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 Directive will be published in
Seán Finan is an associate in the Life Sciences team. His practice covers environmental, food and beverage and pharmaceutical regulation.
Seán has specific experience in a number of key areas for EU and UK clients in the food and beverage, pharmaceutical, cosmetic and consumer goods industries, including:
- General food regulation; novel food regulation; genetically modified and "precision bred" products;
- Advertising claims, particularly environmental claims and "greenwashing";
- Environmental and ESG compliance issues (Extended Producer Responsibility, ); and
- Chemicals legislation (REACH, CLP, Biocides).
Seán is qualified in both England & Wales, and the Republic of Ireland.
Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market.
The move is a significant reversal of the UK’s previous, post‑Brexit policy. In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark. However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely. Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it. Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU. What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers.
Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”). The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)
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:
- Pre-authorization — Environment-related refusals: The European authorities will be able to refuse a marketing authorization application where the accompanying Environmental Risk Assessment (“ERA”) is not adequate, or if the environmental risks have not been sufficiently addressed.
- Post-authorization — Environment-related monitoring and conditions of use: The European authorities will be able to impose environment‑related conditions of use on authorized medicines, including limiting the product to prescription-only or requiring additional post-authorization ERAs. They will also be able to suspend, revoke or vary marketing authorizations where a medicine presents a serious risk to the environment.
- Awareness and knowledge building — Warnings and environmental risk databases: Companies will be required to include additional information on environmental impact in a medicine’s EPAR, and additional awareness‑raising information in the product packaging of antimicrobials.
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
The relationship between the UK and the Republic of Ireland (ROI) came into sharp focus recently, as US President Joe Biden visited ROI. Biden’s visit coincided with the 25th anniversary of the Belfast (Good Friday) Agreement 1998 (GFA) which brought an end to 30 years of Troubles in Northern Ireland (NI). The UK government will have welcomed the fact that President Biden described the Windsor Framework (WF) as one of two pillars (along with the GFA) which are key to future peace and prosperity in NI. The WF is also fundamental to the recent improvement of the tripartite UK-EU-ROI relationship.
The Northern Ireland Protocol (NIP) was part of the UK’s withdrawal from the EU and sought to square the circle of respecting the GFA, whilst maintaining NI’s place in the UK Single Market. But the Unionist community in NI felt the NIP left NI being treated differently from the rest of the UK – a feeling which led to the 2022 suspension of the Stormont Assembly. The negotiation of the WF demonstrated a new and welcome willingness of the UK and the EU to negotiate mutually acceptable solutions to some of the problems created by Brexit (even if the WF has not (so far) achieved one of its objectives of re‑starting power-sharing at Stormont).
What has Changed under the WF?Continue Reading The Implications of the Windsor Framework
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 UK government has proposed legislation to open the way for gene‑edited food products in England. The Genetic Technology (Precision Breeding) Bill (“Precision Breeding Bill”) sets out a new regulatory regime that may provide a faster and easier path to market for certain gene-edited plants, animals and derived products.Continue Reading UK Draft Bill Permits ‘Precision Bred’ Gene-Edited Plants, Animals and Products