Posted on 6th March 2019

On Saturday February the 4^th the United Kingdom Government, Department for Business Energy and Industrial Strategy launched the UK conformity assessment protocol designed to “replace” the CE mark. This is of course in the event that there is a no deal exit from the European Union on the 29^th of March.

So for many months we, as BSIF, have been, to the best of our ability, passing on information and advice “in the unlikely event of a no deal Brexit”. Recent events have, it would appear, given little reason for optimism that the industry can rely on business as usual.

The Personal Protective Equipment market has since the early 90’s been premised on the CE mark and harmonised performance standards for these life critical products. Should we leave the EU without a transitional arrangement in place the process of replacing the CE mark with the UKCA will begin and along with it a whole new chapter for the PPE industry.

The formal government advice follows detain that “The UKCA (UK Conformity Assessed) marking is the new UK product marking that will be used, subject to parliamentary approval, for certain goods being placed on the UK market if we leave the EU without a deal. Personal Protective Equipment marketed under the Regulation (EU 2016/425) is indeed included within the UKCA process.

If the UK leaves the EU without a deal economic operators in the PPE market will still, in the majority of cases, be able to use the CE marking to demonstrate compliance with the legal requirements and to sell products on the UK market after 29 March 2019. However, in some cases you will need to apply the new UKCA marking to products being sold in the UK.

Using the UKCA marking
The rules around using the new UKCA marking will mirror those which currently apply for the application of the CE marking to PPE. This is extremely important and confirms that whatever happens the new UKCA process will copy the CE marking process. Therefore BSIF members and users of PPE will not have to adopt new rules but simply work under a system with a different title.

However, if products require third party assessment of conformity, and if this has been carried out by a UK conformity assessment body, you will have to apply the new UKCA marking after 29 March 2019 (where required by legislation). This will not be the case if the certificate of conformity has been transferred to an EU-recognised body (in which case the CE marking would apply).

If products currently rely solely on a self-declaration of conformity for the CE marking this  will also be available within the UKCA marking based on self-declaration, for those products within scope of the marking. Again the same basic rules will apply.

The UKCA marking will not be recognised on the EU market, and products currently requiring a CE marking will continue to require a CE marking for sale in the EU. In essence the situation described means that under if PPE is CE compliant then it will continue to be compliant in the UK.

Technical documentation
Manufacturers, or brand owners or authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that the product conforms with the statutory requirements. This information can be requested at any time by market surveillance or enforcement authorities to check that your product conforms with the statutory requirements. This can be up to a maximum of 10 years after the product is placed on the market.

BSIF has for a considerable time been at pains to point out to the authorities that market surveillance under present rules fails to deliver the necessary oversight! We see no reason as why this will change under the UKCA and call on those in position to discharge their responsibilities or formally delegate that to the Industry.

The information that must be kept in support of the UKCA again follows CE and brand owners must keep general records of:

• how the product is designed and manufactured
• how the product conforms to the relevant requirements
• the addresses of the manufacturer and any storage facilities

Again like as in CE this should be kept in the form of a technical file which can be supplied if requested by a market surveillance authority.
UK Declaration of Conformity
There will be the need for a UK Declaration of Conformity which must accompany most products lawfully bearing a UKCA marking. In the document you as the manufacturer, should:

• declare that the product is in conformity with the relevant statutory requirements applicable to the specific product
• make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)

Existing UK Notified Bodies can automatically qualify to be UKCA Approval Bodies but as of the 11^th of February BEIS were not able to confirm whether any of the existing 14 Notified Bodies scoped for CE had requested to become “UKCA Approval Bodies”

CE marking of products assessed by UK conformity assessment bodies
If the UK leaves the EU without a deal, the results of conformity assessment carried out by UK conformity assessment bodies will no longer be recognised in the EU.

This means brand owners must get products assessed and marked by an EU recognised conformity assessment body if you want to sell them in the EU. You could also arrange for assessments to be transferred to an EU-recognised body before the UK leaves the EU.
You should speak to your conformity assessment body (Notified Body) in the UK or an equivalent EU-recognised body about how this can be arranged.

Continued use of the CE marking in the UK
You will not need to do anything for goods that are sold on the UK market before 29 March 2019. These goods can continue to circulate in the UK as they do now without any changes to the marking requirements. They are considered to be “placed on the market”.
After 29 March 2019 you will still be able to sell goods which have been made and assessed against EU regulatory requirements and then CE marked on the UK market. This is intended to be for a time-limited period. The UK government will consult with industry and provide notice before ending this time-limited period. BSIF have made it very clear that few if any items of PPE are manufacturer exclusively for use in the UK and therefore any UKCA requirements that are mandated will be in addition to the CE marking.

BSIF have for the last 2 and a half years striven to ensure that the interests of the economic operators in the UK PPE market have been represented to the best of our ability. If indeed we do leave without a deal at least in the short term we will have rules that are familiar, even if they are titled differently.

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