One of the exclusions from CE Marking listed within the Machinery Directive (2006/42/EC) is “agricultural and forestry tractors [only] for the risks covered by [Tractors] Directive 2003/37/EC with the exclusion of machinery mounted on these vehicles” (Article 1 (2) (e)). Hence such tractors in effect required assessment against both Machinery and Tractors Directives. This peculiar nuance existed because at the time the Tractors Directive did not deal with all of the risks associated with using such vehicles and as such a total exclusion could not be made within the Machinery Directive.

A new Regulation (167/2013 – Type approval of Agricultural Vehicles) has since been issued which effectively plugs the holes in 2003/37/EC and therefore Article 1 (2) (e) of the Machinery Directive is amended by 167/2013 to delete the expression “for the risks” and as such the exclusion for agricultural and forestry tractors from the Machinery Directive is now complete.

It is important to note that this exclusion only applies to the tractors themselves and not to any towed, pushed, mounted or semi-mounted machinery, whether these are designed and fitted during the production process or fitted as aftermarket accessories. Such machinery therefore remains within scope of the Machinery Directive.

However, as one quirk is addressed, another has appeared and it should be noted that Trailers and Interchangeable Towed Equipment fall under the scope of both the Tractors Regulations and the Machinery Directive; the requirements for safe road circulation of such products are covered by the former while the health and safety requirements are covered by the latter.

For more information, the guide to application of the Machinery Directive can be found here: https://ec.europa.eu/docsroom/documents/24722.

If you need any help and support with CE Marking under the Machinery Directive, then please call us on 01564 792349.

The second edition of the Guide to Application of the Machinery Directive (2006/42/EC) originally published by the European Commission in June 2010 was amended in July to become edition 2.1. The guide provides useful insight into fulfilling CE Marking obligations for equipment under the scope of the Directive.

The Guide has been updated to include amendments made to the Machinery Directive as a result of changes to the legislation concerning Pesticide Equipment and Agricultural and Forestry Vehicles. In addition, supplementary guidance is offered on ‘Partly Completed Machinery’, ‘Assemblies’, ‘Safety Components’, ‘New and Used Machinery’ and ‘Marking of Machinery’.

To give an example, the guidance on Partly Completed Machinery has been clarified to include any equipment which must undergo further construction in order to perform its specific application; an example being industrial robots which cannot be deemed to be completed machinery until incorporated into the final machinery – therefore such a robot sold as a generic piece of equipment is considered Partly Completed Machinery.

Likewise, the guidance on Safety Components now clarifies that such a component must serve to fulfil a protective measure to eliminate or, if not possible, to reduce a risk.

A copy of the Guide is available on the European Commission website here: https://ec.europa.eu/docsroom/documents/24722

If you need any help and support with CE Marking under the Machinery Directive, then please call us on 01564 792349.

The majority of CE Marking Legislation defines a number of different types of ‘Economic Operators’, one of those being the Manufacturer. The traditional interpretation of a manufacturer is the person or organisation that manufactures the product, however under CE Marking legislation, the term is defined a little differently. Under the New Legislative Framework (NLF), a manufacturer is defined as “any legal or natural person who manufactures [product] or has [product] designed or manufactured under his name or trade name”. Directives not amended under the NLF may have different definitions, however current guidance suggests that in the absence of a robust definition within the Directive, the above should be assumed.

So, what does this mean? The detail that many people miss is the second clause of the definition; i.e. if you ‘re-badge’ a product with your own trade name, then you take on the responsibility of the Manufacturer, and in most cases this will require you to maintain evidence of a Risk Assessment, maintain a Technical File, demonstrate production control and make a Declaration of Conformity as well, of course, as accepting legal liability for the conformity of the product.

A common example of re-badging is high-street DIY store ‘own brand’ power tools; whereas the chain could conceivably have no input into either design or manufacture of the product, in branding it with their own trademark, under CE Marking legislation, they are the ‘Manufacturer’.

Don’t get caught out, if you market products under your own trade name, whether or not you have physically ‘made’ it and whether or not you have conformity documentation from the original ‘Manufacturer’, you must fulfil the legal obligations of the manufacturer summarised above.

If you need any support with CE Marking obligations as a Manufacturer, then please contact us to discuss how we can help.

The new Radio Equipment Directive (RED) has now come into force (on the 13th June) requiring manufacturers of equipment featuring radio devices to now declare their products against the new RED! The new Directive has some significant differences between the new RED and the old Radio and Telecommunications Terminal Equipment (R&TTE) Directive, but one of the biggest talking points has been about the availability of the harmonised standards to use.

Within the old R&TTE, the route to conformity for manufacturers allowed the assessment to be broken into three stages; assessment of electrical safety; assessment of the EMC performance; and assessment of the radio device. The electrical safety and EMC parts could be assessed under the self-declarations options given within the Low Voltage and EMC Directives, and the radio part could either be self-declared using a harmonised standard(s) or otherwise the product had to be assessed by a Notified Body.

The self-declaration option was regularly chosen under the R&TTE, however the significant changes under the new Radio Equipment Directive required all of the harmonised standard to be reviewed and potentially amended. As a result the list of harmonised standards was wiped clean and therefore removing the opportunity for manufacturers to take the self-declaration option. For a long time, the lack of standards was causing a high level of concern, but thankfully the list has been slowly populated with new standards.

Now following the recent update on the 8th June, an additional 29 standards were added to the harmonised standard list and there is now a healthier 140 standards on the list to use for self-declaration. The full list can be viewed on the European Commissions website: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte_en

If you need any help and support with CE Marking under the new Radio Equipment Directive, then please call us on 01564 792349.

The RoHS Directive covers the CE Marking requirements on the restriction of use of certain hazardous substances in electrical and electronic equipment (EEE). This Directive has been around for several years and is well known throughout the electronics industry, however companies are often unaware that the scope of the RoHS Directive has been slowly expanding.

The current Directive (2011/65/EU) came into force on the 2^nd January 2013, but only applied to categories 1 to 7 and 10. The other categories were then scheduled to be phased in over time to give manufacturers the opportunity to bring their house into order. Categories covering medical devices and monitoring & control instruments came into force in 2014 and 2016, and the next category due to be become applicable in 2017 will cover industrial monitoring and control instruments. After this, there is one final category (cat. 11), covering any other EEE that will apply from the 22^nd July 2019.

This latest category will require all industrial monitoring and control instruments to be RoHS compliant by 22^nd July 2017 unless there is an exemption that could be applied. There are number of exclusions that could be applied, but there is one exclusion that stands out:

“(c) equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment” (Article 2, paragraph 4 of 2011/65/EU).

For example, if you are manufacturing industrial monitoring and control instrumentation specifically for use on a large-scale fixed installation (one of the exclusions), then the instruments will be excluded from the RoHS Directive.

If this new category is applicable to you then make sure you don’t leave it too late to comply, as the guidance makes it clear that the supply chain must be clear before the 22^nd July 2017 deadline.

If you need assistance with CE Marking under the RoHS Directive, then please get in contact.