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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

Last week the Court of Justice of the European Union (“CJEU”) upheld a broad interpretation of the concept of “information that relates to emissions into the environment” that EU and Member State authorities (e.g., ECHA, EFSA, Commission, national environmental agencies) must disclose to the public.  According to the CJEU, the information that must be disclosed does not only relate to emissions from industrial installations, and must also include data allowing the public to: (i) know what is, or may be foreseen to be, released into the environment under normal or reasonable conditions of use of a product or substance; (ii) check the correctness of the assessment of the actual or foreseeable emissions on the basis of which product or substance is authorized; and (iii) understand the effect of those emissions on the environment.   This information must be disclosed to the public, upon request, even if it may affect the commercial interests of companies.

The CJEU’s decisions will have a significant impact on all companies that are required to submit regulatory filings to access the EU market under different EU legislation (e.g., REACH, Biocides, Plant Protection Products, Fertilizers, GMOs).  These companies must now assume that much of the data they submit may not be kept confidential.

Continue Reading The Court of Justice of the EU Adopts a Broad Interpretation of the Information on Emissions into the Environment that Authorities Must Disclose to the Public

The European Commission has launched a public consultation on possible EU measures to increase the transparency of nanomaterials on the European market.  The consultation is the first step of a Commission drafting procedure that is likely to end in a proposal for a Regulation on an EU Nano-Registry that the Commission could formally present by Spring 2015.

The Commission’s consultation aims at gathering the views of the public on the currently available information on nanomaterials on the market, whether the information available is sufficient to guarantee the safe use of nanomaterials and products containing them and informed consumer choice, and the different options to address any lack of information.  The consultation will contribute to the preparation of an impact assessment of a possible future Commission proposal.
Continue Reading The European Commission Launches a Public Consultation on a EU Nano-Registry

The attached presentation on the New EU Rules on Articles Treated with Biocidal Products was presented at the Annual Conference on European Food Law 2014 of the Academy of European Law ,  Trier, on May 5, 2014.  The slides discuss the new rules for treated articles of the EU Biocidal…
Continue Reading Presentation on the New EU Rules on Articles Treated with Biocidal Products

This post was originally published as a Covington E-Alert

Very recently, the General Court of the European Union held that European institutions and agencies (e.g., European Commission, ECHA, EFSA, EMA) must disclose to the public, upon their request, information on the impurities and composition of substances emitted into the environment even if this may affect the commercial interests and intellectual property rights of the companies that developed the products.

The Court ruled against a European Commission decision that denied two NGOs access to several documents relating to the approval of the active substance glyphosate in plant protection products.  The refusal was based on the need to protect the commercial interests of the manufacturers of the substance. The Court held that Regulation 1367/2006 on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community Institutions and Bodies (“Aarhus Regulation”) requires EU institutions and bodies to disclose information if it “relates to emissions into the environment” even if it can undermine the commercial interests of companies.  This applies to any information that “relates in a sufficiently direct manner to emissions into the environment.” The Court found that information concerning the identification and quantity of impurities contained in the substances meets that definition.
Continue Reading EU Court Requires EU Authorities to Disclose Information on Impurities and Composition of Substances Submitted by Companies

Originally posted as Covington E-Alert on August 30, 2013

As of September 1, 2013, the new rules of the EU Biocidal Products Regulation apply to goods manufactured in, or imported into, the European Union and European Economic Area (“EU/EEA”).[1]  The Regulation imposes new approval, labeling and disclosure requirements on goods (i.e., substances, mixtures, objects) that have been treated with or that intentionally incorporate biocidal products (so-called “treated articles”), even if such goods do not have a biocidal function.
Continue Reading New EU Requirements on Articles Treated with Biocidal Products

The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this year.  Once adopted, the new Royal Decree will replace Royal Decree 223/2004 on Clinical Trials and will regulate all clinical trials with medicines and medical devices in Spain.

Among other changes, the draft Royal Decree would introduce the following:

EMA has published a draft guideline on the use of phthalates as excipients in human medicinal products. The guideline establishes new Permitted Daily Exposure (“PDE”) values for the following phthalates that are among the most commonly used as excipients in medicinal products:

  • dibutyl phthalate: 0.01 mg/kg/day
  • diethyl phthalate: 4 mg/kg/day
  • polyvinyl acetate phthalate: 2 mg/kg/day

The guideline also concludes that data currently available for cellulose acetate phthalate and hydroxypropyl methylcellulose acetate phthalate do not indicate that their presence in human medicinal products constitutes a potential risk for human safety.
Continue Reading EMA Publishes Draft Guideline on the Use of Phthalates in Medicines

Originally published as Covington E-Alert on October 23, 2012

On October 17, 2012, the European Commission presented a proposal that would limit the consumption of food crop biofuels and bioliquids in Europe.1 The proposal is intended to respond to allegations that food crop biofuels and bioliquids result in higher world…
Continue Reading The European Commission Proposes New Requirements on Biofuels Marketed in Europe

Article originally published in EuroWatch on August 15, 2011

The Council of the European Union has adopted a position at First Reading on a proposal for a Regulation on Biocidal Products that would impose new requirements on goods treated with biocidal products (“Council First Reading”).1 The new rules would apply to a wide variety of consumer goods, such as furniture and other wood products, packaging, electronic equipment, plastic materials, paper and tissue products, absorbent hygiene products, apparel, paints, and kitchen accessories, and are likely to have a significant impact on goods imported into the European Union or European Economic Area.

The Council First Reading would significantly change the EU regulatory framework for materials (i.e., articles, mixtures, and substances) treated with or incorporating biocidal products. On the one hand, the new rules would limit the scope of the strict requirements that apply to biocidal products to only those materials that have a primary biocidal purpose. On the other hand, however, they would also create a new category of rules for all materials that intentionally incorporate or have been treated with biocidal products (so-called “treated articles”) even if such materials do not have a primary biocidal purpose.
Continue Reading Upcoming EU Requirements on Goods Treated with Biocidal Substances

Originally published as Covington E-Alert in April 2011

THE REACH REGULATION AND SUBSTANCES OF VERY HIGH CONCERN

The European Union’s Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH Regulation”) requires the European Chemicals Agency (“ECHA”) to identify so-called Substances of Very High Concern (“SVHCs”)…
Continue Reading Getting Ready For Reach: Substances Of Very High Concern