Defining articles under REACH - article definition

 

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 printed onto it – bearing in mind that the printer cartridge used to print it is a container of chemicals. 

 

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The guidance issued by ECHA, which was incidentally redrafted to avoid some contradictions in early unpublished versions, provides a good source of help.  However, these are ‘guidelines’ and in other words, we are ultimately 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.

 

http://guidance.echa.europa.eu/docs/guidance_document/articles_en.pdf

 

This short document is one of several produced to encourage industry to believe that REACH is not an impenetrable tangle of legislation. REACH appears very complicated and frightening if just reading the legal texts, but the concepts are simple and we need to continually go back to the concepts to find the answers to our problems.

 

Defining an ‘article’

An article is defined within guidance documents as an object with physical properties more important to its function than any chemical properties.  At this point, we need to ignore comments from 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 components are 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 with the intention to understand whether REACH registration and CLP apply. 

 

Material

Exempt from CLP / Registration as 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

Nappies (disposable)

No

It is a container of absorbent polymer

Nappies

(re-usable fabric)

Yes

Fabrics and clothing are typically articles

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 set in place for 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.

Refridgerants, lubricants inside articles

Yes

Althoigh a 'container of lubricant' or 'container of refridgerant' these articles would not work without the chemicals and have been deemed articles.  But to supply new liquids for servicing, they will be a 'chemical'  

Brake pads

 

Yes

Physical nature important

Sticky stuff used 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 and labelling considered for CLP; however, the container may be an article in its own right and in all of the examples above, identification of Substances of Very High Concern is required both for the chemical and article.

 

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 with 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.

 

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 for 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, lese and less examples can be found of articles that release chemicals and in almost every example, 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)

 

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. 

 

With very limited exceptions, the main types of articles that release chemicals are scented products.

 

Foreseeable release

Most articles fit into this category and if Substances of Very High Concern (SVHC) are foreseeably released during use, it will be necessary to warn users.  If that substance requires Authorisation (Annex XIV) or is on the Candidate List for consideration to include on Annex XIV, 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.

 

The term SVHC is defined in Article 57 of REACH and includes those known or suspected to cause cancer, mutagenic or reproductive effects in humans (CMR) or are persistent and bioaccumulative.

 

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 for those needing to justify their use. 

 

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 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, even though 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, so be prepared to reconsider the status.

 

Multi-component articles

How big is an article?  Is it the fold-down plastic tray on an aircraft seat or the whole plane? Current indications are that the sub-components are articles in the own right when considering the 0.1% rule until it is fixed to a second article where upon the whole article is bigger and the percentage content of SVHC needs reconsidering.  Guidance was given in early 2016 by ECHA to stress that sub-articles must be considered.

 

So, the 0.1% fire retardant in the seat-back tray is still of concern, even after fixed to the whole seat and indeed, the whole aircraft.

 

 

NOTIFICATION

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) and is subsequently on the Candidate List or already on Annex XIV, and the risk of exposure to this substance during use cannot be excluded, you will need to Notify.


The key is whether the SVHC is registered for the use in this article (by anyone, not just the direct supplier).  If Authorised or restricted and not allowed in these articles for this use, then Notification is needed. 

 

COMMUNICATION

The EU manufacturer or EU importer of an article is obliged to communicate to downstream users information on SVHC at over 0.1% in their goods. The method of communication is not explicit in the legal text (Article 33 of REACH), but can be through labelling or a Safety Data Sheet; either way, this needs to be proactive to professional users or on request by consumers and will include details of the SVHC and precautions needed to reduce exposure. 

 

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.

 

Denehurst Chemical Safety Ltd