PART 2Amendment of retained direct EU legislation relating to maximum residue levels
CHAPTER 1Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin
Chapter 35
1
Chapter 3 is amended as follows.
2
In Article 18—
a
for paragraph 1 substitute—
1
A product listed in Part 1 of the MRLs register in relation to a constituent territory must not contain, from the time it is placed on the market as food or feed, or fed to animals in that constituent territory, any pesticide residue exceeding—
a
the MRL for that product listed in Part 2 or 3 of the MRLs register in relation to that constituent territory;
b
the level described in paragraphs 1A or 1B, where there is no MRL.
1A
Where there is no MRL for a product listed in Part 2 or 3 of the MRLs register in relation to a constituent territory, the level is the default value for an active substance as listed in Part 5 of the MRLs register in relation to that constituent territory (see Article 18A).
1B
Where in relation to a constituent territory—
a
there is no MRL for the product in Part 2 or 3 of the MRLs register,
b
there is no default value for an active substance listed in Part 5 of the MRLs register, and
c
the active substance is not listed in Part 4 of the MRLs register,
the level applicable is 0.01mg/kg.
b
in paragraph 2—
i
in the words before point (a)—
aa
for “Member States” substitute “A competent authority”;
bb
for “their territories” substitute “its constituent territory”;
cc
for “covered by Annex I” substitute “listed in Part 1 of the MRLs register in relation to its constituent territory”;
ii
in point (b), for “Annex IV” substitute “Part 4 of the MRLs register in relation to that constituent territory”;
c
in paragraph 3—
i
in the first subparagraph—
aa
for the words before point (a) substitute—
By way of derogation from paragraph 1, a competent authority may authorise, further to a post-harvest treatment with a fumigant on its constituent territory, residue levels for an active substance which exceed the limits specified in Part 2 or 3 of the MRLs register in relation to that constituent territory where the active substance/product combinations are listed in Part 7 of the MRLs register in relation to that constituent territory, provided that—
bb
in point (b), for “Annexes II or III” substitute “Part 2 or 3 of the MRLs register”;
cc
in point (c), for “Member States and the Commission” substitute “competent authorities”;
ii
omit the second subparagraph;
d
after paragraph 3 insert—
3A
A competent authority may, in relation to its constituent territory—
a
define combinations of active substances and products for the purposes of paragraph 3;
b
modify or withdraw any such combinations.
3B
As soon as reasonably practicable after defining, modifying or withdrawing a combination in accordance with paragraph 3A the competent authority must—
a
notify the other competent authorities of the defining, modifying or withdrawing of the combination and the reason for that decision, and
b
update the MRLs register accordingly.
e
in paragraph 4—
i
in the first sentence—
aa
for “Article 8(4) of Directive 91/414/EEC” substitute “Article 53 of Regulation (EC) No 1107/2009”;
bb
after “set out in” insert “the EU-derived domestic legislation which transposed4”;
cc
for “Member State” substitute “competent authority”;
dd
after “within its” insert “constituent”;
ii
omit the second, third and fourth sentences;
f
after paragraph 4 insert—
5
Where a competent authority grants an authorisation in accordance with paragraph 4, the competent authority must—
a
notify the other competent authorities of that authorisation;
b
as soon as reasonably practicable, undertake an appropriate risk assessment with a view to setting a temporary MRL for a specified period, or taking any other necessary measure in relation to the products to which the authorisation relates.
6
After the completion of the risk assessment described in paragraph 5(b) the competent authority may set a temporary MRL, and Article 15(3) to (9) applies to any temporary MRL set.
7
In paragraph 4, “EU-derived domestic legislation” has the meaning given by section 2(2) of the European Union (Withdrawal) Act 2018.
3
After Article 18 insert—
Article 18ASetting default values for active substances
1
A competent authority may, in relation to its constituent territory, set a default value for an active substance where—
a
there is no specific MRL for that active substance listed in Part 2 or 3 of the MRLs register in relation to that constituent territory, and
b
the active substance is not listed in Part 4 of the MRLs register in relation to that constituent territory.
2
A competent authority may modify or withdraw a default value listed in Part 5 of the MRLs register in relation to its constituent territory.
3
When setting, modifying or withdrawing a default value, the competent authority must take into account the routine analytical methods available.
4
As soon as reasonably practicable after setting, modifying or withdrawing a default value the competent authority must—
a
notify the other competent authorities of the setting, modifying or withdrawing of the default value and the reason for that decision, and
b
update the MRLs register accordingly.
5
The Secretary of State may set, modify or withdraw a default value in accordance with paragraph 1 or 2 instead of a competent authority—
a
in relation to Wales, with the consent of the Welsh Ministers;
b
in relation to Scotland, with the consent of the Scottish Ministers;
c
in relation to Northern Ireland, with the consent of the Department.
6
Where the Secretary of State sets, modifies or withdraws a default value in accordance with paragraph 5, a reference in paragraph 3 or 4 to the competent authority is to be read as a reference to the Secretary of State.
4
In Article 19—
a
for “covered by Annex I” substitute “listed in Part 1 of the MRLs register in relation to a constituent territory”;
b
after “animals” insert “in that constituent territory”.
5
In Article 20—
a
in paragraph 1—
i
for “Annexes II or III” substitute “Part 2 or 3 of the MRLs register in relation to a constituent territory”;
ii
for “covered by Annex I” substitute “listed in Part 1 of the MRLs register in relation to that constituent territory”;
b
for paragraph 2 substitute—
2
A competent authority may, in relation to its constituent territory—
a
specify concentration factors or dilution factors for—
i
specified processing or mixing operations, or
ii
specified processed or composite products;
b
modify or withdraw any such factors.
3
As soon as reasonably practicable after specifying, modifying or withdrawing concentration or dilution factors in accordance with paragraph 2 the competent authority must—
a
notify the other competent authorities of the specifying, modifying or withdrawing of the factors and the reason for that decision, and
b
update Part 6 of the MRLs register accordingly.
4
The Secretary of State may specify, modify or withdraw concentration or dilution factors in accordance with paragraph 2 instead of a competent authority—
a
in relation to Wales, with the consent of the Welsh Ministers;
b
in relation to Scotland, with the consent of the Scottish Ministers;
c
in relation to Northern Ireland, with the consent of the Department.
5
Where the Secretary of State specifies, modifies or withdraws concentration or dilution factors in accordance with paragraph 4, a reference in paragraph 3 to the competent authority is to be read as a reference to the Secretary of State.