Grimaldi Alliance expands in Sweden with SALC, a leading full service law firm with great tradition and expertise.

GA - active internationally in over 50 jurisdictions - and led by Global Managing Partner Francesco Sciaudone, announces the addition of SALC, a Swedish boutique full service law firm with great experience and professional standing.

SALC, founded in 2006, is GA's new partner for Sweden and the Scandinavian countries, completing the range of professional services that can be offered in the area with important expertise in litigation - domestic and international - and corporate.

SALC's founding partner, Dan Engström, has more than 30 years of experience in dispute resolution, as well as in franchise and commercial contract management.Engström is also admitted to handle international arbitrations, particularly in intellectual property matters.

Jan Stålhandske, another prominent partner in the firm, on the other hand, has extensive experience in the infrastructure and utilities sector and has worked on, among other things, the regulation of postal, railway and telecommunications markets.He specialises in advocacy, arbitration, acting as an arbitrator and as a lawyer.

"We are delighted to announce the entry of SALC into the Grimaldi Alliance. Their experience and professionalism allow us to expand GA's coverage to the Scandinavian region and Sweden in particular, continuing GA's international growth. Every day we receive more and more requests for support in cross-border activities from customers and partners of GA, which is increasingly establishing itself as one of the leading international networks,’ said Francesco Sciaudone, Global Managing Partner of the Grimaldi Alliance.

As of May 28, 2024, the revised Energy Performance of Buildings Directive came into force. New rules tackle both climate change and energy affordability, aiming for a significant decrease in greenhouse gas emissions and overall energy use within the EU's building sector. By 2030, all new buildings will need to be zero-emission and by 2050, the entire EU building stock should reach climate neutrality.

The revised Directive:

Sets benchmarks for building efficiency, by introducing minimum energy performance standards and establishing clear expectations for how much energy can be consumed by buildings. For non-residential buildings, this translates to a specific maximum annual energy use per square meter. A great focus is placed on improving the energy efficiency of the worst-performing buildings, likely through renovations and upgrades. Under the new Directive, Member states will have to renovate 16% of the worst-performing non-residential buildings by 2030 and 26% by 2033. Residential buildings, on the other hand, will see a focus on achieving an overall reduction in average energy use. EU Member states are asked with ensuring a 16% decrease by 2030 and a further 20-22% reduction by 2035. Pushes for phasing-out fossil fuels from heating in buildings, to achieve full decarbonisation of the sector. All new residential and non-residential buildings must have zero on-site emissions from fossil fuels as of: (i) 1st January 2028 for publicly owned buildings and (ii) as of 1st January 2030 for all other new buildings, with a possibility for specific exemptions. By 2040, national building renovation plans will include a roadmap with a view to phase out fossil fuel boilers. Member states have to outline how they will adopt measures to decarbonise heating systems, while subsidising stand-alone fossil fuel boilers will be prohibited as of 2025. Promotes sustainability, by supporting the enhancement and use of solar energy in buildings. All new buildings must comply with "solar ready" criteria, which means that they must be suitable for the deployment of solar energy installations (photovoltaic, solar thermal installations etc.) in new buildings, public buildings and existing non-residential ones, under renovation that requires a permit. New rules also encourage sustainable mobility infrastructure, including recharging points for electric cars in or next to buildings, pre-cabling or ducting for future charging infrastructure and parking spaces for bicycles. Foresees general exemptions for agricultural buildings and heritage buildings. Moreover, Member states may decide to also exclude buildings protected for their special architectural or historical merit, temporary buildings, churches, and places of worship.

Articles 30, 31, 33 and 34 of the revised Directive will apply as from 30th May 2026. Member states will have two years to incorporate new rules into their national legislation, while the European Commission will review the Directive by 2028, in the light of the experience gained and progress made during its implementation.

Corporate law 

Disputes relating to a commercial company: the director does not have the choice of jurisdiction

As a rule, the commercial courts have exclusive jurisdiction to hear disputes relating to commercial companies. By way of exception, non-commercial parties who are not members of the company's governing bodies may choose to bring their disputes before the consular or civil courts. When a dispute arises between the director or another corporate officer or partner of a commercial company and that company or another of its partners or corporate officers and concerns a dispute relating to that commercial company, it therefore falls within the exclusive jurisdiction of the commercial court.

The conditions for taking over an act performed in the name of or on behalf of a company under formation: a major change in case law

Under articles L. 210-6 and R. 210-6 of the French Commercial Code, commercial companies acquire legal personality from the date of their registration in the Trade and Companies Register. Persons who have acted in the name of or on behalf of a company under formation before it has acquired legal personality are jointly and severally liable for all acts performed, unless the company, after having been duly formed and registered, takes over the obligations entered into, which are then considered to have been undertaken by the company from the outset. In the case of an act in which it is not expressly stated that it has been entered into in the name of or on behalf of the company being formed, it is for the judge to assess, in a sovereign manner, by examining all the circumstances, both intrinsic to the act and extrinsic, whether it was not the common intention of the parties that it should be entered into in the name of or on behalf of the company and that the company could then, after acquiring legal personality, decide to take over the commitments entered into

Liability of the manager of a limited liability company (“société à responsabilité limitée, SARL”) and cancellation of his current account: limitation period

Liability claims against a former SARL manager and shareholder are subject to a three-year limitation period. A claim for damages brought against the manager for the cancellation of a current account agreement is subject to the same limitation period, and not to the five-year limitation period under ordinary law.

A creditor of a dissolved civil company (“société civile”) must take action against the company before taking legal action against a partner

A creditor of a civil company may only take action against the partners to recover a company debt after having unsuccessfully taken legal action against the company, even if the company is being voluntarily liquidated.

Statutory auditors (“commissaires aux comptes”) cannot be relieved of their duties without serious misconduct or a serious impediment

The removal of a statutory auditor requires proof of sufficiently serious misconduct. In addition, the mere fact that the entity within which the auditor carries out his duties brings an action for liability against the auditor does not constitute an impediment justifying his removal. 

IP/IT and Communication 

Non-pecuniary damage resulting from a material error in the communication of personal data

In a ruling handed down on 25 January 2024, the Court of Justice of the European Union confirmed that in the event of a personal data breach, the data subject may seek compensation for his or her loss under the conditions of ordinary liability law. A purely hypothetical risk of misuse by an unauthorised third party cannot, however, give rise to compensation.This is not the first time that the Court of Justice of the European Union has shed light on the interpretation of Article 82 of the General Data Protection Regulation, under which any person who has suffered material or non-material damage because of unlawful data processing has the right to obtain compensation for the damage caused by the data controller.

Electronic prescribing: conditions for implementation and entry into force

French decree no. 2023-1222 of 20 December 2023 formalises the entry into force of electronic prescribing by specifying the conditions for its implementation by healthcare professionals, the exercise of patients' rights and the cases in which, by way of derogation, electronic prescribing may not be applied.

Employment law

 It is up to the employer to prove the provision of business premises in order to avoid paying compensation to the employee

According to the Social Law Chamber of the French Supreme Court (“chambre sociale de la Cour de Cassation”), the burden of proving the provision of business premises to determine whether to award compensation for home occupation for business purposes lies with the employer and not the employee.

Untaken leave according to European law

The Court of Justice of the European Union has ruled on the interpretation of the directive about “working time” (“temps de travail”). A worker who has not been able to take all his paid annual leave before resigning is entitled to financial compensation. Member States may not limit this right on the grounds of controlling public expenditure.

A new formality for employers offering a permanent contract to an employee who has completed a fixed-term contract or assignment

The “loi Marché du travail” of 21 December 2022 introduced an obligation for employers offering employees a permanent contract in the same or a similar role as the completed fixed-term contract, to notify such an offer in writing. This obligation applies from 1st January 2024.

Lack of a resumption medical visit by the employee: reversal of case law

Until now, if an employee's resumption medical visit was not organised, he could not claim payment of his remuneration. However, he could be compensated for the loss suffered. In a ruling dated 24 January 2024, the French Supreme Court (“Cour de Cassation”) changed its position on compensation for employees whose resumption medical visit is not scheduled: they are now entitled to payment of their remuneration.

2024 Olympic Games: introduction of a derogation from weekly rest periods

In a decree issued on Friday 24 November, the French government authorised companies involved in broadcasting or organising the Paris 2024 Olympic Games that are experiencing an extraordinary increase in workload to suspend their employees' weekly rest periods "two or more times" between 18 July and 14 August.

Declaration of the professional equality Index before 1 March

By 1st March 2024, all companies with 50 or more employees must have calculated and published their professional quality Index on their website. The professional equality Index enables companies to measure the pay gap between women and men and highlights the areas for improvement where these disparities are unjustified.

The conditions under which foreign nationals can become “entrepreneurs individuels” have been clarified

The Immigration Law (“loi immigration”) n. 2024-42 of 26 January 2024 now stipulates that foreign nationals of countries that are not members of the European Union, the European Economic Area (EEA) or the Swiss Confederation may not work as “entrepreneurs individuels” if they do not have a legal residence permit. 

Real estate law

 It is not a violation to rent a furnished tourist accommodation more than the legal annual limit when it is justified by a professional reason, such as a work placement or the pursuit of a course of study

It should be remembered that, in municipalities that have implemented the “prior declaration registration procedure” (“procédure d'enregistrement de la déclaration préalable”) set out in article L 324-1-1 of the French Tourism Code, any person who offers for rent a furnished tourist accommodation that is declared as their principal residence may not do so for more than 120 days per calendar year, except in the case of a professional reason, health reason or case of force majeure. The legal tribunal ruled that an internship or the pursuit of a course of study can also be considered as a professional reason if it is for a specific and limited period. This exception must be demonstrated by the coincidence in time between the business trips and the periods of rental of the furnished tourist accommodation.

Commercial tenants are not liable for damage caused by obsolescence, unless expressly stated otherwise

A clause in a commercial lease requiring the tenant to return the premises in their original condition does not require him to pay for any damage caused by obsolescence. If an inventory of fixtures was drawn up when the tenant entered the premises, he must return the premises as he received them on the original inventory, except for anything that has perished or been damaged by obsolescence or force majeure. 

Tax 

An act may be considered abusive even if a lawful act could have had the same result

The abuse of rights procedure allows the tax authorities to disregard transactions that may not have been inspired by any motive other than that of evading or mitigating the tax charges that the taxpayer would normally have incurred in view of his actual situation or activities. This procedure can only be applied if the transaction resulted in a tax gain for the taxpayer. The French Council of State (“Conseil d'Etat”) clarifies that acts which have no impact on the taxpayer's burden cannot be dismissed as constituting an abuse of rights even if their sole purpose was to evade or mitigate that burden.

Financial sanctions and penalties taxed abroad are not in principle deductible

The French Council of State (“Conseil d’Etat) has recently ruled that the legal provisions which provide for the non-deductibility of tax sanctions and penalties may apply to sanctions imposed by foreign authorities for breaches of foreign legal obligations.

Sale of a business and retirement: only one year left to benefit from the 500,000 € allowance

French Finance Act (“loi de finances”) 2017-1837 of 30 December 2017 introduced an exceptional allowance of 500,000 € on the capital gain on the sale of an executive who sells his or her business and retires. This scheme, which had already been extended, expires on 31 December 2024. Senior company directors planning to sell their business and retire still have a year to take advantage of this attractive tax window.

Il recente parere dell’EDPB sull’uso del sistema “Pay or Consent”

Sempre più spesso, navigando sui siti di alcune testate giornalistiche o su altre piattaforme online, gli utenti si trovano davanti a una scelta: abbonarsi al servizio oppure acconsentire all’uso dei propri dati per l’invio di contenuti pubblicitari personalizzati.

Una pratica diffusa, quella del “Pay or Consent” (letteralmente: “Paga o Acconsenti”), ma non per questo necessariamente lecita, oggetto del recente parere dell’EDPB (Opinion 08/2024 del 17 aprile 2024). La pronuncia è stata sollecitata da alcune Autorità per la Protezione dei Dati nazionali (Olanda, Norvegia e Germania) e, peraltro, tiene conto anche della sentenza della Corte di Giustizia dell’Unione europea nel caso C-252/21, che ha visto coinvolta Meta.

Tra gli aspetti principali in merito alla configurazione giuridica della fattispecie del “Pay or Consent” emerge senza dubbio la questione della validità del consenso che, si ricorda, ai sensi del GDPR dev’essere, tra le altre cose, liberamente prestato. Ebbene, secondo l’EDPB, la libertà di scelta dell’utente dipende anche dalle opzioni che gli vengono offerte, e risulta difficile immaginare che le piattaforme possano ottenere un consenso liberamente prestato se la scelta si riduce a: pagare un abbonamento o “pagare” con i propri dati.

I titolari, argomenta l’EDPB, non dovrebbero offrire una sola alternativa a pagamento oltre al servizio che include il trattamento dei dati a fini di pubblicità comportamentale, ma dovrebbero prendere in considerazione la possibilità di fornire agli interessati una terza “alternativa equivalente” che non comporti il pagamento di un corrispettivo. Solo in questo modo gli utenti potranno esercitare una vera scelta; infatti, se gli utenti sono messi in condizione di poter usufruire del servizio non solo gratuitamente, ma anche senza dover necessariamente acconsentire alla pubblicità comportamentale, si può dedurre che coloro che prestino il proprio consenso alla profilazione lo facciano liberamente e consapevolmente, e non perché si tratta solo della scelta dell’unica alternativa (apparentemente) gratuita.

A ciò si aggiunga un altro fattore determinante nella validità del consenso prestato: lo squilibrio di potere tra un titolare che ricopre un’importante posizione sul mercato (ad esempio una testata giornalistica) e l’interessato (utente del sito web). Squilibrio che si accentua se si considera la tipologia di servizio e il fatto che lo stesso possa dirsi “essenziale” per gli utenti. In sostanza, il rischio è che nei sistemi “Pay or Consent” gli utenti che non intendono pagare né sottoporsi a un trattamento dei propri dati per l’invio di pubblicità comportamentale si trovino costretti a rinunciare, ad esempio, alla possibilità di informarsi.

Il tema della libertà del consenso prestato è senza dubbio quello che appare più controverso in tale dinamica, ma naturalmente devono essere rispettate anche le altre condizioni affinché il consenso possa dirsi lecito: esso, come noto, dev’essere libero, specifico, informato, inequivocabile ed ottenuto in maniera chiara e comprensibile per l’interessato. Senza trascurare, naturalmente, gli altri principi del GDPR, cui devono attenersi tutti i titolari in occasione di un trattamento di dati personali.

Per approfondimenti:

EDPB, “Opinion 08/2024 on Valid Consent in the Context of Consent or Pay Models Implemented by Large Online Platforms”, 17 April 2024.

AI Act: le nuove regole sull’Intelligenza Artificiale in Europa

Il 21 maggio 2024 è stato approvato il testo definitivo dell’AI Act.

Si tratta del primo regolamento al mondo in materia di intelligenza artificiale volto a promuovere lo sviluppo e l’adozione di sistemi AI sicuri e affidabili all’interno del mercato unico europeo, che operino nel rispetto delle libertà e dei diritti fondamentali dei cittadini, compreso il diritto alla protezione dei dati personali.

L’obiettivo è quello di stimolare nuovi investimenti e promuovere l’innovazione nel campo dell’intelligenza artificiale, considerato un settore ormai cruciale non solo nel mercato europeo ma anche a livello globale, costituendo un elemento di significativa rilevanza strategica in numerosi ambiti e per diversi soggetti.

Innanzitutto, l’AI Act classifica i sistemi di intelligenza artificiale sulla base del rischio per i diritti e le libertà dei soggetti interessati. Infatti, i sistemi di IA che presentano un “rischio limitato” saranno soggetti a obblighi di trasparenza meno rigidi, a differenza dei sistemi di AI considerati ad “alto rischio” che dovranno rispettare una serie di requisiti specifici e che saranno soggetti ad obblighi di trasparenza più stringenti, fatta eccezione per quei sistemi di AI autorizzati dalla legge e impiegati per accertare, prevenire, indagare o perseguire reati.

Inoltre, l’AI Act introduce una serie di divieti con riferimento ad alcune pratiche considerate rischiose, tra cui:

l’adozione di tecniche che manipolano la cognizione e il comportamento individuale; la raccolta casuale di dati biometrici da spazi pubblici, su Internet o tramite i sistemi di videosorveglianza; l’uso di sistemi per il riconoscimento delle emozioni in contesti lavorativi o scolastici; l’implementazione di punteggi di social scoring; l’elaborazione biometrica per l’inferenza di dati appartenenti a categorie particolari; l’impiego di sistemi con funzioni di polizia predittiva rivolti a specifici individui.

L’AI Act detta nuove regole anche con riferimento ai cd. foundation model, ossia quei sistemi computazionali basati sull’AI (ad esempio, ChatGPT) impiegati per diverse attività e finalità, quali la generazione di video, testi e immagini, conversazioni in linguaggio vocale, calcoli e altro ancora.

In relazione a tali sistemi, l’AI Act prevede l’obbligo per i fornitori di effettuare valutazioni d’impatto sui sistemi ad alto rischio o per quelli impiegati nel settore bancario e assicurativo. Tra gli altri obblighi imposti ai fornitori di questi sistemi, rientra anche quello di eseguire test per cercare di risolvere i rischi sistemici e adottare misure che garantiscano un livello adeguato di sicurezza dell’infrastruttura hardware e software.

Un ulteriore aspetto riguarda la previsione di misure volte a favorire lo sviluppo e l’adozione di un’AI sicura. Sotto questo profilo, le autorità competenti di ciascuno Stato membro sono tenute ad istituire uno spazio di sperimentazione normativa dedicato all’AI per garantire un ambiente controllato che promuove l’innovazione e facilita lo sviluppo, l’addestramento, la sperimentazione e la convalida dei sistemi di AI.

In tale contesto, è importante che i sistemi di AI, prima di essere immessi nel mercato, siano stati collaudati. Pertanto, occorre eseguire prove in condizioni reali, ossia sulla base dei dati esistenti forniti da soggetti che abbiano prestato il proprio consenso al trattamento per finalità di sperimentazione normativa per l’AI.

In ogni caso, si pone l’accento sulla tutela del diritto alla protezione dei dati personali, posto che la raccolta dei dati da parte dei sistemi di AI comporta un elevato rischio per i diritti degli interessati ove non fossero adottate misure di protezione o non venissero intraprese azioni per mitigare il rischio di trattamenti illeciti.

Per questa ragione, l’AI Act prevede regole specifiche per la protezione delle persone fisiche i cui dati sono trattati, specie con riferimento alle categorie particolari di dati (come nel caso dei sistemi di AI ad “alto rischio” che utilizzano i dataset per addestrare, testare e convalidare i modelli di apprendimento basati su AI).

I fornitori di tali sistemi possono trattare dati appartenenti a categorie particolari, a condizione che: a) l’utilizzo di tali dati sia limitato e siano adottate adeguate misure di sicurezza, b) siano implementate idonee misure volte a rendere i dati sicuri e protetti nonché soggetti a garanzie adeguate; c) i dati non siano divulgati o comunicati a terzi; e d) i dati siano cancellati una volta raggiunta la finalità del trattamento. 

Infine, non mancano le sanzioni per coloro che violano le previsioni dell’AI Act. Infatti, in base alla tipologia di violazione commessa, l’autorità competente potrà irrogare una sanzione pari ad un importo massimo (che oscilla tra 7,5 e 35 milioni di euro) ovvero, se il trasgressore è un’impresa, a una percentuale del fatturato mondiale totale annuo relativo all’esercizio precedente, se superiore. È prevista un’eccezione per le PMI o startup, a cui si applicheranno sanzioni ridotte.

Per approfondimenti: Artificial Intelligence Act

Il Garante Privacy sanziona un Comune per videosorveglianza illecita e violazione della privacy dei dipendenti

Il Garante per la protezione dei dati personali ha sanzionato un Comune per trattamento illecito di dati personali tramite videosorveglianza. L'intervento è avvenuto a seguito della segnalazione di una dipendente che contestava l'installazione di una telecamera vicino all’orologio-timbratore, l’unico strumento utilizzato per la rilevazione dell’orario di servizio dei dipendenti. Il Comune aveva utilizzato le immagini per contestare alla dipendente alcune violazioni dei propri doveri d’ufficio, tra cui il mancato rispetto dell'orario di servizio e, alla richiesta di motivazioni da parte del Garante Privacy, il Comune ha giustificato la presenza della telecamera con motivi di sicurezza. Tuttavia, il Garante ha rilevato che il Comune non aveva rispettato le procedure di garanzia previste per i controlli a distanza e aveva usato le immagini per scopi disciplinari. Inoltre, il Comune non aveva fornito un'informativa adeguata ai lavoratori e ai visitatori sul trattamento dei dati personali tramite la telecamera.

Per quanto la sanzione irrogata al Comune sia di modesta entità, l’episodio evidenzia chiaramente la delicatezza della tematica, che richiede un’attenta gestione da parte delle aziende.

Per approfondimenti: provvedimento dell’11 aprile 2024 (10013356)

Telemarketing: Il Garante Privacy sanziona due gestori di energia per 100mila Euro

Il Garante per la protezione dei dati personali ha sanzionato due gestori di energia con multe di 100mila euro ciascuno per trattamento illecito di dati personali. L'azione è seguita a due reclami e 56 segnalazioni da parte di utenti che hanno ricevuto telefonate indesiderate e attivazioni non richieste di contratti energetici. Le indagini hanno rivelato che le chiamate, effettuate senza consenso degli interessati, erano rivolte principalmente a utenti iscritti nel Registro pubblico delle opposizioni (Rpo). I call center, dopo aver acquisito i contatti degli utenti da società terze e agenti o procacciatori, contattavano illegalmente gli utenti stessi, molti dei quali sottoscrivevano poi contratti di fornitura. Il Garante ha inoltre ingiunto ai call center di implementare idonee misure tecniche, organizzative e di controllo affinché il trattamento dei dati personali degli interessati avvenga nel rispetto della normativa sulla privacy.

Per approfondimenti: provvedimento dell’11 aprile 2024 (10008076)

Videosorveglianza con riconoscimento facciale a Roma: il Garante apre un’istruttoria

Il Garante per la protezione dei dati personali ha avviato un'istruttoria su un progetto di videosorveglianza con riconoscimento facciale nelle stazioni della metropolitana di Roma. Stando alle notizie di stampa, in vista del Giubileo l'Amministrazione di Roma Capitale prevede di installare telecamere con riconoscimento facciale, capaci di identificare “azioni scomposte” all’interno della metropolitana da parte di chi in passato si è reso autore di “atti non conformi”. Il Garante ha quindi richiesto all’Amministrazione di Roma Capitale di fornire una descrizione tecnica delle funzionalità di riconoscimento facciale, la finalità, la base giuridica del trattamento dei dati biometrici e una copia della valutazione d'impatto sulla protezione dei dati, concedendo all'Amministrazione un termine di 15 giorni per rispondere. L'Autorità ha inoltre ricordato che fino al 2025 è in vigore una moratoria sull'uso di sistemi di videosorveglianza con riconoscimento facciale in luoghi pubblici o aperti al pubblico da parte delle autorità pubbliche o dei soggetti privati. Solo l’autorità giudiziaria, nell’esercizio delle funzioni giurisdizionali, e le autorità pubbliche, a fini di prevenzione e repressione dei reati possono effettuare tali attività di trattamento, previa approvazione del Garante.

Per approfondimenti: comunicato del 9 maggio 2024

Modifiche al Codice Privacy: semplificate le regole per la ricerca medica, biomedica ed epidemiologica

La recente modifica al Codice Privacy italiano, avvenuta tramite la conversione del decreto-legge 2 marzo 2024 n. 19, introduce significativi cambiamenti nel settore della ricerca scientifica in campo medico, biomedico ed epidemiologico. In particolare, secondo la nuova formulazione dell’art. 110 del Codice Privacy, nei casi in cui non sia possibile ottenere il previo consenso dell’interessato, i dati personali dei pazienti possono essere trattati per fini di ricerca scientifica in ambito medico, biomedico ed epidemiologico a condizione che sia stato ottenuto il parere favorevole del comitato etico e che siano osservate le garanzie dettate dal Garante Privacy. È stato dunque eliminato il requisito dell’autorizzazione preventiva da richiedere al Garante Privacy, sostituito dal rispetto delle garanzie indicate dal Garante Privacy nelle regole deontologiche sul trattamento di dati per fini di ricerca. 

Il Garante per la protezione dei dati personali dovrà dunque intervenire con misure generali valide per una pluralità di progetti attraverso le regole deontologiche, che saranno sottoposte a consultazione pubblica, coinvolgendo anche la comunità scientifica nella loro formazione.

Questa riforma ha l’obiettivo di bilanciare la necessità di proteggere i dati personali con l'esigenza di facilitare la ricerca scientifica, particolarmente rilevante nel contesto della salute pubblica.

Per approfondimenti: provvedimento 9 maggio 2024 (10016146)

EDPB: Pubblicata la relazione annuale

La relazione annuale del comitato europeo per la protezione dei dati (“EDPB”) riepiloga le attività svolte dal comitato nel corso dell’anno (raccomandazioni e relazioni sulle migliori pratiche formulate dal comitato, decisioni vincolanti, applicazione pratica degli orientamenti e così via).

Nel corso dell’anno 2023, l’EDPB ha adottato due decisioni vincolanti, una decisione vincolante avente carattere d’urgenza e due nuove linee guida. Inoltre, l’EDPB ha adottato 37 pareri ai sensi dell’art. 64 del GDPR, la maggior parte dei quali riguardanti il tema delle c.d binding corporate rules e quello dei requisiti di accreditamento degli organismi di certificazione. Infine, l’EDPB ha adottato due pareri legislativi, di concerto con l’EDPS.

Con specifico riferimento alle decisioni vincolanti, si segnalano le seguenti:

Decisione vincolante 1/2023, con cui l’EDPB ha risolto una controversia sui trasferimenti di dati da parte di Meta Platforms Ireland Limited. Decisione vincolante 2/2023, con cui l’EDPB ha risolto una controversia in materia di trattamento dei dati di utenti di età compresa tra i 13 e i 17 anni da parte di TikTok Technology Limited, rilevando che i pop-up di registrazione e di pubblicazione dei video non presentassero all’utente le opzioni in modo oggettivo e neutrale. 

Inoltre, nel corso del 2023 l’EDPB ha adottato le seguenti linee guida:

Linee guida 03/2022, adottate in data 14 febbraio 2023, in materia di c.d. design patterns ingannevoli nelle piattaforme di social media, aventi l’obiettivo di stabilire raccomandazioni e orientamenti pratici ai fornitori di social media, su come valutare ed escludere i design ingannevoli nelle piattaforme social. Linee guida 05/2022 sull’utilizzo della tecnologia di riconoscimento facciale (FRT) nell’ambito dell’applicazione della legge. Le linee guida forniscono informazioni rilevanti per i legislatori a livello europeo e nazionale, nonché per le autorità di polizia, quando implementano e utilizzano tali sistemi FRT.

Per approfondimenti: Relazione annuale EDPB

Il parere dell’EDPB sull’utilizzo delle tecnologie di riconoscimento facciale da parte degli operatori aeroportuali

A fine maggio l’EDPB ha adottato un parere (Opinion n. 11/2024) sull’uso delle tecnologie di riconoscimento facciale per semplificare il flusso dei passeggeri e la conservazione dei dati biometrici da parte degli operatori aeroportuali.

Il parere, in particolare, analizza la compatibilità del trattamento con:

il principio di limitazione della conservazione (art. 5, paragrafo 1, lettera e), GDPR), il principio di integrità e riservatezza (articolo 5, paragrafo 1, lettera f), GDPR), la protezione dei dati fin dalla progettazione e per impostazione predefinita (articolo 25 GDPR), la sicurezza del trattamento (articolo 32, GDPR).

Preliminarmente, l’EDPB osserva che nell’UE non esiste un obbligo giuridico uniforme per i gestori aeroportuali e le compagnie aeree di verificare che il nome sulla carta d’imbarco del passeggero corrisponda al nome sul loro documento d’identità, ma l’eventuale obbligo è eventualmente oggetto di leggi nazionali. Pertanto, qualora la legge nazionale non imponga alcuna verifica dell’identità dei passeggeri, non sarà possibile effettuare il riconoscimento mediante l’uso di dati biometrici, in quanto ciò comporterebbe un trattamento eccessivo di dati personali.

Ciò premesso, l’EDPB ha preso in considerazione la conformità del trattamento dei dati biometrici dei passeggeri con riguardo a quattro diversi scenari.

Dati memorizzati unicamente sui dispositivi personali dei passeggeri

In questo scenario, i dati biometrici sono memorizzati nei dispositivi personali dei passeggeri, sotto il loro esclusivo controllo, e vengono utilizzati per l’autenticazione ai vari checkpoint aeroportuali. Questo scenario potrebbe essere compatibile con il GDPR, a condizione che siano implementate adeguate misure di sicurezza e che non esistano soluzioni alternative meno intrusive.

Dati memorizzati centralmente all’interno dell’aeroporto con chiavi di accesso detenute dai passeggeri

Nel secondo scenario i dati biometrici sono memorizzati centralmente nell’aeroporto in forma criptata, la cui chiave di decrittazione è in possesso dei soli passeggeri. L’EDPB ritiene che, sebbene la memorizzazione centralizzata comporti dei rischi, questi possono essere mitigati con adeguate misure di sicurezza, rendendo il processo compatibile con il GDPR, a condizione che il periodo di memorizzazione sia giustificato e limitato al minimo necessario.

Dati memorizzati centralmente sotto il controllo dell’operatore aeroportuale

Un’altra ipotesi considerata dall’EDPB è quella in cui i dati biometrici sono memorizzati centralmente sotto il controllo dell’operatore aeroportuale, consentendo l’identificazione dei passeggeri, per un massimo di 48 ore. Secondo il parere dell’EDPB, questo scenario non è compatibile con il GDPR, poiché la centralizzazione comporta rischi elevati per i diritti fondamentali dei passeggeri in caso di violazione dei dati.

Dati memorizzati nel cloud sotto il controllo delle compagnie aeree o dei loro fornitori di servizi

Infine, l’EDPB valuta il caso in cui dati biometrici sono memorizzati nel cloud sotto il controllo della compagnia aerea o del suo fornitore di servizi, consentendo l’identificazione dei passeggeri. Questo scenario comporta rischi elevati poiché i dati possono essere accessibili a più entità, inclusi fornitori non appartenenti all’EEA. L’EDPB conclude che questo scenario non è compatibile con il GDPR a causa dell’elevato rischio di violazione dei dati e della mancanza di controllo da parte dei passeggeri sui propri dati.

In tutti i casi dovrebbero essere trattati solo i dati biometrici dei passeggeri che si iscrivono attivamente e prestano il proprio consenso.

In conclusione, l’EDPB ha rilevato che gli scenari in cui i dati biometrici sono conservati esclusivamente dai passeggeri (scenario 1) o in una banca dati centrale, ma con una chiave di decrittazione nelle sole mani degli utenti (scenario 2), se implementati con un elenco di garanzie minime raccomandate, sono gli unici che risultano compatibili con i principi del GDPR sopra richiamati e che controbilanciano adeguatamente l’intrusività del trattamento, garantendo agli interessati il massimo controllo sui propri dati personali.

Gli scenari 3 e 4, al contrario, sono considerati dall’EDPB troppo intrusivi e non proporzionati ai benefici attesi e, pertanto, le soluzioni basate sull’archiviazione in una banca dati centralizzata all’interno dell’aeroporto o nel cloud, senza chiavi di decrittazione nelle mani del passeggero, non possono essere ritenute compatibili con i principi sopra richiamati.

Per approfondimenti:

EDPB, “Opinion 11/2024 on the use of facial recognition to streamline airport passengers’ flow (compatibility with Articles 5(1)(e) and(f), 25 and 32 GDPR”, 23 May 2024.  

Common errors in the submission process for Portuguese nationality

The process of obtaining Portuguese nationality can be complex and prone to errors if not approached with care and attention. Errors or omissions can delay the completion of the process, result in additional costs for the applicants, and even lead to the rejection of the application.

Below, we explore some of the most common mistakes made during the submission process for Portuguese nationality:

1. Incomplete or incorrect documentation: Many applicants fail to gather all necessary documents or submit documents that do not meet the specified requirements, such as lack of legalization/apostille or inadequate translation.

2. Errors in application or forms: Incorrectly filling out application forms, omitting information, or making errors in personal data.

3. Submission of outdated documents: It is common for applicants to submit documents that are outdated, such as birth certificates, marriage certificates, and criminal record certificates that need to be within the deadlines required by the Portuguese authorities.

4. Not respecting deadlines: Delaying the submission of necessary documents requested by the Conservatories within the stipulated deadlines.

5. Not presenting sufficient evidence: It is common for applicants not to provide sufficient evidence to demonstrate their right to Portuguese nationality, for example, the lack of sufficient evidence of a genuine connection with the Portuguese community, which is essential in certain cases of naturalization, or the absence of proof of filiation, in requests for children or grandchildren of Portuguese.

6. Lack of awareness of current laws and requirements: Basing the application on outdated information due to changes in nationality laws that were not observed by the applicant or submitting the request without compliance with specific case requirements. In many cases, the transcription of marriage, recognition of de facto union, or other proofs may be necessary requirements before submitting the application.

Avoiding these common errors can significantly increase your chances of success in the process of Portuguese nationality.

The key to a successful application is careful preparation, attention to detail, and, when necessary, the support of professionals experienced in immigration and nationality.

COMPETITION LAW AND STATE AID

EUROPEAN COMMISSION (EC)

Italy: the European Commission approves 2 billion euro State aid measure to support STMicroelectronics to set up a new semiconductor manufacturing facility (31.05.2024) – The European Commission has approved, under EU State aid rules, a 2 billion euro Italian measure to support STMicroelectronics (‘ST') in the construction and operation of an integrated chip manufacturing plant for Silicon Carbide (‘SiC') power devices in Catania, Sicily. The measure will strengthen Europe's security of supply, resilience and digital sovereignty in semiconductor technologies, in line with the objectives set out in the European Chips Act Communication. The measure will also contribute to achieving the digital and green transitions.

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The European Commission amends Guidelines on Regional State aid to allow increased support to Strategic Technologies for Europe Platform projects (31.05.2024) – The European Commission has adopted an amendment to the Guidelines on Regional State aid (‘RAG') to allow Member States to grant higher amounts of regional aid for investment projects covered by the Strategic Technologies for Europe Platform (‘STEP'). The STEP aims to support the development and manufacturing of critical technologies relevant to the EU green and digital transitions, as well as the EU's strategic sovereignty. In particular, the nee amendment increases levels of regional aid for investment projects covered by the STEP by up to 10 percentage points in the regions eligible for aid under Article 107(3)(a) of the Treaty on the Functioning of the European Union and 5 percentage points in the regions eligible for aid under Article 107(3)(c) of the Treaty on the Functioning of the European Union (so-called ‘c' areas).

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The European Commission approves KKR's acquisition of NetCo (30.05.2024) – The European Commission has approved unconditionally, under the EU Merger Regulation, the acquisition by KKR & Co. Inc. (‘KKR') of NetCo. The Commission concluded that the transaction would raise no competition concerns in the European Economic Area (‘EEA'). In particular, the decision concerns the acquisition by KKR of NetCo, which comprises the primary and backbone fixed-line network business of Telecom Italia S.p.A. (‘TIM') as well as FiberCop S.p.A (‘FiberCop'). FiberCop is a joint venture between TIM and KKR comprising TIM's secondary fixed-line network. The European Commission investigated the impact of the transaction on the market for wholesale broadband access services in Italy and concluded that it would not significantly reduce the level of competition.

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The European Commission approves more than 1 billion euro of State aid by seven Member States for the fourth Important Project of Common European Interest in the hydrogen value chain (28.05.2024) – A fourth Important Project of Common European Interest (‘IPCEI') to support research, innovation and the first industrial deployment in the hydrogen value chain. The project contributes to the EU's target of 90% reduction of emissions from the mobility and transport sectors, in order for the EU to become climate-neutral by 2050. By fostering the use of hydrogen as a fuel, it will also help achieve the objectives of the European Green Deal, the EU Hydrogen Strategy and the Sustainable and Smart Mobility Strategy. The project, called ‘IPCEI Hy2Move', was jointly prepared and notified by seven Member States: Estonia, France, Germany, Italy, Netherlands, Slovakia and Spain.

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The European Commission approves up to 1 billion euro of State aid by six Member States for the first Important Project of Common European Interest in the health sector (28.05.2024) – The project, called “IPCEI Med4Cure”, was jointly notified by six Member States: Belgium, France, Hungary, Italy, Slovakia and Spain.IPCEI Med4Cure concerns research and development projects covering all key steps of the pharmaceutical value chain from collection and study of cells, tissues and other samples, to sustainable production technologies of breakthrough therapies, including personalised treatments, and to application of advanced digital technologies. The project aims at accelerating medical advancement and at fostering the resilience of the EU health industry by enhancing drug discovery, in particular for unmet medical needs such as rare diseases and developing innovative and more sustainable production processes for pharmaceuticals. These developments will improve the quality of healthcare and increase the EU's preparedness for emerging health threats while contributing to the green transition.

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Czech Republic: the European Commission approves State more than 3 billion euro aid scheme to support high-efficiency combined heat and power generation (27.05.2024) – The beneficiaries are operators of new or modernised CHP installations in Czechia that meet the definition of high-efficiency cogeneration as set out in the Energy Efficiency Directive. All technologies and projects that enable the production of electricity from high-efficiency CHP installations are eligible, except for those powered by solid fossil fuels, diesel and oil. Projects involving natural gas will be required to either close the aided installations or enable switch to renewable and low-carbon gases by 2050, to avoid lock-in of natural gas. Under the scheme, the aid will take the form of a feed-in premium (bonus) for each MWh of produced electricity for a duration of 15 years. The amount of bonus is set through tenders, except for small installations (up to 1 MWe) where the amount is set administratively by the Czech Energy Regulatory Office on an annual basis and limited to the funding gap.

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France: the European Commission approves State 4 billion euro aid scheme to support decarbonisation measures in the manufacturing sector (24.05.2024) – Under this measure, the aid will take the form of direct grants amounting to up to 30% of the project's investment costs. The measure will be open to companies active in the manufacturing sector in France. Eligible electrification projects must lead to a reduction of greenhouse gas emissions from industrial processes of at least 40% compared to, while energy efficiency projects must lead to a reduction in the energy consumed in industrial processes of at least 20% compared to today. For investments relating to activities covered by the EU Emission Trading System (‘ETS'), the emissions reduction must go below the relevant ETS benchmarks in force at the time of granting the aid.

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The European Commission fines Mondelēz almost 350 million euro for cross-border trade restrictions (23.05.2024) – Mondelēz, headquartered in the US, is one of the world's largest producers of chocolate and biscuit products. Its portfolio includes well-known chocolate and biscuit brands such as Côte d'Or, Milka, Oreo, Ritz, Toblerone and TUC and until 2015 coffee brands such as HAG, Jacobs and Velours Noir. The Commission's investigation found that Mondelēz breached EU competition rules: (i) by engaging in anticompetitive agreements or concerted practices aimed at restricting cross-border trade of various chocolate, biscuit and coffee products; and (ii) by abusing its dominant position in certain national markets for the sale of chocolate tablets. The Commission concluded that Mondelēz's illegal practices prevented retailers from being able to freely source products in Member States with lower prices and artificially partitioned the internal market. Mondelēz' aim was to avoid that cross-border trade would lead to price decreases in countries with higher prices.

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Germany: the European Commission approves State almost 2 billion euro aid scheme to support rail freight transport operators providing single and group wagon transport (21.05.2024) – The aim of the scheme is to help rail operators cover part of the high operating cost. In doing so, the scheme aims to support and preserve the modal shift from road to rail transport, thus promoting a greener means of transport. In single wagon load transport, individual wagons or groups of wagons from different consignors are bundled together to form one train. On the contrary, wagon group transport keeps the same composition from the origin to the destination and is eligible under the scheme for journeys up to a maximum distance of 300 km if operated by short block trains with up to 15 wagons. Both types of transport struggle to reach economic viability. Single wagon load transport entails high costs due to its complex and multi-step nature resulting from the switching and shunting of wagons. Wagon group transport operated by short block trains does not benefit from economies of scale due to the lower number of wagons and the short distances they serve.

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RUSSIAN SANCTIONSCOUNCIL OF THE EUROPEAN UNION (COUNCIL)

DPRK: EU sanctions nine additional individuals and entities involved in the country’s activities related to illegal weapons programmes and supporting Russia’s war of aggression against Ukraine (31.05.2024) – The Council sanctioned a further six individuals and three entities in view of sanctions evasion activities carried out by the Democratic People’s Republic of Korea’s (DPRK) that could generate funds for its illegal nuclear and ballistic missile programmes, in violation of and with flagrant disregard for the relevant UN Security Council resolutions, and in view of the military support given by the DPRK to Russia’s war of aggression against Ukraine.

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Iran: EU lists more individuals and entities for the transfer of drones for Russia’s war of aggression against Ukraine and for the transfer of drones and missiles in the Middle East and Red Sea region (31.05.2024) – The Council adopted restrictive measures against six individuals and three entities for their role in the transfer of unmanned aerial vehicles (UAVs) to Russia in support of its war of aggression against Ukraine; the transfer of UAVs or missiles to armed groups and entities undermining peace and security in the Middle East and the Red Sea region; or for being involved in Iran’s UAV programme.

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Information manipulation in Russia’s war of aggression against Ukraine: EU lists two individuals and one entity (27.05.2024) – The Council decided to impose restrictive measures against two individuals and one entity responsible for conducting propaganda actions targeted at civil society in the EU and its neighbouring countries, gravely distorting and manipulating facts in order to justify and support Russia's war of aggression against Ukraine. The propaganda has repeatedly and consistently targeted European political parties, especially during election periods, as well as targeting civil society, asylum seekers, Russian ethnic minorities, gender minorities, and the functioning of democratic institutions in the EU and its member states.

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Russia: EU sets up new country-specific framework for restrictive measures against those responsible for human rights violations and lists 20 persons (27.05.2024) – The Council established a new framework for restrictive measures against those responsible for serious human rights violations or abuses, repression of civil society and democratic opposition, and undermining democracy and the rule of law in Russia. The decision to establish this new sanctions’ regime is part of the EU’s response to the accelerating and systematic repression in Russia. The new regime was proposed by the High Representative for Foreign Affairs and Security Policy, Josep Borrell, after the untimely death of the opposition politician Alexei Navalny in Siberian prison in February.

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TRADEEUROPEAN COMMISSION (EC)

EU requests World Trade Organization consultation on Colombia’s compliance in frozen fries dispute (31.05.2024) – The European Commission has launched compliance proceedings against the Republic of Colombia in view of its failure to comply with rulings by the WTO Panel and Appeal Arbitrators concerning anti-dumping duties on imports of frozen fries from Belgium, the Netherlands and Germany. This is why the EU is making recourse to the WTO’s compliance consultation process. With this step, the EU seeks to preserve the rights of EU exporters and to send a signal to Colombia – as well as other countries intending to limit EU exports – that anti-dumping investigations need to be carried out in full respect of WTO rules.

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COUNCIL OF THE EUROPEAN UNION (COUNCIL)

EU-Kenya: Council of the EU takes final step to allow the implementation of the Economic Partnership Agreement (30.05.2024) – The Council of the European Union adopted a decision on the conclusion of the EU-Kenya Economic Partnership Agreement (EPA). The agreement will provide duty-free, quota-free EU market access to all exports from Kenya (except arms) as soon as it enters into force, as well as partial and gradual opening of the Kenyan market to imports from the EU. This will boost trade in goods and create new economic opportunities, with targeted cooperation to enhance Kenya's economic development.

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The Council adopts conclusions on the future of industrial policy (24.05.2024) – The Council of the European Union, on the initiative of the Belgian presidency, has adopted conclusions on 'A competitive European industry driving our green, digital and resilient future'. Boosting the competitiveness of European industry should be high on the political agenda of the next European Commission and these conclusions provide the way forward towards a new European competitiveness deal. The conclusions analyse the situation of the EU's industrial sector, explore ways to improve innovation, access to finance and the business environment for manufacturers, and propose the main principles underlying a future EU industrial policy.

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WORLD TRADE ORGANIZATION (WTO)

The European Union initiates compliance proceedings over Colombian duties on frozen fries (04.06.2024) – The European Union has requested World Trade Organization (WTO) consultations with Colombia to address measures taken by Colombia to comply with an earlier WTO panel ruling and arbitration award regarding Colombia’s anti-dumping duties on imports of frozen fries originating in Belgium, the Netherlands and Germany.

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The European Union and Australia affirm intention to implement recent World Trade Organization rulings (24.05.2024) – The European Union and Australia affirmed their intention to implement recent World Trade Organization (WTO) panel rulings regarding EU measures concerning palm oil and biofuels from Malaysia and Australian duties on Chinese imports at a meeting of the Dispute Settlement Body (DSB). China also reported to the DSB on its implementation of a WTO ruling regarding Chinese duties on steel imports from Japan.

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ENERGY AND GREEN DEALEUROPEAN COMMISSION (EC)

The European Commission starts working on a new pilot mechanism to boost the hydrogen market (03.06.2024) – The European Commission takes further steps to support the development of the European hydrogen market by launching work on a pilot mechanism. The new mechanism was created under the recently adopted decarbonised gases and hydrogen package and aims to accelerate investments by providing a clearer picture of the market situation of both off-takers and suppliers and facilitating contacts between them. It will be in place for five years and will be part of the European Hydrogen Bank.

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The European Commission welcomes the new EU Methane Regulation to reduce harmful emissions from fossil fuels in Europe and abroad (27.05.2024) – The European Commission welcomes the first-ever EU rules to curb methane emissions from the energy sector in Europe and across the globe The new regulation obliges the fossil gas, oil and coal industry in Europe to measure, monitor, report and verify their methane emissions according to the highest monitoring standards, and to take action to reduce them. It requires EU gas, oil and coal operators to stop avoidable and routine flaring and to reduce flaring and venting to situations such as emergencies, technical malfunctions or when it is necessary for safety reasons.

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The European Commission welcomes Net-Zero Industry Act (27.05.2024) – The Commission welcomes the final adoption of the Net-Zero Industry Act (“NZIA”), which puts the EU on track to strengthen its domestic manufacturing capacities of key clean technologies. For the EU to become a leader in the clean tech sector, NZIA sets a benchmark for the manufacturing capacity of strategic net-zero technologies to meet at least 40% of the EU's annual deployment needs by 2030. The benchmark provides predictability, certainty and long-term signals to manufacturers and investors and allows progress to be tracked. To support carbon capture and storage projects and increase the availability of CO2 storage sites in Europe, NZIA also sets a target of 50 million tonnes of annual injection capacity in EU geological CO2 storage sites by 2030.

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The European Commission welcomes entry into force of the European Critical Raw Materials Act (23.05.2024) –The Critical Raw Materials Act establishes benchmarks to increase capacities for extraction, processing, and recycling of critical raw materials in the EU and guide diversification efforts. In addition, it creates a framework to select and implement Strategic Projects, which can benefit from streamlined permitting and enabling conditions for access to finance; as well as sets out national requirements to develop exploration programmes in Europe. Moreover, the Regulation will improve the circularity and the efficient use of the critical raw materials by creating value chains for recycled critical raw materials. To ensure resilience of the supply chains, the Act allows the monitoring of critical raw materials supply chains, and information exchange and future coordination on strategic raw materials' stocks among Member States and large companies.

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COUNCIL OF THE EUROPEAN UNION (COUNCIL)

Energy Charter Treaty: the Council gives final green light to EU’s withdrawal (30.05.2024) – The formal decision by the Council of EU gives the final green light for the EU and Euratom to withdraw from the Energy Charter Treaty after the European Parliament approved it during its last plenary session in April 2024. The decisions are linked as they form the two pillars of a political compromise known as the Belgian roadmap on the Energy Charter Treaty. The Energy Charter Treaty (ECT) is a multilateral agreement that entered into force in 1998 and contains provisions on investment protection and trade in the energy sector.

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Sustainable electricity grids: the Council approves conclusions (30.05.2024) – The Council of the EU approved conclusions on the EU’s electricity grid infrastructure, proposing a series of measures for an interconnected and resilient electricity network in Europe, to ensure energy security and achieve decarbonisation in the EU. The Council conclusions highlight the need for long-term, coordinated electricity grid infrastructure planning at European level, and call on the European Commission to assess and identify any gaps and develop measures, if needed, to improve the governance framework at EU level.

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The Council gives final green light to cut methane emissions in the energy sector (27.05.2024) – The Council adopted a regulation on tracking and reducing methane emissions as part of the ‘Fit for 55’ package. The regulation introduces new requirements on measuring, reporting and verifying methane emissions in the energy sector. Mitigation measures, such as detecting and repairing methane leaks and limiting venting and flaring, will aim to avoid methane emissions. Operators will have to measure methane emissions at source level and draw up monitoring reports that will be checked by independent accredited verifiers. Member states will maintain and regularly update an inventory of all wells, as well as mitigation plans for inactive wells, in order to prevent any public health and environmental risks from methane emissions. National authorities will carry out periodic inspections to check and ensure operators' compliance with the requirements of the regulation, including the taking of follow-up remedial measures.

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The Council gives its final approval to the ecodesign regulation (27.05.2024) – The Council adopted the ecodesign regulation, which sets requirements for sustainable products. The regulation replaces the existing ecodesign directive and enlarges its scope, beyond energy products, to all kind of goods placed in the EU market. The new regulation introduces new requirements such as product durability, reusability, upgradability and reparability, rules on the presence of substances that inhibit circularity; energy and resource efficiency; recycled content, remanufacturing and recycling; carbon and environmental footprints; and information requirements, including a Digital Product Passport. The Commission will be empowered to set ecodesign requirements by delegated acts and the industry will have 18 months to comply with them. Ecodesign criteria will be applicable in public procurement to incentivise the public purchase of green products. The new regulation introduces a direct ban on the destruction of unsold textiles and footwear (SMEs will be temporarily excluded) and empowers the Commission to introduce similar bans for other products in the future. The ecodesign regulation will be aligned to the digital services act, when it comes to products sold online.

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EUROPEAN PARLIAMENT (EP)

The European Parliament publishes document on the Energy Performance Building Directive recast (28.05.2024) – The European Parliament has published an accompanying document in sight of the entry into force of the recast Energy Performance of Buildings Directive (“EPBD”). The EPBD has been designed to accelerate building renovation rates, reduce energy consumption, and promote the uptake of renewable energy in buildings. These measures should help the EU reach its target of a net 55 % reduction in greenhouse gas (“GHG”) emissions by 2030, as a stepping stone towards achieving climate neutrality by 2050. Under the revised directive, Member States will have to ensure a reduction in the average primary energy used in residential buildings of at least 16 % by 2030 and between 20 % and 22 % by 2035. To ensure sufficient flexibility and reflect national circumstances, each Member State will be allowed to adopt its own national trajectory to reduce average primary energy use. Member States may choose buildings to target and measures to take, providing 55 % of the energy reduction is achieved by renovating the worst performing buildings.

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BANKING & FINANCEEUROPEAN CENTRAL BANK (ECB)

The European Central Bank publishes the April 2024 Euro area bank interest rate statistics (05.06.2024) – According to the ECB’s Euro area bank interest rate: (i)composite cost-of-borrowing indicator for new loans to corporations and for new loans to households for house purchase unchanged at 5.18% and 3.80%, respectively; (ii) composite interest rate for new deposits with agreed maturity from corporations broadly unchanged at 3.65%; interest rate for overnight deposits from corporations broadly unchanged at 0.91%; (iii)composite interest rate for new deposits with agreed maturity from households decreased by five basis points to 3.11%, driven by both interest rate and weight effects; interest rate for overnight deposits from households unchanged at 0.39%.

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The European Central Bank publishes the April 2024 monetary developments in the euro area (29.05.2024) – According to the ECB’s the April 2024 monetary developments in the euro area, the annual growth rate of the broad monetary aggregate M3 increased to 1.3% in April 2024 from 0.9% in March, averaging 0.8% in the three months up to April. The components of M3 showed the following developments. The annual growth rate of the narrower aggregate M1, which comprises currency in circulation and overnight deposits, was -6.0% in April, compared with -6.6% in March. The annual growth rate of short-term deposits other than overnight deposits (M2-M1) decreased to 15.7% in April from 16.7% in March. The annual growth rate of marketable instruments (M3-M2) increased to 22.6% in April from 19.3% in March.

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The European Central Bank publishes the April 2024 Consumer Expectations Survey results (28.05.2024) – According to the ECB’s Consumer Expectation Survey for the month of April 2024, median consumer inflation perceptions over the past 12 months remained steady, while median inflation expectations for the next 12 months and for three years ahead declined slightly; expectations for nominal income growth and nominal spending growth over the next 12 months remained substantially unchanged; expectations for economic growth over the next 12 months became less pessimistic, while the expected unemployment rate in 12 months-time increased; expectations for home price growth over the next 12 months rose, while expectations for mortgage interest rates over the 12 months ahead remained unchanged.

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EUROPEAN BANKING AUTHORITY (EBA)

The European Supervisory Authorities call for enhanced supervision and improved market practice on sustainability-related claims (04.06.2024) – The European Supervisory Authorities (EBA, EIOPA and ESMA – ESAs) have published their final Reports on Greenwashing in the financial sector. In their respective reports the ESAs reiterate their common high-level understanding of greenwashing as a practice whereby sustainability-related statements, declarations, actions, or communications do not clearly and fairly reflect the underlying sustainability profile of an entity, a financial product, or financial services. This practice may be misleading to consumers, investors, or other market participants. Therefore, the ESAs stress again that financial market players have a responsibility to provide sustainability information that is fair, clear, and not misleading.

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The European Banking Authority and the European Securities and Markets Authority invite comments on the review of the investment firms prudential framework (03.06.2024) – The EBA and ESMA published a discussion paper on the potential review of the investment firms’ prudential framework. The discussion paper aims at gathering early stakeholder feedback to inform the response to the European Commission’s call for advice (CfA). To assess the impact of the possible changes discussed in the paper, the EBA also launched a data collection exercise on a voluntary basis.

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The European Supervisory Authorities sign a memorandum of understanding to strengthen cooperation and information exchange (31.05.2024) – The European Supervisory Authorities (EBA, EIOPA, and ESMA - the ESAs) announced that they have concluded a multilateral Memorandum of Understanding (MoU) to strengthen cooperation and information exchange with the European Union Agency for Cybersecurity (ENISA). This MoU sets out the framework for cooperation and exchange of information on tasks of mutual interest, including policy implementation, incident reporting, and oversight of critical Information Communication Technologies (ICT)third-party providers. It will also promote regulatory convergence, facilitate cross-sectoral learning and capacity building on areas of mutual interest, and information exchange on emerging technologies.

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The European Supervisory Authorities publish templates and tools for voluntary dry run exercise to support the DORA implementation (31.05.2024) – The European Supervisory Authorities (EBA, EIOPA and ESMA – the ESAs) published templates, technical documents and tools for the dry run exercise on the reporting of registers of information in the context of Digital Operation Resilience Act (DORA) announced in April 2024. Financial entities can use these materials and tools to prepare and report their registers of information of contractual arrangements on the use of ICT third-party service providers in the context of the dry run exercise, and to understand supervisory expectations for the reporting of such registers from 2025 onwards.

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The European Banking Authority shows that funds to protect deposits in case of bank failure are going up (28.05.2024) – EBA has published end-2023 data related to two key concepts and indicators in the Deposit Guarantee Schemes Directive (DGSD), namely available financial means (AFMs) and covered deposits. Data shows that: (i)deposits protected by EU deposit guarantee schemes (DGS) increased by 1.7% to 8.5 trillion Euros between 2022 and 2023, whereas funds available to protect those deposits in case of bank failures rose by 14.9% to 73 billion euro; (ii)the high increase in the amount of funds held by DGSs to protect deposits reflects the need for all the DGSs to reach the minimum target level of 0.8% of covered deposits by July 2024; (iii)as of December 2023, 21 of the 36 DGSs in the European Economic Area (EEA) had already reached the minimum target level ahead of the deadline.

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The European Banking Authority issues its final Guidelines on STS criteria for on-balance-sheet securitisation (27.05.2024) – EBA has released its final Guidelines on criteria concerning simplicity, standardisation, transparency, and additional specific criteria for on-balance-sheet securitisations (so-called “STS criteria”). The Guidelines aim to ensure a harmonised interpretation and implementation of STS criteria across the EU, aligning with existing guidelines for asset-backed and non-asset-backed commercial paper (ABCP and non-ABCP) securitisation. By providing a unified interpretation of STS criteria, the Guidelines support the adoption of the STS criteria, which is necessary for preferential risk weight treatment under the Capital Requirements Regulation (CRR).

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The European Banking Authority publishes a Report on the issuance of virtual IBANs (24.05.2024) – EBA published a Report on the issuance of virtual IBANs (“vIBANs”), noting the lack of a common definition and varying practices across the industry. The Report, which sets out the characteristics and use cases of virtual IBANs, highlights issues related to money laundering, consumer protection, authorisation, passporting, and regulatory arbitrage due to differing national interpretations and applications of EU financial regulations. The Report offers recommendations for clarifying EU law and suggests actions that national competent authorities can take to address these issues.

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EUROPEAN SECURITIES AND MARKETS AUTHORITY (ESMA)

The European Banking Authority and the European Securities and Markets Authority invite comments on the review of the investment firms prudential framework (03.06.2024) – ESMA and EBA published a discussion paper on the potential review of the investment firms’ prudential framework. The discussion paper aims at gathering early stakeholder feedback to inform the response to the European Commission’s call for advice (CfA). To assess the impact of the possible changes discussed in the paper, the EBA also launched a data collection exercise on a voluntary basis.

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The European Securities and Markets Authority publishes final MiCA rules on conflict of interest of crypto assets providers (31.05.2024) – ESMA the final Report on the rules on conflicts of interests of crypto-asset service providers (CASP) under the Markets in Crypto Assets Regulation (MiCA). In the report ESMA sets out draft Regulatory Technical Standards on certain requirements in relation to conflicts of interest for crypto-asset service providers (CASPs) under MiCA, with a view to clarifying elements in relation to vertical integration of CASPs and to further align with the draft European Banking Authority (EBA) rules applicable to issuers of asset-referenced tokens (ARTs).

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The European Securities and Markets Authority publishes final MiCA rules on conflict of interest of crypto assets providers (31.05.2024) – ESMA the final Report on the rules on conflicts of interests of crypto-asset service providers (CASP) under the Markets in Crypto Assets Regulation (MiCA). In the report ESMA sets out draft Regulatory Technical Standards on certain requirements in relation to conflicts of interest for crypto-asset service providers (CASPs) under MiCA, with a view to clarifying elements in relation to vertical integration of CASPs and to further align with the draft European Banking Authority (EBA) rules applicable to issuers of asset-referenced tokens (ARTs).

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The European Securities and Markets Authority issues a Statement on firms using AI in investment services (30.05.2024) – ESMA issued a Statement offering guidance to firms using AI technologies in the provision of investment services to retail clients. In its statement, ESMA states that it expects these firms to adhere to relevant MiFID II requirements, especially concerning organizational aspects, business conduct, and the regulatory obligation to act in the client’s best interest. AI applications covered by MiFID II requirements include customer support, fraud detection, risk management, compliance, and aiding firms in delivering investment advice and portfolio management.

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The European Securities and Markets Authority ESMA reminds on rules for sharing information during pre-close calls (29.05.2024) – ESMA issued a Statement reminding issuers of the legislative framework applicable to “pre-close calls” and encouraging adherence to good practices to help maintain fair, orderly, and effective markets. Specifically, ESMA emphasized that any disclosure of inside information must comply with the Market Abuse Regulation (MAR). Therefore, issuers should only share non-inside information during these “pre-close calls”. To address potential concerns, ESMA recommends several good practices for conducting such calls.

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The European Securities and Markets Authority reports on the application of MiFID II marketing requirements (27.05.2024) – ESMA released a joint report on its 2023 Common Supervisory Action (CSA) and the accompanying Mystery Shopping Exercise (MSE) concerning marketing disclosure rules under MiFID II. In collaboration with National Competent Authorities (NCAs), ESMA’s findings indicate global compliance with MiFID II requirements for marketing communications, including advertisements. Further, although ESMA finds that investment firms have generally established procedures to ensure compliance during the development of marketing materials, it also reports that NCAs have expressed concerns about sustainability claims in marketing communications. The report highlights areas for improvement, including the necessity for clear identification of marketing communications and a balanced presentation of risks and benefits.

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The European Securities and Markets Authority consults on commodity derivatives under MiFID review (23.05.2024) – ESMA launched a public consultation on proposed changes to the rules for position management controls and position reporting. The changes come in the context of the review of the Market in Financial Instruments Directive (MiFID II) and aim to minimise the burden on reporting entities. ESMA is consulting on changes to the technical standards (RTS) on position management controls, the Implementing Technical Standards (ITS) on position reporting, and on position reporting in Commission Delegated Regulation (EU). ESMA will review all comments submitted by 21st August 2024.

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COUNCIL OF THE EUROPEAN UNION (COUNCIL)

The Council adopts package of new anti-money-laundering rules (30.05.2024) – Council adopted a new package of anti-money laundering rules, known as the AML package. This AML package includes the new AML Regulation, the 6th AML Directive, and a Regulation establishing the new Anti-Money Laundering Authority (AMLA). The package is further complemented by Regulation (EU) 2023/1113, concerning information accompanying transfers of funds and certain crypto-assets, which was adopted on 31st May 2023. This is the final step of the adoption procedure. Therefore, the texts will now be published in the EU’s Official Journal and enter into force.

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The Council adopts new EU rules to increase banks’ resilience to economic shocks (30.05.2024) – Council adopted new rules updating the Capital Requirements Regulation (CRR) and the Capital Requirements Directive (CRD IV) to the new standards issued under the Basel III framework. The main feature of the reforms is the introduction of an “output floor”, which limits the risk of excessive reductions in banks’ capital requirements and makes these requirements more comparable. This is the last step of the adoption procedure. The amended CRR and CRD IV will now be published in the EU’s Official Journal and enter into force 20 days later.

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EU FUNDSEUROPEAN INVESTMENT BANK (EIB)

Spain: pain: the European Investment Bank and Banco Sabadell sign guarantee agreement to facilitate up to 400 million euro in new financing for SMEs and mid-caps (05.06.2024) – The and Banco Sabadell have signed a guarantee agreement for up to 200 million euro as the first tranche of a total EIB-approved operation of up to 300 million euro. The arrangement will allow the Spanish bank to facilitate up to 400 million euro in new loans over the next two years to finance projects by small and medium-sized enterprises (SMEs) and mid-caps in Spain. The operation will promote private sector investment and support the financing needs of a key segment of the Spanish economy in terms of both growth and jobs.

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France: the European Investment Bank and Brittany region sign finance contract for upper secondary school construction and refurbishment (04.06.2024) – The European Investment Bank and the Brittany region have signed a 25-year, 190 million euro finance contract to help modernise educational facilities and adapt them to local demand, with a view to improving the quality of secondary-level education in the area. Indeed, this loan will help to finance the Brittany region’s upper secondary school plan. In particular, 116 schools in the region are set to benefit from infrastructure upgrades, improvements to energy efficiency and climate resilience, better accessibility, and new educational equipment.

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Spain: the European Investment Bank and CIE Automotive sign 36 million euro loan for research and development in advanced technologies for the European automotive sector (31.05.2024) – The European Investment Bank and Aena have signed a 160 million euro loan to finance upgrades to the passenger terminal at Palma de Mallorca International Airport. The investment to cover building upgrades and improvements to baggage management and fire prevention systems, terminal equipment and security and IT systems. Operation comes under EIB Transport Lending Policy, which prioritises investments in resilient, safe and sustainable critical transport.

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Greece: the European Investment Bank to support businesses and startups in life sciences, health, and sustainability with 200 million euro new equity financing (14.05.2024) – The European Investment Bank and CIE Automotive have signed a loan worth 36 million euro to finance the company’s research, development, and innovation activities, as well as their application in the manufacture of high value-added components for the automotive sector. The financing will also support CIE Automotive’s investments in process optimisation through digitalisation, and in the development of more sustainable manufacturing technology. The investments will take place in the company’s facilities in Spain, Germany, France, and Italy, some of which are located in cohesion regions.

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Finland: mid-caps get growth and investment boost from Finnvera and the European Investment Bank (30.05.2024) – The European Investment Bank will provide a 200 million euro guarantee to Finnvera, the national promotional bank and official export credit agency of Finland, to facilitate the financing of Finnish mid-caps. The programme aims to tackle barriers to accessing finance by sharing risks associated with economic uncertainties like inflation, high interest rates, limited external growth opportunities and unpredictable energy supplies. The EIB support will allow Finnvera to create a portfolio of new loans for a total amount of up to 400 million euro, increasing its lending capacity and offering companies access to financing on favourable terms, such as reduced interest rates and lower collateral requirements. The operation will help mobilise investments of approximately 560 million euro in the real economy

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Finland: the European Investment Bank signs 17 million euro loan to iPhone refurbisher Swappie (30.05.2024) – The European Investment Bank and Swappie, Europe’s largest iPhone refurbisher, have signed a loan agreement to back the high quality refurbishment of iPhones, extending the lifespan of the devices and enabling consumers to reduce their carbon footprint in support of a circular economy. The EIB will provide a five-year, 17 million euro loan to the innovative Finnish startup to support its investment in research and development and robotics aimed at making iPhone repairs quick and reliable. The deal will also allow Swappie to enhance its refurbishment and operational capabilities, while rolling out more products and expanding its international reach. This agreement is backed by the InvestEU programme, which aims to trigger more than 372 billion euro in additional investment between 2021 and 2027.

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Montenegro: the European Investment Bank Global to invest up to 76 million euro in reconstruction of Bar–Podgorica–Vrbnica railway line under Team Europe initiative (29.05.2024) – The European Investment Bank Global has signed a 75.5 million euro financial agreement for the reconstruction of a 167 km long railway section between Bar, Podgorica and Vrbnica. These infrastructural improvements along the extended Trans-European Transport Network (TEN-T) will improve rail capacity, efficiency and safety, benefiting over 1 million passengers a year and international freight traffic. The project will also promote a modal shift from road to rail, contributing to a more sustainable transport system in the country.

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The European Investment Bank Global invests 25 million euro in Amethis Fund III to promote sustainable growth of African businesses (29.05.2024) – The European Investment Bank’s Global arm has invested 25 million euro in Amethis Fund III, a pan-African fund providing private equity growth capital to medium-sized companies on the continent. Amethis Fund III will target companies supplying goods and services to low- and middle-income populations in Africa. The target sectors include healthcare, business services such as logistics and IT, manufacturing and distribution, including agribusiness and fast-moving consumer goods, non-banking financial services, and services related to infrastructure and energy.

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Ukraine: School in Pryvovchanske reopens after major overhaul supported by the European Investment Bank (28.05.2024) – The lyceum in the village of Pryvovchanske, Dnipropetrovsk Oblast, has opened its doors again after a major overhaul under the Ukraine Early Recovery Programme (UERP) financed by the European Investment Bank (EIB). This upgrade has increased the school’s capacity, with almost 200 students from the villages of Pryvovchanske and Malooleksandrivka expected to attend in the upcoming academic year. his is the second school that has reopened in Dnipropetrovsk Oblast this year as part of the 200 million euro EIB loan designed to help Ukrainian municipalities rebuild their social infrastructure.

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Italy: the European Investment Bank provides ETRA with 100 million euro to support the transition to a greener, more circular economy (28.05.2024) – The European Investment Bank and ETRA SpA - Società benefit have signed an agreement concerning 100 million euro of investment in improving recycling facilities and integrated water services in the Veneto region. Specifically, the main initiatives to be financed by the EIB’s investment include the restructuring and construction of waste treatment and water supply installations, the purchase of biomethane-fuelled vehicles and the expansion of water networks. The project will thus help to promote climate action and further the transition towards a more circular economy, which are key objectives of the European Green Deal.

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Czechia: the European Investment Bank backs improved wastewater treatment with CZK 1.3 billion loan for city of Brno (27.05.2024) – The European Investment Bank has signed a 53.2 million euro) loan agreement with Brněnské vodárny a kanalizace (BVK), the municipal water and wastewater company in the Czech city of Brno. The operation will upgrade the sewage sludge treatment facility of BVK’s Modřice wastewater plant, thus further improving environmental protection and public services in Czechia’s second biggest city.

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Spain: the European Investment Bank and Castilla y León regional government sign 120 million euro loan to finance public hospital and healthcare facility renovations in five regional provinces (27.05.2024) – The European Investment Bank has signed a 120 million euro loan with the regional government of Castilla y León to finance the renovation and expansion of a series of hospitals and public healthcare facilities in the Spanish region’s cities of Valladolid, Salamanca, Palencia, Soria and Aranda de Duero. The projects will include the construction of two primary healthcare centres affiliated with the Valladolid and Salamanca University Hospitals, the renovation and expansion of the Palencia Río Carrión Hospital, the second phase of construction of the Soria Santa Bárbara Hospital, and the construction of the new Aranda de Duero Hospital in the regional province of Burgos.

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Spain: the European Investment Bank and Castilla y León regional government sign 25 million euro loan to finance local SME and mid-cap projects focusing on the circular economy and job creation (24.05.2024) – The European Investment Bank (EIB) has signed a 25 million euro loan with the regional government of Castilla y León via the Institute for Business Competitiveness of Castilla y León (ICECyL by its Spanish acronym), a body under the auspices of the regional Ministry of the Economy and Finance, to back small and medium-sized enterprises (SMEs) and mid-caps in the Spanish region. The EIB loan will enable ICECyL to finance projects from this business segment (mostly in the Castilla y León region) focusing on boosting competitiveness, promoting regional circular economy policies, and creating and safeguarding jobs.

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Mauritania: Banque pour le Commerce et l’Industrie and the European Investment Bank partner up to fund SMEs, with EU support (23.05.2024) – Three months after signing a financing arrangement with the European Investment Bank (EIB), the Banque pour le Commerce et l’Industrie (BCI) has already granted MRU 280 million (6.5 million euro) in loans to five SMEs to support employment, entrepreneurship and access to finance for Mauritania’s women and youth. The loans were made in areas like health, clean energy and sustainable food systems. They are a tangible contribution to the Team Europe Initiatives of green transition and stronger human development in Mauritania, set by the European Commission for 2021-2027. The BCI will grant MRU 1 billion (€25 million) in loans to SMEs and mid-caps under the arrangement with the EIB, supporting around 3 000 jobs, especially for youth and women.

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Italy: the European Investment Bank and Cassa Depositi e Prestiti provide 215 million euro for new University of Milan campus (21.05.2024) – The European Investment Bank (EIB) and Cassa Depositi e Prestiti (CDP) have provided 215 million euro in financing, partly backed by InvestEU, to Academo Srl, a project company formed by Lendlease and the Equiter Infrastructure II fund (managed by Ersel AM) to which the University of Milan has awarded the contract to design, build and operate its science and technology campus in the Milano Innovation District (MIND). The goal is to support the creation of new teaching spaces for university students and researchers as part of a broader environmental sustainability-focused urban regeneration project in Milan. This financing is the final step in the operation planning phase coordinated by Lendlease, which involves a total investment of more than 450 million euro.

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Poland: the European Investment Bank backs first Polish satellite programme with loan to Bank Gospodarstwa Krajowego (20.05.2024) – The European Investment Bank (EIB) announced backing for the development and launch of two Earth observation satellites that will provide high-resolution imagery for civilian and defence applications in Poland. The EIB is lending 300 million euro to Bank Gospodarstwa Krajowego (BGK) for the project to support the European space industry with the latest technology in Low Earth Orbit (LEO) satellites. It comes after the EIB’s Board of Directors approved the EIB Group’s new Security and Defence Industry Action Plan which is intended to step up investments in the sector.

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EUROPEAN INVESTMENT FUND (EIF)

InvestEU: the European Investment Fund, 123 Investment Managers and Lendosphere announce a new sustainable debt fund. (27.05.2024) – The European Investment Fund (EIF), as lead investor, is backing the first closing of the 123 Transition Energétique 2 fund to the tune of 30 million euro. The fund combines financing via a marketplace lending platform with institutional investors' contributions.

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InvestEU: the European Investment Fund extends support to Europe’s cultural creative businesses and audiovisual sector (21.05.2024) – The European Investment Fund (EIF) guarantee agreements will facilitate more than 141 million euro of new financing for creative sectors via intermediaries from France, Germany, and Finland. These agreements are supported by the InvestEU programme, which aims to trigger more than 372 billion euro in additional investments over the period 2021-2027. They aim to remedy a market failure in the cultural and creative sectors (CCS) and to stimulate European audiovisual production by facilitating its financing.

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LIFE SCIENCESCOUNCIL OF THE EUROPEAN UNION (COUNCIL)

The Council signs off on measures to make the EU mercury-free (30.05.2024) – The Council adopted a regulation to completely ban the use of dental amalgams and to prohibit manufacturing, import and export of other mercury-added products. The updated rules aim to address the remaining use of mercury in the European Union in line with the EU´s zero pollution ambition. Current rules already ban the use of dental amalgam for treating teeth in children under 15 years old, and pregnant or breastfeeding women. The new rules will extend the prohibition to include everybody in the EU as of 1st January 2025. Exceptions will apply when the use of dental amalgam is deemed strictly necessary by the dental practitioner to address specific medical needs of the patient. Exporting dental amalgam will be prohibited from 1st January 2025; the ban on manufacturing and import in the EU will apply from 1st July 2026. Six additional mercury-containing lamps will also be made subject to a manufacturing, import and export ban as from 31st December 2025 and 31st December 2026.

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The Council adopts new measures to help prevent shortages (30.05.2024) – The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: (i) further extending the transition period for certain IVDs (ii) enabling a gradual roll-out of EUDAMED, the new electronic database (iii) requiring manufacturers to flag up potential shortages of critical medical devices and IVDs. The regulation adopted will enter into force following publication in the EU’s Official Journal.

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The Council adopts new rules on substances of human origin (27.05.2024) – The Council has adopted new rules aimed at improving the safety and quality of blood, tissues and cells used in healthcare and facilitating cross-border circulation of these substances in the EU. The regulation on substances of human origin (SoHO) will ensure better protection for donors and recipients, as well as for children born following medically assisted reproduction. The new rules aim to strengthen the existing legal framework while also increasing flexibility in order to keep up with scientific and technical developments. Under the new regulation, member states may choose to apply stricter measures to protect their citizens.

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EUROPEAN MEDICINES AGENCY (EMA)

Medical devices: new guidance for industry and notified bodies (21.05.2024) – A new revision of the guidance available to applicants, marketing authorization holders and notified bodies of medical devices has been published by the EMA. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices. Products that combine a medicinal product (or substance) and a medical device are regulated either under the pharmaceutical framework or the medical device framework, depending on their main mode of action. The revision is based on the experience gained since the implementation of the new regulations and actual cases encountered.

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DATA, IP AND PRIVACYEUROPEAN COMMISSION (EC)

European Commission establishes AI Office to strengthen EU leadership in safe and trustworthy Artificial Intelligence (29.05.2024) – The Commission has unveiled the AI Office, established within the EC. The AI Office aims at enabling the future development, deployment and use of AI in a way that fosters societal and economic benefits and innovation, while mitigating risks. The Office will play a key role in the implementation of the AI Act, especially in relation to general-purpose AI models. It will also work to foster research and innovation in trustworthy AI and position the EU as a leader in international discussions.

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COUNCIL OF THE EUROPEAN UNION (COUNCIL)

Artificial intelligence (AI) act: the Council gives final green light to the first worldwide rules on AI (27.05.2024) – The Council finally approved a ground-breaking law aiming to harmonise rules on artificial intelligence, the so-called artificial intelligence act. The flagship legislation follows a ‘risk-based’ approach, which means the higher the risk to cause harm to society, the stricter the rules. It is the first of its kind in the world and can set a global standard for AI regulation. The new law aims to foster the development and uptake of safe and trustworthy AI systems across the EU’s single market by both private and public actors. At the same time, it aims to ensure respect of fundamental rights of EU citizens and stimulate investment and innovation on artificial intelligence in Europe. The AI act applies only to areas within EU law and provides exemptions such as for systems used exclusively for military and defence as well as for research purposes.

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CONSULTATIONS AND CALLSEUROPEAN COMMISSION (EC)

The European Commission launches consultation on aviation and fitness check of EU airport legislation (06.06.2024) – The Commission is carrying out a fitness check of EU airport legislation to determine if it is still fit for purpose and delivering on its objectives. This fitness check will consider recent trends such as market consolidation, capacity challenges, labour shortages, increased competition from non-EU airlines/airports and the need to decarbonise. It will also assess the potential for simplification and burden reduction, especially should any inconsistencies or synergies be identified.

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The European Commission launches consultation on Heavy-duty vehicles – extending manufacturer reporting on CO2 emissions and fuel consumption (11.06.2024) – Under EU Regulation 2018/956, vehicle manufacturers are required to report on CO2 emissions from and fuel consumption of heavy-duty vehicles. This initiative amends the Annex to the Regulation to oblige manufacturers of certain medium and heavy lorries, buses, coaches and trailers to report on these vehicles from 2024.

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The European Commission launches consultation on Carbon Offsetting & Reduction Scheme for International Aviation (CORSIA) – rules for calculating offsetting requirements (13.06.2024) – Directive 2003/87 implements the Carbon Offsetting and Reduction Scheme for International Aviation ('CORSIA') under the International Civil Aviation Organization (ICAO). Article 12(8) of this Directive requires the Commission to lay down detailed rules to calculate offsetting requirements under CORSIA for emissions up to 2026. The rules rely on the standards and recommended practices of CORSIA, as interpreted by the Directive.

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The European Commission launches consultation on Cooperation on direct taxation (07.07.2024) – Directive 2011/16/EU (directive on administrative cooperation - DAC) establishes a system for secure administrative cooperation between the national tax authorities of EU countries and lays down rules and procedures for exchanging information. This evaluation will assess the effectiveness, efficiency and continued relevance of the DAC and its amendments (DAC2 to DAC6), as well as its coherence with other policy initiatives & priorities and the EU added value.

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The European Commission launches consultation on energy labelling requirements for computers (18.07.2024) The Regulation aims to help consumers choose the most energy-efficient computers by using a scale from A (most efficient) to G (least efficient). The energy label will also provide other useful information on durability and reparability. The consultation covers both the ecodesign and energy labelling initiatives. This consultation covers both the Eco-design and Energy labelling interlinked initiatives. You just need to provide feedback once.

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The European Commission launches consultation on Trade in seal products – fitness check of EU rules (07.08.2024) – Seals are hunted in parts of the world for commercial, subsistence and cultural reasons. In 1983, following people's concerns about animal welfare, the EU banned the import of certain seal pup skins. In 2009, a general ban on placing seal products on the EU market was introduced, with two exceptions. This initiative will assess if the rules in place remain fit for purpose, focusing on their socio-economic impact and their impact on seal populations.

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Giovanni Sabatini joins GA as senior advisor, where he will coordinate the entire area of expertise in Banking, Regulatory, and Financial Services. In particular, he will be in charge of strategic consultancy in relations with Italian (Bank of Italy, Consob, Ivass, Agcm, Covip) and European (European Commission, European Central Bank, ESMA, EBA, SRB) institutions in the banking, financial and insurance fields.

Graduated in Economics and Business at the LUISS University in Rome, he began his professional career in 1984 at Arthur Young & Co. After an experience in Consob, in 2001 he was CEO of Monte Titoli S.p.A. and Chairman of ECSDA.

After joining Consob as Director of the Intermediaries Division, he was Head of the Legal and Banking Affairs Department of the Ministry of Economy and Finance.

In 2008 he returned to Consob as Co-Director, and from 2009 to 2024 he took on the role of Director General of the ABI.

In recent years, he has been for two two-year terms Chairman of the Executive Committee of FBE, Chairman of the Strategic Committee for Sustainable Growth of FBE, member of the EESC; Vice-Chairman of Bancomat, member of the Board of Directors of Fondo Italiano di Investimento, member of the Italian Committee for Corporate Governance, member of the Consultation Committee of Borsa Italiana. He is Vice-President of CBI and independent director of the Deposit Protection Fund.

‘’We are very excited‘’, says Francesco Sciaudone, Global Managing Partner of GA, ‘’that Giovanni will be able to contribute to the development of GA in a strategic sector such as banking, finance and insurance in Italy and Europe, to the benefit of all national and international clients. Giovanni's contribution will be fundamental to finally building a professional service offer (strategic, legal and tax) for the market and economic operators who have always had to deal with an increasingly complex regulatory mosaic and a plurality of stakeholders.‘’

Gianluca Bertolotti is Grimaldi Alliance's new of counsel in corporate governance and corporate crisis. His arrival further strengthens the Rome office and its area of expertise in commercial, corporate and industrial law, advisory and litigation.

Bertolotti is Professor of Commercial Law and Industrial Law at the University of Roma Tre, where he is also Director of the Commercial Law Area of the School of Specialisation for the Legal Professions. He is also a lecturer at the Guardia di Finanza School of Economic and Financial Police and a member of the Scientific Committee of the Ministry of Economy and Finance for the continuous training of Legal Auditors.

Bertolotti is a highly experienced professional with significant expertise in corporate law, financial markets, corporate governance, arbitration, banking law, crisis law and restructuring; in his long career he has held and continues to hold prestigious institutional and academic positions.

Professor Bertolotti has also been Legal Advisor to the Bicameral Commission of Inquiry into the Banking and Financial Markets System, Judicial Advisor to the Rome Court of Appeal and Head of Assonime's Corporate and Financial Markets sector, and is a lawyer admitted to practice before the Superior Jurisdictions.

"We are delighted to welcome Gianluca Bertolotti to Grimaldi Alliance. I am sure that he will bring with him an important professional background deriving from his years of experience in the academic world and in the profession and will be able to further enrich the quality of professional services that we increasingly want to offer in an integrated manner to national and international clients,’ commented Francesco Sciaudone, Global Managing Partner of Grimaldi Alliance.

TAX

The Organic Law to Address the Internal Armed Conflict, Social and Economic Crisis, published on March 12, 2024, in the Official Gazette, introduces significant reforms in tax matters:

Value Added Tax (VAT):

The VAT rate is increased from 12% to 15%. The VAT rate on local transfers of construction materials is set at 5%. The VAT increase takes effect on April 1.

Temporary Security Contribution:

A contribution of 3.25% on profits subject to income tax for the fiscal year 2022 is established for companies that generated profits during that period. This contribution must be paid in the fiscal years 2024 and 2025, with deadlines established by the IRS, and penalties for non-compliance.

Temporary Contribution to the Banking Sector:

A contribution is established on profits generated in the fiscal year 2023 by banks and savings and credit cooperatives, with rates ranging from 5% to 25% depending on the taxable profit.

Currency Exit Tax:

The ISD rate is raised to 5%, with the possibility of modification by the President following a favorable opinion from the public finance governing body. The regulation for the application of this law must be published by the President within a maximum of 30 days from its entry into force.

TOURISM

The Organic Law for the Strengthening of Tourism Activities and Promotion of Employment introduces significant changes to Ecuadorian tax legislation. Among the most notable reforms are:

Payments abroad for the organization, production, and presentation of artistic and cultural events in Ecuador, made by taxpayers registered as tourism service providers, will be subject to a 15% income tax withholding. If the recipient resides in tax havens, the withholding will be applied according to the general rate. Additionally, the VAT can be reduced to 8% for tourism services on specific days. Uncompensated VAT on the acquisition of goods for the production of construction materials can be considered a deductible expense. It is established that payments abroad made by national and foreign airlines operating within, from, and to Ecuador, and having an operating permit, will be exempt from the Currency Exit Tax. The Internal Revenue Service will determine the procedures for its application. Furthermore, the Organic Code of Territorial Organization, Autonomy, and Decentralization  is reformed, allowing Decentralized Autonomous Governments to qualify tourism investment or reinvestment projects to access a total exemption from municipal taxes, fees, and contributions for a period of seven years. Individuals engaged in commercial transport using tricycles will be entitled to a tax credit for the VAT paid on the purchase of these vehicles. The commercialization of mineral substances is subject to a 10% income tax withholding, although it does not apply to Large Taxpayers.

ECONOMICS

Pitahaya Sets Export Record with Over USD 172 Million in 2023

In 2023, Ecuador's agricultural industry marked a significant milestone with record-breaking fresh pitahaya exports reaching $171.7 million, a 72% increase from 2022, according to the Central Bank of Ecuador. This achievement positions pitahaya as a leading non-traditional export product.

Since opening the U.S. market in 2017, followed by Peru in late 2022 and China in April 2023, pitahaya exports have soared. The U.S. remains the primary market, receiving 80% of Ecuador's production, valued at $137.1 million. Other key markets include Hong Kong (6.55%), Spain (3.53%), Peru (2.35%), and Canada (1.85%).

With a Free Trade Agreement with China underway, exports to China are expected to surge, as the current 20% tariff will be immediately reduced to 0% upon the agreement's implementation.

Pitahaya farming supports around 15,000 families in Ecuador, primarily producing two varieties: yellow and red,

Renowned for its unique tropical flavor and aroma, Ecuadorian pitahaya benefits from exceptional soil and farming conditions. It holds the "Pitahaya Amazónica de Palora" designation of origin, Good Agricultural Practices certification, and international Global GAP certification.

EXTERNAL INVESTMENT

Ecuador Secures Over USD 4.8 Billion in Sustainable Mining Investments

At the World Mining and Exploration Convention in Toronto, Canada, Ecuador's President and his official delegation participated in "Ecuador Day." Organized by the Ecuadorian Chamber of Mining, the event aimed to highlight the country's mining potential, attract foreign investment, and promote sustainable mining practices.

During the official agenda, the head of the Ministry of Production, Foreign Trade, Investments, and Fisheries, signed six investment agreements. These agreements formalized the mutual interest between the Ecuadorian state and investors to develop mining projects, laying the groundwork for future negotiations and collaboration focused on sustainable, responsible, and long-term business practices.

The MTEPS regulates the salary increase applied to workers for the 2024 fiscal year.

 On May 1, 2024, the Bolivian government promulgated Supreme Decree No. 5154, which aims to establish a 3% increase in the basic salary and a 5.85% increase in the National Minimum Wage, resulting in a new amount of Bs.2,500. It applies to all private sector workers. It will be retroactive from January 2024, must be paid by May 31, 2024, and reported to MTEPS by June 30, 2024. In the public sector, it applies to the following sectors: Health, Fiscal Teaching, Departmental Service of Social Management, Armed Forces, and Bolivian Police.

Tax incentives for the importation of flex-fuel technology vehicles and hybrid vehicles.

Supreme Decree No. 5142 of April 10, 2024. Supreme Decree 5142 implements customs and financial tax policies to incentivize the importation and manufacturing of flex-fuel technology vehicles, as well as tax incentives for importing hybrid vehicles. The objective is to "encourage the use of plant-based additives through the importation of flex-fuel technology vehicles, diversifying the energy matrix, and modifying the tax treatment for the importation of hybrid vehicles." The rates for the Customs Duty (GA) and the Specific Consumption Tax (ICE) for the importation of flex-fuel technology motor vehicles will be zero percent for three years, while the rates for the Customs Duty and the ICE for the importation of self-recharging hybrid vehicles will be 10%.

New Regulation for the Registration of Foreign Investment in the Plurinational State of Bolivia. Board Resolution No. 043/2024 of March 26, 2024.

The president of the Central Bank of Bolivia (BCB), Edwin Rojas, presented the "Online RIOF System" (RIOF) developed by the Issuing Entity to facilitate the timely submission of this statistical information, allowing the creation of various specialized documents that it publishes, such as the "Balance of Payments and International Investment Position Report," the "Foreign Private Capital in Bolivia Report," and the "Private External Debt Report."

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EUROPEAN COMMISSION (EC)

The European Commission launches consultation on Trade in e-waste & amendments to the Basel Convention annexes (03.07.2024) – The fifteenth Conference of the Parties to the Basel Convention amended the Basel Convention's Annexes II, III and VIII to bring all imports and exports of electrical and electronic waste under the scope of that Convention. The amendments will enter into force from 1st January 2025 and will apply to all Parties to the Convention, including the EU and its Member States. This initiative incorporates these changes into EU law (EU Waste Shipment Regulation), which is due for publication in April 2024.

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The European Commission launches consultation on Tariff quotas – amended rules on reference quantity requirement (03.07.2024) – Regulation (EU) 2020/760 lays down rules for EU importers to apply for import licences. Importers can apply for licenses for up to the average annual quantity of products with the same origin released for free circulation in the EU in the past 2 years. This initiative adjusts the rules on reference quantity to avoid any risk of market distortions posed by recent market developments in some sensitive sectors.

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The European Commission launches EU environmental law – 2025 implementation review (05.07.2024) – The environmental implementation review is a regular cycle of analysis, dialogue and collaboration to improve the implementation of EU environmental policy and law in EU countries. This initiative identifies the main implementation gaps in EU countries and addresses their root causes, proposes solutions, provides technical assistance and facilitates the exchange of good practices, raises awareness and makes it easier for everyone involved to find information on implementing these policies.

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The European Commission launches consultation on Cooperation on direct taxation (07.07.2024) – Directive 2011/16/EU (directive on administrative cooperation - DAC) establishes a system for secure administrative cooperation between the national tax authorities of EU countries and lays down rules and procedures for exchanging information. This evaluation will assess the effectiveness, efficiency and continued relevance of the DAC and its amendments (DAC2 to DAC6), as well as its coherence with other policy initiatives & priorities and the EU added value.

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The European Commission launches consultation on energy labelling requirements for computers (18.07.2024) – The Regulation aims to help consumers choose the most energy-efficient computers by using a scale from A (most efficient) to G (least efficient). The energy label will also provide other useful information on durability and reparability. The consultation covers both the ecodesign and energy labelling initiatives. This consultation covers both the Eco-design and Energy labelling interlinked initiatives. You just need to provide feedback once.

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The European Commission launches consultation on Trade in seal products – fitness check of EU rules (07.08.2024) – Seals are hunted in parts of the world for commercial, subsistence and cultural reasons. In 1983, following people's concerns about animal welfare, the EU banned the import of certain seal pup skins. In 2009, a general ban on placing seal products on the EU market was introduced, with two exceptions. This initiative will assess if the rules in place remain fit for purpose, focusing on their socio-economic impact and their impact on seal populations.

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