Directive Decoder

Products that are in scope now will need to comply with the new CE requirements 18 months after publication in the Official Journal (expected June).

Consultants ERA Technology have been looking into this.

Is it going to be a problem? Opinions seem to vary. There are three new obligations:

1. CE mark - not an issue as most products are already marked to show compliance with EMC, etc.

2. DoC - these will need to include the new directive, simple to do, manufacturers will need to amend all DoCs for EEE they sell in the EU.

3. Technical files - this will require some work for manufacturers but according to the CE committee that is writing the harmonised EU standard for RoHS compliance, the activities required will be essentially what manufacturers should be doing now, so in fact little if any extra work.

Distributors will have new obligations which will require some extra effort.

Directive Decoder

ERA Technology carried out the initial RoHS review on categories 8 and 9 some 5 years ago now.

The 8 categories of the RoHS directive derived from the 10 WEEE categories with 8 and 9 originally omitted due, in part, because of concerns around the reliability of lead-free solder.

Now, the RoHS recast includes likely implementation dates:

Medical Equipment - 2014 (IVD in 2016)

Monitoring and Control - 2014 (Industrial in 2017)

For an indicative list of category 8 and 9 products click here

Directive Decoder

The Panorama programme on Monday evening (UK) once again highlighted the subject of the illegal shipping of e-waste.

In November 2008 the "60 Minutes" news programme in the US looked at the same story and nearly had the footage confiscated.

Nothing seems to have happened in the meantime.

I went to India some 4 years ago and addressed an audience on hazardous substances.

I have updated my original document, attached, and I urge everyone to have a quick look so as to understand more on this shocking subject.

Backyard recycling

Directive Decoder

If you thought that progress was slow on the implementation of the so called "China RoHS Catalogue" first published in September 2009 but not yet in force, then there is now "China RoHS2" to consider, although nothing appears imminent at present.

A draft was published in July 2010 and now it is a question of which version of China RoHS will be taken forward and, if so, will the other be rejected (or amended) once and for all?

On 16 July 2010, the Ministry of Industry and Information Technology released the "draft measures for the pollution control of electrical and electronic product" the so called China RoHS2 for public consultation.

Among other things, the proposed measures would amend the coverage of products by modifying the definition from "electronic information product-EIP" to "electrical and electronic product-EEE".

There are an ever growing number of substance information requests around DEHP (bis ethylhexyl phthalate) and BPA (bisphenol A).

So what is behind this?

We asked expert industry chemist Dr Paul Goodman of ERA Technology  for his thoughts on the matter.

The Canadian Government has required manufacturers and importers to provide information on the presence of DEHP and BPA since 2008.

The information is required for all types of medical device including electrical and non-electrical equipment. Information on DEHP is required if it is used in the product at a concentration of greater than 0.1% of the equipment (not homogeneous material as with the RoHS Directive). Information on BPA is required for any amount so is needed even if traces are present. However, this is only required if the equipment comes into physical contact with patients or fluids such as for blood transfusions and drips.

If you use hazardous substances registered under REACH, your suppliers now have to provide you in most cases with a new, extended safety data sheet that includes exposure scenarious.

This is one of the main innovations of the REACH Regulation to enable you and your employees and customers to use these substances safely.

Many of the 3500 substances which were registered with the European Chemicals Agency by the 2010 REACH deadline meet the criteria to be classified as hazardous. ECHA is publishing information on all of them on its website. If you use any of these substances, you can expect your suppliers to send you an extended data sheet.

For further details refer to the new ECHA fact sheet attached.

Directive Decoder

The number of substances the EU is able to evaluate under its REACH regime could be reduced because of staffing cuts according to ENDS Europe.

The European Chemicals Agency (ECHA) pays countries in the region of €50,000 for each substance they evaluate but, while funding is not an issue, some Member States are cutting back on technical staff.

The evaluation of substances is an important part of the REACH Regulations and clarifies whether or not the way a substance is used poses a risk to health and / or the environment.

ChemSec, based in Sweden, which was founded in 2002 looks to achieve broad acceptance in society of the key chemical substance principles of precaution, substitution, polluter pays and right to know.

ChemSec aim to highlight the health and environmental risks of hazardous substances and the urgent need to phase them out.