CA-July13-Doc.6.2.b - Final
PA&MRFG-May13-Doc.4.1 - Final
EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
N
OTE FOR DISCUSSION WITH
C
OMPETENT
A
UTHORITIES FOR
B
IOCIDAL
P
RODUCTS
This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with all or a majority of the Member States' Competent
Authorities for biocidal products. Please note, however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of
Justice of the European Union can give authoritative interpretations on the contents of
Union law.
Subject: Approach to dermal absorption assessment for biocidal products authorisation
1.- Background
(1) The Product Authorisation and Mutual Recognition Facilitation Group
(PA&MRFG) has been discussing on the dermal absorption values to be considered in the frame of the dermal absorption assessment for the authorisation of biocidal products (BPs). The purpose of this exercise is to avoid the use of disharmonised criteria leading to potential disagreements at the Mutual Recognition (MR) stage.
(2) On the basis of the suggestions and proposals from Member States (MSs), the Commission services presented a note for discussion on a step wise approach for dermal absorption assessment, in which it was proposed to apply to BPs the default values of the Guidance on Dermal Absorption adopted by the EFSA Panel on Plant Protection Products and their residues
1
.
(3) Upon request from the PA&MRFG, the Technical Meeting (TM) IV-2012 endorsed the use of the EFSA default values
2
. Nevertheless, TM
1 EFSA Journal 2012; 10(4):2665
2 Minutes of TMIV-2012; 3.i.1. Applicability of the default values of the EFSA Guidance on Dermal
Absorption to Biocidal products.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

considered that divergence to higher or lower values may be possible on a case-by-case basis when supported by robust evidence.
(4) The applicability of the whole EFSA Guidance was also endorsed at TM I-
2013
3
, so the section on dermal absorption in MOTA should be updated as appropriate. This update should also clarify the use of the EFSA Guidance in connection with other guidance documents 4 that could be considered by experts as better adapted for some specific product types and where appropriate, provide additional interpretation of some provisions of the
EFSA Guidance.
(5) At the 23 rd PA&MRFG meeting, the Commission Services presented different options to carry out the proposed step wise approach
5
. A broad support for option 3 was provided because it offers the necessary degree of flexibility both for applicants and MSs while ensuring a scientifically sound derivation of dermal absorption values.
2.- Legal and regulatory framework
(6) According to Article 5 of the Biocidal Products Directive (BPD), a BP shall be authorised only if it is established, in the light of current scientific and technical knowledge, that the product is sufficiently effective and has no unacceptable effects.
(7) Article 8(2) of BPD also mentions that the dossiers submitted for product authorisation must fulfil the data requirements of Annexes IIA, IIB, IIIA and IIIB in the light of current scientific and technical knowledge.
Concerning dermal absorption, information has to be submitted by the applicant to address this dossier requirement, as part of the toxicology data for the BP (Point VI of Annex IIB to the BPD).
(8) According to the principle of avoiding unnecessary testing, the manual of product authorisation prescribes that dermal absorption testing is only needed in cases where an unacceptable risk was identified in the first tier.
For this purpose, the Technical Guidance Document (TGD) on Risk
Assessment 6 provides default values (i.e. 100% or 10% depending on physico-chemical properties) which may be applied for a first worst-case
3 Draft minutes of TMI-2013 (page 12); 3.h EFSA Guidance on Dermal Absorption to Biocidal products
– For discussion and endorsement
4 For example, the OECD Guidance on dermal absorption ( ENV/JM/MONO(2011)36 ), the opinion of the Scientific Committee on Consumer Safety on basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients ( SCCS/1358/10 ) or the Guidance document on the estimation of dermal absorption according to a tiered approach: an update (TNO Report V98.1237, 27p, January
1999, Zeist, The Netherlands).
5 PA&MRFG-Dec12-Doc.4.3
6 See Appendix IVB - Dermal absorption; default-values for dermal absorption (page 277).
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exposure estimate. If necessary, an in vitro and/or in vivo dermal absorption study should be carried out to refine the risk evaluation.
(9) Dermal absorption values from Annex I inclusion of the active substance or from product authorisation should be taken into account under certain conditions, in particular with regard to the similarity between the formulation of the BP under assessment and that presented in dermal absorption studies submitted for evaluation.
(10) Lastly, where applicants make use of any information on dermal absorption from Annex I inclusion or product authorisation, a letter of access from the data owner of the data submitted for those purposes has to be requested by evaluating CAs according to Art. 8(2) of the BPD.
3.- Proposed approach to dermal absorption assessment
(11) The following step wise approach for the dermal absorption assessment of
BPs is proposed. In the absence of specific data, it offers a degree of flexibility as to which step shall be taken first (default values vs. reliance on existing data). If it can be demonstrated through either of these steps that there is no unacceptable risk, then the general principle of avoiding unnecessary testing would be achieved.
(12) Step 1) If available, use of data on the specific formulation is recommended.
(13) Step 2) If data on the specific formulation is not available, the applicant in consultation with the evaluating CA, could use either:
(14) 2.a) A default value for a first worst-case exposure estimate from the
EFSA Guidance on Dermal Absorption:
- A default dermal absorption value of 25% may be applied for products containing > 5% (50 g/kg for solids or 50 g/L for liquids) active substance.
- A default value of 75% should be used for products or in use dilutions containing ≤ 5% active substance.
- If log Pow < -1 or > 4 and MW > 500 a default dermal absorption value of 10% may be applied (de Heer et al ., 1999).
Where there is an indication supported by robust evidence that these default values may over or underestimate the dermal absorption, the use of higher or lower values may be possible on a case by case approach.
(15) Or
(16) 2.b) Data from the Assessment Report for Annex I inclusion or for product authorisation provided that conditions 1 and 2 are met:
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1. It is justified that the formulations presented in dermal absorption studies 7 submitted for Annex I inclusion or for product authorisation have a similar composition as compared to the BP to be authorised.
For this similarity assessment, the criteria laid out in section 6.2 of the
EFSA Guidance (Use of data on similar formulations) should be considered. Where appropriate, this section might also be used in connection with expert judgement to support the read-across from other formulations. This can be also applied for formulations giving a worstcase dermal absorption.
2. The applicant holds a letter of access (LoA) from the data owner of the dermal absorption study which is relevant for the BP to be authorised.
Where data from Annex I inclusion is referred to, the applicant must have a LoA to that study, unless it is already included in the dossier to which the applicant has a LoA.
(17) Step 3) If an unacceptable risk is identified in 2.a and no data from Annex
I inclusion or product authorisation is available (due to lack of similarity or letter of access), calculation of external exposure should be refined.
If the unacceptable risk remains, new dermal absorption studies with the
BP to be authorised should be performed to also refine internal exposure.
In this case, in vitro studies according to OECD Test Guideline 428 should be considered as a first option, avoiding, if possible, the resource to in vivo research according to OECD Test Guideline 427.
It should be noted that the refinement of internal exposure using information on dermal absorption needs to be conducted before additional risk mitigation measures, such as personal protective equipment, are prescribed.
(18) In all this process, expert judgement may also be used to conclude on the effect of the formulation type on the extent of dermal absorption in order to limit the recourse to testing, especially in vivo .
4.- Applicability of the proposed approach
(19) Once this approach is formally endorsed, it should be applied following the principles and cut-off dates established by the Note for Guidance on the Relevance of new guidance becoming available during the process of authorisation and mutual recognition of authorisations of biocidal products
8
.
7 The evaluating CA should have access to the original study report in order to evaluate the suitability of such a study. This access will be facilitated through the links of the R4BP-3 applications to IUCLID.
8 CA-July12-Doc.6.2d - Final
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