Let's talk about forthcoming changes to UK conformity assessment as we leave the EU market.
Before I dive into the subject I want to put a little disclaimer here, that the below information is a result of my own personal work and research. I have attended a number of informatory sessions, researched and reviewed the latest legislation, and gathered in its most simple plain English version here. Hopefully, you will find it clearer and informative.
A brief reminder.
At the beginning of 1992, the Single European Market was created and the objective of that was to remove trade barriers throughout the Economic Area. It was allowing companies within the EU the free access to the market in all the different countries without having to meet the particular local requirements.
Within the EU legislation, it was supported by the new approach of EU Directives and ultimately the application of the CE marking.
As well as for all the EU member states (including Norway, Iceland, and Lichtenstein) as well as Switzerland, Turkey and 6 Balcan states the CE mark is applicable. In this very large market over the last 28 years, the UK has become used to the free movement of goods within the market.
CE marking Directives show the extend of the coverage. In reality, the vast majority of the everyday products carry the CE markings.
As changes like Brexit happens, we need to understand the implications and importance to address new requirements.
As a country, Great Britain was divided into the subject of how closely the relationship between the UK and the EU should be. This resulted in the UK referendum held in June 2016 in which 51.9% of the UK population voted in favor of leaving the EU.
The UK government then started the process of withdrawing from the EU and began the Brexit process.
Implications on the CE markings
The CE is trademarked by the EU so it's continuous use was always at risk when the UK has decided to leave.
One of the principles of Brexit was that the UK will be free to establish its own rules and trade agreements. This means of disconnecting the UK law from the EU law. This was already likely to affect the CE markings because it would represent two different systems.
The EU Directives are already transferred into the UK law through the UK Statutory Instruments. It was part of the requirement of the EU that the individual directives have to be transferred into the UK law. And we are referencing the directives on our Declarations of conformity for CE marking compliance.
In December 2019 UK parliament voted to leave the EU and created a new type of domestic law disconnected from the EU law. This is another example of why the CE markings would not continue in the UK.
The UK left the EU on the 1st of January 2020 and we have immediately entered into the implementation period during which transitions apply. The transition period will end on the 31st December 2020. From the 1st of January 2021, UK starts new trading relationships with Europe.
At the moment for the TRansitional arrangements and CE markings very little has changed and we are still working by the EU rules and meeting the requirements of the EU Directives. The only thing that really has changed is that the UK is no longer involved in the EU rules.
Placing Goods on the UK market after 1st of January 2021
In terms of the UK conformity assessment process, the principles of it are very much the same. That is, in order to be in conformity with overall requirements we have to meet a set of technical and administrative requirements.
In regards to technical requirements, on Day 1 they will be the same. While we are putting the EU Harmonized standards on our current CE Declaration of conformity, we will be putting the UK Designated Standards. Simply speaking, we will now be referencing the British Standards. Technically, if your product was in conformity with EU standards it should fundamentally be in conformity with UK ones.
The terminology will change, however. Where we have been used to refer to EN standards we will now be referring to UK designated standards.
There will also be the UK version of the OJ listing, however, as we stand today it does not yet exist.
In all fairness, most of the changes come to the administrative side related to documents. and to demonstrate that the UK requirements have been met, we will now have the UKCA marking. This mark applies from the end of 2020. It only applies to Great Britain (England, Scotland, and Wales) and not Northern Ireland. And, the underpinning legislation for the UKCA mark is not yet in place.
From the 1st of January 2021, the UKCA mark can be used legitimately to demonstrate conformity with EU legislation. However, it does not have to be used until the 1st of January 2022. At the moment we are in, what its called "Standstill Period" which basically means that in most cases the CE markings will continue to operate in the UK throughout 2021.
After the period (except medical devices) for most of the products, the UKCA mark will not be recognized in the EU market, not the Northern Ireland market.
The current conformity is subjected however to two conditions:
1) Product has to e self-declared by writing the Declaration of Conformity
2) If you use the third-party conformity assessment body it should be the EU-27 Notified Body (not UK Notified Body).
Having the above conditions met the UKCA mark in 2021 doesn't have to apply until January 2022 for most products.
Extention will not apply, however, if the product is subject to mandatory third-party conformity assessment and the Notified Body in the UK is used that has not had the certification re-issued by an EN-27 Notified Body.
UKCA markings will be required immediately from the 1st of January 2022. With the exception of medical devices where the CE markings will continue to be recognized until the end of June 2023.
What about the existing stock?
Often, when a legislation change there is always a question about the existing stock. About the products which are already made and conformity marked and in the supply chain already. These products can be available on the UK market and there is no specific time at the moment stated for existing stock.
So, how do we physically apply the UKCA mark?
Essentially, the requirements are the same as for the CE marking. The mark shall be legible, at least 5mm in size, kept in proportion and the preferred location is the product itself. Until the 1st of January 2023, the UKCA mark can be applied to the label attached to the product or accompanying document. Manufacturers, importers, and distributors should take reasonable steps to ensure the markings remain in place.
Declaration of conformity
Declaration of conformity (DoC) is the one we will need to make the most changes. The overall content of the Declaration of conformity is unchanged, but they are modifications to the terminology, that need to be used. This ultimately means that there will be a requirement for two Declarations of Conformity: CE marking and UKCA marking.
The differences are really in terms of the terminology.
1. Firstly, we remove the "EU" word from the title of the declaration. instead of of "EU Declaration" we call it "Declaration"
2. The existing EU Declarations of Conformity will reference the EU Directives when for UKCA marking we will replace it with the UK Statutory Instruments - UK law.
3. If you used the EU-27 notified body as part of the compliance process for CE marking, on the UKCA declaration of conformity we will need to reference UK Approved body.
So, having two separate DoCs, do we need a separate Technical file?
There is no definite answer to that question, but the current industry belief is, no. The technical file and documentation are really the evidence that supports the Declaration of Conformity, so we could simply reference the new UK law into current Technical documentation.
What about the current Test certificates?
In terms of the validity of the existing test reports, these are unaffected. There are some changes however to Notified Bodies.
From 2021 the UK based Notified Bodies will automatically become the UK Approved Bodies with the same scope. This means, that the third-party conformity assessment will be required to be done by an EU-27 Notified Body for the CE marking, and by the UK Approved Body for the UK market. For Northern Ireland- by either EU-27 Notified Body or the UK Approved Body.
For the medical devices, certificates issued by EU-27 Notified Bodies will remain valid until the end of June 2023.
Supply Chain
One of the other things we need to think about is our relationships with our supply chain. At the moment, we still effectively act as manufacturers in the EU and place our products directly onto the EU market. Currently, anyone outside the EU will use the Authorised Representative or an Importer within the EU. From the end of 2020, the UK will be acting as the manufacturer from outside the EU when placing products on the EU market. So the UK's ability to place products directly into the EU market will cease. Therefore manufacturers in the UK will need to place products on the EU market using an Importer or Authorised Representative.
The same is true for products coming into the UK. The manufacturer from outside the UK will need to have an importer or an Authorized Representative carrying the same duties.
What about the Northern Ireland Market?
The " Northern Ireland Protocol" applies after the end of the transitional period. What that means is that the products placed on the Northern Ireland market remain subject to EU law and CE marking requirements. Products do not need to be UKCA marked.
However, if the product is certified by a Notified Body in Northern Ireland, the product will be required to carry UK(NI) mark. The mark does not however exist at the moment.
The UK Approved Bodies can certify products for Northern Ireland Market. Such products should contain the CE and UK(NI) markings.
How do we get ready?
What has become apparent, is that the changes mainly involve the administrative tasks - documentation and UKCA mark. Therefore, we need to ensure, that we prepare our documentation with the new terminology and decide how are we going to apply the UKCA marking. There is a number of decisions to be made given the "Standstill period" and how we physically apply the markings.
This is our opportunity to review the current product conformity and ensure the CE declaration is current and valid. This is to ensure the transferred and translated new Declaration is in compliance.
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