With a no-deal Brexit still a possibility, exporters must understand how they can facilitate the movement of goods regulated under the 'New Approach’ framework, writes FIRA’s Suzie Radcliffe-Hart.
The European Union (Withdrawal) (No. 6) Bill (HL Bill 202) has been proposed in order to “Make further provision in connection with the period for negotiations for withdrawing from the EU”, effectively extending this period by a further three months to the 31st January 2020. The sum of the bill is to force the PM to write to the EU 27 seeking another extension to the Article 50 withdrawal period – preferably to 31st January 2020.
Interestingly, in the event that the EU agrees to a proposed extension, the bill requires the Prime Minister to agree to the exit date, whether this be to the proposed 31st January 2020 or any new exit date which may then be proposed by the EU. This last is of course subject to further approval in the House of Commons.
As we are still facing uncertainty, this article is written from the perspective of a no-deal scenario.
Broadly speaking, product and consumer goods legislation is effectively applied in three categories: Old Approach – described as stand-alone Regulations, typically covering goods such as cars, pharmaceuticals and chemicals; New Approach - essential high-level requirements are given in legislation and compliance is determined by using a series of harmonised standards such as those covering toys or machinery; and Non-harmonised goods – where no CE marking is required, goods are subject to national as opposed to EU legislation.
Currently, EU legislation sets out the ‘essential safety requirements’ which certain products must meet before they can be placed on the EU market. For some of these product areas, manufacturers can choose to demonstrate compliance with these essential requirements by meeting specific ‘harmonised standards’, the reference of which has been published in the Official Journal of the European Union (OJEU). These particular documents when referenced in the OJEU are considered to offer a “presumption of conformity” with the relevant directive under which they are listed.
Some New Approach Directives require a specific Conformity Assessment to be undertaken by a Notified Body before the product can be placed on the market. In this case a product will feature a CE mark and the notified body reference will appear on the product and or its packaging. Others allow the product to be placed on the market, again with the CE marking attached, without a specific Conformity Assessment being undertaken by a Notified Body.
How processes will change post-Brexit
As BSI, the UK’s National Standards Body, is not a Government body, and CEN and CENELEC are not EU parliamentary organisations, they are not affected by Brexit. This means there will be no change in the use of European standards and we will not suddenly see the resurrection of previously superceded British standards, many of which were withdrawn tens of years ago.
However, product marking and specific Conformity Assessments will change.
Products bearing the CE mark that have already been placed on the market will be able to continue to circulate within the UK post-Brexit. In addition, products that meet EU legislative requirements via a specific Conformity Assessment undertaken by an EU Notified Body can still be placed on the UK market, although this is likely to be a time-limited measure.
For those products which have been subject to a specific Conformity Assessment undertaken by a UK-based Notified Body, the results of this specific assessment will no longer be recognised by the EU as of exit day one. This is because UK laboratories that have Notified Body status will no longer be regarded as such.
The EU has made it quite clear that certain compliance activity undertaken in the UK in relation to EU regulations, including conformity assessments performed by UK Notified Bodies, will no longer be recognised, and that the UK will be treated as a third country for regulatory purposes from exit day one.
This will impact goods placed on the market after exit day one, as products that have already been placed on the EU market before exit day, including those that have been subject to a UK-based conformity assessment, will still be able to circulate freely.
Goods placed on the EU market after exit day one will continue to require application of the CE mark. This can either be done via self-certification or by means of a conformity assessment – however, as UK notified bodies will no longer be recognised, either the goods will have to be re-assessed by an EU notified body or manufacturers holding UK conformity assessments can apply for file transfer to an EU notified body.
It should be noted that this restriction only applies to specific Conformity Assessments. Where a CE mark is applied as a form of self-declaration, any test reports issued by an accredited body such as UKAS should still be accepted.
Where goods are classed as medical devices, however, there may be additional requirements to be met, and it is strongly recommended that businesses check with the relevant bodies prior to placing goods on the EU market.
Important notes for distributors
EU-based distributors may, in the event of a no-deal, become importers respectively, and therefore must ensure they are aware of the increased responsibilities of importers. This includes additional obligations in relation to product safety and compliance and in the marking of the product with the importers address.
As these additional responsibilities will apply within the EU from exit day one, where in doubt legal advice should be sought.
What this means for manufacturers
If you are a manufacturer placing products on the EU market on or after 31st October 2019, you should note that:
• Products that were tested by a UK-based notified body will need to be retested by an EU-recognised conformity assessment body before placing on the EU internal market. A list of EU-recognised conformity assessment bodies can be found on the NANDO database. Importantly, after October 2019, in a no-deal scenario, UK-based bodies will no longer be listed on this database
• Alternatively, manufacturers can seek to arrange for their files to be transferred to an EU-recognised notified body to allow for certificates of conformity issued by a UK-based notified body to continue to be valid
In either of the scenarios above, products where third-party testing is required would need to be re-marked with the new EU-recognised notified body’s four-digit number.
Suzie Radcliffe-Hart, technical manager at FIRA International and secretary of the Furniture Industry Research Association, has compiled a 64-page guide entitled Brexit – the importance of planning ahead, which is freely available to all members of the Furniture Industry Research Association here.
