Commercial Information Circulars

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e-mail address : enquiry@tid.gov.hk

Ref : EIC 230/6/14

3 June 2008

Dear Sirs,

Commercial Information Circular No. 302/2008

European Union (EU) * : Requirements for Substances in Articles under REACH

Further to Commercial Information Circular No. 254/2008 of 30 April 2008, the European Chemicals Agency (ECHA) recently released a guidance document on requirements for substances in articles under REACH, which can be accessed through the following link:
http://reach.jrc.it/docs/guidance_document/articles_en.htm.

DETAILS

2. Since the adoption of REACH in December 2006, there has been discussion on how to determine whether a substance should be regarded as "substances in articles" or "substances in containers/carrying materials". For example, the European Commission originally quoted ink cartridge as an example of substances in articles. But there was argument that ink should be regarded as substance while the cartridge is just a container as the main function of ink cartridge is determined by the chemical properties of the ink rather than the cartridge. In this regard, the ECHA published the subject guidance document to provide a clear definition on "substances in articles" and "substances in containers/carrying materials".

Definitions

3. According to the guidance document, an article refers to 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. Substances may be added to give an article certain special properties. For example, in the case of scented eraser, while the main function is determined by the eraser itself, fragrant substances are added to give a particular smell. These fragrant substances are regarded as "substances in articles".
4. In this regard, ink in the cartridge is now classified as "substances in container" as the function of the ink cartridge is determined by the ink rather than the cartridge, which is just a container with a function to enhance the quality of printing. Another example is wet cleaning wipes. The cleaning liquid inside determines the function of the product and the wipe itself is just a "carrying material". For details on how to distinguish substances in articles from substances in containers/carrying materials, please refer to Chapter 3 of the guidance document.

Obligations

5. Producers or importers in the EU have the following obligations for "substances in articles":

   1. Registration

      Pre-register/register the substance in articles if the following conditions are met:

      • the substance is intended to be released under normal and reasonably foreseeable conditions of use; and

      • the substance is present in those articles in quantities over 1 tonne per producer or importer per year.

      unless the substance has already been registered for that use.

   2. Notification

      Notify the substances in articles if the articles contain substances of very high concern (SVHC)** in quantities over 1 tonne per producer or importer per year and above a concentration of 0.1% weight by weight unless:

      • the SVHC has already been registered for that use; or 

      • exposure to human or the environment during normal and reasonable conditions of use including disposal can be excluded.

   3. Information in the supply chain

      Manufacturers, importers and suppliers of articles containing SVHC in a concentration above 0.1% weight by weight should provide the recipients of the articles (and to consumer on request) sufficient information to allow safe use of the articles.

   4. Restriction

      Follow the restrictions on the use of respective chemicals set out in Annex XVII of REACH.

6. For "substances in containers/carrying materials", the requirements under REACH are essentially the same as those applied to substances on its own or in preparations as follows:

   1. Registration

      Pre-register/register the substances according to the tonnage requirements and timelines. There is no exemption for substances that are already registered for that use.

   2. Authorisation

      Authorisation is required for the use and placing on the market of SVHC. It would be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled or its socio-economic benefits outweigh the risks and there are no suitable alternative substances or processes.

   3. Information in the supply chain

      Provide the recipients of the substance or preparation with a safety data sheet complied in accordance with the format set out in Annex II of the Regulation, where:

      • a substance or preparation is classified as dangerous under Directives 67/548/EC or 1999/45/EC; or

      • a substance is classified as PBT or vPvB in accordance with the criteria set out in Annex XIII of the Regulation; or

      • substances subject to authorisation.

   4. Restriction

      Follow the restrictions on the use of respective chemicals set out in Annex XVII of REACH.

   5. Classification and labelling inventory

      Follow the classification and labelling requirements set out in Title XI of REACH.

7. Local manufacturers and exporters may be required to provide information to their EU importers or their "only representative" to fulfil the obligations of REACH. Interested parties may use the Navigator on the ECHA website (http://reach.jrc.it/navigator_en.htm) to identify all relevant requirements and visit our REACH webpage (http://www.tid.gov.hk/english/trade_relations/eu_reach.html) for further information.

ENQUIRIES

8. For enquiries concerning the contents of this circular, please contact the undersigned at telephone number 2398 5684.

Yours faithfully,

(Cyrus NG)
for Director-General of Trade and Industry

* The EU includes Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.

** including category 1 or 2 of substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances, and substances that may cause serious effects to human or the environment.  The cadidate list of SVHC will be released by 1 June 2009.