Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services.
We offer to you advisory as follows:
- Consultation service in the field of chemical safety of articles.
- Analyzes of obligations under relevant national legislation.
- Representing your company in the matter in consultation with the competent state institutions.
If you have questions please contact us by phone +421 2 45943712, or e-mail to ekotox(at)ekotox.sk
According to ECHA Guidance on requirements for substances in articles
Article 3(3) of the REACH Regulation defines an article as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition”.
In order to determine whether or not an object fulfils the definition of an article under REACH, the object’s function and its characteristics need to be assessed. (The term “object” can in principle refer to any product in the supply chain)
- function of an object – the term “function” in the article definition should be interpreted as meaning the basic principle determining the use of the object
- shape of an object means the three-dimensional form of an object, like depth, width and height.
- surface of an object means the outermost layer of an object.
- design of an object means the arrangement of the “elements of design” in such a way as to best accomplish a particular purpose
The shape, surface and design of an object represent its physical appearance and can be understood as other than chemical characteristics and are not to be confused with physical characteristics that result from the chemistry of the material(s) the object is made of.
According to Article 3(3) of the REACH Regulation the shape, surface or design must be deliberately determined and given during a production step (the “production step” of an article can also be understood to include the assembly of the components (which can themselves be articles) of a complex article (e.g. a laptop)
A set of objects that are merely collected together to be supplied does, on the contrary, not have a particular production step during which a specific shape, surface or design is given to the set or kit. This applies regardless of whether the objects are
- used separately (like the different casseroles and pans of a cookware set),
- used together (like in a portable power tool consisting of tool, battery and charger), or
- assembled into a single object (like a flat pack furniture).
Therefore a set of objects cannot be regarded as one article, but has to be regarded as many articles, substances and/or mixtures.
Substances, mixtures and articles can be contained inside of packaging, such as a carton, a plastic wrapping or a tin can. The packaging does not belong to the substance, mixture or article being packaged and i s therefore to be considered as a separate article under REACH.
SUBSTANCES INTENDED TO BE RELEASED FROM ARTICLES
A release of substances from articles is intended if it fulfils an accessory function (to be differentiated from the main function) which is deliberately planned and would not be achieved if the substance were not released. (Substances that are released because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, are generally not intended releases, as the release as such does not provide a function in itself.)
If the release of a substance from an object fulfils the main function of the object, the release is not regarded as “intended release” for the purpose of REACH. In this case the object usually would be considered as a combination of an article and a substance/mixture.
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.
Normal conditions of use means the conditions associated with the main function of an article.
Reasonably foreseeable conditions of use mean conditions of use that can be anticipated as likely to occur because of the function and appearance of the article (even though they are not normal conditions of use)
Registration of substances in articles
Is required when all conditions listed under Article 7(1) of the REACH Regulation are fulfilled:
- The substance is intended to be released under normal or reasonably foreseeable conditions of use
- The total amount of the substance present in all articles with intended release (i.e. including the amounts that are not intended to be released) produced or imported by one actor exceeds 1 tonne per year
For a substance in articles that has to be registered, the producer/importer of the articles shall submit a registration dossier to ECHA and the requirements for the registration dossier are in general the same as for manufacturers and importers of the substance.
REQUIREMENTS CONCERNING SUBSTANCES OF VERY HIGH CONCERN
Candidate List for authorisation
Substances fulfilling one or more of the criteria defined in Article 57 of the REACH Regulation can be identified as “substances of very high concern” (SVHC) and put on the “Candidate List for authorisation”
Notification according to Article 7(2)
Notification of substances in articles is required of producers and importers of articles when all conditions of Article 7(2) are met:
- The substance is included in the Candidate List for authorisation.
- The substance is present in articles produced and/or imported above a concentration of 0.1% (w/w).
- The total amount of the substance present in all articles produced and/or imported, which contain more than 0.1% (w/w) of the substance, exceeds 1 tonne per actor per year.
Obligations according to Article 33
The aim of Article 33 is to ensure that sufficient information is communicated down the supply chain to allow the safe use of articles.
- A supplier of articles containing a SVHC included on the Candidate List for authorisation in a concentration above 0.1% (w/w) has to provide relevant safety information about this substance available to him to the recipients of these articles (Article 33(1)).
- If no particular information is necessary to allow safe use of the article containing a substance from the Candidate List, as a minimum the name of the substance in question has to be communicated to the recipients.
- The information is to be provided to the recipients automatically, i.e. as soon as the substance has been included on the Candidate List for authorisation. Note that the term “recipients” refers to industrial or professional users and distributors, but not to consumers.
- Upon request of a consumer, the same supplier of articles has to provide relevant safety information about the SVHC available to him also to this consumer (Article 33(2)). The consumer has to be provided with this information within 45 calendar days of the request and free of charge
As concerns the obligations to communicate information on substances in articles in general (i.e. communication with recipients and consumers), please note that:
- There is no tonnage trigger for these obligations (i.e. they also apply below 1 tonne per year).
- Packaging is always to be treated as article(s) separate from the contents of the packaging. Therefore, the obligations to communicate information on substances in articles also apply to packaging materials.
- The substance concentration threshold of 0.1% (w/w) applies to the article as supplied.
- The obligations also apply to articles which were produced or imported before the substance was included in the Candidate List and are supplied after the inclusion. Thus, the date of supply of the article is the relevant date.
- The substance name to be communicated is the one appearing on the Candidate List for authorisation.
article producer is a company, if it produces articles within the EEA, regardless of how the articles are produced and where they are placed on the market. (Producer of an article: means any natural or legal person who makes or assembles an article within the Community (Article 3(4))).
article importer is any company located inside the EEA that imports articles from countries´that are located outside the EEA. (Importer: means any natural or legal person established within the Community who is responsible for import (Article 3(11)); import: means the physical introduction into the customs territory of the Community (Article 3(10))).
article suppliers are article producers and importers (as well as other actors in the supply chain such as retailers), if they place articles on the market in the EEA. Thus, the role of article supplier is irrespective of whether the supplier produces the articles himself or whether he purchases them (inside or outside of the EEA). (Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market (Article 3(33)), including retailers (Article 3(14))).