The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019

Existing approvals: Annex modifications U.K.

3.—(1) For the purposes of paragraph 2(3)(c), the Annex is modified in accordance with this paragraph.

(2) In the Annex—

(a) a reference to Member States is to be read as a reference to competent authorities;

(b) a reference to Article 29(6) of Regulation (EC) No 1107/2009 is to be read as a reference to Article 29(6)(a) of that Regulation;

(c) a requirement on a notifier to submit, or on a member State to ensure that a notifier submits, further studies, data or information to the Commission, one or more member States or the Authority within a period of time which has expired before [F1 IP completion day] is to be ignored;

(d) a requirement on member States to inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 is to be ignored;

(3) The entries in the table in Part A of the Annex are modified as follows—

(a) in entry 46 (Cyazofamid), in the seventh column, in the second paragraph, in the second sentence, the second indent is to be read as if “especially for Northern European regions” were omitted;

(b) in entry 173 (Difenoconazole), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The notifier must submit to each competent authority the information set out in point (d) within 2 years from the issuing of specific guidance.”;

F2 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) in entry 176 (Lenacil), in the seventh column, Part B is to be read as if, in the fourth paragraph, in the second sentence, for “the Commission” there were substituted “ each competent authority ”;

(e) in entry 210 (Abamectin), in the seventh column, in Part B, the fourth paragraph is to be read as if for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(f) in entry 211 (Epoxiconazole), in the seventh column, Part B is to be read as if, for the third paragraph there were substituted—

“The notifier must submit to each competent authority further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, the issuing of test guidelines set by the competent authority.”;

(g) in entry 217 (Metazachlor), in the seventh column, Part B is to be read as if, in the fifth paragraph, for “the Commission” there were substituted “ each competent authority ”;

(h) in entry 268 (Tebuconazole), in the seventh column, Part B is to be read as if for the second paragraph there were substituted—

“The notifier must submit to each competent authority further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, the issuing of test guidelines set by the competent authority.”;

F2 (i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(j) in entry 282 (Chlorsulfuron), in the seventh column, Part B is to be read as if, in the fourth paragraph, for “the Commission” there were substituted “ each competent authority ”;

(k) in entry 284 (Dimethachlor), in the seventh column, Part B is to be read as if, in the fifth paragraph, for “the Commission” there were substituted “ each competent authority ”;

(l) in entry 289 (Triflusulfron), in the seventh column, Part B is to be read as if, in the third paragraph, for “the Commission” there were substituted “ each competent authority ”;

(m) in entry 307 (Sulfuryl fluoride), in the seventh column, Part B is to be read as if, in the fourth paragraph—

(i) for “the Commission, Member States and the Authority” there were substituted “ each competent authority ”;

(ii) for “2017” there were substituted “ 2022 ”;

(n) in entry 315 (Fenbuconazole), in the seventh column, Part B is to be read as if, for the sixth paragraph there were substituted—

“The notifier must submit to each competent authority further information addressing the potential endocrine disrupting properties of [F3 fenbuconazole] within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, the issuing of test guidelines set by the competent authority.”;

(o) in entry 318 (Bromuconazole), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The notifier must submit to each competent authority further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, the issuing of test guidelines set by the competent authority.”;

(p) in entry 327 (Oryzalin), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (4) within six months of notification of a decision classifying oryzalin.”;

(q) in entry 328 (Tau-fluvalinate), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority confirmatory information addressing the possible impact on the environment of the potential enantio-selective degradation in environmental matrices, within two years after the issuing of specific guidance.”;

(r) in entry 335 (Fluometuron), in the seventh column, Part B is to be read as if—

(i) in the third paragraph, in the words before point (a), for “the Commission” there were substituted “ each competent authority ”;

(ii) for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (d) within six months of notification of a decision classifying fluometuron.”;

(s) in entry 337 (Carboxin), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (h) within six months of notification of a decision classifying carboxin.”;

(t) in entry 338 (Cyproconazole), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (e) within two years of the issuing of specific guidance.”;

(u) in entry 344 (Diclofop), in the seventh column, Part B is to be read as if, for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (b) within two years of the issuing of a specific guidance document on evaluation of isomers mixtures.”;

(v) in entry 348 (Paclobutrazol), in the seventh column, Part B is to be read as if, for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority—

(a) the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption, and

(b) the information set out in point (5) within two years after the issuing of specific guidance.”;

(w) in entry 352 (Hexythiazox), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (d) within two years after the issuing of specific guidance.”;

(x) in entry 354 (Flurochloridone), in the seventh column, Part B is to be read as if—

(i) in the fourth paragraph, in the words before point (1), for “the Commission” there were substituted “ each competent authority ”;

(ii) for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption.”.

(4) The entries in the table in Part B of the Annex are modified as follows—

(a) in entry 7 (Sprioxamine), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (a) within two years after the issuing of specific guidance.”;

(b) in entry 10 (Tefluthrin), in the seventh column, Part B is to be read as if, for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (3) within two years after the issuing of a specific guidance document on evaluation of isomers mixture.”;

(c) in entry 16 (Terbuthylazine), in the seventh column, Part B is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (4) within six months of the notification of the classification decision for terbuthylazine.”;

(d) in entry 19 (Acrinathrin), in the seventh column, Part B is to be read as if, for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (4) within two years after the issuing of specific guidance.”;

(e) in entry 20 (Prochloraz), in the seventh column, Part B is to be read as if, for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (3) within two years after the adoption of the OECD test guidelines on endocrine disruption.”;

(f) in entry 48 (Sedaxane), in the seventh column, Part B is to be read as if for the sixth paragraph there were substituted—

“The notifier must submit to each competent authority the relevant information within six months of the notification of the classification decision for sedaxane.”;

(g) in entry 49 (Emamectin), the seventh column is to be read as if for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the relevant information within two years after the issuing of a specific guidance document on evaluation of isomers mixtures.”;

(h) in entry 51 (Fluopyram), the seventh column is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (2) within two years after the adoption of the OECD test guidelines on endocrine disruption.”;

(i) in entry 55 (Penflufen), in the seventh column, Part B is to be read as if in the fourth paragraph for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(j) in entry 57 (Penthiopyrad), the seventh column is to be read as if, for the fifth paragraph there were substituted—

“The notifier must submit to each competent authority the relevant information within six months of the notification of the classification decision for penthiopyrad.”;

(k) in entry 60 (Spirotetramat), the seventh column is to be read as if in the fourth paragraph—

(i) for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) for “Community agreed test guidelines” there were substituted “ test guidelines set by the competent authority ”;

(l) in entry 67 (Spinetoram), the seventh column is to be read as if in the fifth paragraph, for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(m) in entry 69 (Amisulbrom), the seventh column is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (5) within two years after the adoption of OECD test guidelines on endocrine disruption.”;

(n) in entry 73 (Ipconazole), the seventh column is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority—

(a) the information set out in point (c) of the fourth paragraph within two years after the issuing of a specific guidance document on evaluation of isomer mixtures, and

(b) the information set out in point (d) of the fourth paragraph within two years after the adoption of OECD or national test guidelines on endocrine disruption.”;

(o) in entry 80 (Meptyldinocap), the seventh column is to be read as if , for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (b) within two years after the issuing of specific guidance.”;

(p) in entry 91 (Flupyradifurone), the seventh column is to be read as if , for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (3) within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(q) in entry 97 (Pinoxaden), the seventh column is to be read as if, for the fifth paragraph there were substituted—

“The notifier must submit to each competent authority the relevant information within six months of the notification of the classification decision for pinoxaden.”;

(r) in entry 99 (Cyantraniliprole), the seventh column is to be read as if for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(s) in entry 100 (Isofetamid), the seventh column is to be read as if—

(i) in the fourth paragraph, in the words before point (1), for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (3) within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(t) in entry 104 (Thifensulfuron-methyl), the seventh column is to be read as if—

(i) in the fourth paragraph, in the words before point (1), for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (4) within six months of the notification of the classification decision for thifensulfuron-methyl.”;

F4 (u) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(v) in entry 107 (Iodosulfuron), the seventh column is to be read as if—

(i) in the fourth paragraph, in the words before point (1), for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (2) within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(w) in entry 108 (Flazasulfuron) and entry 111 (Mesosulfuron), the seventh column is to be read as if for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(x) in entry 112 (Mesotrione), the seventh column is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (3) within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(y) in entry 114 (Propoxycarbazone), the seventh column is to be read as if for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(z) in entry 121 (Silthiofam), the seventh column is to be read as if—

(i) in the fourth paragraph, in the words before point 1, for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) in the fifth paragraph—

(aa) for “Commission” there were substituted “ competent authority ”;

(bb) for the words from “one year” to the end there were substituted “ six months of the notification of the classification decision for [F5 Silthiofam] ”;

(aa) in entry 123 (Zoxamide), the seventh column is to be read as if, in the fourth paragraph—

(i) for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) for “Commission” in the second place it appears there were substituted “ competent authority ”;

(bb) in entry 124 (Trifloxystrobin), the seventh column is to be read as if—

(i) for the fifth paragraph, there were substituted—

“The applicant must submit to each competent authority the information set out in point (1) within six months of the notification of the classification decision for trifloxystrobin.”;

(ii) in the sixth paragraph, for “the Commission” there were substituted “ each competent authority ”;

(cc) in entry 125 (Carfentrazone-ethyl), the seventh column is to be read as if—

(i) for the fifth paragraph, there were substituted—

“The applicant must submit to each competent authority the information set out in point (1) within six months of the notification of the classification decision for carfentrazone-ethyl.”;

(ii) in the sixth paragraph, for “the Commission” there were substituted “ each competent authority ”;

(dd) in entry 126 (Fenpicoxamid), the seventh column is to be read as if—

(i) in the fourth paragraph, in point 3, “, as amended by Commission Regulation (EU) 2018/605,” were omitted;

(ii) in the fifth paragraph—

(aa) for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(bb) for “Commission” in the second place it occurs there were substituted “ competent authority ”;

(ee) in entry 127 (Pethoxamid), in the seventh column, Part B is to be read as if—

(i) in the fourth paragraph, in the words before point 1, for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) in the fifth paragraph, for the words from “one year” to the end there were substituted “ six months of the notification of the classification decision for pethoxamid ”;

(iii) in the sixth paragraph, for “Commission” there were substituted “ competent authority ”;

(iv) in the seventh paragraph, the words from “in accordance with” to the end were omitted.

[F6 (ff) in entry 132 (Mefentrifluconazole), the seventh column is to be read as if—

(i) in the fourth paragraph, in the words before point 1, for “the Commission, the Member States and the Authority” there were substituted “each competent authority”;

(ii) in the fifth paragraph, “, by the Commission,” were omitted;

(gg) in entry 133 (flutianil), the seventh column is to be read as if—

(i) in the fourth paragraph, in the words before point 1, for “the Commission, the Member States and the Authority” there were substituted “each competent authority”;

(ii) in the fifth paragraph, “, from the Commission,” were omitted;

(hh) in entry 134 (Isoxaflutole), in the seventh column, the fourth paragraph is to be read as if—

(i) in the first sentence, for “the Commission, the Member States and the Authority” there were substituted “each competent authority”;

(ii) in the second sentence, “, by the Commission,” were omitted;

(ii) in entry 135 (carvone), the seventh column is to be read as if—

(i) in the fourth paragraph, for “the Commission, the Member States and the Authority” there were substituted “each competent authority”;

(ii) in the fifth paragraph, “, by the Commission,” were omitted.]

[F7 (jj) in entry 137 (Dimethenamid-P), the seventh column is to be read as if, for the fourth and fifth paragraphs there were substituted—

“The applicant must submit to each competent authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.

The applicant must submit the requested information within two years from the date of publication of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(kk) in entry 139 (Florpyrauxifen-benzyl), the seventh column is to read as if, for the fourth paragraph there were substituted—

“The applicant must submit to each competent authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex 2 to Regulation (EC) No 1107/2009 by 24 July 2021.”.]

(5) The entries in the table in Part E of the Annex are modified as follows—

(a) in entry 4 (Benzovindiflupyr), the seventh column is to be read as if, for the fifth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (3) within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(b) in entry 7 (Pendimethalin), the seventh column is to be read as if—

(i) in the fifth paragraph, in the words before point (1), for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

(ii) for the sixth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (2) within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(c) in entry 9 (Propyzamide), the seventh column is to be read as if—

(i) in the fifth paragraph, in the words before point (1), for “the Commission, the Member States and the Authority” there were substituted “ each competent authority ”;

[F8 (ii) for the sixth paragraph there were substituted—

“The applicant must submit to each competent authority the information set out in point (3) within two years after the issuing of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”.]

[F9 (d) in entry 11 (Methoxyfenozide), the seventh column is to be read as if, in the fifth paragraph, in the words before point 1, for “the Commission, the Member States and the Authority” there were substituted “each competent authority”.]

[F10 (e) in entry 12 (Alpha-cypermethrin), the seventh column is to be read as if—

(i) in the third paragraph, in the words before point (1), for “the Commission, the Member States and the Authority” there were substituted “each competent authority”;

(ii) for the fourth paragraph there were substituted—

“The applicant must submit the information requested in point (1) by 31 March 2021; the information requested in point (2) within two years from the date of publication of a guidance document on evaluation of isomer mixtures; and the information requested in point (3) within two years from the date of publication of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.”;

(iii) for the fifth paragraph there were substituted—

“For the information requested in point (4), the applicant must submit an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of androgenic endocrine activity by 30 October 2021.”.]

(6) In this paragraph, “the Annex” has the meaning given in paragraph 2(5).

Textual Amendments

F1 Words in Sch. 1 substituted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(21)(a)

F2 Sch. 1 para. 3(3)(c)(i) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(21)(b)(i)

F3 Word in Sch. 1 para. 3(3)(n) substituted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(2), 6(8)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4 Sch. 1 para. 3(4)(u) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(21)(b)(i)

F5 Word in Sch. 1 para. 3(4)(bb)(z)(ii) substituted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(2), 6(8)(aa)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F6 Sch. 1 para. 3(4)(ff)-(ii) inserted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(2), 6(8)(b)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F7 Sch. 1 para. 3(jj)(kk) inserted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(21)(b)(ii)(aa)

F8 Sch. 1 para. 3(5)(c)(ii) substituted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(2), 6(8)(aa)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F9 Sch. 1 para. 3(5)(d) inserted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(2), 6(8)(b)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F10 Sch. 1 para. 3(e) inserted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(21)(b)(ii)(bb)

Commencement Information

I1 Sch. 1 para. 3 in force at 31.12.20 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)