Photo of Cándido García Molyneux

Cándido García Molyneux

Cándido García Molyneux provides clients with regulatory, policy and strategic advice on EU environmental and product safety legislation. He helps clients influence EU legislation and guidance and comply with requirements in an efficient manner, representing them before the EU Courts and institutions.

Cándido co-chairs the firm’s Environmental Practice Group.

Cándido has a deep knowledge of EU requirements on chemicals, circular economy and waste management, climate change, energy efficiency, renewable energies as well as their interrelationship with specific product categories and industries, such as electronics, cosmetics, healthcare products, and more general consumer products. He has worked on energy consumption and energy efficiency requirements of AI models under the EU AI Act.

In addition, Cándido has particular expertise on EU institutional and trade law, and the import of food products into the EU. Cándido also regularly advises clients on Spanish food and drug law.

Cándido is described by Chambers Europe as being "creative and frighteningly smart." His clients note that “he has a very measured, considered, deliberative manner,” and that “he has superb analytical and writing skills.”

Contact:Read more about Cándido García MolyneuxEmail

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.

Throughout the day our speakers shared their perspectives on a range of legal, regulatory, and business trends, including the evolving regulatory frameworks in the EU and UK; information exchange in ongoing collaboration; investigations and whistleblowing; key ESG topics, and the complexity of options to acquire in pharma deals.

We have set out some of the discussion from the sessions below.

European Life Sciences – The Changing Landscape for Pharma and Biotech

Grant Castle, Head of Covington’s European Life Sciences Regulatory Practice, Peter Bogaert, Marie Doyle-Rossie and Anna Wawrzyniak kicked off with a discussion about the Changing Landscape for Pharma and Biotech.

The UK and EU both aim to deliver access to innovative and transformative medicines and foster international competitiveness in the life sciences industry. Despite the practical challenges faced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in recent years, it has emerged as an ambitious regulator and is establishing innovative regulatory frameworks, including an international reliance scheme (see our update here), point of care manufacturing regulations, and the relaunch of the Innovative Licensing and Access Pathway (ILAP).

The EU is also pursuing a wave of legislative reform, including wide ranging revisions to the EU’s pharmaceutical legislation, the EU’s supplementary protection certificates (SPC) rules, and proposals for a compulsory licensing scheme.

There can sometimes be a tension between the UK’s and EU’s aims and the practical impacts of regulatory reform, especially in the early stages of implementation.Continue Reading The Covington European Life Sciences Symposium 2025

The European Union has just published a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) in the EU’s official journal.  The UWWTD imposes important new Extended Producer Responsibility (“EPR”) obligations that will have a significant financial and administrative impact on companies marketing human medicines and cosmetic products in the EU.  Member States must implement the new UWWTD by July 31, 2027 and must apply the new EPR obligations to in‑scope companies by December 31, 2028. 

In a previous blog, we discussed the new EPR obligations in detail.  In this blog, we outline the key financial provisions of the EPR obligations and raise different questions concerning Member States’ discretion when transposing the EPR obligations into their national laws.

Extended Producer Responsibility under the UWWTD

The UWWTD requires Member States to ensure the treatment of urban wastewaters to remove micropollutants (so‑called fourth stage, or “quaternary” treatment).  Article 9 of the Directive also requires Member States to ensure that producers that market products listed in Annex III (i.e., human medicinal products and cosmetic products) have EPR obligations and pay, via producer responsibility organizations (“PROs”), for the costs of the quaternary treatment of urban wastewater, for data collection, and for other costs required to exercise their EPR. 

Specifically, Article 9 requires that producers subject to EPR obligations must cover:

  • At least 80% of the costs associated with quaternary treatment of wastewater to remove micropollutants.  This includes both capital investments for building or expanding urban wastewater treatment facilities and operational expenses for the treatment facilities.
  • 100% of the costs for gathering data on the products they place on the market.
  • 100% of other costs (e.g., administrative) required to exercise their EPR.

As noted above, Annex III currently lists human medicines and cosmetics as the product groups covered by the EPR obligations.  However, the UWWTD requires the Commission to assess the possible expansion of that list and to make the related legislative proposals by December 31, 2033.

National Implementation: Some Questions

The EPR obligations of the UWWTD will only apply to producers once Member States implement them into their national laws.  The Directive requires Member States to adopt their national implementing laws by July 31, 2027 and to apply the EPR obligations not later than December 31, 2028.  Member States may choose to apply the EPR obligations earlier.

The UWWTD leaves Member States with some discretion as to how they implement the EPR obligations, and also allows Member States to impose stricter and broader requirements.  Recital 3 of the Directive makes this clear, as it states that “[i]n line with Article 193 of the [TFEU] Member States can go beyond the minimum requirements set out in this Directive.  Member States could consider for instance […] imposing additional requirements for, or broadening the spectrum of the application of, their national extended producer responsibility systems.” Continue Reading The EPR Obligations of the New Urban Wastewater Treatment Directive Key Questions and Next Steps for Member States

On 29 June 2024, the Net-Zero Industry Act (“NZIA”) entered into force.  The primary aim of the NZIA is to ensure that the EU has access to secure and sustainable net-zero technologies by scaling up their manufacturing capacity within the EU.

Here are the key takeaways:

  • The NZIA focuses on 19 Net-Zero Technologies (“NZTs”), including renewable fuels of non-biological origin (“RFNBOs”), solar, wind, nuclear, batteries, and carbon capture and carbon storage technologies.  The Regulation sets non-binding benchmarks for 40% local production of such technologies by 2030 and 15% global market share by 2040.  
  • To reach those benchmarks, Net-Zero Technologies Manufacturing Projects (“NZT Manufacturing Projects”) will benefit from streamlined permitting procedures.  Further, NZT Manufacturing Projects that are deemed “strategic” will benefit from expedited permitting timelines.
  • The NZIA introduces a target of achieving an annual injection capacity of at least 50 million tons of CO2 by 2030.  Oil and gas producers identified by Member States must contribute to this target, according to a proportion to be defined by the Commission for each individual producer.  Member States must adopt penalties for non-compliance.
  • National public procurement procedures for NZTs must include requirements for achieving a minimum level of environmental sustainability, to be set out in future implementing regulations.  In addition, for any given public contract having NZTs as part of their subject matter, the contracting authorities and entities must consider the project’s so-called “resilience contribution”, which relates to supply chain diversification.  When the majority (or a near majority) of a specific NZT (or any of its main components) originates from a third country, the contracting authority or entity must impose specific public procurement conditions to reduce dependency on that country. Auctions to deploy renewable energy sources and schemes that incentivize households, companies, and consumers to purchase NZT final products must also be designed to favor bidders that contribute to increasing the sustainability and resilience of the supply of NZTs within the EU.
  • Auctions to deploy renewable energy sources and schemes that incentivize households, companies, and consumers to purchase NZT final products must also be designed to favor bidders that contribute to increasing the sustainability and resilience of the supply of NZTs within the EU.
  • Member States may establish regulatory sandboxes, i.e., schemes enabling companies to test technologies in a controlled real-world environment under monitoring by a competent authority.

Continue Reading The EU Net-Zero Industry Act enters into force

On 23 May 2024, the EU’s Critical Raw Materials Act (“CRMA”) entered into force.  The Regulation’s adoption within just one year after it was first proposed in March 2023 signals the EU’s political commitment to strengthen Europe’s strategic autonomy on the supply of Strategic Raw Materials (“SRMs”) and the broader category of “Critical Raw Materials” (“CRMs”).   

Here are the key takeaways for companies:

  • The CRMA sets non-binding capacity targets within the EU for the extraction, processing, refining, and recycling of SRMs that are key to achieve the green and digital transition.
  • To reach such targets, the CRMA empowers the European Commission (“the Commission”) to recognize projects that extract, process, refine or recycle SRMs, including projects outside the EU, as Strategic Projects (“SPs”) so that they may benefit from easier access to financing, expedited permitting process, and matchmaking with off-takers.  The Commission is expected to recognize the first SPs by the end of 2024.
  • The Commission must monitor disruption risks and propose mitigation measures, if needed, to ensure a secure supply of CRMs.  To enable the Commission to do this effectively, companies may be subject to new specific obligations, such as participating in surveys, carrying out risk assessments of SRMs supply chains, mitigating possible vulnerabilities, reporting on the implementation and the financing of their SPs, labelling some products, and recycling a minimum content of permanent magnets.  
  • The Commission will also create and operate a Joint Purchasing Mechanism to aggregate the demand of interested EU off-takers consuming SRMs and seek offers from suppliers to match that aggregated demand.

Critical and Strategic Raw Materials and Capacity Targets

SRMs are indispensable raw materials for strategic sectors that facilitate transition to a greener, digital economy.  They are characterized by high forecasted demand growth and significant challenges in scaling up production in Europe to meet such demand.  Annex I to the CRMA lists 17 SRMs, including copper, gallium, lithium, manganese, and titanium metal.Continue Reading The EU Critical Raw Materials Act enters into force

In the early hours of December 14, 2023, the Council of the EU (“Council”) and the European Parliament (“Parliament”) reached a provisional political agreement on the Corporate Sustainability Due Diligence Directive (“CSDDD”). Described as a “historic breakthrough” by Lara Wolters, who has led this file for the Parliament, the CSDDD will require many companies in the EU and beyond to conduct environmental and human rights due diligence on their global operations and value chain, and oblige them to adopt a transition plan for climate change mitigation.

Given the CSDDD’s relevance for companies’ ongoing compliance planning on environmental and human rights matters, this blog aims to advise clients on the basic elements of the CSDDD agreement based on press releases from the Council, Parliament, and the European Commission (“Commission”), even if much uncertainty remains. Although a political agreement has been reached, the text of the agreement is not publicly available and a number of details of the legal text will need to be finalized in follow-up technical meetings. Covington will publish a more detailed alert on “how to prepare” for the CSDDD once the full text is available (likely in early 2024).

In Short

After intense negotiations since the Commission published its proposal in February 2022, the Directive is set to lay down significant due diligence obligations for large companies regarding actual and potential adverse impacts on human rights and the environment, with respect to their own operations, those of their subsidiaries, and those carried out by their business partners.Continue Reading Provisional Agreement on the EU’s Corporate Sustainability Due Diligence Directive (CSDDD): Key Elements of the Deal

2022 and 2023 may be remembered as pivotal years for efforts against so-called “greenwashing.”  In this article, we look at some recent developments in the regulation of “green claims” in the UK, the US, and the EU that corporates should be aware of.  We provide a broad summary and comparison snapshot of the UK, US and EU regimes to help companies navigate these rules.  Now is a critical time for companies to get up to speed: authorities in all three jurisdictions are focusing more and more intently on this issue; company reputations will increasingly rise and fall with the strength of their green claims, and national regulators are set to get new powers (including the power to levy significant fines) to tackle companies found in breach.

I.  Summary of recent developments: What’s new in greenwashing?

In January 2022, the UK’s Competition & Markets Authority (“CMA”) launched a sector‑by‑sector review of misleading environmental claims.  The CMA started with the fashion sector, and called out a number of high‑profile, fast‑fashion companies for their practices.  Twelve months later, the CMA announced that it was expanding the investigation to greenwashing around “household essentials”, including food, drink, toiletries and cleaning products.  The CMA’s review is the first concerted application of the CMA’s new Green Claims Code, published in September 2021, which gives guidance for any business (wherever based) making environmental claims in the UK.

Meanwhile, in December 2022, the US Federal Trade Commission’s (“FTC”) launched a review of the “Guides for the Use of Environmental Claims” (“Green Guides”), which was last updated in 2012.  The initial comment period closed on April 24, 2023.  The FTC plans to update the Green Guides to reflect developments in consumers’ perception of environmental marketing claims.  As a part of its ongoing review, the FTC also announced a workshop to examine recyclable claims.  The workshop is scheduled for May 23, 2023 and the public can submit comments on the subject of recyclable claims through June 13, 2023.  For more detail on the review, please see our dedicated blog post, here.

Finally, the EU has proposed two Directives to modernize and harmonize the rules on green claims across the bloc (together, the “EU Green Claims Proposals”).  Currently, EU law does not specifically regulate environmental claims.  Instead, environmental claims are subject only to general consumer protection and advertising rules (set out in Directive 2005/29 on Unfair Business-to-Consumer Practices and Directive 2006/114 on Comparative Advertising).  Admittedly, the EU has published guidance on interpreting and applying the general rules in the context of green claims (see the guidance here, and see our previous blog post discussing the guidance here).  However, in practice, EU Member States approach interpretation and enforcement in a variety of different ways.  On March 3, 2022, the European Commission published a Proposal for a Directive Empowering Consumers for the Green Transition, also known as the “Greenwashing Directive.”  The Greenwashing Directive amends the EU’s existing consumer protection rules, and bans a number of general green claims, such as “climate neutral” or “eco-friendly.”  It also imposes some rules on the use of non-environmental sustainability claims or “social impact” claims, such as “locally produced” or “fair labour.”  One year later, on March 22, 2023, the European Commission presented a Proposal for a Directive on Green Claims (“Green Claims Directive”), which we discussed here.  The Green Claims Directive proposes a new and strict framework, applicable to all companies operating in the EU/EEA, to harmonize the rules on the substantiation of voluntary green claims. 

Below, we outline the key aspects of the different legislative frameworks.Continue Reading The Green Claims Global Drive: Developments in the UK, US and EU

Those in the business of fast‑moving consumer goods (“FMCGs”) are likely aware of the plethora of environmental and product stewardship regulations applicable to the FMCG sector.  These laws are set to increase and expand in application.  What FMCG companies also need to get to grips with are a range of broader (and also fast‑moving!) environmental, social and governance (“ESG”) developments and consequent risks and opportunities.  Companies need to understand how the new world of ESG impacts their supply chains, key ingredients and components, consumer choice and confidence, competitive advantage, market accessibility, and marketing. 

Designed as a ‘primer’ for FMCG companies, in this piece, we cover a range of key trends in the emerging UK and EU ESG legal landscape as relevant for the FMCG sector, from farmers to Food Business Operators (“FBOs”) and from manufacturers to retailers.  We also discuss some key legal and reputational risks; as well as pointers to help companies decipher and prepare for the ESG storm.

We focus on the UK and the EU (first movers on many ESG issues), but the landscape in other jurisdictions (including, for example, the US) is also evolving and becoming more complex.

Key ESG Issues for FMCGs

We think there are four categories of key ESG developments for FMCGs to watch: (I) corporate reporting and disclosure regimes; (II) green/sustainability claims and labelling; (III) supply chain obligations; and (IV) product packaging and presentation.

Many emerging ESG frameworks cut across sectors.  This may be efficient for regulators, but can make identifying sector-specific risks and opportunities more challenging.  We have sought to do that below.Continue Reading Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)

On March 22, 2023, the European Commission published a proposal for Directive on common rules promoting the repair of goods (“Proposal”), which would grant consumers the right to request from producers the repair of products that under EU law are subject to “reparability requirements.”  The Proposal’s aim is to encourage producers to develop more sustainable business models by ensuring that their products are reparable.

The European Parliament and Council are now considering the Proposal for adoption and may introduce amendments.  Manufacturers should consider the impact of the Proposal on their products and suggest their amendments to Members of the European Parliament and Member States. If adopted, the Proposal’s requirements are not likely to apply in the different Member States before the end of 2026.

Contextual Background of the Proposal

The Proposal is intended to achieve the product sustainability and circularity objectives of the European Commission’s Circular Economy Action Plan of 2020, one of the main building blocks of the European Green Deal, that announced the Commission’s intention to introduce legislative initiatives aimed at “improving product durability, reusability, upgradability and reparability.”  Other initiatives affecting the durability, reparability and reusability of appliances and other products include: (i) a proposal for Regulation on Ecodesign Requirements for Sustainable Products (“Proposed Sustainable Products Regulation”), which will replace the existing Ecodesign Directive 2009/125/EC; and (ii) a proposal for a Directive amending Directives 2005/29/EC and 2011/83/EU as regards Empowering Consumers for the Green Transition Through Better Protection Against Unfair Practices and Better Information (“Proposal for a Greenwashing Directive”).Continue Reading European Commission Publishes Directive on the Right of Repair Proposal

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