The lists of harmonised standards on the European Commission’s website are frequently updated to include new or amended standards. These standards, when they appear on the list (formally known as the Official Journal) can, when applied in full, offer a presumption of conformity to the applicable CE Marking Directive. Usually the application of a harmonised standard can simplify the CE marking process, as the standard will not only try to set out best practice, but it will also remove some of the subjective parts often found within the essential requirements of the Directives.

Things, however, are a little different for construction products. Under the Construction Product Regulation, the manufacturer is only required to CE mark their product if a harmonised standard exists. As such, when the list of construction product harmonised standards is updated, it can have a significant impact on manufacturer’s who make, import or distribute products that fall within scope of these ‘new’ standards. Thankfully the list is not changed too often and was last updated on 28^th June 2013, that was until 20^th August 2014 when a new list appear in the Official Journal.

In total 22 ‘new’ standards that have entered onto the list, although the vast majority are the latest versions of the standards that have previously featured on the list. There is only just 5 brand new entries, so it might be worth casting your eye over the new additions to make sure one does not affect your products.

If you believe one of the new standards applies to your products, then we would recommend purchasing a copy of the standard and start to prepare for CE marking your product. There is no need to panic, as whilst the new list of harmonised standards has now been published, there is a transitional period which is given in the final two columns (most of which do not become mandatory until 8^th August 2015).

The list of the 22 ‘new’ standards can be seen in the table below and full list of harmonised standards for construction products can be seen on the European Commission’s website (http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=uriserv:OJ.C_.2014.259.01.0001.01.ENG).

If you have any queries or require support with CE Marking, then please contact us on 01527 595066.

The ‘New’ Construction Product Standards:

The EMC Directive 2004/108/EC is one of a number of CE Marking Directives that are getting a make-over to bring them into line with EU Decision No. 768/2008/EU, in accordance with the New Legislative Framework (NLF) that was introduced in 2008. Subsequently, a NEW recast Electromagnetic Conformity (EMC) 2014/30/EU came into force on the 18^th April 2014, however, the current directive (2004/108/EC) will not be repealed until April 20^th 2016 and until this 2016 date, manufacturers can continue to place products on the market that comply with the current Directive.

OVERVIEW:

The new Directive appears quite different to the Directive it will replace, and the pdf. version has actually doubled in size, but other than rewording, reformatting and reordering the actual changes, the impact on manufacturers is relatively slight; changing to the new Directive should not be too difficult.

SCOPE:

The scope remains the same, however, ‘Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes’ are also now excluded from scope.

OBLIGATIONS:

As with most of the other recast Directives that have been aligned with the NLF, for manufacturers the changes are relatively subtle, with the process being very similar as the current Directive, whilst ensuring that it follows the general principles of Article 30 of Regulation (EC) No 765/2008.

New, or enhanced, requirements for manufacturers include;

Additionally, the Directive now specifically details the obligations of Authorised Representatives, Importers and Distributors. The requirements for importers have particularly been elaborated, and include;

Importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall also ensure that the manufacturer has drawn up the technical documentation, that the apparatus bears the CE marking and is accompanied by the required documents.

Article 14 of the Directive states that the manufacturer may choose to restrict the application of the EU-Type Examination (Annex III) procedure to some aspects of the essential requirements, provided that for the other aspects of the essential requirements the Internal Product Control (Annex II) procedure is applied.

The new Directive also includes increased information regarding Notified Bodies, Notifying Authorities, and Penalties for serious infringements.

TECHNICAL FILE requirements:

It is now stated that the Technical Documentation shall make it possible to assess the apparatus’ conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall cover, as far as relevant, the design, manufacture and operation of the apparatus. The technical documentation shall include at least the following;

Essential requirements:

The Essential Requirements for Apparatus have not changed (other than replacing the word ‘Protection’ with ‘General’) however, some of the requirements for Fixed Installations are no longer contained in Annex I and are now contained within the body of the Directive.

DECLARATION:

The Declaration of Conformity shall have the model structure set out in Annex IV (a template is now provided), shall contain the elements specified in the modules of Annexes II and III as appropriate, and shall be continuously updated as required. It must also be translated into the language or languages required by the member state in which the apparatus is placed or made available on the market.

The new contents include;

The new EMC Directive 2014/30/EU can be found: 

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0030&from=EN

The Pressure Equipment Directive (97/23/EC) is due to be replaced by a brand new Directive that has been aligned to the New Legislative Framework. The arrival of the new Directive (2014/68/EU) will mean that manufacturers will need to review their CE marking procedures and documentation for pressure equipment. The Directive will be implemented into force in two stages;

– Article 13 on Classification shall enter into force on the 1st June 2015
– The remainder of the Directive will enter into force on the 19th July 2016

To help manufacturers prepare for this forthcoming change and to help them understand their requirements, we have compared the current Directive to the new and listed the mains changes between the two.

Overview:

Whilst the new Directive has been re-formatted and there are a lot of changes, most of these changes related to how sections have been reworded and/or re-numbered and/or re-ordered. There are actually very few changes in terms of conformity requirements and it should be easy to prepare for the change in 2016. The most significant changes are likely to evolve around updating documentation. I have given an overview of the key sections of the new Directive below:

Scope:

The scope remains the same, however the Directive is now supported with additional definitions. The new definitions cover generic terms and they are unlikely to have any significant impact for manufacturers already CE marking under the current PED.

Obligations:

The Directive has been rewritten to make the requirements much clearer for the different types of economic operators. The Directive now identifies the 4 types of operators (Manufacturers, Importers, Distributors and Authorised Representatives). For manufacturer’s there are no real changes and the process is the same as what is understood for the current Directive.

Classification & Assessment Modules:

The groups remain, but there is further information on group 1 (to align PED with the CPL Regs (Classification, Labelling & Packaging of Substances and Mixtures Regulation – Reg (EC) No. 1272/2008). This is Article 13, which comes into force on the 1st June 2015, which will be in advance of the rest of the Directive, which is due to come in on the 19th July 2016.

The classification charts remain the same.

The modules have had slight tweaks:

• Module A1 has been renamed to A2
• Module B1 has been incorporated into Module B
• Module C1 has been renamed to C2

All modules have very subtle changes. The main changes are around updating references, adjusting the order of the requirements and giving slightly more guidance (for example giving a more detailed list of what should be included with the technical documentation).

The most significant change is around the quality system requirements mentioned in modules, D, D1, E, E1, G, H and H1.
The new Directive requires:

• some additional basic additional information to be included with applications
• the member of auditing team shall also have knowledge about the application of PED.
• the auditing team should also audit the technical documentation.

The other change is the that module B and B1 have been combined into one module. The terms ‘EC Type-Examination’ and ‘EC Design-Examination’ have been replaced with the term ‘EU-Type Examination

Essential Health & Safety Requirements:

No real changes and the wording predominately remains the same. The changes:

• 2.2.3 (b) Under the calculation for pressure containment: Material Characteristics to be considered – ‘impact strength’ has been replaced by ‘bending rupture strength’
• 3.3 (b) Under markings: The requirement to provide ‘the product group’ has been changed to ‘the fluid group’ (understood to be the same thing)

Declaration:

The Declaration has changed, as follows:

• The title has been slightly altered to ‘EU Declaration of Conformity’
• It is optional to choose to assign a number to the Declaration
• Further information has been given on the type of information that required to be provided to enable to the product to be identified (suggest that an image could be used)
• A statement must be included to say that the Declaration has been issued under the sole responsibility of the manufacturer
• Another statement is required to be included to say that the object being declared is in conformity with the relevant Legislation
• And finally the Directive number has been changed, so the new Directive number (2014/68/EC) must be declared.

Any other changes?

In short no, all of the other changes can be summarised by the comments in the overview.

Link to the Directive: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2014:189:FULL&from=EN

If you need any help with the Pressure Equipment Directive, then please get in contact.

Members of the CE Marking Association frequently send questions into the Technical Team for support on Product Compliance. Where the dilemma may be of interest to a wider audience we like to publish the questions and answers as guidance for other manufacturers. Please note that the question and answer may have been altered for confidentiality reasons.

Your Question

Our company currently dismantles a large number engines from machinery every year to supply used spares for obsolete models of engines worldwide. If we import a used engine into our workshops within the EU to dismantle and sell spares to facilitate the repair of identical units already residing within the EC, what is the position regarding CE marking of used spares taken from the dismantled imported engine?

Answer

An interesting question.

The first premise is that when you import equipment into the EU where the very same product does not exist in the EU, no matter how old, then CE Marking equipment will be placed on the market for the first time and MUST be CE Marked.

Generally, spare parts are NOT covered by the Machinery Directive 2006/42/EC unless they are considered one of the products identified under Article 1 of the Machinery Directive, thus;

Scope (Article 1)

1. This Directive applies to the following products:

(a) machinery;

(b) interchangeable equipment;

(c) safety components;

(d) lifting accessories;

(e) chains, ropes and webbing;

(f) removable mechanical transmission devices;

(g) partly completed machinery.

Please refer to the definitions of the above products in “Article 2 Definitions” of the Machinery Directive.

Please note that safety components will require CE Marking, see Article 1 (1c) of the Directive. This is true unless the safety component falls under the exemption for CE Marking under Article 1 (2a) of the directive. See below;

Scope (Article 1)

2. The following are excluded from the scope of this Directive:

(a) safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;

For all other spare parts there is NO requirement to meet the Machinery Directive 2006/42/EC. Please refer to the EU Guidance notes thus;

Section 1.7.4.2 (t) refers to information about spare parts. In general, the supply of spare parts is not covered by the provisions of the Machinery Directive and is thus a matter for contractual agreement between the manufacturer and the user. However, where parts subject to wear and tear need to be replaced in order to protect the Guide to application of the Machinery Directive 2006/42/EC – 2nd Edition – June 2010 244 health and safety of users, the specifications of the appropriate spare parts must be given in the instructions. Examples of such spare parts include:

– guards for removable mechanical transmission devices – see §319: comments on section 3.4.7;

– flexible guards subject to wear and tear – see §216: comments on section 1.4.1;

– filters for systems to provide clean air to operating positions – see §182: comments on section 1.1.7, and §322: comments on section 3.5.3;

– load bearing components on lifting machinery – see §340 and §341: comments on sections 4.1.2.4 and 4.1.2.5;

– guards and their fixing systems used to retain ejected objects or parts of machinery – see §216: comments on section 1.4.1.

I trust that this helps.

Sources:
– Machinery Directive 2006/42/EC http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006L0042&from=en
– EU Guidance Notes page http://ec.europa.eu/DocsRoom/documents/9483/attachments/1/translations/en/renditions/native

If you need help with CE Marking under the Machinery Directive, then please get in contact!

As of the 1st July 2014, structural steel and aluminium components are required to be CE marked under the Construction Products Regulation (CPR).

The CPR came into force back in 2013, however the requirement to affix the CE mark is dependent upon whether a harmonised technical specification is available and also whether it has passed its date of applicability and that the transitional period has come to end.

For structural steel and aluminium components, these are covered by a European Harmonised Standard, EN 1090-1, which was entered onto the Official Journal in 2012. The standard could have been applied since 1st September 2012, however the transitional period extended up until the 1st July 2014. Due this transitional period, it was a voluntary decision to declare against the new standard, however after this date, it would be a mandatory requirement for all structural components being placed on the European market to be affixed with the CE mark.

However the standard for structural components, EN 1090-1, has been causing some headaches, as the scope of the standard has left many manufacturers throughout Europe struggling to identify if EN 1090-1 applied to them or not.

To help manufacturer’s understand if they are in scope or not, the European Commission have been working on some guidance and it has just recently been published. Whilst they didn’t manage to get the guidance released prior to the start of July, it is better late than never.

The guidance is a non-exhaustive list of items that are not covered by EN 1090-1 and is purely limited to the items where there is CEN consensus (although it does not that an appropriate consultation is still on-going). The full list can be access via the European Commission’s website, but a preview of some of the items are listed below.

The following are just a small selection of items that are not covered by EN 1090-1:

– Castings
– Fastening plates and other cast into concrete fasteners not covered by design codes
– Gates
– Structural components for the moving parts of cranes
– Steel and aluminium stairs, walkways and fences forming integral parts of a machine
– Steel and aluminium components and elements produced on work site
– Roof safety products, including roof ladders and walkways
– Flagpoles

For the full list and to see if your product is covered, then please visit the European Commission’s website.