CA-Nov14-Doc.4.4 - Final
58th meeting 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
Further guidance on the application of the substitution criteria set out under Article 10(1) of the BPR
1. Purpose of the document
With the entry into application of the BPR, principles were defined on the way to assess active substances and the criteria to be taken into consideration for the decision-making. These principles are summarised in document CA-March14-Doc.4.1 - Final - Principles for substance approval.doc, as endorsed at the 55th CA meeting in March 2014.
With regard to the substitution criteria set out under Article 10(1) of the BPR, one of the principles is that only the criteria for which clear rules, methodology or guidance exists for their assessment should be considered, until further guidance has been developed. This is obviously the case for the following criteria:
– Article 10(1)(a): Substances which meets the exclusion criteria under Article 5(1) but are nevertheless approved
– Article 10(1)(b): Substances that meets the criteria to be classified, or that are classified, as respiratory sensitizers
– Article 10(1)(d): Substances that meet two of the criteria for being PBT
The purpose of this document is to provide further guidance on the application of the remaining substitution criteria.
2. Proposal for further guidance on the application of the remaining substitution criteria under the BPR
The aim is to achieve a good differentiation between active substances that qualify as CFS and the ones that are not qualifying as CFS. To limit borderline cases as much as possible, the application of the CFS criteria should be made as easy as possible, and complexity in the interpretation of the criteria should be avoided as far as possible.
For each criterion, the possibility to apply it already, as well as a proposed methodology is indicated.
2.1. Criterion (c) on the significantly lower ADI, ARfD or AOEL
Article 10(1)(c): Substances whose "acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario"
This criterion should be considered once all existing active substances are assessed for a specific product-type (i.e. reviewed under Article 89 of the BPR), before these active substances enter the renewal phase. It would also give a clear indication to companies, in order that they can decide if they want to apply for a renewal of the approval of these active substances.
For instance, this means that once all existing active substances have been approved for PT8, an analysis could be performed to identify CFS for actives substances used for PT8.
Proposed methodology to apply the criterion:
Further guidance should be developed by that time, based on principles such as these ones:
– A statistical methodology such as the one followed in the PPP area could be of interest in order to define the appropriate threshold for the ADI, ArfD and AOEL.
– The threshold for the ADI would only be relevant for certain PTs for which a dietary risk assessment would systematically, or in most cases, be necessary for product authorisation. This should therefore mainly be limited to PT3, 4 and 5 active substances. The need to establish an ADI threshold for other PT, such as PT18 and PT21, should be further considered.
– To facilitate the application of the criterion, the comparison could rather be made at PT level than at the use level, considering the difficulty to define the boundaries of a "use".
For the preparation of the list of CFS meeting this criterion, an external contractor could be call upon to do the work or ECHA could be requested to deliver an opinion in accordance with Article 75(1)(g) of the BPR. The latter may actually be more appropriate as ECHA and the BPC would be expected to have all the expertise required to perform such an analysis.
2.2. Criterion (e) on the concerns linked to critical effects and use even in presence of very restrictive risk management measures
Article 10(1)(e): Substances for which "there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures".
The application of this criterion might be difficult, in particular because of the different interpretations that can be given of it. Considering that criterion (c) on the significantly lower ADI, ARfD or AOEL and (d) on meeting two of the criteria for being PBT already provides for a strong instrument to identity substances of concern for both human health and the environment, criterion (e) would seem to be applicable in a limited number of cases.
It could however be used, on a case-by-case basis, in response to unexpected effects, which could be identified at the time of product authorisation or which could arise during the lifecycle of a product and which shall be reported to the Competent authorities on the basis of Article 47(1) of the BPR.
It is therefore proposed to apply this criterion mainly post approval of the active substance, when based on evidence collected during the lifecycle of products containing this active substance, it appears that an effect considered as critical – yet not identified at the time of the substance approval – cannot be addressed even with very restrictive risk management measure.
It could however, whenever relevant, be also applied at the time of the approval when despite the critical effects identified an active substance would still be approved.
Proposed methodology to apply the criterion
The following principles could be followed:
– The notion of very restrictive risks mitigation measure shall be considered in a qualitative way.
– Identifying an active substance as a CFS under this criterion, for one or all PTs, could be a first step before taking a stronger restriction in the conditions of approval, or even the withdrawal of approval. In case there is an essential need of the substance, the substance could therefore still be approved, but flagged as a CFS.
– When an active substance s to be listed as a CFS under this criterion, it shall rather be for the whole PT than for specific uses, similarly and for the same reasons as for the application criterion (c) on the ADI, ARfD or AOEL.
2.3. Criterion (f) on the significant proportion of non-active isomers or impurities
Article 10(1)(f): Substances that "contain[s] a significant proportion of non-active isomers or impurities".
This criterion could be already applied for taking decision on the approval of active substances.
For active substance currently under review, additional data could be requested from applicants to address the question on the activity of isomers.
Proposed methodology to apply the criterion
It is proposed that:
– this criterion is applicable to chemical substances, the composition of which is well identified and fully known, and not applicable to UVCB substances;
– a significant proportion of non-active isomer(s) or impurities shall be understood as equal to or higher than 20% of presence in total in the active substance. Indeed, a content equal to or higher than 20% w/w impurities would formally lead to a different substance identity according to the current rules of naming of substances[1]. In addition, should the level of impurities be equal to or higher than 20%, this would reflect a need to improve the manufacturing process of the active substance.
– In case further scientific arguments are brought, for instance if the development of resistance to the active substance is highly probable above a lower threshold, the threshold of 20% could be reviewed in general, or for a particular substance on case-by-case basis.
– For active substances already approved, some data on the activity of each isomer in the total active substance shall be submitted in the application for renewal of approval of the active substance, considering that it is part of data listed in Annex II (section 2.6, 2.10, 2.11 and 5.1).
2.4. Additional guidance on the application of criterion (d) on substances that meet two of the criteria for being PBT
The assessment of the PBT criteria under the BPR is made in accordance with Annex XIII on the criteria for the identification of PBT substances in accordance with Annex XIII to REACH Regulation (EC) No 1907/2006. The guidance document developed under that framework should therefore be followed for the identification of PBT substances[2].
In particular, according to this guidance, if one of the metabolites / degradation products of the active substance is a PBT substance, the active substance itself is considered as meeting the PBT criteria.
As a consequence, the status of an active substance with regard to criterion (d) needs to be clarified in case one of its metabolites/degradation products meets 2 out the criteria for being PBT (i.e. if a metabolite is P and B, or B and T, or P and T).
By similarity with the methodology for identification of PBT substances, as well as the choice of this substitution criterion, it is therefore proposed that the same logic as for the PBT identification should be followed for the application of this criterion.
This means that it is proposed that if one of its metabolites/degradation products meets 2 out 3 criteria for being PBT criteria, it should be considered that the criteria (d) is fulfilled for an active substances (ie. the active substance literally "meets two of the criteria for being "PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006").
3. Conclusion
This guidance was agreed during the 58th CA meeting in November 2014 and will serve as a basis for the implementation of the substitution criteria.
Criteria of article 10(1)(a), (b), (d), (e) and (f) of the BPR shall be applied with immediate effect.
Criterion of Article 10(1)(c) shall be applied upon renewal of active substances once all active substances for a given product-type have been assessed.
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[1] Guidance for identification and naming of substances under REACH and CLP (version 1.3 - February 2014)
[2] Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment, version 1.1, November 2012, guidance currently under review