Compliance inSight Consulting Inc.

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.

Growth of the EU since 1951

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

EU Member States

THE CE MARK

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To cor­rect this prob­lem, the idea of a uni­fied CE mark was born. Stand­ing for “Confor­mité Européen”, the CE mark must be present on prod­ucts that are placed on the mar­ket in any EU mem­ber state or any Euro­pean Eco­nom­ic Com­mu­ni­ty (EEC) coun­try. The CE mark is not a safe­ty or cer­ti­fi­ca­tion mark as 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 EEC coun­tries are required to accept the CE mark. While EU law allows mem­ber states to cre­ate laws and reg­u­la­tions that go 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!

DIRECTIVES

Factory Line

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 web site.

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 that non-har­mo­nized stan­dards can be used to declare con­for­mi­ty to the Essen­tial Require­ments of each direc­tive, how­ev­er they pro­vide a pre­sump­tion of con­for­mi­ty when EN stan­dards are used, mak­ing life very 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 10 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 must 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.

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

If you need to under­stand Dec­la­ra­tions more deeply, read this arti­cle on our blog.

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