REACH is an EU-wide reform of the regulatory environment in which chemicals are used. The aim is to improve the protection of human health and the environment through the better, and earlier, identification of the properties of chemical substances. A further benefit will be to enhance the innovative capability and competitiveness of the EU chemical industry.

REACH is intended to establish an integrated system for Registration, Evaluation and Authorisation of Chemicals. It extends the stringent testing which has been required for chemicals introduced since 1981 to those already in use (estimated at 30,000 substances).

The responsibility for providing sufficient information and taking effective risk management measures will lie principally with manufacturers or importers of chemicals. Obligations will also be introduced further down the supply chain particurlarly in terms of the safe use of chemicals.

In force from 1st June 2007, after publication in the European Commission's Official Journal on 30th December 2006, REACH runs to 849 pages and replaces over 40 other laws.
A series of deadlines then follow around pre-registration, by December 2008, immediately followed by a published list of pre-registered substances.
December 2010 will see the end of the first registration period for the most dangerous and / or higher volume substances.

There is no definitive list of chemicals which are likely to be covered by REACH. Chemicals are currently covered by the EINECS (European Inventory of Existing Commercial - chemical - Substances) list of 70,000 to 100,000 chemicals subject to pre 1981 legislation. This list is clearly out of date and many of the chemicals may no longer be on the market.
Chemicals subject to post 1981 legislation are covered by the EUCLID list. As mentioned, a new list will replace around 40 existing regulations. Implementation will be staggered so that the entire process will take about 11 years to complete.

I will cover topics such as obligations on manufacturers and importers, downstream users and issues for the electronics industry, including the supply chain, in a future rant.

If REACH has an impact on your business please drop me a line and tell me why, and what you are doing about it.

DIRECTIVE DECODER

The REACH regulations were adopted in December 2006. REACH stands for “Registration, Evaluation, Authorisation (and restriction) of CHemicals”. This is a complex piece of legislation that will affect manufacturers and importers of chemicals, preparations (such as adhesives, paints, etc.) and “articles”, which include all types of electrical components, sub-assemblies and equipment. There are no exemptions for such as transport, aerospace, etc.

These regulations have been adopted because of the many thousands of high volume chemicals used in the European Union. Today there is no risk data available on 21% of them, inadequate data on 65% and only 3% are fully tested. This means that it is almost impossible to choose a “safe” substance due to a lack of data. REACH aims to ensure that all substances are fully tested.

So what does REACH actually mean?

Here we breakdown Registration, Evaluation, Authorisation (and restriction) of CHemicals:

Registration - Chemical producers are obliged to register safety data for all chemicals produced in quantities above one tonne a year to a central agency. Less information is required the lower the tonnage of chemicals produced per year, with only very basic information required for 1-10 tonnes.

If REACH Policy Reform is something you have heard about, but as it is all about chemicals has no impact on your company, then it maybe time to think again.

Here I look at a couple of frequently asked questions and try and explain who, and how, could be affected:

Q1: What does REACH mean for your company?
A: You are affected if you:
 Manufacture or import chemical substances or mixtures of chemical substances (preparations such as paint, adhesives etc)
 Produce or import articles such as electronic components, sub-assemblies, toys etc, which contain substances to be included in a list of “substances of very high concern” (notification required if >0.1% by weight and >1 tonne per annum) or which are intentionally released or release is reasonably foreseeable (eg ink or perfume) during their use, or during recycling (registration required if >1 tonne per annum).
 Process chemicals or you formulate preparations for end use (for example cleaning products, paints or motor oils) or you use these formulated products professionally. In this case you are a “downstream user”

US companies that donot have a legal presence in the European Union donot have any direct obligations under REACH, regardless of whether or not they sell products into the EU.
However, REACH may have an impact on supply. The costs associated with registration or potential restrictions may lead EU manufacturers to phase out certain substances. Therefore US companies may witness supply difficulties for some products and raw materials.
It is also likely that products, where purchased from the EU, will become more expensive as REACH is implemented.
Any US company with a presence in the EU may well be affected by the REACH requirement that importers, manufacturers, producers and downstream users comply with various procedures including, in some cases, registration of substances.

Directive Decoder

REACH will have far reaching implications for the entire supply chain both within the European Union and beyond.
An interesting question is will China produce its own version of REACH as it did with RoHS and the pending WEEE regulations? I guess the answer may be found in whether or not the significant number of small and medium chemical plants will be ready for REACH like legislation in the foreseeable future?
There is a potential risk to trade as EU downstream users may prefer to purchase from local sources rather than face the burden of registering an imported chemical or facing a potential price increase

Directive Decoder

I make no apologies for repeatedly talking about REACH……it really is coming!

I can hear the cries of “chemicals, nothing to do with us” all over the place, but that would be wrong.

While it is not yet clear how REACH will impact distributors like Farnell, the wider picture is taking shape.

According to the CEO of German company TechniData, “practically every single industrial enterprise that is based in the EU, or that imports into the EU, will be affected by REACH”.

REACH is a new EU regulation that aims to control hazardous substances by ensuring that all chemicals are fully tested by industry and used in safe ways.
Typical examples of products that could be affected:
• Chemicals and preparations include: Oil, grease and other lubricants, adhesives, cutting fluids, cleaning solvents, paints, flux, thinners, liquid soaps, handwash, disinfectants, metal and furniture polish, detergents, coatings (varnish, conformal and corrosion protective), metal bar, sheet, etc.
• Articles as containers for preparations, aerosol cans, marker pens, ink cartridges, brillo soap pads, alcohol wipes, etc.
• Articles with releasable chemicals – soap with a fragrance that is released. Also, potentially all electrical equipment if the authorities decide that metals recovered by recycling should be regarded as a foreseeable release.
REACH also indirectly affects equipment manufacturers because materials such as paints and adhesives that are used in production processes contain chemicals.

As happened with the RoHS Directive, clarification has been sought on how to define the concentration limit featured in the REACH regulations.

REACH requires either informing the authorities or notifying a customer of the presence of a substance in an article (product) under certain circumstances.

Once again the guidance is if the concentration of the substance is greater than 0.1% by weight.

I asked the Health & Safety Executive when we might see the list of high risk substances for REACH.

Their reply:

“The list you appear to be referring to is the so-called 'candidate list' of substances of very high concern. It's possible that this could be published by the European Chemicals Agency (on their website) this year but our expectation is that it will be early next year”.

REACH regulations cover some 849 pages of legislation with 2000 pages of guidance notes.
Farnell has produced a five page Step-by-Step Guide to the regulations, providing a high level overview.
The Guide looks at the background to the regulations and adopts a question and answer theme to address the key points.
This free, best-in-class guide has been adopted by the major trade organisations. AFDEC in the UK, FBDi in Germany and NEDA in North America are all putting the document to good use.
For your copy:
http://uk.farnell.com/images/en_UK/rohs/pdf/reach_step_by_step_pdf_v3.pdf

Directive Decoder

REACH regulations continue to pose questions. Here I look at substances of very high concern (SVHCs).

Notification of SVHC when present in articles:

Article 7 of REACH details the criteria under which an SVHC would need to be notified to the European Chemicals Agency (ECHA) if it is present in an article. Notification would be required if:

(a) The substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, and;

(b) The substance is present in those articles above a concentration of 0.1 % weight by weight of the article (not homogeneous material as with RoHS).

Notification is not required, however, if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. (In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.) or, if the substance has already been registered for that use.

To offer clarity over so called Substances of Very High Concern (SVHC) and when notification is required.

Notification of SVHC when present in articles: Article 7 of REACH details the criteria under which a SVHC would need to be notified to the European Chemicals Agency (ECHA) if it is present in an article (product). In summary, notification would be required if:
(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, and;
(b) the substance is present in those articles above a concentration of 0.1 % weight by weight (of article).

Article 7 of the REACH Regulations details the criteria under which a Substance of Very High Concern, or SVHC, would need to be notified to the European Chemicals Agency (ECHA) if it is present in an article.  In summary, notification would be required if:

(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, and;

(b) the substance is present in those articles above a concentration of 0.1% weight by weight (w/w).

The European Chemicals Agency (ECHA) has published a first draft of substances that could eventually lead to tough authorisation requirements that will potentially prohibit their use unless industry can indicate there is a compelling reason to allow them.

Each entry on the so called "candidate list" of substances of very high concern (SVHCs) has been put forward by a government in the European Union. The list includes three phthalates and the brominated flame retardant HBCDD. 

The ECHA has opened a public consultation on the list - the first to be held around the operation and implementation of the REACH Regulations - in which stakeholders will be encouraged to submit information on use and exposure as well as on safer alternative substances. Comments should be confined to technical issues.

Are you still unsure whether or not you need to pre-register, then later register, for the REACH Regulations?

All pre-registration must take place before 1 December 2008.

Failure to pre-register means that the substance cannot be manufactured or put on the market until it has been fully registered. This would require the compilation and submission of a technical dossier which could take months for large volumes or hazardous substances.

Pre-registration is optional but failure to do this means that after 1 December 2008 the substance will be treated as a non phase-in substance and from that point the requirement to register becomes immediate.

These are required when a substance or preparation (but not articles) are supplied to any user in the European Union

if the substance or the preparation contains a substance that meets the following criteria:

• Classified as a dangerous substance by the Dangerous Substances Directive - i.e. irritant, harmful, toxic, CMR (carcinogen, mutagen, toxic to reproduction) flammable etc or
• It is a PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent, very Bioaccumulative) or
• Classified as a SVHC (Substance of Very High Concern)

This will cover the majority of B2B preparations; if they have an orange hazard label, they need an MSDS.

Directive Decoder

By September 15th, 9062 legal entities had signed up from 27 EU Member States.

1886 were from Germany, 1341 from the UK, 928 from Holland and 830 from France. In total, 352641 pre-registrations had been received by the European Chemicals Agency (ECHA).

141185 of these were from Germany, 138434 from the UK, 17356 from Holland and 13989 from Italy. 

Pre-registration remains open until December 1^st 2008 and the ECHA will publish an intermediate list of pre-registered substances during October and the final list by January 1^st 2009.

Directive Decoder

Articles on REACH seem to be very popular with readers of this blog. With local radio now advertising REACH in the UK in an attempt to raise awareness, it is clear that there will be many companies who are still not aware of the potential impact on their business.

Now is the time to understand more about the REACH Regulations as some, or even all, of the 16 provisional substances of very high concern, or SVHCs, are likely to be officially confirmed in the coming weeks.

There will be an obligation to pass information down the supply chain where these SVHCs are included in articles at a level of above 0.1% by weight.

REACH is some 278 pages of regulations that can be summarised in this quick reference guide and the complimentary Substances in Articles document.

Directive Decoder

The European Chemicals Agency (ECHA) has today confirmed 15 Substances of Very High Concern.

Suppliers will be obliged to tell their customers where any of these are present in articles above permitted values.

ECHA press release. 

Directive Decoder

If you are in the REACH supply chain how should you be looking to pass information onto your customers around Substances of Very High Concern, where present at levels of 0.1% or more, by weight of the product, and information such as safe use?

Well, as I understand it, the web is fine, but not the web alone, and there should be a pro-active element to the communication.

The H&SE in the UK recently said:

"We would recommend that the information should be actively provided in an appropriate format (e.g. paper) when the articles are first supplied to customers. You may also choose to make the information available on websites."

Like many others, are you now thinking that REACH may impact your business after all?

Well, it's time to do a little research especially if you may have to register a substance or if you are obligated to pass information downstream to users.

So where can you access relevant information?

The Farnell Step-by-Step Guide, now on version 5, is free to download and provides a simple to follow overview of the regulations. This is a useful starting point.

Busy times at the minute as customers request detailed information around REACH Substances of Very High Concern.

Those of you who were involved in RoHS back in 2005 / 2006 may well remember the challenge of obtaining timely information around compliance from manufacturers.

Well, it will be no different with REACH.

How long will it take the manufacturer or importer to start the information flow down the supply chain?

Who knows but I suspect that there will be a great deal of managing expectations!

On the 28^th of October the European Chemicals Agency (ECHA) based in Helsinki, produced a short summary of the REACH obligations linked to the Candidate List of Substances of Very High Concern (SVHC).

Companies may have legal obligations resulting from the inclusion of the substances on the Candidate List. These obligations are not linked only to the listed substances on their own, or in preparations, but also to their presence in articles.

Click here for the announcement.

Directive Decoder

The first list of Substances of Very High Concern was published during October.

But which countries were active in putting substances forward for consideration?

Well the clear winners were France with four substances making it through to the final list, as well as one other that did not. Norway proposed three including one going forward unchallenged, Austria, Germany and Sweden two each, with Holland and the UK (C10-C13 chlorinated paraffin's) just one each.

Directive Decoder

The European Chemicals Agency (ECHA) has launched a public consultation on the first draft recommendations around substances to be included in the list of substances subject to authorisation. As RoHS and REACH processes start to come together you will note that the 4 proposed substances for priority assessment, recently announced under "RoHS2" are included in the list....BBP, DBP, DEHP and HBCDD.

ECHA announcement

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

REACH (Registration, Evaluation, Authorisation - and restriction - of CHemicals) is a regulation which many companies in the European Union will have to comply with.

REACH was introduced because many thousands of chemicals are used in the EU without the risks to human health and the environment being fully understood. The attached guide has been brought up-to-date to include the recent announcements around Substances of Very High Concern and gives guidance on how manufacturers and importers need to comply as well as the impact on downstream users.

REACH Guide

Directive Decoder

The weight limit by article in the REACH Regulations has caused some debate. The European Chemical Agency has decreed, by a majority vote, that the 0.1% weight limit of Substances of Very High Concern should apply to the whole complex article.

I hear that there were 2.75 million pre-registrations of substances during the six month window that ended in December.

150,000 substances were pre-registered by some 65,000 companies.

No wonder the ECHA website was under pressure!!

REACH Regulations - Latest Information

Directive Decoder

The REACH competent (enforcement) authority in the UK, the Health and Safety Executive, has stopped taking calls to their helpline for the minute.

A recorded message gives the reason as the build up of work following the pre-registration phase of the REACH Regulations.

Searching for information I came across the Chemical Business Association.

You may wish to add this one to your favourites.

Directive Decoder

RoHS2 and REACH have been the focus of attention for the last few months. However, 2009 will see momentum building around the Energy using Products Directive (EuP).

When does a manufacturer need to supply Safe Use data?

The obligation to provide safe use information is outlined in Article 33 of the regulations.

This information should be supplied if there is a need for safety precautions to be taken for normal use of the articles (products) or their disposal. This will depend on the likely quantity of Substance of Very High Concern (SVHC) that humans or the environment are exposed to from normal use, and the amounts that are known to cause harm (i.e. provide safe use information if humans are likely to inhale or ingest a quantity that is similar to that which is known to be harmful). The necessary precautions will depend on the intended normal use and in many cases no precautions will be required, and so only information on the name of the SVHC need be supplied. 

Directive Decoder

A Humidity Indicator Card (HIC) that contains a Substance of Very High Concern (SVHC) and is included in the packaging of moisture sensitive semiconductors has been the cause of some concern.

The card contains cobalt dichloride, one of the first batch of 15 SVHCs announced by the European Chemicals Agency.

Where SVHCs appear in articles (products) at a level above 0.1% of the weight of the total article then there is an obligation, under REACH "law", to pass certain information down the supply chain in a prompt and pro-active manner.This includes, as a minimum, the name of the substance and, where appropriate, any Safe Use Data.

However, the UK Competent (enforcement) Authority confirms that any outer packaging (the sealed bag the semiconductor is in) and the indicator card should be considered separately. Likewise, if there is anything inserted to protect the semiconductor, such as foam for example, this is also a separate article.

The 0.1% weight threshold would apply to these individually.

So, in summary, there would be no need to mention the SVHC in relation to the semiconductor, but it may need to be mentioned in reference to the HIC.

Directive Decoder

In October 2008 the European Chemicals Agency (ECHA) announced the first batch of so called Substances of Very High Concern (SVHC) under the REACH Regulations (Registration Evaluation Authorisation - and restriction of - Chemicals). REACH considers substances to be of high concern if they are, as a typical example, carcinogenic, mutagenic or toxic for reproduction. Also if they are persistent, liable to bioaccumulate and toxic.

The ECHA has announced legal obligations around the 15 substances that appeared on the first "Candidate List". Suppliers of articles (products) that contain substances in a concentration of above 0.1% by weight of the total article have to provide sufficient information to their customers to ensure safe use of the article.

As a minimum the supplier must advise the name of the substance and, where appropriate, provide a Safe Use Data Sheet.

Everyone in the supply chain needs to understand their obligations.

Click here for easy to follow guidance on Substances in Articles.

Directive Decoder

If you are involved with the REACH (Registration, Evaluation, Authorisation -and restriction- of Chemicals)Regulations you may well be involved in a supply chain, and be concerned about the ever increasing demands for information around articles.

As well as details around substances in articles, you might be asked to confirm what your company pre-registered and what your suppliers pre-registered. Downstream your customers may want you to complete detailed spreadsheets including concentrations of substances and even the horror, US born, document called IPC1752.

So what are your actual obligations?

The European Chemicals Agency (ECHA), based in Finland, has published an updated list of pre-registered substances.

It contains around 143,000 substances that were pre-registered between June and December by some 65,000 companies.

The ECHA does not expect all of these to be registered.

The list consists of pre-registrations submitted by industry. In the ECHA's opinion the list contains many preparations and substances that did not require registration.

List of pre-registrations

Directive Decoder

Currently companies around Europe are assessing their position in the supply chain so as to determine their obligations under the REACH Regulations.

You no doubt will have heard many rumours and have probably been told that you "must" supply certain pieces of information.

Farnell has become the first company in its industry sector to make specific REACH data available on its website.

Information on products, known as articles, that contain Substances of Very High Concern (SVHC) can be accessed at line level. This will include both the appropriate safe use data (usually for an article) and material safety data sheet on these substances that can pose a risk to both human health and the environment.

For details of how to access the information, which is updated on a regular basis, click here.

Directive Decoder

With industry trying to get to grips with providing REACH information and supporting Safe Use data on 15 substances many are wondering when the European Chemicals Agency will publish the next batch of Substances of Very High Concern (SVHC).

The only deadline regarding authorisation in REACH relates to the actual submission of recommendations to the European Commission referring to Annex XIV.

The REACH Regulations require the downstream communication of both the name of the Substance of Very High Concern and the appropriate safe use data.

For the latest obligatory REACH information available on thousands of products from the Farnell website click here.

Directive Decoder

Farnell now has obligatory REACH information at product line level on over 105,000 products with supporting safe use data on 1,300 SVHCs as recently defined under the regulations.

Use the link below to access the data, and comprehensive REACH support, which remains a free of charge service.

Obligatory REACH data

Directive Decoder

The European Chemicals Agency (ECHA) website provides a clue to future Substances of Very High Concern (SVHC).

There have been many reports on how frequently future batches of SVHCs will be published by the ECHA.

While the German Competent Authority leads the way with six potential submissions for new Substances of Very High Concern (SVHC) the original batch, announced in October, was shared across seven countries.

Of the twelve potential Substances of Very High Concern (SVHC) currently awaiting submission of the necessary technical dossier according to the European Chemicals Agency (ECHA) website only one, as we understand it, is used in Electrical and Electronic Equipment (EEE).

The European Chemicals Agency (ECHA) has recommended that seven REACH chemical substances of very high concern (SVHC) should not be used without specific authorisation.

What are the data sheets required to support the REACH Regulations?

(Material) SDS (safety data sheet) is information on a substance or preparation in a prescribed format which is required to be supplied for dangerous substance / preparations, Substances of Very High Concern (SVHC) PBTs or vPvBs. This should be provided on request where a preparation contains hazardous substances above certain limits.

REACH data collection continues to cause chaos within the supply chain.

There are two basic "legal" obligations and no end of "nice to have's".

We are told that we should know our customers and provide specific information to match their needs, and that we should place leaflets in each parcel to be read by the user.

In an industry that ships tens of thousands of packages every single day to thousands of customers, that is simply not going to happen.

We are asked for pre-registration information and certificates of conformity......why!?

For details of what is a legal obligation and what is not, click here.

Directive Decoder

Many manufacturers seem uncertain as to what information should be contained in the obligatory "safe use" data that is required where a Substance of Very High Concern is present in an article.

The problem here is that the REACH regulations do not define any specific format.

The guidelines provide a checklist that could be used to decide what information may be required to forward to professional users. These include:

§        Exposure controls / personal protection

§        Handling and storage

§        Disposal consideration

§        Fire fighting measures

§        Transport information

However, simple things like the substance name, where it is used, why it is used, is it safe and why is it on the Candidate List would be a start?

Directive Decoder

With the REACH impact on industry growing seemingly every day, Article 33 must be the most used phrase of all at the minute.

So just what does it refer to?

According to Article 33(1), any supplier of an article containing Substances of Very High Concern (SVHCs) on the Candidate List in concentrations exceeding 0.1% of the weight of the total article shall supply the recipients with sufficient information, available to the supplier, to allow safe use of the article.

As a minimum, the name of the SVHC shall be provided. Article 33(2) requires the same type of information to be forwarded to consumers upon their request.

Providing the name of the SVHC contained in the article is obligatory. In addition to the name, it is also obligatory to provide any information necessary to ensure safe use.

How many Passive Components will contain one of the 15 Substances of Very High Concern (SVHC) included in the REACH Candidate List?

While not all passives will include SVHCs, some components, such as electrolytic capacitors do contain rubber parts.

These often have a seal made of a type of rubber that may contain one of the phthalates or a Short Chain Chlorinated Paraffin (SCCP).

Electrolytic capacitors also have a plastic label made of plasticised PVC which could also contain phthalates.

Any passive component could contain PVC wire insulation, rubber seals or be filled with flexible potting materials that could contain a phthalate or SCCP.

Directive Decoder

Some Connectors are made of PVC that could be plasticised and some also have rubber seals or flexible adhesives that could contain phthalates.

Any others?.....please drop me a line.

Directive Decoder

Background

Light emitting diodes or LEDs are increasingly used for lighting applications and in displays. This trend is due to research into brighter and more energy efficient devices that are able to compete with fluorescent lamps that contain small amounts of mercury. LED lighting is often used in homes, offices and also in vehicles. Several computer manufacturers now offer laptops with LED displays instead of the standard liquid crystal displays (LCDs). A few LED televisions have also been launched recently. LED displays are more energy efficient than LCDs in laptop PCs because they do not require the conversion of the standard laptop battery voltages to the high voltages required by LCD backlights. LED lighting is still not as energy efficient as fluorescent lighting but researchers expect to be able to attain higher efficiency in the near future.

The development of LED lighting will affect EU legislation in the future in a variety of ways:

On 1 September the European Chemicals Agency published details of a consultation around the 2nd batch of candidate SVHCs.

As with the first batch there are 15 proposed.

However, not all are expected to be used in electrical and electronic equipment. Here chemist Dr Paul Goodman of ERA Technology, trading as Cobham Technical Services gives his view:

The European Chemicals Agency has announced details of a consultation around the next proposed batch of Substances of Very High Concern.

These will have a significant impact as they are expexted to come in to force early next year which, the way things are going, could well be before many manufacturers have provided the obligatory REACH SVHC data on the first batch of 15.

If you are still getting to grips with REACH, what it is, and how it impacts your business then I have updated my two guides which may help:

REACH Step-by-Step Guide

REACH Substances in Articles

Hope they help.

Directive Decoder

Distributor Farnell now has 180,000 pieces of REACH SVHC "Yes / No" data available on its website at product line level.

To the "downstream user" SVHC = No is as important as SVHC = Yes in many respects and provides absolute clarity.

SVHC = No product line level example

Directive Decoder

The ECHA Member State Committee identified today (7 December) 15 new chemical substances for the Candidate List of substances of very high concern (SVHC).

The list will formally be updated in January 2010.

15 New Substances

Directive Decoder

For details of the 15 new SVHCs that will be added to the Candidate List , their CAS number, potential hazard and uses in electrical equipment refer to the attached file:

New SVHCs announced 7 December

Directive Decoder

The European Chemicals Agency (ECHA) has added 14 chemical substances to the Candidate List of Substances of Very High Concern (SVHC).

Discussions on whether the substances need to be subject to authorisation will be taken later.

Companies may have legal obligations resulting from the inclusion of substances on the List. These obligations can apply to the listed substances on their own as well as in mixtures and in articles.

Six Member States - Denmark, Sweden, Austria, Belgium France and Germany are pushing to resolve the long running dispute over the interpretation of REACH obligations relating to the presence of substances of very high concern.

The current interpretation of the threshold is 0.1% by weight of the total article while the six countries feel that the 0.1% threshold should apply per component part.

Three EU Member States - Denmark, France and Germany - have put forward proposals to identify eight chemical Substances of Very High Concern (SVHC).

ECHA press release 8 March

Directive Decoder

On March 8 the ECHA published a consultation on 8 more Substances of Very High Concern.

Here, chemicals expert Dr. Paul Goodman of ERA Technology, trading as Cobham Technical Services takes a look at the possible impact on EEE.

According to ENDS Europe Members of the European Parliament are concerned at the time taken for REACH Substances of Very High Concern (SVHC) to reach the Candidate List.

The European Parliament's environment committee has questioned why there are only 29 substances on the Candidate List even though there are around 500 substances that meet the criteria for SVHCs.

It was observed that it would take more than 30 years, at the current rate of 15 per year, to include all currently known substances on the Candidate List.

After a delay of several years the European Commission's industry and environmental departments have finally agreed on the guidance that allows companies to seek authorisation for REACH substances of very high concern (SVHC).

Under the agreement applicants will not have to submit a substitutions plan but simply provide a timeline of when they might become available.

As a result chemicals on the Candidate List of SVHCs can be moved forward on to a final list that require authorisation.

On 18 June the European Chemicals Agency added 8 further Substances of Very High Concern to the Candidate List for authorisation.

ECHA press release and substances

Directive Decoder

The European Chemicals Agency (ECHA) has launched a public consultation

on its draft recommendation for eight Substances of Very High Concern (SVHC) to be included in the Authorisation List (Annex XIV).

Substances in Annex XIV will require (costly) authorisation to be used after an implementation, or "sunset date".

The use of an SVHC after this date will be illegal unless the use has been authorised.

The European Chemicals Agency (ECHA) has published details of 11 further SVHCs for consultation.

The consultation is open for input until October 14.

The 11 SVHCs that are proposed would be added to the to the Candidate List of substances (currently 38) for possible authoriation.

Full ECHA press release

Directive Decoder

The European Chemicals Agency (ECHA) has published details of 11 proposed Substances of Very High Concern (SVHC).

These were proposed by Austria, Germany and the Netherlands.

Interested parties are invited to comment on the proposals by 14 October 2010.

Here we provide details of their uses in electrical and electronic equipment or otherwise.

11 SVHCs-uses in EEE

Directive Decoder

Earlier this year the European Commission's industry and environment departments agreed on long-awaited guidance that paved the way for companies to seek authorisations for Substances of Very High Concern (SVHCs) under the REACH regulations.

The guidance had been delayed because the two departments had differing views on the requirements for applicants. Finally, it was agreed the applicants need not submit a substitute plan but provide a timeline indicating when substitutes might become available.

The marketing and use of chemicals on this authorisation list will be prohibited unless producers can show there is a strong enough case to allow them.

Member states have now voted to add the first six SVHCs to the authorisation list for special approval (Annex XIV).

The European Chemicals Agency (ECHA) is to publish a list of all

phase-in Substances that have been registered to date under the REACH regulations. The list will indicate what use the chemicals have been registered for but not, unfortunately, the name of the registering company.

The reason for publishing these details is to allay concerns that some substances may not be registered in time for the 30 November deadline which would mean, under the regulations, that the substance would be banned as a result.

The basis for RoHS and REACH substance restrictions are quite different. Restrictions in the original RoHS directive were based on hazards - if a substance is hazardous and there are alternatives, then it could be banned. REACH restrictions are introduced only if a risk to human health or the environment can be proven, it cannot be controlled and safer substitutes exist.

The MCS (Member State Committee) has agreed to add 8 Substances of Very High Concern (SVHCs) to the REACH Candidate List for possible future authorisation.

• chromium trioxide
• acids generated from chromium trioxide and their oligomers 
• cobalt(II)sulphate
• cobalt(II)dinitrate
• cobalt(II)carbonate
• cobalt(II)diacetate
• 2-methoxyethanol
• 2-ethoxyethanol 

Three substances (see below), nominated by Germany, were excluded from the original proposal on the grounds that there was not sufficient scientific evidence available to suggest they were PBTs (persistent, bioaccumulative or toxic).

The European Chemicals Agency has published an updated Candidate List featuring 8 new Substances of Very High Concern for Authorisation.

For details follow the link below:

REACH SVHCs

Directive Decoder

Happy New Year all

The European Chemicals Agency has submitted to the European Commission a recommendation that eight chemical substances of very high concern should in future not be used without authorisation. Four of the substances are classified as both carcinogenic and toxic to reproduction, three as carcinogenic and one as toxic to reproduction. They are all used in processes or products to which workers or consumers are exposed.

The protection of human health and the environment is at the heart of REACH. Making these eight substances of very high concern (SVHCs) subject to authorisation seeks to ensure that their risks are properly controlled and that the substances are progressively replaced.

The 8 Substances of Very High Concern (SVHC) that were published in December take the current total to 46.

As a guide to what SVHCs will potentially be added to the list we turn to the Registry of Intentions for our guide. In theory a couple of months after the required technical documments have been submitted the substances are moved forward to the Candidate List although, as we saw in December, there is still time for any of them to be rejected.

So, with dossiers due in January (9 substances) and August (6) additions to the Candidate List are likely around March and October.

Dr Paul Goodman of Cobham Technical Services (ERA Technology) looks at the 15 substances that are in the Registry of Intentions and their typical uses in industry.

HSE, the REACH UK Competent Authority has updated Information Leaflet number 13 which covers Safety Data Sheets and what they should contain.

Updated SDS guidance

Directive Decoder

Commission Regulation 453/2010 amends EC regulation number 1907/2006 of the European Parliament and of the Council of Ministers on the Registration, Evaluation, Authorisation - and restriction - of Chemicals (REACH).

In theory, manufacturers should now update the safety data sheets (SDS) and automatically send them down the supply chain.

Time will tell!?

Regulation 453/2010

Directive Decoder

Prior to REACH, the provision of Safety Data Sheets (SDS) was governed by the Chemical Hazard, Information and Packaging (CHIP) Regulations.

When REACH came into force it took over the provision of SDS and the guidance for compiling a SDS is now found in Annex II of the REACH Regulation. The move from CHIP to REACH introduced certain changes to the format of SDS which are summarised in the information leaflet at:

The European Chemicals Agency has published 8 further substances for consultation with a view to adding them to the Candidate List of Substances of Very High Concern for Authorisation.

Cobalt Dichloride is included for a second time following a change in classification. It is now deemed toxic for reproduction as well as carcinogenic.

SVHCs for consultation.

Directive Decoder

The Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC), part of REACH, have given their support to the banning of the use of Dimethylfumarate (DMF) in consumer articles and lead and its compounds in jewellery.

Following a number of severe skin reactions a temporary import ban already exists for DMF, but RAC have now concluded that permanent measures are needed as the substance puts consumers "seriously at risk".

In addition the RAC commented that the use of lead in jewellery may "significantly contribute to the exposure of children to lead". However it also implied that if proof can be provided that no lead will be released if items are chewed or sucked, production would still be permitted.

The final decision on the proposed bans will be left to a regulatory committee for the European Commission.

Directive Decoder

The European Chemicals Agency (ECHA) has published version 2 of its excellent guide to REACH Substances in Articles.

The comprehensive document covers such topics as deciding what is an article, substances intended to be released from articles, requirements concerning Substances of Very High Concern (SVHCs) and obtaining information on SVHCs.

This is the ultimate reference guide to substances in articles, one to print of and have on your desk as a key reference document.

Guide to SIA

Directive Decoder

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.

As expected, but somewhat slower than normal, it has been confirmed that 7 Substances of Very High Concern (SVHCs) will be added to the REACH Candidate List for authorisation.

Directive Decoder

On 20^th June 2011 ECHA updated the REACH Candidate List to include seven new Substances of Very High Concern (SVHC) bringing the total to 53.

These substances are listed below

• 2-ethoxyethylacetate
• strontium chromate
• 1,2-Benzenedicarboxylic acid, di-C7-11 branched and linear alkyl esters (DHNUP)
• hydrazine
• 1-methyl-2-pyrrolidone
• 1,2,3-trichloropropane
• 1,2-benzenedicarboxylic acid di-C6-8-branched alkyl esters, C7-rich (DIHP)

One of the most debated topics in respect of the REACH Regulation (1907/2006) is that of Substances in Articles.

Most of the commonly used objects in private households and industries are articles, for example, furniture, clothes, vehicles, books, toys and electronic equipment. An article may be very simple, like a wooden chair, but it could also be rather complex, like a laptop computer.

0.1% by weight of article (as now) or 0.1% by weight of component (9 Member States prefer this).

A hot REACH topic in the coming months I suspect.

What do you think?

Directive Decoder

453/2010 sets out enhanced requirements for the content of Safety Data Sheets or SDS.

Information under 16 headings must now be include, click on the link below:

SDS requirements

Directive Decoder

Six more substances have been added to the REACH Registry of Intentions.

This brings the number of Annex XV dossiers expected on 1 August for new SVHC to 19.

The European Chemicals Agency (ECHA) will publish these around a month later and at that point a 45 day consultation period will start allowing interested parties to submit their comments.

With progress on SVHC slow then a further 19 towards the end of the year would provide a welcome boost.

Registry of Intentions

Directive Decoder

6 new substances were added to the European Chemicals Agency Registry of Intentions during July.

Attached below, courtesy of ERA Technology, is a review of thier uses in electronics.

Registry

Directive Decoder

The European Chemicals Agency (ECHA) has announced a 45 day consultation on 20 Substances of Very High Concern with a view to adding to the Candidate List for authorisation.

Link to further information

Directive Decoder

ECHA has published new (September 2011) guidance on compiling Safety Data Sheets (SDS) that provides information on the issues to consider including what is required within each section. It also takes into account the changes arising from the revised Annex II of the REACH regulations.

Compiling SDS

Directive Decoder

20 new Substances of Very High Concern will be added to the REACH Candidate List taking the total to 73.

The EC has a target of 136 by the end of 2012.

Directive Decoder

On 19 December the European Chemicals Agency (ECHA) based in Finland added a further 20 Substances of Very High Concern (SVHC) to the Candidate List for authorisation taking the total to 73......see details below:

http://bit.ly/yWUR4V

Directive Decoder

If the REACH Regulations can help save lives as well as protect the environment then I am sure we would all endorse it wholeheartedly.

However, there is no doubt that REACH is a significant burden on industry. I can clearly remember an Official addressing a meeting of industry delegates and saying that REACH was "never meant to be a paper chase".

Well it's too late, despite the number of third party organisations offering to provide data on "thousands" of products.

The European Chemicals Agency ECHA has stated that the target, set by the European Commission, of having 136 Substances of Very High Concern (SVHCs) on the Candidate List by the end of 2012 is likely to be missed.

Currently there are 73 substances on the list but only 13 proposals expected to go forward for consultation around the end of February.

ECHA expects the number to be nearer the 100 mark by the end of the year.

Farnell has collected REACH information on around half a million products and found that approximately 0.5% of them contained an SVHC.

Directive Decoder