Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 230/6/14

4 January 2007

Dear Sirs,

Commercial Information Circular No. 15/2007

European Union (EU)* : Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

The European Commission has recently adopted a Regulation concerning the registration, evaluation, authorisation and restriction of chemicals (commonly known as "REACH") to consolidate existing legislations and to establish a new system to control the chemical substances, preparations and substances in articles in the EU. Details are set out in Council Regulation No. 1907/2006 (the Regulation), copy of which can be downloaded from http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_136/l_13620070529en00030280.pdf.

DETAILS

2. All substances and preparations, no matter being manufactured or placed on the EU market on their own or in articles, are subject to the provisions of the Regulation. Certain substances, including radioactive substances, substances subject to customs supervision, non-isolated intermediates, waste, substances in medicinal products, food or feeding stuffs, cosmetic products, and other substances that are specified in the Regulation, are exempted. A European Chemicals Agency (the Agency) will be established to manage the technical, scientific and administrative aspects of the REACH system at the Community level. Provisions that may affect Hong Kong manufacturers and exporters are summarised below.

Substances on their own or in preparations

3. Major provisions concerning substances and preparations include:
   1. Registration (Title II of the Regulation)

      Manufacturers or importers of substances in the EU have to provide a technical dossier, which contains information on the properties, uses, classification and guidance on safe use, for each substance manufactured or imported in quantities of 1 tonne or above per year. Additional information may also be required if the substance is carcinogenic, mutagenic or toxic to reproduction (CMR); persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); or used in large quantities.

      To facilitate the transition to the REACH system, the registration provisions will be applied to "phase-in substances"** in a step-wise fashion as follows:

      1. for substances manufactured or imported in quantities of 1,000 tonnes or above per year; substances classified as very toxic to aquatic organisms in accordance with Directive 67/548/EEC and manufactured or imported in quantities of 100 tonnes or above per year; and CMR category 1 or 2 substances of 1 tonne or above per year, the registration deadline is 1 December 2010;
          
      2. for all substances manufactured or imported in quantities between 100 and 1000 tonnes per year, the deadline is 1 June 2013; and
          
      3. for all substances manufactured or imported in quantities of 1 tonne or above per year, the deadline is 1 June 2018.
   2. Data Sharing (Title III)

      Persons intending to register "phase-in substances" are required to pre-register them between 1 June and 1 December 2008. This is to facilitate data sharing in order to reduce testing on vertebrate animals and save costs to industry. A system will be established to help registrants find other registrants to share data.

   3. Information in the supply chain (Title IV)

      Supplier of a substance or preparation shall 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:

      1. a substance or preparation is classified as dangerous under Directives 67/548/EC or 1999/45/EC; or
          
      2. a substance is classified as PBT or vPvB in accordance with the criteria set out in Annex XIII of the Regulation; or
          
      3. substances subject to authorisation (see point v below).

      The provisions of the current Safety Data Sheets Directive 91/155/EC are carried over into the Regulation. The original Directive 91/155/EC is thus repealed.

   4. Evaluation (Title VI)

      The Agency may check the compliance of registration dossiers with the requirements laid down for registration in the Regulation. It will also check the testing proposals in order to prevent unnecessary animal testing. The Agency may also request the industry to provide further information to clarify suspicions of risks to human health or the environment.

   5. Authorisation (Title VII)

      Authorisation is required for the use and placing on the market of substances of very high concern (i.e., Category 1 or 2 of CMR substances, PBT and vPvB substances, and substances that may cause serious effects to human or the environment). 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. Details of the authorisation process and the list of substances requiring authorisation are set out in Title VII and Annex XIV of the Regulation respectively.

   6. Restriction (Title VIII)

      Any substances on its own, in a preparation or in an article may subject to Community-wide restrictions. Details are set out in Annex XVII of the Regulation. Existing restriction set out in Directive 76/769/EEC are carried over in a consolidated version into the Regulation.

   7. Classification and labelling inventory (Title XI)

      A classification and labelling inventory for dangerous substances and preparations classified in Directives 67/548/EEC and 1999/45/EC will be established and maintained by the Agency. To meet the requirements set out in these two Directives, users can access to the information in the inventory.

Chemicals in Articles

4. Producers or importers of articles in EU (e.g. manufactured goods such as cars, textiles, electronic chips, etc.) should also submit a registration to the Agency if any substance contained in those articles meets the following conditions:
   1. the substance is present in those articles in quantities over 1 tonne per producer or importer per year; and
       
   2. the substance is intended to be released under normal or reasonably foreseeable conditions of use.

Nevertheless, producers or importers are required to notify the Agency if substances requiring authorisation (Annex XIV of the Regulation) are present in the articles in quantities over 1 tonne per producer or importer per year and above a concentration of 0.1% weight by weight. Hong Kong manufacturers and exporters should also note the restriction on certain substances in articles set out in Annex XVII of the Regulation.

5. As the suppliers of chemicals or suppliers of articles containing substances subject to the provisions of the Regulation, Hong Kong manufacturers or exporters may be required to provide information to assist their EU importers in the preparation of registration or authorisation. The information may include the use of substance and a chemical safety report. Details are set out in Titles IV and V of the Regulation.

Entry into force

6. Unless specified, provisions of the Regulation will enter into force on 1 June 2007. Provisions on registration, data sharing, downstream user obligations, evaluation, authorisation and classification and labelling inventory shall apply from 1 June 2008, while provisions on restrictions shall apply from 1 June 2009.

Reference

7. To facilitate understanding of the REACH Regulation, the European Commission has published a document titled "REACH in brief". It is available on the Internet at http://ec.europa.eu/environment/chemicals/reach/reach_in_brief04_09_15.pdf.

ENQUIRIES

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

Yours faithfully,

(Miss Angel POON)

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, the Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom.

** "Phase-in substances" means a substance which meets at least one of the following criteria:
i) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
ii) it was manufactured in the Community at least once in the 15 years before the entry into force of this Regulation;
iii) it was placed on the market in the Community before entry into force of this Regulation and was considered as having been notified in accordance with Directive 67/548/EEC, but does not meet the definition of a polymer.