Key Points U.S. EPA is continuing to regulate and prevent sham COVID-19 products and devices from entering the market under FIFRA. EPA's distinction in regulating pesticide substances versus pesticide devices can cause confusion, but can be addressed if companies take proactive steps to ensure their product's compliance with the requisite legal framework, and self-report when in doubt. As noted in our prior alerts, available here and here, U.S ...
Entities that file disclosures with the Securities and Exchange Commission (“SEC”) should be aware of recent actions by regulators and shareholders questioning the sufficiency of opinion statements made in environmental-related disclosures. Most recently, on March 31, 2016, the SEC announced a settlement with Navistar International Corp ...
The race to achieve net zero emissions has played a significant role in pushing forward the fight against climate change. Key stakeholders are becoming alive to the opportunity presented by a decarbonised economy and those who do not get on board now risk being left behind. What chrnet zero? Simply put, net zero is premised on attaining a balance between greenhouse gas emissions produced and the amount removed from the atmosphere ...
Most large Ukrainian agricultural holdings have undergone substantial group restructuring and/or consolidations in the past 5 years. Many small and medium-size companies were integrated into large agricultural holdings with significant market power. This has led to an appreciable concentration on agricultural markets and, consequently, increased control for competition compliance by agricultural groups on the part of the Anti-monopoly Committee of Ukraine (the AMCU) ...
The COVID-19 pandemic has disrupted every sector of the economy in multiple ways. For businesses whose operations are subject to environmental requirements, including waste management, storage, and disposal laws, these coronavirus-related disruptions may impact a facility’s ability to comply with mandatory reporting and submission deadlines or waste storage time limits ...
The lack of detail in the Budget speech on investment in renewable energy (nothing on hydrogen for example) was disappointing, and surprising to many given the timing of the Autumn Budget with COP26. However, the Comprehensive Spending Review did give a bit more detail. Whether it goes far enough or fast enough to meet ambitious targets is still up for debate ...
On October 3rd ALRUD Law Firm Partner Anton Dzhuplin joined a workshop of international Conference “What is happening in pharmaceutical market?”, which took place at “PHARMASTRATEGIES-2017” summit. The conference annually brings together Country managers, CEOs, top-managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulatory authorities, professional and business media ...
On June 14, 2023, the National Congress approved the bill that creates the Biodiversity and Protected Areas Service and the National System of Protected Areas (the "Bill"). The purpose of the Bill is the conservation of biological diversity and the protection of the national natural heritage through the preservation, restoration and sustainable use of genes, species, and ecosystems ...
Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...
The provisions of the Environment Quality Act (“EQA”) regarding contaminated land require a person intending to change the use of a parcel of land to perform a site characterization study1 if certain specific industrial activities have been carried on there. If this study reveals the presence of contaminants in excess of the limit values prescribed by regulation 3, a notice of contamination must be registered in the land register against the property in question ...
As a part of our conversation with clients webinar series, Helen Wilson, Head of Legal at Weetabix joined Sebastian Price, Partner at Shoosmiths to talk about her experience of career development including success insights, job changes, individual versus organisational impact on progression and more ...
On 24 November 2021 Shoosmiths hosted a webinar exploring recent developments and forthcoming changes in environmental regulation – the COP26 climate change conference, the Environment Act 2021 and trends in sentencing for environmental offences. COP26 David Symons, director of sustainability at WSP UK outlined the three main messages from the COP26 conference: The 1 ...
On June 11, 2020, Resolution No. 29/2020 (“RES 29”) of the Chilean Economic Development Agency (“CORFO”), which approved the regulations that will govern the “Green Credit” program, was published in the Official Gazette. The RES 29 aims to endorse the investment in renewable energy projects during the economic contingency arising post Covid-19. (https://www.corfo.cl/sites/cpp/sala_de_prensa/nacional/10_06_2020_corfo_crea_credito_verde) ...
Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...
Faced with the COVID-19 pandemic, the Portuguese National Authority for Medicines and Healthcare Products (“INFARMED”) and the Directorate-General for Health (“DGS”) have issued guidelines for pharmacies. These guidelines address, in particular, the way pharmacies operate and manage medicines ...
INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it ...
Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
The European Commission has released the long-awaited proposal for a directive on corporate sustainability due diligence. As expected following the resolution approved by the European Parliament on 10 March 2021, the implications for companies are many and will have an impact on their organisation and the way they conduct themselves. The directive also affects the companies and other organisations they have commercial relations with ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
New biodiversity net gain (BNG) requirements are set to be enforced in November 2023, giving developers and the wider real estate industry less than 12 months to prepare. The legislation will require all new developments in England, bar a few exceptions, to deliver at least 10 per cent BNG – impacting commercial and residential developers. The requirements form part of the Environment Act 2021, which received Royal Assent in November 2021 ...
