Photo of Cándido García Molyneux

Cándido García Molyneux is a Spanish of counsel in the Brussels office of Covington & Burling.  His practice focuses on EU environmental law, renewable energies, and international trade law.  He advises clients on legal issues concerning environmental product regulation, emissions trading, renewable energies, energy efficiency, shale gas, chemical law, product safety, waste management, and international trade law and non-tariff trade barriers.  Mr. García Molyneux was very much involved in the legislative process that led to the revision and amendment of the ETS Directive and Renewable Energies Directive.  He is an external professor of environmental law and policy at the College of Europe.

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 food prices and indirect land

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”) and to list them in

Article originally published in the Food Packaging Bulletin, January 2010

As with virtually all goods manufactured in, or imported into, the European Economic AreaI, food packaging is subject to the stringent requirements of Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (the so-called “REACH Regulation”)II. Indeed, while substances “used in