ddrg/super_eurlex huggingface dataset:
Order of the General Court (Third Chamber) of 16 February 2016 —

Industrias Químicas del Vallés v Commission

(Case T‑296/15)

‛Action for annulment — Plant protection products — Implementing Regulation (EU) 2015/408 — Establishing a list of candidates for substitution — Inclusion of metalaxyl on that list — Lack of individual concern — Regulatory act entailing implementing measures — Inadmissibility’

1. Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Individual concern — Criteria — Commission regulation identifying an active substance as a candidate for substitution pursuant to Regulation No 1107/2009 — Action by an importer of the substance in question — Not individually affected — Inadmissibility (Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1107/2009, Art. 80(7), and Annex II, point 4; Commission Regulation No 2015/408, second recital and Art. 1; Council Directive 91/414, Annex I) (see paras 21, 23-26, 28)

2. Actions for annulment — Natural or legal persons — Meaning of ‘regulatory act’ — Any act of general scope other than legislative acts — Commission regulation identifying an active substance as a candidate for substitution pursuant to Regulation No 1107/2009 — Included (Arts 263, fourth para., TFEU and 289(1) to (3) TFEU; European Parliament and Council Regulation No 1107/2009, Arts 78(3), and 79(2); Commission Regulation No 2015/408; Council Decision 1999/468, Arts 3 and 7) (see paras 31-33)

3. Actions for annulment — Natural or legal persons — Regulatory acts — Acts not comprising implementing measures and concerning the applicant directly — Concept of implementing measures — Criteria — Commission regulation identifying an active substance as a candidate for substitution pursuant to Regulation No 1107/20099 — Effects produced through the intermediary of measures taken by the national authorities — Acts constituting implementing measures (Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1107/2009, Arts 20(1), 24(1), 36(2), 41(2)(b), 43(1), 44(3), 45(1), and 50(1) and (4); Commission Regulation No 2015/408) (see paras 34, 41, 44-46, 48, 49)

4. Fundamental rights — Right to effective judicial protection — Review of legality of EU measures — Procedures — Protection of that right by the EU judicature or by the national courts according to the legal nature of the contested measure — Possibility of using an annulment action or reference for a preliminary ruling on validity (Art. 19(1) TEU; Arts 263 TFEU, 267 TFEU and 277 TFEU; Charter of Fundamental Rights of the European Union, Arts 47 and 51(1)) (see paras 51-57)

Re:

APPLICATION for annulment in part of Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ 2015 L 67, p. 18).

Operative part

1. The action is dismissed as inadmissible.
Order of the President of the General Court of 13 June 2016 —

ICA Laboratories and Others v Commission

(Case T‑732/15 R II)

‛Application for interim measures — Environment — Consumer protection — Regulation fixing maximum residue levels for guazatine — Application for suspension of operation of a measure — New application — No new facts — No urgency’

1. Application for interim measures — Suspension of operation of a measure — Dismissal of application — Possibility of bringing a new application — Condition — New facts — Definition (Art. 278 TFEU; Rules of Procedure of the General Court, Art. 160) (see paras 18-20, 24-31)

2. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Burden of proof — Burden resting solely on the person entitled to bring the action in the main proceedings (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 160) (see para. 22)

Re:

APPLICATION, pursuant to Article 160 of the Rules of Procedure of the General Court, for suspension of the operation of Commission Regulation (EU) 2015/1910 of 21 October 2015 amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for guazatine in or on certain products (OJ 2015 L 280, p. 2).

Operative part

1. The application for interim measures is dismissed.
Order of the President of the General Court of 23 May 2016 — Pari Pharma v EMA

(Case T‑235/15 R)

‛Application for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market — Order granting suspension of operation of the decision to grant a third party access to the documents — Application for cancellation — No change in circumstances — Article 159 of the Rules of Procedure of the General Court’

Application for interim measures — Suspension of operation of a measure — Interim measures — Modification or setting aside — Condition — Change in circumstances — Concept (Rules of Procedure of the General Court, Art. 159) (see paras 27, 28)

Re:

APPLICATION based on Article 159 of the Rules of Procedure of the General Court seeking cancellation of the order of 1 September 2015 in Pari Pharma v EMA (T‑235/15 R, EU:T:2015:587), by which it granted the suspension of operation of Decision EMA/271043/2015 of the EMA of 24 April 2015, granting to a third party, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), access to certain documents containing information submitted in the context of an application for marketing authorisation for the medicinal product Vantobra.

Operative part

1. The application for cancellation of the order of 1 September 2015 in Pari Pharma v EMA (T‑235/15 R, EU:T:2015:587) is dismissed.
Persons other than those to whom a decision is addressed may claim to be individually concerned only if that decision affects them by virtue of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and thus distinguishes them individually just as in the case of the person to whom the decision is addressed. An association which is responsible for protecting the collective interests of its members could be regarded as individually concerned by a final decision of the Commission on State aid in two sets of circumstances, namely, first, if it can prove an interest of its own, in particular because its position as a negotiator has been affected by the act of which annulment is sought, or, secondly, where its members or some of them themselves have locus standi.

The concept of regulatory acts which do not entail implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, must be interpreted in the light of that provision’s objective, which consists in preventing an individual from being obliged to infringe the law in order to have access to a court. Where a regulatory act directly affects the legal situation of a natural or legal person without requiring implementing measures, that person could be denied effective judicial protection if he did not have a direct legal remedy before the European Union judicature for the purpose of challenging the legality of the regulatory act. Natural or legal persons in that situation, although directly concerned by the act in question, would be able to obtain a judicial review of that act only after having infringed its provisions, by pleading that those provisions are unlawful in proceedings initiated against them before the national courts.

On the other hand, where a regulatory act entails implementing measures judicial review is ensured. Where responsibility for the implementation of a regulatory act lies with the institutions, bodies, offices or agencies of the European Union, natural or legal persons are entitled to bring a direct action before the European Union judicature against the implementing acts under the conditions stated in the fourth paragraph of Article 263 TFEU, and to plead in support of that action, pursuant to Article 277 TFEU, the illegality of the basic act at issue. Where the implementation of a regulatory act is a matter for the Member States, natural or legal persons may challenge the validity of the national implementing measure before a national court or tribunal and, in those proceedings, plead the invalidity of the basic act at issue and cause that court or tribunal to request a preliminary ruling from the Court of Justice, pursuant to Article 267 TFEU.

(see paras 38-41)
Order of the General Court (Fourth Chamber) of 26 October 2016 —

Edeka-Handelsgesellschaft Hessenring v Commission

(Case T‑611/15)

‛Action for annulment and for failure to act — Access to documents — Regulation (EC) No 1049/2001 — Documents relating to a procedure for applying Article 101 TFEU and Article 53 of the EEA Agreement — Refusal to grant access — New request — Application for annulment — No confirmatory act — Admissibility — Claim for failure to act — Inadmissibility’

1. Actions for annulment — Actionable measures — Definition — Measures producing binding legal effects — Decision confirming refusal of access to documents following an application brought in the name of a third party, the latter having already been refused access to documents concerned by the said decision — Nothing enabling the applicant to be classified as addressee of the decision made in the context of the first procedure — Contested act not confirmatory in character — Admissibility (Art. 263 TFEU; European Parliament and Council Regulation No 1049/2001, Art. 4(1) to (3) and (7)) (see paras 25-29, 35-38, 45-51, 60, 61)

2. Actions for failure to act — Institution not called upon to act — Inadmissibility (Art. 265, second para. TFEU) (see paras 67-70)

Re:

APPLICATION based on Article 263 TFEU and seeking annulment of the Commission Decision of 3 September 2015 refusing the applicant access to the non-confidential version of the Commission’s decision of 4 December 2013, concerning a procedure for applying Article 101 TFEU and Article 53 of the EEA Agreement [Case AT.39914 — Euro Interest Rate Derivatives (EIRD) — Transaction Procedure], and the table of contents of the administrative file for that procedure, and an application based on Article 265 TFEU seeking a declaration that the Commission unlawfully failed to draw up a non-confidential version of Decision C(2013) 8512 final and the contents table relating to that procedure.

Operative part

1. The claim for failure to act is dismissed as inadmissible.

2. The objection of inadmissibility is dismissed as to the remainder.
Order of the General Court (Seventh Chamber) of 28 June 2018 –

Romania v Commission

(Case T‑478/15)

(Actions for annulment — European Union’s own resources — Financial responsibility of the Member States — Obligation to pay the Commission the amount corresponding to a loss of own resources — Letter from the Commission — Act not open to challenge — Inadmissibility)

1. Actions for annulment—Actionable measures—Meaning—Measures producing binding legal effects—Commission letter informally calling on Member State to place traditional own resources at the disposal of the EU budget—Not included (Art. 263 TFEU; Council Regulation No 1150/2000; Council Decision 2007/436) (see paras 28, 32, 41, 44, 53, 55, 61)

2. Actions for annulment—Actionable measures—Meaning—Measures producing binding legal effects—Purely informative measure—Not included (Art. 263 TFEU) (see paras 29, 52)

3. Own resources of the European Union—Establishment and making available by the Member States—Responsibility of the Member States—Scope (Council Regulation No 1150/2000, Arts 2(1), 9(1) and 17(1) and (2); Council Decision 2007/436, Arts 2(1)(a) and 8(1)) (see paras 33, 34, 38)

4. Actions for annulment—Actionable measures—Meaning—Measures producing binding legal effects—Whether that condition can be set aside by invoking the right to effective judicial protection—None (Art. 6(1), third para. TEU; Art. 263, fourth para. TFEU; Charter of Fundamental Rights of the European Union, Arts 47 and 52(7)) (see para. 64)

Re:

Application based on Article 263 TFEU seeking annulment of the decision of the Directorate-General for Budget of the Commission which is contained in the letter with reference Ares (2015) 2453089 of 11 June 2015 by which the latter ordered Romania to provide it with the gross amount of EUR 1 079 513.09, from which 25% should be deducted for collection costs, corresponding to a loss of traditional own resources, at the latest on the first working day following the nineteenth day of the second month following the dispatch of that letter, at the risk of having to pay default interest pursuant to Article 11 of Council Regulation (EC, Euratom) No 1150/2000 of 22 May 2000 implementing Decision 94/728/EC, Euratom on the system of the Communities’ own resources (OJ 2000 L 130, p. 1).

Operative part

1. The action is dismissed.

2. There is no need to rule on the Slovak Republic’s application to intervene.

3. Romania is ordered to bear its own costs and to pay those by the European Commission.
90

Moreover, the serious nature of the damage invoked by the applicant is also established on the following ground: first, the existence of a prima facie case has been shown, in the present case, by the fact that the confidentiality request submitted by the applicant raises complex questions which call for a thorough examination that can be carried out only by the Court when it adjudicates on the substance, and, secondly, the judge hearing an application for interim measures is required to start from the premiss that the information alleged to be confidential is in fact confidential (see paragraph 84 above). Information of an economic nature is classified as confidential only if its disclosure is liable to cause serious damage to the commercial and financial interests of the holder of that information (see, to that effect, judgments of 18 September 1996 in Postbank v Commission, T‑353/94, ECR, EU:T:1996:119, paragraph 87; 30 May 2006 in Bank Austria Creditanstalt v Commission, T‑198/03, ECR, EU:T:2006:136, paragraph 71; and 12 October 2007 in Pergan Hilfsstoffe für industrielle Prozesse v Commission, T‑474/04, ECR, EU:T:2007:306, paragraph 65). It follows that the assessment of whether disclosure of the reports at issue would cause the applicant ‘ordinary’ or ‘serious’ damage cannot be separated from the thorough examination to be carried out by the Court when ruling on the main action. In view of his ancillary role vis-à-vis that of the Court adjudicating on the substance, the judge hearing an application for interim measures is therefore, in any event, required to assume, for the purposes of the present proceedings, not only that the reports at issue are confidential, but also that the damage that may be caused to the applicant by disclosure of those reports is serious (see, to that effect, order in Deza v ECHA, cited in paragraph 52 above, EU:T:2014:686, paragraph 86).
10

In the application, the applicant claims that the Court should: — primarily: — with regard to the rights derived from the private law contract: — recategorise his contractual relationship as an employment contract of an indeterminate duration; — hold that there has been an infringement by the defendants of their contractual obligations and, in particular, of giving notice of termination of a contract of an indeterminate duration and, in consequence, in compensation for the loss suffered by the abusive use of consecutive fixed-term contracts causing the applicant prolonged uncertainty and the infringement of the obligation to give notice of termination of the contract: — order the defendants to pay the applicant compensation in lieu of notice of EUR 176601.55 calculated on the basis of his seniority in post in missions created by the European Union; — in the alternative, order the defendants to pay the applicant compensation in lieu of notice of EUR 45985.15 calculated taking account of the length of his service for Eulex Kosovo; — hold that the dismissal of the applicant is unfair and, in consequence, order the defendants to pay him compensation assessed ex aequo et bono at EUR 50000; — hold that the defendants did not prepare the legal end-of-employment documents; — order them to pay the applicant the sum of EUR 100 per day of non-payment with effect from the bringing of the present action; — order them to send the applicant the end-of-employment documents; — order the defendants to pay interest on the abovementioned sums, calculated at the Belgian legal rate; — with regard to the abuse of power and actual discrimination: — declare that the EEAS, the Council and the Commission treated the applicant in a discriminatory manner, without objective justification, during his employment on the missions which they instituted, as regards his remuneration, pension rights and related benefits and as regards a guarantee of future employment; — hold that the applicant ought to have been recruited as a member of the temporary staff of one of the EEAS, the Council or the Commission; — order the EEAS, the Council and the Commission to compensate him for the loss of remuneration, pension, allowances and benefits caused by the abovementioned breaches of EU law and order them to pay him interest on those sums, calculated at the Belgian legal rate; — prescribe a period within which the parties are to determine that compensation, having regard to the grade and step in which the applicant ought to have been employed, the average progression of the remuneration, the progress of his career, the allowances which he thus ought to have received under that temporary contract, and compare the results obtained with the remuneration actually received by the applicant; — in the alternative: — find that the defendants failed to fulfil their obligations; — order them to compensate the applicant for the harm resulting from that failure, which is estimated ex aequo et bono at EUR 150000; — in any event, order the defendants to pay the costs.
4

The registration procedure comprises two stages. In the first stage, the application for registration of names is subject to scrutiny at national level. That stage is governed by Article 49 of Regulation No 1151/2012, which states the following: ‘1. Applications for registration of names under the quality schemes referred to in Article 48 may only be submitted by groups who work with the products with the name to be registered. ... 2. ... the application shall be addressed to the authorities of that Member State. The Member State shall scrutinise the application by appropriate means in order to check that it is justified and meets the conditions of the respective scheme. 3. As part of the scrutiny referred to in the second subparagraph of paragraph 2 of this Article, the Member State shall initiate a national opposition procedure that ensures adequate publication of the application and that provides for a reasonable period within which any natural or legal person having a legitimate interest and established or resident on its territory may lodge an opposition to the application. The Member State shall examine the admissibility of objections ... 4. If, after assessment of any opposition received, the Member State considers that the requirements of this Regulation are met, it may take a favourable decision and lodge an application dossier with the Commission. It shall in such case inform the Commission of admissible oppositions received from a natural or legal person that have legally marketed the products in question, using the names concerned continuously for at least five years preceding the date of the publication referred to in paragraph 3. The Member State shall ensure that its favourable decision is made public and that any natural or legal person having a legitimate interest has an opportunity to appeal. The Member State shall ensure that the version of the product specification on which its favourable decision is based, is published, and shall provide electronic access to the product specification. With reference to protected designations of origin and protected geographical indications, the Member State shall also ensure adequate publication of the version of the product specification on which the Commission takes its decision pursuant to Article 50(2).’
Order of the General Court (Second Chamber) of 7 March 2017 —

SymbioPharm v EMA

(Case T‑295/16)

(Action for annulment — Medicinal products for human use — Commencement of the procedure for referral to the EMA — Articles 31 to 34 of Directive 2001/83/EC — Medicinal product Symbioflor 2 and medicinal products with similar designations — Act not open to challenge — Preparatory act — Inadmissibility)

Actions for annulment—Actionable measures—Concept—Measures producing binding legal effects—Letter from the European Medicines Agency informing of commencement of the procedure for referral to the committee on medicines for human use—Measure constituting a preliminary step in a consultative procedure—Not included

(Art. 263 TFEU; European Parliament and Council Directive 2001/83, Arts 32 to 34)

(see paras 21, 31, 33, 35)

Re:

APPLICATION based on Article 263 TFEU seeking annulment of the letter from the EMA of 1 April 2016 to initiate a referral procedure referred to in Articles 32 to 34 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), concerning medicinal product Symbioflor 2 and similarly named medicinal products following a notification by the Federal Republic of Germany under Article 31 of that Directive.

Operative part

1. The action is dismissed as inadmissible.