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Denehurst Chemical Safety Ltd

Defining articles under REACH - article definition

Since May 2008, we have had final guidance available from ECHA, but there continues to be much debate as to what are articles and what are containers or what is intentional or foreseeable release.  Even after the guidance has been finalised, industry still needs to determine themselves how their products fit into these categories. 

This short guide gives a fairly light view of some of the issues for those supplying articles.

Articles

Mark Selby, Denehurst Chemical Safety Ltd,

Denehurst, Station Road

Burley in Wharfedale

West Yorkshire, UK

www.denehurst.co.uk


Introduction

When delivering training work or at a conference, the best way to get everyone interested and involved is to discuss articles.  It may not always be relevant to the topic being discussed, but it is guaranteed that the articles vs chemicals debate will provoke a response.


The first thing to consider is the definition of an ‘article’.  It is not helped by the use of the English language that also ascribes the word to a piece of law (eg. Article 7 about articles).  The next step is to consider this document as an article about the article Article and at this point, we are just being silly.  Especially if you print it onto paper, whereupon the sheet of paper is an article with an article about the article Article printed onto it – bearing in mind that the printer cartridge used to print it, is not an article when new, but may become one when empty. 


Since this document is aimed at clarifying the concepts, a simple definition is required and we recommend you ignore the last paragraph.

Those familiar with REACH will realise that the legal text is ambiguous or at least vague and this is especially true with articles.  This makes interpretation difficult for lawyers simple advice is to follow the spirit of the legislation that sets out to improve understanding of potential hazards of chemical and to ultimately improve communication of risk management measures.


The REACH Implementation Projects (RIPs) have resulted in ‘guidelines’; in other words, we are expected to work to guidelines and not legal texts.  If we act in a way to reduce the potential risk of using hazardous chemicals and do not act against the legislation, we can assure ourselves that we are doing the right thing.


Defining an ‘article’

An article is defined within guidance documents (notably RIP 3.8) as an object with physical properties more important to its function than any chemical properties.  At this point, we need to ignore comments from ‘pure’ chemists that the hardness of a plastic chair, for example, is due to the type of polymer used and the cross linking etc (ie chemical identities important) but for the person sitting on the chair, other factors are more important.  Clearly, having four legs and being relatively comfortable is the main selling point and not the chemical identity of the polymer.


It is perhaps easier to consider what are chemicals under the meaning of REACH and stuff with properties that are directly related to the chemical identity is unlikely to be an article.


The easiest way to consider the difference is by way of example – a few are given below, starting with the easy ones :

Material

Article ?

Rationale

Pen

No

Delivery system for ink, where the chemical properties of ink are a priority.

Pen cap

Yes

The cap is an article, but when attached to the rest of the pen, it is part of the ink container.

Wet wipes

No

The fabric is a carrier of alcohol and detergent

Printed paper

Yes

The physical form is main function

Impregnated tissues

No

The tissue is a carrier of the emollient or fragrance - perhaps depends on primary function

Chromatography columns

No

The chemical inside the column is a primary property

Clothing and fabrics from synthetic materials

Yes

Fabrics and clothing are articles, as are the threads used to make them

Polystyrene beads

Yes and no

If supplied to a cup maker, these are chemical (polymer)

If supplied inside a bean-bag to sit on, they are part of an article

Solder

No, when supplied.

Yes, when in use.

Solder to be melted and used to join electronic components is a chemical, but when joining components on a printed circuit board, the whole object is an article.

Tyre

Yes

Despite the chemistry involved in getting the right ‘compound’ for the tyres, the finished round thing is an article.

Wheel bearing

No

Container of lubricant

Brake pads

Yes

Physical nature important

Car

Yes / No

Container of windscreen wash detergents, but 'sealed' chemicals, such as lubricants, hydraulics etc are an essential part of the article 

Sticky stuff around sink

No, supplied

Yes, cured

When supplied out of a tube, it is a chemical, but the cured mastic around the sink after application is an article.

Dry paint

Yes

Components may be foreseeably released, such as abrasion.

Scratch cards

?

One possible example of an article that releases chemicals as a function of its use, or is the release of chemical (scratch off bit) just ‘foreseeable’ under normal use ?


Some of these examples are used later to illustrate other points.


A few of these examples were originally considered to be ‘articles that released substances’ but as time has gone on, there are fewer examples of substances released from articles and instead, these ‘articles’ are increasingly being considered as ‘substance delivery objects’.  Effectively, if the objective is to deliver a chemical, the chemical needs to be registered for that use under REACH; the container may be an article in its own right, or if detached from the ‘container (eg pen top, empty pen case, used ink cartridge) will be considered an article at that time.

There are some interesting examples where chemicals can be said to be contained but never released and do not need registration; two examples are liquid thermometers and spirit levels.  If the chemicals are not released, there may be justification not to register if importing that article (although note that if manufacturing in the EU, the contained chemicals will need to be registered so that you can use them !).


Use of an object

The guidance on articles suggests that one deciding point will be the intention of the supplier.  This was highlighted the other day when holding up a pen to illustrate the use as a chemical delivery device, only to find it did not ‘work’ and the ink did not come out as planned.  The pen was attractively presented and bore the name of a local pub – was the primary function to deliver ink, or to advertise?  It failed in the delivery function, so perhaps it is an article with an occasional (incidental) ability to release a chemical.  This would be hard to justify ! 


It is this sort of fundamental question that can keep legal experts occupied for hours, but it is advised to keep a simple view on this – a child could just as easily suck the ink out of a pen used as advertising as one that actually is intended for writing.

However, the use function is important in other areas and two examples can be used; the first is the supply of polystyrene beads that could be melted and re-formed into cup-shaped objects.  The cups are clearly articles, but the beads would be chemical (polymer) as the size of the beads are less important than the fact they are made of a certain type of property.  Even if a manufacturer agues that the beads have to be a precise size and shape to work in his machine, the counter argument is that you can make a different sized machine.


However, if these polymer beads are stuffed inside a teddy-shaped lump of fabric and a couple of bead eyes and a nose attached, it is now a stuffed toy.  This is an article as the polystyrene beads could be replaced by sawdust, sand, cat litter or a number of other fillers. The use is critical.


A second example is a lump of iron used for smelting (chemical) or used as a door-stop (article).  The concept gets easier the more you think about it.


Articles intended to release chemicals

Having now determined the difference between article and chemical, the intermediate state is an article that releases chemicals.  In this case, the chemical still needs to be registered for such a use and exposure to users or the environment needs to be taken into account.  However, as time has gone on, fewer examples can be defined as those that release chemicals and in almost every example (including some given in the draft Technical Guidance Document), it can be argued that the intended function is based on the chemical – for example, a scented candle delivers scent (it can be a thin candle, a fat one, long or short).  At the time of writing, final guidance is still not yet available.


If you are a supplier of an article releasing a chemical, the chemical being released needs to be registered.  Obviously, if you are an EU manufacturer, the chemical will be registered before you get it so registration is not a big issue, as long as the use patterns covered by the registration match your intended use. 


Foreseeable release

Most articles fit into this category and if substances of very high concern (SVHC)1are foreseeably released during use, it will be necessary to warn users, provide suitable labelling and a Safety Data Sheet and if that substance is restricted or needs authorisation, Notification is required.  The need to make a formal Notification depends on the ‘concentration’ of the SVHC in the article and whether more than a tonne is supplied. The concentration limit is 0.1% and if below this level, Notification is not required.


Examples of foreseeable release include chemicals released from a tyre, dyes from clothes, ink from printed paper, metal dust from grinding, flame retardants from cushions etc.  The latter example is perhaps open to debate, but since many flame retardants are potentially vPvB (you don’t want them to biodegrade or wash out), this is perhaps one area where ‘socio-economic’ advantage will be key.
 

Therefore, unless your article contains SVHC above the agreed thresholds of concern, there is perhaps little you need worry about – however, knowing what is in them is the difficult part for downstream users of articles as the suppliers will want to keep their composition confidential for commercial reasons.  To overcome this, there is a 45 day rule in which a DU or consumer can demand to know if an article contains a SVHC and have an answer in 45 days.  It is expected that some NGOs and lobby groups will ask this question to many suppliers, so we advise that you have your answers ready. 


Un-foreseen release

If you can think of a situation where a chemical is released but you do not expect it to happen, you have foreseen the release – therefore, do not expect many examples.

The same point will apply for un-foreseen as for foreseen – if your article contains an SVHC expect to have to communicate the fact to DUs or NGOs.  It will be virtually impossible to argue against any type of release what so ever, so be prepared to reconsider the status.


Multi-component articles

How big is an article ?  Is it the door knob on a cabin on board the Queen Mary or is it the whole ship ?   Current indications are that the knob is an article until it is fixed to the door and at this point, the door is an article with wooden bits, hinges and obviously the knob.  If the lock mechanism has some grease in it or corrosion inhibitors and if the wood is treated with preservatives, there will be chemicals that can be foreseeably released. 


When the door is bolted onto the rest of the ship, the whole ship is an article and if you then try to think of the chemicals taken to build it, you will need to lie down in a darkened room. 


There are two main points to consider in this case; firstly (and perhaps the most important) have any components been used that contain hazardous substances that can be a risk to users or the environment (noting that risk is a function of the chance of exposure and the known hazard).  If the answer is yes, if the object fit for purpose ?  An example may be that a corrosion inhibitor that is considered a SVHC should not be used on the door hinges, but could be used on the propeller shaft.  This is primarily a duty of care process.


The second point is to consider the concentration in the article – if the corrosion inhibitor is actually a SVHC and needs to be Authorised, and is 0.2% by weight of the hinge, the Hinge would need ‘Notification’.  However, once stuck to the cabin wall, the % weight in the whole ship is significantly lower and the ship does not need Notification.  However, when supplying the hinges with an Authorised substance, the risk assessment of that substance, that is central to the Authorisation, would very likely suggest that using in door hinges is one of the uses advices against !

Use of a corrosion inhibitor on a propeller shaft is technically demanding and there may be a strong socio-economic case for a specialist (Authorised) substances to be used in an essential application.


REACH actually does make some sense when seeing the whole picture.


Notification process

Formal Notification will not be required in many cases, but it is of concern to industry as a threat to their continued supply of articles.  The simple position is that if your article contains > 0.1%  SVHC (eg vPvB, PBT or CMR)1 and is subsequently on the Candidate List and needs Authorisation, and this substance is possibly released during use, you will need to Notify the ECHA.  The article will also need to carry warnings and an SDS is necessary.


As we do not yet have the Candidate List and the whole legal process of Authorisation is still in debate, more advice on the Notification process will be given later.


Conclusions

If supplying products that contain chemicals that are going to be intentionally released, you are almost certainly supplying a container of chemicals.  In this case, the chemicals need to be registered for their intended use if supplied at over 1 tonne.  The risk assessment (CSR) will need to reflect this use and the types of exposure.


If an article has a substance in it or on it, and it has a chance of being released during use (whether a function of its use, such as a tyre or by accident such as a painted door) and the substance is of very high concern and has been Authorised, the article will need Notification.


Either way, manufacturers, suppliers and users of products will need to define if an article or chemical container and whether the contents need registration or not or whether the article could release substances of very high concern during use.  Ask you suppliers what chemicals are used in manufacture and ask your customers or users about possible release patterns.


1   SVHC – Substances of very high concern will include substances considered very persistent and very bioaccumulative (vPvB), persistent, bioaccumulative and toxic (PBT) and carcinogenic, mutagenic and reproductive toxins (CMR) and other substances know to have adverse effects (eg endocrine disrupters) or perhaps nano-particles.  Many of these types of substances will be restricted in use and will be on the proposed ‘Candidate List’ of substances that will need Authorisation for further (restricted) supply. 

 

Denehurst Chemical Safety Ltd - Supporting the chemical industry

info@denehurst.co.uk