Ref. Ares(2019)3777535 - 13/06/2019

EUROPEAN
COMMISSION

Brussels, XXX
SANTE/10094/2015 Rev. 9
[…](2019) XXX draft

COMMISSION REGULATION (EU) …/…
of XXX
amending Regulation (EU) No 546/2011 as regards the assessment of the impact of plant
protection products on honeybees

(Text with EEA relevance)

This draft has not been adopted or endorsed by the European Commission. Any
views expressed are the preliminary views of the Commission services and may not
in any circumstances be regarded as stating an official position of the Commission.

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COMMISSION REGULATION (EU) …/…
of XXX
amending Regulation (EU) No 546/2011 as regards the assessment of the impact of plant
protection products on honeybees
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the
Council of 21 October 2009 concerning the placing of plant protection products on the market
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular
Article 78(1)(c) thereof,
Whereas:
(1)

Commission Regulation (EU) No 546/20112 lays down uniform principles for
evaluation and authorisation of plant protection products, including for the assessment
of the impact of plant protection products on honeybees.

(2)

It is necessary to modify those uniform principles for evaluation and authorisation of
plant protection products in the light of the most recent developments in scientific and
technical knowledge, in particular to provide uniform principles which consider
different exposure routes in the assessment of contact toxicity to bees.

(3)

Regulation (EU) No 546/2011 should therefore be amended accordingly.

(4)

In order to allow Member States and interested parties sufficient time to prepare
themselves to comply with the uniform principles for evaluation and authorisation of
plant protection products as amended by this Regulation, it is appropriate to specify
that it should not apply to applications submitted before the date of application of this
Regulation or for applications for the renewal of an approval of an active substance for
which the supplementary dossiers have been submitted before that date.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Regulation (EU) No 546/2011
Part I of the Annex to Regulation (EU) No 546/2011 is amended as follows:
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OJ L 309, 24.11.2009, p. 1.
Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC)
No 1107/2009 of the European Parliament and of the Council as regards uniform principles for
evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127).

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(1)

in section B, point 2.5.2.3. (b) is replaced by the following:
‘(b) This evaluation shall include:

(2)

(i)

the ratio between the maximum application rate expressed in grams of
active substance per hectare and the contact LD50 expressed in μg of
active substance per bee (ʽhazard quotientʼ) and the ratio between the
estimated oral exposure (expressed in µg active substance per bee) and
the acute oral LD50 expressed in μg of active substance per bee
(ʽexposure/toxicity ratioʼ) and where necessary the persistence of
residues on or, where relevant, in the treated plants;

(ii)

where relevant, the effects on honeybee larvae, honeybee behaviour,
colony survival and development after use of the plant protection product
in accordance with the proposed conditions of use.’

in section C, point 2.5.2.3. is replaced by the following:
‘2.5.2.3. Where there is a possibility of honeybees being exposed, no authorisation
shall be granted if the hazard quotient exceeds or the exposure/toxicity ratio exceeds
or is equal to any of the values indicated in the following table, unless it is clearly
established through an appropriate risk assessment that under field conditions there
are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony
survival and development after the use of the plant protection product in accordance
with the proposed conditions of use:

Acute oral toxicity (LD50)

0.2

Acute contact toxicity (LD50)

downwards spray

42

upwards and sideward spray

85

solid formulations

14

’.
Article 2
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
It shall apply from 1 January 2020.
However, this Regulation shall not apply to applications provided for in Articles 7(1), 33(1)
and 43(1) of Regulation (EC) No 1107/2009 submitted before 1 January 2020.
Moreover, it shall not apply to applications provided for in Article 14(1) of Regulation (EC)
No 1107/2009, for which the supplementary dossiers referred to in Article 6 of Commission
Implementing Regulation (EU) No 844/20123 are submitted before 1 January 2020.
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Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the
provisions necessary for the implementation of the renewal procedure for active substances, as provided
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the
placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

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This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,

For the Commission
The President
Jean-Claude JUNCKER

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