JUDGMENT OF THE GENERAL COURT (Seventh Chamber)

10 July 2024 (*)

(Agriculture – Implementing Regulation (EU) 2021/2325 – Imports into the European Union of organic products from third countries – Recognition of third countries – Execution of controls and certification of products by control bodies – Decision to withdraw an establishment from the list of recognised control bodies for India appearing in the list of recognised third countries – Competence of the Commission – Rights of the defence – Proportionality – Equal treatment – Legal certainty – Legitimate expectations)

In Case T‑123/22,

Ecocert India Pte Ltd, established in Gurugram (India), represented by Y. Martinet, D. Todorova and J. Sohm, lawyers,

applicant,

v

European Commission, represented by A. Dawes and B. Hofstötter, acting as Agents,

defendant,

THE GENERAL COURT (Seventh Chamber),

composed of K. Kowalik-Bańczyk, President, E. Buttigieg and B. Ricziová (Rapporteur), Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure,

further to the hearing on 30 June 2023,

gives the following

Judgment

1        By its action under Article 263 TFEU, the applicant, Ecocert India Pte Ltd, seeks the annulment of Article 1 of Commission Implementing Regulation (EU) 2021/2325 of 16 December 2021 establishing, pursuant to Regulation (EU) 2018/848 of the European Parliament and of the Council, the list of third countries and the list of control authorities and control bodies that have been recognised under Article 33(2) and (3) of Council Regulation (EC) No 834/2007 for the purpose of importing organic products into the Union (OJ 2021 L 465, p. 8) (‘the contested implementing regulation’), in so far as that provision, in conjunction with Annex I to that regulation, removes the applicant from the list of control bodies recognised for India by the competent Indian authority, appearing in the list of recognised third countries, accredited to carry out controls and issue certificates of inspection authorising the placing on the EU market of organic products imported from that country (‘the list of recognised control bodies for India’).

 Legal framework

 Regulation No 834/2007

2        Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ 2007 L 189, p. 1), provides, in Article 33 thereof, entitled ‘Import of products providing equivalent guarantees’ and appearing in Title VI thereof, entitled ‘Trade with third countries’:

‘1.      A product imported from a third country may also be placed on the Community market as organic provided that:

…

(c)      the operators at all stages of production, preparation and distribution in the third country have submitted their activities to a control system recognised in accordance with paragraph 2 …;

(d)      the product is covered by a certificate of inspection issued by the competent authorities, control authorities or control bodies of the third country recognised in accordance with paragraph 2 …, which confirms that the product satisfies the conditions set out in this paragraph.

…

2.      The Commission may, in accordance with the procedure referred to in Article 37(2), recognise the third countries whose system of production complies with principles and production rules equivalent to those laid down in Titles II, III and IV and whose control measures are of equivalent effectiveness to those laid down in Title V, and establish a list of these countries. …

When examining requests for recognition, the Commission shall invite the third country to supply all the necessary information. The Commission may entrust experts with the task of examining on-the-spot the rules of production and the control measures of the third country concerned.

By 31 March of each year, the recognised third countries shall send a concise annual report to the Commission regarding the implementation and the enforcement of the control measures established in the third country.

Based on the information in these annual reports, the Commission assisted by the Member States ensures appropriate supervision of the recognised third countries by regularly reviewing their recognition. The nature of the supervision shall be determined on the basis of an assessment of the risk of the occurrence of irregularities or infringements of the provisions set out in this Regulation.

…’

 Regulation No 1235/2008

3        Article 1 of Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (OJ 2008 L 334, p. 25), entitled ‘Subject matter’, provides:

‘This Regulation lays down the detailed rules for the import of compliant products and the import of products providing equivalent guarantees as provided for in Articles 32 and 33 of Regulation … No 834/2007.’

4        Article 7 of Regulation No 1235/2008, entitled ‘Compilation and content of the list of third countries’, provides:

‘1.      The Commission shall establish a list of recognised third countries in accordance with Article 33(2) of Regulation … No 834/2007. The list of recognised countries is set out in Annex III to this Regulation. The procedures for drawing up and amending the list are defined in Articles 8 and 16 of this Regulation. Amendments to the list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation.

2.      The list shall contain all the information necessary in respect of each third country to allow verifying whether products placed on the Community market have been subject to the control system of the third country recognised in accordance with Article 33(2) of Regulation … No 834/2007 and in particular:

(a)      the product categories concerned;

(b)      the origin of the products;

(c)      a reference to the production standards applied in the third country;

(d)      the competent authority in the third country responsible for the control system, its address, including e-mail and Internet addresses;

(e)      the name, address, email address, internet address and code number of the control authority or authorities and the control body or bodies recognised by the competent authority referred to in point (d) to carry out controls;

(f)      the name, address, email address, internet address and code number of the authority or authorities and the control body or bodies responsible in the third country for issuing certificates with a view to importing into the Union;

(g)      the duration of the inclusion in the list.’

5        Article 8 of Regulation No 1235/2008, entitled ‘Procedure for requesting inclusion in the list of third countries’, provides:

‘…

2.      The Commission shall only be required to consider a request for inclusion which meets the following preconditions.

The request for inclusion shall be completed by a technical dossier, which shall comprise all the information needed for the Commission to ensure that the conditions set out in Article 33(1) of Regulation … No 834/2007 are met for products intended for export to the Community, namely:

…

(f)      the information the third country proposes to include in the list as referred to in Article 7;

…

3.      When examining a request for inclusion in the list of recognised third countries, and also any time after its inclusion, the Commission may request any further information, including the presentation of one or more on-the-spot examination reports established by independent experts. Furthermore, the Commission may, based on risk-assessment and in case of suspected irregularities organise an on-the-spot examination by experts it designates.

…’

6        Article 9 of Regulation No 1235/2008, entitled ‘Management and review of the list of third countries’, provides:

‘1.      The Commission shall only be required to consider a request for inclusion when the third country undertakes to accept the following conditions:

…

(c)      in the light of any information received, the Commission may at any time amend the specifications relating to the third country and may suspend the entry of that country from the list referred to in Article 7; a similar decision may also be made where a third country has not supplied information required or where it has not agreed to an on-the-spot examination.

…’

7        Annex III to Regulation No 1235/2008 contains the list of recognised third countries and their specifications, including the list of recognised control bodies for India.

 Regulation (EU) 2018/848

8        Recital 96 of Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ 2018 L 150, p. 1) states:

‘Third countries recognised for the purpose of equivalence under Regulation … No 834/2007 should continue to be recognised as such under this Regulation, for a limited period necessary to ensure a smooth transition to the scheme of recognition through an international agreement, provided that they continue to ensure that their organic production and control rules are equivalent to the relevant Union rules in force and that they fulfil all requirements relating to the supervision of their recognition by the Commission. That supervision should be based in particular on the annual reports those recognised third countries send to the Commission.’

9        Article 45 of Regulation 2018/848, entitled ‘Import of organic and in-conversion products’, provides:

‘1.      A product may be imported from a third country for the purpose of placing that product on the market within the Union as an organic product or as an in-conversion product, provided that the following three conditions are met:

…

(b)      one of the following applies:

…

(iii)      in cases where the product comes from a third country which is recognised in accordance with Article 48, that product complies with the equivalent production and control rules of that third country and is imported with a certificate of inspection confirming this compliance that was issued by the competent authorities, control authorities or control bodies of that third country; …

…’

10      Article 48 of Regulation 2018/848, entitled ‘Equivalence under Regulation … No 834/2007’, provides:

‘1.      A recognised third country referred to in point (b)(iii) of Article 45(1) is a third country which has been recognised for the purposes of equivalence under Article 33(2) of Regulation … No 834/2007, including those recognised under the transitional measure provided for in Article 58 of this Regulation.

That recognition shall expire on 31 December 2026.

2.      On the basis of annual reports to be sent to the Commission, by 31 March of each year, by the third countries referred to in paragraph 1 regarding the implementation and enforcement of the control measures established by them, and in the light of any other information received, the Commission shall ensure appropriate supervision of the recognised third countries by regularly reviewing their recognition. For this purpose, the Commission may request the assistance of Member States. …

3.      The Commission shall, by means of an implementing act, establish a list of the third countries referred to in paragraph 1 and may amend that list by means of implementing acts.

…

4.      The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation as regards the information to be sent by the third countries listed in accordance with paragraph 3 of this [a]rticle which is necessary for the supervision of their recognition by the Commission, as well as the exercise of that supervision by the Commission, including through on-the-spot examination.

…’

 Delegated Regulation (EU) 2021/1342

11      Recital 5 of Commission Delegated Regulation (EU) 2021/1342 of 27 May 2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council with rules on the information to be sent by third countries and by control authorities and control bodies for the purpose of supervision of their recognition under Article 33(2) and (3) of Council Regulation … No 834/2007 for imported organic products and the measures to be taken in the exercise of that supervision (OJ 2021 L 292, p. 20) states.

‘In order to ensure the appropriate supervision of such third countries …, it is necessary to lay down rules on the procedures for the regular review of their recognition during the transitional periods. For that purpose, this [r]egulation should specify, in particular, the information to be provided by the third countries … to the Commission for the exercise of that supervision, including through on-the-spot examination. In addition, this [r]egulation should set out the measures to be taken by the Commission in the exercise of that supervision, including suspension or withdrawal of recognised third countries … from the [list] established pursuant to [Article] 48(3) … of Regulation … 2018/848.’

12      Article 3 of Delegated Regulation 2021/1342, entitled ‘Review of the recognition of third countries’ provides:

‘In the framework of its regular review of the recognition of third countries pursuant to Article 48(2) of Regulation … 2018/848, the Commission shall apply the following rules and amend the list of third countries accordingly pursuant to Article 48(3) of that Regulation:

(a)      the Commission may at any time amend the specifications in the list on the basis of the information received;

…’

 Background to the dispute

13      The applicant is a private body established in India, whose activity consists of carrying out controls and issuing certificates of inspection for the purposes of importing into the European Union organic and in-conversion products originating in India. It is a subsidiary of the French company Ecocert SA.

14      Until the adoption of the contested implementing regulation, the applicant was included in the list of recognised control bodies for India, which was set out in Annex III to Regulation No 1235/2008 in the list of recognised third countries pursuant to Article 33(2) of Regulation No 834/2007. Thus, it was accredited for carrying out controls and issuing certificates of the National Programme for Organic Production for the purposes of importing into the European Union Category A products, namely unprocessed plant products.

15      In May 2020, the applicant took over the supervision of the Unjha Agro company.

16      On 15 May 2020, the applicant first carried out a remote audit, namely a documentary audit, in order to verify the validity of Unjha Agro’s certification. On the basis of that audit, it issued a first certificate of inspection on 20 May 2020.

17      On 28 September 2020, the applicant carried out an inspection on Unjha Agro’s site, during which it did not find any failings on the part of that company.

18      Between taking over Unjha Agro’s supervision in May 2020 and the on-site inspection of 28 September 2020, the applicant issued eight separate certificates of inspection to Unjha Agro relating to sesame seeds.

19      On 10 November 2020 and on 18 January and 2 February 2021, Member States made three notifications in the Organic Farming Information System (OFIS) concerning consignments of contaminated organic products originating in India. Those three notifications concerned (i) the same product, namely sesame seeds, (ii) the same mode of contamination, namely fumigation with ethylene oxide (‘ETO’), (iii) the same operator, namely Unjha Agro, and (iv) the same control body, namely the applicant.

20      As regards the three contaminated consignments, the applicant had issued certificates of inspection to Unjha Agro based on documentary evidence only and without having carried out any physical check of those consignments.

21      On 20 November 2020, the applicant carried out an unannounced audit on Unjha Agro’s site, during which it was found that the latter had access to a chamber for fumigation by ETO for its conventional products and that organic and conventional products were not appropriately identified and/or labelled. Following that audit, the applicant decided on the full suspension of that company’s activity on 1 December 2020, which was followed by the withdrawal of the certification on 11 February 2021.

22      On 5 October 2021, a first draft of the contested implementing regulation was published in the Comitology Register and, subsequently, on the European Commission’s website for public consultation. That draft aimed to remove the applicant from the list of recognised control bodies for India, which appeared in Annex I to that draft in the list of recognised third countries within the meaning of Article 48 of Regulation 2018/848, read in conjunction with Article 33(2) of Regulation No 834/2007.

23      On 27 October 2021, the applicant submitted a letter challenging its withdrawal from the list of recognised control bodies for India. On 11 November 2021, it participated in a collective meeting by videoconference, during which it submitted its arguments orally to the Commission’s services.

24      On 24 November 2021, the Commission published a new draft of the contested implementing regulation, in which the reasons for the applicant’s withdrawal from the list of recognised control bodies for India were stated in recital 6 and were slightly amended compared to the first draft.

25      The contested implementing regulation was published in the Official Journal of the European Union on 29 December 2021. Pursuant to Article 3 of that implementing regulation, Article 1 and Annex I entered into force on 1 January 2022.

26      Under recital 3 of the contested implementing regulation, ‘the list of recognised third countries established by this Regulation is based on the list as published in Annex III to Commission Regulation … No 1235/2008 … However, in the light of new information received by the Commission from certain third countries since the last amendment of that list, certain changes should be taken into consideration and the list should be adapted accordingly.’

27      Next, pursuant to recital 6 of the contested implementing regulation:

‘As regards India, a large number of consignments totalling to thousands of tons of allegedly organic sesame seed contaminated with … [ETO] have been imported from that third country, in particular from operators controlled by control bodies supervised by India, and resulting in about 90 notifications in the … [OFIS]. It appears that the presence of ETO – which is carcinogenic for humans – was detected in organic products before 2020. Various reliable methods for the analysis of ETO have been developed over the last three decades and have therefore been available in order to detect such contaminations. As regards those OFIS notifications, the levels of contamination found in the consignments have usually by far exceeded the maximum residue level established for ETO, with the exact levels of contamination varying depending on the consignment. This has led both to consumers being misled and to a significant health risk. The occurrence of ETO contamination and the high concentrations found, as well as the lack of response on the root causes of the failure of the control system from the control bodies involved in those contaminations, which are under the supervision of the Indian competent authority, and the inappropriate corrective measures taken by those control bodies and the competent authority, jeopardise the robustness of the controls and the supervision itself. In addition, on the basis of information received by the Commission, it appears that some of the control bodies involved in those OFIS notifications did not respect the scope of recognition of India as regards the products that may be imported into the Union. For all those reasons and in accordance with Article 3, point (a), of Delegated Regulation … 2021/1342, the following control bodies should not appear in the list of control bodies recognised by the Indian competent authority: “… Ecocert India …”.’

28      Furthermore, Annex I to the contested implementing regulation contains the list of recognised third countries and their specifications. That list includes, as regards India (point 5), the list of recognised control bodies for India. The applicant does not appear in the latter list.

 Forms of order sought

29      The applicant claims that the Court should:

–        annul Article 1 of the contested implementing regulation, read in conjunction with Annex I (point 5 concerning the Republic of India) to that implementing regulation, so far as concerns India, in so far as that provision removes the applicant from the list of recognised control bodies for India;

–        order the Commission to pay the costs.

30      The Commission contends that the Court should:

–        dismiss the action;

–        order the applicant to pay the costs.

 Law

31      In support of the action, the applicant puts forward, in essence, six pleas in law, alleging, first, the lack of competence of the Commission to remove it from the list of recognised control bodies for India, second, infringement of the rights of the defence, third, in essence, manifest errors of assessment, fourth, a breach of the principle of proportionality, fifth, a breach of the principles of equal treatment and non-discrimination and, sixth, a breach of the principles of legal certainty and legitimate expectations.

 The first plea in law, alleging the lack of competence of the Commission to remove the applicant from the list of recognised control bodies for India

32      The applicant submits that, by removing it from the list of recognised control bodies for India, which appears in the list of recognised third countries in Annex I to the contested implementing regulation, the Commission exceeded the limits of its competence and infringed both the provisions of Article 33(2) of Regulation No 834/2007, read in conjunction with Article 7 of Regulation No 1235/2008, and the provisions of Article 48 of Regulation 2018/848, read in conjunction with Article 3 of Delegated Regulation 2021/1342, the latter regulations being applicable since 1 January 2022.

33      In particular, the applicant maintains, first, that the provision on which the Commission based the contested implementing regulation, namely Article 3(a) of Delegated Regulation 2021/1342, has been applicable only since 1 January 2022. According to the applicant, the same applies as regards Regulation 2018/848, although Regulation No 834/2007 was repealed by Regulation 2018/848 as of 17 June 2018. Regulation No 834/2007 continued to apply but only to pending applications from third countries. However, the transitional measures did not confer on the Commission the necessary competence to review the current list of third countries. Therefore, the Commission should first use the list as it appeared in Annex III to Regulation No 1235/2008, and it could only have amended that list by means of an implementing act after Regulation 2018/848 and its implementing acts became applicable, namely after 1 January 2022.

34      Secondly, the applicant claims, in essence, that it follows in particular from Article 7 of Regulation No 1235/2008 and Article 33(2) of Regulation No 834/2007, as well as from Article 48 of Regulation 2018/848 and Article 3 of Delegated Regulation 2021/1342, that the Commission could only establish or review a list of recognised exporting third countries, such as the Republic of India, without being able to review individually the control bodies appearing therein. According to the applicant, the Commission plays no role in the verification and approval procedure of control bodies for India, since only the Agricultural and Processed Food Products Export Development Authority (APEDA, India) is competent to include or remove an establishment from the list of recognised control bodies for India. Such an interpretation is confirmed by recital 6 of the contested implementing regulation according to which those control bodies ‘are under the supervision of the Indian competent authority’. The applicant considers that, although APEDA imposed on it the sanctions deemed appropriate, it nevertheless remains accredited by that competent Indian authority. Thus, according to the applicant, the Commission could remove the Republic of India from the list of recognised third countries, but not the control bodies.

35      Thirdly, the applicant maintains that, although Article 9(1)(c) of Regulation No 1235/2008 provides for the possibility for the Commission, at any time, to amend the specifications, the fact remains that that article also provides that the amendment of information relating to a third country referred to in Article 7(2) of that regulation must be carried out in the light of the information received and preceded by a request notified to the Commission. Thus, the only possibility available to the Commission to update the content of the list of third countries is based, as regards the specifications, on information received from the third country itself.

36      Fourthly, the applicant notes that, under Article 7(2) of Regulation No 1235/2008, the information appearing in the list of recognised third countries is not intended to determine whether or not certain control bodies should be included, but to provide all relevant information to allow verification of whether the products placed on the market have been subject to the control system of the recognised third country. Furthermore, it observes that the concept of ‘specifications’ is not defined either in Regulation 2018/848 or in Delegated Regulation 2021/1342, or in the contested implementing regulation, as was the case previously in Article 7(2) of Regulation No 1235/2008. Thus, there is no requirement that the names of the control bodies appear in the list of recognised third countries. Appearance in the list is therefore not a condition for a control body to continue operating in India.

37      The Commission disputes the applicant’s arguments.

38      At the outset, it should be borne in mind that the contested implementing regulation was adopted on the basis of Regulation 2018/848, in particular Article 48(3) of that regulation. Recital 6 of that implementing regulation, which sets out, among other things, the reasons for the applicant’s withdrawal from the list of recognised control bodies for India, refers to Article 3(a) of Delegated Regulation 2021/1342.

39      In the first place, it is therefore important, first of all, to examine the applicant’s argument that, in essence, the Commission could amend the list of recognised third countries which appeared in Annex III to Regulation No 1235/2008 by means of an implementing act only after Regulation 2018/848 and those implementing acts became applicable, namely after 1 January 2022.

40      Regulation 2018/848 and Delegated Regulation 2021/1342 entered into force, respectively, on 17 June 2018 and 5 September 2021, that is to say before the entry into force of the contested implementing regulation on 1 January 2022, and those three regulations became applicable on the same day, namely 1 January 2022. Thus, the Commission was not required to wait until Regulation 2018/848 and Delegated Regulation 2021/1342 had become applicable before reviewing the situation of the third countries appearing in the list of recognised third countries since those two regulations were already in force at the time of the adoption of the contested implementing regulation and became applicable on the same date as the latter.

41      In the second place, it is appropriate to examine the applicant’s argument relating to the Commission’s alleged lack of competence to review the list of recognised control bodies for India.

42      In the present case, the importation of Indian organic products falls under the equivalence scheme governed by Article 45(1)(b)(iii) of Regulation 2018/848, read in conjunction with Article 48 of that regulation and with Article 33(2) of Regulation No 834/2007.

43      In particular, under Article 48(2) of Regulation 2018/848, the Commission is to ensure appropriate supervision of the recognised third countries by regularly reviewing their recognition on the basis of annual reports provided by the third countries and in the light of any other information received. Furthermore, paragraph 3 of that article provides that the Commission is to establish the list of recognised third countries and may amend it by means of implementing acts.

44      Furthermore, on the basis of paragraphs 2 and 3 of Article 48 of Regulation 2018/848, Delegated Regulation 2021/1342, which supplements that regulation with rules relating, in particular, to the information to be sent by third countries for the purposes of supervision of their recognition under Article 33(2) of Regulation No 834/2007 and the measures to be taken in the exercise of that supervision, specifies, in Article 3(a), that, in the framework of its regular review of the recognition of third countries, the Commission may at any time amend the specifications in the list on the basis of the information received. In addition, the provisions of Article 3(b) to (d) of Delegated Regulation 2021/1342 lay down the conditions under which the Commission may suspend the entry of a third country from the list or withdraw the entry of a third country from the list.

45      Thus, since, in the exercise of its supervision, it is open to the Commission not only to suspend the entry of a recognised third country in the list of such countries or to withdraw it from the list, but also to amend the specifications in that list, it must be stated that that also implies that it can remove an establishment from the list of control bodies recognised for such a third country.

46      Although Delegated Regulation 2021/1342 does not define the concept of ‘specifications’, it must be stated that that concept must be interpreted in the light of the provisions of Regulation No 834/2007 and of the provisions of and Annex III to Regulation No 1235/2008.

47      In that regard, first, Article 45(1)(b)(iii) and Article 48 of Regulation 2018/848 are intended to regulate the conditions for continuation of the scheme of recognised third countries for the purposes of the equivalence established by Article 33(2) of Regulation No 834/2007 for a limited period, namely until 31 December 2026, which is necessary, according to recital 96 of Regulation 2018/848, in order to ensure a smooth transition to the scheme of recognition through an international agreement. Thus, those provisions must not be interpreted in isolation, but it is necessary, in that regard, to take into account, during that transitional period, the regulations establishing that scheme of recognised third countries for the purposes of equivalence, namely both the provisions of Regulation No 834/2007, in particular Article 33(2) thereof, and those of Regulation No 1235/2008 which implemented the latter article.

48      Secondly, it follows from recitals 3 and 6 of the contested implementing regulation that the list of recognised third countries established by that implementing regulation and comprising relevant specifications for each third country, including a list of recognised control bodies, is based on the list of recognised third countries published in Annex III to Regulation No 1235/2008.

49      It is important to note that Annex III to Regulation No 1235/2008 also included relevant specifications referred to in Article 7 and Article 9(1)(c) of that regulation, namely the information necessary to verify whether the products placed on the internal market have been subject to the control system of the recognised third country. In particular, those specifications contained the information listed in Article 7(2) of that regulation, including information on the recognised control bodies for the specific third countries.

50      Consequently, it follows from a combined reading of the provisions referred to in paragraphs 47 to 49 above that the term ‘specifications’, used in Article 3(a) of Delegated Regulation 2021/1342, has its origin in particular, first, in Article 7 of Regulation No 1235/2008, which specifies and lists the information covered by the specifications of recognised third countries, and, secondly, in Annex III to that regulation which contains the information forming an integral part of the list of recognised third countries for the purposes of equivalence under Article 33(2) of Regulation No 834/2007, which also includes the information on the recognised control bodies for the specific third countries.

51      In the light of the above, it should be stated that the right of the Commission, provided for in Article 3(a) of Delegated Regulation 2021/1342, to amend the specifications in the list of recognised third countries necessarily includes the possibility of removing an establishment from the list of recognised control bodies for the specific third country.

52      For the same reasons as those noted in paragraphs 46 to 51 above, it is also necessary to reject the applicant’s argument that it is not required that the names of the control bodies appear in the list of recognised third countries, in so far as the concept of ‘specifications’ is not defined either in Regulation 2018/848 or in Delegated Regulation 2021/1342, or in the contested implementing regulation.

53      In the third place, in so far as the applicant claims that the Commission cannot update the content of the list of third countries with regard to the specifications apart from on the basis of information received from the third country itself, it must be stated that that argument cannot succeed.

54      It should be observed that Article 48(2) of Regulation 2018/848 specifies that the Commission is to ensure appropriate supervision of the recognised third countries on the basis of the annual reports that the third countries must send to it and ‘in the light of any other information received’. Furthermore, Article 3(a) of Delegated Regulation 2021/1342 sets out, in essence, that the Commission may at any time amend the specifications in the list ‘on the basis of the information received’. Those provisions are not capable of any interpretation other than that the Commission has a certain freedom in the choice of the information which it can take into account in the context of the review of the recognition of third countries. In any event, it cannot be considered that, when fulfilling its obligation to review the recognition of third countries, the Commission is dependent only on the information provided by the third countries concerned.

55      Furthermore, without any freedom of choice as to the information that it may take into account for the purposes of amending the specifications in the list of recognised third countries, the Commission would not be able to ensure appropriate supervision.

56      Thus, Article 48(2) and (3) of Regulation 2018/848 and Article 3(a) of Delegated Regulation 2021/1342 must be interpreted as meaning that they provide the Commission with the possibility to amend, in the light of any information received, the specifications in the list of recognised third countries, including the lists of recognised control bodies for the specific third countries.

57      Furthermore, in so far as the applicant refers, in that context, to Article 9(1)(c) of Regulation No 1235/2008, it is in no way apparent from the wording of that provision that the expression ‘in the light of any information received’ refers specifically and solely to information received from the third country as provided for in Article 9(1)(a) and (b) of that regulation.

58      Having regard to all of the foregoing, it must be stated that the Commission was competent to withdraw the applicant from the list of recognised control bodies for India appearing in the list of recognised third countries in Annex I to the contested implemented regulation.

59      The applicant’s other arguments cannot call that conclusion into question.

60      First, in so far as the applicant maintains that it follows from recital 6 of the contested implementing regulation that the control bodies are under the supervision of the competent Indian authority and that, therefore, only APEDA is competent to include it in or withdraw it from the list of recognised control bodies for India, it is sufficient to note that the competence of that Indian authority to recognise control bodies for India does not rule out the Commission’s competence to withdraw the applicant from that list in the exercise of its supervision on the basis of Regulation 2018/848 and Delegated Regulation 2021/1342.

61      Secondly, with regard to the applicant’s argument that the information contained in the list of third countries is not intended to determine whether or not to include certain control bodies, but to provide all relevant information to allow the verification of whether the products placed on the market have been subject to the control system of the recognised third country, it is sufficient to note that, in the light of the considerations set out in paragraphs 42 to 58 above, that argument is ineffective. Whatever the use of the information contained in the list of recognised third countries, that use has no impact on the question of whether the Commission was competent in the present case to withdraw the applicant from the list of recognised control bodies for India.

62      Thirdly, with regard to the applicant’s line of argument that the transitional measures of Regulation 2018/848, in particular Article 58 thereof, did not confer on the Commission the competence required to review the current list of recognised third countries, it is sufficient to recall that it is Article 48(2) and (3) of that regulation which confers such power on the Commission.

63      Consequently, the first plea in law must be rejected as unfounded.

 The second plea in law, alleging, in essence, infringement of the rights of the defence

64      The applicant maintains that, by withdrawing it from the list of recognised control bodies for India, the Commission exceeded its powers and deprived the applicant of any procedural guarantee, in so far as the legal basis used for that withdrawal did not provide for the possibility for individual entities to be heard. In the reply, it specifies that the infringement of its rights of the defence results from the illegal legal basis and procedure chosen for the adoption of the contested implementing regulation.

65      In particular, the applicant claims that, to the extent that the Commission did not inform it in advance of the adoption of the negative decision to be taken against it and, by depriving it of its procedural rights of access to the file and to be heard, the latter infringed the second paragraph of Article 263 TFEU.

66      Furthermore, the applicant maintains that, since the contested implementing regulation was adopted without it being informed in advance and without giving it the right to justify its actions before the publication of the draft of that implementing regulation, the information appearing, in particular, in recital 6 of that implementing regulation is circulating in the public domain and therefore it is very likely that it can expect damage to its reputation and loss of clients.

67      The Commission disputes the applicant’s arguments.

68      At the outset, in so far as the applicant seeks, once again, to call into question the competence of the Commission to withdraw it from the list of recognised control bodies for India, it is appropriate to refer to the answer given to the first plea in law.

69      Next, it should be borne in mind that, under Article 41(2)(a) of the Charter of Fundamental Rights of the European Union, the right to good administration includes the right of every person to be heard before any individual measure which would affect him or her adversely is taken. Furthermore, it is settled case-law that respect for the rights of the defence constitutes, in any proceedings initiated against a person and likely to result in a measure adversely affecting that person, a fundamental principle of EU law which must be ensured even in the absence of any provision in the rules governing that procedure expressly providing for observance of those rights. The latter requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they may effectively make known their views on the evidence on which the contested decision is based (see judgment of 22 June 2023, Arysta LifeScience Great Britain v Commission, C‑259/22 P, not published, EU:C:2023:513, paragraph 47 and the case-law cited).

70      However, the right of every person to be heard is not intended to apply where a person considers himself or herself to be affected by an act of general application (judgment of 22 June 2023, Arysta LifeScience Great Britain v Commission, C‑259/22 P, not published, EU:C:2023:513, paragraph 50).

71      As regards measures of general application, unless there is express provision to the contrary, neither the process of their drafting nor those measures themselves require, by virtue of general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected (see judgment of 8 July 2020, BRF and SHB Comércio e Indústria de Alimentos v Commission, T‑429/18, EU:T:2020:322, paragraph 94 and the case-law cited).

72      In the present case, it is apparent from recital 6 of the contested implementing regulation, as set out in paragraph 27 above, that the Commission withdrew certain establishments from the list of recognised control bodies for India on the basis of the findings relating to the importation of ETO-contaminated sesame seeds originating in India.

73      In that regard, it follows from Article 45(1)(b)(iii) and Article 48(1) to (3) of Regulation 2018/848, read in conjunction with Article 33(2) of Regulation No 834/2007 and with Article 7(2) of Regulation No 1235/2008, that the possibility for establishments located in a third country to certify organic and in-conversion products intended for the EU market requires, first, the inclusion of the third country in question in the list of recognised third countries and, secondly, the inclusion of the establishment concerned in the list of control bodies recognised by the competent authorities of those third countries set out in those provisions. However, the EU legislature does not reserve to control bodies located in a third country any role in triggering the related procedures nor does it grant them the possibility of referring the matter to the Commission in the event that the competent authority of a recognised third country were to refuse to include them in the list of recognised control bodies.

74      Thus, the control bodies included in the list of control bodies recognised by the competent authorities of recognised third countries, which appears in the list of those third countries, are not the beneficiaries of an individual right conferred on them pursuant to an act of EU law and the object of which is the performance of controls and certification of products intended for export to the EU market. It follows from Article 45(1)(b)(iii) of Regulation 2018/848 as well as Article 33(1)(c) of Regulation No 834/2007 that the inclusion of a control body on the aforementioned list is made in particular for the purposes of the operation of the control system provided for at the level of recognised third countries (see, by analogy, judgment of 8 July 2020, BRF and SHB Comércio e Indústria de Alimentos v Commission, T‑429/18, EU:T:2020:322, paragraphs 37 and 79).

75      Thus, an implementing act, such as the contested implementing regulation, under which the Commission withdraws certain establishments from the list of control bodies recognised for specific third countries does not constitute a bundle of individual acts the object of which is the revocation of a right supposedly conferred on those establishments. The implementing act in question in fact alters the second of the two conditions which must be satisfied, as has been set out in paragraph 73 above, for an establishment located in a third country to be able to carry out controls and certify organic products intended for the EU market. It follows that the contested implementing regulation means that the importation into that market of products from India which are accompanied by a certificate of inspection issued by the control bodies withdrawn from the list is no longer permitted. That rule applies to all economic operators that might have an interest in importing such certified products by those bodies, but also to the customs authorities of the Member States of the European Union, such that the contested implementing regulation is of general application (see, by analogy, judgment of 8 July 2020, BRF and SHB Comércio e Indústria de Alimentos v Commission, T‑429/18, EU:T:2020:322, paragraph 38).

76      Furthermore, as regards the procedure leading to the adoption of the contested implementing regulation, it must be pointed out that, pursuant to Article 48(3) of Regulation 2018/848, read in conjunction with Article 55(2) thereof, the Commission is to establish and amend the list of recognised third countries by means of implementing acts by following the examination procedure provided for in Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ 2011 L 55, p. 13). Neither Delegated Regulation 2021/1342 nor those regulations contain provisions enshrining the applicant’s right to be heard or to have access to the file before the Commission decides to withdraw it from the list of recognised control bodies for India.

77      It follows that the procedure which resulted in the adoption of the contested implementing regulation does not require the Commission to enable the applicant, which it has withdrawn from the list of recognised control bodies for India, effectively to make known its point of view and to have access to the file before such adoption, inasmuch as that procedure was not initiated against the applicant and did not result in the adoption of an individual measure addressed to it.

78      In any event, the Commission granted to the ‘interested parties’ a period of more than six weeks to make their point of view known on the first draft of the contested implementing regulation which was published on its website. On 27 October 2021, the applicant sent a letter to the Commission to make its views known as regards that draft and, on 11 November 2021, it participated in a videoconference with the Commission in that regard.

79      In the light of the foregoing, the applicant’s argument that the Commission did not follow the required procedural requirements and deprived it of its rights of the defence must be rejected.

80      As regards the applicant’s argument that, in essence, it can expect damage to its reputation and loss of clients due to the circulation, in the public domain, of the information appearing in particular in recital 6 of the contested implementing regulation, it is important to note that that argument is neither accompanied by details nor supported by evidence. Therefore, even if such an argument were to be effective, it would have to be dismissed.

81      In the light of the foregoing, the second plea in law must be rejected.

 The third plea in law, alleging, in essence, manifest errors of assessment

82      In the context of the present plea, the applicant invokes various manifest errors of assessment by the Commission. The applicant alleges that, first, the Commission did not take into account the fact that the applicant had no knowledge of the use of ETO as a fumigant to combat salmonella at the time when the first notifications were made, namely in September 2020, secondly, the Commission did not draw the appropriate conclusions from the fact that the applicant had taken all the necessary corrective measures and, thirdly, the Commission did not take into account the sanctions adopted by APEDA. Fourthly, as regards the Commission’s submission that the applicant did not respect the scope of the recognition of India with regard to the products which can be imported into the European Union, the applicant maintains that the classification of sesame seeds as processed products falling within Category D is incorrect in view of the uncertainty surrounding the concept of ‘processed products’ and its application in the present case.

83      At the outset, it should be borne in mind that, according to settled case-law, within the framework of the common agricultural policy, the co-legislators may be required to confer broad implementing powers on the Commission, since only the latter is in a position to keep track of agricultural market trends and to act quickly when necessary. The limits of those powers must be determined by reference amongst other things to the essential general aims of the market organisation concerned (see judgments of 27 November 1997, Somalfruit and Camar, C‑369/95, EU:C:1997:562, paragraph 62 and the case-law cited, and of 30 June 2005, Alessandrini and Others v Commission, C‑295/03 P, EU:C:2005:413, paragraph 74 and the case-law cited). Thus, in matters relating to agriculture, the Commission is authorised to adopt all the implementing measures which are necessary or appropriate for the implementation of the basic legislation, provided that they are not contrary to such legislation or to the implementing legislation adopted by the Council (see judgment of 30 June 2005, Alessandrini and Others v Commission, C‑295/03 P, EU:C:2005:413, paragraph 75 and the case-law cited).

84      The case-law also specifies that the Commission enjoys wide discretion in matters of the common agricultural policy (see judgment of 9 March 2017, Poland v Commission, C‑105/16 P, not published, EU:C:2017:191, paragraph 48).

85      In that regard, taking into account the broad discretion which the Commission enjoys in the supervision of recognised third countries within the meaning of Article 48(2) of Regulation 2018/848, it is not for the Courts of the European Union, in the review of legality entrusted to them under the first paragraph of Article 263 TFEU, to substitute their own assessment for that of the Commission with regard to the measures to be taken (see, by analogy, judgment of 8 July 2020, BRF and SHB Comércio e Indústria de Alimentos v Commission, T‑429/18, EU:T:2020:322, paragraph 109). Consequently, the review by the Courts of the European Union must be limited to verifying that the measure in question is not vitiated by any manifest error or misuse of powers and that the Commission has not manifestly exceeded the limits of its discretion (judgments of 9 September 2004, Spain v Commission, C‑304/01, EU:C:2004:495, paragraph 23, and of 23 March 2006, Unitymark and North Sea Fishermen’s Organisation, C‑535/03, EU:C:2006:193, paragraph 55).

86      In the present case, it follows from recital 6 of the contested implementing regulation reproduced in paragraph 27 above that the withdrawal of certain establishments from the list of recognised control bodies for India, including the applicant, was justified, in essence, for two reasons. The first reason concerns (i) despite the appearance of contamination by ETO and the high concentrations observed, the lack of reaction to the causes of the failure of the control system on the part of the control bodies, and (ii) the inappropriate corrective measures taken by the latter and by the competent Indian authority. The second reason concerns the fact that some of the control bodies involved in those OFIS notifications did not respect the scope of recognition of India as regards the products which could be imported into the European Union.

87      The Commission argues that the present plea is ineffective because the applicant does not challenge certain reasons summarised in recital 6 of the contested implementing regulation which are sufficient, in themselves, to justify the withdrawal of the applicant from the list of recognised control bodies for India, including, in particular the second reason concerning non-compliance with the scope of recognition of India. However, it is important to note that it is apparent from that recital, and in particular from the wording ‘for all those reasons’, that, in deciding on such a withdrawal, the Commission relied on all the reasons invoked in that recital considered as a whole. Therefore, the third plea in law is effective and it is necessary to examine its merits.

 The first reason for the applicant’s withdrawal from the list of recognised control bodies for India

88      The applicant disputes the first reason for its withdrawal from the list of recognised control bodies for India in that, in particular, the Commission did not take into account the fact that it had no knowledge of the use of ETO as a fumigant to combat salmonella at the time when the first notifications were made (first part), that the Commission did not draw the right conclusions from the fact that it had taken all the necessary corrective measures (second part) and that the Commission did not take into account the sanctions adopted by APEDA against it (third part).

–       The first part

89      The applicant alleges, in essence, that the Commission did not take into account the fact that the applicant had no knowledge of the use of ETO as a fumigant to combat salmonella at the time when the first notifications were made. In particular, it argues that (i) before the ETO crisis of September 2020, the Commission itself did not consider it necessary to reinforce controls on sesame seeds originating in India with regard to the possible use of ETO, (ii) in 2014 and 2018, the Commission’s Food and Veterinary Office (‘FVO’) carried out a mission in India, but fumigations with ETO were not mentioned in the reports of that office, and (iii) at the time when the first OFIS notifications were made, in September 2020, the use of ETO as a fumigant against salmonella in the food industry was hardly known to any stakeholders, including authorities, control bodies and analytical laboratories. Furthermore, the applicant maintains that (iv) the European Union Reference Laboratories (‘EURL’) only published the reference method for analysing ETO in December 2020, (v) in September 2020, there was no accredited laboratory in either India or France to analyse ETO and (vi) all control authorities and control bodies carry out a risk analysis in order to target the most relevant unauthorised substances in their controls, since it is practically impossible to search for and analyse all the substances forbidden in the European Union.

90      In order to establish those claims, the applicant has provided various pieces of evidence, namely:

–        an Information Report from the French Senate of 17 February 2021, confirming, according to the applicant, that, at the start of the alert, only seven laboratories were able to analyse ETO for the entire territory of the European Union and that that substance was not included in the control and surveillance plans, whether at EU or national level, and that that substance was therefore not systematically searched for in official controls or in self-controls,

–        an Analytical Observations Report from the EURL of December 2020 relating to the reference method for analysing ETO,

–        the 2020 Annual Report from the 2016-2020 Multi-annual National Control Plan, confirming, according to the applicant, that ETO was not included in those controls,

–        the responses from 8 laboratories out of the 11 interviewed, of which only 4 allegedly responded that the trials or tests were feasible but not accredited,

–        the internet links to the reports of the European Food Safety Authority (EFSA) on pesticide residues in food, published in 2018, 2019 and 2020, demonstrating, in essence, according to the applicant, that none of the authorities had carried out an analysis of ETO before 2020 because it had not been found that that substance presented a risk,

–        the internet link to a study entitled ‘Food safety governance and guardianship: The role of the private sector in addressing the EU ethylene oxide incident’, published on 12 January 2022 and demonstrating, according to the applicant, that ETO had not been detected as a ‘substance/hazard’ in respect of India before 2020.

91      The Commission disputes the applicant’s arguments.

92      It should be noted at the outset that, as is apparent from the analysis in paragraphs 54 to 57 above and from the case-law cited in paragraphs 83 and 84 above, the Commission has wide discretion with regard to the supervision of recognised third countries within the meaning of Article 48(2) of Regulation 2018/848.

93      In the present case, in the first place, it has been shown that the use of ETO as a fumigant was known both by the applicant’s parent company and by the control authorities in the Member States of the European Union.

94      In particular, the applicant’s parent company had been aware of cases of contamination of organic products due to ETO fumigation since August 2017 in the light of OFIS notification 270/2017 concerning rosemary provided by the Commission in Annex B.8 to the defence. It is apparent from the observations of that parent company relating to that notification, appearing in Annex D.2 to the rejoinder, that that parent company considered ETO to be a more general risk requiring monitoring. Next, as follows from Annexes D.3 and D.4 to the rejoinder, on 8 September 2015 and on 22 November 2017, ETO had been detected in two other consignments in respect of which OFIS notifications had been made and in respect of which the same parent company was the control body responsible. In those circumstances, the applicant cannot reasonably rely on its lack of knowledge, in September 2020, of the use of ETO as a fumigant for organic products.

95      Furthermore, in its 2016 Report on Pesticide Residues in Food set out in Annex D.5 to the rejoinder, EFSA stated that ETO had been detected in 15 out of the 16 samples in one Member State.

96      Furthermore, it is apparent from the Analytical Observations Report of the EURL of December 2020, appearing in Annex A.11 to the application, that, on the portal of the EU Rapid Alert System for Food and Feed (RASFF), notifications regarding ETO in sesame seeds originating in India were made in September 2020.

97      Thus, the applicant has not succeeded in calling into question the fact that, in September 2020, the use of ETO as a fumigant was known to competent authorities and control bodies.

98      In the second place, with regard to the applicant’s claim relating to the absence in India and France of laboratories accredited to analyse ETO, notification OFIS INTC 129/2015 of 8 September 2015, appearing in Annex D.3 to the rejoinder, in the context of which the applicant’s parent company was a contact person as regards the contamination, referred to an analysis carried out by the Eurofins Analytics France laboratory established in France.

99      Furthermore, with regard to laboratories in the European Union, the applicant itself admits that, according to the Information Report from the French Senate of 17 February 2021, at the start of the alert, seven laboratories were able to analyse ETO for the entire territory of the European Union. In addition, it follows from the considerations set out in paragraphs 94 to 96 above that ETO was analysed and controlled in that territory in September 2020 and before then.

100    As regards the items of evidence relating to the 11 laboratories interviewed in India, appearing in Annex C.14 to the reply, it should be stated that the submission, together with the reply, of those items which bear a date prior to that of the filing of the application, was made late for the purposes of Article 85(1) and (2) of the Rules of Procedure of the General Court. Since the applicant failed to provide justification for that late submission, they must be dismissed as inadmissible pursuant to those provisions. In any event, those items are not convincing for the purposes of demonstrating the merits of the claim at issue.

101    First, on 11 December 2020, a company informed the applicant that it had laboratories accredited to test ETO in India according to the method recommended by the European Union and attached a document containing the list of laboratories accredited as at 9 September 2020 for the analysis of organic products. Secondly, another company informed the applicant that it had accreditation to test ETO between 2018 and December 2020. Furthermore, the applicant does not explain how those replies are consistent with its assertion that there was no laboratory accredited to analyse ETO in India in September 2020.

102    In the third place, the applicant does not provide any evidence to support its claims that the consignments which it certified and which gave rise to an OFIS notification were duly accompanied, before exportation, by a phytosanitary certificate issued by the Indian Ministry of Agriculture stipulating that the consignment was free of any fumigation.

103    In the fourth place, the applicant claims that it follows from Commission Implementing Regulation (EU) 2020/1540 of 22 October 2020 amending Implementing Regulation (EU) 2019/1793 as regards sesamum seeds originating in India (OJ 2020 L 353, p. 4), which set at 50% the frequency of physical and identity checks to be carried out at the borders of the European Union to detect the presence of pesticide residues on sesame seeds originating in India, that the Commission itself did not deem it necessary, before the ETO crisis in September 2020, to consider that sesame seeds originating in India required a reinforcement of the controls at the European Union’s borders. The applicant further states that, at that time, ETO was not part of any control plan of the ‘European authorities’. In that regard, it is sufficient to note that the mere fact that the Commission had not yet required a reinforcement of the controls did not exempt the recognised control bodies for India, and in particular the applicant, from carrying out the controls with all the necessary diligence in order to detect the presence of pesticide residues on sesame seeds originating in India, since, as is apparent from paragraphs 94 to 99 above, the use of ETO as a fumigant was known and controlled in the European Union.

104    In the fifth place, first, as regards the reports of EFSA published online in 2018, 2019 and 2020, it must be stated that the fact, allegedly emerging, according to the applicant, from those reports, that there was a negligible quantity or absence of ETO analyses in 2018 and 2019 and that it was only in 2020 that EFSA mentioned in the report a non-negligible quantity of such analyses, is not capable of demonstrating that ETO did not present a risk before 2020. As is apparent from paragraph 95 above, according to the 2016 EFSA report, analyses to detect the presence of ETO had been carried out on 16 samples and the presence of ETO had been detected in 15 samples. Secondly, as regards the study entitled ‘Food safety governance and guardianship: The role of the private sector in addressing the EU ethylene oxide incident’, published online on 12 January 2022, demonstrating, according to the applicant, that ETO had not been detected as a substance or hazard in respect of India before 2020, it is sufficient to note, like the Commission did, that, even if that claim were true, it would have no impact on the applicant’s obligation to control with the required diligence the presence of pesticide residues on sesame seeds originating in India.

105    In the light of the above, the evidence put forward by the applicant does not permit the inference that, in September 2020, first, the applicant had no knowledge of the use of ETO as a fumigant and, secondly, there was no laboratory accredited to analyse ETO in India or ETO was not known, controlled and analysed in the European Union. Furthermore, with regard to the applicant’s argument that the EURL did not publish the reference method for analysing ETO until December 2020, it is sufficient to note that the applicant specifies in the reply that it does not claim that there were no available methods to detect ETO. Thus, by those arguments, the applicant has not succeeded in establishing that the Commission’s assessment that, despite the appearance of ETO contamination and the high concentrations observed, there was no reaction on its part to the causes of the failure of the control system is vitiated by a manifest error and therefore that the first ground of the contested implementing regulation does not warrant its withdrawal from the list of recognised control bodies for India.

106    Furthermore, the applicant has also failed to establish though its other arguments that the assessment at issue is vitiated by a manifest error. First, the lack of reference to ETO fumigations in the reports of the FVO, after its missions to India in 2014 and 2018, does not change the fact that the applicant should have been aware before 2020 of the risk of ETO fumigation for organic products in India. Secondly, the applicant cannot absolve itself of its responsibility to ensure the control of prohibited substances in the European Union by asserting that it was impossible for control bodies to research and analyse all of those substances.

107    Therefore, the first part must be rejected as unfounded.

–       The second and third parts

108    By the second part, the applicant claims that the Commission did not take into account the fact that the applicant had taken, in a timely manner, all the appropriate corrective measures, which even went beyond those necessary simply to rectify the situation.

109    First, as regards the measures adopted before receiving the OFIS notifications relating to Unjha Agro, the applicant alleges that, on 6 October 2020, it had learned of the discovery of the first cases of ETO on sesame originating in India and had started collecting detailed information on the molecule, its uses and the means to detect it. It states that, following the implementation of a general obligation introduced on 16 October 2020 by the Indian Oilseeds and Produce Export Promotion Council to test for the presence of ETO in sesame before any sale outside India from 21 October 2020, it reinforced its controls and informed all its operators, by email, that ETO tests would be required before any certificates of inspection for sesame-based products were issued.

110    Secondly, the applicant maintains that, after receiving, on 9 November 2020, information from an international certification body, of which it was subsequently officially notified by APEDA on 16 November 2020, relating to the presence of ETO in sesame seeds exported by Unjha Agro, it adopted the corrective measures. On 11 November 2020, the operator concerned was informed and the contaminated consignments were blocked.

111    The applicant specifies that, on 20 November 2020, it carried out an unannounced on-site audit within 10 days (including the weekend) of the notification, which, in the context of the COVID-19 pandemic and in view of the logistical constraints linked to the organisation of such an audit, was reasonable. During that audit, it was found that organic and conventional products were not identified and/or labelled appropriately and that the client had access to a chamber for fumigation by ETO for its conventional products.

112    The applicant also states that, on 1 December 2020, it decided on a full suspension of the operator concerned and, on 30 December 2020, following the publication of the APEDA circular of 24 December 2020, prohibiting exportation of organic sesame, it reinforced its controls and extended mandatory ETO tests to a list of 11 products at risk. That list has been frequently updated since then and currently includes 25 products at risk.

113    The applicant further states that, on 11 February 2021, following its investigation, it withdrew the certification of the operator concerned and, in 2021, it decided, in particular, to increase the number of unannounced inspections and reinforced the controls prior to the issuing of the certificate of inspection.

114    By the third part, the applicant alleges that the Commission failed to take account of the sanctions imposed on it by APEDA despite that body being the only authority competent to take action.

115    The Commission disputes the applicant’s arguments.

116    It is necessary to examine whether the Commission made a manifest error of assessment in considering that the corrective measures taken by the applicant were inappropriate.

117    In the first place, while the applicant’s first audit could be carried out remotely, namely on the basis of documents, in particular due to the restrictions linked to COVID-19, the fact of not having detected the deficiencies during the planned inspection on Unjha Agro’s site on 28 September 2020 is an error to be attributed to the applicant, especially since, according to the latter, the auditor had verified the risk of fumigation with prohibited substances.

118    In the second place, it should be noted, like the Commission did, that, in its 2020 and 2021 annual reports appearing in Annexes B.14 and B.15 to the defence, APEDA drew attention to the lack of experience of the applicant’s inspectors. It is true that, in 2021, as is apparent from Annex B.15 to that pleading, APEDA decided to renew the applicant’s accreditation. However, that fact alone cannot dispel the doubts concerning the experience of the inspectors in 2020, expressed by APEDA in those annual reports.

119    That finding cannot be called into question by the list of auditors who carried out the inspections of Unjha Agro in 2020 appearing in Annex C.13 to the reply, put forward in order to show that the applicant’s inspectors had between five and a half and 10 years of experience, given that that list is a simple table unsupported by evidence. Nor is that finding called into question by the unsubstantiated explanations provided by the applicant during the hearing.

120    In the third place, as follows from APEDA’s 2021 annual report appearing in Annex B.15 to the defence, that report found that the applicant had not carried out unannounced and additional inspections in accordance with the requirements. Likewise, it is apparent from the document including an evaluation of the corrective actions submitted by the applicant in respect of the non-conformities dating back to 2021, appearing in Annex C.12 to the reply, that APEDA criticised the applicant for not carrying out sufficient unannounced inspections. Those facts further confirm that the applicant’s approach when carrying out its tasks was not sufficiently diligent, even in 2021, that is to say after the unfortunate experience with Unjha Agro.

121    In the fourth place, although the applicant learned of the discovery of the first cases of ETO in sesame originating in India on 6 October 2020, it follows from the evaluation report of the French accreditation committee appearing in Annex A.14 to the application that it was only from 20 October 2020 that it began to inform its clients in India of the dangers associated with organic products contaminated following ETO fumigation and of the need to test organic products in order to detect those contaminations.

122    Likewise, the applicant does not provide convincing explanations concerning the 10-day delay between the first of the three OFIS notifications and the unannounced inspection of Unjha Agro. It merely relies on the logistical constraints linked to the organisation of an unannounced audit and the COVID-19 pandemic.

123    In that context, the applicant’s argument that APEDA imposed sanctions on it without withdrawing its accreditation as a recognised control body for India cannot succeed. The APEDA sanctions confirm that the applicant was not blameless in the execution of controls during the ETO crisis. The fact that its accreditation was renewed in India has no impact on the assessment of the measure adopted by the Commission in the present case.

124    In that regard, the Commission is free to establish stricter requirements compared to those established in a third country with regard to compliance with import rules and thus go so far as to require, having regard to the protection of human health, which is an objective of the legislation concerned, a practically irreproachable performance on the part of the competent bodies of third countries (see, by analogy, judgment of 8 July 2020, BRF and SHB Comércio e Indústria de Alimentos v Commission, T‑429/18, EU:T:2020:322, paragraph 80).

125    In the light of those considerations and in view of the wide discretion available to the Commission with regard to the supervision of recognised third countries within the meaning of Article 48(2) of Regulation 2018/848 (see paragraphs 54 to 57, 83 and 84 above), the applicant’s arguments examined in paragraphs 117 to 124 above do not permit the inference that the Commission made a manifest error in considering that the corrective measures taken by the applicant were inappropriate.

126    Furthermore, by its other arguments claiming that, following the publication of the APEDA circular of 24 December 2020, it, first, reinforced its controls and extended the mandatory ETO tests to a list of 11, and later to a list of 25, products at risk, and, secondly, increased, in 2021, the number of unannounced inspections and reinforced the controls prior to the issuing of the certificate of inspection, the applicant likewise does not establish that the finding at issue is vitiated by a manifest error. The deficiencies concerning the corrective measures taken by the applicant in respect of consignments of contaminated organic products originating in India cannot be called into question by the subsequent adoption of other measures aimed at improving its control process.

127    In the light of the foregoing, the second and third parts must be rejected as unfounded.

 The second reason for the applicant’s withdrawal from the list of recognised control bodies for India

128    At the outset, it should be noted, first, that, under Annex III to Regulation No 1235/2008, the Commission recognised that the Republic of India respected principles and rules of production and controls equivalent to those of the European Union only in respect of unprocessed plant products falling within Category A and vegetative propagating material and seeds for cultivation falling within Category F. That fact is not disputed by the applicant. Secondly, the Commission considers that the applicant issued certificates of inspection for processed products, namely products which fall outside the scope of the recognition for India.

129    In order to demonstrate that the Commission made a manifest error of assessment in considering that it had not respected the scope of the recognition for India with regard to the products which may be imported into the European Union, the applicant merely maintains that the classification of sesame seeds as processed products falling within Category D is incorrect in view of the uncertainty surrounding the concept of ‘processed products’ and its application in the present case.

130    In that regard, it is important to note that the applicant raised that argument for the first time in its request for a hearing, even though the Commission had pointed out in the defence that the applicant had not disputed several reasons appearing in recital 6 of the contested implementing regulation. It should also be noted that, in the reply, the applicant merely maintained that it did not need to respond to all of the conclusions in that recital.

131    Under Article 84(1) of the Rules of Procedure, no new plea in law may be introduced in the course of proceedings unless it is based on matters of law or of fact which come to light in the course of the procedure. However, a plea or a head of claim which amounts to amplifying a plea or head of claim put forward previously, whether directly or by implication, in the originating application and which is closely connected therewith must be declared admissible (see judgment of 11 November 2020, AV and AW v Parliament, T‑173/19, not published, EU:T:2020:535, paragraph 52 and the case-law cited). To be regarded as an amplification of a plea or a head of claim previously advanced, a new argument must, in relation to the pleas or heads of claim initially set out in the application, present a sufficiently close connection therewith in order to be considered as forming part of the normal evolution of debate in proceedings before the Court (see judgment of 8 July 2020, VQ v ECB, T‑203/18, EU:T:2020:313, paragraph 56 and the case-law cited).

132    In the present case, the argument based on the incorrect classification of sesame seeds as processed products nevertheless cannot be considered an amplification of any of the pleas of the action, since, in the application, the applicant did not dispute the second reason for its withdrawal from the list of recognised control bodies for India.

133    In those circumstances, it is appropriate to consider that the argument at issue is new and, in so far as it is not based on elements of law and fact which came to light during the proceedings, to reject it as inadmissible.

134    In the light of the foregoing, the third plea in law must be rejected in its entirety.

 The fourth plea in law, alleging a breach of the principle of proportionality

135    The applicant claims that its withdrawal from the list of recognised control bodies for India is disproportionate to the irregularities found, in so far as, first, the withdrawal of five control bodies from that list has a considerable impact on exports from India to the European Union, since the products certified by those bodies represent 80% of exports, secondly, it took corrective measures and, thirdly, among the 520 operators certified by the applicant in Category A, only one was concerned by the presence of ETO in its exports. In addition, monitoring or suspension could have achieved the same result without removing the applicant from that list.

136    Furthermore, the applicant maintains that the Commission should have carried out an exhaustive study of the impacts and the various alternatives before adopting the contested implementing regulation and should have taken account of the sanctions already imposed on the applicant by APEDA.

137    The Commission disputes the applicant’s arguments.

138    In the first place, in view of the wide discretion of the Commission in the present case (see paragraphs 54 to 57, 83 and 84 above), only the manifestly inappropriate nature of the applicant’s withdrawal from the list of recognised control bodies for India in terms of the objective which the Commission is seeking to pursue can affect the lawfulness of such a measure (see, to that effect, judgment of 26 June 2012, Poland v Commission, C‑335/09 P, EU:C:2012:385, paragraph 71 and the case-law cited).

139    In the second place, the applicant has not produced any evidence to demonstrate the alleged impact of the contested implementing regulation on exports from India to the European Union. Furthermore, as the Commission rightly maintains, there are still 24 control bodies in the list of recognised control bodies for India, bearing in mind that the regulatory framework allows for the certification, by a new control body, of products which have been subject to controls carried out by a control body the recognition of which has been withdrawn (see, by analogy, order of 24 March 2021, Graanhandel P. van Schelven v Commission, T‑306/19, not published, EU:T:2021:166, paragraph 55).

140    In the third place, with regard to the corrective measures taken by the applicant, it is apparent from the examination of the third plea that the applicant has not succeeded in demonstrating that the Commission had vitiated its analysis by a manifest error of assessment.

141    In the fourth place, having regard to the fact that, as is apparent from paragraphs 54 to 57, 72 to 77, 83 and 84 above, the Commission has, first, wide discretion in relation to the supervision of recognised third countries and that, secondly, the applicant does not enjoy an individual right concerning the execution of controls and certification of products intended for exportation to the European Union, the fact that only one operator certified by the applicant in Category A was concerned by the presence of ETO is not sufficient to demonstrate the manifestly disproportionate nature of the measure taken by the Commission. For the same reasons, the Commission was not under an obligation to carry out a study of the various alternatives before adopting the contested implementing regulation.

142    In the fifth place, with regard to the applicant’s argument that the Commission should have taken into account the sanctions which had already been imposed on it by APEDA, it is sufficient to refer to the analysis of that argument in paragraph 124 above.

143    In those circumstances, it must be stated that the applicant has not demonstrated that the Commission, in deciding to withdraw the applicant from the list of recognised control bodies for India, breached the principle of proportionality.

144    Accordingly, the fourth plea in law must be rejected as unfounded.

 The fifth plea in law, alleging a breach of the principles of equal treatment and non-discrimination

145    The applicant claims in particular that its withdrawal from the list of recognised control bodies for India is discriminatory since the decision to withdraw only certain control bodies from that list is discretionary and is not justified by objective factors or by differences. It maintains that only five control bodies are covered by the contested implementing regulation, whereas at least nine bodies were directly or indirectly concerned by the OFIS notifications relating to ETO for Category A products. It argues that, although other cases of generalised dysfunction led to the imposition of sanctions on all actors, the Commission decided, in a discriminatory manner, to remove the certification of certain control bodies on the basis of the OFIS notifications alone and thus created unfair competition between foreign control bodies.

146    The Commission disputes the applicant’s arguments.

147    It should be borne in mind that the principle of equal treatment must be reconciled with respect for legality, according to which a person may not rely, to his or her benefit, on an unlawful act committed in favour of a third party (see judgment of 16 June 2016, Evonik Degussa and AlzChem v Commission, C‑155/14 P, EU:C:2016:446, paragraph 58 and the case-law cited).

148    It is apparent from the examination of the third plea that, in the present case, the applicant has not succeeded in calling into question the merits of the reasons for which it was withdrawn from the list of recognised control bodies for India. In that regard, even assuming that the Commission should have withdrawn other control bodies from that list, that fact cannot have any impact on the legality of Article 1 of the contested implementing regulation, read in conjunction with Annex I to that implementing regulation, as regards India (point 5), in so far as the applicant has been withdrawn from that list.

149    Furthermore, as regards the argument that the Commission does not have direct supervisory powers over control bodies under Article 33(2) of Regulation No 834/2007, or that the information received on the basis of which the Commission can amend the specifications must be understood as information sent by the third country and not as the result of the investigations carried out by the Commission, it is important to note that the applicant does not explain how those arguments have any link with the breach of the principles of equal treatment and non-discrimination which it invokes. In any event, those arguments must be rejected on the same grounds as those set out in the context of the examination of the first plea.

150    Lastly, the applicant’s argument alleging that, in many cases, other control bodies of suppliers – downstream in the chain – also participate, on another scale, in detecting the source of the contamination and that the OFIS notifications therefore do not reflect reality is likewise not capable of calling into question the conclusion set out in paragraph 148 above. Such an argument concerning the conduct or possible liability of other control bodies cannot call into question the applicant’s conduct and liability.

151    It follows that the applicant has not demonstrated that the Commission, in deciding to withdraw the applicant from the list of recognised control bodies for India, breached the principles of equal treatment and non-discrimination, with the result that the fifth plea in law must be rejected as unfounded.

 The sixth plea in law, alleging a breach of the principles of legal certainty and legitimate expectations

152    The applicant submits that, by adopting the contested implementing regulation, the Commission breached the principles of legal certainty and legitimate expectations. According to the applicant, the legal provision on the basis of which the Commission decided to withdraw it from the list of recognised control bodies for India is neither clear nor predictable in application. Furthermore, it claims that the maintenance of its inclusion on that list since 2006 has given rise to legitimate expectations. Likewise, it asserts that Article 48 of Regulation 2018/848, providing that the recognition of third countries under Article 33(2) of Regulation No 834/2007 ends on 31 December 2026, gave rise to a legitimate expectation that the recognition of India and of control bodies for India would not, in principle, be revised before 2026. According to the applicant, the present case does not fall within the discretion of the EU institutions, given that the Commission does not have a power of direct supervision over the control bodies under Article 33(2) of Regulation No 834/2007. Thus, it considers that its withdrawal from the abovementioned list is an arbitrary decision that neither the Member States, nor third countries, nor the control bodies could have anticipated.

153    Furthermore, the applicant emphasises, again, that it learned of its withdrawal from the list upon publication of the contested draft regulation on 5 October 2021, without any notice.

154    The Commission disputes the applicant’s arguments.

155    As regards the principle of the protection of legitimate expectations, it must be recalled, first of all, that, in the field of the common agricultural policy, economic operators are not justified in having a legitimate expectation that an existing situation, which is capable of being altered by the competent authorities in the exercise of their discretionary power, will be maintained (see judgment of 22 October 2009, Elbertsen, C‑449/08, EU:C:2009:652, paragraph 45 and the case-law cited).

156    In the present case, in the first place, it follows, implicitly but necessarily, from the examination of the first and second pleas, that the legal provisions on the basis of which the Commission decided to withdraw the applicant from the list of recognised control bodies for India were sufficiently clear, with the result that their application was predictable for the applicant.

157    In the second place, in so far as the applicant seeks, once again, to call into question the competence of the Commission to withdraw it from the list of recognised control bodies for India, it is appropriate to refer to the examination of the first plea, from which it follows that the Commission had such competence. Therefore, neither the maintenance of the applicant’s inclusion on that list since 2006, nor Article 48 of Regulation 2018/848, could give rise to a legitimate expectation on the part of the applicant that the list of control bodies for India would not be not amended before 31 December 2026.

158    In the third place, in answer to the applicant’s argument alleging that it learned of its withdrawal from the list of recognised control bodies for India upon publication of the draft of the contested regulation, without being given the slightest notice or having the possibility of expressing its view before that publication, it is sufficient to refer to the examination of the second plea.

159    It follows that the applicant has not demonstrated that the Commission, in deciding to withdraw the applicant from the list of recognised control bodies for India, breached the principles of legal certainty and legitimate expectations.

160    Therefore, the sixth plea in law must be rejected and, consequently, the action must be dismissed in its entirety.

 Costs

161    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (Seventh Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Ecocert India Pte Ltd to pay the costs.

Kowalik-Bańczyk Buttigieg Ricziová

Delivered in open court in Luxembourg on 10 July 2024.

V. Di Bucci S. Papasavvas

Registrar President

*      Language of the case: English.