The new year is fast approaching and with it comes an end to the UK’s Brexit transition period.
Whilst attempts are still being made to carve out a post-Brexit trade deal many, including key figures on both sides of the negotiating table, have speculated that it is unlikely a deal will be reached. Even if a last minute trade deal is struck, it is unlikely that tariff free access to the market will continue, still less that the UK and EU will agree to unfettered movement and ongoing alignment of all categories of products.
Businesses should take care to ensure that products remain compliant with the rules and regulations of the territory in which they are distributed and pay close attention to any changes within the regulations in the new year.
If a no-deal Brexit transpires (and in many possible permutations in which a "deal" is reached which does not include provisions governing product alignment and movement of goods) the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 will take effect from 1 January 2021. Whilst this will not result in a complete overhaul of the EU products regime currently applicable in the UK, there will be key changes which distributors and manufacturers of products should be aware of.
It is important to note that these changes apply to products generally, but that additional considerations are required for some specific categories of products including (amongst others) food, cosmetics or medicines which are subject to their own legislative regimes.
CHANGES IN STATUS
On 1 January 2021 UK based suppliers of products will be re-classified as 'importers' as opposed to 'distributors' when bringing goods from the European common market into the UK (provided the goods were not previously placed on the market prior to 31 December 2020). Importers' obligations differ to those of distributors, namely they are required to include their name and business address on product packaging and to ensure that the product complied with the relevant product compliance regimes. In order to provide some scope for a transition into the post-Brexit era, the Government will allow for such information to be provided on accompanying documentation until 31 December 2022.
Businesses currently operating as distributors will therefore need to consider whether they will be re-classified as of 1 January and, if so, take appropriate measures to ensure they are including the appropriate information on packaging and accompanying documentation.
NEW MARKING REQUIREMENTS
Products placed on the EU market must be marked with CE marking in order to demonstrate compliance with health, safety, and environmental protection standards. On 1 January 2021, the UK will introduce a new UKCA marking to replace the CE marking. Goods placed on the UK market will need to bear the UKCA marking in order to demonstrate product conformity with relevant UK legislation. In order to allow businesses to adjust the CE marking will be phased out and most goods bearing the CE marking will continue to be accepted in the UK until 1 January 2022. Following the end of the transition period the UKCA marking must be applied to all relevant products being placed on the UK market. If however all of the following apply to a product, the new UKCA marking will need to used immediately after 1 January 2021 (prior to the end of the transition period):
- the product is for the UK market;
- it is covered by legislation which requires the UKCA marking;
- it requires mandatory third-party conformity assessment; and
- conformity assessment has been carried out by a UK conformity assessment body and conformity assessment files have not been transferred from a UK body to an EU recognised body before 1 January 2021.
It is important to note that the above will not apply to existing stock, for instance if the product was manufactured and placed on the market prior to 1 January 2021. In such cases the CE mark will continue to be acceptable for the product's onward distribution to its intended recipient.
The technical requirements and conformity assessment processes that are used to demonstrate conformity with EU regulatory requirements will largely remain the same. Manufacturers using EU based notified bodies however, will need to seek UK based bodies to carry out conformity assessments prior to placing the UKCA marking on their products. Similarly, businesses using UK based notified bodies to assess conformity of products with EU regulations will need to contract EU based notified bodies to certify their products. Newly classified importers will also be responsible for ensuring the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings. The Government have set-up a new UK Market Conformity Assessment Bodies (UKMCAB) database in order to replace the EU’s New Approach Notified and Designated Organisations (NANDO) database. The UKMCAB database lists all bodies that can provide conformity assessment for goods placed on the UK market.
Businesses (whether acting as manufacturers, distributors or importers) should already be considering whether products they supply will need to be marked differently, the time limits within which such markings should be applied and whether any manufacturing processes need to be adapted to cater to new requirements prior to 1 January 2021.
Particular consideration should also be given to liabilities to consumers in respect of defective goods (importers are likely to be the party sued for any defective product liabilities) and ensuring that contractual indemnities are in place with suppliers, contractual guarantees from manufacturers of conformity and a right of access to underlying technical and conformity documentation, and to contractual rights to share quality data so as to carry out assessments of any product safety issues and the potential for product recalls and other corrective actions.
There are two types of documentation that will be required prior to placing products on the UK market post-Brexit:
1. UK Declaration of Conformity (UK DOC)
This is a formal declaration by a manufacturer (of a manufacturers authorised representative) that the product to which it applies meets all the legislative and regulatory requirements applicable to that product. DOC's must be made available to market surveillance authorities upon their request. A UK DOC must be drawn up for any products bearing the UKCA marking from the 1 January 2021 and should generally include:
- manufacturer's name and full business address or that of the manufacturers authorised representative;
- the product’s serial number, model or type identification
- a statement, stating the manufacturer takes full responsibility for the product’s compliance;
- details of the approved body which carried out the conformity assessment procedure (if applicable);
- the relevant legislation with which the product complies;
- manufacturer's name and signature; and
- the date the declaration was issued
2. Product records.
Documentation must be kept by a manufacturer or authorised representative to demonstrate that a product conforms with applicable regulatory requirements. Such documentation must be kept for 10 years after the product has been placed on the market and should be made available to market surveillance authorities or enforcement authorities upon request.
The information to be included on the record will vary depending upon the product to which it relates and the relevant legislation that applies such a product. General records of the following however should always be retained:
- how the product is designed and manufactured;
- how the product has been shown to conform to the relevant requirements; and
- the addresses of the manufacturer and any storage facilities.
Whilst these obligations are placed upon the manufacturer, newly classified importers are also responsible for (a) ensuring the manufacturer has drawn up the correct technical documentation and (b) maintaining a copy of the declaration of conformity for a period of 10 years. Importers should therefore consider not only if the product has been correctly marked, but also whether the correct corresponding documentation is available.
More information regarding the new UKCA marking and technical documentation is available on the gov.uk website.