Legislative update – Sept. 2009 -- REACH, RoHS2

Guest post by Gary Nevison, Farnell

Summary
The legal obligations within the REACH Regulations and the potential impact of the so called “RoHS2” proposals dominate the legislative scene at present. Also, obligations are starting to filter through as part of the eco design/energy using Products Directive that monitors energy efficiency throughout a products life cycle. Going-forward, the scope of this directive will become more diverse to encompass energy related products.

Industry, and the design engineer, needs to be aware of developments and the potential impact on their companies.

REACH
Regulation 1907/2006, the Regulation, Evaluation, Authorisation -and restriction-of Chemicals (REACH) entered into force on 1 June 2007 after almost 8 years of debate and covering some 849 pages of regulation.

The only census on chemicals, taken in 1981, highlighted that 100,106 substances were placed on the market. Of those used, manufactured or imported at levels of 1000 tonnes or more, 21 percent had no safety data at all while a further 65 percent provided insufficient safe use data. Only 3 percent had been fully tested.

At the same time, instances of allergies, asthma, certain types of cancer and reproductive disorders were on the increase in Europe. Skin diseases alone resulted in the loss of 3 million working days per year.

Driven by the obligatory flow of safety data throughout the supply chain, REACH seeks to provide protection to health and the environment.

The biggest challenge to industry to date has been around the collection of data advising where a so called Substance of Very High Concern (SVHC) is present in a product, known as an article in the regulations, at a level of 0.1% by weight of the total article.

As a minimum obligation the name of the substance along with supporting safe use data must flow downstream through the supply chain.

Substances that are categorised as SVHC include those that are carcinogenic, mutagenic or toxic for reproduction. Also, substances that are persistent, liable to bio-accumulate and toxic, and finally “others” such as endocrine disrupters that can have a particular impact on aquatic life.

Back in October 2008, the first batch of 15 substances of very high concern was published by the European Chemicals Agency and, the following January, seven of these were earmarked for a consultation on whether or not they should be subject to a very costly “authorisation of use” requirement. These seven were approved and the European Commission will determine the date when these will be added to Annex XIV.

These obligations will then enter into force some 42-48 months later on what is known as the sunset date. Where such an authorisation is approved, downstream users can only use these substances for the use that they have been authorised for and they can only be purchased from the company granted the authorisation.

The REACH data collection has resulted in the circulation of hundreds of “standard letters” in a multitude of formats. Many manufacturers have refused to reply to the ad-hoc requests they receive preferring to promote websites or central databases (these have been slow to develop).

Guidance on the regulation encourages a more pro-active approach rather than simply providing a link to a website. Likewise, there have been many random requests for information that is not obligatory such as pre-registration details and RoHS style certificates of compliance.

Future batches of SVHCs will be published on an on-going basis, with the next expected early 2010, so REACH will not be a box that can be ticked as complete for several years to come.

“RoHS2”
Looking back the Restriction of Hazardous Substances (RoHS) Directive 2002/95 entered into force on 1 July 2006. It featured six restricted substances across eight broad categories of product pulled from the 10 categories in the Waste Electrical and Electronic Equipment (WEEE) Directive. There were 29 exemptions to assist manufacturers and design engineers where no viable alternative was available and a whole raft of “grey” definitions that required clarity.

“RoHS2” proposals look to move the directive forward and provide greater clarity. However, some of its provisions will potentially have cost and resource issues for industry.

The proposals recommend that the two remaining categories from the original WEEE categories, namely medical devices and monitoring and control instruments be added to the scope from 2014 (in-vitro diagnostics from 2016 and industrial “test” equipment in 2017). These were originally omitted from the directive due to reliability concerns over the use of lead-free solder.

While there are no substances actually restricted under the proposals, four are recommended for priority assessment. Three plasticisers used in a variety of applications and a flame retardant may well be restricted. Ironically, the substances, BBP, DBP, DEHP and HBCDD are four of the seven subject to authorisation of use under the REACH Regulations.

The fate of these substances under RoHS will be open to consultation after the revised directive comes into scope sometime in 2011-2012. Either way, any restriction under RoHS will probably be sooner than under the REACH process and the analysis is unlikely to be done twice.

Under a separate review by European Commission consultants, 29 exemptions will continue under the proposals, many with amended wording for clarity, 6 will be withdrawn and one new one will be granted. These could come into force next year and that will be followed by a transposition period of, on average, 18 months allowing manufacturers the time to comply.

In addition, a further six exemptions were added in June 2009 that had been proposed a year earlier.

RoHS2 also clarifies definitions such as equipment within out of scope equipment, spare parts and military where the latter clearly does not include dual use equipment.

A standard, and rigid declaration of conformity appears in annex 7 and will replace the multitude of different certificates, statements and compliance documents under the original legislation.

There now appears to be no scope for qualifying statements such as “so far as we are aware” and “to the best of our knowledge”.

It is proposed that RoHS will become a CE mark directive placing responsibilities on manufacturers, importers and distributors. There are many requirements including building technical files and keeping for 10 years, ensuring products comply, that they are supplied with the CE mark and the manufacturer or importer is identified on the product. Sample testing should also be carried out where appropriate, and corrective action is undertaken where product is found to be non compliant.

Finally under the proposals, the broad product categories and list of indicative products move from the WEEE Directive and sit in annex 1 and 2 of the RoHS Directive.

The terminology “RoHS2” is unofficial and is used simply to highlight the proposed changes to the original directive.

Energy using Products
Directive 2005/32/EC, Energy using Products, entered into force on 11 August 2007.

The main aim is to monitor energy efficiency throughout the life cycle of a product from the mining of raw material right through to recycling at end-of-life.

The focus is clearly on the design phase of the product since it is considered that this is the determining stage affecting the resources used in a product.

The directive does not apply to means of transport (planes, cars etc) but, apart from this, the scope is deliberately broad covering, in principle, any product which when in use depends on, generates, transfers or measures energy (electricity, fossil fuel or renewable).

Obligations on manufacturers will result from a series of specific “implementing measures” the first of which was adopted in January 2009.

The criteria required before a product can be considered for assessment is that is that it must sell more than 200,000 units per year in the European Union, have a significant environmental impact and present considerable potential for improvement. The latter is important as the target is for a 20% improvement in energy efficiency by 2020.

During phase one, studies were commission on 20 broad product categories ranging from water heaters, televisions and lighting, through to imaging equipment and personal computers.

Beyond that, a further 17 categories have been highlighted from ovens and hobs, machine tools and air-conditioning equipment through to transformers and networking equipment.

Among the first obligations to come in to force were energy efficiency improvements covering standby and off-mode losses, simple converter boxes for digital television, external power supplies and office, street and domestic lighting.

However, the European Parliament has now adopted the European Commission’s (EC) proposal to widen the scope of the directive to include energy related products. Until now the Energy using Products Directive was limited to products that consume energy during use such as boilers, computers, televisions, industrial fans and light bulbs.

However, many products have an indirect impact on the energy in use such as water using devices, taps and showerheads for example, and double glazing windows or insulating material.

Improvement in design could clearly result in the significant saving of energy.

For example, water saving taps and shower heads reduce water consumption and therefore the amount of energy used for hot water.

Under the EuP Directive studies had to set requirements for individual products where, in fact, it is the performance of the whole system that often needs to be optimised not just a single component or products.

The new directive will repeal the existing 2005/32/EC.