CE Mark (Ireland Brexit)

Exit day is 12th April (this Friday) – Exit time is 12.00 CET midnight

On 13th April, the UK will be a third country and UK Notified Bodies will lose their status as EU Notified Bodies. These “Notified Bodies” assess the conformity of products before they can be placed on the EU market. Once approved by the Notified Body, the CE Mark can be affixed to them.

At present, there are 1,500 Notified Bodies (NBs) in the EU, 174 operating in the UK including 50 NBs for Construction.

9 NBs are in Ireland, 3 of which are the NSAI (National Standards Authority of Ireland).  The NSAI is a Notified Body for Construction Products, Medical Devices and Non-Automatic Weighing Scales.

Irish products which currently rely on a UK Notified Body for CE marking will no longer be able to be placed on the EU market.

Irish companies with products certified by UK Notified Bodies will also not be able to continue to export these to the UK, despite the fact that the UK government issued guidance earlier in the year stating that the CE Mark would continue to be recognised for an unspecified period of time until the mark is replaced by a proposed new UKCA mark.

This is because the UK bodies which issued those CE Marks will no longer be authorised to do so by the EU. The certification would need to be transferred to an EU Notified Body.

Companies must also be mindful of the Declaration of Conformity, which is a legal document that must accompany all CE Marked products sold in the European Union and other countries which recognise the mark.

After Exit day, “distributers” of UK products in Ireland will become “importers” or, they may become authorised representatives, or they may even be treated as a manufacturer if they are marketing the products under their own brand. These roles all entail further legal obligations.

Where a product is being sourced from the UK or another country and no longer carries a CE Mark, other steps will need to be taken. The certification will need to be transferred from the UK Notified Body to an EU27 Notified Body or a new CE Mark applied for.

Further information is here.

[the Exit day may change, please keep following this Blog]

HSA Brexit Guide (Ireland Brexit)

From 30th March 2019, the UK will become a “third country”. The Health and Safety Authority (HSA) is the Competent Authority for a range of EU Regulations and Directive in Ireland.

The HSA has now issued a Brexit Overview document – here.

Cardinal Environment will be setting up a Brexit Law List for Ireland EHS Legislation Systems and Checklists, shortly. We will place this and other guidance on that list.

This HSA Brexit Overview reminds :

(1) Products imported from the UK from 30 March 2019 need to be EU compliant.

(2) Irish companies need to know the full supply chain for all their products (for example machinery, chemicals) and how it is linked to the UK or NI, including via distributors.

(3) Unless Irish companies can source their product from another EU supplier, the Irish company may become an EU importer after Brexit, with additional legal responsibility for compliance of the product with EU law. I posted about this recently.

(4) After Brexit, Irish companies will no longer be able to rely on notified bodies based in the UK to undertake 3rd party conformity assessments required under relevant EU law. They will need to source a notified body legally designated to carry out conformity assessments in the EU27.

This applies to Chemicals, Machinery, Transportable Pressure Equipment, and other classes of Industrial Products.

The above also applies in the rest of the EU27, and in the EEA.

UKCA mark (UK Brexit)

I posted earlier that the Government issued instructions on the CE mark and the new UKCA mark. This post sets out more detail.

The UK issued a technical notice on Construction Products – here.

The UK then issued instructions re the new UKCA mark – here.

A couple of points :

(1) Manufacturers will not have to use the UK marking (UKCA mark) immediately. In the event that the UK leaves the EU without a deal manufacturers will be able, for a period of time, to continue to use the CE marking when placing their products on the UK market (if their product meets the relevant EU requirements). This would include products that have had any necessary third-party assessment carried out by an EU-recognised notified body. The Government would consult businesses before taking a decision on when this period would end.

(2) Products being exported to the EU will need to carry the CE marking (CE mark) to demonstrate compliance with the relevant EU regulatory requirements.

(3) Manufacturers will need to use the UK marking if their products require third party assessment of conformity and if this has been carried out by a UK-based Notified Body (post-exit called an ‘Approved Body’). In that case you will have to apply the new UKCA marking after 29 March 2019 as the EU will cease to recognise UK notified bodies. This will not be the case if the certificate of conformity has been transferred to an EU-recognised Notified Body (in which case the CE marking would apply, and would be valid for both the EU and UK markets.

Questions about the UK mark should be sent to BEIS in the first instance: goods.regulation@beis.gov.uk  They are receiving a high volume of correspondence at the moment but will endeavour to get back to you as soon as possible.

I am hearing that CE marks can continue for medical devices, I will post a separate post when I have more details.

Border changes : partnership pack (UK Brexit)

In a major update and bringing together of already issued instructions, the new Partnership Pack (borders) is now issued. Here

Please note the Hauliers sections, and the sections for Specialist Traders.

Note : I already posted about bi laterals in place to continue existing transboundary waste movement contracts. But note the further work that needs to be done in this area.

Latest Instructions (UK Brexit)

UPDATE : HMRC has issued further easements (imports to UK) – here.

UPDATE : the EU Council has agreed its positions on basic road and air connectivity. Here and here.

The following are latest instructions issued by the UK government and agencies :

(1) agreement is reached to continue the EU dual-use controls (Open General Licence) – applies to certain equipment – here (UK) – background – here (EU).

(2) using UKCA label (goods) – and CE marked goods circulation – here.

(3) letters issued individually to EU trading businesses – here.

(4) simplified customs procedures (updated) – here. (I updated the post I had made earlier on this topic)

Transitional simplified procedures – here.

More Technical Notices (UK Brexit Preparedness)

The UK has today issued further Brexit Preparedness Notices. The existing online location is updated – here.

Please note particularly :

(1) CE marking – in the “Labelling products and making them safe” group

(2) Driving

(3) BAT standards – in the “Protecting the environment” group

(4) F-gases and ODS – in the “Protecting the environment” group

(5) The three Notices in the “Travelling between the UK and the EU” group

(6) Oil and gas activities – in the “Regulating energy” group

(7) European Works Councils in the “Workplace rights” group (already issued)

Any questions, please email me.

UK exits the EU (industrial products)

I posted a number of times in the last six months about European Commission Notices to Operators in different sectors.

22nd January 2018 sees the publication of the latest European Commission Notice to Stakeholders re EU rules in the field of industrial products. This Notice is here.

(1) As of the withdrawal date, the EU rules in the field of non-food and non- agricultural products (industrial products – see indicative list below), whether for use by consumers or professionals, no longer apply to the United Kingdom.

(2) This Notice applies primarily to (the full indicative list is in the Annex to the Notice) : this is a selection (based on the Cardinal EHS Legislation Registers

* products covered by the General Product Safety Directive

* products covered by ROHS

* batteries and waste batteries

* combustion appliances

* products covered by the Eco-design Rules

* simple pressure vessels

* electrical equipment

* machinery

* products covered by the EMF Rules

* measuring instruments

* non-automatic weighing instruments

* pressure equipment

* transportable pressure equipment

* ATEX equipment

* PPE

* marine equipment

(3) This notice should be read in conjunction with any complementary, more specific notices on the legal consequences of the United Kingdom’s withdrawal that may be published with regard to any of the EU laws listed in the annex of this Notice.

(4) EU law designates the importer to be the economic operator established in the EU who places a product from a third country on the EU market. As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the EU. Ditto, aneconomic operator established in the EU-27 who, prior to the withdrawal date, was considered as an EU distributor will become an importer for the purposes of EU product legislation.

(5) Currently, EU product legislation does not generally oblige the manufacturer to designate an authorised representative. However, if the manufacturer chooses to do so, the applicable legislation requires the authorised representative to be established in the EU. In addition, specific EU legislation does provide for the obligation to have an authorised representative (e.g. EU legislation on medical devices, transportable pressure equipment, or marine equipment) or a responsible person (cosmetic products) established in the Union.

Authorised representatives or responsible persons established in the United Kingdom will not, as from the withdrawal date, be recognised as authorised representatives or responsible persons for the purposes of the applicable EU product legislation. The Notice advises manufacturers to take the necessary steps to ensure that, as from the withdrawal date, their designated authorised representatives or responsible persons are established in the EU-27.

(6) In some product areas, EU legislation requires the intervention of a qualified third party, known as Notified Body, in the conformity assessment procedure.

(7) EU product legislation requires Notified Bodies to be established in a Member State and be designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant act of EU product legislation. Therefore, as from the withdrawal date, UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the Commission’s information system on notified organisations (NANDO database). As such, UK bodies will not be in a position to perform conformity assessment tasks pursuant to EU product legislation as from the withdrawal date.

(8) When the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by a body recognised as an EU Notified Body at the time of the placing of that product on the market will be required for products placed on the market as from the withdrawal date.

(9) The Notice advises economic operators to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body to demonstrate compliance for their products placed on the market as from the withdrawal date.

(10) Where economic operators hold certificates issued by a UK Notified Body prior to the withdrawal date and plan to continue placing the product concerned on the EU-27 market as from the withdrawal date, the Notice advises the operators to consider either applying for a new certificate issued by an EU-27 Notified Body or arranging for a transfer – on the basis of a contractual arrangement between the manufacturer, the UK Notified Body, and the EU- 27 Notified Body – of the file and the corresponding certificate from the UK Notified Body to an EU-27 Notified Body, which would then take over the responsibility for that certificate. This responsibility depends on the specific conformity assessment procedure required for the product concerned under the applicable product legislation set out in the Annex.

[The Withdrawal Date is 00:00 30 March 2019, both the EU and the UK authorities have signalled a willingness to agree a Transition Period – I will post separately about this.]