CA-Sept13-Doc.6.2.a – Final.Rev1
(Amended by CA-May14-Doc.5.2.a)
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:
Authorisation of biocidal products classified as skin sensitisers
requiring PPE for non-professional users
1.- Background
(1)
At several meetings of the Product Authorisation and Mutual Recognition
Facilitation Group meeting (Restricted Session), the scope of authorisations of
wood preservatives which require the use of personal protective equipment (PPE)
when using these products was discussed. While the reference Member State
(RMS) had authorised such products for both professional and non-professional
users, some concerned Member States (CMSs) thought it necessary to restrict the
use to professional users only.
(2)
CMSs then based the proposed restrictions on article 5(1)(b) of Directive 98/8/EC
(BPD) and paragraph 73 of Annex VI thereof, where it is mentioned that a
product shall not normally be authorised if the only possible method to reduce
exposure for non-professional users would be the wearing of personal protective
equipment.
(3)
As a result, different approaches during mutual recognition have been followed by
CMSs; some of them granted authorisations for both professional and non-
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
professional use as the RMS; other MSs intended to mutually recognise the
products imposing the use of PPE for non-professional users, and others restricted
or intended to restrict the authorisation to professional use only.
(4)
This note for guidance aims to provide an interpretation of the legal framework
regarding the authorisation of biocidal products classified as skin sensitisers
requiring PPE for non-professional users, as well as some circumstances and
principles to be considered by Competent Authorities (CAs) when making
decisions, in order to avoid disharmonised situations and discrepancies at the
mutual recognition stage1.
2.- Legal framework and analysis
(5)
Article 19(1)(b)(iii) of Regulation (EU) No 528/2012 concerning the making
available on the market and use of biocidal products (the BPR) establishes that a
condition for the authorisation of a biocidal product is that the biocidal product
has no immediate or delayed unacceptable effects itself, or as a result of its
residues, on the health of humans, including that of vulnerable groups, or
animals, directly or through drinking water, food, feed, air, or through other
indirect effects.
(6)
In paragraph 63 of Annex VI to the BPR, it is also mentioned that if, for nonprofessional users, the wearing of personal protective equipment would be the
only possible method for reducing exposure to an acceptable level for this
population, the product shall not normally be considered as complying with
criterion (iii) under point (b) of Article 19(1) for this population (emphasis
added).
(7)
This approach is consistent with recital (3) of the BPR, which mentions that this
Regulation should be underpinned by the precautionary principle to ensure that
the manufacturing and making available on the market of active substances and
biocidal products do not result in harmful effects on human or animal health or
unacceptable effects on the environment.
(8)
The wording of paragraph 63 of Annex VI of the BPR clearly indicates that the
default approach is that products shall not be authorised to the general public
when the wearing of personal protective equipment would be the only possible
method of ensuring the safe use of the product.
(9)
However, the wording also leaves a margin of discretion, enabling Member States
to authorise products under certain circumstances.
(10)
The purpose of this note is to provide guidance as to what these circumstances
might be and on the principles to be considered when deviating from the default
approach.
1
This paper does not address the cases where the assessment of the biocidal product classified as
sensitiser demonstrates a reduced exposure (e.g. a reduction in the bioavailability of free sensitiser
substance as a consequence of the formulation design) and therefore, the wearing of PPE would not be
necessary as a RMM for the safe use of the product by non-professionals.
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3. Proposed way forward
3.1.Circumstances
(11)
In the absence of alternatives of less concern or where alternatives are very
limited, a decision to authorise a product classified as skin sensitiser and requiring
the wearing of PPE may be more justified than when several alternatives are
available.
(12)
Therefore, the first and main consideration shall be whether alternative biocidal
products of less concern authorised for the same use by general public are
available and suitable. The evaluating CA may also take into consideration
whether non-chemical alternatives are available.
(13)
This consideration shall however not be handled as a formal comparative
assessment in accordance with Article 23 of the BPR, but be considered within
the specific context of paragraph 63 of Annex VI to BPR where evaluating CAs
has to justify the reasons why they deviate from the default approach set under
that paragraph.
(14)
In this context, the more alternatives are available the more strictly the following
principles shall be applied.
3.2 Principles to be considered by CAs
(15)
In order to seek harmonization and avoid discrepancies during mutual recognition,
where an evaluating CA seeks to grant an authorisation of a biocidal product
classified as skin sensitiser and requiring the wearing of PPE for non-professional
users, that CA should take into account the following principles:
(a)
2
The hazard category or sub-categories of any component included in the
biocidal product (active substance or substance of concern) that triggers
classification of the mixture as skin sensitiser according to table 3.4.5 of
Annex I to CLP Regulation2:
–
Where the product contains sub-category 1A substances as defined
in table 3.4.2 of Annex I to CLP Regulation (according to human
evidence or animal studies) where a high frequency of occurrence
of sensitization in humans and a certain severity of reaction could
be expected, a potential failure in the wearing of the PPE by nonprofessional users could lead to frequent sensitization cases. In
such a situation, the product would be expected to be restricted to
professional users only.
–
On the contrary, where the product contains sub-category 1B
substances where low to moderate frequency of occurrence of
sensitization in humans and non-severe reactions could be
expected, a potential failure in the wearing of the PPE by nonprofessional users is unlikely to cause frequent sensitization. In this
Consolidated version of the CLP Regulation available here (3.4.2.2. Skin sensitisers; pages 139 to 144)
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case, a more flexible approach could be justified and the product
may be authorised for non-professional users.
Where the product contains category 1 substances (i.e. the data is
not sufficient for sub-categorisation), expert judgement will be
required on a case-by-case basis to decide whether use of the
product is to be restricted to professionals only or made available
to non-professionals. The judgement shall be based on the strength
of the available data, including the frequency of occurrence of
sensitization in humans and the severity of reaction.
When looking at this principle, the CA should also consider:
(b)
(c)

the concentration of category 1, sub-category 1A or subcategory 1B substances in the final product (e.g. a high
concentration of a substance classified as category 1 or subcategory 1B in a biocidal product might pose a risk equal or
higher to that of a substance in subcategory 1A but used at
low concentration).

whether other co-formulants in the biocidal product might
contribute to the risk of sensitization (e.g. irritants enhance
penetration and facilite transportation to the immune system
in the deeper layer, which in some cases is necessary for a
sensitization).
The likelihood of real applicability of the provisions in terms of wearing
PPE (respirators, breathing-masks, overalls, gloves and goggles) by this
population of users:
–
The proposed PPE should be adequate for the use by nonprofessional users. As an example, wearing gloves seems to be an
easy and reachable provision for any user, even for general safety
purposes.
–
The proposed PPE to wear is expected to be available for the nonprofessional users. Where the PPE has to meet specific
requirements which might limit its availability for amateur users,
the supply of that PPE within the package of the product3 could be
considered as a condition for product authorisation.
Other elements contributing to minimising exposure4 to the biocidal
product and thus having an impact on the risk of skin sensitisation (e.g.
pack design), the information provided on the product label and packaging
in terms of instructions for use and application of the product, as well as
3
See REACH restriction in Annex XVII (entry 56) on Methylenediphenyl diisocyanate (MDI). Products
can be supplied to the general public if the suppliers ensure before the placing on the market that the
packaging contains the required protective gloves.
4
In terms of level, frequency and duration of exposure.
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the corresponding hazard and precautionary statements according to table
3.4.7 of Annex I to CLP Regulation.
3.3 Decision making by the evaluating CA
(16)
On the basis of the analysis of the availability and suitability of alternatives and
on the application of these principles, the evaluating CA shall decide whether or
not to deviate from the default approach and to authorise the product for the
general public.
(17)
Any deviation from the default approach shall be duly justified within the product
assessment report (PAR). In the absence of such justification, the product shall
not be authorised for the general public in accordance with paragraph 63 of Annex
VI to BPR.
3.4 Handling of applications for MR of products authorised for the general public
(18)
In order to facilitate the smooth running of the MR procedures, the following
approach is suggested:
(a)
Where the RefMS is prepared to authorise for the general public a product
that should normally not be authorised for this user category, the
Commission services propose that unless there is a scientific disagreement
on the conclusions of the risk assessment, which should be handled in
accordance with Article 35 of the BPR, differences of approach by a CMS
due to the availability of suitable alternatives are handled in accordance
with Article 37(1)(c) of the BPR, on the grounds of the protection of the
health of humans. The product authorisation could then be adjusted to
professional users only in that CMS, avoiding any unnecessary impacts on
the market of the RefMS as a consequence of the MR disagreement.
The above approach can be applied either to applications for MR in
parallel or for MR in sequence.
(b)
Procedures for MR in parallel where the RefMS cannot authorise the
product for the general public according to the circumstances referred to in
section 3.1 of this paper: the PAR prepared by the RefMS should clearly
explain the reasons for such a conclusion (e.g. due to the availability of
authorised alternatives of less concern) and that, otherwise, the
consideration of the principles set in section 3.2 of this paper would have
led to an authorisation decision.
In such a situation, CMSs in which the circumstances referred to in section
3.1 of this paper are different from those in the RefMS (e.g. lack of
availability of alternatives of less concern) could authorise the product for
the general public.
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Annex: Relevant information in Annex I to CLP Regulation
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Precautionary statement prevention:
P261: Avoid breathing dust/fume/ gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace
P280: Wear protective gloves/ protective clothing/eye protection/face protection (Manufacturer/supplier to specify type of
equipment. — Specify protective gloves).
Precautionary statement response:
P302 + P352: IF ON SKIN: Wash with plenty of soap and water.
P333 + P313: If skin irritation or rash occurs: Get medical advice/attention.
P321: Specific treatment (see … on this label).
P363: Wash contaminated clothing before reuse.
Precautionary statement disposal:
P501: Dispose of contents/container to …
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