Finalised version of documents
CA-May13-Doc.5.4 and
CA/35/2013
EUROPEAN COMMISSION
ENVIRONMENT DIRECTORATE-GENERAL
Green Economy
Chemicals
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Resources Based, Manufacturing and Consumer Goods Industries
REACH
Chemicals Industry
GUIDANCE NOTE
This document intends to provide guidance in the interest of consistency, and has been
drafted by the Commission services responsible for the CLP and Biocidal Products
Regulations with the aim of finding an agreement with all or a majority of the Member
States. 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:
Classification and labelling of biocidal products
EXECUTIVE SUMMARY
The Commission proposes the following implementation of the provisions in the
Biocidal Products Regulation and the CLP Regulation on classification and labelling of
biocidal products with regard to the content of the authorisation1:
A. An applicant for authorisation of a biocidal product must, among others, propose,
where relevant, hazard and precautionary statements to be included in the
summary of product characteristics ('SPC'), which take into account the full
composition of the product and comply with the CLP Regulation or – until
1 June 2015 – the Dangerous Preparations Directive. Applicants have an interest
in proposing label statements complying with the CLP Regulation already before
that date, where possible, in order to avoid having to notify a change of the
authorised product at a later stage, when compliance with that Regulation will
become mandatory. With that proposal as the point of departure, Competent
Authorities for biocidal products or, where relevant, the Commission will include
hazard and precautionary statements as a condition for the original product
authorisation granted based on the Biocidal Products Regulation. A precautionary
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It should be noted that the actual authorisation does not contain obligations with regard to all label
elements in accordance with the CLP Regulation. Articles 20 and 22 of the BPR specifically mention
only hazard and precautionary statements as being part of the authorisation. However, the CLP
Regulation also applies and companies holding authorisation have to complete the label with all other
elements required by the CLP Regulation (in particular pictograms and signal words). Authorities
deciding on authorisations under the BPR have the possibility to verify these elements – even though
they are not part of the formal authorisation delivered.
statement which has been proven unnecessary in the risk assessment because of
the intended use of the product should be left out of the authorisation and of the
label.
B. Where an authorisation holder wishes to change the label elements related to
classification that are part of the authorisation (i.e. hazard and precautionary
statements) of a product, or is compelled by the CLP Regulation to do so, the
change has to be notified to the Competent Authority or, where relevant, ECHA,
in accordance with Article 50(2) of the Biocidal Products Regulation. If the
change leads to new hazard or precautionary statements being imposed as a
condition for the product authorisation, the authorisation needs to be updated to
reflect this new condition.
DOCUMENT BACKGROUND AND PURPOSE
1) Questions have been raised by Member States regarding the relationship between the
rules of the Biocidal Products Regulation and those of the CLP legislation. A paper
drafted by the Commission services was tabled for the meeting of September 2012 of
the biocides product authorisation and mutual recognition facilitation group
('PA&MRFG'; Restricted-PA&MRFG-Sept12-Doc4.2). The Austrian Competent
Authority ('CA') for biocidal products proposed a harmonised approach to some of
the questions in a paper tabled for the PA&MRFG meeting of December 2012
(PA&MRFG-Dec12-Doc4.2.c). Two papers tabled for the biocides CA-meeting of
December 2012 by the French CA for biocidal products (CA-Dec12-Doc.5.4) and
CEFIC (CA-Dec12-Doc.5.4) requested further clarifications from the Commission
regarding its opinion on the issue. In response, the Commission has, in collaboration
with the CAs for biocides and CLP, developed this document, which has been
endorsed by the biocides CA-meeting of May 2013 (CA-May13-Doc.5.4) and by the
Caracal meeting of November 2013 (CA/35/2013).
DETAILS OF THE PROPOSED IMPLEMENTATION
2) The EU legislation on classification, packaging and labelling applies to biocidal
products, alongside with Regulation (EU) No 528/2012 ('the Biocidal Products
Regulation'). This follows, i.a., from Article (2)(3)(m) of the Biocidal Products
Regulation, and, e contrario from Articles 1 of Regulation (EC) No 1272/2008 (the
'CLP Regulation') and of Directive 1999/45/EC (the 'Dangerous Preparations
Directive'; hereinafter jointly referred to as the 'CLP legislation').
General requirements for first authorisations of biocidal products
3) It follows from Article 69 of the Biocidal Products Regulation that holders of
authorisations of biocidal products must ensure that the authorised products are
classified and labelled in accordance with the approved summary of biocidal product
characteristics (SPC), as well as with the CLP legislation. In practice, appropriate
labelling will be one of the key instruments for ensuring that the resource-intensive
process of substance approval and product authorisation provided for by the Biocidal
Products Regulation will lead to acceptably safe use of authorised biocidal products.
4) The CLP legislation obliges manufacturers, importers and downstream users to
classify substances or mixtures before placing them on the market. It obliges
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suppliers of hazardous substances to ensure that the substances or mixtures are
labelled in accordance with the legislation. In accordance with Article 61 of the CLP
Regulation, mixtures (i.e. the majority of biocidal products) have to be labelled in
accordance with either the Dangerous Preparations Directive or the CLP Regulation
until 1 June 2015, and in accordance with the CLP Regulation alone after
1 June 2015.
5) Pursuant to Article 20(1)(a)(ii) of the Biocidal Products Regulation, an applicant for
product authorisation must join to its application, i.a., a draft SPC including, i.a.,
hazard and precautionary statements. For the sake of complying with the applicable
CLP legislation, the applicant will have to provide a draft SPC which is compatible
with that legislation, taking into account the properties of the active substance(s) as
well as any relevant co-formulants.
6) Pursuant to Article 22 of the Biocidal Products Regulation, a biocidal product
authorisation granted by a Member State or the Commission shall include an SPC,
which shall include, i.a., hazard and precautionary statements. The Commission
services presume that CAs will take the hazard and precautionary statements
proposed by the applicant as the point of departure for their product authorisation
evaluation, but that the authorisation finally granted by a Member State or the
Commission may, where justified, impose different statements as a condition for the
authorisation.
7) The fact that the hazard and precautionary statements on the label are part of the
conditions for authorisation is clear from Article 22 of the Biocidal Products
Regulation. It has the advantage of transparency, and of including those statements –
like any element of the authorisation – in the scope of mutual recognition, hence
preventing a situation where the free movement of goods is de facto hampered by
different labelling requirements (possibly due to different views on the most
appropriate interpretation of the CLP legislation) in different Member States.
P-statements and risk mitigation measures
8) It has been questioned how a product should be labelled in a case where the
classification of a product in accordance with CLP legislation would lead to the
inclusion of a certain precautionary statement on the label, whereas the risk
assessment indicates that those precautionary measures are not required because of
limited exposure. The Commission services consider that irrelevant precautionary
statements can be confusing, and should therefore be avoided. A precautionary
statement which has been proven unnecessary in the risk assessment because of the
intended use of the product should therefore be left out of the authorisation and of the
label by virtue of Article 22(3) of the CLP Regulation.
Transition between Dangerous Preparations Directive and CLP Regulation
9) It has been pointed out that many biocidal product authorisations will be granted
between now and 1 June 2015, i.e. during the period when a person placing a mixture
on the market can choose to label it in accordance with either the rules of the CLP
Regulation or those of the Dangerous Preparations Directive. It has also been pointed
out that some prospective authorisation holders will currently not be in a position to
propose classification and labelling complying with the CLP Regulation, since not all
their mixture suppliers will yet comply with that Regulation. Member States and
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stakeholders have asked for advice on how to best deal with this transition between
the Dangerous Preparations Directive and the CLP Regulation.
10) The Commission services note that, while prospective authorisation holders cannot
be required to propose labelling for mixtures complying with the CLP Regulation
before 1 June 2015, they nevertheless have an interest in doing so on a voluntary
basis, where possible. Should they do so, the SPC included in the original
authorisation in accordance with Article 22(2) of the Biocidal Products Regulation
could contain hazard and precautionary statements compatible with the CLP
Regulation. Should they not (be in a position to) do so, the SPC of the original
authorisation would have to contain hazard and precautionary statements compatible
with the Dangerous Preparations Directive instead, and any authorisation valid
beyond 1 June 2015 would have to be amended as of that date with regard to the
hazard and precautionary statements included in the authorised SPC, in order to
reflect the rules of the CLP Regulation.
Proposed or newly adopted harmonised C&L
11) The Commission services have also been asked whether a product authorisation
should include hazard and precautionary statements based on proposed or newly
adopted harmonised C&L of an active substance or a co-formulant. Three scenarios
might require different solutions in this respect:
a)
The first scenario is where a biocidal product contains a substance for which
a procedure for new, harmonised C&L is on-going by the time when the
product has to be authorised for the sake of respecting the deadlines of the
Biocidal Products Regulation.
(i) In such a case, any hazard and precautionary statements in the
authorisation linked to that substance will have to rely only on the
product assessment, and – where relevant – the substance
assessment.
(ii) This being said, where – at the time of the product assessment – a
proposal for harmonised C&L for a substance contained in the
product has been submitted, and a RAC opinion has been adopted,
the evaluating authority should, in the absence of evidence to the
contrary, consider this opinion as the latest reliable scientific
evidence even if the procedure for formal inclusion of the
substance into Annex VI to the CLP Regulation is still on-going.
(iii)Where, on the other hand, a RAC opinion has not yet been
adopted, an evaluating authority may consider a proposal for new
harmonised C&L to represent the latest, reliable scientific
knowledge and take that proposal into account in the product
assessment, in particular if the applicant for authorisation agrees
with the proposal for harmonised C&L. However, in situations
where an applicant disagrees with the proposed harmonised
classification, the evaluating authority should apply its own
judgement with regard to the proposal from the applicant, taking
into account the risk that the RAC opinion and the subsequent
inclusion into Annex VI may be different from the proposal for
harmonised C&L. Reliance – in disagreement with the applicant –
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on proposed harmonised C&L, which is unfounded and therefore
subsequently not followed, risks leading to litigation by the
applicant, or to disagreement with other Member States in the
mutual recognition procedure, in particular if it leads to restrictions
based on Article 19(4) or Article 23 of BPR.
(iv) Should the harmonised C&L differ from that, which was relied on
for the product authorisation, the CLP legislation requires the
authorisation holder to update the label without undue delay
(where the new hazard is more severe or imposes new
supplemental labelling elements) or within 18 months (in other
cases), while explicitly foreseeing that he can apply the updated
C&L already earlier. Regulation 354/2013 ('Regulation on changes
of biocidal products') gives the authorisation holder another 12
months to notify the updated hazard and precautionary statements
to ECHA or to the Member State who has granted the
authorisation.
b)
The second scenario is where the C&L of a substance in the product has
already been harmonised in the past, but a procedure for updated C&L is still
pending by the time when the product needs to be authorised.
(i) In such a case, compliance with the existing harmonised C&L is
legally required until the latter is formally changed by the
Commission. The existing harmonised C&L will therefore have to
be reflected in any biocidal product authorisation granted before
the adoption of the Commission Regulation updating the C&L in
Annex VI.2
(ii) Thereafter, as described under a(iv) above, the CLP legislation
requires the authorisation holder to update the label without undue
delay or within 18 months – while explicitly foreseeing that he can
apply the updated C&L already earlier – and the Regulation on
changes of biocidal products gives the authorisation holder another
12 months to notify the updated hazard and precautionary
statements to ECHA or to the Member State who has granted the
authorisation.
c)
The third scenario is where, by the time of product authorisation, the
Commission has only recently adopted a decision on new or updated
harmonised C&L while a decision on an authorisation request (based on no
harmonised C&L, or on the previous C&L) is still pending.
(i) The hazard and precautionary statements in the product
authorisation should then reflect the new or updated harmonised
C&L to the extent possible without delaying the authorisation
2
The Netherlands have a reservation against this interpretation, since the new conclusion may be based
on new data relating to important health endpoints such as carcinogenicity, mutagenicity and
reprotoxicity, which was not considered for the harmonised C&L in the past. Therefore, and in view of
the fact that updating harmonised C&L can be a time consuming process, the Netherlands is of the
view that the CA granting the authorisation is responsible for making sure that known, important
hazards are communicated via the label, even before the harmonised C&L has been formally updated.
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procedure beyond the deadlines provided for by the Biocidal
Products Regulation. That is because biocidal product
authorisations should reflect the latest scientific knowledge at the
time when the authorisation is granted.
(ii) In the Commission services' view, the fact that the CLP legislation
does not require immediate alignment to updated harmonised C&L
does not prevent the Biocidal Products Regulation from requiring
new product authorisations to reflect the latest C&L. In this
respect, it is noted that the Biocidal Products Regulation provides
phase out periods for existing products where an authorisation
imposes new conditions.
Scientific progress and changes to product composition
12) It follows from Articles 6(4) and 7(3) of the Dangerous Preparations Directive and
from Article 15 of the CLP Regulation that the person placing a mixture (or
substance) on the market may have to re-classify it at any time in light of new
scientific or technical information, or following a change in composition. Article 30
of the CLP Regulation establishes the deadlines for updating labels, where relevant.
13) Article 50(2) of the Biocidal Products Regulation obliges an authorisation holder to
notify the CA or, where relevant, ECHA, in case it seeks to change any of the
information submitted in relation to the initial application for authorisation. In the
Commission services' opinion, this includes re-labelling of a product, be it because of
new scientific or technical information, because of a change in composition, or
because of new regulatory requirements (such as the 1 June 2015 deadline for
application of the rules on mixtures in the CLP Regulation). The same provision
obliges the CA or, where relevant, the Commission, to decide whether the product
still fulfils the criteria for being authorised and, if so, whether the terms and
conditions of the authorisation need to be amended.
14) In accordance with the Regulation on changes of biocidal products, changes to C&L
which are limited to what is necessary to comply with newly applicable requirements
of the CLP Regulation will only have to be notified to the CA or ECHA within 12
months after their implementation. Where, following such a notification, hazard or
precautionary statements are accepted or imposed by the CA or the Commission as
new conditions for the authorisation, the SPC included in the authorisation will have
to be updated in accordance with the Regulation on changes of biocidal products.
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Finalised version of documents
CA-May13-Doc.5.4 and
CA/35/2013
Annex
RELEVANT LEGAL PROVISIONS
Article 2 of the Biocidal Products Regulation
"…
3.
Subject to any explicit provision to the contrary in this Regulation or other
Union legislation, this Regulation shall be without prejudice to the following
instruments:
…
(e)
Directive 1999/45/EC of the European Parliament and of the Council
of 31 May 1999 concerning the approximation of the laws, regulations and
administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous preparations3;
…
(m) Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on classification, labelling and packaging
of substances and mixtures4;"
Article 20 of the Biocidal Products Regulation
1.
The applicant for an authorisation shall submit the following documents
together with the application:
(a)
for biocidal products other than biocidal products meeting the conditions
laid down in Article 25:
3
OJ L 200, 30.7.1999, p. 1.
4
OJ L 353, 31.12.2008, p. 1.
…
(ii)
a summary of the biocidal product characteristics including the
information referred to in points (a), (b) and (e) to (q) of Article
22(2), as applicable;"
Article 22 of the Biocidal Products Regulation
"1.
An authorisation shall stipulate the terms and conditions relating to the making
available on the market and use of the single biocidal product or the biocidal
product family and include a summary of the biocidal product characteristics.
2.
Without prejudice to Articles 66 and 67, the summary of the biocidal product
characteristics for a single biocidal product or, in the case of a biocidal product
family, the biocidal products within that biocidal product family, shall include
the following information:
…
(i)
hazard and precautionary statements;"
Article 50 of the Biocidal Products Regulation
"2.
An authorisation holder seeking to change any of the information submitted in
relation to the initial application for authorisation of the product shall apply to
the competent authorities of relevant Member States having authorised the
biocidal product concerned, or in the case of a Union authorisation, the Agency.
Those competent authorities shall decide, or, in the case of a Union
authorisation, the Agency shall examine and the Commission decide whether the
conditions of Article 19 or, where relevant, Article 25 are still met and whether
the terms and conditions of the authorisation need to be amended."
Article 69 of the Biocidal Products Regulation
1.
Authorisation holders shall ensure that biocidal products are classified,
packaged and labelled in accordance with the approved summary of biocidal
product characteristics, in particular the hazard statements and the precautionary
8
statements, as referred to in point (i) of Article 22(2), and with
Directive 1999/45/EC and, where applicable, Regulation (EC) No 1272/2008.
In addition, products which may be mistaken for food, including drink, or feed
shall be packaged to minimise the likelihood of such a mistake being made. If
they are available to the general public, they shall contain components to
discourage their consumption and, in particular, shall not be attractive to
children.
2.
In addition to compliance with paragraph 1, authorisation holders shall ensure
that labels are not misleading in respect of the risks from the product to human
health, animal health or the environment or its efficacy and, in any case, do not
mention the indications "low-risk biocidal product", "non-toxic", "harmless",
"natural", "environmentally friendly", "animal friendly" or similar indications.
In addition, the label must show clearly and indelibly the following information:
(a)
the identity of every active substance and its concentration in metric units;
(b)
the nanomaterials contained in the product, if any, and any specific related
risks, and, following each reference to nanomaterials, the word "nano" in
brackets;
(c)
the authorisation number allocated to the biocidal product by the
competent authority or the Commission;
(d)
the name and address of the authorisation holder;
(e)
the type of formulation;
(f)
the uses for which the biocidal product is authorised;
(g)
directions for use, frequency of application and dose rate, expressed in
metric units, in a manner which is meaningful and comprehensible to the
user, for each use provided for under the terms of the authorisation;
(h)
particulars of likely direct or indirect adverse side effects and any
directions for first aid;
9
(i)
if accompanied by a leaflet, the sentence "Read attached instructions
before use" and, where applicable, warnings for vulnerable groups;
(j)
directions for the safe disposal of the biocidal product and its packaging,
including, where relevant, any prohibition on the reuse of packaging;
(k)
the formulation batch number or designation and the expiry date relevant
to normal conditions of storage;
(l)
where applicable, the period of time needed for the biocidal effect, the
interval to be observed between applications of the biocidal product or
between application and the next use of the product treated, or the next
access by humans or animals to the area where the biocidal product has
been used, including particulars concerning decontamination means and
measures and duration of necessary ventilation of treated areas; particulars
for adequate cleaning of equipment; particulars concerning precautionary
measures during use and transport;
(m) where applicable, the categories of users to which the biocidal product is
restricted;
(n)
where applicable, information on any specific danger to the environment
particularly concerning protection of non-target organisms and avoidance
of contamination of water;
(o)
for biocidal products containing micro-organisms, labelling requirements
in accordance with Directive 2000/54/EC.
By way of derogation from the first subparagraph, where this is necessary
because of the size or the function of the biocidal product, the information
referred to in points (e), (g), (h), (j), (k), (l) and (n) may be indicated on the
packaging or on an accompanying leaflet integral to the packaging.
3.
Member States may require:
(a)
the provision of models or drafts of the packaging, labelling and leaflets;
(b)
that biocidal products made available on the market in their territories be
labelled in their official language or languages."
10
Article 4 of the CLP Regulation
"1.
Manufacturers, importers and downstream users shall classify substances or
mixtures in accordance with Title II before placing them on the market.
…
4.
Where a substance or mixture is classified as hazardous, suppliers shall ensure
that the substance or mixture is labelled and packaged in accordance with Titles
III and IV, before placing it on the market."
Article 15 of the CLP Regulation
"1.
Manufacturers, importers and downstream users shall take all reasonable steps
available to them to make themselves aware of new scientific or technical
information that may affect the classification of the substances or mixtures they
place on the market. When a manufacturer, importer or downstream user
becomes aware of such information which he considers to be adequate and
reliable, that manufacturer, importer or downstream user shall without undue
delay carry out a new evaluation in accordance with this Chapter.
2.
Where the manufacturer, importer or downstream user introduces a change to a
mixture that has been classified as hazardous, that manufacturer, importer or
downstream user shall carry out a new evaluation in accordance with this
Chapter where the change is either of the following:
(a)
a change in the composition of the initial concentration of one or more of the
hazardous constituents in concentrations at or above the limits in Table 1.2 of
Part 1 of Annex I;
(b)
a change in the composition involving the substitution or addition of one or
more constituents in concentrations at or above the cut-off value referred to in
Article 11(3).
3.
A new evaluation in accordance with paragraphs 1 and 2 shall not be required if
there is valid scientific justification that this will not result in a change of
classification.
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4.
Manufacturers, importers and downstream users shall adapt the classification of
the substance or the mixture in accordance with the results of the new evaluation
except where there are harmonised hazard classes or differentiations for
substances included in Part 3 of Annex VI.
5.
For paragraphs 1 to 4 of this Article, when the substance or mixture concerned is
within the scope of Directive 91/414/EEC or Directive 98/8/EC, the
requirements of those Directives shall also apply."
Article 22 of the CLP Regulation
"1.
The label shall include the relevant precautionary statements.
2.
The precautionary statements shall be selected from those set out in the tables in
Parts 2 to 5 of Annex I indicating the label elements for each hazard class.
3.
The precautionary statements shall be selected in accordance with the criteria
laid down in Part 1 of Annex IV taking into account the hazard statements and
the intended or identified use or uses of the substance or the mixture.
4.
The precautionary statements shall be worded in accordance with Part 2 of
Annex IV."
Article 30 of the CLP Regulation
"1.
The supplier shall ensure that the label is updated, without undue delay,
following any change to the classification and labelling of that substance or
mixture, where the new hazard is more severe or where new supplemental
labelling elements are required under Article 25, taking into account the nature
of the change as regards the protection of human health and the environment.
Suppliers shall cooperate in accordance with Article 4(9) to complete the
changes to the labelling without undue delay.
2.
Where labelling changes are required other than those referred to in paragraph 1,
the supplier shall ensure that the label is updated within 18 months.
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3.
The supplier of a substance or a mixture within the scope of
Directives 91/414/EEC or 98/8/EC shall update the label in accordance with
those Directives."
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