Questions and Answers for Selling Goods on the EU Single Market

General questions

1. What are the rules for selling a product on the EU Single Market?

All products placed on the EU Market must comply with the essential health and safety requirements (EHSRs) of the appropriate union harmonisation legislation.

2. Who checks that the rules are complied with?

There are approximately 30 Directives and Regulations governing rules of sale, ranging from toys to pressure equipment. Each Directive and Regulation will have a designated Market Surveillance Authority who is responsible for checking and enforcing compliance with the EHSRs.

3. What has the Health and Safety Authority got to do with the manufacture, import and export of products?

The Health and Safety Authority is the designated Market Surveillance Authority for the following products:

1. Lifts and Safety Components ( Dir. 2014/33/EU)
2. Machinery (Dir. 2006/42/EC)
3. Products for use in Explosive Atmospheres ( Dir. 2014/34/EU)
4. Pressure Equipment ( Dir. 2014/68/EU)
5. Personal Protective Equipment (Reg. No. 2016/425)
6. Gas Appliances (Non Domestic) ( Reg. No. 2016/1628)

The Authority remit covers all products governed by these Directives and Regulations including both professional and consumer products. 

4. If I am only a distributor selling somebody else’s product, do I have to worry about these rules?

Yes, Union harmonisation legislation put specific statutory obligations on all economic operators including distributors.

5. What is an Economic Operator?

An economic operator means a manufacturer, authorised representative, importer or distributor.

A manufacturer is the person who manufactures the product or has the product designed and manufactured, and markets that product under their trade name.

An importer is a person established within the European Economic Area (EEA) who first places a product from a third country on the market of the EEA.

A distributor is any person in the supply chain, other than the manufacturer or importer who makes a product available on the market.

An authorised representative is a person established in the EEA who has received a written mandate from a manufacturer to act on their behalf on specific tasks.

6. How do I check what legislation applies to the product I am selling on the market?

Contact the Authority at contactus@hsa.ie.

7. What is the CE mark?

It is the marking whereby the manufacturer indicates that the product complies with the applicable Union harmonisation legislation.

8. What is a Declaration of Conformity (DOC)?

It is a document drawn up by the manufacturer stating that their product complies with the Essential Health and Safety Requirements (EHSRs) of the relevant Union harmonisation legislation.

9. Is complying with a standard the same as complying with the law?

Not necessarily,  however the law states that a product that complies to the relevant harmonised standard(s) is given the presumption of conformity to the EHSRs of the legislation.

10. If my product complies with a harmonised standard can I sell it in the EEA?

Yes, if accompanied by a Declaration of Conformity (DOC).

11. What is the difference between a harmonised standard and a non-harmonised standard?

Harmonised means it is recognised by the European Commission and is published in the official journal and gives the presumption of conformity to the EHSRs. A non-harmonised standard does not. Harmonised Standards also provide a good indication of state of the art and must be taken into account when applying the EHSRs.

12. Where do standards come from?

In practice two European Standards Organisations (ESOs) are involved in the development of standards; CEN and CENELEC.

13. Who is responsible for the conformity assessment of a product?

The manufacturer is responsible for the conformity assessment. As part of their obligations, they must:

1. prepare a technical file demonstrating the product satisfies the EHSRs
2. carry out the appropriate procedures for assessing conformity that may include any necessary tests etc.;
3. draw up the Declaration of Conformity
4. affix the CE mark. 

14. What obligations does an importer have before placing a product on the market for the first time? 

1. Ensure that the manufacturer has carried out the steps (para 13) above.
2. Put their own name and contact details on the product. This is in addition to the manufacturer’s markings.
3. Notify the Authority of any risks or non-compliances with the product if they become aware of any.
4. Keep a register of complaints.
5. Keep distributors informed.
6. Keep copies of Declarations of Conformity (DOC) and technical documentation for 10 years.
7. Withdraw or recall unsafe or non-compliant products as appropriate.*

15. What obligations does a distributor have before making a product available on the market? 

1. Ensure the product bears the CE Mark.
2. Ensure that the product is accompanied by the required documents and instructions.
3. Ensure manufacturer and importer markings are on the product.
4. Notify the Authority of any risks or non-compliances with the product if they become aware of any.
5. Keep copies of DOCs and technical documentation for 10 years.
6. Must not supply products that they know are not in compliance with the legislation.
7. Withdraw or recall unsafe or non-compliant products as appropriate.*

16. What if I want to sell the product exclusively under my name even if I am not the OEM (Original Engineering Manufacturer)?

You  assume the role of the manufacturer and therefore must meet all the duties and obligations arising (see para 13 above).

17. What is a Notified Body?

A body authorised to carry out conformity assessment tasks. Some Union harmonisation legislation requires the oversight of a Notified Body as part of the conformity assessment process for certain products.  The manufacturer has the obligation to identify and engage the services of an appropriate Notified Body for the conformity assessment of their product.

18. What is the position of second hand products entering Ireland from outside the EU

In general, Union harmonisation legislation does not apply to the placing on the market of used or second hand product. In Ireland the putting into service and use of second hand product for professional use is subject to the Health, Safety and Welfare at Work (General Application ) Regulations S.I. 299 of 2007 Part 4 Use of Work Equipment. 

There is one exception to this general rule. The Machinery Directive applies to used or second-hand machinery that was first made available with a view to distribution or use outside the EU when it is subsequently placed on the market or put into service for the first time in the EU.  The person responsible for placing on the market or putting into service such used machinery for the first time in the EU, whether he is the manufacturer, importer, distributor or the user himself, must fulfil all the obligations set in the Directive (see para 13 above).

Note: A second hand product arriving in Ireland may have been first placed on the market of some other Member State at some other time in the past.

It is advised to contact the Authority for advice on your specific case.

19. Further Information

Contact the Authority at contactus@hsa.ie

The Authority website - www.hsa.ie/Brexit

The Irish National Accreditation Board (INAB) – www.inab.ie

Useful web sites:  https://www.cen.eu/  https://www.cenelec.eu/  

*The Machinery Regulations do not include explicit obligations for importers or distributors of machinery. If a machinery manufacturer established outside the EU takes the decision to place his products on the market in the EU, he is able to fulfill his obligations under the Machinery Directive himself provided the person authorised to compile the technical file is established in the Community.

If you choose to import machinery from outside the EU, such as from an export company or via the internet. You may be able to  ensure that the manufacturer has fulfilled his obligations according to the Directive. However, if that is not ensured, you must fulfill these obligations yourself. If you cannot ensure that the manufacturer has fulfilled his obligations and you are not prepared or unable to fulfill these obligations yourself, then you are advised not to import such machinery. This includes machinery for own use