If no one in your supply chain purchases materials from EU suppliers or exports to the EU, there is no REACH impact on your business–yet. But, don’t think other countries or U.S. states won’t adopt copycat legislation as has been done with other laws. China is already developing China REACH. Be prepared.

Roles Under REACH

Manufacturer: A natural or legal entity/person established within the EU who manufactures a substance within the EU.

Importer: A natural or legal entity/person in the EU responsible for the physical introduction of a substance into the EU.

Downstream user (DU): A natural or legal entity/person in EU, other than the manufacturer or the importer, who uses a substance, on its own or in a preparation, in the course of his or her industrial or professional activities. Not a consumer or a distributor.

OR/Only representative: A natural or legal entity/person who fulfills all the REACH obligations for and appointed by non-EU entities/persons that export substances to the EU. Must have sufficient background in the handling of substances and the information related to them.

Requirements for ‘Articles’

Articles manufactured in or imported into the EU are regulated in two fundamental ways under REACH:

  1. The manufacturer/importer of an article must register any chemical substance contained in the article if the total amount exceeds 1 mt per year and the substance is intended to be released during normal and reasonable foreseeable conditions of use (e.g., air fresheners, scented erasers [more common in EU]).
  2. If the article contains a SVHC (listed on the Candidate List) with a concentration greater than or equal to 0.1% weight by weight (w/w) and the total amounts of SVHC contained in the article exceed 1 mt per year, the manufacturer or importer must notify ECHA unless it can be shown that exposure to the SVHC can be excluded during normal or reasonably foreseeable conditions of use, including disposal. There is no need to notify ECHA if the substance has already been registered for that particular use. Notification begins June 1, 2011.

Examples of SVHCs:

  • Polycyclic Aromatic Hydrocarbons (PAHs) and aromatic hydrocarbons found in resins, oil distillation products, tars, etc.
  • Azo-Dyes used for textiles, leather, and food coloring
  • Some toxic metals such as mercury, lead, chromium, antimony, beryllium, and arsenic found in alloys, colors, ceramic products, coatings, etc.
  • Halons still used in coolants, refrigerators, and solvents
  • Halogen Carbonhydrates used in fire retardants such as TBBA, other bromium-compounds, fluorinated compounds, etc.
  • Some monomers for plastics such as vinyl chloride, etc.

SVHC Information

Under REACH [Article 33], manufacturers and importers have a duty to communicate certain information about any SVHC that may be present in their article above 0.1% w/w:

  • You must provide the “recipient” of the article with the name of the SVHC and information on safe use.
  • You must also provide this information to anyone (consumers), upon request, within 45 days.

This requirement can be problematic for a number of reasons:

  • There is no tonnage threshold (as there is for ECHA notification).
  • Information to recipient must be provided as soon as the SVHC “candidate list” is published.
  • There are no exemptions. For example, the requirement applies even if it can be shown that exposure can be excluded during normal and foreseeable conditions of use or if the SVHC has already been registered for a particular use.
  • Many manufacturers do not have the data necessary to determine whether disclosure is required. For example, they may not have information on the types and amounts of substances with SVHC characteristics present in their products.

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