EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE GENERAL Safety

european commission health and food safety directorate general safety of the food chain pesticides and biocides note for di

EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE GENERAL
Safety of the food chain
Pesticides and Biocides
Note for discussion with Competent Authorities for Biocidal Products
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 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: Mutual recognition of safe and efficacious uses meeting the
conditions in Article 19 of the BPR assessed but not authorised by the
reference Member State
1.- Background and purpose of the document
1.
At the 63rd CA meeting, Industry representatives asked the
Commission how mutual recognition (MR) procedures should operate
in cases where, while the conclusions of the risk and efficacy
assessment conducted by the reference Member State (refMS) could
led to the authorisation of some of the intended uses in the
application, the refMS does not authorise such uses because of
some national policies (e.g. not authorisation of anticoagulant
rodenticides for the general public).
2.
The answer to this question might not only have an impact on the
uses which could be authorised through MR in the concerned MSs
(cMSs), which might have different policies, but also in on the
choice of the refMS by prospective applicants and as a result a
possible delay inlead to procedures for applicants because of an
unbalanced distribution of the workload for MSs.
3.
This notes aims at addressing such request.
2.- Analysis and proposed way forward
2.1. Grounds for national policies affecting the uses to be authorised
by the refMS
4.
Article 42 of Regulation (EU) 528/20121 (the "BPR")the BPR
provides for Union authorisation valid, in principle, throughout
the Union "for biocidal products which have similar conditions of
use across the Union with the exception of biocidal products that
contain active substances that fall under Article 5 and those of
product-types 14, 15, 17, 20 and 21" (emphasis added).
5.
Thus, the BPR recognises that there might be uses of certain
biocidal products that, due to different conditions of use or due
to different national, non-harmonised policies2, may be subject to
different regulatory approaches in various MSs provided that the
product authorisation complies with the requirements in Article 19
of the BPR.
6.
The "different conditions of use through the EU" are determined by
the fact that some policies are determined at national level or by
specific factual situations of a country and, even if not
expressively mentioned, it seems logical to assume that they
correspond to the grounds listed in Article 37 of the BPR. In
other words, the EU co-legislators considered them within the
grounds allowing derogations to MR so that authorisations granted
by other MSs can be adapted according to those grounds, and
contribute to a level playing field within its territory.
7.
The existence of "different conditions of use through the EU" has
consequences on the authorisation of uses granted under Article
19. For instance, the evaluating body might conclude that "the
biocidal product is sufficiently effective" (see Article
19(1)(b)(i)), but that in the refMS, for example, a certain target
organism might not present in harmful quantity and therefore the
uses targeting that organism will not be authorised in its
territory. This assessment can be included in the documents
underlying the authorisation.
2.2.- How to reflect the assessment and the effect of national
policies in the refMS
8.
As pointed out by Article 30 of the BPR, in the product assessment
report (PAR) the refMS summarise “the conclusions of its
assessment and the reasons for authorising the biocidal product or
for refusing to grant an authorisation” (see Article 30(3)(a)) in
order to “decide whether to grant an authorisation in accordance
with Article 19” (see Article 30(1)).
9.
Therefore, as Article 30 does not give additional details on the
content of the PAR, in the conclusions of the assessment, a MS
granting a national authorisation or the refMS for a procedure for
MR in parallel (MR-P) could provide either:
a.
A positive outcome stating that the conditions of Article 19
are met and conclude that the biocidal product (or some of the
intended uses in the application) should be authorised in its
territory; or
b.
A negative outcome stating that the conditions of Article 19
are not met and conclude that the biocidal product (or some of
the intended uses) should not be authorised in its territory;
or
c.
A positive outcome stating that the conditions of Article 19
are met, but at the same time, specifying the uses of the
biocidal product that will not be authorised in its territory
due to the grounds referred to in Article 37 of the BPR.
10.
Therefore, it is recommended that, where relevant, the PAR is
drafted in accordance with paragraph 9(c) above, so that cMSs have
a clear understanding of which uses have not been authorised by
the refMS due to a national policy or situation while having been
found to be safe and sufficiently effectivecompliant with Article
19 of the BPR during the assessment of the application.
2.3.- Article 37 of the BPR and mutual recognition in sequence
11.
Article 32(2) of the BPR points out that "Without prejudice to
Article 37, all Member States receiving applications for mutual
recognition of a national authorisation for a biocidal product
shall, in accordance with and subject to the procedures set out in
this Chapter, authorise the biocidal product under the same terms
and conditions." (emphasis added).
12.
Mutual recognition in sequence (MR-S) presupposes the existence of
a national authorisation already granted in a single MS. In the
light of the above, a question might arise on which approach to
follow in case an applicant requests MR-S of an authorisation for
which certain uses in the initial application were not authorised
in the refMS for reasons of national policy or situation.
13.
The fact that Article 33(2) of the BPR only refers to the
agreement on the summary of biocidal product characteristics (SPC)
can also be interpreted in a wider manner, in so far as the SPC
compiles the conclusions of the documents underlying the
assessment of the application (i.e. the PAR).
In fact, for the principle of useful effect3, some terms might have
the widest interpretation as possible in order to give the broadest
application to provisions that extend the application of EU law. This
is clearly the case of rules on MR procedures, which allow the
functioning of the internal market, which is one of the objectives of
the BPR.
14.
Article 37 of the BPR states that "By way of derogation from
Article 32(2), any of the Member States concerned may propose to
refuse to grant an authorisation or to adjust the terms and
conditions of the authorisation to be granted, provided that such
a measure can be justified on grounds of" (emphasis added).
15.
Therefore, Article 37 should not only be interpreted as granting
the possibility to cMSs to refuse or to restrict the first
authorisation, but also the possibility to extend the
authorisation to be granted through MR-S for the reasons below:
a.
The BPR uses in Article 37 the term "adjust", which literally
means to alter or modify something and which should not be
interpreted as a meaning of "restrict". This interpretation is
confirmed by the fact that the BPR uses the words "restrict"
and "adjust" in different context and with different meanings.
Whereas:
*
"Restrict" is used to indicate that a certain use or the
making available on the market must be reduced or limited4,
*
"Adjust" is used not to indicate necessary a restriction,
but a more flexible adaptation on the basis of the
specific situation5.
b.
In Article 37, the EU co-legislators also use the more general
term "measure", instead of derogation, in order to indicate
that a justification can be provided both in case of:
*
a restriction or refusal, and
*
an extension of the authorisation to be granted through
MR-S, as long as the decision not to authorise some uses
in the initial authorisation was based on a national
policy or situation of the refMS justified on the basis of
Article 37 of the BPR (e.g. for instance that those uses
were considered as compliant with Article 19 of the BPR
safe and sufficiently effective in the PAR of the refMS).
c.
The flexibility of the provision is confirmed by the fact that
the "adjustment" by the cMS is carried out on the basis of a
procedure that requires a negotiation and agreement between
the applicant and the competent authority (CA) (see Article
37(2) of the BPR).
16.
Therefore, it is proposed that in the context of MR-S the cMSs may
also authorise, by virtue of Article 37, some uses that were not
included in the initial authorisation of the refMS due to a
national policy and provided that those uses were considered as
compliant with Article 19 of the BPRsafe and sufficiently
effective in the PAR.
2.4.- Article 37 of the BPR and Mmutual recognition in parallel
17.
Article 34 of the BPR refers to biocidal products which have not
been authorised yet and therefore, there is no need for an
existing product authorisation (or existing authorised uses).
18.
Article 34(4), second paragraph, specifies that the refMS, after
evaluating the application6, shall “draft an assessment report in
accordance with Article 30 and shall send its assessment report
and the summary of biocidal product characteristics to the Member
States concerned and to the applicant”.
19.
Article 34(5) of the BPR establishes that "Within 90 days of
receipt of the documents referred to in paragraph 4, and subject
to Articles 35, 36 and 37, the Member States concerned shall agree
on the SPC,…". The agreement on the proposed SPC is based on the
assessment made available by the refMS through the PAR.
20.
Articles 34(5) and 34(7) explicitly mention the link with Article
37 derogations. However, the wording in Article 37 of the BPR
states that "By way of derogation from Article 32(2), any of the
Member States concerned may propose to refuse to grant an
authorisation or to adjust the terms and conditions of the
authorisation to be granted, provided that such a measure can be
justified on grounds of" (emphasis added).
21.
In the light of the above, a question might arise on whether, in
case of MR-P, the refMS can also make use of Article 37 of the BPR
to derogate from the agreed SPC when granting the national
authorisation in accordance with Articled 34(7) of the BPR and
adjust that authorisation for reasons of national policy.
22.
If those MSs acting as refMS were prevented from doing so, there
would be a significant distortion in the functioning of the whole
regulatory system in the biocides area, due to the high risk to
have applicants submitting their applications exclusively to the
MSs which are less likely to have national policies impacting on
the intended uses in the application and, as a consequence,
affecting the MR process.
23.
Such an approach would also oblige applicants to carefully
identify and analyse the various national policies and
subsequently impose on a number of MSs a disproportionate
administrative burden compared to others. This outcome was
certainly not the intention of the EU co-legislators.
24.
Therefore, it is proposed that Article 37(1) is not interpreted
literally but also in the light of the provision's objective,
which is to adapt the terms and conditions in the SPC agreed
during the MR phase to the national policies applicable in the MSs
having to authorise the product, including the refMS.
25.
When implementing such an approach, the refMS should assess inter
alia that the national policy, based on Article 37 of the BPR is:
26.
justified exclusively on the grounds listed in Article 37(1),
letters (a) to (e), as this should be considered as an exhaustive
list7.,
a.
appropriate to reach the objective8, and
b.
proportionate, i.e. the measure must not go beyond what is
necessary to achieve the intended outcome9.
3.- Practical implementation
3.1.- Preparation of the PAR by refMS
27.
A MS having to prepare a PAR reflecting the assessment of an
application for national authorisation, either in the context of a
purely national authorisation or acting as refMS for MR-P, should
clearly indicate in the PAR:
a.
The intended uses in the application10 for which the
conditions of Article 19 are met, but cannot be authorised in
its territory due to a national policy and
b.
The link of such a policy with the grounds referred to in
Article 37 of the BPR.
3.2.- MR in sequence
28.
For MR-S, the applicant will have to:
a.
Clearly indicate in the application11 submitted via R4BP that,
those uses that were not authorised by the refMS as a result
of the implementation of a national policy, should be
considered within the application for the purpose of the new
authorisation to be granted by the cMS.
b.
Include those uses in the draft SPC submitted within the
application.
29.
The cMS may also authorise, in accordance with one or more of the
grounds referred to in Article 37(1) of the BPR, the
above-mentioned uses provided that there is evidence in the PAR
that the conditions in Article 19 are met. The applicant should be
involved in this process and agree with the proposed adjustments.
3.3.- MR in parallel
30.
The refMS should clearly flag in the draft SPC (in English) those
elements that might be affected by a national policy (e.g. by
adding a footnote “The target organism (or use) cannot be
authorised in RefMS due to …..”)12.
31.
The above-mentioned elements should also be clearly flagged in the
SPC in English agreed during the MR phase and entered in R4BP by
the refMS.
32.
Following the agreement on the draft SPC in English, the refMS may
also, in accordance with one or more of the grounds referred to in
Article 37(1) of the BPR, adapt the terms and conditions in the
agreed SPC to the national policies applicable in the refMS. The
applicant should be involved in this process and agree with the
proposed adjustments.
33.
When granting the national authorisation in accordance with
Articled 34(7) of the BPR and following the above-mentioned
adaptation, the final SPC issued by the refMS in its official
language(s) and to be disseminated by ECHA will list the uses
authorised in the refMS only.
4.- Case of uses that cannot be authorised by the refMS as a result of
the provisions in Articles 5(2) or 23 of the BPR
34.
It is proposed that the reasoning and practical implementation
outlined in this paper is also applied, where relevant, to
intended uses in the application being considered to be compliant
with Article 19 of the BPR in the PAR but for which the outcome
of:
a.
the assessment shows that none of the conditions in Article
5(2) is met in the refMS and as a consequence, that use cannot
be authorised by the refMS, or
b.
the comparative assessment carried out in accordance with
Article 23 of the BPR shows that the conditions in Article
23(3) to not authorise such use are met in the refMS13.
54.- Action requested
35.
The Commission services invite MSs and stakeholders to discuss
note ofthe CA meeting to endorse the proposal outlined in this
paper.
1 Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market
and use of biocidal products (OJ L 167, 27.6.2012, p. 1.).
2 E.g. animal welfare for product-types 15, 17 and 20, different
national rules implementing environmental directives, public policy
and defence.
3 See e.g. the interpretation of the term “worker” in current Article
45 TFEU (ECJ, Case 53/81, Levin; Case 344/87, Bettray; Case 139/85,
Kempf; Case C456/02, Trojani) and the interpretation of the term
“State” for the vertical direct effect of Directives (ECJ, Case
103/88, Fratelli Costanzo; Case 222/84, Marshall; Case C188/89,
Foster).
4 See Article 2(7): "restricting or banning the use"; Article 4(2):
"shall be restricted"; Article 5(2) "shall be restricted"; Article
19(5) "shall be restricted"; Article 23(3): "prohibit or restrict";
Article 27(2) "restrict or prohibit"; Article 58(2), "conditions and
restrictions"; Article 69(2)(m): categories of users to which the
biocidal product is restricted"; Annex VI, point 9: "restrictions on
use or other conditions"; Annex VI, point 56: "subject to specific
conditions/restrictions".
5 See Annex II, point 5; Annex III, point 5; Article 44; in the same
meaning the BPR uses the term "adapt".
6 It is important to underline the role of the refMS as evaluating
body of an application which is submitted to several MSs at the same
time. The refMS would then have a similar role as the eCA under the UA
procedure, so the assessment cannot be based on the conditions of use
or policies applicable in the refMS only.
7 See ECJ, case 113/80, Commission v. Ireland, para. 7, in relation to
current Article 36 TFEU derogations.
8 See ECJ, case 331/88, Fedesa, para. 14.
9 See ECJ, case C-320/03, Commission v. Austria, para 87.
10 This obviously does not cover cases where the applicant did not
include in the application certain uses knowing that they are not
authorised by the refMS. If those uses are not assessed by the refMS
at all, they cannot be subject to MR in the cMSs.
11 E.g. via a supporting document.
12 In line with the agreed approach in document CA-May15-Doc.4.4 –
Final.rev3 (Q&A pair number 20), available at
https://circabc.europa.eu/w/browse/0179339e-57cc-4f66-b49f-c0b32c21779b
13 Please note that according to document CA-May15-Doc.4.3.a – Final,
paragraph 117, a recommendation to restrict or prohibit the relevant
product can be made even when an alternative product is only
authorised in another MS or a non-chemical alternative is only
available in another MS.
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