As of January 2021, many imports and exports of agricultural products covered by EU tariff quotas will be subject to the new licensing rules of Commission Delegated Regulation (EU) 2020/760 (“Delegated Regulation”) and Commission Implementing Regulation (EU) 2020/761 (“Implementing Regulation”) (together, “Licensing Regulations” or “Regulations”). The new Regulations introduce significant changes to – and are
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.
Since July 4, 2020 the manufacture, marketing and use of perfluorooctanoic acid (“PFOA”), its salts and PFOA-related compounds (collectively, “PFOAs”), and products containing them, is significantly restricted in the European Economic Area (“EU/EEA”). The restrictions were introduced by a Commission Delegated Regulation amending Annex I to the EU POPs Regulation, and are intended to implement a decision of the ninth meeting of the Conference of the Parties to the Stockholm Convention that was held from April 29 to May 10, 2019.
The new PFOA restrictions will have significant impact on a wide variety of products marketed, and businesses operating, in the EU/EEA, including semiconductors, textiles, firefighting products, pharmaceuticals, medical devices, and materials used in the life sciences industry. In effect, the new restrictions implementing the Stockholm Convention are significantly broader than the restrictions on PFOAs that were introduced under the EU REACH Regulation in 2017, and which the Commission now intends to repeal. …
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The COVID-19 pandemic has focused attention on the need for resilient supply chains, including perhaps most importantly, the critical need for sustainable supplies of healthy food. In line with this, the European Commission (the “Commission) has published a Communication on a Farm to Fork Strategy (the “Strategy”) where it announces a series of legislative and policy initiatives intended to place sustainability at the center of EU food law and policy by ensuring fair, healthy and environmentally-friendly food systems. The Strategy is one of the main pillars of the European Green Deal that, in December 2019, the European Commission announced as its policy flagship for the next five years.
Continue Reading The European Commission Announces a Sustainable Food Strategy for Europe
The European Commission has just adopted a Regulation that will lift the existing ban on imports of poultry meat from Ukraine that was triggered by the January 2020 Highly Pathogenic Avian Influenza (“HPAI”) outbreak in the western part of the country.
On January 19, 2020 the Ukrainian authorities informed the World Organization of Animal Health…
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.
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.…
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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 Products Regulation, the evolving Commission’s…
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”). 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.…
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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:
- Spanish Clinical Trials Register: the draft Royal Decree would establish a Spanish Clinical Trials Register publicly accessible on the website of the Spanish Medicines Agency. …
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