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Articles Guidance
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Articles Guidance in a Nutshell
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ECHA Guidance on Requirements for Substances in Articles

Articles

An article is 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. Packaging is generally considered a separate article from its contents.

Registration.

An article producer or importer must submit registration for a substance if the following conditions are met:

  • The substance is intended to be released from the produced and/or imported articles during normal or reasonable foreseeable conditions of use.
  • The total amount of the substance present in all articles produced and/or imported, from which the substance is intended to be released, exceeds 1 tonne per year.
    • The amounts intended to be released as well as the amounts which are not intended to be released or are not released at all need to be counted.
    • If different types of article with intended release are produced and/or imported, the quantities in all articles with intended release need to be summed.
Note:  A substance does not have to be registered by the article producer or importer if it has already been registered for that use.

 

Notification.

An article producer or importer must submit notification to ECHA in some cases.
 

Notification is required when all of the following conditions are met: However no notification is required if any of the following conditions are met:
  • The substance is included in the Candidate List of SVHC
  • The substance has already been registered for the use in the article by another company.
  • The substance is present in articles produced and/or imported at a concentration above 0.1% (w/w).
  • The articles have only been produced and/or imported by the producer/importer before the substance was included in the Candidate List.
  • 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 year for the producer/importer.
  • There is no exposure of the substances to humans or the environment during normal or reasonably foreseeable conditions of use including disposal.  (This determination is difficult and costly to make.)
 
Article notification requirements started on June 1, 2011.  A required notification is due six months after a substance has been added to the Candidate List. Notifications require information including identity information for the notifier, registration number, substance identity and classification, description of use of the substance in the article, and tonnage range. Notification is accomplished through IUCLID and REACH-IT.

 

Communication.

Article 33 of REACH requires suppliers of articles to inform the recipient and consumers if an article contains any of the substances on the Candidate List of SVHC above 0.1% (by weight per article). Suppliers of such articles have to provide relevant safety information about the substance available to them to the recipients of these articles—at a minimum the name of the substance. REACH does not specify the format for the information.  Possible formats include labels, use instructions, or a website. Information available to the article supplier necessary to ensure safe use of an article must be provided to consumers upon request, within 45 days and free of charge. There are no tonnage triggers, and the communication obligations apply to articles that were produced or imported before the substance was included in the Candidate List, but are supplied after the inclusion on the list. The following summary table is from ECHA’s Guidance in a Nutshell.

 
Obligation: Registration of substances in articles Notification of substances in articles Communication of information on substances in articles
Legal basis in REACH Article 7(1) Article 7(2) Article 33
Actors concerned article producers and article importers article producers and article importers article suppliers
Substances concerned substance intended to be released from articles substance included in Candidate List of SVHCs substance included in Candidate List of SVHCs
Tonnage threshold 1 tonne per year 1 tonne per year NA
Concentration in article threshold NA 0.1% (w/w) 0.1% (w/w)
Exemption for substance already registered for that use yes yes no
Exemption when exposure can be excluded no yes no

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.