EB-001/1 Estimating Bulletin Date 24/11/22 PAG. 1 OF 6 UKCA Marking in UK an UKNI Northern Ireland (updating 14/11/22) After the exit of Great Britain from European Union (BREXIT) the legislation changed, and it will affect the manufacturing industry in UK and the delivery of products to UK from abroad. The fall-out of this change will also have implications on Harry Pye’s activities. The changes in the Legislation affecting HP, are summarized in below table EU Directive /Regulation 2014/68/EU (PED) 2014/29/EU 2014/34/EU 2006/42/EC 2014/32/EU (EU)2016/425 2014/35 EN 1090 (EU) 305/2011 Pressure equipment - Directive 2014/68/EU Simple Pressure Vessels ATEX Machinery Directive Measuring Instruments Personal protective equipment Regulation Low Voltage Fabricated structural steelwork products UK legislation Pressure Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016 Supply of Machinery (Safety) Regulations 2008 Measuring Instruments Regulations 2016 Regulation 2016/425 on personal protective equipment as brought into UK law and amended Electrical Equipment (Safety) Regulations 2016 UK Construction Products Regulation (CPR) European Directive could be found here: https://eur-lex.europa.eu/homepage.html Statutory guidance for Pressure Equipment (Safety) Regulations 2016: Great Britain Updated on 14 Nov 2022 could be found here: https://www.gov.uk/government/publications/pressure-equipment-safety-regulations2016/pressure-equipment-safety-regulations-2016-great-britain Statutory guidance for Pressure Equipment (Safety) Regulations 2016: Northern Ireland ,updated 17 Nov 2022 could be found here: https://www.gov.uk/government/publications/pressure-equipment-safety-regulations-2016 In particular, for Pressure Equipment and Pressure systems which previously required the CE marking, are now under a ‘new approach’: UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). The UKCA marking came into effect on 1st January 2021. However, to allow businesses time to adjust to the new requirements, we will still be able to use the CE marking until 1st January 2025 in most cases. For more info : https://www.gov.uk/guidance/using-the-ukca-marking EB-001/1 Estimating Bulletin Date 24/11/22 PAG. 2 OF 6 Timeline What are the differences between UKCA and CE marking? In technical terms, the differences between the requirements for CE marking and for UKCA marking are slight. Products which meet the technical requirements for one will mostly meet the requirements for the other for the near future. Most of the differences between the two systems are administrative in nature and reflect the fact that the UKCA mark only applies in Great Britain . Other differences are related to the separation of UK conformity assessment bodies from the EU Notified Body system. The UKCA is using “Approved Body” instead of Notified Body. Here the list : https://www.gov.uk/uk-market-conformity-assessment-bodies Products from the EU and from outside the EU, to be placed on the UK market must conform to UKCA marking requirements. Product subject to EU based Notified Bodies undertaking EU conformity assessment will be accepted on the GB market only until 31 December 2025! This will affect not so much the raw materials (e.g., plates, pipes, etc.) but equipment like valves, instruments, machineries, etc. Material manufacture certification of quality assurance provided by an EU body will still be accepted to satisfy the requirement in the UK of specific product control. Materials must comply with designated standards or have a particular material appraisal (i.e., ASME Materials). The CE marking will continue to be recognized for products placed on the market in other 27 EEA European Union countries (Including North Ireland). The UKCA mark is not accepted by any of the member state or EEA authorities of the European Union. If HP currently hold any CE marking certificates for products and they are issued by a UK notified body, then this certificate is likely to be transferred by them to a UKCA marking certificate. EB-001/1 Estimating Bulletin Date 24/11/22 PAG. 3 OF 6 What aspects are not changing? For the moment, many facets are the same; the scope of products covered, technical requirements (essential requirements, standards) and conformity assessment procedures are all initially identical for the two different markets. If your product is sold in both the EU and the UK, the technical file to show that it meets these requirements will also be the same. Use of ASME codes and Materials required the same procedures as per CE Marking. What is the specific UK legislation that needs to be followed? To implement the new regime, the UK government has issued several Statutory Instruments to amend current legislation. The main regulations are The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which runs to 659 pages https://www.legislation.gov.uk/uksi/2019/696/contents/made These regulations amend most of the UK CE marking regulations for products placed on the UK market and stipulate that the UKCA mark replaces the CE mark. Are standards changing? The British Standards Institution (BSI) www.bsigroup.com , emphatically maintains its commitment to the EN and international standards systems and ‘harmonised standards’ remain best practice for both CE and UKCA marking. The UK regulations term them designated standards and the lists of harmonised and designated standards are largely the same. BSI is unlikely to withdraw EN standards but in time the UK designated list is likely to differ slightly as UK authorities such as HSE bring their influence to bear on standards which they do not like. A full list of UK designated standards can be found on the UK Government website: https://www.gov.uk/government/publications/designated-standards-construction-products Glossary (that differ from CE Marking) Approved Body : A conformity assessment body which has been approved by the Secretary of State or was previously a UK ‘notified body’ before 1 January 2021. Authorised Representative :A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. From 1 January 2021, authorised representatives for the GB market must be based in the UK. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly. HP UK Should have appointed already its own Authorised Representative own Authorised Representative ensuring that requirements are achieved. EB-001/1 Estimating Bulletin Date 24/11/22 PAG. 4 OF 6 Competent Body: a body such as an Approved Body or a Recognised third-party Organisation (RTPO) or user inspectorate (UI) recognised as being able to carry out conformity assessment. Enforcing Authority – In Great Britain, for equipment intended for use in the workplace, this is the Health and Safety Executive. For products for consumer use this is local trading standards authorities. For equipment intended for use on nuclear sites it is the Office for Nuclear Regulation. UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods (including pressure equipment or assemblies) being placed on the GB market, in place of the CE marking, which is the conformity marking used in Northern Ireland and the European Union. UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory thirdparty conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the Northern Ireland market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying Northern Ireland goods. Synoptic table Market Access UK Manufacturer Product Marking EU Manufacturer Product Marking Non EU/UK Manufacturer Great Britain UKCA UKCA UKCA Northern Ireland CE or UK(NI) CE or UK(NI) CE or UK(NI) European Union CE CE CE Code & standards Official/ competent body UKCA Designated Standards Approved Body CE Harmonised Standard Notified Body (NoBo) Definitions EB-001/1 Estimating Bulletin Date 24/11/22 PAG. 5 OF 6 Safety gate The enforcement of the CE mark is down to individual countries, which have their own ‘Market Surveillance Authorities’. You can find the non-compliance products here: https://ec.europa.eu/safety-gate-alerts/screen/webReport In the UK, the Health and Safety Executive (HSE) & The GOV.UK website https://resources.hse.gov.uk/convictions/ ttp://www.hse.gov.uk/prosecutions/ Failure to comply could lead to a product recalls, prohibition notices, fines or imprisonment. Conclusions / Actions The Estimations and Proposals/Quotes, issued by Harris Pye, for Products and Systems falling under this new Legislation have to comply with UKCA Marking & UKNI Marking. Since the timeline of the use of CE Marking is close ( 31st Dec. 2024) , the estimators have to consider the following changes for quotation where the products / systems are placed in the market in UK. Impact on Estimations: Estimators have to be aware on new or increased costs for: I. II. III. IV. Approved Body for UKCA marking Instead of NoBo for CE Marking. Material and Equipment sourced outside UK should be UKA Marked Welders and Welding Process Qualification(WQR & PQR to be check validity with QC). NDE Personnel Qualification (to be check validity with QC) EB-001/1 Estimating Bulletin Date 24/11/22 PAG. 6 OF 6 Impact on Proposal wording: Estimators must change the quote Wording as following: I. II. III. IV. All the relevant European Codes must be mentioned as designated standards with pre prefix ‘BS” (i.e., EU Standard EN100204 shall be: BSEN 100204) Note that designated standards are subject to Changes from BSI https://knowledge.bsigroup.com/search?query=&type=all for updating. CE Marking shall be replaced with UKCA Marking or UKNI Marking Notified Body (No/Bo), shall be replaced with Approved Body or Competent body Changing language references to English only Impact on Proposal Scope: I. II. HP has to limiting the applicability to products for the UK market only, excluding by default the CE marking. In the event the Client wish to have both Marking: CE and UKCA; there will be no more the a/m limitation. Note that double marking (CE+UKCA) will be possible. The related additional cost & wording upgrading shall be considered. Issued by Head of Proposal :Riccardo Crosara – Nov. 2022
