# L_2023047EN.01002901.xml

| 15.2.2023 | EN | Official Journal of the European Union | L 47/29 |
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15.2.2023

EN

Official Journal of the European Union

L 47/29

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COMMISSION REGULATION (EU) 2023/334

of 2 February 2023

amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for clothianidin and thiamethoxam in or on certain products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,

Whereas:

| (1) | For clothianidin and thiamethoxam maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. The European Food Safety Authority (the ‘Authority’) reviewed these MRLs in accordance with Article 12 of Regulation (EC) No 396/2005 (2) and recommended MRLs which were found to be safe for consumers. Commission Regulation (EU) 2016/156 (3) included these MRLs in Annex II to Regulation (EC) No 396/2005. Some of these MRLs were based on Codex maximum residue limits (CXLs) and had already been included in Annex II to Regulation (EC) No 396/2005 through earlier amendments (4). |
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(1)

For clothianidin and thiamethoxam maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. The European Food Safety Authority (the ‘Authority’) reviewed these MRLs in accordance with Article 12 of Regulation (EC) No 396/2005 (2) and recommended MRLs which were found to be safe for consumers. Commission Regulation (EU) 2016/156 (3) included these MRLs in Annex II to Regulation (EC) No 396/2005. Some of these MRLs were based on Codex maximum residue limits (CXLs) and had already been included in Annex II to Regulation (EC) No 396/2005 through earlier amendments (4).

| (2) | On 11 July 2015 (5) the Codex Alimentarius Commission (CAC) adopted a new set CXLs for clothianidin and thiamethoxam. As they were found to be safe for consumers in the Union (6) by the Authority, Commission Regulation (EU) 2017/671 (7) included them in Regulation (EC) No 396/2005. |
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(2)

On 11 July 2015 (5) the Codex Alimentarius Commission (CAC) adopted a new set CXLs for clothianidin and thiamethoxam. As they were found to be safe for consumers in the Union (6) by the Authority, Commission Regulation (EU) 2017/671 (7) included them in Regulation (EC) No 396/2005.

| (3) | Clothianidin and thiamethoxam were included in Annex I to Council Directive 91/414/EEC (8) on 1 August 2006 and 1 February 2007, respectively, and, therefore, before the entry into force of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (9). The most recent risk assessments (10) (11) for bees from the exposure to these substances conducted by the Authority under Regulation (EC) No 1107/2009 found that, due to their intrinsic properties, the exposure from outdoor use of clothianidin and thiamethoxam leads to unacceptable risks for bees, or such risks could not be excluded based on the available data. Therefore, Commission Implementing Regulations (EU) 2018/784 (12) and (EU) 2018/785 (13) restricted, the approval of clothianidin and thiamethoxam, respectively, to uses in permanent greenhouses only and required that the resulting crops stayed within a permanent greenhouse during their entire life cycle. |
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(3)

Clothianidin and thiamethoxam were included in Annex I to Council Directive 91/414/EEC (8) on 1 August 2006 and 1 February 2007, respectively, and, therefore, before the entry into force of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (9). The most recent risk assessments (10) (11) for bees from the exposure to these substances conducted by the Authority under Regulation (EC) No 1107/2009 found that, due to their intrinsic properties, the exposure from outdoor use of clothianidin and thiamethoxam leads to unacceptable risks for bees, or such risks could not be excluded based on the available data. Therefore, Commission Implementing Regulations (EU) 2018/784 (12) and (EU) 2018/785 (13) restricted, the approval of clothianidin and thiamethoxam, respectively, to uses in permanent greenhouses only and required that the resulting crops stayed within a permanent greenhouse during their entire life cycle.

| (4) | Following the adoption of these restrictions, all applications for the renewal of the approval of the active substances clothianidin and thiamethoxam were withdrawn. Therefore, the approval of clothianidin expired on 31 January 2019 and the approval of thiamethoxam expired on 30 April 2019. |
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(4)

Following the adoption of these restrictions, all applications for the renewal of the approval of the active substances clothianidin and thiamethoxam were withdrawn. Therefore, the approval of clothianidin expired on 31 January 2019 and the approval of thiamethoxam expired on 30 April 2019.

| (5) | In the light of the Authority’s risk assessment for bees and of all the available pertinent information, there is currently no evidence that would allow any outdoor uses for clothianidin and thiamethoxam to be considered as safe for bees. Producers of the substances can however, at any time, submit additional information, as provided in Articles 7 of Regulation (EC) No 1107/2009, demonstrating the safety for bees of outdoor uses of clothianidin and thiamethoxam. That information, if submitted, would be reviewed within the time period provided for in that Regulation. To date, no such information has been submitted. |
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(5)

In the light of the Authority’s risk assessment for bees and of all the available pertinent information, there is currently no evidence that would allow any outdoor uses for clothianidin and thiamethoxam to be considered as safe for bees. Producers of the substances can however, at any time, submit additional information, as provided in Articles 7 of Regulation (EC) No 1107/2009, demonstrating the safety for bees of outdoor uses of clothianidin and thiamethoxam. That information, if submitted, would be reviewed within the time period provided for in that Regulation. To date, no such information has been submitted.

| (6) | Adverse effects of clothianidin and thiamethoxam on bees are directly linked to the intrinsic properties of those substances. Therefore, the risks for bees from outdoor uses of these substances are unlikely to be limited to the Union. |
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(6)

Adverse effects of clothianidin and thiamethoxam on bees are directly linked to the intrinsic properties of those substances. Therefore, the risks for bees from outdoor uses of these substances are unlikely to be limited to the Union.

| (7) | There is a substantial body of evidence showing that active substances which are neonicotinoids, such as clothianidin and thiamethoxam, play an important role in the decline of bees and other pollinators worldwide. The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services on pollinators, pollination and food production concluded in its 2016 assessment report (14) that neonicotinoids (such as clothianidin and thiamethoxam) have adverse effects on bees and other pollinators. The impact of neonicotinoids on wildlife has been assessed by the International Union for Conservation of Nature (IUCN) Task Force on Systemic Pesticides since 2012. The Worldwide Integrated Assessment of the Impact of Systemic Pesticides on Biodiversity and Ecosystems (WIA) has examined 1 121 scientific studies and results indicate that pollinator populations are highly vulnerable to the existing levels of pollution with neonicotinoids and are likely to have large-scale and wide ranging negative biological and ecological impacts (15). A recent review of the existing scientific knowledge corroborated this conclusion indicating that neonicotinoid use is driving the decline of pollinator population in different world regions (16). |
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(7)

There is a substantial body of evidence showing that active substances which are neonicotinoids, such as clothianidin and thiamethoxam, play an important role in the decline of bees and other pollinators worldwide. The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services on pollinators, pollination and food production concluded in its 2016 assessment report (14) that neonicotinoids (such as clothianidin and thiamethoxam) have adverse effects on bees and other pollinators. The impact of neonicotinoids on wildlife has been assessed by the International Union for Conservation of Nature (IUCN) Task Force on Systemic Pesticides since 2012. The Worldwide Integrated Assessment of the Impact of Systemic Pesticides on Biodiversity and Ecosystems (WIA) has examined 1 121 scientific studies and results indicate that pollinator populations are highly vulnerable to the existing levels of pollution with neonicotinoids and are likely to have large-scale and wide ranging negative biological and ecological impacts (15). A recent review of the existing scientific knowledge corroborated this conclusion indicating that neonicotinoid use is driving the decline of pollinator population in different world regions (16).

| (8) | Since the ban on outdoor uses of clothianidin and thiamethoxam in the Union, several countries outside the Union have also restricted the use of clothianidin and thiamethoxam to protect pollinators, including bees (17) (18) (19). Other countries are currently re-evaluating their approval of these active substances (20) (21) (22). |
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(8)

Since the ban on outdoor uses of clothianidin and thiamethoxam in the Union, several countries outside the Union have also restricted the use of clothianidin and thiamethoxam to protect pollinators, including bees (17) (18) (19). Other countries are currently re-evaluating their approval of these active substances (20) (21) (22).

| (9) | Regulation (EC) No 396/2005 establishes in accordance with the general principles laid down in Regulation (EC) No 178/2002 (23) provisions related to maximum residue levels of pesticides residues in or on food and feed of plant and animal origin. In accordance with Article 5(1) of the latter Regulation, food law shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers’ interests, including fair practices in food trade, taking into account, where appropriate, the protection of animal health and welfare, plant health and the environment. |
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(9)

Regulation (EC) No 396/2005 establishes in accordance with the general principles laid down in Regulation (EC) No 178/2002 (23) provisions related to maximum residue levels of pesticides residues in or on food and feed of plant and animal origin. In accordance with Article 5(1) of the latter Regulation, food law shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers’ interests, including fair practices in food trade, taking into account, where appropriate, the protection of animal health and welfare, plant health and the environment.

| (10) | There is growing worldwide concern that the decline of pollinators is a serious threat to global biodiversity, the environment and sustainable development, as well as to maintaining agricultural productivity and food security. According to the Convention on Biological Diversity’s International Initiative for the Conservation and Sustainable Use of Pollinators (24), pollination is one of the most important mechanisms in the maintenance and promotion of biodiversity and, in general, life on earth. Many ecosystems, including agro-ecosystems and two thirds of major food crops depend on pollinators for quality or yield. The Food and Agriculture Organization of the United Nations (FAO) calls for actions to address the drivers of pollinator decline for the sake of sustainable global food production (25). Highly dependent on pollination, foods such as fruits, vegetables, nuts and seeds are the main dietary contributors of micronutrients necessary to prevent the risk of some non-communicable diseases in humans (26) (27). Therefore, pollinators are important to ensure diversity in diet and to reduce the threat to biodiversity in the global environment. |
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(10)

There is growing worldwide concern that the decline of pollinators is a serious threat to global biodiversity, the environment and sustainable development, as well as to maintaining agricultural productivity and food security. According to the Convention on Biological Diversity’s International Initiative for the Conservation and Sustainable Use of Pollinators (24), pollination is one of the most important mechanisms in the maintenance and promotion of biodiversity and, in general, life on earth. Many ecosystems, including agro-ecosystems and two thirds of major food crops depend on pollinators for quality or yield. The Food and Agriculture Organization of the United Nations (FAO) calls for actions to address the drivers of pollinator decline for the sake of sustainable global food production (25). Highly dependent on pollination, foods such as fruits, vegetables, nuts and seeds are the main dietary contributors of micronutrients necessary to prevent the risk of some non-communicable diseases in humans (26) (27). Therefore, pollinators are important to ensure diversity in diet and to reduce the threat to biodiversity in the global environment.

| (11) | As the decline in pollinators is an issue of international concern, Union measures need to be adopted to protect pollinator populations worldwide, including bees, from the risks of active substances, such as the neonicotinoids clothianidin and thiamethoxam. Preserving the pollinator population within the Union only would be insufficient to reverse the worldwide decline of pollinator populations and its effects on biodiversity, agricultural production and food security, also in the Union. |
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(11)

As the decline in pollinators is an issue of international concern, Union measures need to be adopted to protect pollinator populations worldwide, including bees, from the risks of active substances, such as the neonicotinoids clothianidin and thiamethoxam. Preserving the pollinator population within the Union only would be insufficient to reverse the worldwide decline of pollinator populations and its effects on biodiversity, agricultural production and food security, also in the Union.

| (12) | In accordance with Article 3(2)(d) of Regulation (EC) No 396/2005, MRLs for clothianidin and thiamethoxam were based on Good Agricultural Practices (GAPs) as defined in Article 3(2)(a) of that Regulation, which took into account, in particular, considerations of efficiency to combat plant pests, and protection of the environment and public health in the context of the authorisation of the use of plant protection products containing those substances. The MRLs resulting from these GAPs were subsequently considered and found safe for consumers in the Union. It is now appropriate to complement the regulatory response to date by better integrating within it environmental considerations taking into account in particular whether the GAPs used in the past as a basis for setting MRLs ensure a sufficient protection of the environment, based on current knowledge. GAPs involving outdoor uses of clothianidin and thiamethoxam are not acceptable, in light of current scientific and technical knowledge, due to their effects on bees. Given the global nature of pollinator decline, there is a need to ensure that also commodities imported into the Union do not contain residues resulting from GAPs based on outdoor uses of clothianidin and/or thiamethoxam, in order to avoid the transfer of adverse effects on bees from food production in the Union to production of food in other parts of the world that is then imported into the Union (28). This is appropriate to ensure that all products produced or consumed in the Union are free from clothianidin and thiamethoxam and the production is not associated with pollinator mortality. In view of this, CXLs based on GAPs that do not achieve the appropriate level of protection of the Union should no longer be provided for as MRLs pursuant to Regulation (EC) No 396/2005. |
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(12)

In accordance with Article 3(2)(d) of Regulation (EC) No 396/2005, MRLs for clothianidin and thiamethoxam were based on Good Agricultural Practices (GAPs) as defined in Article 3(2)(a) of that Regulation, which took into account, in particular, considerations of efficiency to combat plant pests, and protection of the environment and public health in the context of the authorisation of the use of plant protection products containing those substances. The MRLs resulting from these GAPs were subsequently considered and found safe for consumers in the Union. It is now appropriate to complement the regulatory response to date by better integrating within it environmental considerations taking into account in particular whether the GAPs used in the past as a basis for setting MRLs ensure a sufficient protection of the environment, based on current knowledge. GAPs involving outdoor uses of clothianidin and thiamethoxam are not acceptable, in light of current scientific and technical knowledge, due to their effects on bees. Given the global nature of pollinator decline, there is a need to ensure that also commodities imported into the Union do not contain residues resulting from GAPs based on outdoor uses of clothianidin and/or thiamethoxam, in order to avoid the transfer of adverse effects on bees from food production in the Union to production of food in other parts of the world that is then imported into the Union (28). This is appropriate to ensure that all products produced or consumed in the Union are free from clothianidin and thiamethoxam and the production is not associated with pollinator mortality. In view of this, CXLs based on GAPs that do not achieve the appropriate level of protection of the Union should no longer be provided for as MRLs pursuant to Regulation (EC) No 396/2005.

| (13) | Furthermore, all authorisations for plant protection products containing clothianidin and/or thiamethoxam in the Union have been revoked. It is therefore appropriate to delete the corresponding MRLs set out in Annex II of Regulation (EC) No 396/2005, in accordance with Article 17 of that Regulation in conjunction with Article 14(1)(a). |
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(13)

Furthermore, all authorisations for plant protection products containing clothianidin and/or thiamethoxam in the Union have been revoked. It is therefore appropriate to delete the corresponding MRLs set out in Annex II of Regulation (EC) No 396/2005, in accordance with Article 17 of that Regulation in conjunction with Article 14(1)(a).

| (14) | Therefore, taking into account all the factors relevant to the matter under consideration in accordance with Article 14(2), read in the light of Article 11 of the Treaty of the Functioning of the European Union, requiring that ‘environmental protection requirements must be integrated into the definition and implementation of the Union’s policies and activities, in particular with a view to promoting sustainable development’, all the current MRLs for clothianidin and/or thiamethoxam as set out by Regulation (EC) No 396/2005 should be lowered to the Limit of Determination (LODs). |
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(14)

Therefore, taking into account all the factors relevant to the matter under consideration in accordance with Article 14(2), read in the light of Article 11 of the Treaty of the Functioning of the European Union, requiring that ‘environmental protection requirements must be integrated into the definition and implementation of the Union’s policies and activities, in particular with a view to promoting sustainable development’, all the current MRLs for clothianidin and/or thiamethoxam as set out by Regulation (EC) No 396/2005 should be lowered to the Limit of Determination (LODs).

| (15) | The Commission consulted the European Union reference laboratories on analytically achievable LODs specific to each product. Those LODs should be listed in Annex V in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(15)

The Commission consulted the European Union reference laboratories on analytically achievable LODs specific to each product. Those LODs should be listed in Annex V in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005.

| (16) | Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
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(16)

Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

| (17) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(17)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (18) | In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced in or imported into the Union before the modification of the MRLs and for which information shows that for such products complying with the existing MRLs a high level of consumer protection is maintained. |
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(18)

In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced in or imported into the Union before the modification of the MRLs and for which information shows that for such products complying with the existing MRLs a high level of consumer protection is maintained.

| (19) | A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit operators in third countries, especially in least developed and developing countries, and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. Such adaptation of agricultural practices can be reasonably expected to be achieved after at least two growing seasons. |
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(19)

A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit operators in third countries, especially in least developed and developing countries, and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. Such adaptation of agricultural practices can be reasonably expected to be achieved after at least two growing seasons.

| (20) | In order to meet the needs of international trade, applications for import tolerances for clothianidin or thiamethoxam maybe be submitted pursuant to Article 7 of Regulation (EC) No 396/2005 and should provide relevant information to demonstrate that the GAPs applying for the specific uses of the active substances are safe for pollinators. That information, if submitted, would be assessed on a case by case basis within the time period provided for in that Regulation. In the context of the assessment of a request for an import tolerance, if an applicant provides scientific evidence that the use of these neonicotinoids does not adversely impact pollinators, if all requirements are met, an import tolerance could be set by the Commission. |
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(20)

In order to meet the needs of international trade, applications for import tolerances for clothianidin or thiamethoxam maybe be submitted pursuant to Article 7 of Regulation (EC) No 396/2005 and should provide relevant information to demonstrate that the GAPs applying for the specific uses of the active substances are safe for pollinators. That information, if submitted, would be assessed on a case by case basis within the time period provided for in that Regulation. In the context of the assessment of a request for an import tolerance, if an applicant provides scientific evidence that the use of these neonicotinoids does not adversely impact pollinators, if all requirements are met, an import tolerance could be set by the Commission.

| (21) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(21)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products, which were produced in the Union or imported into the Union before 7 March 2026.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 7 March 2026.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 2 February 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  EFSA (European Food Safety Authority), 2014. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for clothianidin and thiamethoxam according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2014;12(12):3918, 120 pp. doi:10.2903/j.efsa.2014.3918.

2

(3)  Commission Regulation (EU) 2016/156 of 18 January 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for boscalid, clothianidin, thiamethoxam, folpet and tolclofos-methyl in or on certain products (OJ L 31, 6.2.2016, p. 1).

3

(4)  Commission Regulation (EU) No 441/2012 of 24 May 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bifenazate, bifenthrin, boscalid, cadusafos, chlorantraniliprole, chlorothalonil, clothianidin, cyproconazole, deltamethrin, dicamba, difenoconazole, dinocap, etoxazole, fenpyroximate, flubendiamide, fludioxonil, glyphosate, metalaxyl-M, meptyldinocap, novaluron, thiamethoxam, and triazophos in or on certain products (OJ L 135, 25.5.2012, p. 4).

4

(5)  Joint FAO/WHO food standards programme Codex Alimentarius Commission. Appendices III and IV. Thirty-Eight Session. Geneva, Switzerland, 6-11 July 2015.

5

(6)  European Food Safety Authority; Scientific support for preparing an EU position in the 47th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2015;13(7):4208 178 pp. doi: 10.2903/j.efsa.2015.4208.

6

(7)  Commission Regulation (EU) 2017/671 of 7 April 2017 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for clothianidin and thiamethoxam in or on certain products (OJ L 97, 8.4.2017, p. 9).

7

(8)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

8

(9)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

9

(10)  European Food Safety Authority; Peer review of the pesticide risk assessment for bees for the active substance clothianidin considering the uses as seed treatments and granules. EFSA Journal 2018;16(2):5177.

10

(11)  European Food Safety Authority; Peer review of the pesticide risk assessment for bees for the active substance thiamethoxam considering the uses as seed treatments and granules. EFSA Journal 2018;16(2):5179.

11

(12)  Commission Implementing Regulation (EU) 2018/784 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin (OJ L 132, 30.5.2018, p. 35).

12

(13)  Commission Implementing Regulation (EU) 2018/785 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance thiamethoxam (OJ L 132, 30.5.2018, p. 40).

13

(14)  IPBES (2016). The assessment report of the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services on pollinators, pollination and food production. S.G. Potts, V. L. Imperatriz-Fonseca, and H. T. Ngo (eds). Secretariat of the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services, Bonn, Germany. 552 pages. https://doi.org/10.5281/zenodo.3402856.

14

(15)  IUCN SSC CEM Task Force on Systemic Pesticides. Worldwide Integrated Assessment. Peer reviewed scientific journal articles compiled in Environmental Science and Pollution Research volume 22, issue 1, January 2015.

15

(16)  Neonic Insecticides and Invertebrate Species Endangerment, Pierre Mineau. Module in Earth Systems and Environmental Sciences. 2021.

16

https://www.sciencedirect.com/science/article/pii/B9780128211397001264.

(17)  Health Canada’s Pest Management Regulatory Agency. Re-evaluation Decision RVD2019-05, Clothianidin and Its Associated End-use Products: Pollinator Re-evaluation. Pest Management Regulatory Agency 11 April 2019 ISSN: 1925-0886.

17

(18)  Health Canada’s Pest Management Regulatory Agency. Re-evaluation Decision RVD2019-04,. Thiamethoxam and Its Associated End-use Products: Pollinator Re-evaluation. Pest Management Regulatory Agency 11 April 2019 ISSN: 1925-0886.

18

(19)  Ministerio de Ganadería, Agricultura y PESCA de Paraguay. Resolución No 503/019 DGSA Modificación de etiquetas para los Productos Fitosanitarios a base de los ingredientes activos Clotianidina, Imidacloprid, Tiametoxan y Clorpirifos. December 2019.

19

(20)  Australian Pesticides and Veterinary Medicines Authority. Reconsideration of Neonicotinoid Approvals and Registrations. Commonwealth of Australia Gazette No. APVMA 23, November 2019. https://apvma.gov.au/sites/default/files/apvma_gazette_23_19_november_2019.pdf.

20

(21)  New Zealand Environmental Protection Authority. Application to decide whether there are grounds for reassessment of the neonicotinoids clothianidin, thiamethoxam, imidacloprid, thiacloprid, and acetamiprid (APP203949). December 2019. https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203949/APP203949_Final_Neonicotinoids_Decision_16-12-2019.pdf.

21

(22)  United States Environmental Protection Agency. Proposed Interim Registration Review Decision Case Numbers 7620 and 7614. Docket Numbers EPA-HQ-OPP-2011-0865 and EPA-HQ-OPP-2011-0581. January 2020.

22

(23)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

23

(24)  https://www.cbd.int/doc/decisions/cop-14/cop-14-dec-06-en.pdf.

24

(25)  FAO. 2019. The State of the World’s Biodiversity for Food and Agriculture, J. Bélanger & D. Pilling (eds.). FAO Commission on Genetic Resources for Food and Agriculture Assessments. Rome. 572 pp. https://www.fao.org/3/CA3129EN/CA3129EN.pdf.

25

(26)  Effects of decreases of animal pollinators on human nutrition and global health: a modelling analysis. MR Smith, GM Singh, D Mozaffarian, SS Myers. The Lancet 386, Issue 10007; 2015. doi: 10.1016/S0140-6736(15)61085-6.

26

(27)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Europe’s Beating Cancer Plan. COM (2021) 44. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=COM%3A2021%3A44%3AFIN.

27

(28)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system. COM (2020) 381. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0381.

28

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ANNEX

Annexes II and V to Regulation (EC) No 396/2005 are amended as follows:

| (1) | in Annex II the columns for clothianidin and thiamethoxam are deleted; |
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(1)

in Annex II the columns for clothianidin and thiamethoxam are deleted;

| (2) | in Annex V the columns for clothianidin and thiamethoxam are added:

  ‘Pesticide residues and maximum residue levels (mg/kg)









  Code number | Groups and examples of individual products to which the MRLs apply
   (1) | Clothianidin | Thiamethoxam |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0,01
   (*) | 0,01
   (*) |
| 0110000 | Citrus fruits | | |
| 0110010 | Grapefruits | | |
| 0110020 | Oranges | | |
| 0110030 | Lemons | | |
| 0110040 | Limes | | |
| 0110050 | Mandarins | | |
| 0110990 | Others (2) | | |
| 0120000 | Tree nuts | | |
| 0120010 | Almonds | | |
| 0120020 | Brazil nuts | | |
| 0120030 | Cashew nuts | | |
| 0120040 | Chestnuts | | |
| 0120050 | Coconuts | | |
| 0120060 | Hazelnuts/cobnuts | | |
| 0120070 | Macadamias | | |
| 0120080 | Pecans | | |
| 0120090 | Pine nut kernels | | |
| 0120100 | Pistachios | | |
| 0120110 | Walnuts | | |
| 0120990 | Others (2) | | |
| 0130000 | Pome fruits | | |
| 0130010 | Apples | | |
| 0130020 | Pears | | |
| 0130030 | Quinces | | |
| 0130040 | Medlars | | |
| 0130050 | Loquats/Japanese medlars | | |
| 0130990 | Others (2) | | |
| 0140000 | Stone fruits | | |
| 0140010 | Apricots | | |
| 0140020 | Cherries (sweet) | | |
| 0140030 | Peaches | | |
| 0140040 | Plums | | |
| 0140990 | Others (2) | | |
| 0150000 | Berries and small fruits | | |
| 0151000 | (a) | grapes |

(2)

in Annex V the columns for clothianidin and thiamethoxam are added:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply
   (1)

Clothianidin

Thiamethoxam

(1)

(2)

(3)

(4)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0,01
   (*)

0,01
   (*)

0110000

Citrus fruits

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others (2)

0120000

Tree nuts

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others (2)

0130000

Pome fruits

0130010

Apples

0130020

Pears

0130030

Quinces

0130040

Medlars

0130050

Loquats/Japanese medlars

0130990

Others (2)

0140000

Stone fruits

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others (2)

0150000

Berries and small fruits

0151000

(a)

grapes

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | strawberries |
| --- | --- |

(b)

strawberries

0153000

| (c) | cane fruits |
| --- | --- |

(c)

cane fruits

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others (2)

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

other small fruits and berries

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others (2)

0160000

Miscellaneous fruits with

0161000

| (a) | edible peel |
| --- | --- |

(a)

edible peel

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats

0161050

Carambolas

0161060

Kaki/Japanese persimmons

0161070

Jambuls/jambolans

0161990

Others (2)

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

inedible peel, small

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others (2)

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

inedible peel, large

0163010

Avocados

0163020

Bananas

0163030

Mangoes

0163040

Papayas

0163050

Granate apples/pomegranates

0163060

Cherimoyas

0163070

Guavas

0163080

Pineapples

0163090

Breadfruits

0163100

Durians

0163110

Soursops/guanabanas

0163990

Others (2)

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01
   (*)

0,01
   (*)

0211000

| (a) | potatoes |
| --- | --- |

(a)

potatoes

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

tropical root and tuber vegetables

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others (2)

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

other root and tuber vegetables except sugar beets

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others (2)

0220000

Bulb vegetables

0,01  (*)

0,01  (*)

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others (2)

0230000

Fruiting vegetables

0,01
   (*)

0,01
   (*)

0231000

| (a) | Solanaceae and Malvaceae |
| --- | --- |

(a)

Solanaceae and Malvaceae

0231010

Tomatoes

0231020

Sweet peppers/bell peppers

0231030

Aubergines/eggplants

0231040

Okra/lady's fingers

0231990

Others (2)

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

cucurbits with edible peel

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others (2)

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

cucurbits with inedible peel

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others (2)

0234000

| (d) | sweet corn |
| --- | --- |

(d)

sweet corn

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

other fruiting vegetables

0240000

Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

0,01
   (*)

0,01
   (*)

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others (2)

0242000

| (b) | head brassica |
| --- | --- |

(b)

head brassica

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others (2)

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

leafy brassica

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others (2)

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

kohlrabies

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

lettuces and salad plants

0,01
   (*)

0,01
   (*)

0251010

Lamb's lettuces/corn salads

0251020

Lettuces

0251030

Escaroles/broad-leaved endives

0251040

Cresses and other sprouts and shoots

0251050

Land cresses

0251060

Roman rocket/rucola

0251070

Red mustards

0251080

Baby leaf crops (including brassica species)

0251990

Others (2)

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

spinaches and similar leaves

0,01  (*)

0,01  (*)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others (2)

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

grape leaves and similar species

0,01  (*)

0,01  (*)

0254000

| (d) | watercresses |
| --- | --- |

(d)

watercresses

0,01  (*)

0,01  (*)

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

witloofs/Belgian endives

0,01  (*)

0,01  (*)

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

herbs and edible flowers

0,02
   (*)

0,02
   (*)

0256010

Chervil

0256020

Chives

0256030

Celery leaves

0256040

Parsley

0256050

Sage

0256060

Rosemary

0256070

Thyme

0256080

Basil and edible flowers

0256090

Laurel/bay leaves

0256100

Tarragon

0256990

Others (2)

0260000

Legume vegetables

0,01
   (*)

0,01
   (*)

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others (2)

0270000

Stem vegetables

0,01
   (*)

0,01
   (*)

0270010

Asparagus

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270050

Globe artichokes

0270060

Leeks

0270070

Rhubarbs

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others (2)

0280000

Fungi, mosses and lichens

0,01  (*)

0,01  (*)

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01  (*)

0,01  (*)

0300000

PULSES

0,01
   (*)

0,01
   (*)

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others (2)

0400000

OILSEEDS AND OIL FRUITS

0,01
   (*)

0,01
   (*)

0401000

Oilseeds

0401010

Linseeds

0401020

Peanuts/groundnuts

0401030

Poppy seeds

0401040

Sesame seeds

0401050

Sunflower seeds

0401060

Rapeseeds/canola seeds

0401070

Soyabeans

0401080

Mustard seeds

0401090

Cotton seeds

0401100

Pumpkin seeds

0401110

Safflower seeds

0401120

Borage seeds

0401130

Gold of pleasure seeds

0401140

Hemp seeds

0401150

Castor beans

0401990

Others (2)

0402000

Oil fruits

0402010

Olives for oil production

0402020

Oil palms kernels

0402030

Oil palms fruits

0402040

Kapok

0402990

Others (2)

0500000

CEREALS

0,01
   (*)

0,01
   (*)

0500010

Barley

0500020

Buckwheat and other pseudocereals

0500030

Maize/corn

0500040

Common millet/proso millet

0500050

Oat

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat

0500990

Others (2)

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0610000

Teas

0,05
   (*)

0,05
   (*)

0620000

Coffee beans

0,05  (*)

0,05
   (*)

0630000

Herbal infusions from

0,05  (*)

0,05  (*)

0631000

| (a) | flowers |
| --- | --- |

(a)

flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

| (c) | roots |
| --- | --- |

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others (2)

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

any other parts of the plant

0640000

Cocoa beans

0,02  (*)

0,02  (*)

0650000

Carobs/Saint John's breads

0,05  (*)

0,05  (*)

0700000

HOPS

0,05
   (*)

0,05
   (*)

0800000

SPICES

0810000

Seed spices

0,05  (*)

0,05  (*)

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others (2)

0820000

Fruit spices

0,05  (*)

0,05  (*)

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others (2)

0830000

Bark spices

0,05  (*)

0,05  (*)

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,05  (*)

0,05  (*)

0840020

Ginger (10)

0840030

Turmeric/curcuma

0,05  (*)

0,05  (*)

0840040

Horseradish (11)

0840990

Others (2)

0,05  (*)

0,05  (*)

0850000

Bud spices

0,05  (*)

0,05  (*)

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,05  (*)

0,05  (*)

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,05  (*)

0,05  (*)

0870010

Mace

0870990

Others (2)

0900000

SUGAR PLANTS

0,01
   (*)

0,01
   (*)

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others (2)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Commodities from

0,02
   (*)

0,02
   (*)

1011000

| (a) | swine |
| --- | --- |

(a)

swine

1011010

Muscle

1011020

Fat

1011030

Liver

1011040

Kidney

1011050

Edible offals (other than liver and kidney)

1011990

Others (2)

1012000

| (b) | bovine |
| --- | --- |

(b)

bovine

1012010

Muscle

1012020

Fat

1012030

Liver

1012040

Kidney

1012050

Edible offals (other than liver and kidney)

1012990

Others (2)

1013000

| (c) | sheep |
| --- | --- |

(c)

sheep

1013010

Muscle

1013020

Fat

1013030

Liver

1013040

Kidney

1013050

Edible offals (other than liver and kidney)

1013990

Others (2)

1014000

| d) | goat |
| --- | --- |

d)

goat

1014010

Muscle

1014020

Fat

1014030

Liver

1014040

Kidney

1014050

Edible offals (other than liver and kidney)

1014990

Others (2)

1015000

| (e) | equine |
| --- | --- |

(e)

equine

1015010

Muscle

1015020

Fat

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others (2)

1016000

| (f) | poultry |
| --- | --- |

(f)

poultry

1016010

Muscle

1016020

Fat

1016030

Liver

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others (2)

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

other farmed terrestrial animals

1017010

Muscle

1017020

Fat

1017030

Liver

1017040

Kidney

1017050

Edible offals (other than liver and kidney)

1017990

Others (2)

1020000

Milk

0,01
   (*)

0,01
   (*)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

0,01  (*)

0,01  (*)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others (2)

1040000

Honey and other apiculture products (7)

0,05  (*)

0,05  (*)

1050000

Amphibians and Reptiles

0,01  (*)

0,01  (*)

1060000

Terrestrial invertebrate animals

0,01  (*)

0,01  (*)

1070000

Wild terrestrial vertebrate animals

0,01  (*)

0,01  (*)

1100000

PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)

1200000

PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)

1300000

PROCESSED FOOD PRODUCTS (9)

---

(*)  Indicates lower limit of analytical determination.

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I.’

---