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28.4.2012 Official
Journal
of
the
European
Union L
116/19
COMMISSION IMPLEMENTING REGULATION (EU) No 369/2012
of 27 April 2012
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substances blood meal, calcium carbide, calcium carbonate, limestone, pepper and quartz sand
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
26 September 2011 for calcium carbide
( 7 ) on
17 October 2011, for calcium carbonate ( 8 ) and for lime
stone ( 9 ) on 6 July 2011, for pepper dust extraction resi
due ( 10 ) on 4 July 2011, and for quartz sand ( 11 ) on
Having regard to the Treaty on the Functioning of the European
6 July 2011. The draft assessment reports and the
Union,
conclusions of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 9 March 2012 in the format of
the Commission review reports for blood meal, calcium
Having regard to Regulation (EC) No 1107/2009 of the
carbide, calcium carbonate, limestone, pepper dust
European Parliament and of the Council of 21 October 2009
extraction residue and quartz sand.
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Article 13 (2) thereof,
(3) In
accordance
with
Article
12(2)
of
Regulation
(EC)
No
1107/2009 the Commission invited the notifiers to
submit their comments on the conclusions of the Auth
ority. Furthermore, in accordance with Article 13(1) of
Whereas:
that Regulation, the Commission invited the notifiers to
submit comments on the draft review reports for blood
meal, calcium carbide, calcium carbonate, limestone,
pepper dust extraction residue and quartz sand. The
(1) The
active
substances
blood
meal,
calcium
carbide
notifiers submitted their comments, which have been
calcium carbonate, limestone, pepper and quartz sand
carefully examined.
were included in Annex I to Council Directive
91/414/EEC ( 2 ) by Commission Directive
2008/127/EC ( 3 ) in accordance with the procedure
(4)
It is confirmed that the active substances blood meal,
provided for in Article 24b of Commission Regulation
calcium carbide, calcium carbonate, limestone, pepper
(EC) No 2229/2004 ( 4 ) of 3 December 2004 laying
and quartz sand are to be deemed to have been
down further detailed rules for the implementation of
approved under Regulation (EC) No 1107/2009.
the fourth stage of the programme of work referred to
in Article 8(2) of Council Directive 91/414/EEC. Since
the replacement of Directive 91/414/EEC by Regulation
(EC) No 1107/2009, these substances are deemed to
(5) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
have been approved under that Regulation and are
1107/2009 in conjunction with Article 6 thereof and
listed in Part A of the Annex to Commission Imple
menting Regulation (EU) No 540/2011 of 25 May
( 7 ) European Food Safety Authority; Conclusion on the peer review of
2011 implementing Regulation (EC) No 1107/2009 of
the pesticide risk assessment of the active substance calcium
the European Parliament and of the Council as regards
carbide. EFSA Journal 2011; 9(10):2419. [48 pp.]. doi:10.2903/
j.efsa.2011.2419. Available online: www.efsa.europa.eu/efsajournal.
the list of approved active substances ( 5 ).
htm.
( 8 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance calcium
carbonate. EFSA Journal 2011; 9(7):2298. [28 pp.] doi:10.2903/
j.efsa.2011.2298. Available online: www.efsa.europa.eu/efsajournal.
(2) In
accordance
with
Article
25a
of
Regulation
(EC)
No
htm.
2229/2004, the European Food Safety Authority, here
( 9 ) European Food Safety Authority; Conclusion on the peer review of
inafter ‘the Authority’, presented to the Commission the
the pesticide risk assessment of the active substance limestone.
conclusions on the peer review for blood meal (
EFSA Journal 2011; 9(7):2299. [33 pp.]. doi:10.2903/

6 ) on
j.efsa.2011.2299. Available online: www.efsa.europa.eu/efsajournal.
htm.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 10 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 230, 19.8.1991, p. 1.
the pesticide risk assessment of the active substance pepper dust
( 3 ) OJ L 344, 20.12.2008, p. 89.
extraction residue. EFSA Journal 2011; 9(7):2285. [37 pp.].
( 4 ) OJ L. 379, 24.12.2004, p. 13.
doi:10.2903/j.efsa.2011.2285. Available online: www.efsa.europa.
( 5 ) OJ L 153, 11.6.2011, p. 1.
eu/efsajournal.htm.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 11 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance blood meal.
the pesticide risk assessment of the active substance quartz sand.
EFSA Journal 2011; 9(10):2394. [36 pp.]. doi:10.2903/
EFSA Journal 2011; 9(7):2300. [40 pp.]. doi:10.2903/
j.efsa.2011.2396. Available online: www.efsa.europa.eu/efsajournal.
j.efsa.2011.2300. Available online: www.efsa.europa.eu/efsajournal.
htm.
htm.

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L 116/20
EN
Official Journal of the European Union
28.4.2012
in the light of current scientific and technical knowledge,
(8) The
measures
provided
for
in
this
Regulation
are
in
it is necessary to amend the conditions of approval of
accordance with the opinion of the Standing
blood meal, calcium carbide, calcium carbonate, lime
Committee on the Food Chain and Animal Health,
stone, pepper and quartz sand. It is, in particular, appro
priate to require further confirmatory information as
regards blood meal, calcium carbonate and pepper. At
HAS ADOPTED THIS REGULATION:
the same time certain technical adaptations should be
made, in particular the name of the active substance
Article 1
‘pepper’ should be replaced by ‘pepper dust extraction
residue‘.
Part A of the Annex to Implementing Regulation (EU) No
540/2011 is amended in accordance with the Annex to this
Regulation.
(6) The
Annex
to
Regulation
(EU)
No
540/2011
should
therefore be amended accordingly.
Article 2
This Regulation shall enter into force on the twentieth day
(7) A
reasonable
period
of
time
should
be
allowed
before
the
application of this Regulation in order to allow Member
following that of its publication in the Official Journal of the
States, notifiers and holders of authorisations for plant
European Union.
protection products to meet the requirements resulting
from amendment to the conditions of the approval.
It shall apply from 1 September 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 April 2012.
For the Commission
The President
José Manuel BARROSO

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28.4.2012 Off
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) Row 222 on the active substance blood meal is replaced by the following:
EN
Common Name,

Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
'Blood meal
Not available
≥ 990 g/Kg 1
September
2009 31
August
2019 PART
A
CAS No: 90989-74-5
Only uses as repellent may be authorised. Blood meal must be in compliance with Regu
lation (EC) No 1069/2009 (*) and Regulation (EU) No 142/2011 (**).
CIPAC No: 909
PART B
In assessing applications to authorise plant protection products containing blood meal for
uses other than with direct application localised on individual plants, Member States shall
pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and
icial
shall ensure that any necessary data and information is provided before such an auth
Jour
orization is granted.
nal
For the implementation of the uniform principles, as referred to in Article 29(6) of Regu
lation (EC) No 1107/2009, the conclusions of the amended review report on blood meal
of
(SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the
the
Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be
European
taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Union
The notifier shall submit to the Member States, the Commission and the Authority,
confirmatory information on the specification of the technical material, by 1 March 2013.
(*) OJ L 300, 14.11.2009, p. 1.
(**) OJ L 54, 26.2.2011, p. 1.'
(2) Row 223 on the active substance calcium carbide is replaced by the following:
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
'Calcium carbide
Calcium acetylide
≥ 765 g/kg
1 September 2009 31
August
2019 PART
A
CAS No: 75-20-7
Containing 0,08 –
Only uses as repellent may be authorised.
0,9 g/kg Calcium
CIPAC No: 910
Phosphide
PART B
L
For the implementation of the uniform principles, as referred to in Article 29(6) of Regu
116/21
lation (EC) No 1107/2009, the conclusions of the amended review report on calcium
carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised

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L 116/22
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall
be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.'
EN

(3) Row 224 on the active substance calcium carbonate is replaced by the following:
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
'Calcium carbonate
Calcium carbonate ≥ 995 g/kg 1
September
2009 31
August
2019 PART
A
CAS No: 471-34-1
Only uses as repellent may be authorised.
CIPAC No: 843
PART B
Off
For the implementation of the uniform principles, as referred to in Article 29(6) of Regu
icial
lation (EC) No 1107/2009, the conclusions of the amended review report on calcium
Jour
carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised
in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall
nal
be taken into account.
of
Conditions of use shall include, where appropriate, risk mitigation measures.
the
European
The notifier shall submit confirmatory information as regards:
— further data on the specification of the technical material,
— analytical methods for the determination of calcium carbonate in the representative
Union
formulation and of the impurities in the technical material.
These information shall be submitted to the Member States, the Commission and the
Authority by 1 March 2013.'
(4) Row 237 on the active substance limestone is replaced by the following:
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
'Limestone
Calcium carbonate ≥ 980 g/kg 1
September
2009 31
August
2019 PART
A
CAS No: 1317-65-3
Only uses as repellent may be authorised.
CIPAC No: 852
PART B
For the implementation of the uniform principles, as referred to in Article 29(6) of Regu
28.4.2012
lation (EC) No 1107/2009, the conclusions of the amended review report on

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28.4.2012 Off
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be
taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.'
EN

(5) Row 239 on the active substance pepper is replaced by the following:
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
'Pepper dust
Steam distilled and It is a complex
1 September 2009 31
August
2019 PART
A
extraction residue
solvent extracted
mixture of
(PDER)
Black pepper –
chemical
Only uses as repellent may be authorised.
Piper nigrum
substances, the
CAS No: not allocated
component
PART B
icial
piperine as marker
CIPAC No: not allo
should be
In assessing applications to authorise plant protection products containing pepper dust
Jour
cated
minimum 4 %
extraction residue (PDER) for uses other than in home garden area, Member States shall
pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and
nal
shall ensure that any necessary data and information is provided before such an auth
of
orization is granted.
the
For the implementation of the uniform principles, as referred to in Article 29(6) of Regu
European
lation (EC) No 1107/2009, the conclusions of the amended review report on pepper
(SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be
taken into account.
Union
Conditions of use shall include, where appropriate, risk mitigation measures
The notifier shall submit to the Member States, the Commission and the Authority,
confirmatory information on the specification of the technical material, by 1 March 2013.'
(6) Row 247 on the active substance quartz sand is replaced by the following:
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
'Quartz sand
Quartz, Silicon
≥ 915 g/kg
1 September 2009 31
August
2019 PART
A
dioxide
CAS No: 14808-60-7,
Maximum 0,1 % of
Only uses as repellent may be authorised.
7637-86-9
particles of
Crystalline Silica
PART B
L
CIPAC No: 855
(with diameter
116/23
below 50 um.)
In assessing applications to authorise plant protection products containing quartz sand for
uses other than on trees in forestry, Member States shall pay particular attention to the

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L 116/24
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
necessary data and information is provided before such an authorization is granted.
For the implementation of the uniform principles of Annex VI, the conclusions of the
review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II
EN
thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall

be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.'
Off
icial
Jour
nal
of
the
European
Union
28.4.2012

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Document Outline

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