The Implications of Brexit on Access of Products to the EU Market
Irish manufacturing businesses will need to take note of the following details:
1. Does your manufacturing business rely on the services of third party certification through a notified body?
You may have been using the services of a UK based notified body. After the transitional period, UK based notified bodies will no longer be recognised and you will need to source another EU based notified body listed in the European database, NANDO Database. Approved notified bodies are free to offer their services throughout Europe and your current notified body should facilitate the transfer of your files and data to the new body selected.
Where needed, the certification from an EU-27 notified body will be required to place products on the European market.
Similarly, if your supply chain has relied on the services of a UK based notified body you should ensure that they have sourced an alternative, in order to safeguard continuity of supply for your business.
You should be aware that your new notified body will have a different notified body number which is unique to them and allocated by the Commission appointment process. This may need to be reflected in the documentation and certification associated with your product.
Ireland has responded by approving notified bodies established in Ireland and which cover the following product areas - machinery, marine equipment, transportable pressure equipment, radio equipment, construction products, PPE, recreational draft, measuring instruments. For a list of accredited notified bodies established in Ireland, please see www.inab.ie and the NANDO database.
For notified bodies certifying medical devices, please contact the Health Products Regulatory Authority (www.hpra.ie).
2. Are you now responsible for placing products on the European Market?
A product is placed on the market when it is made available for the first time on the Union market, by either a manufacturer or importer, who is known as an economic operator. Products are also placed on the market if the economic operator supplies to a distributor.
Products made available on the market must comply with the relevant Union legislation at the moment of placing on the European market.
3. Have your responsibilities altered from product distributor to importer?
UK manufacturers and importers will no longer be considered as established in the European Union, thus potentially shifting your legal responsibilities from distributor to importer. As a result, you may have additional or new legal obligations depending on the product type involved. Case Study 1 outlines the implications of this change under the Transportable Pressure Equipment Directive (TPED) (2010/35/EU). Case Study 2 advises on possible changes to your responsibilities in relation to the Machinery Directive 2006/42/EC.
4. Do you use the services of a recognised authorised representative?
After the transitional period, UK based authorised representatives will no longer be recognised and you will need to source another representative based in the EU-27.
Accreditation and Recognition of Certificates
The Irish National Accreditation Board (INAB) is the sole body in Ireland with responsibility for the accreditation of notified bodies. It is part of the Health and Safety Authority.
INAB accreditation is internationally recognised through mutual recognition arrangements between accreditation bodies in each Member State.
As goods and services continue to trade through the European market, it is important to ensure that they are supported by reliable accredited testing, inspection and certification. This ‘passport to trade’ facilitates cross border movement of goods and services.
National market surveillance authorities will check the certificates for products being placed on the EU-27 market.
To check the reliability of your certificate….follow these 4 steps
|1||Check that there is an accreditation mark on the report or certificate.|
|2||Check that the accreditation mark is of a National Accreditation Body (NAB) - in Ireland this is INAB.|
|3||Check that your supplier is accredited for the competence, the tests and the results you need.|
|4||Check that the tests have been carried out against international standards. Alternatively, check that the standards and methods used can be accepted in the country of destination.|
The INAB accreditation mark is:
UKAS is the national accreditation body for the UK. The European Co-operation for Accreditation (EA) is an association of accreditation bodies and it has issued a statement on Brexit and UKAS membership here.
For advice on the continued recognition of INAB accredited certificates, please make contact at the email address provided below.
For further advice or information on any of the above, please contact:
- European Commission notice on industrial products REV2
- European Commission notice on industrial products REV1
- European Commission questions and answers on industrial products Questions and Answers
- European Commission notice on transportable pressure equipment
- European Commission notice on transportable pressure equipment REV1
- Information on the single market for goods Single Market
- INAB accreditation www.inab.ie
- HSA Brexit information https://www.hsa.ie/eng/Topics/Brexit/
- Questions and Answers for Selling Goods on the EU Single Market
- Questions and Answers for Selling Machinery / Equipment or Goods on the EU Single Market after Brexit
- Mutual recognition Information
Case Study 1: Transportable Pressure Equipment Directive 2010/35/EU
Obligations of importers and distributor
Importers and distributors are economic operators under the Transportable Pressure Equipment Directive (TPED). They are established within the Union and are defined as follows:
- An importer places transportable pressure equipment (TPE) or parts thereof from a third country on the Union market.
- A distributor (other than the manufacturer or importer) makestransportable pressure equipment or parts thereof availableon the market.
Under TPED, ‘placing on the market’ is the first making available of TPE on the Union market while ‘making available on the market’ is any supply of TPE for distribution or use on the Union market in the course of a commercial public service activity, whether in return for payment or free of charge.
The obligations of importers and distributors under the TPED can be summarised as follows:
|Before placing TPE on the market, the importer needs to ensure:||Before making TPE available on the market, the distributor needs to ensure:|
- the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation;
- the TPE is Pi (π) marked;
- it has a certificate of conformity. The name and address of the importer should be in the certificate of conformity or attached to it;
- Keep a copy of the technical documentation.
- the TPE is Pi (π) marked;
- it has a certificate of conformity with the contact address for the importer.
Use of UK notified bodies to do inspections of TPE
Irish companies currently using UK notified bodies to carry out inspections of TPE, such as periodic, intermediate and exceptional checks will have to source alternative bodies from within the EU as UK notified bodies will no longer be recognised after the transitional period.
Further background and guidance to the TPED is here.
Case Study 2: Machinery Directive 2006/42/EC
Obligations on Distributors and Wholesalers of Machinery before and after Brexit
- The ‘CE’ symbol is required on most machinery sold in the European Economic Area (EEA).
- The manufacturer, the authorised representative or any natural or legal person who places on the market or puts into service such a product, is responsible for the compliance and conformity assessment of the product.
- Placing on the market means making a product available for the first time in the Community.
- Machinery such as garden machines, construction machinery or any machine as defined in the Machinery Directive 2006/42/EC must be safe, meet the requirements of the Directive and bear the CE marking before they can be placed on the European Market.
Distributors selling or distributing goods from UK
- The UK based manufacturer bears most of the obligations for conformity.
- The Irish distributor may be entitled to rely on the “presumption of conformity” that is afforded by correct CE marking and the provision to the end user of the Declaration of Conformity (DOC).
- It is not necessary to check the whole design of the machine against the Essential Health and Safety Requirements (EHSRs) of the Directive before supplying if the technical file is located within the European Community.
- The machine must also be in the same package and accompanied by an appropriate Declaration of Conformity (DOC) and Instruction Manual in the required language.
This scenario assumes that the UK adopts none of the technical rules for products post Brexit and becomes a third country (e.g., similar to China or India).
- The Irish distributor bringing in machinery from UK is now placing the product on the market for the first time.
- This means the IE distributor now becomes the EU importer.
- As an importer, there are additional responsibilities to ensure the manufacturer has complied with all the requirements for conformity.
- Importer needs full access to the technical file for the product showing how design and construction meets all EHSRs.
- Should the distributor or importer market the product under their own name, they then take over the full responsibilities as if they were the manufacturer.
- The distributors should not supply products to the market that they know are not compliant with the legislation.
Annex IV Machinery
- Where the product is high risk and listed in Annex IV of Machinery Directive there are additional requirements. Machines such as chainsaws, bench saws, power presses are all examples of Annex IV machines.
- As with all machinery under the Directive, these machines must be fully compliant, be CE marked and be accompanied by a Declaration of Conformity.
- 3rd party verification may be required i.e. a valid type-examination certificate issued by an approved European Notified Body, unless the product meets in full all requirements of the most recent version of the relevant harmonised standard.
- Where harmonised standards do not exist for the machine, additional procedures are required to ensure the machine is in compliance and can be placed on the market.
- UK Notified Bodies will no longer be valid within the EU after the withdrawal date.