Conformity Assessment in Europe & the UK from January 1, 2021
The United Kingdom formally left the European Union on the January 31, 2020. However, a transition period until midnight, Central European Time, on December 31, 2020, was agreed to allow the continued application of rules and regulations, including those surrounding the conformity marking and assessment of products (“Transition Period”).
Although both the UK and EU have indicated a willingness to work to achieve a negotiated agreement in relation to the regulatory regime after the Transition Period, plans were also implemented for the introduction of a United Kingdom Conformity Assessment (UKCA) Mark in the event that a deal was not reached. As the time to reach such a deal reduces, both the UK Government and the EU are advising manufacturers to consider the implications of a ‘no deal’ scenario on their business activities.
Scope of This Guidance
This guidance document is intended to consider the implications of a no-deal outcome for manufacturers of electrical/electronic and mechanical products and systems, and personal protective equipment (PPE), specifically in relation to compliance with the following European Directives and Regulations:
- Low Voltage Directive (2014/35/EU) LVD
- Electromagnetic Compatibility Directive (2014/30/EU) EMCD
- Radio Equipment Directive (2014/53/EU) RED
- Machinery Directive (2006/42/EC) MD
- Measuring Instruments Directive (2014/32/EU) MID
- Personal Protective Equipment (2016/425) PPE
- Equipment and Protective Systems intended for use in Potentially Explosive Atmospheres (2014/34/EU) ATEX
Implications of a No Deal – Summary
If at the end of the Transition Period there is no deal on the conformity assessment of products, manufacturers will need to consider and account for the following changes:
- The EU will not recognize conformity assessment activities performed by UK Notified Bodies for products placed on the market on and after January 1, 2021
- The EU will not recognize the ‘UKCA’ mark
- After December 31, 2022, the UK will stop recognizing the ‘CE’ mark or conformity assessment activities that have been performed by EU27 Notified Bodies. Until then the ‘CE’ marking will continue to be recognized
- EU Directives require some activities to be performed by entities located within the EU/EEA of which the UK is no longer a member
- Adopted/new UK legislation has been amended to require some activities to be performed by an entity located in the UK
Manufacturers will need to consider carefully the implications of Brexit on the conformity of their products and take appropriate action to ensure that declarations and product markings are updated at the appropriate times. They will also need to ensure that the various economic operators within the supply chain are located in the correct territory.
Introduction of a UK Compliance Mark
In preparation for the introduction of a new conformity marking system for goods intended to be placed on the UK market, the UK Government has made provision for the introduction of a new compliance mark to replace the existing European CE mark.
The relevant UK regulations have been amended to broadly replace references to the CE mark with reference to the UKCA mark. References to European Harmonized standards will be replaced with references to UK Designated Standards and the role of Notified Bodies will be replaced with UK Approved Bodies.
The intention is that the technical impact to manufacturers shall, as far as possible, be reduced. The detailed changes are provided for in UK Statutory Instrument 2019: 696, The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. This instrument was subject to minor changes in Statutory Instrument 2019: 1246 and will be amended again in 2020 to enshrine the date of the end of the Transition Period rather than the exit day (which has already occurred) into the legislation.
Application of the UKCA Mark
The rules governing the use and application of the UKCA mark are not dissimilar to those which apply to the use of the CE Mark. The mark may only be applied to products in accordance with the specific regulations which apply to that product by the manufacturer or their authorized representative. The mark must not be applied to any product which does not fall within the scope of at least one regulation which requires the application of the mark. By applying the UKCA mark, the manufacturer (or the authorized representative) is taking responsibility for the compliance of the product with all applicable legislation.
The mark will generally be required to be applied to the product itself, unless the regulations allow it to be applied to the packaging or accompanying documentation. The mark may be reduced or enlarged as long as the proportion and ratio remains the same. The minimum size of the mark is generally 5mm and it must be applied securely and in a way that its meaning may not be misconstrued.
Manufacturers may choose to mark both the CE and UKCA marks on a product as long as both the UK and EU compliance conditions are met.
UK ‘Grace Period’/ Additional Transition Period
The UK Government has agreed that for manufacturers wishing to supply goods into the UK, the ‘CE’ mark, including the results of conformity assessment activities performed by an EU27 Notified Body, will continue to be recognized until January 1, 2022. This means that for most situations, manufacturers will be able to continue to rely on the CE Marking of a product, as long as the technical rules remain aligned between the EU and UK.
This period of grace does not however extend to products which require the mandatory involvement of a Notified or Appointed Body, which are intended for supply in the UK market, and for which the certification has not been transferred to an EU27 Notified body. In these cases, the product certificates will, by default, become UKCA certificates and the UKCA mark must be placed on the product immediately. This requirement would not apply to products already manufactured and ready to place on the market before January 1, 2021.
Currently, manufacturers have the option of applying harmonized standards as a means of demonstrating that the essential requirements of a directive are met. The harmonization process is one that results in the publication of the relevant standard in the Official Journal.
Moving forward an alternative ‘Designation’ process will be implemented in the UK, which will result in a list of standards considered suitable being published by the Secretary of State in the UK. These Standards will operate in a similar way as harmonized standards, as a voluntary means to demonstrate conformity with the corresponding UK Regulations. Those standards which are harmonized at December 31, 2020, will become UK ‘Designated Standards’ on January 1, 2021.
Further, where manufacturers are referring to standards, for example in Declarations of Conformity (“DoCs”), it will be necessary, where they exist, to refer to British versions of a Standard (e.g. BS EN 62368-1) rather than to the European version.
Conformity Assessment Bodies
On January 1, 2021, UK-based Notified Bodies will automatically become ‘Appointed Bodies’ under the UKCA legislation. Any UK Notified Body issued certificates, that have not been transferred to an EU27 Notified Body, will automatically become valid as a means for illustrating conformity under the UK Regulations to which they apply.
On January 1, 2021, UK-based Notified Bodies will cease to be appointed under EU rules. Where, as at December 31, 2020, legislation requires the involvement of a European Notified Body in the Conformity Assessment process and products continue to be placed on the EU27 market after December 31, 2020, any Conformity Assessment certifications, including Type Examination Certificates issued by a UK Notified Body, will cease to be valid as a means of demonstrating conformity.
Similarly, EU27 Notified Body certificates will cease to be acceptable as a means of demonstrating conformity with UK Regulations, but subject to the period of grace referred to above (i.e. until January 1, 2022).
The legislation currently imposes specific requirements on some economic operators associated with the supply of products in relation to their geographic location. Most notably, for the directives covered by this guidance, the importer and any authorized representative who the manufacturer may choose to appoint must be located within Europe. With the withdrawal of the UK from Europe, any individual who fulfilled these roles and was located in the UK would cease to meet the location requirements for supply into the EU27 territory. As a result, an organization previously only considered a “Distributor” may find themselves becoming an “Importer” within the meaning of the legislation and any DoC signed by a UK-based authorized representative would cease to be valid. The obligations imposed on an importer are generally more onerous than those placed on a distributor.
The UK legislation has been drafted or is in the process of being updated to require that, from January 1, 2021, any appointed authorized representative for UKCA purposes will need to be resident in the UK. The requirement to appoint an authorized representative is largely voluntary, so this will only affect those manufacturers who rely on an authorized representative to sign a DoC on their behalf.
In addition, the requirement to mark the name and address of the importer onto the product in the case of the EMC Directive, the Low Voltage Directive, the Measuring Instruments Directive and the Radio Equipment Directive, will, when the UK Regulations are amended, allow for the relevant information to be provided on the packaging or accompanying document for a period of 18 months following the end of the Transitional Period. After this time, the UK based Importer will generally have to be marked on the product.
Conformity Assessment - Northern Ireland
The rules relating to the conformity marking of products intended to be supplied into Northern Ireland currently differ from the rest of the United Kingdom. This reflects the fact that there is a land border between Northern Ireland and the Republic of Ireland.
As a consequence, products imported into Northern Ireland will generally be required to comply with European Conformity processes and procedures.
Implications for Existing Products - Summary
Where a manufacturer has existing products which they intend to continue to supply to either the European or UK markets after December 31, 2020, they will need to consider the effects and impact of Brexit. The extent of this impact will vary depending upon the nature of the product. Given that the technical requirements will be aligned on January 1, 2021, the changes should be largely administrative.
For Products Subject to Self-declaration
For those products which are subject to a self-declaration by the manufacturer prior to being placed on the market, the changes will be minimal. The Essential Requirements of the Directives will mirror the Essential Requirements of the UK Regulations and therefore the products will remain compliant. Any test reports generated as a means of demonstrating compliance will remain valid wherever they were generated.
For the supply of products into the EU, the product marking will remain the same, however care should be taken to ensure that the DoC is signed by either the manufacturer or an EU resident authorized representative. Where, previously, the importer to the EU was based in the UK, a new importer will need to be identified in the EU and their details will need to be marked or supplied where this is required by the directives.
For the supply of products into the UK, manufacturers may continue using the CE Marking arrangements up to December 31, 2021. However, they will need to transition to UKCA marking arrangements at an appropriate time. Where CE marking arrangements are relied upon, the manufacturer will need to ensure that a UK importer is identified for the product and that the EU DoC is translated into English if it isn’t already.
On moving to the UKCA marking, the Manufacturer will need to ensure that the DoC is updated to reflect UK Regulations rather than EU Directives and to reference British Standards rather than European Standards. The DoC will need to be signed by either the manufacturer or a suitable authorized representative. Where the regulations require the importer to be marked on the product, it will be allowable for the UK manufacturer to be marked on the packaging or accompanying documentation for 18 months following the end of the Transition Period (i.e. until July 1, 2022).
For Products Subject to Notified Body Assessment
Where the product in question requires the involvement of a Notified Body in the conformity assessment process, the actions required will depend upon where the current Notified Body is located and where the product is intended to be supplied.
European Law generally prohibits two Notified Bodies from certifying the same product simultaneously and therefore it is not possible to transfer an existing Notified Body certificate from the EU to the UK, or vice versa, whilst still maintaining the original certification. Any transfer will require the cancellation of the original certification.
Where a transfer becomes necessary, the guidance documents issued by the EU and the UK provide two alternatives. A manufacturer may choose to surrender the original certificate and make a new application to a Notified Body of their choice. Alternatively, a manufacturer may choose to work with the existing Notified Body and the new Notified body to agree a transfer of responsibility for the certification. This option allows a continuity in the certification process and minimizes the work and cost involved.
Where a product is currently certified by SGS United Kingdom, as a Notified Body we have worked closely with SGS Fimko (based in Finland), which has a Notified Body scope matching that of SGS United Kingdom. As a result, a simplified ‘Transfer of Responsibility’ process has been introduced, allowing a manufacturer, in the majority of cases, to apply for the responsibility for the product certification to transfer to SGS Fimko.
It will be necessary for a manufacturer to update the reference to the Notified Body on the DoC, and, where the directive requires, the Notified Body number to be marked on the product, to the SGS Fimko number (0598).
This process is triggered by the completion of an application form available from SGS United Kingdom or SGS Fimko. Where the process involves a simple transfer with no update to the certification there will generally be no charge. This process must however be completed before the end of the Transition Period. It will not be possible after December 31, 2020.
Where a product is currently certified by SGS United Kingdom and the decision is made to take no action, that certificate will automatically transfer to become an ‘Appointed Body’ certificate on January 1, 2021. It will not be possible to rely on the existing CE marking in this instance and as a consequence ‘UKCA’ marking will be required in accordance with the requirements of the relevant regulations. In addition, the DoC will need to be updated.
Moving forward, it will be possible that manufacturers will be able to achieve dual European CE and UKCA Conformity Assessments in parallel, reducing cost and time to market.
UK Implementation of EU Directives
Manufacturers will need to become accustomed to thinking of compliance in the United Kingdom in terms of the relevant UK/National Regulations which are applicable to their products. Whilst these regulations have always existed, up until now it has been common practice to refer to directives. From January 1, 2021, it will be necessary to include reference to the applicable UK Legislation on for example the DoCs. The UK implementations of the Directives are shown below:
- The Electrical Equipment Safety Regulations 2016 (SI 2016/1101)
- The Electromagnetic Compatibility Regulations 2016 (SI 2016/1091)
- The Supply of Machinery (Safety) Regulations 2008 (SI2008/1597)
- The Radio Equipment Regulations 2017 (SI2017/1206)
- The Measuring Instruments Regulations 2016 (SI2016/1153)
- The Personal Protective Equipment Regulations (SI2002/1144)
- The Equipment and Protective Systems intended for Use in Potentially Explosive Atmospheres Regulations 2016 (SI206/1107)
Where you require additional information, or you wish to discuss the application of this guidance or to discuss the transfer of responsibility for an existing certification please contact:
EMC / Product Safety / Machinery / RED / MID
SGS United Kingdom Limited
Unit 12 a – b Bowburn South Industrial Estate
t: +44 (0) 1913 772 000
SGS United Kingdom Limited
Rossmore Business Park
t: +44 (0) 1934 622 517
SGS Baseefa Limited
Rockhead Business Park
t: +44 (0) 1298 766 600
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