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Lucas Falco, a Belgian qualified lawyer, is an associate in the Public Policy Practice Group. Lucas advises clients on EU public policy strategy and regulatory law with a particular focus on food, drugs and devices, environment, international trade, data privacy, and gaming.

His experience covers representing multiple international clients, such as EU trade associations on multiple aspects of EU law (including representation before courts and strategic advice).

Lucas also worked with EU Member States on EU public policy, providing him with considerable knowledge and insights in various procedures at national and EU level, such as the notification Directive, implementation of EU law at the national level (including drafting of national implementation acts) and infringement proceedings.

Lucas has significant experience in advocacy strategy and regulatory advice.

His expertise encompasses a broad range of environmental issues (e.g., single-use plastics, waste, hand hygiene), food and beverages (labeling requirements, market access), drugs and devices (market access, IPR), gaming, and international trade and customs (TRQs).

The European Parliament and Council are about to formally adopt a General Product Safety Regulation (“GPSR”), which will repeal and replace the General Product Safety Directive 2001/95 (“GPSD”)Just like the GPSD, the GPSR sets out the basic rules on the safety of products placed on, or made available in, the EU market and intended for, or likely to be used by, consumers.  While the GPSR builds on the existing legal framework of the GPSD it introduces several changes and new requirements that aim to enhance the protection of consumer’s health and safety, and adapt its requirements to new technologies.

This blog post outlines 16 changes and new requirements that the GPSR introduces and that industry should carefully take into consideration.

Changes Introduced by the GPSR

The GPSR will introduce the following 16 changes:

Continue Reading Sixteen Changes of the Upcoming EU General Product Safety Regulation

Last week the European Commission published its long-awaited proposal for a Packaging and Packaging Waste Regulation (“proposed Regulation”), and a Communication on an “EU Policy Framework on Biobased, Biodegradable and Compostable Plastics” (“Communication”).  The proposed Regulation is intended to replace the Packaging and Packaging Waste Directive 94/62 (“Packaging Directive”) and to ensure that all packaging marketed in the EU/EEA is fully recyclable or reusable by 2030.  If adopted, the proposed Regulation’s new requirements and restrictions will have a significant impact on industry, distributors, and consumers.  The European Parliament and Council must now consider the proposed Regulation for adoption through the so-called “ordinary legislative procedure,” which will allow for the introduction of amendments and is likely to take at least 18 months.  

This blog post highlights the main changes and new requirements that the proposed Regulation would introduce, and outlines the principal recommendations of the Commission’s Communication.

Main changes introduced by the proposed Regulation

The proposed Regulation would introduce the following eight main changes:

1.         Adoption of a Regulation.  The first important change is that the EU legislation on packaging and packaging waste would take the form of a Regulation rather than a Directive.  This, together with the harmonization clause of Article 4 of the proposed Regulation and the inclusion of certain packaging items in the definition of Article 3, is intended to limit Member States’ attempts to impose additional requirements on packaging. 

2.         Ban on Certain Packaging Formats.  The proposed Regulation would also propose to ban single-use packaging formats, including single-use composite packaging (e.g., containers); single-use packaging for fresh fruits and vegetables; single-use plastic grouped packaging used to group cans, tubs, tins and pots together; single-use hotel miniature packaging (e.g., sachets around miniature bar soap); and single-use plastic and composite trays and boxes for foods and beverages in the HORECA sector (e.g., trays or boxes used to wrap hamburgers).

3.         Compostability Requirements.  The proposed Regulation would also require that particular categories of packaging (e.g., sticky labels attached to fruits and vegetables, very lightweight plastic carrier bags, and tea and coffee bags and single-serve units intended to be used and disposed of with the product) be “compostable in industrially controlled conditions in bio-waste treatment facilities.”  The proposed Regulation does not itself  define the criteria that these types of packaging must meet to be compostable.  However, its Impact Assessment states that companies may demonstrate the compostability of their packaging on the basis of existing EU harmonized standards, such as, e.g., Standard EN 13432:2000.  European authorities are also likely to take into account the compostability criteria for plastics of the Communication (see below).

The proposed Regulation would also empower the Commission to subject other packaging items to the obligation to be compostable through delegated acts if justified and appropriate due to technological and regulatory developments impacting the disposal of compostable packaging and if the packaging meets the criteria of Annex III.

Other types of packaging that are not subject to the compostability obligation mentioned above would have to be designed in a way that they can be recycled without affecting other waste streams (such as the bio-waste waste streams).  Contrary to earlier version of the proposal, the proposed Regulation does not seem to impose a general ban on compostable plastic polymers. 

4.         New Deposit and Return Schemes.  The proposed Regulation would require EU Member States to put in place deposit and return schemes for single-use plastic and metal beverage bottles of up to three liters (with the exception of wine, spirits and milk). 

In addition, the proposal would also require Member States to encourage the introduction of systems for the reuse and refill of packaging in an environmentally sound manner.

Continue Reading The Commission unveils its proposal for a Packaging and Packaging Waste Regulation, and provides recommendations on Biobased, Biodegradable and Compostable Plastics

On September 15, 2022, the European Commission published a draft regulation that sets out cybersecurity requirements for “products with digital elements” (PDEs) placed on the EU market—the Cyber Resilience Act (CRA). The Commission has identified that cyberattacks are increasing in the EU, with an estimated global annual cost of €5.5 trillion. The CRA aims to strengthen the security of PDEs and imposes obligations that cover:

  1. the planning, design, development, production, delivery and maintenance of PDEs;
  2. the prevention and handling of cyber vulnerabilities; and
  3. the provision of cybersecurity information to users of PDEs.

The CRA also imposes obligations to report any actively exploited vulnerability as well as any incident that impacts the security of a PDE to ENISA within 24 hours of becoming aware of it.

The obligations apply primarily to manufacturers of PDEs, which include entities that develop or manufacture PDEs as well as entities that outsource the design, development and manufacturing to a third party. Importers and distributors of PDEs also need to ensure that the products comply with CRA’s requirements.

Continue Reading EU Publishes Draft Cyber Resilience Act

In December 2020, the European Commission presented a proposal for a new Regulation on Batteries and Waste Batteries.  The proposed Regulation aims to replace the current framework of Directive 2006/66/EC and seeks to achieve objectives set out in the European Green Deal and subsequent strategies, such as the transition to a carbon neutral and circular economy and the growth of renewable energies and clean mobility.  (Covington lawyers hosted a webinar that outlines the main features of the proposed Regulation and the ordinary legislative procedure that the proposal will follow.)

The proposal includes a host of product sustainability and safety requirements, conformity assessments and end-of-life management obligations for the producers of all types of batteries.  These requirements concern, among many others, carbon footprints, recycled content, chemical restrictions, durability, removability, replaceability, supply chain due diligence, waste collection, treatment and recycling, conformity assessments and CE markings, etc.  The proposed rules are expected to have a significant regulatory impact on the emerging European markets for industrial batteries and e-vehicle batteries.

One of the most striking features of the proposal is that many of its provisions are limited to establishing general principles and empower the European Commission to adopt the regulatory details by means of “Commission Delegated Regulations” and “Commission Implementing Regulations.”  In effect, the Commission’s proposal would leave it to the officials of the Commission and Member States to decide many of the technical details, which will eventually shape the markets of e-vehicle, industrial, automotive and portable batteries in Europe.  While delegating powers to the Commission is very common in EU legislation, the extent to which the proposal leaves regulatory decision-making to the Commission seems unprecedented.  It is uncertain whether the European Parliament and Council will agree to relinquishing so many critical details to the Commission.

This substantial delegation of power to the Commission also means that companies active on these markets that wish to advocate their position on the regulatory framework of batteries will need to do so not only during the proposal’s ordinary legislative procedure, but also during the adoption of the implementing rules and guidance by the Commission.  This is likely to be a long and ongoing process that will take at least six years after the conclusion of the ordinary legislative procedure.

Continue Reading The European Commission’s Planned Role to Implement its Proposed Sustainable Batteries Regulation

 On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive.  Both Directives are more than fifteen years old, and their implementation diverges widely across the member states.  The rules on human blood and tissue gain increasing importance for

Introduction

Health technology assessment (“HTA”) is a multidisciplinary assessment process that seeks to evaluate the added therapeutic value of health technologies (i.e., drugs, certain medical devices, medical treatments including surgical procedures, and measures for disease prevention and diagnosis) based on both clinical and non-clinical elements.  Until now, HTA has strictly fallen in the purview of EU Member States; they have cooperated among themselves in this field for more than 20 years on a purely voluntary basis.  This has led to initiatives such as EUnetHTA, which is a network of national HTA bodies, and its various Joint Actions.  Article 15 of the Cross-Border Healthcare Directive (Directive 2011/24) also provides for that national bodies responsible for HTA should cooperate on a voluntary basis.  Gradually, these various actions have developed common criteria for the performance of HTA at national level.  For example, the last “Joint Action 3” of EUnetHTA seeks to define common assessment methodologies, develop common ICT tools, and conduct and produce joint clinical assessments and HTA reports.

EU Member States have acknowledged the significant role that HTA plays and called on the European Commission to continue to support such initiatives (see, e.g., Council conclusions of December 6, 2014, on innovation for the benefit of patients).  However, in a resolution of March 2, 2017, the European Parliament went a step further and called on the Commission to propose legislation on health technology assessment at the EU level to provide transparent and harmonized criteria to evaluate the added therapeutic value of drugs and other health technologies.

The Proposal For an EU HTA Regulation

On January 31, 2018, the European Commission introduced its proposal for a Regulation on Health Technology Assessment.

The Commission identifies several problems with the existing situation.  It considers that health technology developers suffer from distorted market access, because the lack of common criteria means that they are confronted with data and evidence requests which vary between EU Member States.  In addition, under the existing regime, national HTA bodies are responsible for the clinical assessment required to evaluate the added therapeutic value of health technologies; this means that all national HTA bodies perform their own clinical assessments in parallel, which generate costs and a duplication of work.  Finally, the Commission deems that the current voluntary approach is not sustainable, because it is based on projects that are always run for a limited timeframe, with a limited budget, and are therefore subject to new negotiations at the end of each financial cycle.

Continue Reading The Commission’s Proposal on Health Technology Assessment – Will the EU Member States Accept its Mandatory Provisions?