Regulatory Framework in Europe & the Changes Related to Brexit for PFD's
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The document discusses the implications of Brexit on regulations for personal protective equipment (PPE) and marine equipment in the UK and EU. It outlines the transition from EU to UK legislation, the UKCA marking requirements, and the Northern Ireland protocol, which maintains regulatory alignment with the EU. Additionally, it highlights how UL can assist manufacturers in navigating these changes and obtaining necessary certifications.
Regulatory Framework in Europe & the Changes Related to Brexit for PFD's
- 1. UL and the UL logo are trademarks of UL LLC © 2022. What Brexit Means for the PPE and Marine Regulations in Europe and the UK Brexit and UKCA webinar UL AND THE UL LOGO ARE TRADEMARKS OF UL LLC © 2022. ALL RIGHTS RESERVED. THIS DOCUMENT MAY NOT BE COPIED WITHOUT WRITTEN PERMISSION FROM UL AND ONLY IN ITS ENTIRETY. THE DOCUMENT IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE. THE INFORMATION PROVIDED IN THIS DOCUMENT IS CORRECT TO THE BEST OF OUR KNOWLEDGE, INFORMATION AND BELIEF AT THE DATE OF ITS PUBLICATION.
- 2. What we are going to discuss • What is Brexit? • Overview of the EU regulatory environment • Overview of the new U.K. legislation and marks • What this means for you • How UL can help
- 5. The UK
- 6. Overview of the EU regulatory environment
- 7. EU regulations and marks PPE Regulation Marine Equipment Directive (EU) 2016/425 2014/90/EU
- 8. Placing PFD’s on the EU market PPE Regulation Category 2 PPE Regulation Category 3 Marine Equipment Directive Market placement General market General Market Placement on board EU flagged ship Products Buoyancy Aids Lifejackets; Immersion Suits; Abandonment Suits Lifejackets; Immersion Suits; Lifebuoys; Thermal Protective Aids Required Modules/Certificates B B + (C2 or D) B + (D; E; or F) Typical Standards EN ISO 12402-5 EN ISO 12402-4; EN ISO 12402-3; EN ISO 12402-2; EN ISO 15027 MSC.81(70) / LSA Code 2017 UL and the UL logo are trademarks of UL LLC © 2022.
- 9. Overview of the new UK legislation and marks
- 10. EU and UKCA regulations and marks EU PPE Regulation Marine Equipment Directive (EU) 2016/425 2014/90/EU U.K. Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as introduced to U.K. law and amended) Merchant Shipping (Marine Equipment) Regulations 2016 SI 2016/1025 (EU) 2016/425 amended by SI 2019/696 Merchant Shipping (Marine Equipment (Amendment, etc.) (EU Exit) Regulations 2019 SI 2019/470
- 11. How the regulations will work • The requirements of the EU Regulations and Directives became U.K. law and remain substantially the same. • Any responsible person or authorized representative appointed must be based in the U.K. • Current EU Harmonised Standards will be published as U.K. Designated Standards. • There is currently no system in place to update Designated Standards should EN standards be reviewed and amended. • Market Surveillance remains the same for the U.K.: • PPE at work — Health and Safety Executive • PPE for private users — Trading Standards • Office for Product Safety and Standards controls the strategy
- 12. PPE regulation implementation period U.K. • The United Kingdom Conformity Assessed (UKCA) regime applies since Jan.1, 2021. • Since Jan. 1, 2021, goods can be placed on the U.K. market with the CE or UKCA marking until Jan. 1, 2023. • Starting January 2023, goods can only be placed on the U.K. market with the UKCA marking. • UKCA marking Category 2 products require a Module B certificate issued by a U.K. Approved Body. • UKCA marking Category 3 products require a Module B and either a Module C2 or D certificate issued by a U.K. Approved Body. • Until Jan. 1, 2023, UKCA marking can be applied by a label affixed to the product or on accompanying packaging. EU • Since Jan. 1, 2021, certificates issued by U.K. Notified Bodies are no longer valid for placing products on the EU market. • EU Notified Bodies must establish an entity and register as an Approved Body in the U.K. to issue the UKCA marking.
- 13. Marine shipping regulations implementation period U.K. • The United Kingdom Red Ensign regime applies since Jan. 1, 2021. • Since Jan. 1, 2021, goods can be placed on U.K. flagged ships with a Wheel mark or Red Ensign mark until Jan. 1, 2023. • Starting January 2023, goods can only be placed on U.K. ships with a Red Ensign mark. • Red Ensign mark products require a Module B and either a Module D,E or F certificate issued by a U.K. Approved Body. EU • From Jan. 1, 2021, certificates issued by U.K. Notified Bodies are no longer valid for placing products on the EU market. • EU bodies must establish an entity and register as an Approved Body in the U.K. to issue a Red Ensign mark.
- 14. Northern Ireland (the exception) • The exception to the UKCA mark is the Northern Ireland Protocol. • The protocol was developed to avoid a hard border between Northern Ireland and Ireland. • It remains with the consent of the people of Northern Ireland, and a vote will happen every four years. The first vote will take place in 2024. • Northern Ireland remains in regulatory alignment with the EU, meaning: • CE marked products continue to be accepted in Northern Ireland. • If a U.K. Approved Body carries out the assessment for goods going to Northern Ireland, then the UKNI mark is applied. • Northern Ireland has unfettered access to the rest of the Great Britain market, meaning CE and UKNI products can be placed on the Great Britain market from manufacturers in Northern Ireland. • UKCA marked products alone cannot be placed on the Northern Ireland market.
- 15. What marks are required where? Source: www.gov.uk/guidance/using-the-ukni-marking
- 16. What this means for you
- 17. Major changes that might affect you Manufacturers with U.K. Notified Body: Require certificates issued by an EU27 Notified Body to place goods on the EU market. Manufacturers with EU Notified Body: To place goods on the U.K. market, manufacturers will need to obtain certificates from a U.K. Approved Body this year.
- 18. How UL can help
- 19. How UL can help UL International (Netherlands) B.V. • Accredited by RvA to issue Module B/C2/D under PPE Regulation (EU) 2016/425. • Accredited by RvA to issue Module B/D/E/F under Marine Equipment Directive 2014/90/EU. UL International (U.K.) Ltd. • Accredited by UKAS to issue Module B/C2/D under PPE Regulation (EU) 2016/425 (EU Exit). • Accredited by UKAS to issue Module B/D/E/F under Merchant Shipping Regulations. UL can provide market access services for both the U.K. and EU at the same time.
- 20. Michael Kirkland Senior project engineer Michael.Kirkland@ul.com Questions?
- 21. UL and the UL logo are trademarks of UL LLC © 2022. Thanks for listening
Editor's Notes
- #2: Hello, welcome to the UL Webinar on Brexit and the UK conformity assessment procedures. This webinar will discuss the impact of Brexit and the new requirements for placing products on the market of the UK
- #3: IN this webinar we will discuss, What is Brexit?, an overview of the EU regulatory environment, an overview of the new UK legislation and marking and then what this means for our valued customers and how UL can help. https://crc.ul.com/shared/download/AsedfZZQz2sAXBjR8BhHCTH2
- #4: Brexit was the withdrawal of the United Kingdom (UK) from the European Union (EU) which took effect 1st January 2021. This means that the UK no longer employs European laws and products being placed on the market must meet new UK legislator frameworks.
- #5: We firstly need to identify what constitutes the UK and EU. The UK is here circled in red with the remaining EU 27 countries shown. https://crc.ul.com/shared/download/cQy8kf7xruoVGZJuBqdfCk9L
- #6: The United Kingdom of Great Britain and Northern Ireland is a union of the countries made up of great Britain being England, Scotland and Wales with Northern Ireland.
- #7: We will next discuss and overview of the EU regulatory environment for PPE and Marine products. Within Europe, Directives and Regulations make conformity assessment of certain products a requirement to ensure products are safe and perform as required.
- #8: Two such frameworks are the PPE Regulation and Marine Equipment Directive. The Personal Protective Equipment Regulation covers all PPE placed on the EU market and the Marine Equipment Directive covers products intended to be placed on EU flagged sea going ships. The demonstration of meeting the PPE Regulation is by applying the CE mark whereas the MED uses the wheelmark.
- #10: We will now look at how the marks to be used under the new UK regulatory framework.
- #11: The PPE Regulation was brought into UK law and amended by Statutory Instrument 2019/696 which changed elements of the legislation for the UK market. Conformity with the UK legislation is demonstrated with the UKCA mark. The Marine Equipment Directive is brought into UK law with the Merchant Shipping (Marine Equipment) Regulations 2016 SI 2016/1025 and amended for Brexit under the (EU Exit) Regulations 2019 SI 2019/470. Compliance with the amended Merchant Shipping Regulations in the UK is demonstrated with the red ensign mark.
- #12: The EU legislation has been brought into UK law and amended for the UK market however the requirements remain substantially the same as the EU legislation. Current EU harmonised standards will be published for use in UK law as UK Designated Standards and published on the UK Government website Market surveillance authorities will remain the same within the UK. Essentially manufacturers will now have to replicate the conformity assessment which is undertake for the EU in the UK before placing goods on the UK market. Products which needs conformity assessment by a certification body will be undertake by UK Approved Bodies appointed by the UK secretary of state.
- #13: UKCA: The United Kingdom Conformity Assessment (UKCA) regime applies from January 1st 2021. From January 1st 2021 goods can be placed on the UK market with a CE or UKCA mark until 1st January 2022. From January 2022 goods can only be placed on the UK market with a UKCA mark. UKCA mark category 2 products require a Module B certificate issued by a UK Authorised Body. UKCA mark category 3 products require a Module B and either Module C2 or D certificate issued by a UK Authorised Body. Until January 1st 2023 the application of the UKCA can be applied by a label affixed to the product or on accompanying packaging. EU: From 1st January 2021 certificates issued by UK Notified Bodies are no longer valid for placing products on the EU market. EU bodies must establish an entity and register as an Approved Body in the UK to issue a UKCA mark.
- #14: UK: The United Kingdom Red Ensign regime applies from January 1st 2021. From January 1st 2021 goods can be placed on UK flagged ships with a Wheel mark or Red Ensign Mark until 1st January 2023. From January 2023 goods can only be placed on UK ships with a Red Ensign mark. Red Ensign mark products require a Module B and either Module D/E/F certificate issued by a UK Authorised Body. EU: From 1st January 2021 certificates issued by UK Notified Bodies are no longer valid for placing products on the EU market. EU bodies must establish an entity and register as an Approved Body in the UK to issue a Red Ensign mark.
- #15: Northern Ireland remains the exception to the UKCA mark. To avoid a hard border in Norther Ireland, CE marked goods will continue to be allowed to be place on the NI market. Goods may also be placed on the NI market under the UK legislation using the UKNI mark conducted by a UK approved body acting as a Notified Body under EU law.
- #16: The table on screen now shows the accepted marking for different markets from the UK government website.
- #17: What does this all mean for you?
- #18: Manufacturers who previously placed products on the market with a UK Notified Body can no longer use this certificate and must transfer to an EU 27 Notified Body to mark products with the CE mark. Manufacturers with CE marks from EU Notified Bodies will need to obtain UK certification from a UK approved body to place products on the UK market form the dates given in previous slides.
- #19: How can UL help you comply with the new legislatory environment?
- #20: UL is accredited as both an EU Notified Body in the Netherlands and as a UK Approved and can issue certificates for Europe and the UK under the PPE and Marine environment.
- #21: Should you have any questions, please feel free to get in touch and we will respond as soon as possible.
- #22: Thankyou for listening.