CHAPTER II

ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS
SECTION 2

Safeners and synergists

Approval of safeners and synergists
Article 25
1
A safener or synergist shall be approved, where it complies with Article 4.
2
Articles 5 to 21 shall apply.
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Safeners and synergists on the market on or before 14th June 2011
Article 25A
1
A safener or synergist is deemed to be approved for the purposes of this Regulation in each constituent territory if on or before 14th June 2011 it was—
a
held for the purpose of sale within the European Union, an EEA state or the United Kingdom, including being offered for sale or other form of transfer, whether free of charge or not;
b
sold, distributed or otherwise transferred within the European Union, an EEA state or the United Kingdom, but not including return to the previous seller; or
c
released for free circulation into the territory of the European Union, an EEA state or the United Kingdom.
2
For the purposes of paragraph 1, “
the European Union
” does not include the Republic of Croatia.
3
A safener or synergist is deemed to be approved in accordance with paragraph 1 in a constituent territory until—
a
where an application for approval of that safener or synergist is received in accordance with Article 7 (as applied by Article 25(2)), the date on which a decision is made by the competent authority for that constituent territory or the Secretary of State in accordance with Article 13 (as applied by Article 25(2));
b
otherwise, the earliest of the following dates—
i)
the date on which the competent authority or the Secretary of State decides to withdraw approval of the safener or synergist for that constituent territory in accordance with Article 21 as applied by paragraph 4;
ii)
the date on which the first regulations made under Article 8(4)(a) in respect of safeners or synergists (as the case may be) which apply to that constituent territory come into force.
4
Article 21 applies to a safener or synergist deemed to be approved in accordance with paragraph 1 as if—
a
a reference to an active substance were a reference to that safener or synergist;
b
paragraph 2 were omitted;
c
in paragraph 3—
i)
in point (a), the words from “or the assessment” to “Article 20A,” were omitted;
ii)
point (b) (and the “or” immediately preceding it) were omitted;
d
in paragraph 5, for “or (b) apply” there were substituted
“applies”
;
e
paragraph 8(b) (and the “and” immediately preceding it) were omitted;
f
in paragraph 9, in the words before point (a) “or 2” were omitted.

Safeners and synergists already on the market
Article 26
By 14 December 2014, a Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4) establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force. The Regulation shall include the establishment of data requirements, including measures to minimise animal testing, notification, evaluation, assessment and decision-making procedures. It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified period.
Art. 25A inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(33) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Art. 25(3) omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(32) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)