New ATEX 2014/34/UE directive - consequences for manufacturers

The new ATEX Directive: impact and consequences for manufacturers

The new ATEX 2014/34/UE does not introduce significant changes for the ATEX manufacturers. Changes between the requirements of Directive 94/9/EC and the ATEX Directive 2014/34/UE are defined in Annex XII of Directive 2014/34/UE.

Changes to the Directive 2014/34/UE mainly concern:

  1. Definition in Article 2, the different economic actors (12.) "Manufacturer" (13). "Agent (14)." Importer "(15.) 'Distributor' (16)." Economic operators " in relation to the placing on the market of ATEX products (10).
  2. How to notify notified bodies and the requirements that apply to member states (Articles 17 to 33).
  3. Market surveillance (Articles 34-38) in application of Regulation (EC) No 765/2008.

In the correlation table in Annex XII between Directive 94/9/EC and Directive 2014/34/UE, you may notice that:

  • Many articles have been added to clarify certain aspects
  • Some items were completed,
  • Other items change numbering
  • Some items were deleted (Article 5, paragraph 1, first paragraph, Article 12, paragraph 1, Article 6, paragraphs 1 and 2, Article 7, Article 8, paragraph 7, Article 9, Article 10, paragraph 1, Article 10, paragraph 3, Article 11, Articles 12 and 13, Article 14, paragraph 1 and paragraph 3, Article 15, paragraph 2).
  • Annexes I to IX were fully retained with minor modifications
    • So there is no change of the Essential Requirements of Health and Safety as defined in Annex II.
    • There is also no change in the various evaluation procedures.
    • The terms of Annex III of the Directive, however, are modified. The notified body (NB) will not issue an EC type examination certificate but a EU-type examination certificate. The result of this change is that in case of major normative change in the harmonized standards that impacts the already certified products, the Notified Body will no longer issue an addition to an EC type examination certificate. A new EU-type examination certificate will be issued and will require changing of the documentation.
  • Annexes X and XI were removed and three annexes were added (Annex X, XI, XII)
    • Annex X: EU DECLARATION OF CONFORMITY - the manufacturer will issue a EU declaration of conformity. A definition is also given in Article 14 EU Declaration of Conformity
    • Annex XI: PART A: Repealed Directive with list of its successive amendments
    • Annex XII: Correlation table between the ATEX directive 94/9/EC and the ATEX Directive 2014/34/UE

Impacts for manufacturers are defined in Article 6: Obligations of manufacturers

The main points and impacts of this new directive for manufacturers are:

  1. The CE marking is not changed
  2. If changes in the harmonized standards do not impose major modifiactions, then the manufacturer may refer to the official documents he has obtained from a notified body under the ATEX Directive 94/9/EC
  3. The manufacturer shall make reference to Directive 2014/34/UE in the instructions and Declaration of conformity instead of the reference to ATEX Directive 94/9/EC
  4. The manufacturer shall write a EU declaration of conformity instead of the current EC declaration of conformity.

 


Concerning the CE marking, the new Directive is more precise and defines:

Article 2 (26)        ‘CE marking’ means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

  • For already certified and for which there is no major change in the harmonized product standards, the manufacturer may continue to use the EC type examination and the notification of the Quality Assurance System Certification, obtained in accordance with Directive 94/9/EC.
  • The CE marking is affixed to products is meanwhile not changed to the new Directive imposing (Whereas (25)  The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Directive. 

Other sections specify the rules and conditions for affixing the CE marking, including

  • Article 15: General principles of the CE marking,
  • Article 16: Rules and conditions for affixing the CE marking and other markings

Article 41 : Transitional provisions

1.   Member States shall not impede the making available on the market or the putting into service of products covered by Directive 94/9/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016.

2.   Certificates issued under Directive 94/9/EC shall be valid under this Directive.

Article 42 : Transposition

1.   Member States shall adopt and publish by 19 April 2016 the laws, regulations and administrative provisions necessary to comply with Article 1, points 2 and 8 to 26 of Article 2, Article 3, Articles 5 to 41 and Annexes III to X. They shall forthwith communicate the text of those measures to the Commission.

They shall apply those measures from 20 April 2016.

(...)

Article 44: Entry into force and application

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Points 1 and 3 to 7 of Article 2, Article 4 and Annexes I, II, XI and XII shall apply from 20 April 2016.

Note: The Directives eg 2014/34/EC apply to Member States and not to the manufacturers. Member States must transpose the directive into their internal regulation. They must do it at least not later than 19 April 2016.

Because this Directive is concerning the placing on the market of products, the full text of the Directive will be transposed in the various national laws without any change. So manufacturers have until April 20, 2016 to prepare.

Member States must incorporate the Directive into their national legislation from the entry into force of the Directive eg April 25, 2014 (March 29, 2014 + 20 days).

Hereafter the amended articles of ATEX Directive 94/9/EC and new items added by the ATEX Directive 2014/34/UE:

Article of the ATEX Directive 94/9/EC

New Article of the ATEX Directive 2014/34/UE

Article 1, paragraph 1

Article 1, paragraph 1 a)

Article 1, paragraph 2

Article 1, paragraph 1, point b)

Article 1, paragraph 3

Article 2, paragraphs 1) to 9)

Article 1, paragraph 4

Article 1, paragraph 2

Article 2

Article 3

Article 3

Article 4

Article 4

Article 5

Article 5, paragraph 1, second subparagraph

Article 12, paragraph 2

Article 5, paragraph 2

Article 5, paragraph 3

Article 6, paragraph 3

Article 39, paragraphs 1-4

Article 6, paragraph 4

Article 39, paragraph 5, second subparagraph

Article 8, paragraphs 1-6

Article 13, paragraphs 1-6

Article 10, paragraph 2

Article 16, paragraph 1

Article 14, paragraph 2

Article 41, paragraph 2

Article 15, paragraph 1

Article 42, paragraph 1

Article 16

Article 45

 

Articles added by ATEX 2014/34/UE

Article of the ATEX Directive 94/9/EC

New section of the ATEX Directive 2014/34/UE

-

Article 1, paragraph 1, point C)

-

Article 2, point 10) 26)

-

Articles 6-11

-

Article 39, paragraph 5, first paragraph

-

Articles 14 and 15

-

Article 16, paragraphs 2-6

-

Articles 17 to 33, Articles 34 to 38 and Article 40

-

Article 41, paragraph 1

-

Article 42, paragraph 2

-

Articles 43 and 44