On November 5, 2025, the Spanish Ministry for Ecological Transition and Demographic Challenge (“MITECO”) adopted a Resolution setting out the National Plan for the control of compliance with access and benefit-sharing (“ABS”) obligations under Regulation 511/2014 implementing the Nagoya Protocol in the European Union. The National Plan sets out a
Continue Reading ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing RulesThe Cali Fund and Why Legal Certainty Matters for Life Sciences R&D
On February 26, 2025, the Cali Fund was officially launched. Established by the 196 parties to the Convention on Biological Diversity (“CBD”), the Cali Fund invites pharma, cosmetics, food, AI, plant breeding, animal breeding, biotech, and other companies to “share monetary benefits” from uses of digital sequence information on
Continue Reading The Cali Fund and Why Legal Certainty Matters for Life Sciences R&DJust Weeks After COP16: CBD Secretariat Launches Stakeholder Consultations for the Operationalization of the DSI Mechanism. How Should Companies Engage?
The Secretariat of the Convention on Biological Diversity (CBD) has opened four consultations inviting stakeholder input on the development of the new Multilateral Mechanism on Benefit-Sharing (MLM) for Digital Sequence Information (DSI), including the establishment of the global benefit-sharing fund known as “The Cali Fund.”
Companies are encouraged to
Continue Reading Just Weeks After COP16: CBD Secretariat Launches Stakeholder Consultations for the Operationalization of the DSI Mechanism. How Should Companies Engage?New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products
Today, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027. Some studies suggest that the costs that producers would have to collectively pay could
Continue Reading New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsEU Adopts New Rules on Greenwashing and Social Impact Claims
On January 17, 2024, the European Parliament formally endorsed its provisional agreement with the Council on the Directive Empowering Consumers for the Green Transition through Better Protection against Unfair Practices and Better Information (“Greenwashing Directive”). The Council is now expected to endorse the provisional agreement after which the
Continue Reading EU Adopts New Rules on Greenwashing and Social Impact ClaimsHistoric Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companies
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
Continue Reading Historic Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companiesBrazil Ratifies the Nagoya Protocol
On March 4, 2021, Brazil deposited with the United Nations its ratification of the Nagoya Protocol (“Protocol”) (see here the announcement of Brazil’s Ministry of Foreign Affairs). This represents Brazil’s formal commitment to be bound by the Protocol.
On August 6, 2020, the Brazilian Senate passed a Decree that ratifies the Nagoya Protocol. The Protocol complements Brazil’s existing access and benefit sharing rules relating to Brazil’s genetic heritage and associated traditional knowledge (“ABS Framework”). One important effect of this ratification is that other countries parties to the Protocol will have to ensure that users of Brazilian genetic heritage and associated traditional knowledge comply with the Brazilian ABS Framework. However, the inverse is also true. Brazil will need to ensure that Brazilian users of foreign genetic heritage and associated traditional knowledge comply with the access and benefit sharing regime of the country of origin.
Continue Reading Brazil Ratifies the Nagoya Protocol
EU Guidelines on Cosmetic Product Safety Reports
On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation). The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements for cosmetic product safety reports. The Implementing Decision will enter into force in mid-December 2013.
Under the Cosmetics Regulation, cosmetic products placed on the EU market must be safe for human health when used under normal and reasonably foreseeable conditions of use, taking into account, among other things, the product’s presentation and labelling. A legal or natural person designated within the EU as the “responsible person” must ensure that each cosmetic product placed on the EU market has a cosmetic product safety report drawn up in accordance with the requirements of Annex I of the Cosmetics Regulation. This safety report forms part of the product’s information file, which the responsible person must keep for a period of 10 years following the placing on the market of the last batch of product.Continue Reading EU Guidelines on Cosmetic Product Safety Reports