g d atex directive transition from 94/9/ec to
TRANSCRIPT
Guidance document on the ATEX transition_14-10-2015.pdfEUROPEAN
COMMISSION Directorate-General for Internal Market, Industry,
Entrepreneurship and SMEs Industrial Transformation and Advanced
Value Chains Advanced Engineering and Manufacturing Systems
GUIDANCE DOCUMENT ON THE ATEX DIRECTIVE TRANSITION
FROM 94/9/EC TO 2014/34/EU
The new ATEX Directive 2014/34/EU1 is the result of the alignment of the previous ATEX Directive 94/9/EC to the "New Legislative Framework" (NLF)2, in particular to Decision No 768/2008/EC3, as well as to the provisions of the Treaty on the Functioning of the European Union (TFEU) after the Treaty of Lisbon.
Being the result of an alignment and a recast, the main changes in the new Directive 2014/34/EU with respect to the previous Directive 94/9/EC are quite limited, and do not concern the most substantial characteristics of the act that remain the same: scope, essential health and safety requirements, categorization and conformity assessment procedures. The main changes are the following:
Reference number: according to the model YYYY / No / UE Definitions: horizontal additions from the NLF Economic operators (manufacturers, authorised representatives, importers,
distributors) and their obligations: more detailed descriptions from the NLF Harmonised standards and presumption of conformity: reference to Regulation (EU)
No 1025/2012 on European Standardisation4 CE marking: reference to Regulation (EC) No 765/20085 Notified bodies: more detailed requirements and procedures from the NLF
1 Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the
harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast) (OJ L 96, 29.3.2014, p. 309)
2 See http://ec.europa.eu/growth/single-market/goods/new-legislative-framework/index_en.htm 3 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82)
4 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12)
5 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30)
2
Market surveillance and safeguard procedure: reinforced activities and new simplified procedures (also related to the "Product safety and market surveillance package"6)
ATEX committee and implementing acts: reference to Regulation (EU) No 182/20117 ("Comitology") concerning Commission Implementing Decisions on formal objections against harmonised standards, safeguard clauses against products and challenges on the competence of notified bodies
EU declaration of conformity: more detailed contents, and a model, from the NLF EU-type examination certificate: conditions for validity and date of expiry from the
NLF
The new ATEX Directive 2014/34/EU is applicable from 20 April 2016.
This document includes a list of "Frequently Asked Questions and Answers" on the transition to the ATEX Directive 2014/34/EU, which covers both "horizontal" and "sectorial" questions, this is to say, those common to all the EU legislation aligned to the "New Legislative Framework"8 and those specifically related to Directive 2014/34/EU. It reflects the result of ongoing discussions, notably at the workshop on the transition to the new ATEX Directive 2014/34/EU held on 30th September 2015. It should be noted that this document is preliminary, pending the revision of the Blue Guide and the new ATEX Guidelines. Upon finalisation of the revised Blue Guide (planned for end of 2015) and the ATEX Guidelines (planned for the first quarter of 2016) the latter documents have to be considered as the main references for the interpretation of horizontal issues related to the New Legislative Framework and the ATEX Directive respectively.
A list of reference documents for guidance is provided at the end of the document.
6 See http://ec.europa.eu/growth/single-market/goods/building-blocks/market-
surveillance/organisation/index_en.htm 7 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying
down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)
8 Pyrotechnic Articles Directive 2013/29/EU (applicable 1 July 2015); Civil Explosives Directive 2014/28/EU, Simple Pressure Vessels Directive 2014/29/EU, Electromagnetic Compatibility Directive 2014/30/EU, Non-automatic Weighing Instruments Directive 2014/31/EU, Measuring Instruments Directive 2014/32/EU, Lifts Directive 2014/33/EU, ATEX Directive 2014/34/EU, Low Voltage Directive 2014/35/EU (applicable 20 April 2016); Radio Equipment Directive 2014/53/EU (applicable 13 June 2016); Pressure Equipment Directive 2014/68/EU (applicable 19 July 2016) and Marine Equipment Directive 2014/90/EU (applicable 18 September 2016). See http://ec.europa.eu/growth/single- market/goods/new-legislative-framework/index_en.htm
3
irective 94/9/EC
irective 94/9/EC , in the new
D irective
D irective is the result of the
alignm ent to the reference provisions of the N
ew Legislative Fram
ew ork, in
"product" is introduced in A rticle 1(1) including (a) equipm
ent and protective system
s, (b) safety-, controlling- and regulating devices, and (c) com
ponents, now explicitly listed in the scope.
The list of exclusions from the scope in A
rticle 1(2) rem ains the sam
e.
anufacturer – can an operator/user also be a m
anufacturer? The definition of m
anufacturer requires the act of m aking a product available
on the m arket. U
sers and operators do not m ake products available on the
m arket, so they are usually not considered to be m
anufacturers. H ow
D irective 2014/34/EU
, any natural or legal person w
ho m anufactures a product or has a product designed or
m anufactured, and m
e or tradem ark or
uses it for its ow n purposes, is a m
anufacturer. This m eans that an
operator/user w ho produces a product for his ow
n use becom es a m
anufacturer. In this case he has to m
eet all the related obligations and requirem ents of the
D irective, including the necessary conform
ity assessm ent procedures.
This also applies to products that w ere originally not put on the m
arket for the use in potentially explosive atm
ospheres and w hich have been m
odified by an operator/user in a w
ay that they can now be used in hazardous areas. This
represents a substantial m odification of the products and the resulting "new
" products fall under the scope of D
irective 2014/34/EU . The sam
e applies to products w
here due to m odifications, the integrity of type of protection is
concerned, and thus a re-evaluation is necessary. A s in these cases a product
w ill not be put on the m
arket, the criterion of initial putting into service of the product applies here.
4
uide"
porters or distributors? - "A
that prom
ew here
else and is paid w hen people order the goods and
after requests the m anufacturer outside the EU
to send directly the batch of products or one single product to the custom
er - "Fulfilm
citizen address label and send the goods
"Econom ic operators" are defined in A
rticle 2(16) of the A TEX
D irective
and the distributor". The com m
on elem ent to all these actors is that they m
ake products available on the m
arket. N ew
electronic com m
erce) have developed and there are new types of actors, like
agents or fulfilm ent houses. It is often not entirely clear w
hether they can be considered to be im
porters or distributors according to the relevant definitions. The particular role as econom
ic operators that certain actors w ill play w
ill have to be decided according to their specific activities. For exam
ple, a "fulfilm ent
house" generally goes beyond a purely logistic role and plays an essential role in the distribution chain, and it should be considered as a distributor. The subject is still under consideration in the C
om m
ight be provided on that issue.
See also § 3. "The actors in the product supply chain and their obligations" in the "Blue G
uide"
W hich is the difference betw
een "m aking
m arket" in the fram
ew ork of D
aking available on the m
arket" is m entioned, but for the sam
e activity w
operators are covered – e.g. A rticles 6, 7 and 8 –
"placing on the m arket" is m
entioned)?
arket" is the overall concept. A ny transfer betw
een econom
ic operators of a product is considered as m aking available. "Placing on
the m arket" is a specific case of m
aking available, nam ely it is the first tim
e that the product is introduced on the m
arket. It is im portant because at that
m om
ny subsequent transfer is a "m aking
available". The operation is reserved either for a m
anufacturer or an im porter, i.e. the
m anufacturer and the im
porter are the only econom ic operators w
ho place products on the m
arket. W hen a m
anufacturer or an im porter supplies a
product to a distributor or an end-user for the first tim e, that operation is
labelled in legal term s as placing on the m
arket. A ny subsequent operation, for
instance, from a distributor to another or to an end-user is defined as m
aking available. It should be noted the difference betw
een "m aking available on the m
arket" in
A
rticle 5, as the general concept referred to free m ovem
ent in the EU internal
m arket in any m
om ent, and "placing on the m
arket" in A rticles 6, 7 and 8,
referred to the first tim e that the product is introduced on the EU
m arket.
anufactured for the m anufacturer's ow
n use the product is not placed on the m
arket: in this case the legislation applies at the m
om ent of putting into service.
See also §§ 2.2. "M aking available" and 2.3. "Placing on the m
arket" of the "Blue G
uide"
products through the internet? EU
harm onisation legislation applies to all form
of supply, including distance selling and selling through electronic m
eans (as the internet): in any case, products intended to be m
ade available on the EU m
arket m ust be in
conform ity w
ith the applicable legislation. A
product offered in a catalogue or by m eans of electronic com
m erce has to
ebsite directs its offer to the EU
m arket and includes an ordering and shipping
system . Products offered for sale online by sellers based outside the EU
are considered to be placed on the EU
m arket if sales are specifically targeted at
EU consum
See also § 2.1. "Product coverage" of the "Blue G uide"
In m any cases products can be m
arketed through the internet or other distance/electronic m
eans but the product is not physically in the EU
. Placing on the m
arket requires the products to be physically in the EU
territory?
ber
specification is required, but not necessarily a serial num
ber? W ould there be a w
ay to specify the sequential serial num
ber using a barcode?
bering m ust allow
onstrates the conform ity of the specific
type of product, in particular for A TEX
the EU declaration of conform
ity or the attestation of conform
ity. A
barcode can be used if this can reasonably be considered by a m anufacturer
as an appropriate w ay enabling the m
anufacturer and authorities to identify and trace his products and to m
ake the link to the relevant docum entation.
D epending on the product, it is up to the m
anufacturer to decide w hether the
identification elem ent should allow
the identification of each single product or just the relevant batch or type. B
ut m anufacturers should be aw
are that w hen
public authorities in charge of m
arket surveillance recall products and it is not possible to distinguish betw
een batches or serial num bers, all products of that
brand m ust be rem
oved from the m
ation on the packaging or in a docum
ent accom panying the product if the size or nature of the product does
not allow it. O
f course if the inform ation is not visible at a first sight, it m
ust be easily and safely accessible.
See also § 4.2.2.3. "Identification elem ent" of the "Blue G
uide"
Article 6(7)
If lack of space, w ould be possible to indicate the
nam e and address w
ithin the product? The m
anufacturer m ust indicate his (1) nam
e, (2) registered trade nam e or
trade m ark and (3) a single contact postal address at w
hich he can be contacted, on the product or, w
hen not possible because of the size or physical characteristics of the product, on its packaging and/or on the accom
panying docum
entation. If the inform
ation is put inside the product, it m ust be easily accessible by the
M arket Surveillance A
uthorities w ithout dam
bling it w ith specific tools.
See also §§ 3.1. "M anufacturer" and 4.2.2.1. "The requirem
ent to indicate nam
e and address of the m anufacturer" of the "Blue G
uide"
ic operator placing the product on the EU
m arket?
ic operator that places the product on the m
arket i.e. the m anufacturer or im
porter, not the distributor.
A N
SW ER
In the case that a com pany is based in a third
country and in an EU country, is it necessary to
put the inform ation of both places as
m anufacturer and im
porter?
For im ported products, it is required to indicate the nam
e and address of the m
anufacturer and of the im porter, as a basic traceability requirem
ent for m
arket surveillance. B
porter, belong to the sam e group or com
pany and if the com
pany based in the EU takes the full m
anufacturer's responsibility, the indication of the branch based in the EU
w ill suffice to
See also § 4.2.2. "Traceability provisions" of the "Blue G uide"
The postal address in w hich the m
anufacturer can be contacted, m
ust be the one of the m
anufacturer?
N ot necessarily. The postal address m
ust be "at w hich [the m
anufacturer] can be contacted": this is not necessarily the address w
here the m anufacturer is
actually established. This address can for exam ple be the one of the authorised
representative or of the custom er services.
See also § 4.2.2.1. "The requirem ent to indicate nam
e and address for m
anufacturers" of the "Blue G uide"
H ow
contact details shall be in a language easily understood?
The address does not have to be translated. The characters of the language m
ust allow identifying the origin and the nam
e of the com pany. This is not
possible w ith certain alphabets.
W hat elem
e, house no. etc.?
The address m ust be specific enough for a letter to arrive in the right place. N
ot all addresses are com
posed of street nam es and/or house num
bers.
anufacturer's docum
TEX D
irective? The docum
ents that are required to accom pany the product include the
instructions and safety inform ation to be draw
n up and provided by the m
anufacturer to the end-user of the product. O ne single docum
ent can include both instructions and safety inform
ation. It includes also a copy of the EU
declaration of conform ity or the attestation of
conform ity, w
TEX product, as per A
rticle 6(2).
andatory docum entation
ation) m ust include all the
necessary inform ation for the safe use of the product, to enable the end-users to
assem ble, install, operate, store, m
aintain, repair, and dispose of it. It is for the m
anufacturer to determ ine the relevant inform
ation w hich should
be included in the instructions and safety inform ation for a particular product.
Should each product sold in a bulk contain the instructions and safety inform
ation? In principle, every individual product m
ust be accom panied by the instructions
and safety inform ation but it does not m
ean that the full instructions m ust be
given in paper. In som
e specific cases, w here several identical products are bundled in a
packaging for use in one application (e.g. installation equipm ent), it is
sufficient to accom pany the shipping unit w
ith one set of instructions. If another econom
ic operator along the distribution chain dism antles the bundle
and sells the products individually, he should ensure that each product individually sold is accom
panied by the necessary instructions and safety inform
ation. This item
lue G uide".
uide"
A ccording to A
rticle 6(8) the m anufacturer shall ensure that the product is
accom panied by instructions and safety inform
ation: the term "product"
TEX com
panied by instructions, too. Taking into consideration that com ponents
are often very sm all item
s supplied in a w ide range of batch sizes and package
quantities, an alternative m eans of satisfying the inform
ation obligation is to attach the instructions to delivery docum
entation or to the sm allest additional
packaging. The topics that shall be included in the instructions for equipm
ent according to D
irective 2014/34/EU are specified in A
nnex II point 1.0.6. This point is only valid for equipm
ent and so it is not applicable to com ponents.
The content of the instructions for A TEX
com ponents has to be adapted
accordingly: they shall describe the substantial properties of the com ponent
9
and illustrate how
the com ponent has to be installed into the product according
to the intended use.
Products not in conform
shall im m
hich authorities have to be inform
ed?
The "acceptable level of risk" for a product is determ ined by the com
pliance w
ith the essential health and safety requirem ents. The EH
SR s of the A
TEX
D irective have not been changed and therefore the previous thresholds for
assessing the risks w ould continue to apply.
Provision of inform
ation and docum
M ay "a com
em ber State or EEA
country contact an econom
porter, distributor) for inform
ation and docum entation
ent of the local national authorities, or not?
The D irective m
akes reference to "a com petent national authority", that could
be any of the countries of the EU and the EEA
in w hich EU
ended to contact directly the econom
ic operator even if he is based in a different M
em ber State. The inform
ation of local national authorities in direct contacts betw
een any national/EEA authority and econom
ic operators, is advisable, for a m
atter of transparency and good co-operation. If the authority needs inform
ation to com plete the com
pliance evaluation and the econom ic operators
does not provide the inform ation requested, then the first authority can request
the assistance of the local national authority. The legal basis for this type of m
utual assistance is set out in A rticle 24(2) of R
egulation (EC ) 765/2008. If
the econom ic operator does not voluntary take corrective action, the com
petent national authority w
notify them as appropriate via IC
SM S/R
A PEX
em ber States w
ill take follow up
m easures in the context of the safeguard clause procedure and in particular the
local national
authority w
ill contact
the m
and requests corrective action in relation to all relevant products.
See also §§ 7.4. "Safeguard m echanism
s for M em
ation between the M em
ber States and the European Com
m ission" of the "Blue G
uide"
10
efore placing a product on the m
arket im porters shall ensure that the
appropriate conform ity assessm
oes it m
ust have a copy of the EU
declaration of conform ity or the
attestation of conform ity and the related
technical docum entation?
The im porter needs to have a copy of the EU
declaration of conform ity and has
to keep it for 10 years after a product has been placed on the m arket. The
im porter has to ensure that the technical docum
entation can be m ade available
to the com petent national authority upon request. Even if there is no explicit
obligation, the im porter is advised to require form
al assurance in w riting from
the m
hen requested by the m
arket surveillance authority. W hat is im
portant is that the authorities receive the docum
entation and that at im porter's request the m
anufacturer provides the inform
ation to M em
ber States. The im
anufacturer has carried out the appropriate conform
ity assessm ent procedure for the product. Therefore, the
im porter m
ust check w hether the m
anufacturer has fulfilled his requirem ents,
but it does not have to carry out a "new " conform
ity assessm ent of the product.
In addition to that, the im porters has a due diligence obligation w
ith regard to the conform
ity of the product. If he disposes of further inform ation that should
reasonably m ake him
believe that the product is not in com pliance he should
not place the product on the m arket.
The m anufacturer retains the overall responsibility for com
pliance; such responsibility cannot be transferred to the im
porter.
uide"
ents" that are m
ents” that the im porter needs to m
ake sure that are present are the ones w
hich have to accom pany the product, as described in each EU
legislation. In the A
ity or the attestation of conform
ity w hich m
instructions and safety inform ation.
Language of instructions and
ported w ith instructions
can the im porter him
self create a translation of the instructions that w
ill accom pany the product
The m anufacturer, the im
porter and the distributor have the obligation to ensure that the product to be placed on the EU
m arket is accom
ation in a language w hich can be easily
understood by end-users, as determ ined by the M
em ber State concerned.
11
arket? M
em ber State, to ensure that all the languages are available. N
othing prevents econom
w hich they are translated.
W hat happens if the product is placed on a
national m arket for w
hich the m anufacturer has
not foreseen a translation?
A m
anufacturer has a certain set of languages w here he intends to ship the
product but if it goes som ew
here else, im porter and distributor m
ust ensure that instructions are translated in the relevant language. It depends on how
econom
W hat happens w
ith "bad" translations? A
ation, as w ell as any
labelling, shall be clear, understandable and intelligible. Therefore, "bad" (inaccurate, incom
plete, etc.) translations cannot be accepted and the product should be considered non-com
pliant.
ents" that are m
entioned in this paragraph? The "required docum
ents” that the distributor needs to m ake sure that are
present are the ones w hich have to accom
pany the product, as described in each EU
legislation. In the A TEX
D irective it is the EU
declaration of conform
hich m ust accom
ation.
requirem ents w
E m
ation?
The distributor m ust not carry out any specific additional checks apart from
those explicitly m
e also has to check that the m
anufacturer and im porter have indicated their nam
e, registered trade nam e or
trade m ark and the address at w
hich they can be contacted on the product, or, w
hen not possible because of the size or physical characteristics of the products, on its packaging and/or accom
panying docum entation, and that the
product bears a type, batch or serial num ber or other elem
ent allow ing its
identification. The distributor m
ust be able to identify the person (e.g. m anufacturer or his
authorised representative, the im porter or another distributor) w
ho has provided him
w ith the product in order to assist the m
arket surveillance authority in its efforts to obtain the EU
declaration of conform ity or the
attestation of conform ity and the necessary parts of the technical
12
entation. M arket surveillance authorities have the possibility to address
their request for the technical docum entation directly to the distributor. The
latter, is how ever not expected to be in possession of the relevant
docum entation.
In addition to that, the distributor also has a due diligence obligation w ith
regard to the conform ity of the product. If he disposes of further inform
ation that should reasonably m
ake him believe that the product is not in com
pliance he should not m
ake the product available on the m arket.
See also section 3.4. "D istributor" of the "Blue G
uide"
provide the necessary docum ents, taking into
account the fact that even the sm allest distributor
should provide the inform ation?
There is not specific tim e lim
it in the directive for a "reasonable period". This period has to be assessed by the authorities on a case-by-case basis, taking into account the level of urgency/seriousness of risk and the efforts for the econom
ic operator to follow -up the request. A
default period could be e.g. 10 w
orking days, but giving the possibility to shorten it or extend depending of the case. M
em ber States are free to fix a default period in their national law
s, but there should alw
ays be a possibility to shorten or prolong that period.
H arm
onised standards
Article 12
harm onised
D irective? W
onised standards are not published in such date?
The C om
m ission w
andates (M
/B C
/C EN
TEX D
irective 2014/34/EU :
according to A rticle 43, references to the repealed D
irective shall be construed as references to the new
D irective. Therefore, there is no need to change
reference num bers contained in harm
onised standards: any reference to the previous D
irective 94/9/EC should be read as a reference to the new
D irective
2014/34/EU . In particular, as the legal provisions supported by a harm
onised standard (the essential health and safety requirem
ents) have not been changed, A
nnex Z referencing to the repealed D irective can be read as referencing to the
new D
irective itself. C
irective 94/9/EC
safety requirem ents of the new
D irective 2014/34/EU
s rem ain the sam
e. There is in principle no need to revise the standards
13
A N
SW ER
to m
ake changes in A nnex Z only: revision of standards by C
EN and
C EN
ELEC can follow
the norm al revision cycle (approx. 5 years) in order to
adequately follow the state of the art and/or to answ
er to specific needs. In any case, for the sake of clarity and transparency, the first list of references of harm
onised standards under D irective 2014/34/EU
w ill be published on the
O JEU
e tim e of the last list under
D irective 94/9/EC
(probably in February-M arch 2016). The contents of the last
list under D irective 94/9/EC
w ill be the identical to the first list under
D irective 2014/34/EU
ention the new
declaration of conform
ity for A TEX
m arket for the first tim
e m ust be in line w
ith D irective
94/9/EC . A
ccording to A rticle 41 products that are already in the distribution
chain (including stockpiles: see R ecital 49), before 20 A
pril 2016, can continue to be distributed w
ith the EC declaration of conform
ity referring to D irective
94/9/EC , as they have already been law
fully placed on the EU m
arket. D
or EU ) rem
arket (= m ade
available on the EU m
arket for the first tim e). There is no need to change
legislative references in docum ents accom
panying the product. For products placed on the EU
m arket as of 20 A
pril 2016 (or, in the case of products m
anufactured for ow n use, put into service), the EU
declaration of conform
ith the new A
irective requires the product to be accom panied by the
declaration of conform ity, it is difficult for m
anufacturers to ensure that the declaration is exchanged from
one day to the next. In order to facilitate the transition to the new
A TEX
hen conform ity still has to be declared to the
old D irective 94/9/EC
described above is in conform ity with the relevant U
nion harm onisation
th, 2016) and D irective
2014/34/EU (from
arket? If the product rem
ains the sam e and no changes in the state of the art (as from
the harm
onised standards, if available) took place, the sam e declaration of
conform ity can continue to be used.
Is it necessary to change the declaration of conform
ity w hen the referred harm
onised standards change?
It w ould depend on the kind of changes in the new
harm onised standard
superseding the previous one, as indicated by the relevant European Standardisation O
rganisation (C EN
ELEC ) in the standard itself. For
"substantial" changes, related to the state of the art, re-assessm ent of the
product w ill be necessary; for "form
al" or "non-substantial" changes, an update of the declaration of conform
ity w ill be enough. The im
portant issue to consider is that the previous standard has lost the presum
ption of conform ity,
ed" but has to be dem onstrated, in
particular in the technical docum entation.
Structure and contents of the EU
declaration of
conform ity
Article 14(2)
declaration of conform
ity that follow s
nnex X to D
inim um
, he w
ents of the EU declaration of conform
ity. The elem
do not add any additional requirem
ent. In any case, additional inform ation can be included.
A nnex X
harm onised standards used" w
hen other directives (for instance 2014/30/EU
, A nnex IV
standards used, including the date of the standard". D
oes it m ean that for the A
TEX
of the standards used?
The reference of the harm onised standard should be indicated in a precise,
com plete and clearly defined w
ay; this im plies that the version and/or date of
the relevant standard should be specified. Therefore, it can be necessary to include the date if the version cannot be identified in a different m
anner (e.g. year of adoption). This is especially useful w
hen tw o versions of the sam
e standard are providing for presum
ption of conform ity at the sam
e tim e, during
the transitional period betw een the publication of the reference of the
superseding standard on the O JEU
and the date of cessation of presum ption of
conform ity of the superseded standard.
Is the translation of the EU declaration of
conform ity the m
ent under his nam e
EU harm
onisation legislation does not specify w ho has the obligation to
translate. There can be a contractual arrangem ent betw
een the m anufacturer
ho does the translation.
ark? C an the im
porter translate the declaration before he places the product on the m
arket or can the distributor translate it before m
aking it available on the m arket and provide
the translation together w ith the EU
declaration of conform
hich is for exam
to the new A
com pulsory, m
declaration of conform ity, w
hich is already translated in all the EU
official languages.
declaration of conform
The EU declaration of conform
ity m ust be signed by the m
anufacturer (by an individual w
orking for the m anufacturer) or his authorised representative, and
the em ployee's function shall also be indicated. If the translation of the EU
declaration of conform
ity is not signed by the m anufacturer, a copy of the
original EU declaration of conform
ity signed by the m anufacturer m
ust also accom
See also section 4.4. "EU declaration of conform
ity" of the "Blue G uide"
Products subject to m
ore than on EU
declarations of conform
product?
ity is required w
henever a product is covered by several pieces of EU harm
onisation legislation (directives or regulations) requiring an EU
declaration of conform
ity; such single declaration m ust refer to all of legislation applicable to
the product and the related essential requirem ents. For this reason, if the A
TEX
D irective applies to a product as w
ell, its reference should be included in the single or "global" EU
declaration of conform ity w
hich m ust accom
pany the product. This should be checked by the im
porter or distributor. The single EU
declaration of conform ity can be one-page docum
ent listing the different directives or a dossier m
ade up of relevant individual declarations of conform
ity (see recital 24).
ity" of the "Blue G uide"
Products presenting a risk
rticle 35 w hich
describes the procedure for dealing w ith products
The procedure described in A rticle 35 has different possible developm
ents, tow
pliant products are placed on
16
m arket.
If upon request of the m arket surveillance authority the econom
ic operator agrees to take the necessary corrective action (voluntary m
easures by the operator), the procedure ends here. In this case, if the m
arket surveillance authority considers that the risk goes beyond its national territory, the authority w
ill inform the C
ission and the other M em
ber States of the results of the evaluation and the actions the econom
ic operator intends to take. H
ow ever, if the econom
ic operator does not take corrective action as requested, the m
arket surveillance authority shall take appropriate m easures
against the product (com pulsory m
easures). In this case, the national authorities notify the m
easure to the C om
m ission and to the other M
em ber
States, w ho have the possibility to object to it during a 3-m
onth period. If no objection is raised, the m
easure is deem ed to be justified. In this case all
M em
ber States are obliged to take appropriate action against the product on their territories. If objections are raised, the C
om m
w hether the m
easure should be considered as justified or not (the U nion
safeguard procedure in A rticle 36).
The purpose is that restrictive m easures against the product are not an
unjustified restriction of the free m ovem
ent of goods. A dditionally, it is an
inform ation-sharing tool betw
een m arket surveillance authorities: this
exchange of inform ation, although non-com
pulsory in the phase of voluntary corrective actions, is also expected to be subm
itted by the m arket surveillance
authorities to the other M em
ber States.
onths'" tim e to raise
objections by a M em
ber State or the C om
m ission
em ber State?
It is three calendar m onths, to be calculated according to the general provisions
of R egulation (EEC
o 1182/71 of the C ouncil of 3 June 1971
determ ining the rules applicable to periods, dates and tim
e lim its, and in
particular A rticle 3. For exam
ple: if a notification com es in on 15 Septem
ber 2016, the day of notification does not count and the three m
onths' tim e w
ecem ber 2016, 24:00h.
hat is the m eaning of A
rticle 37, especially The procedure of A
rticle 37 has to be seen as exceptional case. In principle the
17
rticle 35? essential requirem
D irective 2014/34/EU
are perform ance
based and technology neutral. H ow
ever, the directive takes into account the state of the art w
hen it w as drafted. It is possible that w
ith the evolution of tim
e, new technologies and the state of the art, the essential requirem
ents do not cover all risks, in particular related to new
products. This is the case foreseen in A
rticle 37. In this case a product m ay form
ally com ply w
ith the essential requirem
ust have to possibility to take restrictive m
easures against the product and this procedure allow
s them to do so. The difference to the "norm
al" safeguard procedure is that A
rticle 37 deals w ith "com
pliant products", w hile A
rticle 35 deals w ith
products presenting a risk for not com plying w
ith the applicable requirem ents.
Form al non-
arking, or the incorrect drafting of the EU
declaration of conform ity; a
form al non-com
pliance?
U nless there are reasons to believe that the product presents a risk, there are
cases w here non-com
ber of adm inistrative or form
al requirem
irective 2014/34/EU
arking or the incorrect drafting of the EU
declaration of conform ity are expressly m
entioned in A rticle 38(1)(c) and (f)
respectively but it is rarely just a form al non-com
pliance: it could be related to m
ore substantial safety issues. In any case, this A rticle 38 does not affect
A rticle 35 (products presenting a risk).
The C E m
arking, the EU declaration of conform
ity and the technical files can be defined as the cornerstone to place A
TEX products on the EU
m arket.
ithdraw al - Recalls" in the
"Blue G uide"
Is the lack of the indication of the year of construction on a com
ponent, a form al non-
com pliance?
The requirem ent to m
ark the "year of construction" is set up in section 1.0.5. "M
arking" of A nnex II to D
irective 2014/34/EU , for equipm
ent and protective system
s but not for com ponents. So in principle the lack of such inform
ation on the com
pliance according to A
uch should the national authorities w ait
It depends on each case but alw ays considering the proportionality principle in
18
easures to restrict or prohibit the product being m
ade available on the m arket?
actions taken by national m arket surveillance authorities vis-à-vis econom
ic operators, for non-com
e tim e.
plications of the dates of publication, adoption, entry into force, transposition and applicability?
The m ost im
portant date is 20 A pril 2016, the date of applicability, from
w hich
M em
ber States have to apply the provisions of the new D
irective 2014/34/EU ,
rem
e points in the new D
irective that can be already applied because they have not changed. Furtherm
ore, the EU declaration of conform
ity m ust
until 19 A pril 2016 but the new
m odel
pril 2016) is the date by w hich M
em ber States
m ust have transposed the relevant provisions of the new
A TEX
D irective
rticle 42. The adoption date (26 February 2014) is w
hen the text w as adopted by the
European Parliam ent and the C
ouncil, and has no practical im plications, as the
date of publication on the O JEU
(29 M arch 2014) and the correlated date of
entry into force (18 A pril 2014, 21
st day follow ing the publication).
A re references to 94/4/EC
to be regarded as references to 2014/34/EU
also in "private docum
the m anufacturer to the custom
er?
This provision is related to EU legal texts and the transpositions of such
legislation. It does not specifically target private docum ents, as these are
subject to national contractual law . It is how
ever not valid for docum ents
w hich are required from
m anufacturers under the A
TEX directive (e.g.
entation), they have to explicitly refer to the new
D irective 2014/34/EU
ber States during the transposition period?
M em
ber States m ust adopt and publish, by 19 A
pril 2016, the national legal provisions acts (law
s, regulations, adm inistrative provisions) to transpose the
relevant provisions of the new A
TEX D
pril 2016. A
e, M em
om m
hich they adopt.
Transitional provisions for notified bodies
W hich are the m
ain tasks for national notifying authorities and for notified bodies during the transposition period?
M em
ber States m ust appoint notifying authorities at the national level and the
national notifying authorities m ust re-notify their conform
ity assessm ent
bodies (notified bodies) before 20 A pril 2016, through the new
devoted space in the C
om m
m onitoring, inform
ation and co-operation activities of notifying authorities and notified bodies, according to the relevant provisions of the D
irective (A rticles
portant that M em
TEX D
irective or the parts relevant for the notification into national legislation as soon as possible and in any event w
ell ahead A pril 2016, in order to ensure that notifying
procedures are com pleted in tim
e, and notified bodies under the new A
TEX
pril 2016.
ith D
pril 2016?
irective 2014/34/EU , certificates issued
under D irective 94/9/EC
ination certificates or quality assurance certificates issued by notified bodies) until 19 A
pril 2016 w
irective 2014/34/EU until their fixed expiration date.
C ertificates issued according to D
irective 94/9/EC can still be used for EU
declarations of conform
.
-type exam ination
irective 94/9/EC ?
pril 2016 addenda (supplem ents) to "old" certificates w
ill be possible, such as EC
-type exam ination certificates and quality assurance
certificates issued according to D irective 94/9/EC
. H ow
ever, these addenda need D
irective 2014/34/EU as a reference base and therefore can only be
issued by notified bodies under the new A
TEX D
irective 2014/34/EU .
according to D irective 2014/34/EU
? N
otified bodies can issue certificates in accordance w ith the new
A TEX
irective should be issued before 20 A
pril 2016. O
can issue certificates under the new
D irective.
TEX D
to the new A
ith a validity date from 20 A
pril
20
ork before that date.
aintain the reference num
ination certificate issued under D
irective 94/9/EC w
converted into an EU -type exam
ination under D
rem ain
, so there is no need to "convert" certificates. The num
bering of certificates is under the autonom y of the notified body, the
D irective does not specify anything in this respect. If the practice of a notified
body is to "re-issue" the w hole certificate instead of issuing addendum
s, the certificate can continue carrying the sam
e num ber and refer to the new
D
irective. In any case, the reference num ber of a certificate m
ust allow to
clearly identify it w ith respect to the approved type, according to A
nnex III(6).
A TEX
pril 2016 w ith
pril 2016?
There is no "transition period" in A rticles 41, 42 and 43, or a "period of
overlapping" of D irectives 94/9/EC
and 2014/34/EU .
ity for A TEX
m arket m
irective 94/9/EC . EU
declarations of conform
ity and certificates m ust be in accordance to the new
D
pril 2016 for A TEX
products placed on the EU
m arket or put into service for the first tim
e as by that date. In order to facilitate the transition to the new
A TEX
declaration of conform ity can indicate the follow
ing: "The object of the declaration described above is in conform
ity w ith the relevant U
nion harm
th, 2016) and D
affect the classification of equipm
ent-groups into categories or the essential health and safety and health requirem
ents for equipm ent and protective
system s intended for use in hazardous areas?
N o. W
, in the new D
essential health and safety requirem ents for equipm
ent and protective system s
intended for use in potentially explosive atm ospheres have not changed. The
new D
irective is the result of the alignm ent to the reference provisions of the
N ew
o 768/2008/EC and
R egulation (EC
) N o 765/2008.
riteria determ ining the classification of equipm
ent-groups into categories" w
nnex II "Essential health and safety
Essential health and safety
Annex II requirem
ents relating to the design and construction of equipm ent and
protective system s intended for use in potentially explosive atm
ospheres".
Annex III(6), (7) and (8)
Is it necessary to lim it the period of validity for
EU -type exam
The new A
TEX D
irective 2014/34/EU includes, in points 6, 7 and 8 of A
nnex III, som
e references to validity (conditions for, if any, and expiry) of EU -type
exam ination certificates. Such references w
ere not present in the previous D
irective 94/9/EC and com
odule B ). In this sense, in the D
irective does not im pose an
obligation on establishing a period of validity for EU -type exam
ination certificates but foresees the possibility to do so w
hen this is deem ed
appropriate. The situation rem ains as it is under the current A
TEX D
irective 94/9/EC
.
See also § 4.1.2.6. "Revision of harm onised standards" in the "Blue G
uide"
If no date of expiry of the validity of the certificate is given, does it m
ean that records (a copy of the EU
-type exam ination certificate, its
annexes and additions, the technical file etc.) shall be kept indefinitely by notified bodies?
Y es. The obligations for notified bodies concerning the referred docum
ents rem
ain for the w hole validity period of the certificate, in order to ensure the
proper traceability.
Technical docum
entation - R
isk analysis
The new "B
docum entation" explains that no additional risk
assessm ent m
entation m ust be created, if harm
onized standards are m
of a risk analysis. H ow
can w e know
w hether a
standard is developed on the basis of a risk analysis? In particular, point 2 of A
nnex V III "Internal
requires from
adequate analysis and assessm ent of the risk(s) in
This statem ent presupposes a good evaluation of the risks of the product and
m atch betw
een the risks analyses and risks covered by the harm onised
standards. A
ent procedure requires the m anufacturer to start a risk
analysis of the specific risks of the product to address them in order to com
ply w
ith the essential health and safety requirem ents because not all products
present the sam e risks w
hich has to be distinguished from the analysis referred
to in the B lue G
uide §4.3, nam ely how
to appropriately address the identified risks. The w
ay to address these risks can be done in several w ays, such as w
ith the harm
onised standards" of the "Blue
22
and requirem
risk evaluation should be realized?
G uide"
ent carried out by the m
anufacturer also be necessary w ith
D irective 2014/34/EU
nnex III(3)(c), A nnex V
III(2) and A nnex IX
(2.1) to D
entation shall include an adequate risk analysis and risk assessm
ent. These shall cover all risks, also those being non-typical for explosion protection, including e.g. risks caused by voltage, noise or m
ovable parts (see A nnex II point 1.2.7 of
D irective 2014/34/EU
dditionally, further EU harm
onization legislation applicable to the product has to be considered. The reason is that the A
TEX D
ay em erge from
any product w ithin the scope. The application of a
harm onized standard can sim
plify risk analysis and risk assessm ent.
See also § 4.1.1. "D efinition of essential requirem
ents" of the "Blue G uide"
U nit verification - R
Annex IX
This conform ity assessm
ent procedure does not require any retention of record by the notified body. D
oes it m ean that no record is form
ally requested to be available for surveillance authorities from
the N B
?
Even not explicitly indicated, the notified body should keep the appropriate docum
entation supporting the certificate of conform ity issued according to
point 4 of A nnex IX
, w ithin the general obligation to inform
and co-operate w
ith the national m arkets surveillance authorities and the other notified bodies.
See also § 5.2.2. "Roles and responsibilities" of the "Blue G uide"
References for guidance
x The "Blue Guide" on the implementation of EU product rules (version 1.1 - 15/7/2015)
x "CERTIF" documents (non-binding interpretative documents issued by the European Commission): - CERTIF doc. 2008-002 - Differences between Conformity assessment modules as laid down in new approach (Decision 93/465/EEC - old modules) and as laid down in the new legal framework (Decision 768/2008/EC - new modules) - CERTIF 2009–03 - Orientations for selecting and implementing the modules (as laid down in Decision 768/2008 of the new legal framework) – SMES specificities - CERTIF 2009–04 - Introduction to conformity assessment and conformity assessment procedures of the new legal framework (as laid down in Decision 768/2008 of the new legal framework) - CERTIF 2009-08 - Using standards to assess the competence of conformity assessment bodies in the context of the New Legislative Framework - CERTIF 2010-05 Rev1 - Overview of market surveillance procedures (including safeguard clause mechanism) in the area of harmonised products - CERTIF doc 2010-06 - Notifications of Notified Bodies in NANDO – requirements of Regulation 765/2008 and Decision 768/2008 - CERTIF 2012-06 REV1 – Notified Bodies - The use of the notified bodies number for activities not required by EU legislation - CERTIF 2013-04 REV2 – Ensuring continuous competence of notified bodies - CERTIF 2013-07 – Time frames for notification of NBs following the entry into force of the Alignment Package - CERTIF 2013-08 – NANDO procedure for notification of notified bodies that are not accredited by a national accreditation body - CERTIF 2013-11 REV1 – Time frames for notification of NBs following the entry into force of the Alignment Package - CERTIF Guidance papers on accreditation (July 2014) - CERTIF 2015-01 REV2– The functioning of NANDO with regard to providing accurate information, objection periods, notification procedures and notified bodies groups
x ATEX 2014/34/EU Guidelines (in preparation; will be available on the ATEX
website on EUROPA)
GUIDANCE DOCUMENT ON THE ATEX DIRECTIVE TRANSITION
FROM 94/9/EC TO 2014/34/EU
The new ATEX Directive 2014/34/EU1 is the result of the alignment of the previous ATEX Directive 94/9/EC to the "New Legislative Framework" (NLF)2, in particular to Decision No 768/2008/EC3, as well as to the provisions of the Treaty on the Functioning of the European Union (TFEU) after the Treaty of Lisbon.
Being the result of an alignment and a recast, the main changes in the new Directive 2014/34/EU with respect to the previous Directive 94/9/EC are quite limited, and do not concern the most substantial characteristics of the act that remain the same: scope, essential health and safety requirements, categorization and conformity assessment procedures. The main changes are the following:
Reference number: according to the model YYYY / No / UE Definitions: horizontal additions from the NLF Economic operators (manufacturers, authorised representatives, importers,
distributors) and their obligations: more detailed descriptions from the NLF Harmonised standards and presumption of conformity: reference to Regulation (EU)
No 1025/2012 on European Standardisation4 CE marking: reference to Regulation (EC) No 765/20085 Notified bodies: more detailed requirements and procedures from the NLF
1 Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the
harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast) (OJ L 96, 29.3.2014, p. 309)
2 See http://ec.europa.eu/growth/single-market/goods/new-legislative-framework/index_en.htm 3 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82)
4 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12)
5 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30)
2
Market surveillance and safeguard procedure: reinforced activities and new simplified procedures (also related to the "Product safety and market surveillance package"6)
ATEX committee and implementing acts: reference to Regulation (EU) No 182/20117 ("Comitology") concerning Commission Implementing Decisions on formal objections against harmonised standards, safeguard clauses against products and challenges on the competence of notified bodies
EU declaration of conformity: more detailed contents, and a model, from the NLF EU-type examination certificate: conditions for validity and date of expiry from the
NLF
The new ATEX Directive 2014/34/EU is applicable from 20 April 2016.
This document includes a list of "Frequently Asked Questions and Answers" on the transition to the ATEX Directive 2014/34/EU, which covers both "horizontal" and "sectorial" questions, this is to say, those common to all the EU legislation aligned to the "New Legislative Framework"8 and those specifically related to Directive 2014/34/EU. It reflects the result of ongoing discussions, notably at the workshop on the transition to the new ATEX Directive 2014/34/EU held on 30th September 2015. It should be noted that this document is preliminary, pending the revision of the Blue Guide and the new ATEX Guidelines. Upon finalisation of the revised Blue Guide (planned for end of 2015) and the ATEX Guidelines (planned for the first quarter of 2016) the latter documents have to be considered as the main references for the interpretation of horizontal issues related to the New Legislative Framework and the ATEX Directive respectively.
A list of reference documents for guidance is provided at the end of the document.
6 See http://ec.europa.eu/growth/single-market/goods/building-blocks/market-
surveillance/organisation/index_en.htm 7 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying
down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)
8 Pyrotechnic Articles Directive 2013/29/EU (applicable 1 July 2015); Civil Explosives Directive 2014/28/EU, Simple Pressure Vessels Directive 2014/29/EU, Electromagnetic Compatibility Directive 2014/30/EU, Non-automatic Weighing Instruments Directive 2014/31/EU, Measuring Instruments Directive 2014/32/EU, Lifts Directive 2014/33/EU, ATEX Directive 2014/34/EU, Low Voltage Directive 2014/35/EU (applicable 20 April 2016); Radio Equipment Directive 2014/53/EU (applicable 13 June 2016); Pressure Equipment Directive 2014/68/EU (applicable 19 July 2016) and Marine Equipment Directive 2014/90/EU (applicable 18 September 2016). See http://ec.europa.eu/growth/single- market/goods/new-legislative-framework/index_en.htm
3
irective 94/9/EC
irective 94/9/EC , in the new
D irective
D irective is the result of the
alignm ent to the reference provisions of the N
ew Legislative Fram
ew ork, in
"product" is introduced in A rticle 1(1) including (a) equipm
ent and protective system
s, (b) safety-, controlling- and regulating devices, and (c) com
ponents, now explicitly listed in the scope.
The list of exclusions from the scope in A
rticle 1(2) rem ains the sam
e.
anufacturer – can an operator/user also be a m
anufacturer? The definition of m
anufacturer requires the act of m aking a product available
on the m arket. U
sers and operators do not m ake products available on the
m arket, so they are usually not considered to be m
anufacturers. H ow
D irective 2014/34/EU
, any natural or legal person w
ho m anufactures a product or has a product designed or
m anufactured, and m
e or tradem ark or
uses it for its ow n purposes, is a m
anufacturer. This m eans that an
operator/user w ho produces a product for his ow
n use becom es a m
anufacturer. In this case he has to m
eet all the related obligations and requirem ents of the
D irective, including the necessary conform
ity assessm ent procedures.
This also applies to products that w ere originally not put on the m
arket for the use in potentially explosive atm
ospheres and w hich have been m
odified by an operator/user in a w
ay that they can now be used in hazardous areas. This
represents a substantial m odification of the products and the resulting "new
" products fall under the scope of D
irective 2014/34/EU . The sam
e applies to products w
here due to m odifications, the integrity of type of protection is
concerned, and thus a re-evaluation is necessary. A s in these cases a product
w ill not be put on the m
arket, the criterion of initial putting into service of the product applies here.
4
uide"
porters or distributors? - "A
that prom
ew here
else and is paid w hen people order the goods and
after requests the m anufacturer outside the EU
to send directly the batch of products or one single product to the custom
er - "Fulfilm
citizen address label and send the goods
"Econom ic operators" are defined in A
rticle 2(16) of the A TEX
D irective
and the distributor". The com m
on elem ent to all these actors is that they m
ake products available on the m
arket. N ew
electronic com m
erce) have developed and there are new types of actors, like
agents or fulfilm ent houses. It is often not entirely clear w
hether they can be considered to be im
porters or distributors according to the relevant definitions. The particular role as econom
ic operators that certain actors w ill play w
ill have to be decided according to their specific activities. For exam
ple, a "fulfilm ent
house" generally goes beyond a purely logistic role and plays an essential role in the distribution chain, and it should be considered as a distributor. The subject is still under consideration in the C
om m
ight be provided on that issue.
See also § 3. "The actors in the product supply chain and their obligations" in the "Blue G
uide"
W hich is the difference betw
een "m aking
m arket" in the fram
ew ork of D
aking available on the m
arket" is m entioned, but for the sam
e activity w
operators are covered – e.g. A rticles 6, 7 and 8 –
"placing on the m arket" is m
entioned)?
arket" is the overall concept. A ny transfer betw
een econom
ic operators of a product is considered as m aking available. "Placing on
the m arket" is a specific case of m
aking available, nam ely it is the first tim
e that the product is introduced on the m
arket. It is im portant because at that
m om
ny subsequent transfer is a "m aking
available". The operation is reserved either for a m
anufacturer or an im porter, i.e. the
m anufacturer and the im
porter are the only econom ic operators w
ho place products on the m
arket. W hen a m
anufacturer or an im porter supplies a
product to a distributor or an end-user for the first tim e, that operation is
labelled in legal term s as placing on the m
arket. A ny subsequent operation, for
instance, from a distributor to another or to an end-user is defined as m
aking available. It should be noted the difference betw
een "m aking available on the m
arket" in
A
rticle 5, as the general concept referred to free m ovem
ent in the EU internal
m arket in any m
om ent, and "placing on the m
arket" in A rticles 6, 7 and 8,
referred to the first tim e that the product is introduced on the EU
m arket.
anufactured for the m anufacturer's ow
n use the product is not placed on the m
arket: in this case the legislation applies at the m
om ent of putting into service.
See also §§ 2.2. "M aking available" and 2.3. "Placing on the m
arket" of the "Blue G
uide"
products through the internet? EU
harm onisation legislation applies to all form
of supply, including distance selling and selling through electronic m
eans (as the internet): in any case, products intended to be m
ade available on the EU m
arket m ust be in
conform ity w
ith the applicable legislation. A
product offered in a catalogue or by m eans of electronic com
m erce has to
ebsite directs its offer to the EU
m arket and includes an ordering and shipping
system . Products offered for sale online by sellers based outside the EU
are considered to be placed on the EU
m arket if sales are specifically targeted at
EU consum
See also § 2.1. "Product coverage" of the "Blue G uide"
In m any cases products can be m
arketed through the internet or other distance/electronic m
eans but the product is not physically in the EU
. Placing on the m
arket requires the products to be physically in the EU
territory?
ber
specification is required, but not necessarily a serial num
ber? W ould there be a w
ay to specify the sequential serial num
ber using a barcode?
bering m ust allow
onstrates the conform ity of the specific
type of product, in particular for A TEX
the EU declaration of conform
ity or the attestation of conform
ity. A
barcode can be used if this can reasonably be considered by a m anufacturer
as an appropriate w ay enabling the m
anufacturer and authorities to identify and trace his products and to m
ake the link to the relevant docum entation.
D epending on the product, it is up to the m
anufacturer to decide w hether the
identification elem ent should allow
the identification of each single product or just the relevant batch or type. B
ut m anufacturers should be aw
are that w hen
public authorities in charge of m
arket surveillance recall products and it is not possible to distinguish betw
een batches or serial num bers, all products of that
brand m ust be rem
oved from the m
ation on the packaging or in a docum
ent accom panying the product if the size or nature of the product does
not allow it. O
f course if the inform ation is not visible at a first sight, it m
ust be easily and safely accessible.
See also § 4.2.2.3. "Identification elem ent" of the "Blue G
uide"
Article 6(7)
If lack of space, w ould be possible to indicate the
nam e and address w
ithin the product? The m
anufacturer m ust indicate his (1) nam
e, (2) registered trade nam e or
trade m ark and (3) a single contact postal address at w
hich he can be contacted, on the product or, w
hen not possible because of the size or physical characteristics of the product, on its packaging and/or on the accom
panying docum
entation. If the inform
ation is put inside the product, it m ust be easily accessible by the
M arket Surveillance A
uthorities w ithout dam
bling it w ith specific tools.
See also §§ 3.1. "M anufacturer" and 4.2.2.1. "The requirem
ent to indicate nam
e and address of the m anufacturer" of the "Blue G
uide"
ic operator placing the product on the EU
m arket?
ic operator that places the product on the m
arket i.e. the m anufacturer or im
porter, not the distributor.
A N
SW ER
In the case that a com pany is based in a third
country and in an EU country, is it necessary to
put the inform ation of both places as
m anufacturer and im
porter?
For im ported products, it is required to indicate the nam
e and address of the m
anufacturer and of the im porter, as a basic traceability requirem
ent for m
arket surveillance. B
porter, belong to the sam e group or com
pany and if the com
pany based in the EU takes the full m
anufacturer's responsibility, the indication of the branch based in the EU
w ill suffice to
See also § 4.2.2. "Traceability provisions" of the "Blue G uide"
The postal address in w hich the m
anufacturer can be contacted, m
ust be the one of the m
anufacturer?
N ot necessarily. The postal address m
ust be "at w hich [the m
anufacturer] can be contacted": this is not necessarily the address w
here the m anufacturer is
actually established. This address can for exam ple be the one of the authorised
representative or of the custom er services.
See also § 4.2.2.1. "The requirem ent to indicate nam
e and address for m
anufacturers" of the "Blue G uide"
H ow
contact details shall be in a language easily understood?
The address does not have to be translated. The characters of the language m
ust allow identifying the origin and the nam
e of the com pany. This is not
possible w ith certain alphabets.
W hat elem
e, house no. etc.?
The address m ust be specific enough for a letter to arrive in the right place. N
ot all addresses are com
posed of street nam es and/or house num
bers.
anufacturer's docum
TEX D
irective? The docum
ents that are required to accom pany the product include the
instructions and safety inform ation to be draw
n up and provided by the m
anufacturer to the end-user of the product. O ne single docum
ent can include both instructions and safety inform
ation. It includes also a copy of the EU
declaration of conform ity or the attestation of
conform ity, w
TEX product, as per A
rticle 6(2).
andatory docum entation
ation) m ust include all the
necessary inform ation for the safe use of the product, to enable the end-users to
assem ble, install, operate, store, m
aintain, repair, and dispose of it. It is for the m
anufacturer to determ ine the relevant inform
ation w hich should
be included in the instructions and safety inform ation for a particular product.
Should each product sold in a bulk contain the instructions and safety inform
ation? In principle, every individual product m
ust be accom panied by the instructions
and safety inform ation but it does not m
ean that the full instructions m ust be
given in paper. In som
e specific cases, w here several identical products are bundled in a
packaging for use in one application (e.g. installation equipm ent), it is
sufficient to accom pany the shipping unit w
ith one set of instructions. If another econom
ic operator along the distribution chain dism antles the bundle
and sells the products individually, he should ensure that each product individually sold is accom
panied by the necessary instructions and safety inform
ation. This item
lue G uide".
uide"
A ccording to A
rticle 6(8) the m anufacturer shall ensure that the product is
accom panied by instructions and safety inform
ation: the term "product"
TEX com
panied by instructions, too. Taking into consideration that com ponents
are often very sm all item
s supplied in a w ide range of batch sizes and package
quantities, an alternative m eans of satisfying the inform
ation obligation is to attach the instructions to delivery docum
entation or to the sm allest additional
packaging. The topics that shall be included in the instructions for equipm
ent according to D
irective 2014/34/EU are specified in A
nnex II point 1.0.6. This point is only valid for equipm
ent and so it is not applicable to com ponents.
The content of the instructions for A TEX
com ponents has to be adapted
accordingly: they shall describe the substantial properties of the com ponent
9
and illustrate how
the com ponent has to be installed into the product according
to the intended use.
Products not in conform
shall im m
hich authorities have to be inform
ed?
The "acceptable level of risk" for a product is determ ined by the com
pliance w
ith the essential health and safety requirem ents. The EH
SR s of the A
TEX
D irective have not been changed and therefore the previous thresholds for
assessing the risks w ould continue to apply.
Provision of inform
ation and docum
M ay "a com
em ber State or EEA
country contact an econom
porter, distributor) for inform
ation and docum entation
ent of the local national authorities, or not?
The D irective m
akes reference to "a com petent national authority", that could
be any of the countries of the EU and the EEA
in w hich EU
ended to contact directly the econom
ic operator even if he is based in a different M
em ber State. The inform
ation of local national authorities in direct contacts betw
een any national/EEA authority and econom
ic operators, is advisable, for a m
atter of transparency and good co-operation. If the authority needs inform
ation to com plete the com
pliance evaluation and the econom ic operators
does not provide the inform ation requested, then the first authority can request
the assistance of the local national authority. The legal basis for this type of m
utual assistance is set out in A rticle 24(2) of R
egulation (EC ) 765/2008. If
the econom ic operator does not voluntary take corrective action, the com
petent national authority w
notify them as appropriate via IC
SM S/R
A PEX
em ber States w
ill take follow up
m easures in the context of the safeguard clause procedure and in particular the
local national
authority w
ill contact
the m
and requests corrective action in relation to all relevant products.
See also §§ 7.4. "Safeguard m echanism
s for M em
ation between the M em
ber States and the European Com
m ission" of the "Blue G
uide"
10
efore placing a product on the m
arket im porters shall ensure that the
appropriate conform ity assessm
oes it m
ust have a copy of the EU
declaration of conform ity or the
attestation of conform ity and the related
technical docum entation?
The im porter needs to have a copy of the EU
declaration of conform ity and has
to keep it for 10 years after a product has been placed on the m arket. The
im porter has to ensure that the technical docum
entation can be m ade available
to the com petent national authority upon request. Even if there is no explicit
obligation, the im porter is advised to require form
al assurance in w riting from
the m
hen requested by the m
arket surveillance authority. W hat is im
portant is that the authorities receive the docum
entation and that at im porter's request the m
anufacturer provides the inform
ation to M em
ber States. The im
anufacturer has carried out the appropriate conform
ity assessm ent procedure for the product. Therefore, the
im porter m
ust check w hether the m
anufacturer has fulfilled his requirem ents,
but it does not have to carry out a "new " conform
ity assessm ent of the product.
In addition to that, the im porters has a due diligence obligation w
ith regard to the conform
ity of the product. If he disposes of further inform ation that should
reasonably m ake him
believe that the product is not in com pliance he should
not place the product on the m arket.
The m anufacturer retains the overall responsibility for com
pliance; such responsibility cannot be transferred to the im
porter.
uide"
ents" that are m
ents” that the im porter needs to m
ake sure that are present are the ones w
hich have to accom pany the product, as described in each EU
legislation. In the A
ity or the attestation of conform
ity w hich m
instructions and safety inform ation.
Language of instructions and
ported w ith instructions
can the im porter him
self create a translation of the instructions that w
ill accom pany the product
The m anufacturer, the im
porter and the distributor have the obligation to ensure that the product to be placed on the EU
m arket is accom
ation in a language w hich can be easily
understood by end-users, as determ ined by the M
em ber State concerned.
11
arket? M
em ber State, to ensure that all the languages are available. N
othing prevents econom
w hich they are translated.
W hat happens if the product is placed on a
national m arket for w
hich the m anufacturer has
not foreseen a translation?
A m
anufacturer has a certain set of languages w here he intends to ship the
product but if it goes som ew
here else, im porter and distributor m
ust ensure that instructions are translated in the relevant language. It depends on how
econom
W hat happens w
ith "bad" translations? A
ation, as w ell as any
labelling, shall be clear, understandable and intelligible. Therefore, "bad" (inaccurate, incom
plete, etc.) translations cannot be accepted and the product should be considered non-com
pliant.
ents" that are m
entioned in this paragraph? The "required docum
ents” that the distributor needs to m ake sure that are
present are the ones w hich have to accom
pany the product, as described in each EU
legislation. In the A TEX
D irective it is the EU
declaration of conform
hich m ust accom
ation.
requirem ents w
E m
ation?
The distributor m ust not carry out any specific additional checks apart from
those explicitly m
e also has to check that the m
anufacturer and im porter have indicated their nam
e, registered trade nam e or
trade m ark and the address at w
hich they can be contacted on the product, or, w
hen not possible because of the size or physical characteristics of the products, on its packaging and/or accom
panying docum entation, and that the
product bears a type, batch or serial num ber or other elem
ent allow ing its
identification. The distributor m
ust be able to identify the person (e.g. m anufacturer or his
authorised representative, the im porter or another distributor) w
ho has provided him
w ith the product in order to assist the m
arket surveillance authority in its efforts to obtain the EU
declaration of conform ity or the
attestation of conform ity and the necessary parts of the technical
12
entation. M arket surveillance authorities have the possibility to address
their request for the technical docum entation directly to the distributor. The
latter, is how ever not expected to be in possession of the relevant
docum entation.
In addition to that, the distributor also has a due diligence obligation w ith
regard to the conform ity of the product. If he disposes of further inform
ation that should reasonably m
ake him believe that the product is not in com
pliance he should not m
ake the product available on the m arket.
See also section 3.4. "D istributor" of the "Blue G
uide"
provide the necessary docum ents, taking into
account the fact that even the sm allest distributor
should provide the inform ation?
There is not specific tim e lim
it in the directive for a "reasonable period". This period has to be assessed by the authorities on a case-by-case basis, taking into account the level of urgency/seriousness of risk and the efforts for the econom
ic operator to follow -up the request. A
default period could be e.g. 10 w
orking days, but giving the possibility to shorten it or extend depending of the case. M
em ber States are free to fix a default period in their national law
s, but there should alw
ays be a possibility to shorten or prolong that period.
H arm
onised standards
Article 12
harm onised
D irective? W
onised standards are not published in such date?
The C om
m ission w
andates (M
/B C
/C EN
TEX D
irective 2014/34/EU :
according to A rticle 43, references to the repealed D
irective shall be construed as references to the new
D irective. Therefore, there is no need to change
reference num bers contained in harm
onised standards: any reference to the previous D
irective 94/9/EC should be read as a reference to the new
D irective
2014/34/EU . In particular, as the legal provisions supported by a harm
onised standard (the essential health and safety requirem
ents) have not been changed, A
nnex Z referencing to the repealed D irective can be read as referencing to the
new D
irective itself. C
irective 94/9/EC
safety requirem ents of the new
D irective 2014/34/EU
s rem ain the sam
e. There is in principle no need to revise the standards
13
A N
SW ER
to m
ake changes in A nnex Z only: revision of standards by C
EN and
C EN
ELEC can follow
the norm al revision cycle (approx. 5 years) in order to
adequately follow the state of the art and/or to answ
er to specific needs. In any case, for the sake of clarity and transparency, the first list of references of harm
onised standards under D irective 2014/34/EU
w ill be published on the
O JEU
e tim e of the last list under
D irective 94/9/EC
(probably in February-M arch 2016). The contents of the last
list under D irective 94/9/EC
w ill be the identical to the first list under
D irective 2014/34/EU
ention the new
declaration of conform
ity for A TEX
m arket for the first tim
e m ust be in line w
ith D irective
94/9/EC . A
ccording to A rticle 41 products that are already in the distribution
chain (including stockpiles: see R ecital 49), before 20 A
pril 2016, can continue to be distributed w
ith the EC declaration of conform
ity referring to D irective
94/9/EC , as they have already been law
fully placed on the EU m
arket. D
or EU ) rem
arket (= m ade
available on the EU m
arket for the first tim e). There is no need to change
legislative references in docum ents accom
panying the product. For products placed on the EU
m arket as of 20 A
pril 2016 (or, in the case of products m
anufactured for ow n use, put into service), the EU
declaration of conform
ith the new A
irective requires the product to be accom panied by the
declaration of conform ity, it is difficult for m
anufacturers to ensure that the declaration is exchanged from
one day to the next. In order to facilitate the transition to the new
A TEX
hen conform ity still has to be declared to the
old D irective 94/9/EC
described above is in conform ity with the relevant U
nion harm onisation
th, 2016) and D irective
2014/34/EU (from
arket? If the product rem
ains the sam e and no changes in the state of the art (as from
the harm
onised standards, if available) took place, the sam e declaration of
conform ity can continue to be used.
Is it necessary to change the declaration of conform
ity w hen the referred harm
onised standards change?
It w ould depend on the kind of changes in the new
harm onised standard
superseding the previous one, as indicated by the relevant European Standardisation O
rganisation (C EN
ELEC ) in the standard itself. For
"substantial" changes, related to the state of the art, re-assessm ent of the
product w ill be necessary; for "form
al" or "non-substantial" changes, an update of the declaration of conform
ity w ill be enough. The im
portant issue to consider is that the previous standard has lost the presum
ption of conform ity,
ed" but has to be dem onstrated, in
particular in the technical docum entation.
Structure and contents of the EU
declaration of
conform ity
Article 14(2)
declaration of conform
ity that follow s
nnex X to D
inim um
, he w
ents of the EU declaration of conform
ity. The elem
do not add any additional requirem
ent. In any case, additional inform ation can be included.
A nnex X
harm onised standards used" w
hen other directives (for instance 2014/30/EU
, A nnex IV
standards used, including the date of the standard". D
oes it m ean that for the A
TEX
of the standards used?
The reference of the harm onised standard should be indicated in a precise,
com plete and clearly defined w
ay; this im plies that the version and/or date of
the relevant standard should be specified. Therefore, it can be necessary to include the date if the version cannot be identified in a different m
anner (e.g. year of adoption). This is especially useful w
hen tw o versions of the sam
e standard are providing for presum
ption of conform ity at the sam
e tim e, during
the transitional period betw een the publication of the reference of the
superseding standard on the O JEU
and the date of cessation of presum ption of
conform ity of the superseded standard.
Is the translation of the EU declaration of
conform ity the m
ent under his nam e
EU harm
onisation legislation does not specify w ho has the obligation to
translate. There can be a contractual arrangem ent betw
een the m anufacturer
ho does the translation.
ark? C an the im
porter translate the declaration before he places the product on the m
arket or can the distributor translate it before m
aking it available on the m arket and provide
the translation together w ith the EU
declaration of conform
hich is for exam
to the new A
com pulsory, m
declaration of conform ity, w
hich is already translated in all the EU
official languages.
declaration of conform
The EU declaration of conform
ity m ust be signed by the m
anufacturer (by an individual w
orking for the m anufacturer) or his authorised representative, and
the em ployee's function shall also be indicated. If the translation of the EU
declaration of conform
ity is not signed by the m anufacturer, a copy of the
original EU declaration of conform
ity signed by the m anufacturer m
ust also accom
See also section 4.4. "EU declaration of conform
ity" of the "Blue G uide"
Products subject to m
ore than on EU
declarations of conform
product?
ity is required w
henever a product is covered by several pieces of EU harm
onisation legislation (directives or regulations) requiring an EU
declaration of conform
ity; such single declaration m ust refer to all of legislation applicable to
the product and the related essential requirem ents. For this reason, if the A
TEX
D irective applies to a product as w
ell, its reference should be included in the single or "global" EU
declaration of conform ity w
hich m ust accom
pany the product. This should be checked by the im
porter or distributor. The single EU
declaration of conform ity can be one-page docum
ent listing the different directives or a dossier m
ade up of relevant individual declarations of conform
ity (see recital 24).
ity" of the "Blue G uide"
Products presenting a risk
rticle 35 w hich
describes the procedure for dealing w ith products
The procedure described in A rticle 35 has different possible developm
ents, tow
pliant products are placed on
16
m arket.
If upon request of the m arket surveillance authority the econom
ic operator agrees to take the necessary corrective action (voluntary m
easures by the operator), the procedure ends here. In this case, if the m
arket surveillance authority considers that the risk goes beyond its national territory, the authority w
ill inform the C
ission and the other M em
ber States of the results of the evaluation and the actions the econom
ic operator intends to take. H
ow ever, if the econom
ic operator does not take corrective action as requested, the m
arket surveillance authority shall take appropriate m easures
against the product (com pulsory m
easures). In this case, the national authorities notify the m
easure to the C om
m ission and to the other M
em ber
States, w ho have the possibility to object to it during a 3-m
onth period. If no objection is raised, the m
easure is deem ed to be justified. In this case all
M em
ber States are obliged to take appropriate action against the product on their territories. If objections are raised, the C
om m
w hether the m
easure should be considered as justified or not (the U nion
safeguard procedure in A rticle 36).
The purpose is that restrictive m easures against the product are not an
unjustified restriction of the free m ovem
ent of goods. A dditionally, it is an
inform ation-sharing tool betw
een m arket surveillance authorities: this
exchange of inform ation, although non-com
pulsory in the phase of voluntary corrective actions, is also expected to be subm
itted by the m arket surveillance
authorities to the other M em
ber States.
onths'" tim e to raise
objections by a M em
ber State or the C om
m ission
em ber State?
It is three calendar m onths, to be calculated according to the general provisions
of R egulation (EEC
o 1182/71 of the C ouncil of 3 June 1971
determ ining the rules applicable to periods, dates and tim
e lim its, and in
particular A rticle 3. For exam
ple: if a notification com es in on 15 Septem
ber 2016, the day of notification does not count and the three m
onths' tim e w
ecem ber 2016, 24:00h.
hat is the m eaning of A
rticle 37, especially The procedure of A
rticle 37 has to be seen as exceptional case. In principle the
17
rticle 35? essential requirem
D irective 2014/34/EU
are perform ance
based and technology neutral. H ow
ever, the directive takes into account the state of the art w
hen it w as drafted. It is possible that w
ith the evolution of tim
e, new technologies and the state of the art, the essential requirem
ents do not cover all risks, in particular related to new
products. This is the case foreseen in A
rticle 37. In this case a product m ay form
ally com ply w
ith the essential requirem
ust have to possibility to take restrictive m
easures against the product and this procedure allow
s them to do so. The difference to the "norm
al" safeguard procedure is that A
rticle 37 deals w ith "com
pliant products", w hile A
rticle 35 deals w ith
products presenting a risk for not com plying w
ith the applicable requirem ents.
Form al non-
arking, or the incorrect drafting of the EU
declaration of conform ity; a
form al non-com
pliance?
U nless there are reasons to believe that the product presents a risk, there are
cases w here non-com
ber of adm inistrative or form
al requirem
irective 2014/34/EU
arking or the incorrect drafting of the EU
declaration of conform ity are expressly m
entioned in A rticle 38(1)(c) and (f)
respectively but it is rarely just a form al non-com
pliance: it could be related to m
ore substantial safety issues. In any case, this A rticle 38 does not affect
A rticle 35 (products presenting a risk).
The C E m
arking, the EU declaration of conform
ity and the technical files can be defined as the cornerstone to place A
TEX products on the EU
m arket.
ithdraw al - Recalls" in the
"Blue G uide"
Is the lack of the indication of the year of construction on a com
ponent, a form al non-
com pliance?
The requirem ent to m
ark the "year of construction" is set up in section 1.0.5. "M
arking" of A nnex II to D
irective 2014/34/EU , for equipm
ent and protective system
s but not for com ponents. So in principle the lack of such inform
ation on the com
pliance according to A
uch should the national authorities w ait
It depends on each case but alw ays considering the proportionality principle in
18
easures to restrict or prohibit the product being m
ade available on the m arket?
actions taken by national m arket surveillance authorities vis-à-vis econom
ic operators, for non-com
e tim e.
plications of the dates of publication, adoption, entry into force, transposition and applicability?
The m ost im
portant date is 20 A pril 2016, the date of applicability, from
w hich
M em
ber States have to apply the provisions of the new D
irective 2014/34/EU ,
rem
e points in the new D
irective that can be already applied because they have not changed. Furtherm
ore, the EU declaration of conform
ity m ust
until 19 A pril 2016 but the new
m odel
pril 2016) is the date by w hich M
em ber States
m ust have transposed the relevant provisions of the new
A TEX
D irective
rticle 42. The adoption date (26 February 2014) is w
hen the text w as adopted by the
European Parliam ent and the C
ouncil, and has no practical im plications, as the
date of publication on the O JEU
(29 M arch 2014) and the correlated date of
entry into force (18 A pril 2014, 21
st day follow ing the publication).
A re references to 94/4/EC
to be regarded as references to 2014/34/EU
also in "private docum
the m anufacturer to the custom
er?
This provision is related to EU legal texts and the transpositions of such
legislation. It does not specifically target private docum ents, as these are
subject to national contractual law . It is how
ever not valid for docum ents
w hich are required from
m anufacturers under the A
TEX directive (e.g.
entation), they have to explicitly refer to the new
D irective 2014/34/EU
ber States during the transposition period?
M em
ber States m ust adopt and publish, by 19 A
pril 2016, the national legal provisions acts (law
s, regulations, adm inistrative provisions) to transpose the
relevant provisions of the new A
TEX D
pril 2016. A
e, M em
om m
hich they adopt.
Transitional provisions for notified bodies
W hich are the m
ain tasks for national notifying authorities and for notified bodies during the transposition period?
M em
ber States m ust appoint notifying authorities at the national level and the
national notifying authorities m ust re-notify their conform
ity assessm ent
bodies (notified bodies) before 20 A pril 2016, through the new
devoted space in the C
om m
m onitoring, inform
ation and co-operation activities of notifying authorities and notified bodies, according to the relevant provisions of the D
irective (A rticles
portant that M em
TEX D
irective or the parts relevant for the notification into national legislation as soon as possible and in any event w
ell ahead A pril 2016, in order to ensure that notifying
procedures are com pleted in tim
e, and notified bodies under the new A
TEX
pril 2016.
ith D
pril 2016?
irective 2014/34/EU , certificates issued
under D irective 94/9/EC
ination certificates or quality assurance certificates issued by notified bodies) until 19 A
pril 2016 w
irective 2014/34/EU until their fixed expiration date.
C ertificates issued according to D
irective 94/9/EC can still be used for EU
declarations of conform
.
-type exam ination
irective 94/9/EC ?
pril 2016 addenda (supplem ents) to "old" certificates w
ill be possible, such as EC
-type exam ination certificates and quality assurance
certificates issued according to D irective 94/9/EC
. H ow
ever, these addenda need D
irective 2014/34/EU as a reference base and therefore can only be
issued by notified bodies under the new A
TEX D
irective 2014/34/EU .
according to D irective 2014/34/EU
? N
otified bodies can issue certificates in accordance w ith the new
A TEX
irective should be issued before 20 A
pril 2016. O
can issue certificates under the new
D irective.
TEX D
to the new A
ith a validity date from 20 A
pril
20
ork before that date.
aintain the reference num
ination certificate issued under D
irective 94/9/EC w
converted into an EU -type exam
ination under D
rem ain
, so there is no need to "convert" certificates. The num
bering of certificates is under the autonom y of the notified body, the
D irective does not specify anything in this respect. If the practice of a notified
body is to "re-issue" the w hole certificate instead of issuing addendum
s, the certificate can continue carrying the sam
e num ber and refer to the new
D
irective. In any case, the reference num ber of a certificate m
ust allow to
clearly identify it w ith respect to the approved type, according to A
nnex III(6).
A TEX
pril 2016 w ith
pril 2016?
There is no "transition period" in A rticles 41, 42 and 43, or a "period of
overlapping" of D irectives 94/9/EC
and 2014/34/EU .
ity for A TEX
m arket m
irective 94/9/EC . EU
declarations of conform
ity and certificates m ust be in accordance to the new
D
pril 2016 for A TEX
products placed on the EU
m arket or put into service for the first tim
e as by that date. In order to facilitate the transition to the new
A TEX
declaration of conform ity can indicate the follow
ing: "The object of the declaration described above is in conform
ity w ith the relevant U
nion harm
th, 2016) and D
affect the classification of equipm
ent-groups into categories or the essential health and safety and health requirem
ents for equipm ent and protective
system s intended for use in hazardous areas?
N o. W
, in the new D
essential health and safety requirem ents for equipm
ent and protective system s
intended for use in potentially explosive atm ospheres have not changed. The
new D
irective is the result of the alignm ent to the reference provisions of the
N ew
o 768/2008/EC and
R egulation (EC
) N o 765/2008.
riteria determ ining the classification of equipm
ent-groups into categories" w
nnex II "Essential health and safety
Essential health and safety
Annex II requirem
ents relating to the design and construction of equipm ent and
protective system s intended for use in potentially explosive atm
ospheres".
Annex III(6), (7) and (8)
Is it necessary to lim it the period of validity for
EU -type exam
The new A
TEX D
irective 2014/34/EU includes, in points 6, 7 and 8 of A
nnex III, som
e references to validity (conditions for, if any, and expiry) of EU -type
exam ination certificates. Such references w
ere not present in the previous D
irective 94/9/EC and com
odule B ). In this sense, in the D
irective does not im pose an
obligation on establishing a period of validity for EU -type exam
ination certificates but foresees the possibility to do so w
hen this is deem ed
appropriate. The situation rem ains as it is under the current A
TEX D
irective 94/9/EC
.
See also § 4.1.2.6. "Revision of harm onised standards" in the "Blue G
uide"
If no date of expiry of the validity of the certificate is given, does it m
ean that records (a copy of the EU
-type exam ination certificate, its
annexes and additions, the technical file etc.) shall be kept indefinitely by notified bodies?
Y es. The obligations for notified bodies concerning the referred docum
ents rem
ain for the w hole validity period of the certificate, in order to ensure the
proper traceability.
Technical docum
entation - R
isk analysis
The new "B
docum entation" explains that no additional risk
assessm ent m
entation m ust be created, if harm
onized standards are m
of a risk analysis. H ow
can w e know
w hether a
standard is developed on the basis of a risk analysis? In particular, point 2 of A
nnex V III "Internal
requires from
adequate analysis and assessm ent of the risk(s) in
This statem ent presupposes a good evaluation of the risks of the product and
m atch betw
een the risks analyses and risks covered by the harm onised
standards. A
ent procedure requires the m anufacturer to start a risk
analysis of the specific risks of the product to address them in order to com
ply w
ith the essential health and safety requirem ents because not all products
present the sam e risks w
hich has to be distinguished from the analysis referred
to in the B lue G
uide §4.3, nam ely how
to appropriately address the identified risks. The w
ay to address these risks can be done in several w ays, such as w
ith the harm
onised standards" of the "Blue
22
and requirem
risk evaluation should be realized?
G uide"
ent carried out by the m
anufacturer also be necessary w ith
D irective 2014/34/EU
nnex III(3)(c), A nnex V
III(2) and A nnex IX
(2.1) to D
entation shall include an adequate risk analysis and risk assessm
ent. These shall cover all risks, also those being non-typical for explosion protection, including e.g. risks caused by voltage, noise or m
ovable parts (see A nnex II point 1.2.7 of
D irective 2014/34/EU
dditionally, further EU harm
onization legislation applicable to the product has to be considered. The reason is that the A
TEX D
ay em erge from
any product w ithin the scope. The application of a
harm onized standard can sim
plify risk analysis and risk assessm ent.
See also § 4.1.1. "D efinition of essential requirem
ents" of the "Blue G uide"
U nit verification - R
Annex IX
This conform ity assessm
ent procedure does not require any retention of record by the notified body. D
oes it m ean that no record is form
ally requested to be available for surveillance authorities from
the N B
?
Even not explicitly indicated, the notified body should keep the appropriate docum
entation supporting the certificate of conform ity issued according to
point 4 of A nnex IX
, w ithin the general obligation to inform
and co-operate w
ith the national m arkets surveillance authorities and the other notified bodies.
See also § 5.2.2. "Roles and responsibilities" of the "Blue G uide"
References for guidance
x The "Blue Guide" on the implementation of EU product rules (version 1.1 - 15/7/2015)
x "CERTIF" documents (non-binding interpretative documents issued by the European Commission): - CERTIF doc. 2008-002 - Differences between Conformity assessment modules as laid down in new approach (Decision 93/465/EEC - old modules) and as laid down in the new legal framework (Decision 768/2008/EC - new modules) - CERTIF 2009–03 - Orientations for selecting and implementing the modules (as laid down in Decision 768/2008 of the new legal framework) – SMES specificities - CERTIF 2009–04 - Introduction to conformity assessment and conformity assessment procedures of the new legal framework (as laid down in Decision 768/2008 of the new legal framework) - CERTIF 2009-08 - Using standards to assess the competence of conformity assessment bodies in the context of the New Legislative Framework - CERTIF 2010-05 Rev1 - Overview of market surveillance procedures (including safeguard clause mechanism) in the area of harmonised products - CERTIF doc 2010-06 - Notifications of Notified Bodies in NANDO – requirements of Regulation 765/2008 and Decision 768/2008 - CERTIF 2012-06 REV1 – Notified Bodies - The use of the notified bodies number for activities not required by EU legislation - CERTIF 2013-04 REV2 – Ensuring continuous competence of notified bodies - CERTIF 2013-07 – Time frames for notification of NBs following the entry into force of the Alignment Package - CERTIF 2013-08 – NANDO procedure for notification of notified bodies that are not accredited by a national accreditation body - CERTIF 2013-11 REV1 – Time frames for notification of NBs following the entry into force of the Alignment Package - CERTIF Guidance papers on accreditation (July 2014) - CERTIF 2015-01 REV2– The functioning of NANDO with regard to providing accurate information, objection periods, notification procedures and notified bodies groups
x ATEX 2014/34/EU Guidelines (in preparation; will be available on the ATEX
website on EUROPA)