Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025
The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the biotechnology sector in the European Union (EU) while maintaining high safety standards. The new European Biotech Act will aim to ensure that the EU makes the most of the biotechnology revolution for the benefit of society, the environment, and the economy, while making it easier to develop and bring to market products across all biotechnology sectors in the EU. According to the EC, the European Biotech Act would address the following issues:
European companies have difficulty expanding within the single market because of “a complex regulatory framework that is perceived as slow and burdensome.” According to the EC, there are cases where implementation of the relevant EU regulatory framework diverges among EU member states, resulting in regulatory environments that are complex to navigate for companies and that can hinder the development or commercialization of biotechnology products. In addition, barriers at national or regional levels can further delay or hinder market entry.
The growth and development of biotechnology companies in Europe is hindered by market fragmentation, risk capital constraints, and scattered innovation support. EU companies lack sufficient access to risk-tolerant capital, and there is a lack of coordinated private and public investment to support the translation of innovation into products and the scaling-up of production for innovative biotechnology products.
The EC states that the EU does not tap into the full potential of its scale when it comes to pooling capacities to make it more competitive globally. Because national interests often lead to support for local companies, many biotechnology clusters exist throughout the EU. Some clusters are mostly of regional relevance, do not cover all the steps from laboratory to market, duplicate efforts at low scale, do not fully use their capacities, or have limited resources.
Manufacturing biotechnology products requires highly specialized equipment and a highly qualified and multidisciplinary workforce. According to the EC, in the EU, there is a mismatch between the labor supply and the biotechnology and biomanufacturing skills required.
Artificial intelligence (AI) and big data — including access to supercomputing capacity and to large, integrated, high-quality datasets — offer huge potential for all sectors underpinned by biotechnology, provided that appropriate safeguards are put in place.
The impact assessment will explore the following areas:
Speed and streamlining: “Time-to-market” is an essential parameter for the successful translation of innovation into commercial products. Where appropriate, the regulatory environment for biotechnology needs to be simplified, including the procedures for risk assessments. The aim is to facilitate and speed up the development and approval of biotechnology products and to bring them to the market faster and more easily, without compromising safety for health and for the environment or biosecurity standards. Best practices for accelerated time-to-market at EU, national, and regional levels need to be promoted.
Financing: Having access to sufficient capital is key to supporting the process of translating innovation into product development and the scaling-up of production capacities. Risk-tolerant capital is essential for the development of the biotechnology industry at seed phase, scale-up stage, and at later stages of development.
Scale: Tapping into the potential of the EU in terms of both scale of production and market size can help to ensure that companies thrive in Europe. Further options could be to look at possible support for the development, operation, governance, and coordination of biotechnology clusters or centers of excellence in the EU. The EC states that an open, competitive and at-scale business environment will be essential to keep the EU ahead in the global race.
Skills: Specific measures will be considered to improve the upskilling and reskilling of the workforce in the biotechnology area. This is to ensure that companies have access to adequately trained staff and to equip academic developers with the necessary entrepreneurial skills to create and grow a company.
Use of data and AI in the biotechnology sector: Access to data, storage services, and computing resources is essential for biotechnology research and innovation and for the development of AI tools and solutions to support the development of biotech products. According to the EC, having access to supercomputing capacity and AI testing facilities is essential to enable biotechnology companies and organizations to use data effectively. Targeted projects and tailored programs at the EU level have the potential to facilitate and push forward the development and adoption of digital solutions and AI in all biotechnology sectors.
Comments are due June 11, 2025. The EC plans a public consultation on the draft legislation in the fourth quarter of 2025, and to adopt final legislation in the third quarter of 2026.
DHS Terminates Temporary Protected Status for Nepal
On June 5, 2025, the U.S. Department of Homeland Security (DHS) announced that it would terminate the temporary protected status (TPS) for Nepal, effective Aug. 5, 2025.
As background, DHS grants TPS to eligible individuals from countries experiencing ongoing armed conflict, environmental disasters, or other extraordinary conditions, which allows them to live and work in the United States without fear of deportation.
Nepal was first given TPS designation in 2015 for an 18-month period after an earthquake devastated the country. DHS subsequently extended the TPS designation for an additional 18-month period. Later, DHS, under the first Trump administration, sought to end Nepal’s TPS designation in 2018, but this was challenged in federal court. As a result of the litigation, DHS rescinded its decision to terminate TPS for Nepal. DHS has since extended TPS for Nepal on several other occasions, up through the current expiration date of Aug. 5, 2025.
Employees currently working pursuant to TPS under Nepal will lose work authorization on Aug. 5, 2025, and must depart the United States unless they have applied for alternative U.S. immigration benefits that provide work authorization under a different program or category.
Nanjing’s Intellectual Property Protection Center Bans the Use of Generative AI in Drafting Patent Application Documents Submitted for Pre-Examination
On June 4, 2025, Nanjing’s Intellectual Property Protection Center (NIPPC) announced it is banning the use of artificial intelligence (AI) in drafting patent application documents submitted for pre-examination. China’s pre-examination system enables applicants to submit their patent applications to a regional office for an initial examination and potentially receive expedited examination at China’s National Intellectual Property Administration (CNIPA) if certain conditions are met. The NIPPC stated that it was determined that “relevant content [of patent applications] was directly generated by artificial intelligence.”
The NIPPC stated:
I、 Clear prohibition requirements1. It is strictly prohibited to use AI generated content directly in patent application documents. The patent application documents shall be manually written, drawn, edited, and organized by the applicant or their authorized patent agency based on real inventions, research results, and related materials.2. It is strictly prohibited to use AI to generate research and development evidentiary materials, including but not limited to experimental data reports, technical research and development documents, scientific research achievement explanations, etc. The R&D certification materials should be generated by real R&D activities, objectively and accurately reflecting the R&D process and results, and have verifiability and traceability.II、 Explanation of the consequences of violationFor those who violate the prohibition regulations, the relevant pre-trial cases will not be approved, and a “Pre-Examination Quality Notice” will be issued to the applicant and the agency.For serious cases, according to the “Management Measures for Pre Examination Services of Filing Entities and Agency Institutions (2024)” (宁知保〔2024〕32号), the qualification for pre-examination services will be suspended for a certain period of time and included in the negative list of graded and classified management.3. For particularly serious circumstances that clearly violate Article 20 of the Patent Law and Article 11 of the Implementing Regulations of the Patent Law, reports will be made to the administrative authorities at all levels, and corresponding administrative penalties will be recommended for the applicant and the agency in accordance with the law.III、 Notification of verification measuresIn the subsequent pre-examination review of cases, the Nanjing Intellectual Property Protection Center will use various methods to verify the application documents and research and development certification materials, including but not limited to: using professional text detection tools to analyze the originality of the content; organizing review experts to evaluate the rationality, logic, and professionalism of the documents; requiring the applicant to explain, clarify or provide further supporting materials for the key content in the document.
The original Notice is available here (Chinese only).
Ad Restrictions on HFSS Products in the UK to Take Effect on 5 January 2026, with Voluntary Compliance from Advertisers and Broadcasters from 1 October 2025
The UK Government has delayed the implementation of the Advertising (Less Healthy Food Definitions and Exemptions) Regulations 2024 (“Regulations”), which were due to come into force on 1 October 2025, in order to explicitly exempt ‘pure brand’ advertising from the Regulations. The Regulations will now come into force on 5 January 2026. However, despite this delay, advertisers and broadcasters have voluntarily committed to complying with the restrictions from 1 October 2025 (as originally planned).
In a letter addressed to the Government, representatives from the advertising industry stated their commitment not to run ads for specific, identifiable less healthy food or drink products. The letter was signed by key advertising bodies, such as the Advertising Association, ISBA, the IPA and IAB. The letter was also signed by major media organisations and broadcasters, including Channel 4, ITV, Sky and Reach plc, along with the Food and Drink Federation.
The Regulations will impose new restrictions banning ads for “identifiable” food and drinks that are high in fat, salt or sugar (“HFSS”) from being shown on TV before 9pm in the UK or at any time in online paid-for advertising. The aim of the Regulations is to reduce the exposure of HFSS marketing to children by restricting such advertising, with the forthcoming change following numerous governmental commitments regarding HFSS restrictions over the past few years.
What restrictions will be introduced?
The restrictions being introduced include:
a 9pm watershed for “identifiable” less healthy food and drink advertising on TV. This will also include all on-demand programme services (“ODPS”); and
the introduction of a complete ban on paid-for less healthy food and drink advertising online, including on non-Ofcom regulated ODPS.
The Regulations will apply to businesses involved or associated with the manufacture or sale of “less healthy” food or drink with 250 or more employees (which includes franchises) who pay to advertise HFSS products. Only HFSS products that are “identifiable” will be regulated.
Which products are covered by the Regulations?
HFSS products within the scope of the Regulations are those:
falling within one of the 13 product categories in the schedule to the Regulations;[1] and
scoring at least a certain number of points under the relevant Nutrient Profiling Model technical guidance .
To help businesses understand the types of products that may fall outside the scope of the Regulations, Department of Health and Social Care (“DHSC”) guidance provides a list of non-exhaustive exemptions (e.g. neither dried fruit snacks nor garlic bread are HFSS products).
There are also numerous exempt products that are already subject to separate regulations, which include (among others) infant formula, total diet replacement products, meal replacement products (which use an approved health claim) and food for special medical purposes.
Enforcement
The Regulations will be enforced by the Advertising Standards Authority (“ASA”) and Ofcom. Non-compliant businesses could face the following (among others):
enforcement notices and corrective action;
consumer and competitor complaints;
financial penalties where the business makes serious breaches; and/or
reputation damage, which may be incurred as result of the ASA (and the press) publicly reporting on any non-compliance.
Pure brand advertising
‘Pure brand’ advertising refers to advertising that focuses on promoting a brand’s overall identity and recognition, rather than specific product features or promotions. However, the ASA considered that it was not clear whether pure brand advertising was caught within the scope of the restrictions or not.
Following this, the DHSC published a number of statements to clarify its position regarding pure brand advertising. Ashley Dalton, Parliamentary Under-Secretary of State for Public Health and Prevention, stated on 22 May 2025 that “the Government intends to make and lay a Statutory Instrument (SI) to explicitly exempt ‘brand advertising’ from the restrictions. The SI will provide legal clarification on this aspect of the existing policy, as it was understood and agreed by Parliament during the passage of the Health and Care Bill. This will enable the regulators to deliver clear implementation guidance and mean that industry can prepare advertising campaigns with confidence”.
As such, businesses can still promote their brands insofar as any ads do not identify less healthy products and be exempt from the restrictions.
Next steps
With only months until the restrictions are introduced, businesses within the food and drink sector and those supplying them (such as advisors, agencies and consultancies) should familiarise themselves with the new advertising obligations and assess current product compliance using the nutritional scoring to determine how impacted they will be. With the ASA shaping its guidance so regularly, businesses should monitor updates to proactively ensure that they are keeping abreast of any developments. Businesses may also want to consider adapting their marketing strategy to promote healthier products or reformulating certain products so that they are no longer deemed “less healthy” and caught by the restrictions.
[1] These products include (among others): soft drinks (category 1); savoury snacks (category 2); breakfast cereals (category 3); confectionary (category 4); ice cream/lollies (category 5); cakes and cupcakes (category 6); sweet biscuits and bars (category 7); “morning goods”, which includes pastries and pancakes (category 8); desserts and puddings (category 9); sweetened yoghurt (category 10); pizza (category 11); chips and wedges (category 12); and ready meals, products ordered from a menu that are intended to be consumed as complete meal, breaded or battered seafood or meat product and sandwiches (category 13).
The authors wish to thank Royce Clemente for his contribution to this post.
Crack the Code: A Guide to the UK Stewardship Code 2026
On 3 June 2025, the Financial Reporting Council (“FRC”) published its new UK Stewardship Code 2026 (the “Code”). The voluntary Code applies to asset managers, asset owners and services providers with the aim of providing greater transparency on reporting in respect of the stewardship roles undertaken on behalf of clients and beneficiaries.
Although the UK Stewardship Code is voluntary, certain UK-regulated firms are required to disclose their adherence to it under the Financial Conduct Authority’s Handbook (specifically under Environmental, Social and Governance sourcebook and Conduct of Business sourcebook). The Code is widely embraced across not only the UK asset management sector, but also by international firms and non-UK managers, with a current status of 297 signatories managing £52.3 trillion in assets under management, making it highly relevant to a broad range of firms.
The Main Features of the new 2026 Code include:
1. Streamlined Reporting Requirements
The number of principles has reduced and reporting prompts have been shortened with the aim to avoid a “box-ticking” approach.
Signatories can now choose between submitting:
A combined report (to be made annually during one of the two application windows); or
Separate Policy and Context Disclosures (to be made every 4 years) and Activities and Outcomes Reports (to be made annually).
2. Refined Definition of Stewardship
The definition has been revised to clarify that stewardship is about the responsible allocation, management, and oversight of capital to create long-term sustainable value for clients and beneficiaries. The previous definition from the 2020 code was considered by some to imply by some that stewardship encompassed a duty to deliver on societal or environmental benefits in addition to the economic aspect.
3. Tailored Principles for Different Signatories
New specific principles have been introduced for proxy advisors, investment consultants and engagement service providers.
4. Optional Guidance for Non-Equity Asset Classes
The FRC has published draft guidance which can be found here to help organisations report on stewardship across asset classes beyond listed equity, such as fixed income or real estate.
What does this mean for Asset Managers, Asset Owners, and Service Providers?
In essence, the new Code will allow for more focused reporting as either a single combined report can be submitted or, alternatively, split into a separate policy and Context Disclosure and Activities and Outcomes Report – this will hopefully reduce the administrative burden and allow more flexibility with the stewardship role.
The Code will also likely trigger more substantive engagement as managers must show how stewardship activities (such as engagement or voting) have influenced investment decisions or outcomes.
The optional guidance will also provide asset managers the chance to report on stewardship with respect to non-equity assets which will be beneficial for diversified portfolios or multi-asset strategies.
Lastly, the Code now distinguishes between different types of signatories, so asset managers for example, are assessed based on their specific role and influence in the investment chain, and this more tailored approach may enhance the relevance of the principles to certain signatories.
Key Dates for applying
The Code will have two application windows for signatories or hopefully signatories to submit reports:
Spring 2026: applications from asset managers and service providers will be due by 30 April 2026. Applications from asset owners will be due by 31 May 2026.
Autumn 2026: all applications will be due by 31 October 2026.
Transition period
To support the move towards the UK Stewardship Code, 2026 will be treated as a transition year. All existing signatories submitting a renewal application will remain on the signatory list throughout this period. The reasoning behind the transition period is to recognise that organisations will have already met the requirements under the 2020 code and will seek to encourage them to embrace the updated Code without the need for reassessment by the FRC.
Current signatories to the Stewardship Code who are scheduled to report in the autumn cycle are still expected to provide their reports by 31 October 2025.
For new signatories that are not party to the current 2020 code, they will be subject to the full assessment process.
How can firms get ready for the new Code?
1. Review and Understand the 2026 Code
Check the refined definitions of stewardship and how it aligns with your firm’s investment philosophy or values. Familiarise your team with the revised principles paying attention to the new structure and reporting options.
2. Assess Current Practices
Consider conducting a gap analysis comparing your current stewardship policies and reporting against the new Code.
3. Choose a Reporting Path
Decide whether to submit a combined report or to split the reporting disclosures based on internal resources and complexity of your investment strategies.
4. Engage with Service Providers
If you use proxy advisors, consultants, or engagement services, ensure they are aware of the new Code and have measures in place to support your compliance. A review of contracts and expectations would also be beneficial to align with the Code’s tailored principles for these providers.
There is also the option to submit feedback on the draft guidance (especially for non-equity asset classes) before the 31 August 2025 deadline (Comments can be sent to [email protected]).
EDPB Finalizes Guidelines on Data Transfers to Third Country Authorities and Training Materials on AI and Data Protection
Data Transfers to Third Country Authorities
On June 4, 2025, the European Data Protection Board (“EDPB”) published the final version of Guidelines 02/2024 on Article 48 of the GDPR (the “Guidelines”) regarding data transfers to third country authorities.
The predominant focus of the Guidelines is to clarify that judgements or decisions from third country authorities cannot be automatically or directly recognized or enforced in an EU Member State, reaffirming that a request from a foreign authority does not inherently constitute a legal basis for the processing or a ground for the transfer.
The Guidelines highlight that international agreements may provide for both a legal basis and a ground for transfer, although the Guidelines also recognize that other legal bases or grounds for transfer could be considered where no international agreement exists or where such agreement lacks adequate safeguards. However, while other bases under Article 6 may be suitable, the EDPB clarified that Article 6(1)(b), which provides a lawful basis where processing is necessary for the performance of a contract, cannot be relied upon by a private entity in the EU as an appropriate legal basis to answer a request for transfer or disclosure from a third country authority.
For more information on the Guidelines, read our previous blog on the topic.
Training Materials on AI and Data Protection
During its June plenary meeting, the EDPB presented two new Support Pool of Experts projects, Law & Compliance in AI Security and Data Protection (aimed at data privacy officers and privacy professionals) and Fundamentals of Secure AI Systems with Personal Data (aimed at cybersecurity professionals, developers or deployers of high-risk AI systems), to provide training materials on AI and data protection.
The EDPB hopes that the projects will help provide professionals with essential competences in AI and data protection, creating a “more favorable environment for the enforcement of data protection legislation.”
With the reports, the EDPB, factoring in the “very fast evolution of AI,” has launched a one-year pilot project consisting of a modifiable community version of the reports, enabling external contributors to propose changes or add comments to the documents.
President Trump Announces New Travel Ban
On June 4, 2025, President Trump announced a new travel ban through a proclamation titled “Restricting the Entry of Foreign Nationals to Protect the United States from Foreign Terrorists and Other National Security and Public Safety Threats.” The ban, which echoes his 2017 efforts to restrict entry to the United States for nationals of certain countries deemed to be national security risks, expands the number of affected countries and divides them into two categories: Full Suspension of Entry and Partial Suspension of Entry. It will go into effect on June 9, 2025 with no announced end date.
Key provisions include:
Full Entry Bans: Nationals from the following 12 countries are barred from entering the United States: Afghanistan, Burma (Myanmar), Chad, Republic of the Congo, Equatorial Guinea, Eritrea, Haiti, Iran, Libya, Somalia, Sudan, and Yemen.
Partial Entry Ban: Seven additional countries—Burundi, Cuba, Laos, Sierra Leone, Togo, Turkmenistan, and Venezuela—face the following partial entry restrictions: halting issuance of new visitor (B1/B2), student (F, M), and exchange (J) visas and reduction in validity for nearly all other nonimmigrant visa categories, including all employment visa categories (subject to the exceptions listed below).
Justification: The proclamation cites the following national security concerns as the basis for the new ban, with varied reasons listed for each suspended country: sponsorship of terrorism, lack of sufficient government to issue passports and civil documents, lack of appropriate vetting and screening measures, high overstay rates for past visa recipients, and refusal to accept back nationals being removed from the United States, among others.
Applicability: The travel ban only applies to nationals of the designated countries who, on June 9, 2025: (1) are outside the U.S. and (2) do not hold a valid, issued U.S. visa.
Exceptions and Waivers:
Categorical Exceptions: The ban does not apply to the following:
U.S. Lawful Permanent Residents (LPR or green card holder).
Dual nationals of the restricted countries traveling on the passport of an unrestricted country (e.g., Haitian/French dual national entering the U.S. on their French passport).
Individuals traveling on most diplomatic visas.
Athletes and related personnel and families entering to participate in the World Cup, Olympics, or other “major sporting event.”
Immediate family members seeking to enter on immigrant visas (i.e., applying for LPR status from outside the US).
Most applicants for adoption.
Certain Special Immigrant Visas (Afghan and US Government employees).
Immigrant visas for certain ethnic and religious minorities form Iran.
Those granted asylum or protections under the Convention Against Torture (CAT), and those admitted to the US as a refugee.
Case-by-case Waivers: The Attorney General and Secretary of State may designate individual exceptions for those entering in the national interest of the US. Mechanisms for these waivers have not been announced and will likely be implemented through U.S. embassies and consulates as during President Trumps first term.
The new travel ban is expected to face legal challenges, likely even before it’s effective date five days after its issuance. It is drafted to narrow the scope and reasons for the restrictions, so it remains to be seen whether the courts will allow it to go into full or partial effect on June 9, 2025.
CODEX ALIMENTARIUS: Main Outcome of the 44th Committee on Methods of Analysis and Sampling (CCMAS44)
The 44th session of the Codex Alimentarius Committee on Methods of Analysis and Sampling (CCMAS44) successfully addressed all topics on its agenda. CCMAS44 endorsed methods of analysis from commodity standards and recommended approval of others e.g., on chocolate, chocolate products and other cocoa-based products, fruits juices and nectars, fish products, follow-up formulas, food grade salt. CCMAS44 held intense discussions on methods of analysis for the protein content in quinoa and on the method for the determination of the moisture content in whey powder. CCMAS44 agreed also to establish an expert group under the auspice of the IFU to inform the work on the methods proposed for fruit juices and nectars. CCMAS44 finally agreed on rounded numeric performance criteria for the determination of nitrate and nitrite ions in food matrices. CCMAS44 decided also to start working on methods for the identity of “sugars and honey”. It also endorsed the method discussed during the last CCNFSDU44 meeting on dietary fiber with a further question back to CCNFSDU with a proposed amendment to a more comprehensive footnote. CCMAS44 adopted a comprehensively amended information document about sampling plans (with an entire new part 3 on Bayesian sampling plans) to inform the implementation of the current guidelines on sampling. CCMAS44 advanced the work on a consolidated list of methods for the presence of allergens that would be subject to another intersessional work. CCMAS44 re-established EWGs (including one to advance the harmonization of names for principles in the general standard of methods of analysis) and agreed to convene a working group in person immediately prior its CCMAS45 session (2026) [ii].
See more information available about CCMAS44 working documents quoted in this article [iii], as well as in the official report of the CCMAS44 meeting [iv]. Codex standards, guidelines, codes of practices and related miscellaneous texts quoted in this article are readily and freely available [v].
ENDORSEMENT OF METHODS OF ANALYSIS AND SAMPLING AND REVIEW OF METHODS INCLUDED IN THE GENERAL STANDARD FOR METHODS OF ANALYSIS (CXS 234, 2024 version)
Methods applicable cocoa products and chocolate; fish and fishery products; foods for special dietary uses; fruit juices and nectars; milk and milk products; and miscellaneous products such as dried meat and food grade salt
CCMAS44 agreed to (i) endorse all the methods and amended methods resulting from the work of pre-session VWG and an in-Session WG (IWG as summarized in CCMAS44’s CRD02 Rev.1 working document); (ii) revoke and retype the methods, as included in Appendix II of CCMAS44 report); (iii) inform the CCNFSDU that the methods of analysis submitted by it to CCMAS were forwarded for adoption by CAC48 and all the relevant methods of analysis be revoked consequentially. CCMAS44 agreed to re-establish its EWG on methods chaired by Canada (and not customarily by Australia), for further consideration on (a) cocoa products and chocolate; (b) foods for special dietary uses; and (c) fruit juices and nectars. CCMAS44 praised the work of Dr Richard Coghlan (Australia), as the outgoing chair of the EWG, VWG and IWG. CCMAS44 also agreed to re-establish a Physical Working Group (PWG) on methods endorsement led by the USA and co-led by Hungary, Japan and Uruguay to meet immediately prior to CCMAS45, to (a) consider all methods of analysis and sampling submitted by Codex Committees for endorsement, (b) the outcomes of the work of the EWGs on methods including retyping of the ISO 1871 method for determining protein in quinoa (see further below); the proposals on the workable packages on chocolate and cocoa-based products as well as on sugars and honey, and any other matters referred by other Codex Committees or submitted by Members and Observers.
CCMAS44 concluded favorably its work on methods applicable to (a) cocoa products and chocolate; (b) fish and fishery products; (c) foods for special dietary uses; (d) fruit juices and nectars; (e) milk and milk products; and (f) miscellaneous products such as dried meat and food grade salt. CCMAS44 did not propose changes to existing methods already included in CXS 234 applicable to (a) cereals, pulses and legumes and derived products; (b) fruit juices and nectars; (c) milk and milk products; and (d) miscellaneous products (e.g., dried meat and food grade salt). CCMAS44 also revoked methods as consequential changes from other adopted for the same standardized food [vi].
In order to advance the technical discussions on the remaining work package of methods in fruit juices and nectars, CCMAS44 agreed to convene an expert group under the auspices of the International Fruit and Vegetable Juices and Nectars Association (IFU) to (a) determine the ranges of parameters relevant for quality and authenticity; (b) determine the range of measurements or maximum LOD; (c) evaluate the list of endorsed methods included in CXS 234 and those listed in the commodity standard CXS 247 (2024 version) ; (d) determine/consider if the presently endorsed methods are still appropriate and “fit-for-purpose” to control the “quality and authenticity” of fruit juices; (e) determine/consider if any of the presently endorsed methods should be revoked and eliminated from CXS 234 and CXS 247; (f) assess whether any new method(s) could be considered by the CCMAS endorsement working group in the future, for addition to CXS 234 for the general provision of juice “quality and authenticity”; and (g) collate relevant validation data for any new procedures that CCMAS could consider in the future. In particular, the expert group shall identify clearly which methods should be maintained in CXS 234, revoked, or replaced. Codex Members were invited in contributing to this work by contacting directly IFU and nominate nationally relevant fruit juice experts to participate eventually to the work of that IFU-led expert group, in their individual capacity. CCMAS44 praised the coordinating work ensured by Dr David Hammond [vii] at IFU.
With regards the work package on methods for chocolate and chocolate products and other cocoa-based products, CCMAS44 agreed to re-establish an EWG chaired by Serbia and co-chaired by USA to continue reviewing the relevant methods listed. With regards to the work package of relevant methods for sugars and honey, CCMAS44 agreed to establish an EWG chaired by Uruguay to review these methods applicable to sugars and honey. Both EWGs should submit their report sufficiently in advance to CCMAS45.
As examples of methods endorsed, CCMAS44 agreed to retain the method for determination of amino acid nitrogen in fish sauce, AOAC 920.04 and AOAC 920.03, in CXS 234. CCMAS44 endorsed AOAC 935.47 and AOAC 937.09B as Type III methods. CCMAS44 agreed to transfer the method for the determination of sodium chloride in food grade salt as described in the Standard for food grade salt (CXS 150) with editorial amendments to CXS 234. CCMAS44 also agreed with an update to the hyperlink in the footnote referencing the method for iodine in food grade salt in CXS 234. In addition, CCMAS44 agreed to transfer the related sampling plan to CXS 234. CCMAS44 noted that the sampling plan was currently incompatible with the provision for sodium chloride and would require further review and agreed that such review could be taken up later under the work on the review of sampling plans and inform CCFA accordingly. CCMAS44 also noted the editorial amendment to the principle for the example methods AOAC 2015.06 / ISO 21424 |IDF 243 that meet the numeric performance criteria for copper in milk fat products and agreed to the removal of ISO 5738 | IDF 76 and AOAC 960.40 as example methods. All relevant commodity committees will be informed accordingly.
CCMAS44 further requested CCNFSDU to consider (a) whether it would be appropriate to develop numeric performance criteria (NPC) for methods of analysis for Type II and Type III methods; or (b) develop additional methods for follow-up formula to align with those for infant formula for common provisions (see Part 3.2 of Appendix II of CCMAS44 report). With regard to the recommendation for CCNFSDU to consider developing NPC, the chair of the VWG clarified that CCMAS’s preference was for committees to consider this approach. CCMAS44 noted that this approach would provide flexibility for countries to choose methods that meet these criteria. This approach was in accordance with the Procedural Manual that preference should be given to set NPC. CCMAS44 further agreed that the name and format for principles for the corresponding methods for infant formula included in CXS 234 would not be aligned with those agreed for follow-up formula at this stage pending ongoing discussion on the harmonization of names and format for principles. It was noted that CCNFSDU was also in the process of reviewing all methods for provisions in standards under their purview to assess their fitness-for-purpose and to identify additional/replacement methods, or other corrections.
Dietary fibre reference in Table 6 of CXS 234 “Methods of analysis for dietary fibre: Guidelines for use of nutrition and health claims (CXG 23, 2013 version): Tables of conditions for claims”
CCMAS44 endorsed the methods proposed by the outcome of the EWG and VWG (as presented in CCMAS44 CRD02 Rev.1 working document), together with the footnote proposed by CCNFSDU44 which reads “Isolated, purified, and/or synthetic fibres captured by AOAC 2022.01/ICC Standard 191/AACC 32-61.01 that do not meet the Codex definition of dietary fibre in the Guidelines on nutrition labelling (CXG 2-1985) should be subtracted from the final measurement, where deemed appropriate by competent authorities.” CCMAS44 also agreed to request CCNFSDU to clarify whether the footnote was only applicable to the methods AOAC 2022.01/AACC 32-61.01/ICC Standard No. 191. If not, the footnote should then apply to all methods for dietary fibers included in Table 6 of CXS 234, or a subset of these methods listed in that Table 6. Should CCNFSDU agrees, then CCMAS would delete the footnote applied only to AOAC 2022.01/AACC 32-61.01/ICC Standard No. 191.
CCNFSDU was further asked to consider a proposed amendment to the current footnote 2 included in Table 6 of CXS 234. Such proposed amendment would address the concerns raised that the footnote forwarded by CCNFSDU should be consistently applied to all methods in CXS 234, Table 6. Should CCNFSDU agree to amend footnote two, then the footnote forwarded by CCNFSDU to accompany AOAC 2022.01/AACC 32.61.01/ICC Standard No. 191 could then be deleted. The recommended additional phrase to existing footnote 2 is shown in bold as follows: « Two issues are left for national authorities: to include monomeric units 3-9 and which isolated or synthetic compounds have physiological benefit. (Refer to the Guidelines on nutrition labelling (CXG 2-1985)). Isolated, purified, and/or synthetic fibres captured by the analysis that do not meet the Codex definition of dietary fibre in CXG 2-1985 should be subtracted from the final measurement, where deemed appropriate by competent authorities. »
SPECIFIC DISCUSSIONS ON SOME METHODS
Determination of the protein content in quinoa products (conforming to CXS 333, 2020 version)
This agenda was very much disputed. CCMAS44 however agreed to retain the method for determining protein in quinoa already in CXS 234 as a Type IV method (method ISO 1871), noting the reservation of Peru. CCMAS44 requested the re-established PWG on endorsement to consider retyping of ISO 1871 method for determining protein in quinoa based on the information provided in CCMAS44’s CRD19, referring to a comprehensive comparative analytical work performed by several national metrological institutes based in Latin America in this matter. Brazil also suggested an extension of Extension of the ISO 20483 method to quinoa offered as an alternative method. It was suggested that the necessary validation studies could be performed and discussed again within ISO to determine if this method could be extended from cereals and pulses to a pseudocereal such as quinoa. ISO indicated that a decision to extend ISO 20483 to quinoa should be subject to a formal request according to ISO procedures. In that regard, it was also noted that ISO might even end up validating a dedicated method (to Quinoa) instead of extending the existing ISO 20483 to Quinoa [viii].
Determination of the moisture content in whey powders (conforming to CXS 289, 2022 version)
CCMAS44 agreed to forward the 102NP method with the footnote as amended in paragraph 41 to CAC48 for adoption as a Type IV method (Appendix II, Part 1.5), for whey powder, on an exceptional basis, in line with Section 3.9 (v) of the information document “Comprehensive guidance for the process of submission, consideration and endorsement of methods for inclusion in CXS 234” and to make the consequential amendments to Appendix XI of CXS 234 (2024 version).
Determination of the particle size of milling products using sieve analysis for use on edible cassava flour and gari
CCMAS44 acknowledged that no amendment to CXS 234 was necessary for the moment, despite some technical elements presented in CCMAS44’s CRD9 document by the International Association for Cereal Science and Technology (ICC) about the revision of ICC Recommendation N. 207, to render it applicable to edible cassava flour and to gari (in particular to include appropriate sieve sizes). CCMAS noted that the ICC revision work was in its final approval stage at ICC level. It was recalled that the current ICC Recommendation N. 207 had already been endorsed by CCMAS43.
SAMPLING PLANS
Information document to the General guidelines on sampling (CXG 50, 2023 version) – e-book with sampling plans applications
CCMAS44 considered the outcome of an inter-sessional EWG chaired by New Zealand and co-chaired by Germany to develop an information document on how implementing the revised Codex Alimenta-rius General guidelines on sampling (CXG 50, 2023 version). Such information document should not be considered as an official Codex text, but simply there to inform countries and food business operators for internal use by CCMAS and other Codex commodity committees. CCMAS44 agreed to publish the revised information document (as presenting in CCMAS44 report’s Appendix IV) and inform Codex committees of the publication of this document. It also agreed to remove the current information document titled “Practical examples of sampling plans” from the Codex website. Finally, it was noted that as other applications (Apps) were being developed, they would be forwarded to the Codex Secretariat for inclusion to the list of applications in the information document and that CCMAS would be informed accordingly. Other supporting resources, such as webinars, would be made available on the CCMAS webpage as well. The agreed information document should also be considered a living document, meaning CCMAS could update it when needed and where warranted [ix].
Review of sampling plans in the general standard for methods of analysis (CXS 234, 2024 version) and development of sampling plans for lots consisting of bulk material/heterogenous lots, including for mycotoxins
CCMAS44 agreed to continue developing the various discussion papers on (a) the review of sampling plans in CXS 234, particularly the various approaches to placing the sampling plans in the standard(s), the format and content of the presentation of sampling plans, and the responsibility for assessing the parameters that determine the selection of the appropriate sampling plan for a given commodity/provision combination; and (b) the development of sampling plans for bulk materials/heterogenous lots, including mycotoxins, including proposed sampling plans for consideration by CCMAS45, and to inform CCCF of this decision. CCMAS44 also noted that work on sampling plans for bulk materials/heterogenous lots, including for mycotoxins, should be conducted in close collaboration with CCCF; and noted the possible need for CCMAS to provide support to commodity committees in their review of sampling plans. CCMAS44 agreed to re-establish an EWG, chaired by New Zealand and co-chaired by Germany to advance the revisions of these discussion papers and prepare a dedicated discussion paper on sampling plans for bulk materials/heterogenous lots, including for mycotoxins, to be discussed by CCMAS45.
OTHER ASPECTS
Numeric performance criteria for the determination of nitrate and nitrite ions in food matrices
CCMAS44 considered the outcome of an intersessional EWG work led by Australia and co-chaired by the USA, including discussions held by the in session VWG. CCMAS44 agreed with the Numeric Performance Criteria (NPC) elaborated (and rounded up during the session) for nitrate and nitrite in three food matrices (i.e., ripened cheeses; processed comminuted meat, poultry, and game products; and, heat-treated processed meat, poultry, and game products in whole pieces of cuts) and agreed to forward these NPC back to CCFA for information. Initial CCFA request was for CCMAS to establish NPC for methods of analysis in these specified food matrices; provide information on available analytical methods suitable for both the adopted MLs and the lowest proposed residue levels; and clarify whether the methods measured nitrate and nitrite ions separately or in combination [x].
Methods of analysis for precautionary allergen labelling
CCMAS44 considered the outcome of an EWG led by the USA and its prior consideration by the IWG. Due to several factors related to the presentation of the list of methods, the need for further consideration, and new method validation guidelines, CCMAS44 agreed to re-establish an EWG chaired by USA and co-chaired by UK to finalize the review of the methods presented at CCMAS 44 against the recently updated CEN and AOAC validation guidelines and performance requirements [xi] and simplify the presentation of the methods and their validation status. CCMAS44 tasked the new EWG to draft a response to CCFL49 for consideration by CCMAS45. CCMAS44 confirmed that the EWG would not have to address the second question from CCFL regarding sampling plans.
Nitrogen to protein conversion factors for commodities approved by Codex Commodity Committees
CCMAS agreed to forward the list of Nitrogen to Protein conversion factors as amended, for approval by CAC48 and future inclusion as an Annex to the General Standard on Methods of Analysis (CXS 234), while noting some inconsistencies with these conversion factors especially for various soy products, and it suggested that these factors should be reviewed in the future. CCMAS44 noted that these factors would need to be reviewed by the relevant Codex Commodity Committees to ensure further consistency [xii].
Harmonization of names and format for principles identified in CXS 234, 2024 version
CCMAS44 considered the outcome of an intersessional EWG work led by Brazil and Chile. Purpose of this work was to (i) establish a centralized database consolidating all methods relevant to CCMAS; (ii) harmonize terminology for analytical methods across Codex standards; and (iii) develop a publicly accessible database on methods of analysis and sampling for inclusion on the Codex website. The work of the EWG to develop harmonized terminology for analytical methods, format for principles and provision names was thus to support the development of such a structured database. CCMAS44 significantly updated the document but was unable to address all the issues. CCMAS44 agreed to re-establish the EWG, led by Brazil and co-led by Chile to further revise the “Harmonization of Names for Principles in CXS 234-1999”, including its annexes A, B, and C, using the text included in CCMAS44 report Appendix VI as its working basis, with the aim of ensuring that the principles in CXS 234 are properly included and continue discussions on Annex D, focusing on separating the provisions into three distinct groups (editorial or no-change provisions, provisions linked to active committees, provisions linked to inactive committees) and making corresponding recommendations [xiii].
Endnotes
[i] Food Production Systems Engineer; Food Standards, Safety and Regulatory Specialist; Counsellor at Keller and Heckman LLP Brussels office
[ii] CCMAS is the specialised body of the Codex Alimen-tarius Commission Food Standard Program dealing with the most complex scientific and technical matters relating to (a) methods of analysis (i.e., analytical chemistry); (b) sampling plans (i.e., statistical analysis) other than those covered by specialised horizontal committees, and (c) any other issues related to these. In addition, CCMAS endorses the methods proposed by Codex Committees developing commodity and food standards. As such, CCMAS outputs are key to help countries and food business operators in performing their conformity assessment to existing Codex food standards, hence ensuring food safety and authenticity of such standardized foods, helping minimizing food fraud, and guaranteeing a better traceability and fair practices in international trade of these food supplies.
CCMAS44 was held virtually through five 3-hour daily sessions from May 5 to 8, 2025 and was preceded by a pre-session virtual working group (VWG) on “Endorsement”, held on April 29 and 30, 2025 and which prepared decisions for CCMAS44 on nearly all agenda items (item 2, 3, 4, 5, 7 and 8). The PWG also continued its work during part of the plenary as an in-session working group (IWG). CCMAS44 adopted its draft report virtually on May 14, 2025. CCMAS44 was attended by 74 Member countries, one Member organization and 21 Observer organizations. The session was chaired by Dr Attila Nagy, Director, National Food Chain Safety Office (NFCSO) and co-chaired by Dr Zsuzsa Farkas, Head of Department, Department of Digital Food Science, University of Veterinary Medicine, Budapest. The next CCMAS meeting (CCMAS45) was tentatively scheduled from 9 to 13 March 2026, to be held in person in Budapest (Hungary) and be preceded by the PWG on “Endorsement” and a regular meeting of the contact group of inter-agencies developing and validating methods of analysis and sampling (i.e., composed of ISO, IDF, AOAC International, FOSFA International, USP-Food Chemical Codex, AACC, ICC, AAFCO, NMKL, ICUMSA, and the international association MoniQA).
[iii] See https://www.fao.org/fao-who-codexalimentarius/ meetings/detail/en/?meeting=CCMAS&session=44&
[iv] See https://www.fao.org/fao-who-codexalimentarius/ meetings/en/
[v] See https://www.fao.org/fao-who-codexalimentarius/ codex-texts/en/
[vi] Adopted methods — Cocoa products and chocolate: Updated methods on fat-free cocoa solids, fat-free milk solids (determined as milk protein), Total Fat (on a dry basis), Cocoa shell (determined as spiral vessel count), cocoa shell (determined as stone cell count). Fish and fishery products (Quick Frozen Fish Sticks (Fish Fingers), Fish Portions and Fish Fillets – Breaded or in Batter – CXS 166 (2017 version)): Fish content (declaration) – Nitrogen, Moisture, Total Fat, Ash. Performance criteria for the methods for sodium chloride and for salt determined as chloride expressed as sodium chloride for boiled dried salted anchovies; fish sauce; salted Atlantic herring and salted sprat; salted fish and dried salted fish of Gadidae family of fishes; Sturgeon caviar. Foods for special dietary uses: Follow up formulas – Vitamin A palmitate (retinyl palmitate), Vitamin A acetate (retinyl acetate), Vitamin A (two AOAC methods), Vitamin E, Vitamin D, Thiamine, Riboflavin, Niacin, Vitamin B6, Vitamin B12, Pantothenic acid, Folic acid, Vitamin C, Biotin, Iron, Calcium, Phosphorous, Magnesium, Sodium, Chloride, Potassium, Manganese, Iodine, Selenium, Copper, Zinc, Total Nucleotides, Choline, Myo-innosi-tol, L-carnitine, Total amino acids (excluding taurine and tryptophan) and Tryptophan both for some selected uses specified in CXS 156 (2023 version), Total fatty acids, Crude Protein, Folic acid (addition of ISO 20631). All Foods: content of insoluble and soluble dietary fibres of higher and lower molecular weight (applicable in food that may, or may not, contain resistant starches (AOAC 2022.01/AACC 32-61.01/ICC Standard n° 191 as type I method) with note relating to the subtraction rule resulting from Codex definition of dietary fiber as deemed appropriate by the competent authority. Fruit juices and nectars: L-Ascorbic acid (4 methods), Citric acid (all uses), High Fructose Corn Syrup and Hydrolyzed Inulin Syrup (in apple juices as permitted ingredients), L-Malic Acid, Saccharin, Soluble solids, Sucrose, Phosphorous/Phosphate. Milk and milk products:amendment to the commodity standard on the moisture content to add whey powders to the list, Numeric Performance Criteria for methods used for the quantification of Copper and Iron. Miscellaneous products -Dried Meat: Chloride as sodium chloride; Food Grade Salt: Iodine (only for products fortified with Iodate) and Sodium Chloride and description of the determination of sodium chloride and related sampling method for food grade salt.
Revoked methods — Fish and fishery products (Salted Fish and Dried Salted Fish of the Gadidae Family of Fishes – CXS 167 (2018 version): Determination of salt content, Salt saturation. Follow up formulas: Vitamin A by colorimery (AOAC 974.29, Type IV), Iodine (milk-based formula, AOAC 992.224 by Ion selective potentiometry). All foods: previously mentioned methods for dietary fibers (AOAC 2011.25 and AACC Intl 32-50.1). Fruit Juices: Carbon dioxide (additives and processing aids) by IFU n°42, Malic acid by EN 1138.
Unchanged methods — Cereals, Pulses and Legumes and derived products: Quinoa – protein content (type IV) until further work discussed. Fruit Juices and Nectars: Malic acid (additives); Preservatives in fruit juices (sorbic acid and its salts). Milk and milk products: Whey powder — Water (moisture) noting that the water content is excluding the crystallized water which is bound to lactose (that part being generally known as the moisture content). Dried meat: Chloride as sodium chloride (≥ 0.25% or ≥ 1.0%).
Methods for further consideration until CCMAS45 with some amended during the IWG/CCMAS44 sessions – Chocolate and Chocolate Products: Cocoa butter (determined as fat); Milk fat; Moisture; Moisture (Determined as Water); Non-cocoa butter vegetable fat; Fat; Free fatty acids; Unsaponifiable matter; Cocoa butter equivalents in cocoa butter and plain chocolate; Cocoa butter Equivalents in Milk Chocolate; Determination of center and coating of filled chocolate (all methods approved for the chocolate type used for the coating and those approved for the type of center concerned). Cocoa powders (cocoa) ad dry cocoa-sugar mixtures: Moisture (Determined as Water); Determination of full-fat cocoa powder, fat-reduced cocoa powder, and highly fat-reduced cocoa powder; Determination of cocoa butter (to be developed). Follow-up formula: Riboflavin, Niacin (x2), Vitamin B6 (x2), Vitamin B12 (x2), Folic acid (x2), Biotin, Iron (x2), Calcium (x2), Phosphorous, Magnesium (x2), Sodium, Chloride, Potassium, Manganese, Selenium (x4), Copper, Zinc, Choline. Fruit juices and nectars: Benzoic acid and its salts – Sorbic acid and its salts, Benzoic acid and its salts, Sulphur dioxide alts, Sulphur dioxide (x3), Tartaric acid in grape juices, Total Nitrogen, Acetic acid (acetate), Alcohol (ethanol), Anthocyanins, Ash, Beet sugar, Benzoic acid, C13/C12 ratio of ethanol derived from fruit juices, Carbon stable isotope ratio (x2), Carotenoids (as total carotenoids and as individual groups), Centrifugable pulp, Chloride (expressed as sodium chloride), Chloride, Essential oils, Essential oils in citrus fruit, Fermentability, Formol number, Free amino acids, Fumaric acid, Glucose Fructose and Sucrose/Saccharose, Glycerol, Hesperidin and Naringin (x2), Hydroxymethylfurfural (x2), D-isocitric acid (x2), D- and L- Lactic Acid, L-Malic/Total Malic ratio to detect added D-Malic acid, pH value (x2), Proline, Relatice density (x2), Sodium Potassium Calcium and Magnesium, D-Sorbitol, Starch, Titratable acids, Total dry matter at 70°C, Total solids (by microwave oven drying), Vitamin C (dehydro-ascorbic acid and ascorbic acid). Fruit juices: Carbon stable isotope ratio of sugars from fruit juices. Apple Juice: High Fructose Corn Syrup and Hydrolyzed Inulin. Orange juice: Sugar beet derived syrups in frozen concentrated orange juice.
[vii] See https://ifu-fruitjuice.com/page/LCHP2
[viii] CCMAS44 recalled that CCMAS43 endorsed the method for determining protein in quinoa (ISO 1871) as Type IV, noting that the typing could be reconsidered should more information be provided. The VWG considered replies to CL 2024/91-MAS, but information provided at that time of the IWG met did not allow the VWG to find any consensus on retyping the ISO 1871 method as a type I method. During the VWG, another method was also offered as an alternative Type I method for the determination of protein in quinoa (i.e., ISO 20483), but it was noted a lack of specific validation data of that method for pseudocereals such as quinoa. The ISO representative informed the VWG that quinoa could be added in future as a validated matrix and that ISO might consider taking up that work if needed (based on an ISO member internal request and ISO working procedures). CCMAS44 extensively discussed the information submitted by seven countries from Latin America (Bolivia, Peru, Ecuador, Colombia, Chile, Uruguay, and Argentina), as presented in CCMAS44’s CRD19 document. Such information was recognised to be supportive of a retyping of the method ISO 1871 as Type I (official method). Information in CRD19 informed CCMAS44 on details about the validation studies and process, the reagents used, the conditions of the methods, the catalysts used, while noting that a single reference material for quinoa was also used during the validation studies. An explanatory footnote was proposed (e.g. regarding conditions, the catalysts and reagents used), noting that the same footnote would be consequentially applied to the ISO 1871 method for determining protein in Tehena to ensure consistency. It was also reiterated that CCMAS should apply the same decisions regarding the use of ISO 1871 for the determination of protein to Tehena to ensure consistency. Members and Observers which did not support the proposal expressed concerns that ISO 1871 was a general guidance and not a step-by-step method, since it did not specify conditions and chemicals. In accordance with the definition for a Type I method, a detailed analysis of the steps taken across the different validation studies would be necessary to retype ISO 1871 from Type IV to Type I, even though there was no issue with the validation data themselves. CCMAS44 agreed that this topic should be deferred to the PWG on endorsement that would meet immediately prior to CCMAS45 to allow more time to review CRD19.
[ix] The document provides additional information about the sampling plans referred to in the CXG 50, by providing examples for each of the main types of sampling plans, additional information on other sampling plans, including Bayesian plans, and links to the Apps for designing and evaluating such sampling plans. App 1 evaluates and designs sampling plans for homogeneous lots, which is included in the information document by link. Apps 2 and 3 were being developed and would be included in the information document once available. As more Apps are developed, links to these Apps would be included also in the information document. Other resources (e.g. video clips, webinars) would be provided to the extent possible on Codex website (such as the one held on April 28, 2025). As recommended during the two previous CCMAS sessions on this matter for including sampling plans involving smaller sample sizes or less testing, part 3 of the document includes presentation of Bayesian plans, based on risk- or utility-based approaches, while the overall rest of the document structure remained largely unchanged. CCMAS44 discussed an edited version of the information document, as included in CCMAS44’s CRD35. Some concerns were expressed by Japan about the inclusion of Bayesian plans in the information document, as the scope of current CXG 50 (2023 version) was restricted to acceptance sampling plans for inspecting isolated homogeneous lots (i.e., and therefore not using Bayesian approaches). It was clarified that Bayesian sampling plans provided a potential way to reduce testing costs and was an area of still on-going international scientific work, including within ISO, about which a technical report on applying Bayesian methods to acceptance sampling was expected to be published end 2025. It was also suggested that the information document may need to be complemented with information relating to the Codex Principles for the Use of Sampling and Testing in International Food Trade (CXG 83, 2015 version).
[x] CCMAS44 noted the NPC were developed for both adopted MLs and the lowest proposed residue levels in the relevant food matrices. It also reviewed the list of methods submitted by CCFA, including one recently published method added and provided a summary of the method validation data (in Appendix 3 of CCMAS44 working document CX/MAS 25/44/10) for assessment against the NPC. “Examples of applicable methods that met the established criteria” that met the NPC had been identified from Appendix 3 and were presented in Appendices 1 and 2 of CX/MAS 25/44/10. The revised versions were therefore presented in Appendix VI of CCMAS44 CRD02 Rev.1. It was highlighted that should CCFA decide to revise the lowest proposed residue levels, suitable analytical methods should be selected based on the information provided in Appendix III of CCMAS44 working document CX/MAS 25/44/10.
[xi] (a) Dr. Latimer, George W, Jr. (ed.), ‘Validation Procedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices’, in Dr. George W Latimer, Jr. (ed.), Official Methods of Analysis of AOAC INTERNATIONAL, 22nd Edition (New York, 2023; online, AOAC Publications, 4 Jan. 2023). (b) EN 17855:2024 Foodstuffs – Minimum performance requirements for quantitative measurement of the food allergens milk, egg, peanut, hazelnut, almond, walnut, cashew, pecan nut, Brazil nut, pistachio nut, macadamia nut, wheat, lupine, sesame, mustard, soy, celery, fish, mollusks and crustaceans, CEN, 2024.
[xii] The proposed conversion factors for adoption were included in Appendix III of the CCMAS44 report. Nitrogen To Protein Conversion Factors For Commodities Approved By Commodity Committees Proposed For approval by CAC48 and Future Inclusion as an Annex to CXS 234: Animal Protein Source: Milk and milk products – 6.38; Meat and meat products – 6.25. Infant formula: The calculation of the protein content of infant formulas prepared ready for consumption should be based on N x 6.25, unless a scientific justification is provided for the use of a different conversion factor for a particular product. The value of 6.38 is generally established as a specific factor appropriate for conversion of nitrogen to protein in other milk products, and the value of 5.71 as a specific factor for conversion of nitrogen to protein in other soy products. Follow-up formula for older infants and product for young children: The calculation of the protein content of the final product ready for consumption should be based on N x 6.25, unless a scientific justification is provided for the use of a different conversion factor for a particular product. The protein levels set in this standard are based on a nitrogen conversion factor of 6.25. For information the value of 6.38 is used as a specific factor appropriate for conversion of nitrogen to protein in other Codex standards for milk products. In accordance with the Guidelines on nutrition labelling (CXG 2-1985), the calculation of protein for nutrient declaration purposes should be based on a conversion factor of 6.25, unless a different factor is specified in the present annex. Fish and fishery products: Crackers from marine and freshwater fish, crustaceans and molluscan shellfish – 6.25. Plant Protein Source: Wheat, wheat protein products – 5.71; Maize – 6.25; Quinoa – 6.25; Sorghum – 6.25; Millet (grains and flour) – 5.71; Gochujang – 6.25. Soya and non-fermented soybean products: 5.71; Tempe – 5.71; Natto – 5.71; Cheonggukjang – 5.71. Vegetable protein Products (VPP): Products produced by separation from wheat and soya grains and flours of certain non-protein constituents (starch, other carbohydrates) – 6.25. Soy protein products – 6.25. CCMAS44 noted that the list would continue to be updated as new nitrogen to protein conversion factors were agreed by commodity committees. It was also explained that in cases where such nitrogen to protein conversion factors had been developed by a committee adjourned sine die (or dissolved) and needed further review, the Codex Secretariat would look into some practical modalities for such a review.
[xiii] The document included in Appendix VI of CCMAS44 report is entitled “Harmonization of Names for Principles in CXS 234-1999” is composed of the following sections: 1. General Guidelines; 2. Definitions (Principle, Biological assay, Chromatography, Colorimetry, Gravimetry, Potentiometry, Sensory assay, Spectroscopy, Mass Spectrometry (MS), Titrimetry, Visual examination, Volumetry); 3. Criteria Used (3.1. Assays Whose Results are Method Dependent – e.g., Moisture at 105°C – Gravimetry, etc.; 3.2 Assays Whose Results are independent of the method – e.g., Nitrate – UV-Vis (ultraviolet visible) – Spectrophotometry, etc.); 4. Additional information (to consider removing any additional information such as “ashing”, “ceramic filter filtration”, etc.); Annex A — Principles of Methods of Analysis (e.g.; Anodic Stripping Voltammetry (ASV), etc.); Annex B – Acronyms and abbreviations (e.g., AAS Atomic Absorption Spectrophotometry; etc.); Annex C List of Acronyms for Standard Method References (e.g., AACC, USP, ISO, etc.); and the to-be-developed Annex D – List of Provisions. CCMAS44 also noted the view that the provisions in CXS 234 should remain aligned with those in the commodity standards to avoid misalignment and confusion. It was further emphasized that the provisions in CXS 234 reflected the original commodity standard provisions and should not be oversimplified as this could remove essential context. Some provisions indicated method complementarity and had been the subject of extensive discussions. Some of the proposed changes in Annex D carried significant implications. Therefore, consultation with commodity committees and other relevant committees was necessary and for better clarity future proposed changes would be presented in three groups: those requiring no changes or only editorial changes; those changes linked to active commodity committees; and those changes related to adjourned sine die or abolished commodity committees. The Codex Secretariat also clarified that, in general, CCMAS did not have the authority to make such changes to provisions falling within the remit of a Commodity Committee adjourned sine die (or abolished/dissolved). If necessary, such proposals should be referred to the CAC, as per the mechanism followed precedingly with the proposed amendment of a provision in section 3.3 of the Codex Standard for Edible Casein Products (CXS 290).
The BR Privacy & Security Download: June 2025
On May 5, 2025, the newest Commissioner of the Federal Trade Commission (FTC), Mark R. Meador, spoke at the Second Annual Antitrust Conference at George Washington University.
His prepared remarks offer insight into his approach to antitrust enforcement, addressing what he sees as common antitrust enforcement myths.
In dispelling the first myth—“antitrust is regulation”—the Commissioner is very clear: “Antitrust is law enforcement, period. Full stop.”
He similarly and succinctly rejects four other myths related to antitrust enforcement:
“Vertical integration is always procompetitive.” Commissioner Meador makes the contrary case that vertical integration is not always procompetitive, particularly in non-physical markets such as technology.
“Innovation can justify exclusion.” The Commissioner instead asserts the need to identify conduct that forecloses alternatives.
“We need national champions to compete with China.” The Commissioner suggests, to the contrary, that competition is better suited by free enterprise.
“Structural remedies are an extreme measure.” He counters that structural remedies can be a way to restore free markets.
Commissioner Meador concludes his comments with what might be seen as a policy warning, making clear that the current FTC’s interest in antitrust enforcement is not limited to technology platforms or “Big Tech,” but extends to every industry, including “groceries, healthcare, and energy.”
Additional Authors: Daniel R. Saeedi, Rachel L. Schaller, Gabrielle N. Ganze, Ana Tagvoryan, P. Gavin Eastgate, Timothy W. Dickens, Jason C. Hirsch, Adam J. LandyAmanda M. Noonan, and Karen H. Shin.
The Latest Changes to the Ontario Employment Standards Act, 2000
Several 2024 amendments to the Ontario Employment Standards Act, 2000 (ESA) will be implemented in summer 2025, and more new requirements will take effect starting in 2026. Below is a detailed overview of these changes, organized by their effective dates. Employers in Ontario may want to note these deadlines and update their processes and policies accordingly.
Quick Hits
Starting June 19, 2025, employees in Ontario with at least thirteen consecutive weeks of employment will be entitled to an unpaid leave of absence for up to twenty-seven weeks in a fifty-two-week period for serious medical conditions certified by a qualified health practitioner.
Effective July 1, 2025, Ontario employers would be required under the amended law to provide new employees with specific employment information in writing before their first day of work, including the employer’s legal name, the employer’s contact information, the employee’s work location, the employee’s starting wage rate, the company’s pay period, and the anticipated hours of work.
Beginning January 1, 2026, employers in Ontario with more than twenty-five employees are required under the amended law to disclose the range of expected compensation, disclose the use of AI in hiring, confirm if a job posting is for an existing vacancy, and are prohibited from requiring “Canadian experience.”
Changes Effective June 19, 2025
Long-Term Illness Leave
Under the amended law, employees with at least thirteen consecutive weeks of employment will be entitled to an unpaid leave of absence for up to twenty-seven weeks in a fifty-two-week period if they have a serious medical condition certified by a qualified health practitioner.
The law does not require that the weeks of leave be taken consecutively. Employees may extend the leave within the same fifty-two-week period by submitting another medical certificate if the condition extends beyond the initial duration noted in the original certification and the twenty-seven-week period has not yet been exhausted.
This new leave does not amend existing obligations under the Ontario Human Rights Code and any contractual leave entitlements or disability benefits plans and policies.
This new leave is in addition to the regular three-day sick leave, for which employees are not required to provide a medical note.
The newly amended law requires employers to retain related records for three years after the leave expires.
Changes Effective July 1, 2025
New Rules About Employment Information
Employers will now be required to provide new employees with the following information in writing, prior to the employee’s first day of work or as soon as reasonably possible thereafter:
the employer’s legal name (and operating or business name, if different);
the employer’s contact information (including address, telephone number, and one or more contact names);
the location from which the employee will be performing work;
the employee’s starting wage rate or commission, as applicable;
the applicable pay period/pay day; and
a general description of the employee’s anticipated hours of work.
This requirement does not apply to employers with fewer than twenty-five employees or to assignment employees.
Changes Effective January 1, 2026
Effective January 1, 2026, employers with more than twenty-five employees that are posting jobs are required to disclose the range of expected compensation and use of artificial intelligence (AI) in the hiring process and confirm whether the job posting is for an existing vacancy. The amended law prohibits employers from requiring applicants to have “Canadian experience.”
The amendments require employers that interview applicants for publicly advertised jobs to provide information about the status of the hiring process within forty-five days of interviews or, if the employer interviews applicants more than once, within forty-five days of the last interview.
Employers may want to ensure these changes are implemented by the relevant deadlines, and that the relevant policies are updated accordingly.
DJI Says “Bring It On” to U.S. Drone Security Scrutiny
In a surprising move, China-based DJI, the world’s largest drone manufacturer, is not flinching at the prospect of tighter U.S. restrictions on Chinese drone companies. In fact, they’re embracing it.
Currently, the Trump administration is finalizing executive orders that would affect the commercial drone landscape in the U.S., which could be set for a serious shake-up. These potential measures would require companies like DJI, and its competitor Autel, to undergo national security reviews before selling new drone models in the U.S.
You might think DJI would be sounding the alarm—but instead, they’re rolling out the welcome mat. “DJI welcomes and embraces any opportunities to demonstrate our privacy controls and security features,” explained a company spokesperson.
The company has been submitting its systems for independent security audits since 2017. Evaluations from heavyweights like Booz Allen Hamilton, FTI Consulting, and even U.S. government bodies like the Department of the Interior and Idaho National Laboratory have come to a consistent conclusion: DJI’s drones are secure, and there’s no evidence of data being transmitted to unauthorized entities—including the Chinese government.
The legal spotlight is now on Section 1709 of the FY2025 National Defense Authorization Act. This provision requires a designated national security agency to determine—within a year—whether DJI’s equipment presents an “unacceptable risk” to U.S. national security.
If that assessment isn’t completed within the deadline, DJI could end up on the FCC’s Covered List by default, effectively barring them from launching new products in the U.S.
So, yes, the stakes are high. But DJI seems ready to bet on its track record.
In response to longstanding concerns over data privacy and national security, DJI has introduced several robust features aimed at giving control back to users:
Local Data Mode: Operates like an air-gapped device—no internet, no data leakage.
Default Data Settings: No automatic syncing of photos, flight logs, or videos.
Third-party software compatibility: Users can fly DJI drones and analyze data using U.S.-based software, without touching DJI’s ecosystem.
DJI no longer allows U.S. users to sync flight records to its servers.
“Unlike our competitors, we do not force people to use our software,” DJI spokesperson pointed out.
While the upcoming executive orders are designed to boost domestic drone production and address national security risks, DJI is using the moment to double down on its commitment to transparency. Their message is clear: judge us by the tech, not the passport.
Whether that’s enough to maintain access to the U.S. market will depend on how these reviews play out—and how political winds blow in the coming months.
But one thing’s for sure: DJI isn’t backing down. It’s gearing up for inspection—and maybe even looking forward to it.
Stay tuned as we track legal developments on this issue and how it could reshape the drone industry in the U.S.
Competition and Consumer Law Round-Up June 2025
What’s Inside This Issue?
This edition of the K&L Gates Competition & Consumer Law Round-Up provides a summary of recent and significant updates from the Australian Competition and Consumer Commission (ACCC), as well as other noteworthy developments in the competition and consumer law space.
Key Developments in Environmental / Greenwashing Guidance and Enforcement
EnergyAustralia Settles Greenwashing Action Brought by Advocacy Group
AU$8.25 Million Penalty Ordered Against Clorox for Misleading Greenwashing Claims
Enforcement
Oil and Gas Company Qteq Found to Have Engaged in Cartel Conduct
Federal Court Orders Captain Cook Vocational College to Pay AU$30.4 Million in Penalties for Unconscionable Conduct and Misleading Representations
ACCC Commences Proceedings Against Retailer City Beach for Noncompliant Button Battery Products
Mergers and Acquisitions
ACCC Raises Concerns With Rural Merchandiser Elders’ Proposed Acquisition of Delta
Qube’s Acquisition of MIRRAT Not Opposed by ACCC
Notifications and Authorisations
ACCC Proposes to Grant Authorisation to Australian Payment Network to Facilitate Wind Down of Cheque Industry
Noteworthy Developments
Mandatory Information Standard for Toppling Furniture Brought into Effect
Click here to view the Round-Up.