The European Union

The Euro­pean Union (EU) has roots that go back to the post-World War II era when the Euro­pean Coal and Steel Com­mu­ni­ty was formed in 1951. At its peak, the EU includ­ed 28 countries.

A blue and white graphic shows the EU's expansion from 1952 through 2013, when there were 28 member states.
Growth of the EU, 1951–2013

Many changes occurred between then and now, but the EU as most peo­ple know it became a real­i­ty in the ear­ly 1990s. Free­dom of trade between the mem­ber states was crit­i­cal for the union’s suc­cess as a whole. One of the main trade bar­ri­ers was the pres­ence of dif­fer­ent tech­ni­cal stan­dards and manda­to­ry prod­uct cer­ti­fi­ca­tions in each country.

A graphic map showing the current 27 member states in the EU since the UK left the union at the end of 2020.

THE CE MARK

The CE Mark on a grid background shows the correct proportions of the mark.

The idea of a uni­fied CE mark was born to cor­rect this prob­lem. Stand­ing for “Con­for­mité Européen,” the CE mark must be on prod­ucts placed on the mar­ket in any EU mem­ber state or Euro­pean Eco­nom­ic Com­mu­ni­ty (EEC) coun­try. The CE mark is not a safe­ty or cer­ti­fi­ca­tion mark under­stood in North Amer­i­ca. The CE mark is gen­er­al­ly a self-declara­to­ry mark, mean­ing that man­u­fac­tur­ers and dis­trib­u­tors are the ones who decide if the prod­uct meets the require­ments and then place the mark on the product.

There are some notable excep­tions to this rule, includ­ing machin­ery falling under Annex IV of the Machin­ery Direc­tive (2006/42/EC from 31-Dec-09 onward), pres­sure ves­sels falling under the Sim­ple Pres­sure Ves­sels Direc­tive (2014/29/EU) and pres­sure ves­sels and equip­ment falling under the Pres­sure Equip­ment Direc­tive (2014/68/EU). These direc­tives require the involve­ment of a Euro­pean Noti­fied Body as part of the con­for­mi­ty assess­ment program.

All EU mem­ber states and EFTA coun­tries are required to accept the CE mark. While EU law allows mem­ber states to cre­ate laws and reg­u­la­tions beyond the EU Direc­tives, they are also strong­ly dis­cour­aged from mak­ing laws that will cre­ate new tech­ni­cal bar­ri­ers to trade. For machine builders and dis­trib­u­tors, this means one mark for 25+ countries!

Brexit

Brex­it was the process involv­ing the UK and North­ern Ire­land’s exit from the EU. The use of the CE Mark in the UK was per­mit­ted to 2021-12-31; how­ev­er, an exten­sion to the imple­men­ta­tion lim­it date to 2022-12-31 was announced in mid-2021. After the manda­to­ry date pass­es, only the UKCA and UKNI marks will be accept­ed. See our UKCA/NI page for more infor­ma­tion if you are sell­ing in the UK or North­ern Ireland.

DIRECTIVES

The Euro­pean Union is sub-divid­ed into Gen­er­al Direc­torates (DG) with spe­cif­ic respon­si­bil­i­ties. The EU par­lia­ment in Brus­sels pub­lish­es Direc­tives which are sim­i­lar to gov­ern­ment “Acts” in the North Amer­i­can system.

Machin­ery and relat­ed prod­ucts fall under DG Indus­try. There are spe­cif­ic direc­tives for a wide vari­ety of sub­jects. These direc­tives use “har­mo­nized stan­dards,” denot­ed by the pre­fix “EN,” as the basis for con­for­mi­ty assess­ment under each direc­tive. Where the involve­ment of a Noti­fied Body is required, you have a wide selec­tion of orga­ni­za­tions to choose from. Lists of NB’s under each direc­tive are also avail­able from the Direc­tive website.

When it comes to indus­tri­al machin­ery, there are a few key direc­tives that typ­i­cal­ly apply:

STANDARDS

There are poten­tial­ly hun­dreds of stan­dards that can apply, and it is the respon­si­bil­i­ty of the man­u­fac­tur­er or the importer of record to ensure that ALL of the applic­a­ble direc­tives and stan­dards have been applied to the prod­uct. A list of the cur­rent har­mo­nized stan­dards under each direc­tive can be found by vis­it­ing the Har­mo­nized Stan­dards List of Direc­tives and Sub­jects page. This page pro­vides access to the text of the direc­tives, as well as to lists of stan­dards har­mo­nized under each directive.

EU law also allows non-har­mo­nized stan­dards to declare con­for­mi­ty to the Essen­tial Require­ments of each direc­tive. How­ev­er, they pro­vide a pre­sump­tion of con­for­mi­ty when EN stan­dards are used, mak­ing life much sim­pler from the con­for­mi­ty assess­ment perspective.

TECHNICAL FILES

Man­u­fac­tur­ers are required to devel­op and main­tain a Tech­ni­cal File for each prod­uct. The file must be main­tained for ten years fol­low­ing the last date of man­u­fac­ture of the prod­uct and must be avail­able in Europe through an orga­ni­za­tion locat­ed with­in the EU. This could be a branch office, a dis­trib­u­tor, a Noti­fied Body or a lawyer.

Tech­ni­cal Files are con­fi­den­tial and need not be sup­plied to customers.

DECLARATIONS OF CONFORMITY

Every prod­uct must be accom­pa­nied by a Dec­la­ra­tion of Con­for­mi­ty. This legal doc­u­ment should fol­low a com­mon for­mat and include the man­u­fac­tur­er’s name, trade­mark and con­tact infor­ma­tion, along with a list of the direc­tives and stan­dards used in the assess­ment of the prod­uct and infor­ma­tion on any Noti­fied Body(ies) involved in the con­for­mi­ty assess­ment of the prod­uct. Each Direc­tive will lay out the require­ments for mark­ing and for the con­tent of the Dec­la­ra­tion in the Annex­es to the Directive.

Man­u­fac­tur­ers’ Dec­la­ra­tions should gen­er­al­ly fol­low the require­ments found in EN ISO/IEC 17050–1 and EN ISO/IEC 17050–2.

To under­stand Dec­la­ra­tions more deeply, read this arti­cle on our blog.