《Sedgwick:2024年美国产品安全及召回报告(英文版)(63页).pdf》由会员分享,可在线阅读,更多相关《Sedgwick:2024年美国产品安全及召回报告(英文版)(63页).pdf(63页珍藏版)》请在三个皮匠报告上搜索。
1、DATA,TRENDS&PREDICTIONS FOR EUROPEAN INDUSTRIESPRODUCT SAFETY AND RECALLE UROP E A N E DI T IONSTATE OF THENATION 2024The Sedgwick brand protection Recall Index is the leading resource for manufacturers,suppliers,and retailers seeking an unbiased,informed perspective on past and present trends and p
2、redictions for whats next in product safety and product recalls.It is an indispensable tool for strategic planning and risk mitigation.The European report reviews five product categories and three sub-categories:Automotive,Food and Beverage,Pharmaceutical,Medical Device,and Consumer Product includin
3、g Electronics,Clothing,and Toys.It analyses data from regulators across Europe,including the UK and the European Union,to provide businesses with unique insights and exclusive market-leading commentary on matters of product safety essential to their operations.This edition brings you a year-in-revie
4、w of 2023 to showcase the state of the nation.It also includes a more detailed breakdown of recall data and regulatory activity from the fourth quarter of 2023,October 1 December 31.The total number of recalls in the UK and EU across all the categories we monitor has been consistently rising over th
5、e past nine years.It hit a new record in 2023 with 12,498 events.That represents an increase of 18.5%compared to 2022,and 23.6%compared to 2021.Looking at quarterly data,2023 had the four highest quarters for recall activity in the past ten years.Quarters two,three and four each recorded more than 3
6、,000 recalls,with quarter one falling just short with 2,919.For context,the average number of recall events per quarter in 2023 was just 2,636.The Food and Drink,Medical Device,Pharmaceutical,Electronics,and Clothing industries all experienced an uplift in recall activity in 2023 compared to 2022.Wi
7、th the exception of Pharmaceutical,each of these sectors recorded ten-year highs.And while the Automotive sector saw fewer recalls than it did in 2022,2023 still represented the second-highest total in the past 10 years.As we have seen since the introduction of the European Green Deal in 2020 and ot
8、her related measures that have followedincluding the Circular Economy Action Plan and the Fit for 55 progammeregulators across all industries are actively thinking about environmental concerns.That is seen through proposals to lower emissions and prevent false“greenwashing”claims in both the UK and
9、EU.There are also continued efforts to extend producer responsibilities for waste disposal and packaging materials,encouraging companies to recycle instead of disposing of defective or extra products.One such measure currently pending in the EU will ban manufacturers from destroying unsold footwear
10、and textiles.Regulating online marketplaces is also a priority for officials in the UK and EU.Both jurisdictions are developing safeguards to keep counterfeit products out of e-commerce marketplaces and place more accountability on third-party sellers.Another area that has the attention of regulator
11、s is artificial intelligence and machine learning(AI/ML).The UK has proposed a business-friendly approach to AI governance that allows industries to develop their own rules instead of instituting broad cross-sector regulations.Conversely,the EU is using a risk-based method that will apply to both de
12、velopers and deployers of AI technology with requirements for transparency when these tools are used.Patient safety continues to be a focus of regulators as well,whether it is ensuring there are no disruptions of supplies for critical medicines,streamlining regulatory approvals for new medications,o
13、r authorising and overseeing the use of software as a medical device(SaMD)and artificial intelligence as a medical device(AIaMD).As a reminder,this edition of the Recall Index report focuses on European Union and UK recall data and regulatory developments.If your operations or supply chain include t
14、he U.S.,we encourage you to review our U.S.Recall Index.That edition shares and analyses data and regulatory trends from the U.S.Consumer Product Safety Commission(CPSC),the U.S.Food and Drug Administration(FDA),the U.S.National Highway Traffic Safety Administration(NHTSA),and the U.S.Department of
15、Agriculture(USDA).Like this edition,it also includes unique perspectives from our strategic U.S.partners.U.S.edition available here:click hereIf you would like more information about what we have observed in recent quarters,you can find previous editions of the European Recall Index below:Q3 2023 Eu
16、ropean Recall Index:click hereQ2 2023 European Recall Index:click hereQ1 2023 European Recall Index:click hereQ4 2022 European Recall Index:click hereSTATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries3C O N T E N T SState of the nation 20246SUMMARY14AUTOMOTIV
17、E27FOOD AND BEVERAGE42PHARMACEUTICAL55MEDICAL DEVICE68CONSUMER PRODUCTS79CONSUMER PRODUCTS:ELECTRONICS94CONSUMER PRODUCTS:TOYS107CONSUMER PRODUCTS:CLOTHING122CONCLUSION123ABOUT SEDGWICK BRAND PROTECTIONSTATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries5SUMMAR
18、YThere were multiple regulations that moved forward in 2023 that,once enacted,will have implications across many sectors.The EUs Artificial Intelligence Act(AI Act)and the Cyber Resilience Act(CRA)were provisionally approved by the European Parliament and the European Council at the end of the year.
19、A ban on AI systems that are determined to pose an“unacceptable risk”could take effect within six months of final approval of the rule.The UKs Competition and Markets Authority(CMA)published its initial review of foundation models(FMs)in September.In its report,the CMA recommended seven key principl
20、es for companies to follow when using these models to develop AI systems.However,the UK has said that it is not planning any specific AI regulations in the short term.It wants to promote innovation and empower specific sectors to decide what oversight is appropriate for their industry.A range of leg
21、islation around environmental protection and sustainability also advanced in 2023.One of these is the EUs Batteries Regulation,which went into force in August.It includes specific requirements for labelling,conformity assessments,and raw materials due diligence for batteries,among other obligations.
22、It will impact the automotive industry and consumer goods in particular.The EU is also working to finalise its Waste Framework Directive,which sets legally-binding food waste reduction targets to be achieved by Member States by 2030.Food processors and manufacturers will be affected,as well as resta
23、urants,food services,and households.The measure also applies to paper,metal,plastic,and glass waste,and an amendment was added in 2023 that specifically targets textile waste and extends textile producers responsibilities to the full product lifecycle.Another cross-industry waste regulation is the E
24、Us revised Packaging and Packaging Waste Directive.Toys and consumer goods will have new obligations.There are new provisions for food service companies as well since takeaway containers are covered in the regulations.Transport packaging for online distributors will also be regulated.Both the Europe
25、an Parliament and the European Council adopted versions of the directive in the fourth quarter,but there remains some differences still to work out.With new regulations set to make operations more sustainable,regulators are also increasing their oversight to ensure companies are not making false cla
26、ims about the environmental impact of their products and operations.In 2023,the UKs Advertising Standards Authority(ASA)launched a new rule,and the UKs Committees of Advertising Practice(CAP)and Broadcast Committee of Advertising Practice(BCAP)released new guidelines calling for advertisers to be tr
27、ansparent,substantiate any environmental claims,and provide proper context for statements.The UKs Competition and Markets Authority(CMA)also launched several greenwashing investigations across several industries including“fast-moving consumer goods”(FMCG)such as perishable and non-perishable food an
28、d drink,cleaning products,homecare products,and personal care items.In the EU,the final plenary vote on the rule to ban greenwashing is expected in Parliament in early 2024.Member states will have 24 months to incorporate the new rules into their law once the regulation is in force.One regulation th
29、at has been delayed is the UKs move to a UK conformity assessment mark(UKCA)in place of the EUs CE mark for products sold on the UK market.Companies were required to change by December 2024,but the UK Department for Business and Trade(DBT)said it would“indefinitely extend”the use of the EUs conformi
30、ty mark.For consumer product manufacturers and marketers producing or selling goods in the EU,the full text of the new European General Product Safety Regulation(GPSR)was published in May and will go into force on 13 December 2024.The GPSR provides the basic rules for product safety that must be fol
31、lowed to be permitted on the EU market.The new regulation puts additional obligations on online marketplaces to report product-related accidents and mandates that incidents that cause death or serious health effects are reported quickly,among other responsibilities.In recognition of the consumer ris
32、ks with online sales,the UKs Office for Product Safety and Standards(OPSS)launched a product safety campaign in March 2023 urging consumers to be cautious when buying products from online platforms.Regulators across the UK and EU are trying to protect consumers from risks of new technologies whether
33、 those are AI or e-commerce marketplaces.They are also trying to ensure that companies are doing their part to protect the environment and be accountable for the full lifecycle of the products they make or distribute.While these are admirable goals,they place heavy burdens on companies to comply.Her
34、e are some of the highlights for the year:Automotive In March,EU Member States gave final approval to a law that requires all new cars sold to have zero CO2 emissions starting in 2035.It also mandates 55%lower CO2 emissions from 2030 compared to 2021 levels as part of the EUs“Fit for 55”initiative.H
35、owever,the European Parliament and European Council weakened nitrous oxide emission standards for trucks and delayed the effective date for the new rules that are part of Euro 7,the EU rules for type-approval and market surveillance of motor vehicles.While automakers supported the changes,they voice
36、d concerns that the regulations are still overly burdensome.UK regulators also delayed some of their emissions controls.In September,the government said its ban on new diesel and petrol cars would take effect in 2035 instead of the original date of 2030.The European Commissions Vehicle General Safet
37、y Regulation started applying on 6 July 2023.The rule requires certain advanced driver assistant systems(ADAS)for new vehicles and puts in place a framework for the approval of automated and fully-driverless vehicles in the EU.In keeping with other actions to support waste management and sustainable
38、 practices,in July the European Commission published its proposal to increase the automotive industrys circularity.Included in the plan are requirements for the use of recycled plastic in new vehicles,goals to recycle plastics from end-of-life vehicles,and inspections and digital tracking to ensure
39、end-of-life vehicles are disposed of properly.Even with the delay of some emissions rules,automakers are facing significant changes to their production and sourcing to make the move from combustion-engine vehicles to low-and zero-emissions cars and trucks.Increased environmental controls and the add
40、ition of new technologies such as ADAS only add to the challenges for an industry that is already highly regulated.For a more in-depth analysis of the automotive sector in 2023,and our predictions for the remainder of 2024,click here.STATE OF THE NATION 2024|Product Recall Data,Trends and Prediction
41、s for European Industries7Food and beverage One of the top issues for the food and beverage industry in 2023 was food fraud and its impact on consumer trust and the integrity of the food supply chain.Both the UKs Food Standards Agency(FSA)and the European Commission took actions to prioritise tracea
42、bility systems and promote collaboration to ensure product authenticity and uphold consumer confidence.Consumer protection through accurate food labelling is also a concern.The UKs FSA and Food and Drink Federation both released guidances in September to reduce exposure to intentional and unintentio
43、nal allergens in the food system.Packaging was another priority that has a sizable impact on food producers and distributors.In addition to the EUs waste regulations,the UKs Department for Environment,Food,and Rural Affairs(Defra)has developed a new Extended Producer Responsibility(EPR)system.The ru
44、le applies to companies that supply packaged goods to the UK market under their own brand,place goods into unbranded packaging,import products in packaging,own an online marketplace,hire or loan out reusable packaging,or supply empty packaging.Defra announced a delay in the enforcement date for the
45、EPR requirements from October 2024 to October 2025.This is good news for companies in the food sector who have to make adjustments to comply.The UKs ban on single-use plastic took effect in October and impacts many food service operators.UK regulators are also evaluating current rules around food co
46、ntact materials,which may result in more changes for the food sector.Many of the new environmental regulations place an especially heavy burden on the food and beverage industry.Producers,packers,and distributors will have to work closely to ensure they are in compliance.For a more in-depth analysis
47、 of the food and beverage sector in 2023,and our predictions for the remainder of 2024,click here.PharmaceuticalIn April,the European Commission adopted a proposal for a new Pharmaceutical Directive and Pharmaceutical Regulation,which revise and replace the existing general legislation.The proposed
48、Pharmaceutical Strategy for Europe is the largest reform in more than 20 years.The strategy is designed to make medicines more available,accessible,and affordable.It also aims to improve innovation and competitiveness for the EU pharmaceutical sector and promote higher environmental standards for ma
49、nufacturing that align with the European Green Deals objectives.Industry trade groups such as the European Federation of Pharmaceutical Industries and Associations(EFPIA)have said some of the measures would harm the EUs pharmaceutical sector.In an effort to make medicinal products available to UK ci
50、tizens more quickly,the UKs Medicines and Healthcare products Regulatory Agency(MHRA)is developing an International Recognition Procedure(IRP).The IRP would fast-track UK approval for products already approved by one of seven reference regulators from another jurisdiction including the EU,the United
51、 States,and Japan.Taking lessons learned during the COVID-19 pandemic,EU regulators are working proactively to prevent shortages of key antibiotics and other critical medicines.The European Commission,European Medicines Agency(EMA),and Heads of Medicines Agencies(HMA)accomplished several tasks in th
52、e fourth quarter including developing a European Union list of critical medicines.There are also more actions planned for the coming year to prevent supply chain disruptions.Like other industries,the pharmaceutical sector is evaluating use of artificial intelligence and machine learning(AI/ML).In Ju
53、ly,the EMA published a draft reflection paper to gather input from stakeholders about the risks and benefits of AI/ML across different stages of the pharmaceutical product lifecycle.As with other industries,the pharmaceutical sector will need to walk the fine line between embracing innovation and en
54、suring new technologies have been thoroughly vetted to protect consumers.For a more in-depth analysis of the pharmaceutical sector in 2023,and our predictions for the remainder of 2024,click here.Medical devicesAfter its instruction in 2017,the EU Medical Devices Regulation(MDR)and In Vitro Diagnost
55、ic Medical Devices Regulation(IVDR)entered into force on 20 March 2023.However,the transition periods for devices certified under the previous rules have been extended several times to prevent shortages while the industry and regulators work to adapt to the new laws.In 2023,the UKs Medicines and Hea
56、lthcare products Regulatory Agency(MHRA)also published updates to its medical device regulations,including provisions for registering devices in the UK that are considered valid under the EUs MDR transitional arrangements,even if the products current conformity assessment(CE)certificate is expired.B
57、oth the EU and UK are clarifying and refining their clinical trials regulations for medical devices and medicines.Changes include considerations for single-arm clinical trials(SATs)to support marketing authorisation applications and guidances around the EUs Clinical Trial Regulation(CTR).The medical
58、 device industry is also working to realise the benefits of new technology without sacrificing patient safety.The MHRA published guidances in April and May about its role in authorising and overseeing the use of software as a medical device(SaMD)and artificial intelligence as a medical device(AIaMD)
59、,as well as how to report adverse incidents.Due to the risk to patient,there will always be considerable oversight for medical devices.Regulators do seem to be somewhat understanding of the challenges for manufacturers and distributors,as evidenced by the delays in enforcing many of the new rules.Fo
60、r a more in-depth analysis of the medical device sector in 2023,and our predictions for the remainder of 2024,click here.Consumer products The consumer products industry saw a considerable amount of comprehensive regulatory activity in 2023.The European Parliament and European Council came to a prov
61、isional agreement on the Ecodesign for Sustainable Products Regulation(ESPR),which is part of the EUs Circular Economy Action Plan under the European Green Deal.Under the rule,companies will need to comply with broad performance and information requirements related to their products environmental im
62、pact.Metrics for reliability,repairability,energy efficiency,recycled content,and other factors will be evaluated.The measure will hit the textile industry particularly hard because it includes a ban on the destruction of textile products such as clothing,footwear,and accessories.Consumer product co
63、mpanies also face more legal risk from the EU Representative Actions Directive(Directive 2020/1828).The rule went into force in June and harmonises the class action regimes across the 27 EU Member States.Another regulation that adds risk for companies is the revised EU Product Liability Directive(PL
64、D),which received provisional approval from the European Parliament and the European Council in December.Under the PLD,consumers who suffer damage from a product can claim compensation from the marketer of the product.The updated regulation also adds protections from software and artificial intellig
65、ence(AI)in products and the use of online marketplaces.New regulations for online marketplaces went into force in June with the EU General Product Safety Regulation(GPSR),which expands liability and responsibility for online sellers by requiring stakeholders to consider interconnectivity in product
66、safety assessments,mandating accident reporting,and improving product traceability,among other measures.UK regulators are also expanding consumer protections online with the proposed Digital Markets,Competition and Consumers Bill,which gives the Competition and Market Authority(CMA)more power and re
67、sources.It also sets specific obligations to ensure trust and transparency,fair dealing,and open choice from large digital companies.STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries9As companies face increased liability and expanded accountability,it will b
68、e important for them to stay up-to-date with how the various rules build on each other.They must also evaluate if any partner and vendor agreements need to be revised.For a more in-depth analysis of the consumer product sector in 2023,and our predictions for the remainder of 2024,click here.Electron
69、ics The electronics industry will need to find ways to adapt to the new regulations around the use of artificial intelligence,the requirements for batteries,and initiatives involving waste,packaging,and recycling.Another proposal that will change the way much of the sector operates is the EUs right
70、to repair bill.The rule addresses challenges for consumers created by inconvenience,lack of transparency,or difficulty accessing repair services.Its aim is to encourage consumers to repair products instead of disposing of damaged but repairable goods.Many electronics manufacturers,especially mobile
71、phone makers,have a reputation for making their products difficult for third parties to repair.The right to repair bill would prohibit that.Electronics products are also affected by the UKs Product Security and Telecommunications Infrastructure Act(PSTI Act),which became law in December 2022 and set
72、s mandatory security requirements for consumer products that connect to the Internet.The Security Requirements for Relevant Connectable Products were published in April 2023,and the regime enters into effect on 29 April 2024.The quickly evolving nature of technology makes it difficult for regulators
73、 to keep up with innovations.That puts additional pressure on electronics companies to ensure they are thoughtful in the development and deployment of new products.For a more in-depth analysis of the electronics sector in 2023,and our predictions for the remainder of 2024,click here.Toys The UKs Off
74、ice for Product Safety and Standards(OPSS)launched a product safety campaign in March 2023 to encourage consumers to be wary when buying products from online platforms.In August,the agency published its Smarter Regulation:UK Product Safety Review consultation,a plan for a comprehensive regulatory ov
75、erhaul.It contains 13 different proposals to offer flexible,business-friendly standards.Both of these initiatives would apply across sectors,but product safety is particularly relevant in the toy sector as a way to protect children.The European Commission published its proposed Toy Safety Regulation
76、 for comment in July.Some of the changes from the current Toy Safety Directive include a Digital Product Passport for toys and measures to reduce exposure to harmful chemicals.The regulation would also reinforce other EU regulations around batteries,labelling,and online sales.The feedback period end
77、ed in October and the Commission is reviewing the input.Another cross-industry change is the EUs new Geographical Indication protections for craft and industrial products.Toys and other products such as lace,wool clothing,and crystal will have similar protections to those already in place for many a
78、gricultural products and spirits.The goal is to support the economies of various regions and promote interest in heritage craft traditions while also giving consumers confidence that they are buying authentic products.Several other broad regulations will have consequences for the toy industry includ
79、ing rules around batteries,waste,packaging,and ecodesign requirements.Manufacturers can expect strict oversight since the safety of children is always a priority.For a more in-depth analysis of the toys sector in 2023,and our predictions for the remainder of 2024,click here.STATE OF THE NATION 2024|
80、Product Recall Data,Trends and Predictions for European Industries11Clothing Several of the regulations that support the European Green Deal will place a considerable burden on the clothing industry,including the European Parliaments recommendations for an EU strategy for sustainable and circular te
81、xtiles.The proposed rules will affect the entire supply chain and force more cooperations from sourcing to sales.These changes have led to more collaboration across the industry including the formation of a new fashion programme to support and guide the creation of a circular fashion ecosystem in th
82、e UK.In addition to the Waste Framework Directive and Ecodesign for Sustainable Products Regulation(ESPR),which have specific provisions targeting textile companies,there are two other EU-wide rules that will significantly affect the industry.The first is the European Unions Deforestation Regulation
83、(Regulation(EU)2023/1115),which came into force in June with restrictions on the use of rubber and leather.The second rule is the proposed EU ban on all products made with forced labour,which was approved by the relevant committees in Parliament in October.The clothing industry is likely to be desig
84、nated a“high risk”sector,adding additional burdens to show forced labour has not been used in making products.Another move that could cause sourcing and production problems for clothing makers is the European Chemicals Agencys proposed ban on approximately 10,000 perfluoroalkyl and polyfluoroalkyl s
85、ubstances,or PFAS.These chemicals are commonly used in the fashion sector to provide stain resistance,waterproofing,and other functionality.If the ban is implemented,producers would have to find alternatives in order to provide the features many consumers want.While many of the environmental changes
86、 regulators are calling for will be hard for many industries,it seems that the clothing and textile industry will be forced to make some of the most costly and comprehensive adjustments.For a more in-depth analysis of the clothing sector in 2023,and our predictions for the remainder of 2024,click he
87、re.STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries13Activity in the automotive sector across the UK and EU in the fourth quarter of 2023 was consistent with priorities throughout the year.Many stakeholders were focused on the transition to self-driving car
88、s and zero-emissions vehicles.In the UK,King Charles laid out the governments plan for the safe use of automated vehicles and the UK Parliament has a draft bill under consideration.In the EU,the European Parliament and European Council have adopted changes to Euro 7,the EU rules for type-approval an
89、d market surveillance of motor vehicles.Trilogue discussions have begun among the three main EU legislative bodies.The version agreed upon by Parliament and the Council weakened nitrous oxide emission standards for trucks and delayed the effective date for the new rules.These changes frustrated envi
90、ronmental groups and pleased automakers,though manufacturers still feel the rules are onerous.One tool that may help the automotive industry comply with the Euro 7 rules is a new type of battery.Companies are developing sodium-ion batteries that would be safer,more cost-effective,and more sustainabl
91、e than batteries currently on the market.The batteries do not rely on scarce raw materials such as lithium,nickel,cobalt,and graphite.It will likely be several years before this type of battery has the power needed for the automotive industry and gains regulatory approval,but it is a promising innov
92、ation.We can expect to see continued progress on issues related to electric vehicles and automated vehicles throughout 2024,though the specific challenges are less certain.Automakers and suppliers will need to be flexible with changing deadlines and requirements.AUTOMOTIVEAmidst evolving automotive
93、regulations,the pursuit of safer and more sustainable technologies,like sodium-ion batteries,emerges as a promising solution for automakers.”STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries15King Charles vision for the UKs self-driving future not only sets
94、strict safety standards but shifts liability from users to companies,fostering innovation and investment with legal clarity.”The Kings Speech promotes self-driving vehicles Deploying self-driving or automated vehicles(AVs)will be a priority in the UK in 2024.The Kings Speech,delivered by King Charle
95、s on 7 November 2023 as part of the State Opening of Parliament,shared an ambitious plan for AVs.The next day,the UK Parliament introduced the Automated Vehicles Bill(the AV Bill)designed to facilitate and regulate the safe implementation of self-driving vehicles.In addition to providing safety stan
96、dards,it also offers legal certainty to automakers in an effort to encourage further research and investment.The bill had its second reading in the House of Lords in late November before moving into the committee phase.Attorneys with Akin Gump Strauss Hauer&Feld LLP called the draft bill“one of the
97、most comprehensive regulatory frameworks for self-driving vehicles globally.”It is aimed at providing legal certainty and unlocking business confidence for further research,innovation,and investment.A number of stakeholders provided input during the public comment period including original equipment
98、 manufacturers,automated driving systems developers,fleet operators,insurance providers,safety and road user groups,academics,and professional organisations.As we have seen with the UKs approach to regulating artificial intelligence(AI),regulators seem to be taking a business-friendly attitude with
99、the AV Bill to ensure there is some flexibility in light of the rapidly changing technology involved.The draft is not overly prescriptive in how companies should meet the requirements.The legal experts highlight five of the main provisions of the proposed bill:1)the definition of a self-driving vehi
100、cle;2)a rigorous safety framework with ongoing obligations for companies including the need to keep vehicles safe and to report safety-related data governed by an overarching“Statement of Safety Principles;”3)clear liability for incidents involving automated vehicles;4)creating a central digital map
101、 with local speed limits,road closures,and other information that can be accessed by the automated vehicles;and 5)only allowing the use of“self-driving”in marketing of vehicles that meet the required safety threshold set out in the AV Bill.The new rule will also set sanctions and penalties,including
102、 fines,requirements to take corrective action,suspension of operation,and criminal offenses for events in which self-driving cars are involved.However,it also states that people will have immunity from prosecution when a self-driving vehicle is driving itself.A review of the proposal by attorneys wi
103、th Borden Ladner Gervais LLP stated that when the self-driving feature is engaged,the human in the vehicle is not responsible for controlling steering,accelerating,braking,signalling,or monitoring the driving environment.This means they would have immunity from serious road traffic offences and coul
104、d not be held liable for criminal offences which arise from self-driving activities.Drivers,or users-in-charge,will still be liable for ensuring the vehicles are roadworthy and properly insured.Under the bill,the legal responsibility for self-driving vehicles shifts away from the human user and towa
105、rd the companies developing and operating such vehicles.Liability for road traffic offences that occur when the self-driving feature is engaged will fall on the authorised self-driving entities and the relevant“no-user-in-charge”operators.These provisions mean that companies will need to ensure that
106、 they are meeting the safety requirements,have reviewed their adverse event response plans,and have updated any liability insurance so that they are protected.This will be particularly important in the early stages of deployment while there is still so much to learn about how the vehicles respond on
107、 public roads.STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries17Sodium-ion batteries do not rely on scarce raw materials.This means automakers in Europe could reduce their dependency on foreign materials and create more diverse supply chains.”Auto industry
108、gets support on pollution regulationsIn October,the European Parliaments Committee on the Environment,Public Health,and Food Safety(ENVI)adopted its proposals to update Euro 7,the EU rules for type-approval and market surveillance of motor vehicles.The measures will lower pollutant emissions standar
109、ds including those for nitrogen oxides,particulate matter,and carbon monoxide,and set battery durability requirements for passenger cars,vans,buses,and trucks.According to a statement from Parliament,the proposed rules would also implement an updated environmental vehicle passport(EVP)with informati
110、on about fuel consumption,battery health,emissions limits,and periodic technical inspections results;stricter lifetime requirements for vehicles,engines,and pollution control systems;an obligation to install on-board systems for monitoring certain parameters including excess exhaust emissions and re
111、al-world fuel consumption;and specific rules for small and ultra-small volume manufacturers.The draft text looks at limits for brake particle emissions and tyre abrasion rates and works to align them with international standards currently being developed by the United Nations Economic Commission for
112、 Europe.The new benchmarks would apply to all types of vehicles,including zero-emission cars and trucks.A report in Automotive News Europe described the version of the Euro 7 proposal adopted by Parliament as weaker than the original draft.The European Council agreed to the same version,which does n
113、ot raise the pollution limits for cars from those in Euro 6.However,it weakens nitrous oxide emissions for trucks and delays the effective date for the new rules to three years from the date that all the secondary legislation associated with the proposal is passed.Originally the European Commission
114、had wanted the Euro 7 rules to apply from 2025.The European Automobile Manufacturers Association(ACEA)called the changes adopted by the European Parliament“a more realistic approach”but said the automakers are still facing a“heavy price tag”and will need to make significant investments to comply wit
115、h Euro 7.ACEA Director General,Sigrid de Vries,noted that these changes are coming when the industry is already dealing with geopolitical and economic issues such as higher energy prices,supply chain shortages,inflation,and low consumer demand.De Vries called for a balance between environmental conc
116、erns and industrial competitiveness.After its adoption by Parliament,the proposal moved to trilogue negotiations among Parliament,the Commission,and the European Council to reach a provisional agreement.Automakers should follow the discussions carefully to see if any more changes are made to the sta
117、ndards or the timeline.Industry explores alternative to lithium-ion batteriesOne of the biggest challenges for automakers as they move toward zero-emissions electric vehicles is the shortage of reliable and available partsfrom semiconductor chips to lithium-ion batteries.There have also been documen
118、ted safety concerns about the risk of battery fires.The automotive industry is carefully following the development of alternatives,including sodium-ion batteries.A press release from one of the leading sodium-ion battery manufacturers claims its products are safer,more cost-effective,and more sustai
119、nable than conventional nickel,manganese,and cobalt (NMC)or iron phosphate(LFP)chemistries.As the EU moves forward with its proposed ban on forced labour,producing batteries that do not contain components such as lithium,nickel,cobalt,and graphite that are often mined in harsh conditions,will offer
120、another advantage.The company said that its first generation of sodium-ion cell is designed primarily for energy storage,and it does not yet have products with the higher energy density required to power electric vehicles.However,the company already has several major car makers as investors and cust
121、omers,according to an article in The Guardian.The Guardian reported that the sodium-ion batteries do not rely on scarce raw materials that are currently often sourced from China.This means automakers in Europe and other regions could reduce their dependency on foreign materials and create more diver
122、se supply chains.It may be some time before sodium-ion batteries have sufficient power to be used in cars and be produced widely enough to be affordable.There will also need to be strenuous testing done before regulators will approve them for use in automobiles.This illustrates some of the many chal
123、lenges facing manufacturers as they try to meet the growing regulatory and consumer demands for lower emission vehicles.STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries19BY THE NUMBERSLooking at quarterly data,there was a 51.2%decrease in automotive recalls
124、 across the EU and UK from Q3 to Q4 2023.The number of events declined from 217 to 106.This sharp decline played a significant role in the overall decrease observed throughout the year.There were 84 recalls tied to injuries in Q4 2023,reflecting a 48.8%decrease from the 164 reported in the previous
125、quarter.Fire risk was the second-most common cause for recalls,linked to 10 events.Environment was third and was cited in six recalls.Passenger cars were the most common product category recalled in Q4 2023 with 75 events,a significant decrease from the 147 recalled in the previous quarter.Motorcycl
126、es were the second-most-recalled product with five events,though there were also two recalls for spare motorcycle parts.Germany issued the most notifications in Q4 with 44,down from 68 in Q3.The UK had the second-most with 22,77.1%fewer than last quarter.France submitted 20 alerts in Q4 2023,putting
127、 it in third place.Despite the total number of European automotive recall events declining 3.3%in 2023(from 752 in 2022 to 727),it remained the second-highest number of recalls in the last 10 years.Moreover,2023 was the only year to have two quarters with more than 200 recall events(Q2 with 214,and
128、Q3 with 217).Despite the prominence of Injury risks,Fire related events reached record-breaking levels in 2023(accounting for 19.9%of annual recalls).Injuries was the leading cause of European recall events in 2023,accounting for 546(or 75.1%).This decline was largely attributed to Q4 2023 which saw
129、 106 recalls.Only 2 quarters in the last 5 years have recorded fewer events(Q4 2020 and Q4 2021).European automotive recall events fell 3.3%,from 752 in 2022,to 727 in 2023.This was followed by France and Portugal with 72(9.6%)and 26(3.5%)notifications respectively.The UK and Germany dominated annua
130、l recall notifications,accounting for 40.4%and 34.3%respectively.40.4%34.3%72720233.3%RECALLS AHEADRECALLS BY NOTIFYING COUNTRY IN Q40United KingdomGermanyFranceBelgium4030201050PortugalNUMBER OF EVENTS BY RISK TYPE IN Q40FireInjuriesEnvironmentEnvironment,Fire8512963Fire,InjuriesSTATE OF THE NATION
131、 2024|Product Recall Data,Trends and Predictions for European Industries21THE DRIVE FOR INNOVATION BRINGS NEW REGULATIONS FOR THE AUTO INDUSTRYThe strength of supply chains,vehicle safety,environmental issues,and accessibility are some of the concerns at the forefront of regulators minds.The previou
132、s year has notably seen additional targets for zero-emission vehicles and initial moves to legislate for the use of automated vehicles.We predict that the development of a charging infrastructure for electric vehicles(EVs)and trials of micromobility products will be among the challenges to watch out
133、 for in the year to come.Targets for zero-emission vehicles The EU and UK recognize that the way vehicles are powered is changing.Last year both jurisdictions took important steps towards zero-emission mobility.In March 2023,EU Member States adopted the Commissions proposal to make all new cars and
134、vans registered in the EU zero-emission from 2035.This milestone marked the first step in the adoption of the“Fit for 55”legislative proposals presented by the Commission as part of the European Green Deal.New technologies and trends in the automotive industry mean that the regulatory frameworks for
135、 vehicles are changing radically.EU and UK regulators are keen to embrace transport choices that provide safer and greener ways of moving around.While these innovations have the potential to deliver significant benefits,they also give rise to potential challenges.LEO FIELDING,SENIOR COUNSEL,SHOOK,HA
136、RDY&BACON INTERNATIONAL LLPIn September 2023,the UK prime minister confirmed that the government intends to introduce its new zero-emission vehicle(ZEV)mandate for new cars and vans from January 2024.The ZEV mandate will set annual minimum targets for the number of new zero-emission cars and vans so
137、ld in the UK.The standards will start from 22%for cars and 10%for vans in 2024 and rise steadily to reach 80%for cars and 70%for vans by 2030 and 100%for cars and vans by 2035.To accommodate this rapid transition to electric vehicles,manufacturers across the EU and UK will face significant challenge
138、s in restructuring their manufacturing processes.They will need to make substantial changes to their assembly lines,supply chains,and workforce training.Securing access to the relevant raw materials for batteries such as lithium,cobalt,and nickel in sufficient quantities to hit production targets wi
139、ll be another major hurdle for a number of manufacturers.Charging networks for electric vehiclesIn 2024 we can expect to see continued expansion in the networks of charging points for EVs across the EU and UK.In the EU,the growth of the EV charging infrastructure is surging,whether analyzed by insta
140、lled capacity or the number of charging points.According to reports from ChargeUp Europe,the installed public charging capacity in EU Member States is forecast to increase nine-fold by 2030.However,the spread across the EU is uneven,with certain markets such as the Netherlands,Germany,and France acc
141、ounting for the majority of this expansion.Latvia,Lithuania,Estonia,and other Member States are seeing much smaller increases.This disparity highlights concerns around the deepening of a two-speed Europe divide over time.The EU agreement on the Alternative Fuels Infrastructure Regulation that establ
142、ishes a minimum floor for the deployment of infrastructure is a step in the right direction.However,further action will be needed to address this issue.In the UK,a 70 million UK pilot scheme was launched on 6 December 2023 for EV charging points.It is focused on motorway service areas,which are stra
143、tegically important as regularly-spaced stopping points along the motorway.Speaking at COP28,UK Transport Secretary Mark Harper laid out plans for up to 10 trial sites in England with boosted electrical network capacity to ensure that the sites are future-proofed to at least 2035 to meet growing dem
144、and.Secretary Harpers announcement is part of the governments rapid charging fund which is designed to accelerate the automotive industrys own investments in transport decarbonisation.Access to a comprehensive ultra-rapid(150kW+)charging point network should increase consumer confidence in the avail
145、ability of an enroute charging infrastructure.Concerns about“range anxiety”have been raised by numerous consumer studies.Consumers worry an EV will run out of charge,and that fear has been a key barrier to purchasing and using EVs for long-distance journeys.As demand for EV charging increases over t
146、ime,it will be more and more important for charging point equipment manufacturers and operators,fleet providers,motorway service areas,and electricity suppliers to work together on arrangements for the roll-out of charging point networks.One challenge will be keeping costs affordable for the sites,p
147、articularly the cost of a grid connection and the ongoing costs of unused network capacity.UK motors ahead with regulating automated vehiclesGovernments must continue to proactively grow public The past year has been busy for automated vehicles as new and far-reaching regulation started to work its
148、way through the UK Parliament.The Automated Vehicles Bill(AV Bill),announced in the Kings Speech in November 2023,implements the recommendations contained within the 2022 joint report by the Law Commission of England and Wales and the Scottish Law Commission(the Law Commissions).STATE OF THE NATION
149、2024|Product Recall Data,Trends and Predictions for European Industries23The AV Bill makes provisions for new legal entities responsible for the safety of self-driving systems.It also creates a new legal status for a driver who has handed control of a vehicle to a self-driving system.The Kings Speec
150、h identified three aims of the regulation:creation of a rigorous safety framework,ensuring clear legal liability,and consumer protection.These goals are expected to be achieved by the following means:Safety frameworkThe UK Department for Transport and its agencies will be given new powers to authori
151、se self-driving vehicles and ensure in-use compliance with the safety standards.Companies will have to meet safety requirements from the point a vehicle is introduced onto the road.Otherwise,they will face new sanctions and penalties such as fines,requirements to take corrective action,and suspensio
152、n of operation.Criminal offences will apply in serious cases.The AV Bill sets out new processes to investigate incidents involving self-driving vehicles to ensure that lessons are fed back into the safety framework.Legal liabilityOnce authorised,companies will have ongoing obligations to keep their
153、vehicles safe and ensure that they continue to drive in accordance with British laws.They will be required to report certain safety-related data to the authorisation authority and the in-use regulator.Companies must also comply with other relevant laws,including data protection and environmental pro
154、tection legislation.When a vehicle is in self-driving mode,users will be immune from prosecution for the way it drives.Non-driving responsibilities will remain with the user,such as maintaining appropriate insurance for the vehicle and ensuring proper loading.They will also be responsible for any pa
155、rt of the journey where the person is in control of the vehicle.Consumer protectionThe AV Bill prohibits misleading marketing of AVs.Only vehicles that meet the safety threshold can be marketed as self-driving.Companies cannot make claims that vehicles are self-driving if they dont meet these criter
156、ia.The AV Bill itself is currently at the Committee Stage in the UK House of Lords.However,the UK Government is still moving ahead to develop,consult on,and table core statutory instruments and statutory guidance from 2024 through to 2026.These activities will be subject to government priorities and
157、 Parliamentary time.As the secondary legislation is developed,it will be critical for industry representatives to continue to engage with Parliament and other stakeholders on the technical details.It will also be interesting to see whether the European Commission will take its cue from the debate ta
158、king place in the UK and propose equivalent measures or develop a completely different regime.Micromobility/e-scooters The year ahead is looking like an exciting time for micromobility products as UK regulation governing electric scooters,or e-scooters,is expected to zip forward.In a recent governme
159、nt consultation,the general view was that,with the right regulatory framework,micromobility vehicles could offer significant benefits,particularly for last-mile connections in urban areas.However,there was relatively little robust evidence available as e-scooter use remained a relatively new phenome
160、non.LEO FIELDING,SENIOR COUNSEL,SHOOK,HARDY&BACON INTERNATIONAL LLP CONTINUED FROM PREVIOUS PAGEE-scooter trials are expected to continue to run across the UK until 31 May 2024.These trials launched 4 years ago in 2020 but the deadline for completion was extended numerous times in part due to the CO
161、VID-19 pandemic.After the 31 May deadline,the Department for Transport is expected to publish a report with significant research and data points.The impact of rental e-scooters on the demand for travel by car,walking,cycling,and public transport,and the extent to which any mode shift could be realis
162、ed by users switching trips to rental e-scooters,will be assessed based on the trial data.Some initial changes are already underway.From 5 December 2023,a new licence validation procedure applies under which members of e-scooter rental trials must provide certain additional information including the
163、ir name,driving licence number,and a photograph of the front of their driving licence.Rental fleet operators are also required to ensure they have robust systems in place for capturing and storing this additional information.More widely,we will need to wait and see if the divergent regulations intro
164、duced by several cities and regions in the EU will eventually be implemented within a single EU horizontal framework.The road aheadThere are a lot of changes ahead for the automotive industry.The move to electric and automated vehicles will mean big shifts in sourcing,production,and operations.Autom
165、akers cant do it alone.They will need support from regulators and other stakeholders to succeed.STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries25As Europe tackles regulatory shifts,like the Packaging and Packaging Waste Regulation,and the UK enforces its s
166、ingle-use plastic ban,the food industry braces for transformative changes.”On 7 November 2023,a leading European consumer organisation and other member organisations from 13 countries raised a complaint with the European Commission.The groups alleged that several major plastic drinking water bottle
167、companies were making misleading commercial claims about the recyclability of their products.The primary issues raised in the action were the use of the terms“100%recyclable”and“100%recycled”,as well as green imagery which gave the false idea that the plastic bottles have a positive environmental im
168、pact.The organisations are asking for an investigation by the European Commission and other consumer protection authorities into the“green claims.”This comes as European regulators are working to finalise the Packaging and Packaging Waste Regulation(PPWR).However,there are differences between the te
169、xt agreed on by the European Parliament and the European Council.Whatever the final provisions are,they will require changes in the food sector,especially for packaging for takeaway food.The UK is also looking at plastic waste with its ban on single-use plastic which took effect in October and impac
170、ts many food service operators.Regulators in the UK are also reviewing food contact material regulations,which will bring more changes for the industry.Bacterial and viral contamination are common reasons for food recalls,especially with produce.A new study from the European Food Safety Authoritys(E
171、FSAs)Panel on Biological Hazards(BIOHAZ)looks at how water used in post-harvest processing might affect food safety.The report also recommends steps companies and regulators could take to better protect the food supply chain.New controls on EU commodities at UK borders were introduced in January 202
172、4,with more on the way.They are part of the UK Food Standards Agencys(FSAs)Border Target Operating Model(BTOM),one of the biggest changes to border systems in the past 40 years.The BTOM applies security controls to all imports as well as sanitary and phytosanitary controls specifically to imports of
173、 live animals,animal products,plants,and plants products.It aims to help simplify and digitise controls as the UK works toward a new Single Trade Window.FOOD ANDBEVERAGESTATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries27The new BTOM rules may reflect some of
174、 the findings in the latest“Our Food”report from the FSA and Food Standards Scotland(FSS).The regulatory agencies found that in 2022 the UK increased the number of high-risk foods now subject to enhanced checks at the border.As we have seen in other sectors,regulations to meet the goals of the EUs G
175、reen Deal are impacting processes across the food industry.Safety concerns about chemicals are also forcing changes to conventional business processes.Food and beverage companies need to be flexible to meet the growing regulatory demand and adapt to the new mandates.UK and Scotland release“Our Food”
176、annual report In October,the UK Food Standards Agency(FSA)and Food Standards Scotland(FSS)released their second annual“Our Food”report.The publication examines trends in UK food standards in 2022,including food and feed safety standards such as allergen management.It also covers other requirements t
177、hat support consumers such as animal welfare and sustainability metrics and rules on food composition,nutritional content,labelling,and advertising.The data analysed in the report comes from a range of sources including local authorities,government statistics,border checks notifications,and sampling
178、 and surveillance activities by the FSA and FSS.The regulators examined four key areas:1)the impact of the economic environment on consumer choice and behaviours,2)how the UK food system is influenced by international factors and the safety of imported foods,3)the current landscape of business compl
179、iance,and 4)available evidence on the safety and authenticity of food in the market,including reports involving food allergens.The report highlights some of the big challenges for consumers such as rising food prices at a time when other household expenses were also increasing.In addition,one in fiv
180、e people across England,Wales,and Northern Ireland was classified as“food insecure”due to limitations in diet and/or food intake as the result of financial or personal circumstances.The Scottish data showed similar results.The document also states that the UK has increased the number of high-risk fo
181、ods now subject to enhanced checks at the border due to concerns about pesticide residues and other toxins in products from certain countries,though it admits other factors may have contributed to the uptick as well.In addition,the number of local authority inspections returned to pre-COVID-19 pande
182、mic levels.However,the number of food safety workers was lower across all jurisdictions compared to a decade ago,and many open positions are going unfilled.This places a considerable burden on existing food safety personnel.In more positive news,the agencies report that despite food businesses seein
183、g steep increases in their costs,there was not a reduction in compliance with food hygiene standards.Information from a number of sources,including national sampling programmes by regulators and reported food incidents and foodborne disease outbreaks,did not show any sizeable change in food safety a
184、nd authenticity standards during the observation period.Stakeholders will have to watch how the FSA and FSS will use these results to shape regulatory policies and priorities going forward.Food packaging materials in the spotlightIn November,the European Parliament adopted its position on new EU-wid
185、e Packaging and Packaging Waste Regulation(PPWR).The rule is designed to reduce waste and encourage reuse and recycling.While the measures are for a wide range of products,they will certainly impact the food sector.The proposal agreed upon by Parliament called for overall packaging reduction targets
186、 as well as specific goals for reducing plastic packaging.It also implements a ban on lightweight plastic carrier bags with certain exceptions and prohibits the use of Bisphenol A and per-and polyfluoroalkyl substances(PFASs)in food contact packaging.The draft bill wants to make the reuse of contain
187、ers a standard practice.It calls for hotels,restaurants,cafs,and other final distributors of beverages and takeaway food to allow consumers to bring their own containers.With some exceptions,the regulation mandates that all packaging should be recyclable,though the specific criteria will be set in s
188、econdary legislation.STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries29Attorneys with Squire Patton Boggs note that the version adopted by Parliament has significant changes compared to the November 2022 proposal by the European Commission.The latest draft
189、does not ban the use of single-use packaging such as plates,cups,boxes,and sachets of condiments for on-site consumption.The European Council adopted its version of the PPWR in December that includes the Commissions restrictions on certain packaging formats,including single-use plastic packaging for
190、 fruit and vegetables,food and beverages,and condiments.The Council also supports requirements for tea bags and sticky labels on fruit and vegetables to be compostable and gave Member States the authority to mandate that coffee pods and other packaging be compostable under specific conditions.While
191、the EU works to finalise its regulations,the UKs ban on certain single-use plastics came into force in October.No business is allowed to sell,or in any way supply,single-use plastic balloon sticks and cutlery;single-use plastic plates,trays,or bowls;or single-use polystyrene food or drink containers
192、.There are limited exceptions for the latter two product categories.Legal experts with Burges Salmon LLP caution retailers,food vendors,takeaway restaurants,and the hospitality industry that the ban applies to existing stocks,not just supplies purchased after the enforcement date.Enforcement officer
193、s are authorised to enter and inspect businesses and request company records if they suspect a breach of the rule.Fines and other civil sanctions are expected to be the primary means of enforcement.In addition to single-use plastic items,UK regulators are looking at food contact materials.The UK Foo
194、d Standards Agency(FSA)launched a consultation in September seeking input on implementation,effectiveness,and current relevancy of the Materials and Articles in Contact with Food(England)Regulations 2012.The inquiry closed in November and may be the first step in changes to the rules.While many comp
195、anies have already started to transition away from plastics,finding alternatives that are cost-effective and offer the same durability as plastic may be a challenge.Any new material will also have to meet the expectations of consumers and the demands of regulators.Regulators look at water safety for
196、 produceFruits and vegetables typically experience more recalls than any other category in the food and drink sector.In November the European Food Safety Authoritys(EFSAs)Panel on Biological Hazards(BIOHAZ)released a report examining the impact of the water used in the post-harvest handling and proc
197、essing of fresh and frozen fruits,vegetables,and herbs.The research was looking to see if the presence of microbiological hazards such as Listeria monocytogenes,Salmonella,E.coli,and norovirus was connected to the water.According to an article in Food Safety Magazine,in addition to looking at the ha
198、zards,the panel also investigated 1.the routes and rates of contamination of water and the commodities;2.specific intervention strategies to ensure the appropriate microbiological quality of water;and 3.relevant parameters to assess the appropriate microbiological quality requirements of water used
199、in the post-harvest handling and processing of commodities.In an analysis of the study,attorneys with Keller and Heckman LLP said a Hazard Analysis Critical Control Point(HACCP)-based approach,combined with good manufacturing practices(GMP)and good hygienic practices(GHP)are necessary for water mana
200、gement.They also noted that the report found several existing practices that were recommended by BIOHAZ,including water cooling,were not well implemented in many organisations.To make the food system safer,the BIOHAZ Panel suggested the creation of clear guidelines about how water disinfection treat
201、ments can be used in the post-harvest handling and processing of fruit,vegetables,and herbs,as well as the development of technical guidance for intervention strategies as part of a process water management plan.In addition,the panel recommended that outbreak investigation reports include more infor
202、mation about postharvest processing and if water might have been a source for the pathogen in question.Companies that handle and process these types of commodities should review the report and assess their operations against the Panels suggestions.While these are all best practices for now and not m
203、andatory regulations,the EFSA may use the findings as the first step in drafting new rules.Amidst frequent recalls of fruits and vegetables,companies should assess their practices against BIOHAZ suggestions as potential precursors to future regulations.”STATE OF THE NATION 2024|Product Recall Data,T
204、rends and Predictions for European Industries31BY THE NUMBERSThe leading cause of food and beverage recalls in Q4 was non-bacterial contamination,with 578 events,up from 470 last quarter.The most common contaminants of concern were aflatoxins and pesticides,which were linked to 80 and 78 recalls res
205、pectively this quarter.The second leading concern across the food and beverage sector was bacterial contamination which was cited in 241 recalls.Salmonella was the most common risk and was tied to 146 recalls,followed by Listeria with 37,and E.Coli with 29.In Q4 2023,the top three most impacted prod
206、uct categories in Europe mirrored those of Q3.Fruits and vegetables recorded the greatest number with 216 recalls,marking a 12.5%increase from 192 in Q3.Nuts,nut products,and seeds ranked second with 139 recalls,9.4%higher than the 127 recalls recorded in the previous quarter.Poultry meat and poultr
207、y meat products was third with 118 events,marginally down 3.3%compared to the 122 recalls reported in Q3 2023.In terms of notifications,the Netherlands issued the most in Q4 with 210,compared to 156 last quarter.France was second with 144,and Germany was third with 140 notifications.The UK submitted
208、 30 notifications in Q4 2023,one more than it had in both Q2 and Q3 2023.European food and beverage recalls surged to a ten-year high in 2023.A total of 4,837 events were recorded across the UK and EU,marking a 7.0%uplift from the 4,519 events of 2022.Quarter four exemplified this upward trend,marki
209、ng a fifth consecutive quarter of growth.European regulators reported a total of 1,308 recall events during this period,reflecting a 9.5%rise compared to Q3.RECALLS BY NOTIFYING COUNTRYItalyFranceGermanyNetherlandsBelgium075500200Q4 2023Q3 2023TOP CAUSE OF RECALLS IN Q40Bacterial contamin
210、ationNon-bacterial contaminationExcessive substance levelsUndeclared allergenCertification480360240120600TOP PRODUCT CATEGORY RECALLED IN Q40Nuts,nut products and seedsFruits and vegetabesHerbs and spicesPoultry meat and poultry meat productsCereals and bakery products25020015010050STATE OF THE NATI
211、ON 2024|Product Recall Data,Trends and Predictions for European Industries33This was followed by Nuts,Nut products and seeds(with 514 events),and poultry meat and poultry meat products(with 396).Accounting for 801 events(16.6%),Fruit and vegetables was the most impacted category in 2023.The most pre
212、valent contaminant in 2023 was Aflatoxins,with 324 events,followed by Chlorpyrifos(264),and Pesticides(200).Contamination(non-bacterial)was the leading cause of recalls in 2023 with 1,990 events.This uplift was largely attributed to Q4 2023 which saw 1,308 recalls.Only 1 quarter in the last 3 years
213、has recorded more events(Q4 2021 with 1,340).European food and drink recall events increased 7.0%in 2023,marking a 10-year high for the sector.7.0%STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries35Geopolitical and economic concernsIn February 2023,the EU Co
214、uncil adopted its tenth package of restrictive measures against Russia in response to the ongoing Ukraine conflict.The measure put tighter restrictions on the export of dual-use goods and measures against entities that support the conflict or deliver drones to be used by Russia.According to a statem
215、ent by the European Commission,the new restrictions applied to approximately 11.4 billion in exports to the EU.Meanwhile,the UKs Office of National Statistics(ONS)released data on the impact of sanctions on trade with Russia.The agency reported that even those food and drink products that were exemp
216、t from export bans were at low levels of trade.In December 2023,the UK government introduced legislation for further measures while announcing a new Office of Trade Sanctions Implementation(OTSI)to“strengthen enforcement and clamp down on companies dodging Russian sanctions.”The potential inflationa
217、ry effect and possibility of shortages resulting from sanctions and the continuing Ukraine conflict had been predicted back in 2022.Food inflation made headlines multiple times in 2023.We reported on continued challenges in the food sectors supply chains in March 2023.Some of the product scarcity wa
218、s unrelated to the conflict,such as the limited availability of salad items caused by unseasonal weather.However,businesses were also combatting significant inflation.If at least some of those costs arent passed on to their end customers,it can squeeze operating profits and present cash-flow challen
219、ges.Inflation fell significantly towards the end of 2023,but prices remain high when compared to before the COVID-19 pandemic.There is unlikely to be a“quick fix,”especially as certain commodities and ingredients remain more expensive and difficult to procure.In its autumn statement,the UK governmen
220、t confirmed that higher rates for the National Minimum Wage(NMW)and National Living Wage(NLW)would be applied from 1 April 2024.While employers want to ensure that their staff can cope with rising living costs,the reality is that these new rates may well hit the food and drink sector hard and could
221、add to inflationary pressures if companies need to raise prices of commodities to meet the new wage standards.Legislators and regulators in the UK seem to recognise the geopolitical and economic pressures.In response,they have introduced or are adapting proposals affecting the sector and promised a
222、series of“regulatory reform announcements”to decrease burdens,lower the cost of living,and spur economic growth.EXTERNAL FACTORS CREATE FOOD INDUSTRY CHALLENGESFood and drink businesses faced many challenges in 2023.There was an unstable geopolitical and economic landscape,which impacted supply chai
223、ns,product accessibility,and consumer purchasing.Divergent regulatory requirements in European countries and the effect of new UK border arrangements on trade between the EU and the UK also created difficulties for companies that will continue in 2024.These issues are in addition to the myriad of fo
224、od safety regulations that companies must navigate.NICOLA A.SMITH,PARTNER,SQUIRE PATTON BOGGS(UK)LLPFor example,there was a further delay on implementing the ban on“multi-buy”deals for High Fat Salt and Sugar(HFSS)foods.The ban is now scheduled to take effect in October 2025.There had been push back
225、 from consumers and retailers about the impact on food budgets if this measure was introduced in line with the original timetable.The UK government also announced a delay in its proposed mandatory food waste reporting.Instead,regulators will try to increase the number of food businesses reporting on
226、 a voluntary basis,until at least 2026.This decision was reportedly based on the belief that any additional costs needed for companies to implement the change would be passed to consumers and this wasnt the time to increase food prices.Rising grocery prices as a result of the UKs cost-of-living cris
227、is prompted the Competition and Markets Authority(CMA)to examine the grocery sector.The CMA wanted to determine if anticompetitive practices between retailers were contributing to the higher prices.In July 2023,the CMA published an update on its investigation that looked at factors including market
228、concentration,the growth of discount supermarkets,market share losses by retailers with high prices,retailer profitability compared to rate of inflation,competitive pricing strategies by retailers,and consumers switching retailers to find the best-priced goods.The CMA reported that not all consumers
229、 are receiving the benefits of retail competition.There is a lack of online shopping offered by discount retailers and some consumers rely on convenience stores,which are more expensive and lack own-brand products.However,it concluded that recent inflation for groceries was not driven“at an aggregat
230、e level by weak or ineffective competition between retailers.”Divergent regulatory requirementsAfter the UK left the EU,the possibility of divergence in legal requirements and minimum standards between the two jurisdictions opened up.Although EU legislation that was in force at the end of the Brexit
231、 transition period carried over into domestic UK law because of“grandfathering”provisions,the Trade and Co-Operation Agreement reached when the transition period ended did not require ongoing alignment of regulation or standards.The exception is in the case of Northern Ireland,because of the effect
232、of the Northern Ireland Protocol.In 2023,we saw the cancellation of the automatic sunset of retained EU law that had been proposed,under the so-called“Brexit Freedoms Bill”,but we also saw much more awareness among businesses of the potential impact that significant divergence could bring,including
233、divergence between the speed and conditions of approval between the EU and the UK,for example of novel foods,additives,or health claims(now approved in the UK by the Food Standards Agency(FSA).STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries37In addition to
234、 potential differences between the UK and the EU,businesses are also becoming more aware of the possibility of divergence between requirements in the four nations of the UK for devolved matters.A prime example of the complexities of possible UK divergence,and the political implications of invoking t
235、he provisions of the Internal Market Act 2020,was seen in 2023,with the development of different Deposit Return Schemes and the ultimate postponement of the Scottish scheme.Of course,there are also cases of divergence between different countries of the EU.If requirements are not completely harmonise
236、d,legislation allows for derogations by Member States in certain areas,as well as different interpretations or enforcement approaches.There are many examples of divergence between EU countries that were highlighted in 2023.These include use of the term“probiotic”to describe certain foods,the enforce
237、ment approach for labelling quantity/contents on a multipack label,the determination for oral cannabidiol(CBD)oils as a“lifestyle”product,and specific Member State bans on“lab-grown”(synthetic)meat.Some areas coming to the forefront as being issues where there is not,or will not be,full alignment be
238、tween the EU and UK or among EU Member States,include registration requirements for food supplements and the regulatory framework for precision-bred organisms in food and animal feed.Any inconsistency in regulations can have a detrimental impact on the levels of trade between countries,which may con
239、tribute to existing supply chain challenges.Border controlOne of the key developments around divergence in 2023,which will continue into 2024,is border arrangements in the UK.The first phase of UKs strategy for businesses to implement post-Brexit steps when importing products of animal origin came i
240、nto play from October 2023 after being pushed back on numerous occasions since the end of the Brexit transition period.From January 2024,food business operators must ensure that the packaging and labelling of their pre-packed foods sold in Great Britain contain a physical UK address for the food bus
241、iness operator(FBO).If the FBO is not in the UK,then the label must include the address of their UK-based importer.The guidance from the UK government details the specific requirements and stresses that a physical mailing address must be given,not just an email address or phone number.This requireme
242、nt is a“hangover”from Brexit.The EU required EU FBOs addresses to appear on the packaging for products placed on the market in the EU immediately after the end of the Brexit transition period.However,the UK government allowed a grace period for the equivalent requirement in Great Britain.This grace
243、period has ended,coinciding with the implementation of phased increased border checks as part of the UKs new Border Target Operating Model(BTOM).Under the BTOM,importers into the UK will be required to pre-notify authorities that their consignment will be entering Great Britain via the Import of pro
244、ducts,animals,food,and feed system(IPAFFS).For some products,a health certificate will also be required.There may be additional documentation,identification,and physical checks at the UK border,depending on the risk classification of the product.Relevant consignments must also enter via a point of e
245、ntry with a Border Control Post(BCP)that has been designated to receive these goods.Operators can find it challenging to determine which category particular products they import come under,particularly composite products containing products of animal origin(POAO),where the wording of the guidance is
246、 not particularly clear,especially in relation to the relevance of POAO content over 20%and over 50%.Procedures and agreements with suppliers may need to be adapted to reflect the additional obligations on distributors on both sides of the border who have become“importers”following Brexit.The Decemb
247、er 2023 Board report from the UKs FSA outlined the agencys risk categorisation strategy to support the BTOM.After ranking the various concerns,FSA risk managers,working with Food Standards Scotland and the UK Health Security Agency,evaluated the BTOM risk scores and took account of additional data s
248、ources,including the latest data available on border notifications,rejections,outbreaks,and incidents.They used this information to assign the BTOM risk category.The food safety recommendations for categories provided by the FSA were then combined with data on animal health from a Department for Env
249、ironment,Food and Rural Affairs(DEFRA)expert group to recommend each products risk category.Each country and commodity combination is assigned into a high,medium,or low BTOM risk category.It appears from the Board report that this approach largely follows that taken for products from the rest of the
250、 world(outside the EU)but that there are specific evidence-driven recommendations for several countries where the UK has either equivalence agreements,free trade agreements or detailed knowledge of the processes they follow.The report also notes that the FSA will input into trusted trader schemes be
251、ing developed by the UK government.Movements of goods between Great Britain(GB)and Northern Ireland(NI)were also a focus area in 2023,because of the implementation of the Windsor Framework agreement,which regulates trade practices between GB and NI.Under the agreement,a broad range of products movin
252、g from GB to NI,intended for“final consumption”in NI,can now be processed through a“green lane.”These products are subject to fewer checks and controls than goods moving through NI on to other markets including the EU.NICOLA A.SMITH,PARTNER,SQUIRE PATTON BOGGS(UK)LLP CONTINUED FROM PREVIOUS PAGESTAT
253、E OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries39While this will ultimately facilitate movements of various products,there are implications for businesses in the short term.For example,there are general labelling requirements for boxes or crates of agrifood pr
254、oducts being moved to NI as well as phased-in requirements for labelling of individual products for some product types.Businesses have sought to understand the impact of the changes on their own products and supply chains and this is likely to continue as the new red lane and green lane processes in
255、 NI bed in.Enforcement resources stretched thinA key issue for regulators in 2024 will likely be how business compliance can best be achieved against the background of resource-challenged local authorities.The agenda and papers published for the FSAs board meeting in December indicated that the boar
256、d was reviewing the performance of local authorities and the programme for“Achieving Business Compliance.”The report on local authority performance highlights resourcing challenges,staff shortages,and difficulties in recruiting and retaining competent officers as key challenges for the enforcement o
257、f food law.There are particular concerns around backlogs in inspections of“lower risk”establishments,challenges in meeting required intervention frequencies,and sampling and enforcement levels compared to pre-pandemic levels.The identification by the FSA of these concerns and its proposed actions ma
258、y result in an increased focus on food safety in coming years by local authority enforcement officers.However,the lack of resources underlying the concerns seems likely to continue,at the very least in the short term.It remains to be seen whether the Achieving Business Compliance programme that is i
259、ntended to modernise local authority enforcement will address the issues.Local authorities will start to transition to the risk-based system for food standards between early 2024 and March 2025.Preparing for challengesFood businesses can look at the challenges of 2023 as early indicators of key area
260、s of focus for 2024.This can help with planning strategies for addressing ongoing challenges and complying with new legislation,standards and guidance,which could be particularly important for businesses navigating the possibilities of post-Brexit divergence and changing trading rules.NICOLA A.SMITH
261、,PARTNER,SQUIRE PATTON BOGGS(UK)LLP CONTINUED FROM PREVIOUS PAGESTATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries41In October,the European Commission announced fines for five companies in the pharmaceutical sector totaling 13.4 million for participating in a
262、 cartel concerning an important pharmaceutical ingredient.A sixth company that was part of the cartel was given leniency for assisting with the investigation.All six companies admitted their involvement in the cartel and agreed to settle the case.This is the first time the Commission has penalised a
263、 cartel in the pharmaceutical industry and in relation to an active ingredient.The Commissions investigation showed that the companies worked together from 1 November 2005 to 17 September 2019 to fix the minimum sales price of the ingredient to distributors and generic drug manufacturers and to allo
264、cate quotas.A seventh company decided not to settle and is still under investigation.The fines should serve as a warning to companies that regulators are taking notice of their operations.Another priority for regulators is preventing shortages of critical medicines.The European Commission,European M
265、edicines Agency(EMA),and Heads of Medicines Agencies(HMA)took several actions in the fourth quarter to try to improve processes and communication around ensuring adequate supplies.The organisations outlined several other measures they plan to implement in the coming year to prevent supply chain disr
266、uptions.The EMA is also trying to make information about medicines easily accessible with a pilot project to test electronic product information(ePI)that could supplement or potentially replace paper inserts and certain labelling for medications.In another labelling change,the UKs Medicines and Heal
267、thcare products Regulatory Agency(MHRA)provided more guidance on changes to product labels for medicines sold in Northern Ireland.Starting in 2025,products will need a“UK only”label and marketing authorisation by the MHRA instead of the current EU labelling and marketing authorisations.Regulators se
268、em to be collaborating more with other bodies,which may result in consistent regulations and processes that benefit both the industry and consumers.PHARMACEUTICALIn a landmark move,the European Commission fined five pharmaceutical companies 13.4 million for participating in a cartel related to a cru
269、cial ingredient,signaling increased regulatory scrutiny.”STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries43European Commission focused on preventing shortagesAfter issuing recommended actions to avoid shortages of key antibiotics in July,the European Commis
270、sion adopted additional measures in October designed to prevent and mitigate critical medicine shortages in the EU.The first step in the initiative was the October launch of a solidarity mechanism developed by the European Medicines Agencys(EMAs)Medicines Shortages Steering Group(MSSG).This voluntar
271、y system lets Member States request assistance from one another to obtain stocks when they are facing a shortage of critical medicines.Other parts of the Commissions plan include a European Union list of critical medicines,which was shared in December by the Commission,the EMA,and the Heads of Medic
272、ines Agencies(HMA).A medicine is considered“critical”if it is deemed“essential to ensure the provision and the continuity of quality healthcare,and to guarantee a high level of public health protection in Europe,”according to the Commission.There are more than 200 active substances used in human med
273、icines on the initial list.The list will be reviewed annually and will support and expedite the Commissions analysis of supply chain vulnerabilities for these vital medicines.The first evaluation is expected in April 2024.From there,the Commission,EMA,and Member States may recommend measures to addr
274、ess any vulnerabilities that are discovered.The Commission is also planning a dedicated Joint Action in 2024 to promote regulatory flexibility by Member States to allow medicines to reach patients in a timely manner.This may include extending a medicines approved shelf-life or quickly authorising an
275、 alternative medicine.In addition,the Commission anticipates publishing a guidance in early 2024 on strengthening the security of critical medicines.It also expects to conduct an EU joint procurement next winter for antibiotics and treatments for respiratory viruses.The initiatives will be supported
276、 through a Critical Medicine Alliance which will help diversify supply and stimulate and modernise production of critical medicines.The Alliance will enable national authorities,industry,civil society representatives,the Commission,and EU agencies to coordinate action at the EU level to prevent shor
277、tages and address supply chain challenges.Furthermore,the Commission promised to create a network of international partners to bolster supply chain resilience and develop strategic partnerships with third countries for the production of critical medicines based on demand.While the trade association
278、the European Federation of Pharmaceutical Industries and Associations(EFPIA)came out in support of the goals of the proposal,it felt some of the requirements could have unintended consequences.Pharmaceutical manufacturers,ingredient suppliers,and other stakeholders should review the list of critical
279、 medicines.If they have products on the list,they should start planning for any changes they may need to make.EMA introduces first electronic product information for human medicinesEvery medicine authorised in the EU has certain standards for the information contained on the label and accompanying p
280、ackage leaflet explaining how the product should be prescribed and used.Typically,the information can be found on regulatory websites as a PDF document and as a printed package leaflet within the medicines box.There are clear advantages to providing this information electronically-it is easier to ke
281、ep it updated,it is more accessible to healthcare professionals and patients,and there are fewer costs and less waste for manufacturers if they are not printing materials.In July 2023,the Heads of Medicines Agencies(HMA),the European Commission,and the European Medicines Agency(EMA)launched a pilot
282、project with 25 medicines to create and test electronic product information(ePI)for selected human medicines in real regulatory procedures.The goal is to transition to an electronic system for medicines evaluated at a Member State or EU level.The ECs strategic initiatives to prevent medicine shortag
283、es demonstrate a visionary approach,introducing a solidarity mechanism,a list of critical medicines,and plans for regulatory flexibility.”STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries45With the UK Only labelling implementation date set for Jan 2025,compa
284、nies face challenges in uncoupling Northern Ireland from EU packaging,demanding strategic adjustments in compliance with the new framework.”In November,the agencies published the first ePIs harmonised across the EU.The published ePIs are for medicines evaluated by the EMA or by national authorities
285、in Denmark,the Netherlands,Spain,or Sweden.They were submitted as part of the regulatory application process by companies participating in the pilot project.The ePIs all use the EU ePI Common Standard to ensure a consistent structure throughout all Member States and allow the information to work acr
286、oss different e-health platforms.The EMA predicts that future developments may include automatic update notifications,access to supportive videos or audio content,and online adverse-reaction reporting tools,among other functions.The pilot project will conclude in July 2024.The results will guide how
287、 ePIs may be integrated into common practice and used across the EU.It is unclear how quickly the EMA might adopt ePIs more widely and what kind of regulations would be involved.Medicine manufacturers and distributors should evaluate their current product information processes and consider if ePIs w
288、ould offer any advantages for their operations.UK offers guidance on new labelling for medicinal productsIn late September 2023,the UKs Medicines and Healthcare products Regulatory Agency(MHRA)published additional guidance on changes to labelling and packaging for medicinal products intended for the
289、 UK market.These changes come as part of the Windsor Framework,which the UK and EU agreed to on 27 February 2023.According to lawyers with Covington&Burling LLP,the Northern Ireland Protocol(NIP)that was signed after Brexit applies specific EU legislation“to and in”Northern Ireland,including regulat
290、ions for medicines.Medicinal products currently placed on the market in Northern Ireland are subject to EU pharmaceutical rules,and medicines being imported from the UK are treated as a third-country product.That changed with the adoption of the Windsor Framework,which aims to safeguard the supply a
291、nd access of medicines from Great Britain into Northern Ireland.The latest guidance makes the MHRA responsible for assessing all medicinal products,including new and innovative products,destined for the UK internal market and Northern Ireland,according to the legal experts.Medicines will receive a s
292、ingle UK-wide marketing authorisation(MA)and a single“UK only”labelled pack.Products that comply with these rules will be able to move freely between Great Britain and Northern Ireland.In addition,instead of allowing products with the European Commissions EU-wide MAs directly into Northern Ireland,t
293、he MHRA must first grant the product a UK MA and it must be labelled“UK only.”Prescription-only medicines must not display EU safety features or unique barcodes.The“UK Only”labelling will take effect on 1 January 2025.Products with this label will not be available on the market in Ireland or elsewhe
294、re in the EU,except under special conditions.In addition,joint packs that are shared with another EU country or countries will no longer be permitted.The latest MHRA guidance provides additional information about the implementation of the Windsor Framework,including a glossary of terms,a timeline fo
295、r when the provisions go into force,the phase-out of the EU Falsified Medicines Directive(FMD),and how to handle existing packaging on the market in Northern Ireland and Great Britain.The document also addresses issues such as how to manage Marketing Authorisation Applications that are under assessm
296、ent,packaging for UK traditional herbal and homeopathic medicinal products,authorisation for Parallel Imports,and the future of product licences that currently only cover Great Britain(PLGBs).As the attorneys with Covington&Burling LLP note,there are benefits to having a single medicines regulatory
297、framework for the entire UK.However,implementing the new system will require adjustments for many companies which will need to uncouple Northern Ireland from EU packaging and align it with Great Britain.STATE OF THE NATION 2024|Product Recall Data,Trends and Predictions for European Industries47BY T
298、HE NUMBERSLooking at Q4 2023 in isolation,there were 40.9%fewer pharmaceutical recalls across Europe compared to Q3 2023.The final quarter of the year closed with 65 events,down from 110 the quarter previous.Only one quarter in the past three years has recorded fewer events(Q3 2022 with 60).Having d
299、ominated European pharmaceutical recall activity in 2023,safety risks closed the year with 24 events in Q4,marking a 9.1%uplift on the 22 events recorded in Q3.The second-most cited reason for recall in Q4 was mislabelling with seven events,followed by Failed Specifications with 5 events.France issu
300、ed the most notifications,with 16 alerts in Q4 2023,down from 20 in the previous quarter.Germany was second with 15 notifications,and Spain was third with 13 alerts.The UK had six notifications this quarter compared to 19 in Q3.Looking at the year as a whole,the top three issuing countries were Fran
301、ce with 78 notifications,Germany with 60,and the UK with 49.The number of pharmaceutical recalls across the UK and EU increased by 7.7%in 2023,from 311 events to 335.This was followed by Germany with 60 events,the UK(49),and Spain(42).At 78 events(23.3%),France submitted the highest number of recall
302、 notifications in 2023.This was followed by Foreign materials/contamination with 44 events,Mislabelling(38),and Failed specifications(31).Accounting for 107 events(31.9%),Safety concerns were the leading cause of recall in 2023.This uplift was largely attributed to Q3 2023 which saw 110 recalls.This
303、 is the highest quarterly figure recorded in over 3 years.At 335 events,European pharmaceutical recalls increased 7.7%in 2023(from 311 in 2022).23.3%RECALLS BY NOTIFYING COUNTRY IN Q4GermanyFranceDenmarkSpainUnited Kingdom0181512963RECALLS BY QUARTERQ1 2023Q4 2022Q3 2023Q2 2023Q4 202305TO
304、P CAUSE OF RECALLS IN Q4MislabellingSafetyQualityFailed specificationsForeign materials/contamination20161284024NAVIGATING THE EVOLVING PHARMACEUTICAL LANDSCAPE:A REVIEW OF 2023 AND OUTLOOK FOR 2024In 2023,the European Commission proposed comprehensive strategies to overhaul the EUs pharmaceutical l
305、egislation,marking the most significant changes in the pharmaceutical space in two decades.Simultaneously,the UK Government made regulatory changes to expedite approvals for medicines and streamline clinical trials in the UK.EU focus on patient safety In April 2023,the European Commission published
306、two major revisions to EU pharmaceutical law:a draft directive relating to medicinal products for human use(COM/2023)192)and a proposed regulation laying down EU procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicin
307、es Agency(EMA)(COM/2023)193).The proposals are the foundation of the European Health Union,which aims to protect the health of European citizens,help member states prevent and address any future pandemics,and improve resilience in Europes health system.The proposed legislation will replace existing
308、laws on a wide range of aspects.Key elements include establishing a single market to ensure timely and equitable access to safe,effective,and affordable medicines and promoting an innovation-friendly environment for research,development,and the production of medicines.The new rules also look to stre
309、amline regulatory frameworks to enhance the availability of medicinal products across the EU;strengthen environmental protections,particularly in the context of tackling antimicrobial resistance as a significant health threat;and promote sustainability throughout the medicines lifecycle.The reformed
310、 regulation and directive create a harmonised and patient-centric pharmaceutical landscape within the EU and support the EMAs mandate to mitigate and prevent systemic shortages and ensure supplies of critical medicinal products.However,given the dispute among Member States and the potential effects
311、on key stakeholders,the timing and manner of the proposals adoption are uncertain.Over the past few years,the pharmaceutical industry has faced a variety of market-disrupting events impacting both supply chains and human talent.As the industry navigated this ever-evolving landscape,it also witnessed
312、 an array of significant EU and UK legislative and regulatory developments last year that have the potential to again reshape the future of healthcare.ELAINE BARKER,MANAGING ASSOCIATE,ADDLESHAW GODDARD LLPThe draft legislation is going through the usual legislative process,where it will be reviewed
313、and negotiated by the European Parliament,the European Council,and the European Commission.In October 2023,Parliament proposed revisions to the Commissions proposals,which included extended regulatory data protection periods for non-orphan drugs and establishing the European Medicines Facility,which
314、 is tasked with research and development on novel antimicrobials.With diverging views on several topics,further revisions and additions seem likely.The legislative process is expected to be protracted,and its not anticipated these reforms will be adopted before 2025 or even 2026.Clinical trial chang
315、es Clinical trials were another priority in 2023.The EUs clinical trials system has undergone updates in recent years,prompting the UKs Medicines and Healthcare product Regulatory Agency(MHRA)to adapt its own regulations post-Brexit.Following a public consultation in 2022 on proposed changes to clin
316、ical trials legislation,the MHRA published its response in March 2023.These proposals are designed to update the current law governing clinical trials,the Medicine for Human Use(Clinical Trials)Regulations 2004.In its draft rule,the MHRA outlined four key goals for the new clinical trials regulatory
317、 framework:1)prioritise patients and their safety;2)establish a regulatory environment that is both proportionate and agile;3)solidify the UKs position as a preferred destination for international trials;and 4)develop a structure characterised by its streamlined,flexible nature and responsiveness to
318、 innovation.While the UKs proposed changes differ from the EU methodology,they align in terms of trial requirements(such as adopting a risk-based approach to approval applications,and prioritising transparency and public accessibility).The UK proposal was seen as a clear departure from the EU approv
319、al timelines with the contemplated reliance on guidance instead of legislation for specific components inevitably providing greater flexibility than the EUs rules-based system allows.These proposals reflect a strategic approach by the UK to be seen as offering a more modern and flexible approach tha
320、t will make it easier and more efficient to run clinical trials in the UK.In October 2023,the EMA revised transparency regulations governing European clinical trials submitted via the Clinical Trials Information System(CTIS).The revised rules simplify procedures and enhance data accessibility for st
321、akeholders to improve user experience and enable easy access to clinical trial information through a streamlined CTIS public website.The revisions include publishing relevant data and documents aligned with the needs of the public,patients,and clinical researchers in the EU/EEA,reducing complexity i
322、n how information is presented,making it easier for users to search through structured data fields,and eliminating the deferral mechanism which previously delayed the publication of certain data and documents.Getting medicines to market in the UK Last year we also saw the MHRA announce the recogniti
323、on of new routes to market for cutting-edge medicines that have been approved by regulators in Australia,Canada,the European Union,Japan,Switzerland,Singapore,or the United States,also known as Reference Regulators.The International Recognition Procedure(IRP)framework will enable innovative medicine
324、s already approved by one of the Reference Regulators to reach patients in the UK more efficiently.The benefits include not only expedited access for patients but also cost reductions and more streamlined regulatory procedures for the pharmaceutical industry.These developments potentially pave the w
325、ay for faster product approvals,which would give UK patients faster access to new medicines.However,the products must still be approved elsewhere through a full and standalone assessment before they can begin their journey through the IRP approval process in Great Britain.More details were released
326、in October 2023 on the eligibility criteria for the various alternative pathways available.Hopefully in 2024 we will see more explicit delineation by the MHRA of its regulatory flexibilities and the impact of the IRP beyond its role as a pathway to market and patient access,such as how it might impa
327、ct other industry activities.A clearer understanding of the regulatory pathway to market will help companies make informed decisions to optimise their development strategies and engage with the MHRA in a manner consistent with the evolving industry standard.STATE OF THE NATION 2024|Product Recall Da
328、ta,Trends and Predictions for European Industries51One to watch:Circular packaging As part of the European Green Deal and the new circular economy action plan,the Commission put forward a proposed Packaging and Packaging Waste Regulation(PPWR)in November 2022.The pharmaceutical industry is one of ma
329、ny sectors that will be significantly impacted by the more comprehensive requirements which will be directly applicable for all Member States.The proposed regulations expand the scope of the current Packaging and Packaging Waste Directive(PPWD)and introduce new provisions aligned with the European G
330、reen Deal,such as a definition of“recyclability,”minimum requirements for the recycled content of plastic packaging,mandatory QR codes,EU-harmonised symbols,and a 40%“empty space”ratio limit.As a regulation instead of a directive,all Member States will be required to fulfil their obligations at the
331、same time and in the same way.Of particular concern to the pharmaceutical industry are the requirements for packaging recyclability and recycled content,with deadlines set for compliance.The industry may benefit from an exemption for packaging that is directly in contact with medicinal products and
332、certain medical devices.Despite these exemptions,pharmaceutical manufacturers may face challenges in meeting the proposed requirements to comply with the introduction of EU-harmonised symbols,mandatory QR codes,and size restrictions on packaging.In November 2023,Parliament adopted its text for the d
333、raft PPWR.By December 2023 the European Council had agreed on its negotiating position in its so-called General Approach,which approved significant changes in the text including the deletion of the maximum 40%threshold for packaging empty space,clear dates of entry into force for the requirements relating to packaging minimisation and recyclability,and a new review mechanism to assess the feasibil