On 19 June 2023, after almost 20 years of negotiations, the United Nations (“UN”) member states adopted a landmark treaty to ensure the conservation and sustainable use of marine Biodiversity of areas Beyond National Jurisdiction (the “BBNJ” treaty).
One of the cornerstones of the BBNJ treaty is the creation of a
“Delays in clinical trials result in delays of potentially life-saving treatments”
The European Commission is streamlining the rules for clinical trials of medicines consisting of, or containing genetically modified organisms (“GMOs”). Under the current EU GMO framework, getting authorization for clinical trials of GMO medicines is a long and costly process. Industry groups have vocally criticized it; and the Commission itself has voiced the need for change.
The Commission proposes a single, centralized application for clinical trials of GMO medicines. The sponsor will include a detailed environmental risk assessment with the application. In turn, the Commission will exempt clinical trials from the scope of many GMO rules. The new system will be leaner, greener and will get potentially life-saving treatments to patients with less administrative delay.
The changes are part of the EU’s new package of revisions to the bloc’s common pharmaceutical regime, set out in a draft Regulation and a draft Directive, published by the Commission on 26 April 2023. The new GMO medicines rules are just one part of a range of environment‑focused reforms to EU pharmaceutical law set out in the proposals — for more information, see our post here.
Continue Reading EU Pharma Legislation Review Series: GMO Medicines
Pharmaceutical companies take note: the EU plans to refuse marketing authorizations for environmentally-unfriendly medicines.
The EU has published a package of revisions to the bloc’s common pharmaceutical regime. Many revisions aim to reduce the environmental impact of human medicinal products. The key environmental measures include:
In this post, we lay out what pharmaceutical companies need to know about the key environmental measures.
Continue Reading EU Pharma Legislation Review Series: Addressing Environmental Risks
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)
The Italian Legislative Decree 196/2021 (“Italian Decree”) implementing the Single-Use Plastic Directive (“SUPD”) will enter into force on January 14, 2022. The Italian Decree diverges from the SUPD on significant aspects: it provides a more flexible definition of plastic; delays the entry into force of the ban on prohibited SUPs; and exempts from such ban specific biodegradable and compostable materials. The Decree also imposes specific return obligations on waste plastic bottles. While the Italian Decree provides companies with additional flexibilities to market their SUPs in Italy, companies should carefully assess the risks that may arise if EU Courts finally hold that the Decree is not compatible with EU law.
Continue Reading Italy Transposes Into National Law The EU Single-Use Plastic Products Directive
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.
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 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”).[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