Q&A info

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

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.

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. 

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.

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

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. 

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