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Rosa Oyarzabal

Rosa Oyarzabal Arigita is an associate in the Life Sciences team. She assists clients across a range of regulatory, legal and procedural matters in the pharmaceutical and food sectors, and her practice focuses on EU and Spanish regulatory advice.

Rosa has acquired significant experience in the pharmaceutical advertising space, both at EU level as well in Member States such as Spain and Belgium. She is also familiar with the EU food and advertising rules, and regularly advises clients in the plant-based sector on these topics. As part of her practice, Rosa also assists clients with the implementation of the Nagoya Protocol and the access and benefit sharing rules of a number of jurisdictions.

Rosa has assisted in multiple litigations in front of the European Court of Justice, including as part of pro bono efforts. For example, Rosa plead in front of the Court of Justice for case C-356/21, concerning the rights of LGBTQIA+ self-employed persons to not be discriminated against when contracting with another party and during the performance of their activities.

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On January 17, 2024, the European Parliament formally endorsed its provisional agreement with the Council on the Directive Empowering Consumers for the Green Transition through Better Protection against Unfair Practices and Better Information (“Greenwashing Directive”).  The Council is now expected to endorse the provisional agreement after which the Directive will be published in the EU Official Journal and enter into force.

The Greenwashing Directive aims to contribute to the EU’s green transition by empowering consumers to make informed purchases using reliable sustainability information about products and traders.  To do so, the Directive amends Directive 2005/29 on Unfair Business-to-Consumer Practices (“Unfair Commercial Practices Directive”) by introducing specific rules on sustainability and environmental claims.  The Greenwashing Directive is intended to work in tandem with the proposed Directive on substantiation and communication of explicit environmental claims (the “Proposed Green Claims Directive”), which we reported on here. 

Companies should keep a close eye on the transposition of this Directive, as it will have a significant impact on how they communicate about their sustainability, environmental, and social or ethical efforts.  Covington can help companies with navigating these regulatory requirements while meeting their business objectives.Continue Reading EU Adopts New Rules on Greenwashing and Social Impact Claims

On March 22, 2023, the European Commission (“Commission”) presented its proposal for a Directive on substantiation and communication of explicit environmental claims (“Proposed Green Claims Directive”).  The Proposed Green Claims Directive is intended to work in tandem with the Commission’s 2022 Proposal for a Directive empowering consumers for the green transition through better protection against unfair practices and better information (“Proposed Greenwashing Directive”).  Both Proposed Directives are intended to contribute to the EU’s green transition towards a circular, climate-neutral and clean economy by enabling consumers to make informed purchasing decisions based on reliable information about the sustainability of products and traders.  In particular, the Proposed Green Claims Directive would create a common methodology for substantiating green claims about the environmental footprint of products, services and companies and require companies making environmental claims to secure a certification of compliance from an independent national “verifier.”Continue Reading Greenwashing: EU Unveils Ambitious Proposal on Green Claims

The European Union (“EU”) is coming closer to adopting mandatory rules for companies that use carbon credits.

  • First, the European Parliament and Council are considering for adoption a Commission for a Regulation on a Carbon Removal Certification Framework (“CRCF Regulation Proposal”).

These two regulatory initiatives are closely tied to each other.  In effect, the draft ESRS that the Commission is considering for adoption require subject entities to disclose GHG removals and GHG mitigation projects financed through carbon credits.

The EU’s aim of regulating carbon credits coincides with its push for carbon neutrality by 2050, and a related significant proliferation of companies publicly committing to achieve “net-zero” emissions by mid-century, which has triggered an uptick in strategic purchases of carbon credits in the voluntary carbon market (“VCM”). The CRCF Regulation Proposal and the upcoming ESRS will help to expand sustainable and verified carbon removals and encourage investment in technological innovation.   

Companies turning to the VCM to reach their net zero goals, and others active in the generation, trading, and use of carbon credits, will want to follow these initiatives closely.  Opportunities remain for companies to express views that may shape the final contours of these regulations.Continue Reading The EU’s Emerging Mandatory Disclosure and Certification Rules for Carbon Credits

The European Commission is expected to present a Proposal for a Directive on Green Claims  (“Proposed Green Claims Directive” or “the Proposal”) within the next few months.  Together with the Proposal for a Directive empowering consumers for the green transition through better protection against unfair practices and better information (“Consumer Empowerment Directive Proposal”), the Proposed Green Claims Directive would contribute to the EU’s green transition towards a circular, climate-neutral and clean economy by creating a common methodology for the substantiation of green claims that concern the environmental footprint of products, services and companies.  It would aim to reduce greenwashing and enable consumers to take informed purchasing decisions based on reliable information about the sustainability of products and traders.

If adopted, it is likely to significantly limit the environmental claims that businesses can make in the EU/EEA.  Businesses may want to consider approaching the Commission to try to influence the final legislative proposal that it is expected to present by March 2023.  Once the Commission presents its legislative proposal, businesses should consider proposing amendments to the European Parliament and Council. Continue Reading Upcoming EU Rules on Green Claims

Last December, the European Commission published its legislative Package on Hydrogen and Decarbonized Markets (“Package”), which proposes new rules aiming to develop a hydrogen market in the EU. The new rules bring much awaited legal clarity to the concepts and role of blue and green hydrogen within the EU’s energy regulatory framework for the climate transition.

In effect, the Commission’s legislative Package is intended to promote the use of blue hydrogen until at least 2030 provided that it achieves the same decarbonization as green hydrogen (i.e., 70% GHG reduction).  However, the European Parliament and Council may amend both the proposed definition and conditions of blue hydrogen and the proposed regulative incentives during their consideration of the Package and its adoption through the legislative procedure that will now follow.  Moreover, the European Commission will be empowered to develop much of the methodologies implementing the definitions of blue and green hydrogen.  Companies intending to engage in blue and green hydrogen operations in the EU/EEA would be well advised to closely follow these developments.Continue Reading New Definitions for Blue and Green Hydrogen: The European Commission’s Package on Hydrogen and Decarbonized Gas Markets

On April 21, 2021, the European Commission approved “in principle” a Delegated Regulation establishing the criteria under which different economic activities substantially contribute to climate change mitigation and adaptation under Regulation 2020/852 on the Establishment of a Framework to Facilitate Sustainable Investment (“Taxonomy Regulation”).  Among other things, the Delegated Regulation defines the climate mitigation and adaptation criteria that the manufacture of hydrogen must meet to be considered a “sustainable investment” in the European Union.
Continue Reading The European Commission Approves the EU Criteria on Sustainable Hydrogen Activities