CA-Sept14-Doc.5.6 - Final
EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green economy
ENV.A.3 - Chemicals
NOTE FOR GUIDANCE
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:
Consideration of the SPC First Aid instructions in the context of MR
procedures
1.- Background and purpose of the document
(1)
At CG-4 a member of the Coordination Group raised the issue of how to deal
with First Aid instructions as required by Article 22(2)(n) of Regulation
528/2012 (BPR) in the context of mutual recognition (MR) procedures. This
involves addressing the key elements to be considered for the agreement on
the summary of biocidal product characteristics (SPC) proposed by the
reference Member state (RefMS), as well as the more appropriate conflict
resolution procedure in case of MR disagreements (Article 35 vs. Article 37
of the BPR).
(2)
At CG-4 there was an agreement between Member States (MSs) that there
should be some degree of flexibility with regard to first aid instructions in
the SPC in order to avoid MR disagreements.
(3)
This paper addresses these questions and provides some guidance on the key
information to be considered for the agreement on the SPC while
maintaining some flexibility to address information that can be countryspecific or subject to well established national practice.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
2.- Relevant provisions in the BPR
(4)
Article 32(2) of the BPR mentions that, without prejudice to Article 37, all
MSs receiving applications for MR shall authorise biocidal products under
the same terms and conditions.
(5)
Article 33(2) and 34(5) of the BPR set the agreement on the SPC as the key
milestone in the MR procedures. In this context, Article 22(2)(n) of the BPR
describes First Aid instructions as an element of the SPC that has to be
subject to that agreement.
(6)
Article 37 of the BPR sets derogations from Article 32(2), allowing
adjustments in the terms and conditions of the authorisation on grounds of,
among others, public policy or the protection of health and life of humans or
animals.
3.- Information included within the First Aid instructions
(7)
According to the discussion held at CG-4 and the subsequent comments
submitted by CG members, different types of information can be found
within this section of the SPC:
(a)
Hazard based instructions according to the legal classification of the
biocidal product, without prejudice of the relevant section of the SPC
concerning the classification and labelling of the product.
(b)
Instructions linked to the toxicological properties of the active substance
(e.g. use of an anti-dote for rodenticides).
(c)
Instructions based on the safety data sheet (SDS) of the product or of its
components, which can potentially address misuse or accidents when
using the product.
(d)
Instructions developed by other competent bodies at national level (e.g.
national poison centres) according to the information provided by industry
in accordance with Article 45 of Regulation (EC) No 1272/2008.
(e)
Information referring to the contact details of national poison information
centres, in accordance with national legislation.
4.- Agreed way forward
(8)
The Commission services note that two different categories can be established
with regard to the information to be provided under this section of the SPC:
(a)
First, information which is inherent to the properties of the biocidal
product that has been assessed by the evaluating CA of the reference MS,
which remains valid in any MSs (e.g. subparagraphs 7(a) to (c)).
2/4
(b)
Second, information which reflects more specific details or well
established practice at national level (e.g. subparagraphs 7(d) and (e)). It
has to be noted that some First Aid instructions might have been
developed following a coherent approach with other regulatory areas in
order to be adapted to some national needs in terms of understanding by
the general public, and that can also be subject to frequent updates within
this context.
(9)
The Commission services also note that more detailed guidance would be
necessary in order to establish a harmonised content and wording of this
section in the SPC, which could facilitate the MR. In the absence of such
guidance, MSs are invited to focus on the substance of the First aid Instructions
proposed by the RefMS and not on the formal aspects (e.g. slightly different
wording).
(10)
Against this background, and with a view to avoid unnecessary MR
disagreements as agreed by MSs at CG-4, the Commission services consider
that:
(a)
Information under the First Aid instructions section, which is inherent to
the properties of the biocidal product (e.g. derived from C&L, SDS of
individual components or concerning antidotes) or linked to the risk
assessment of the product, has to be subject to an agreement during the
MR procedure. This information should be clearly identified by the refMS
in the draft SPC (e.g. under a specific subheading).
Any disagreements on these elements, other than wording, should be
referred to the CG in accordance with Article 35 of the BPR.
(b)
Information under this section, which reflects more country-specific
information (e.g. national poison centres contact details) or wellestablished practice in terms of first aids instructions, should be also
clearly identified by the refMS in the draft SPC. The refMS may include a
standard sentence when referring to this kind of information (e.g. “Please
contact the national poison centre and follow the respective
instructions”)1.
This information can be subject to an adjustment by the concerned MSs in
accordance with Article 37 of the BPR on grounds of public policy or
health protection.
Where such an adjustment only concerns the national poison centres
contact details and with a view to avoid administrative burden, the
Commission services consider that a tacit agreement with the applicant
could be implemented. However, any adjustments by the CMS on the
grounds of well-established practice should be subject to agreement with
1
The final SPC linked to the national authorisation in the refMS and CMSs, which will be disseminated,
will contain the specific information with respect to the national poison centres and possible relevant
instructions based on well-established national practice.
3/4
the applicant and where the applicant disagrees, referred to the
Commission in accordance with Article 37(2) of the BPR.
(c)
Authorisations holders should also ensure consistency between the first aid
instructions established within the SPC (i.e. the product authorisation) and
those in the safety data sheet made available in that MS for the biocidal
product in accordance with Article 70 of the BPR, where applicable.
4/4