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REACH* - Registration, Evaluation and Authorisation of Chemicals

SIMPLE SUMMARY FOR EU PRODUCER/IMPORTER OF PRODUCTS (vs. CHEMICALS)

• REGISTRATION of chemical substance in Products (“articles”) if both conditions apply:
  
  • Substance is intended to be released under normal or reasonably foreseeable conditions
• Examples:  ballpoint pens, markers, scented candles.  At issue:  overdyed jeans intended to fade out in wash
• Note:  Cosmetics, lamp oils, inks and similar combinations of substances are considered “preparations,” not products or “articles” and covered under different REACH article (Art 6).
  
• Substance is present in quantities totaling over 1 tonne per producer or importer per year (calculate tonnage over all items produced/imported by the company)
  
• “PRE-REGISTRATION” of chemicals released in products must be filed in order to take advantage of phase-in periods for formal Registration:
  
  • Must occur by 1 Dec 2008.   If miss deadline, formal Registration must be done within 12 months OR must keep product off market.  
    
• ORGANIZE with other potential registrants of same chemical for same use
  
  • Only one registration per chemical per use permitted, so producers/importers of chemicals must meet to share information and costs.  (Each company obliged to register but based on shared data file.)
    
  • Note: Producers/importers of articles do not register substances if already registered for specific use.
    
• NOTIFICATIONto Chemical Agency of “Substances of Very High Concern” (SVHC) in products if:
  
  • Identified on official list to be published, including:
•  Carcinogen, mutagen, toxic to reproduction (CMR); persistent, bioaccumulative & toxic (PBT); or substances with probable serious effects to human health or environment
  
• Substance must be present above concentration of 0.1% by weight
  
• Chemical must be present in quantities totaling over 1 tonne per producer or importer per year (calculated over all products)  
• PROVIDE “SAFE USE” INFORMATION on SVHC’s to consumers:
  
  • Upon request & within 45 days, consumer must be provided with sufficient information, available to supplier, to allow safe use.    Duty begins when SVHC Candidate List published (estimated 2009).
    
  • Applies regardless of need to “Notify” the chemical based on tonnage.
    
• FAILURE TO REGISTER OR NOTIFY:
  
  • REACH is EU Regulation, not Directive.  Hence text must be adopted as is without member states adaptation.
    
  • Member states set penalties for violations.  Failure to pre-register, for applicable products, means   product denied entry.  NGO’s will be policing compliance to provisions such as response to safe-use information requests for presence of SVHC in products.
    
• Timelines

1 June 2007: REACH Regulation enters into force (effective date).

1 June - 30 November 2008: Pre-register chemicals intended to be released from products.

1 February 2009:  Meetings with other potential registrants to share data, determine who does Registration 

1 December 2010:  Registration deadline for most dangerous substances and others at high volumes (>1000 tonnes/year)

1 June 2011: Notification of Substances of Very High Concern

1 June 2013:  Registration deadline for substances > 100 tonnes/year

1 June 2018:  Registration deadline for substances > 1 tonne/year

*REACH:  Regulation (EC) 1907/2006.  Chemicals in products (“articles”) covered in Article 7.