Directive Decoder

It might just be me, but there feels to be more going on at the minute in the world of legislation than at any time since the pre RoHS days.

So I thought I would provide some brief updates.

Click on the link to find out more about:

The 4 potential restricted substances proposed under "RoHS2"

Category 8 (medical devices) and 9 (monitoring & control instruments) products in scope and those requiring clarity

Timescales for "RoHS2" implementation, restricted substances and exemptions

REACH substances for authorisation

Have a quick look at these articles and bring yourself up-to-date on the latest legislative developments.

Directive Decoder

The European Commission (EC) has published its proposals to amend the directive 2002/95/EC (RoHS) and this introduces new obligations for the electronics industry. The main changes that are being proposed in "RoHS2" will affect most of the electronics industry and these include:

-         Originally, compliance was the responsibility of  "producers" who had to ensure that they supplied compliant equipment. The original directive defined "Producer" but interpretation of who is responsible has not always been straightforward. The EC's proposals remove all references to producers and introduce four new Articles that clearly define the responsibilities of manufacturers (Article 7), authorised representatives (Article 8), importers (Article 9) and distributors (Article 10).

-         Medical Devices (category 8) and Monitoring and Control Instruments (Category 9) will be included in the scope of RoHS from 1 January 2014 except for in vitro diagnostic (IVD) from 1 January 2016 and industrial monitoring and control instruments from 1 January 2017. Implanted medical devices will be reviewed before 2020 do determine if these will be included.

Introduction

Article 6 of the RoHS (Restriction of Hazardous Substances) directive requires the European Commission (EC) to carry out a review of the directive and to consider any changes to its scope that are required. Since the review started in 2005 there have been stakeholder consultations and studies by consultants into several aspects of RoHS. The Commission has published its proposals and here we consider the impact of "RoHS2" on industry.

Background

Unlike in the original RoHS Directive, the EC now has to take into account the aims of the Lisbon strategy so that development of an environmental strategy also considers growth and employment. Another fundamental change is that RoHS substance restrictions would be imposed only if there is an unacceptable risk to human health and the environment, whereas previously it was based only on the precautionary principal.

Scope

The scope of RoHS is specified in Annex I and is no longer linked to the scope of the WEEE (Waste Electrical and Electronic Equipment) Directive.  The new Annex I includes two additional categories namely Medical Devices (category 8) and Monitoring and Control Instruments (category 9). Two areas that required clarity, military equipment and equipment that is part of out-of-scope equipment are now specifically excluded from RoHS. Annex II has also been added and is a binding list of products that are included, and the EC is able to amend this list as required.

All of these changes are helpful in making explicit the intended scope and avoiding the different interpretations of RoHS and WEEE legislation that have occurred across the European Union (EU).

The RoHS directive has applied since 1 July 2006 but the amended directive now explicitly states, "placed on the Community market", the word "community" has been added to ensure that Member States do not interpret this as their national market and act locally. The two additional categories 8, and 9, will be included in scope from the 1 January 2014 except for in vitro diagnostic medical devices (1 January 2016) and industrial monitoring and control instruments from 1 January 2017.

Back in 2006 we can clearly remember the concerns around "Semiconductor Evaluation Boards" often referred to as "Development Tools".

Were they in scope of the RoHS Directive or not?

Certainly manufacturers hoped not, and many believed not. This eventually resulted in NWML, the UK enforcement agency, posting guidance on their website.

The proposed amendments to the RoHS (Restriction of Hazardous Substances) Directive will impact industry, but just how much?

While the implementation dates may seem a few years away industry needs to be aware of the potential impact.

While new product categories will not feature until 2014 and beyond, and the new directive enter into force until 2011-2012 allowing an 18 month period for Member State transposition, there are other elements that need consideration.

Many people felt an initial sense of relief that the changes announced as part of the so called "RoHS2"  proposals, back in December 2008, were not as widespread as feared. While new product categories (medical devices and monitoring and control instruments) will fall within scope, and it is likely that 4 new substances will be captured under RoHS (or REACH) and the separate review of exemptions will have some impact, the implementation dates of all three looked to be some way out in the future.

However, many appear to have overlooked the impact on industry of the proposed CE marking regime to RoHS.

If the proposals are adopted, which seems likely, RoHS compliance could well become a much more complex and resource sapping activity for everyone in the supply chain.

Like many in the electronics industry we waited with some anticipation for the European Commission to publish its proposals for amending the RoHS Directive, which they did in December 2008.  Also like many others, we felt an initial sense of relief that a number of the more sweeping changes - new hazardous substances, additional product categories and, separately, the removal of exemptions - that had been forecast were not included or had implementation dates some way in the future. However, what many people appeared to have overlooked, and which will potentially have at least as dramatic an impact on our industry is the proposed introduction of the CE marking regime to RoHS.

The headlines are:

The new RoHS Directive was published this morning (1 July 2011) in the Official Journal (OJ) of the European Union. 

The UK Government (Department of Business Innovation and Skills) expects the future transposition timetable to look as follows:

Directive entry into force - 21 July 2011 (20 days after publication)
UK Consultation - Autumn / Winter 2011
New UK Regulations published - October / November 2012
UK RoHS Guidance - October / November  2012
Transposition deadline and UK Regulations enter into force - 2 January 2013

Text from the OJ 

Directive Decoder

RoHS Recast 2011/65/EU becomes law today.

Attached is a guide to the recast from respected organisation Orgalime.

Orgalime Guide

Directive Decoder

The European Commission has awarded a contract to BIO Intelligence Service, supported by ERA Technology to carry out an impact assessment on the RoHS Recast 2011/65/EU.

The study will include scope, category 11 products, definitions (such as large-scale fixed installations and homogeneous material) as well a review of costs and benefits.

For a comprehensive summary see below:

RoHS2 study

Directive Decoder

Article 2.2 was discussed recently at the 3^rd Stakeholder meeting of the RoHS Impact Assessment in Brussels.

Article 2.2 states that equipment added to scope as a result of the RoHS Recast (2011/65/EU) can be "made available" in the European Union until 22 July 2019. This means that any such products cannot be sold, leased, loaned or given away after this date, including second hand or hire equipment,  if they contain RoHS restricted substances.

Looking on the radar this will affect category 8 and 9 products that will fall in to scope from various dates starting in July 2014.

Thanks to Dr Paul Goodman of ERA Technology.

Directive Decoder