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REACH

Prescrizioni in materia di sostanze contenute in articoli

Do I have to register substances in articles?

The registration requirement for substances in articles (as required by Article 7 (1) of REACH) applies only if all the following conditions are met: 

  • the substance is intended to be released during normal and reasonable foreseeable conditions of use; and 
  • the total amount of the substance present in the article exceeds one tonne per producer or importer per year; and 
  • the substance has not yet been registered for that specific use. Pre-registrations, however, do not relieve you from the obligation to register.

If the substance has already been registered for your specific use, then you do not need to register. This registration can be done in your supply chain or any other supply chain. Chapter 3.3.1 of the Guidance on requirements for substances in articles provides advice on how to find out if the substance is already registered for that use.

In order to determine what is an article in this context, especially regarding border line cases between containers and articles, you can consult the Guidance on requirements for substances in articles

Under what conditions and when do I have to notify to ECHA substances of very high concern in articles?

Substances that meet the criteria outlined in Article 57 of the REACH Regulation are commonly referred to as substances of very high concern (SVHCs). You must notify SVHCs present in articles (Article 7(2)) if the following conditions are met:

  1. the substance has been included in the Candidate List of SVHCs for authorisation; and
  2. the substance is present in articles above a concentration of 0.1% weight by weight (w/w); and
  3. the total amount of the substance in those articles (i.e. those containing more than 0.1% (w/w) of the Candidate List substance) exceeds one tonne per producer or importer per year; and
  4. exemptions do not apply.

Two specific exemptions can apply to the notification of substance in articles:

(a) exemption based on exclusion of exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal (Article 7(3)) and

(b) exemption for substances already registered for that use (Article 7(6)).

You must notify Candidate List substances in articles at the latest six months after the SVHC has been included on the Candidate List for authorisation (Article 7(7)).

The Candidate List will be updated continuously when substances that meet the criteria of Article 57 are identified.

You can find further information at: http://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.

The Candidate List can be found at: http://echa.europa.eu/candidate-list-table.

As Article 7(6) of REACH states "Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use" does it refer to the same supply chain or to different supply chains?
Provided that the substance has been registered by any manufacturer/importer for that specific use, paragraphs 1 to 5 of Article 7 of the REACH Regulation shall not apply. This means that it is not relevant whether the registration was done within the same supply chain or within another supply chain.
Can I already rely on the provisions of Article 7(6) of REACH when a substance in an article has been pre-registered?
No, because Article 7(6) of the REACH Regulation only applies if the substance has already been registered for that use.
What is an intended release of a substance from articles?

A substance is intended to be released from articles if it fulfils an accessory function which would not be achieved if the substance was not released. A scented children's toy, for example, is an article with intended release of substances, because fragrance substances contained in the toy are released in order to fulfil an accessory function, namely to scent. Consequently, the release of a substance because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, is generally not considered as an intended release, as the release as such does not provide a function in itself.

An intended release of a substance from an article has furthermore to occur under normal or reasonably foreseeable conditions of use. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article's life cycle is not an intended release. Similarly, a release in an accident or due to any form of misuse which is not in accordance with the use instructions of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.

May steel semi-finished products such as slabs, blooms and billets be considered as articles?
The transition point of steel and steel semi-finished products from substances/mixtures to articles during processing is to be determined by comparing the importance of physical and chemical characteristics for achieving the object's function. If it can be unambiguously concluded that the shape/surface/design are more relevant for the function than the chemical composition, the object that it is assessed is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or mixture. To determine whether or not steel semi-finished products constitute an article one can use the indicative questions given in Section 2.3 - 'Deciding whether an object is an article or not' of the Guidance on requirements for substances in articles http://echa.europa.eu/guidance-documents/guidance-on-reach
 
ECHA also advises industry to consult sector-specific guidance documents provided by business associations. However, it is up to the individual companies to examine their specific situation and determine whether their product may be considered as an article.
Is there any notification fee for the submission of a notification of Substances of Very High Concern (SVHC) in articles per Article 7 (2) of REACH?
There is no fee charged for the notification of SVHC in articles.
I have stopped production/import of the article containing a Substance of Very High Concern (SVHC). Do I have to notify?

If the production/import ended before the SVHC was included in the Candidate List or before the notification obligation starts to apply (i.e. 6 months after a substance has been included in the Candidate List or 1 June 2011 for substances placed on the Candidate List before 1 December 2010) then you do not have to notify. However, you may still have obligation, under Article 33 of REACH, to provide the recipient of the article, or the consumer upon request, with sufficient information to allow safe use of the article, including, as a minimum, the name of that substance. 

Do I have to consider the tonnage produced/imported before the Substance of Very High Concern (SVHC) was put on the Candidate List for the calculation of the tonnage in accordance with Article 7 (2) of REACH?
For articles which have been produced/imported for at least three consecutive years, the tonnage to be reported must correspond to the average tonnage of the substance in the article produced/imported during these three full years. If the substance in the article has only been produced or imported for two full years, the average of these two full years must be notified. However, if the substance in the article has been produced or imported only since the previous calendar year, the tonnage will be calculated based on the previous calendar year only and no averaging will be made.
 
For instance, substances that had been placed on the Candidate List before 1 December 2010 must have been notified by the producer or importer of the article by 1 June 2011. The producer or importer should have provided the average tonnage of the three or two preceding years, or the tonnage of 2010, depending on for how many consecutive years they had imported or produced the article. 
 
Thus, there are situations, where volumes of the substance predating the inclusion in the candidate list are considered in the tonnage calculation for the notification of a substance in an article.
 
Where production/import of the article starts in the current year, you are advised to notify as soon as the 1 tonne threshold is exceeded. In that case please indicate an expected tonnage range for the whole year.
Do article producers and importers notify only once according to Article 7 (2) of REACH, or should the notifications be updated?
While registrations of substances in articles must be updated with relevant new information, there is no legal requirement to update a "notification of substances in articles" dossier. However, ECHA recommends that notifiers update their notification dossier whenever there is a change in the information that was notified. Furthermore, it is also in the interest of the notifier to maintain an updated dossier, because based on the notification, ECHA may take a decision according to Article 7 (5) of REACH to require producers or importers of articles to submit a registration.
How can producers or importers of articles find information on whether an SVHC has already been registered for use in a particular article and whether the exemption in Article 7(6) of REACH thus applies?
The possibilities that companies have to verify whether a substance has been registered for a particular use are clarified in the Guidance on requirements for substances in articles. It should be noted that the sameness of both the substance identity and the use must be ensured. The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
 
Sources of such information are e.g. the safety data sheets, supply chain communication and trade associations. The ECHA website also provides information from registration dossiers. The amount of available information will often be larger for EU-producers of articles than for importers of articles. Thus it may often be easier - particularly for importers of articles - to notify an SVHC in an article than to document that the substance has already been registered for the particular use in the specific article.
Is a permanent magnet a substance/mixture or an article under REACH?

A permanent magnet should be considered as a substance or a mixture (and not an article) under REACH. This is because its shape, surface or design are less relevant for its function than its chemical composition. As a substance or a mixture, a permanent magnet is subject to the applicable provisions of the REACH and CLP regulations (e.g. it needs to be appropriately packaged and labelled).

Permanent magnets are used in different sizes and forms. They should create a (strong) permanent magnetic field and be stable to perform their main function of attracting or repelling other magnetic objects through a magnetic force (e.g. in cupboards to keep a door closed). They should also have high magnetic coercivity (i.e. they should be difficult to demagnetise).  

The materials to be used to produce permanent magnets should either be either materials with permanent magnetic fields or materials with a susceptibility to be magnetised by applying an external magnetic field. The latter should also retain the imprinted magnetic pattern (high magnetic coercivity). 

The magnetism is one example of a physical property that results from the chemistry of the materials an object is made of, given in the Guidance on requirements for substances in articles (subchapter 2.2). The Guidance also states that such material characteristics or properties are not to be confused with the shape, surface and design of an object.

The stability (magnetic coercivity) and the strength of the created permanent magnetic field appear to be the most important properties of a permanent magnet. Therefore, the magnetic properties of the permanent magnet, which are strongly related to its chemical composition, determine its function.

Are ammunition cartridges designed to launch a projectile (e.g. a bullet) considered as ‘articles' under REACH?
Yes, ammunition cartridges that are designed to launch a bullet are considered to be articles with an integral substance/mixture (the propellant) because the shape, surface and design of such ammunition cartridges determine their function to a greater degree than does its chemical composition.
It should be noted that this answer is limited to ammunition cartridges that are designed to launch a projectile (i.e. a bullet). It does not necessarily apply to ammunition where the function of the object is the deliberate release of a mixture (i.e. flares, gas grenades, etc.). 
 
This Q&A was first published on ECHA website on 04/08/2016.
When do I have to communicate information on Candidate List substances in articles down the supply chain and to consumers? What information do I need to communicate?

If you are a supplier of an article containing a substance, you have to provide to the recipient of the article (Article 33(1)) or to a consumer (Article 33(2)) relevant safety information, available to you, when both the following conditions are met:

  • The substance is included in the Candidate List for authorisation, and
  • The substance is present in the article produced and/or imported above a concentration of 0.1% (w/w).

The information is to be provided to the recipient of the article, i.e. industrial or professional users and distributors, when the article is supplied for the first time after the inclusion of the substance into the Candidate List and to the consumer upon request by that consumer, within 45 calendar days of that request and free of charge.

The communication of information at the request of a consumer is independent of whether the article was purchased by that particular consumer.

The information you should communicate must be sufficient to allow safe use of the article, considering all life cycle stages of the article including disposal. Section 3.4.1 of the Guidance on requirements for substances in articles describes in detail which information should be communicated.

If no particular information is necessary to allow safe use of the article containing a Candidate List substance, e.g. when exposure can be excluded at all life cycle stages of the article including disposal, as a minimum the name of the substance in question has to be communicated to the recipients of the article or to consumers.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Do the articles assembled or joined together in a complex object remain articles?

In the Guidance on requirements for substances in articles, the term “complex object” refers to any object made up of more than one article. In complex objects, several articles can be joined or assembled together in various manners. For example, they can be mechanically assembled (e.g. pair of (metallic) scissors, foldback clips) or joined using substance(s)/mixture(s) (e,g. block of sticky notes, glued chip in a bank card, unpainted bicycle frame formed by welding together multiple steel tubes). The more articles it is made of, the more complex an object becomes.

Articles that are assembled or joined together in a complex object remain articles, as long as they keep a special shape, surface or design, which is more decisive for their function than their chemical composition, or as long as they do not become waste (as defined in the Waste Framework Directive - Directive 2008/98). An importer or a supplier of a complex object (e.g. foldback clip) is importer or supplier of the various articles the complex object is made from, and must therefore comply with the applicable communication and notification obligations for each one of them (e.g. the bent strip of steel and the two metallic wire handles of the foldback clip). Whether the complex object is an article depends on whether it fulfils the criteria of the definition of an article. 

How do I determine the concentration of a Candidate List substance in an article?

The determination of the concentration of a Candidate List substance, to check whether it is above the 0.1% w/w threshold or not, is essential to check whether communication and notification obligations apply.

Table 5 in the Guidance on requirements for substances in articles illustrates and explains in detail several scenarios on how to determine the concentration of a Candidate List substance (weight by weight (w/w)) in an article or in articles incorporated in a complex object (any object made up of more than one article). In summary:

  • Scenario I. Article made from a Candidate List substance as such or in a mixture: the concentration is calculated over the total weight of the article (e.g. plastic chair produced by injection moulding)
  • Scenario II.  Candidate List substance as such or in a mixture used for joining two or more articles (complex object): the concentration of the Candidate List substance is calculated over the total weight of the complex object (e.g. unpainted bicycle frame formed by welding together multiple steel tubes, using a mixture containing the substance)
  • Scenario III. Candidate List substance in coatings (e.g. paint, lacquer, varnish, functional coating) -  III. A) Fully coated article; III. B) Partially coated article; III. C) Coated complex object: the concentration of the Candidate List substance in the (fully/partially) coated article is calculated over the total weight of the coated article or of the complex object
  • Scenario IV.  Very complex objects (e.g. sofa, bicycle, mobile phone, car and aircraft): the calculation rules set out for scenarios I to III above apply for each article or simpler complex object.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

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