Questions and answers from the webinar 4/12-2020

It has already been decided that BSI will stay as a member in CEN and CENELEC until end of 2021 no matter what kind of deals will be reached between the UK and the EU. Membership and conditions thereafter will be dealt with at the General Assembly in June 2021.

 

In Danish Standards, and in the European community of 34 national standards bodies, we find that the UK experts through BSI play a large and constructive role in European standardization. We would like to keep it that way.

 

We also see the need for CEN/CENELEC (the European Standardisation Organisations) to be a constructive and reliable partner for the European Member States and the European Commission (EC). So, we also have to pay attention to the signals coming from them.

 

Thus, we would like to strike a balance – keeping BSI in our system as much as we can – and at the same time accommodate the needs of Member States and the EC. We can expect that there will be some discussions regarding standardization requests and harmonized standards, after 31st December 20202, but these are discussions to come and we have not seen specific positions from Member States or the EU Commission on this point.

Danish Standards is not a political institution, but a National Standards Body, who serves the need of the Danish community at large and support the industry through relevant standards. Danish Standards is a member of CEN-CENELEC (and ETSI), the European Standardization organizations, along with 33 other standards bodies. As we are not legislators, but standards makers, we must wait for a political decision in the Brexit negotiations, before we can judge how to best adapt to the situation. CEN-CENELEC does not have any direct influence on the negotiations between the EU and the UK. In that sense, we have no political position.

 

We would like UK to be part of the future making of standards, and of course use those standards in the UK internal market for the benefit of Danish businesses as well, because it will ease trade across borders if we use the same standards. But we must bear in mind, that UK in the future will have the right to set their legislation independently of the EU. If this legislation diverges from that of EU, this will affect the standards as well. And if this happens, the conditions of membership of CEN-CENELEC will have to be discussed.

It is correct that the joint development of standards between IEC and CENELEC is challenged by the EC’s new processes regarding harmonization of EN’s. It is difficult to foresee whether the UK for the future will align towards the European or the international standards. But we do expect that in the future there will probably be a deviation between the UK and EU legislation. Right now, UK has ‘copied’ a large majority of European legislation (Directives and regulation) into the SI (Statutory Instruments) and have taken the corresponding standards and made them ‘Designated standards’. However, we do not know for how long the European and UK legislation and standards will continue to be identical.

Turkey, Serbia, Republic of North Macedonia, Switzerland and now UK are all “Non-EEA countries”

 

There is a slightly different approval criteria in CEN and CENELEC. However, for both organizations the following apply from CEN/CENELEC Internal Regulation part 2

 

6.2.X.1 Votes from all members are counted first, and the proposal shall be adopted if the CEN/CENELEC approval criteria are fulfilled.

 

In case the proposal is not adopted in accordance with 6.2.X.1, the votes of the members from EEA countries shall be counted separately, applying the same approval criteria as in 6.2.X.1.

 

This basically means that only in the case of e.g. non-approval of standards, there will be a second counting, where the non-EEA countries votes are omitted. If a non-EEA country has voted no, and the proposal is approved in the second counting, the non-EEA country is not obliged to adopt the final standard.

 

"Which products should be UKCA marked after 31 Dec 2020? Is it only CE certified products that are included?"

 

The UKCA marking applies to the product groups that were previously subject to requirements for CE marking. In addition, UKCA marking also includes aerosols. Please note that several product groups that are covered by UKCA marking are also subject to special rules. This applies to Medical Equipment, Railway Interoperability, Construction Products and Civil Explosives. You can find more information here:

https://www.gov.uk/guidance/using-the-ukca-mark-from-1-january-2021

It depends on the time it is being placed on the market. If it is placed before 1/1-2021 no UKCA mark requirements for most cases. If it is placed on the market before 1/1-2022, the CE mark is valid until that date (for most products). For CE-marked products placed on the UK market after 1/1-2022 the UKCA mark is mandatory. Placing on the market means that the products are produced and sold, distributed to importers and distributors or that documentation for a sales process is available.

The UKCA marking can be used from 1 January 2021. However, to allow businesses time to adjust to the new requirements, you will still be able to use the CE marking until 1 January 2022 in most cases.

 

In some cases, you will need to apply the new UKCA marking to goods being sold in Great Britain immediately from 1 January 2021. You are encouraged to be ready to use the UKCA marking as soon as possible before this date.

 

The CE marking will only be valid in Great Britain for areas where GB and EU rules remain the same. If the EU changes its rules and legislation and you wish to CE mark your product based on those new rules, you will not be able to use the CE marking to sell in Great Britain even before 31st December 2021. Check whether you will need to use the UKCA marking by reading the guidance on placing manufactured goods on the market in Great Britain.

 

You will need to use the new UKCA marking immediately after 1st January 2021 if all of the following apply. Your product:

 

• is for the market in Great Britain
• is covered by legislation which requires the UKCA marking
• requires mandatory third-party conformity assessment · conformity assessment has been carried out by a UK conformity assessment body and you haven’t transferred your conformity assessment files from your UK body to an EU recognised body before 1 January 2021

This does not apply to existing stock, for example if your good was fully manufactured and ready to place on the market before 1 January 2021. In these cases, your goods can still be sold in Great Britain with a CE marking even if covered by a certificate of conformity issued by a UK body.

That is correct. According to the EU Construction Products Regulation (CPR), traders are required to CE mark construction products covered by a harmonized product standard (hEN) when the construction product is placed on the market or made available on the market. CPR is the only European regulation where harmonized standards are mandatory.

 

All existing harmonized European standards under CPR, will become UK ‘designated standards’. This will mean that immediately after the end of the transition period harmonized European standards and UK designated standards will be identical.

 

The government will publish and maintain the list of these designated standards on a UK Database.

 

For the GB legislation which makes amendments to the regime for construction products post transition period, please follow these links:

• Construction Products (Amendment etc.) (EU Exit) Regulations 2019
• Construction Products (Amendment etc.) (EU Exit) Regulations 2020

 

The UK government will implement their own implementation process and whether this will be aligned with the EU process, or not, differences will evolve. Time will show how these differences will take form.

For EN/ISO standards (which are the case for harmonized standards) BSI, as a CEN/CENELEC member, must implement all the standards without changes. However, there is always a possibility to have A-deviations to European standards.

All the modules are the same because the UK regulation is the same in terms of its basic requirements – while marking, conformity assessment bodies and references have changed, the essential requirements and routes to conformity assessment have not.

It is the abbreviation for UK conformity assessment

From www.gov.uk:

 

The new UK legal framework

 

From 1 January 2021, the UK government is putting in place a domestic legal framework that will allow UK conformity assessment bodies to continue operating for most products being placed on the GB market.

 

The new UK legal framework and the technical requirements for becoming a UK approved body or a UK-recognized RTPO, UI or TAB will be broadly the same as they are now.

 

EU notified bodies are required to share information with UK approved bodies when requested by a certificate holder, and UK approved bodies should do the same with EU notified bodies. This will help facilitate the issuing of new certificates of conformity, where needed, without the need to repeat the entire certification process.

 

Conversion to UK arrangements

 

Most conformity assessment bodies in the UK will automatically have their status converted under the new UK framework.

 

UK-based notified bodies will become UK approved bodies, and UK-based RTPOs, UIs and TABs will become UK-recognized RTPOs, UIs and TABs respectively.

 

You do not need to take any action to be transferred under this arrangement. UK-based notified bodies who become approved bodies will keep the same 4-digit identification number as they have now.

It is a question on the regulation and for the regulators to answer. We suggest an email to goodsregulation@beis.gov.uk, the business Ministry

It depends on the time it is being placed on the market. If it is placed before 1/1-2021 no UKCA mark requirements. If it is placed on the market in the transition period, the CE mark is valid until 1/1-2022 (for most products). For CE-marked products placed on the UK market after the transition period the UKCA mark and all its requirements are mandatory.

The UKCA notified body has to have a registered company in the UK

That is correct. For products already placed on the market before 1/1-2021, there is no changes.

From www.gov.uk:

 

UK distributors and suppliers

 

You willneed to confirm whether you or your supplier will become an ‘importer’ after 1st January 2021. You’ll become an importer if you’re the first one bringing goods from outside the UK and placing them on the market in Great Britain. If someone has already placed a good on the UK market before you sell it in Great Britain, you will remain a distributor and will not have any additional responsibilities.

 

As an importer, you will need to make sure that from 1 January 2021:

 

• goods are labelled with your company’s details, including your company’s name and a contact address. Until 31 December 2022 you can provide these details on the accompanying documentation rather than on the good itself. After 31 December 2022, your details must be affixed to the product or, in circumstances where the legislation currently allows, on the packaging or an accompanying document
• the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings
• the manufacturer has drawn up the correct technical documentation and complied with their labelling requirements
• you maintain a copy of the declaration of conformity for a period of 10 years
• goods conform with the relevant essential requirements

You must comply with the above immediately for goods placed on the GB market from 1 January 2021, for both CE and UKCA marked goods.

In principle other regulation will be changed over to UK regulation but there will be changes and you will have to check with UK government regulation.

We can not find any information on this, but we believe that it will follow the same principles as for the CE-mark, which means that it is only the final product that needs to be marked. However, using marked components, ease the manufacturers documentation requirements.

From www.gov.uk:

 

The transition period for the UKCA labeling has been extended until 31/12 2024. For products such as medical equipment, building materials, equipment for trains and ships, etc., other rules apply.

Further information can be found here: https://www.gov.uk/guidance/using-the-ukca-marking#when-the-ukca-marking-comes-into-use 

 

If you are a Northern Ireland company, you will still be able to place qualifying Northern Ireland goods on the GB market with an EU conformity assessment marking, such as the CE marking, after 31st December 2021.