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Directive 76/769/EEC, the Restriction of Hazardous Chemical Substances Directive, has been amended dozens of times since its publication in 1976. With the formal entry into force of Annex 17 of the REACH Regulation on June 1, 2009, Directive 76/769/EEC and its supplementary regulations were repealed, and all content was transferred to Annex 17 for continued implementation. Currently, REACH Annex 17, "Restrictions on the Manufacturing, Sale and Use of Hazardous Substances," includes 58 categories of substances. Hazardous chemical substances listed in Annex 17 are subject to restrictions and cannot be freely manufactured, sold, or used.
Since June 1, 2009, EU member states have been able to submit plans for preparing new prohibited or restricted substances, and the European Commission can request ECHA to prepare relevant reference documents. According to information currently available to ECHA, member states plan to submit their first lists of prohibited substances in the spring of 2010. The European Commission will then review the documents submitted by ECHA and decide whether to include them in Annex 17.
Guidance in a Nutshell
To make the corresponding documents published by the European Chemicals Agency (ECHA) easier for industry to understand, a series of concise guidance documents are being produced. These documents are primarily aimed at managers in industry (including SMEs) to explain the main elements of the full guidance framework in a simplified manner, and to provide an overview of REACH implementation from different perspectives. However, readers should still refer to the full documents if they have any questions about the details.
Finished Product Requirements (Guidance in a Nutshell – Requirements for Substances in Articles)
Substances of Very High Concern (SVHCs) in the finished product must be notified no later than six months after being included in the candidate list of authorized substances. It is worth noting that notification has been in effect since June 1, 2011. Legal liability applies to finished products that were produced or imported into the EEA by the producer or importer before the SVHC was included in the candidate list of authorized substances, and supplied after the SVHC project was included in the candidate list of authorized substances. Therefore, the date of supply of the finished product is crucial.
Packaging materials are considered a separate finished product, so when SVHC exceeds 0.1%, businesses are also obligated to inform buyers and general consumers.
source
ECHA電子報No.3 May/June 2009
COMMISSION REGULATION (EC) No 552/2009
Guidance in a nutshell