Regulation 13 Chapter 11I1

Chapter 11 is amended as follows.

For Article 80, substitute—

“Article 80

Existing transitional measures

1

The following application is taken to have been made under Article 7(1) on the date it was made—

Common Name, CIPAC Identification Number	Applicant	Date of application
Ethametsulfuron CIPAC-No: 834	DuPont de Nemours GmbH	29th June 2010

1A

For the determination of the application described in paragraph 1, this Regulation is to be read subject to the modifications in paragraphs 1B to 1F.

1B

Article 4(1) is to be read as if—

(a)

in the first subparagraph—

(i)

“in accordance with Annex II” were omitted;

(ii)

the words from “, taking into account” to “that Annex,” were omitted;

(b)

the second subparagraph were omitted.

1C

Article 4(2)(a) is to be read as if the words from “, taking into account” to “available,” were omitted.

1D

Article 4(3) is to be read as if—

(a)

point (a) were omitted;

(b)

in point (b), the words from “or consequences” to “effects are available;” were omitted;

(c)

points (c), (d) and (e)(iii) were omitted;

1E

Article 4(7) is to be ignored.

1F

Article 11(2) is to be read as if the third subparagraph were omitted.

1G

Anything done before F1IP completion day in relation to the application described in paragraph 1—

(a)

by the United Kingdom —

(i)

under Directive 91/414/EEC, as the member State described in Article 6 of that Directive;

(ii)

as the rapporteur Member State under Regulation 188/2011;

(b)

by the European Food Safety Authority under Directive 91/414/EEC or Regulation 188/2011,

is taken to have been done by the relevant competent authority as the assessing competent authority.

1H

If the application described in paragraph 1 is approved in accordance with Article 13—

(a)

Article 13(1) to (4) of Directive 91/414/EEC applies in relation to that approval for a period of 10 years beginning with the date of approval;

(b)

Regulation 544/2011 and Regulation 545/2011 apply in relation to that approval as if, in Article A1(1)(a) of each Regulation, for the words from “as it had effect” in the first place it occurs to the end there were substituted “ as read with Article 80(1) of that Regulation ”.

1I

In paragraph 1G—

(a)

“rapporteur Member State” has the meaning given by Article 2(1) of Regulation 188/2011;

(b)

the “relevant competent authority” is the Secretary of State.

2

Paragraphs 2A to 2E apply to an active substance—

(a)

included in Annex 1 to Directive 91/414/EEC;

(b)

approved in accordance with paragraph 1 of this Article as it had effect immediately before IP completion day .

2A

Article 13(1) to (4) of Directive 91/414/EEC applies—

(a)

for active substances covered by Article 8(2) of Directive 91/414/EEC, for a period of five years beginning with the date of the inclusion or approval of the active substance;

(b)

for active substances which were not on the market in the European Union, an EEA state or the United Kingdom on 26th July 1993, for a period of 10 years from the date of the inclusion or approval of the active substance.

2B

In paragraph 2A(b), “on the market” means any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the European Union, an EEA state or the United Kingdom or disposal.

2C

In paragraphs 2A(b) and 2B, the “European Union” does not include the Republic of Croatia.

2D

Regulation 544/2011 applies to the active substance, and is to be read as if, in Article A1(1) of that Regulation—

(a)

point (a) were omitted;

(b)

for F2point (c)(i) there were substituted—

“(i)

described in Article 80(2) of Regulation (EC) No 1107/2009, and”.

2E

Regulation 545/2011 applies to the active substance, and is to be read as if, in Article A1(1) of that Regulation—

(a)

point (a) were omitted;

(b)

in F3point (c)(ii), for “to which point (a) applies” there were substituted “ described in Article 80(2) of Regulation (EC) No 1107/2009 ”.

2F

In this Article—

(a)

“assessing competent authority” has the same meaning as in Subsection 2 of Section 1 of Chapter 2;

(b)

“Directive 91/414/EEC” means Council Directive 91/414/EEC concerning the placing of plant protection products on the market, as it had effect by virtue of paragraph 1 and 2 of this Article as those paragraphs had effect immediately before IP completion day , read in accordance with paragraph 2G;

(c)

“Regulation 188/2011” means Commission Regulation (EU) No 188/2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive as it had effect immediately before IP completion day;

(d)

“Regulation 544/2011” means Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances;

(e)

“Regulation 545/2011” means Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products.

2G

For the purposes of this Article, Article 13(1) to (4) of Directive 91/414/EEC is to be read as if—

(a)

a term used in those paragraphs which is defined in this Regulation has the meaning given in this Regulation;

(b)

in paragraph 1—

(i)

in the words before point (a), for “Without prejudice to Article 10, Member States” there were substituted “ A competent authority ”;

(ii)

in point (a), for “Annex III” there were substituted “ Regulation 545/2011 ”;

(iii)

in point (b), for “Annex II” there were substituted “ Regulation 544/2011 ”;

(c)

in paragraph 3—

(i)

for “Member States” there were substituted “ a competent authority ”;

(ii)

for “Annex II” there were substituted “ Regulation 544/2011 ”;

(iii)

in point (b), for the words from “two years” to the end there were substituted “ by 26th July 1993 ”;

(iv)

point (c) (and the “or” immediately preceding it) were omitted;

(v)

in point (d), for “paragraphs 3(b) and (c)” there were substituted “ paragraph 3(b) ”;

(d)

in paragraph 4—

(i)

for “Member States” there were substituted “ a competent authority ”;

(ii)

for “Annex III” there were substituted “ Regulation 545/2011 ”;

(iii)

point (c) (and the “or” immediately preceding it) were omitted.”.

Omit Article 81.

In Article 83—

Omit Article 84.

After Article 84, omit the words from “This Regulation” to “all Member States”.