Paragraph 16 Plant Protection Products (Fees and Charges) Regulations 2011

After Schedule 2 insert—

“SCHEDULE 3

Maximum residue level supplementary information fees

Regulation 4(2A)

Fees for the evaluation of supplementary information provided in accordance with Article 14(3) of the MRL Regulation are in accordance with the following table.

Item Category Fee (£)

Notes
(1)
This category is for an MRL supplementary information requirement to provide additional information on aspects of the data already evaluated or to provide evidence of the commercial availability of standards for MRL compliance.

(2)
This category is for an MRL supplementary information requirement to provide an analytical method for MRL compliance.

(3)
This category is for an MRL supplementary information requirement to address the toxicological relevance of a metabolite identified in plants or products of animal origin.

(4)
This category is for an MRL supplementary information requirement to address plant or livestock metabolism or any other nature of residue study.

(5)
This category is for an MRL supplementary information requirement to provide additional residue trials or any other magnitude of residue study including monitoring data.

Fees for multiple submissions to address MRL supplementary information for the same active substance are calculated on a modular basis with a charge applied for each MRL supplementary information requirement. Large or novel studies to address MRL supplementary information requirements will incur an additional fee, as a multiple of the original fee, if significant extra work is required over and above the usual level for the module in question.

1 Preliminary consideration of application to determine whether the application can proceed further 229
2 Co-ordination of applications 1,872
3 Simple reasoned case⁽¹⁾ 416
4 Analytical method⁽²⁾ 416
5 Toxicology⁽³⁾ 3,120
6 Metabolism and residues evaluation⁽⁴⁾ 6,760
7 Residues evaluation⁽⁵⁾ 2,028

”

Item	Category	Fee (£)
Notes
(1) This category is for an MRL supplementary information requirement to provide additional information on aspects of the data already evaluated or to provide evidence of the commercial availability of standards for MRL compliance.
(2) This category is for an MRL supplementary information requirement to provide an analytical method for MRL compliance.
(3) This category is for an MRL supplementary information requirement to address the toxicological relevance of a metabolite identified in plants or products of animal origin.
(4) This category is for an MRL supplementary information requirement to address plant or livestock metabolism or any other nature of residue study.
(5) This category is for an MRL supplementary information requirement to provide additional residue trials or any other magnitude of residue study including monitoring data.
Fees for multiple submissions to address MRL supplementary information for the same active substance are calculated on a modular basis with a charge applied for each MRL supplementary information requirement. Large or novel studies to address MRL supplementary information requirements will incur an additional fee, as a multiple of the original fee, if significant extra work is required over and above the usual level for the module in question.
1	Preliminary consideration of application to determine whether the application can proceed further	229
2	Co-ordination of applications	1,872
3	Simple reasoned case⁽¹⁾	416
4	Analytical method⁽²⁾	416
5	Toxicology⁽³⁾	3,120
6	Metabolism and residues evaluation⁽⁴⁾	6,760
7	Residues evaluation⁽⁵⁾	2,028