in water.
Industry has originally proposed that separate Annex I inclusions are necessary and sees no justification for this change.
Section 2. Definitions, last paragraph states the following:
“On the other hand, the mere biocidal intention of a user of one or more substances does not bring a product containing those substances within the scope of the BPD.”
On further reflection about practical issues having seen the introduction of in-situ biocides within the BPR we recommend including one additional sentence directly after the sentence above.
"Similarly, if a substance (such as a stabiliser) is supplied to the user to modify the activity of an active substance already supplied to the user , then such substance should not be considered a precursor either."
Industry considers this additional sentence necessary in order to indicate to all applicants the direction of the regulatory decision-making process regarding in-situ substances.
Finally Cefic wants to re-emphasize to the Commission and all Member States that applicants who submitted an ‘in-situ’ dossier under the Biocidal Products Directive have already been discussing with their RMS the way how such dossier needed to be structured and agreed on the way forward, e.g. decisions on the data requirements for the in-situ active substance & precursor(s), which also led to commercial agreements on data sharing/data access with interested third parties. Last minute principal changes after almost 6 years discussion are inappropriate.
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For further information, please contact:
Raf Bruyndonckx – Phone: +32 2 676 7366 – Email:
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