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Harmonised standard meaning

What does Harmonised standard mean?
In legal practice, a harmonised standard is a European technical standard developed by CEN, CENELEC or ETSI at the European commission’s request to show how products can meet “essential requirements” of EU harmonisation legislation. Using a harmonised standard is voluntary, but if the standard is cited in the Official Journal of the EU (OJEU) it gives a presumption of conformity that supports CE marking and market access. The concept and process are set out in EU law, principally Regulation (EU) 1025/2012 on European standardisation (standardisation requests replacing earlier “mandates”), with the information procedure now in Directive (EU) 2015/1535 (which replaced Directive 98/34/EC). Jurisdictional position: - Ireland: Harmonised standards apply in full for CE marking and product compliance. - Northern Ireland: Under the Windsor Framework, EU product rules continue to apply; harmonised standards give presumption of conformity for CE/UKNI marking. - Great Britain (England & Wales and Scotland): Post‑Brexit, EU harmonised standards no longer of themselves confer a legal presumption. The domestic equivalent is a “designated standard” (listed by the UK government) which provides presumption of conformity for GB regulations and UKCA marking. Many designated standards are identical to corresponding EN harmonised standards, but legal effect arises from UK designation, not OJEU citation.
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NEWS
UK and EU information law highlights: data protection and cybersecurity—EDPB GDPR seal, third-country guidance, NCSC review, EU Cyber Solidarity Act, NIS2/CER enforcement, LexTalk and content updates

In this issue: Data protection Cybersecurity LexTalk® Information Law: a Lexis®Nexis community Daily and weekly news alerts New and updated content Data protection EDPB approves certification criteria for EU Data Protection Seal under EU GDPR The EDPB has endorsed the certification criteria for the EU Data Protection Seal, a scheme confirming adherence to the EU GDPR (Regulation (EU) 2016/679) within processing activities, including cross-border transfers to third countries. The seal underpins appropriate safeguards for such transfers, providing a harmonised assurance benchmark across the EU. It also sets out the functions of supervisory authorities, accreditation bodies and certification bodies to secure consistent application of GDPR rules. See: LNB News 03/12/2024 34. Guidance for consultation on data sharing with third-country authorities The EDPB has issued refreshed guidance clarifying the framework for transfers to authorities in third countries. It addresses cases where such disclosures proceed under appropriate safeguards in the EU GDPR, for example via standard contractual clauses or...

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NEWS
EU financial services: ESMA algorithmic trading briefing; MAR buy-back RTS changes; AIFMD/UCITS liquidity RTS and MiFIR amendments in OJ; Insurance Europe on IRRD; updated ESMA Q&As

EU financial services developments ESMA publishes supervisory briefing on algorithmic trading under MiFID II ESMA has released a supervisory briefing aimed at ensuring uniform oversight of algorithmic trading throughout the EU under the Recast Markets in Financial Instruments Directive (2014/65/EU) (MiFID II). It equips National Competent Authorities (NCAs) with actionable tools and clearer expectations for monitoring firms that deploy algorithmic trading, concentrating on areas of divergent practice such as pre-trade controls, governance structures, testing regimes and the outsourcing of algorithmic trading systems. The paper also considers new technological trends and sets out points to consider for the application of AI. Although not legally binding, the briefing supplements existing obligations and helps NCAs pursue a harmonised supervisory approach overall. Source: ESMA issues a supervisory briefing on algorithmic trading ESMA proposes amendments to buy-back programme rules following Listing Act changes ESMA has issued a report suggesting updates to Commission Delegated Regulation 2016/1052 concerning buy-back programmes and stabilisation measures (RTS), reflecting the amendments to the Market Abuse Regulation (MAR)...

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NEWS
ISO 42001 and the EU AI Act: overlaps, gaps for high-risk systems, missing CE marking and cooperation duties, governance extras, and forthcoming harmonised standards

To conclude, although ISO 42001 calls for many measures akin to those set out by the AI Act, the latter tends to be narrower and more detailed. Following the ISO framework will often assist with meeting legal duties, including under the AI Act, and in some circumstances could even be sufficient; however, this may prompt competent authorities to judge that ISO compliance is not the same as AI Act compliance, even where obligations intersect. Overlapping requirements, different focus ISO 42001 and the AI Act diverge conceptually and in their respective legal character significantly: ISO 42001 is a voluntary standard centred on organisational AI management and governance, whereas the AI Act is a mandatory regulation directed at product safety and oversight. Even so, ISO 42001 offers a practical baseline for tackling AI compliance efforts. For illustration, the AI Act demands that high‑risk AI systems enable automatic event logging throughout their lifecycle to maintain traceability of how the system functions over time, across its full period of...

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PRACTICE NOTES
UK Construction Products Regime: UKCA/CE marking with continued CE recognition, designated standards, conformity assessment, enforcement, GB-NI divergence, and reforms post-Grenfell under the Building Safety Act 2022

Why are construction products regulated? Construction products are regulated to: confirm that any item entering the market meets all legal obligations, and build trust among consumers, public authorities and manufacturers regarding product conformity What sort of products are affected? ‘Construction product’ means any product or kit manufactured and placed on the market for permanent incorporation in construction works, or their parts, where its performance affects how those works satisfy the basic requirements. This includes items such as doors, windows, shutters and gates, membranes, thermal insulation, chimneys and flues, sanitary appliances, fire alarms, flooring, fire-retardant products, space heating appliances, power cables, glass, fixings, and many others. Key definitions Placing on the market ‘Placing on the market’ is the first time a construction product is made available on the GB market, as described in UK government guidance. Making available on the market ‘Making available on the market’ means any supply of a construction product for distribution or use...

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PRACTICE NOTES
EU Packaging Regulation (EU) 2025/40: Design, sustainability, labelling and market placement obligations; recyclability, reuse, recycled content and PFAS limits; key dates and compliance duties for manufacturers, importers and distributors

Context and adoption Rapidly increasing packaging output, together with low rates of re-use, limited collection, and weak recycling, creates major obstacles to achieving a low-carbon circular economy in the EU. Packaging consumes large quantities of virgin resources and makes up 36% of the EU’s municipal solid waste. The Commission reports that 40% of plastics and 50% of paper used within the EU goes into packaging. On 11 March 2020, the Commission set out a new Circular Economy Action Plan. As a pillar of both the European Green Deal and the EU’s Industrial Strategy, the Plan unveiled actions to make sustainable products standard in the EU and to ensure less waste. In line with these commitments, on 30 November 2022 the Commission tabled a proposal for a new regulation on packaging and packaging waste, to amend Regulation (EU) 2019/1020 (the Market Surveillance Regulation) and Directive (EU) 2019/904 (the Single Use Plastics Directive), and to repeal Directive 94/62/EC (the EU Packaging and Packaging Waste Directive). The resulting Regulation (EU)...

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PRACTICE NOTES
FIDIC Pink Book 2010 (MDB Harmonised): overview of structure, pricing, payment, variations, claims, dispute resolution and termination; key differences from the Red Book 1999 and shift to 2017 forms

This Practice Note offers a concise overview of the FIDIC Multilateral Development Bank (MDB) Harmonised form (often referred to as the Pink Book) 2010. It highlights the main features of the Pink Book and identifies concepts handled or treated differently in the Red Book 1999, on which it is grounded. For a fuller comparison between the Red and the Pink Books, see Practice Note: FIDIC contracts—Red Book (1999 edition) and Pink Book compared. For a detailed primer on the Red Book (1999 edition), see Practice Note: FIDIC contracts—introduction to the Red Book 1999. In December 2017, FIDIC issued new editions of the Red, Yellow and Silver Books. For insight into what exactly changed in those releases, see Practice Note: FIDIC contracts 2017—what’s changed? [Archived] and, for additional detail on the Red Book 2017 edition, see Practice Note: FIDIC contracts—introduction to the Red Book 2017. Genesis of the Pink Book The Pink Book was prepared by FIDIC in close collaboration with eight MDBs. Taking the FIDIC Red Book 1999...

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