Summary of REACH by RSJ Technical Consulting

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What is REACH?

REACH is short for the Registration, Evaluation and Authorization of Chemicals

Regulation (EC) 1907/2006

The following summary is intended to familiarize you with the key concepts in REACH and provide a broad framework for understanding this exceedingly complex piece of legislation.

The purposes of REACH (as set forth in the 131 recitals of the preamble):

ê	Establish a comprehensive and detailed database of the chemical substances in the European Community: manufactured, placed on market, imported or used
ê	Motivate companies to develop cost-effective and safer alternatives to hazardous substances by requiring the evaluation of all substances (not just new ones)
ê	Shift responsibility for testing and risk evaluation from government and regulatory authorities to the manufacturers or importers of the substances, producers of articles and downstream users
ê	Establish graduated requirements for testing and risk evaluation based upon the likelihood of causing harm to human health or the environment:
	i.e. increasing quantities of the substance (manufactured, imported or used) increase the likelihood of harm
	i.e. substances having certain dangerous characteristics (carginogenic, mutagenic, toxic to reproduction; persistent, bioaccumulative and toxic or very persistent and very bioaccumulative; very toxic to aquatic organisms; probable serious effects) increase the likelihood of harm
ê	Reduce duplication of testing (especially on vertebrate animals) through mandatory information sharing, with cost sharing required in the first twelve years
ê	Establish a mechanism for controlling or restricting the use of hazardous substances (the provisions for evaluation of substances, authorization and restrictions)
ê	Establish an independent agency (ECHA) to manage the regulation of chemical substances

The focus of REACH is on substances:

It is the substance rather than the finished product that is subject to the requirements of REACH. Each substance in the product should be considered for registration, notification, classification, etc. (although many will meet the criteria for exemption). Under REACH, substances are defined as being either 'in themselves', in a preparation, or in an article, with different criteria applying to each.

ê	Substance 'in itself': a chemical element and its compounds, including additives necessary to preserve stability and impurities derived from processing
ê	Preparation: a mixture or solution composed of two or more substances
ê	Article: an object whose function is determined by its shape, surface or design rather than by its chemical composition

The requirements of REACH (these function independently of each other, and exemption from one requirement does not necessarily mean an exemption from the others):

REGISTRATION of SUBSTANCES:
	Applies to manufacturers/importers of substances 'in themselves' or in preparations. Also applies to producers/importers of substances in articles that are 'intended to be released'.
	Registration is required when quantity of substance is 1 tonne or more per year in the European Community. One metric tonne equals 1000 kg or about 2204 lbs.
	Chemical safety assessment is required for manufacturers/ producers/importers with 10 tonnes or more. Testing requirements increase with tonnage.
	Effective date was June 1, 2008. However, registration deadlines for 'phase-in' substances that were pre-registered in 2008 are staggered over the next decade:
	Dec 1, 2010: 1 tonne if carcinogenic/mutagenic/toxic reproduction Dec 1, 2010: 100 tonnes if very toxic to aquatic organisms Dec 1, 2010: 1,000 tonnes June 1, 2013: 100 tonnes June 1, 2018: 1 tonne
SAFETY DATA SHEET:
	Applies to manufacturers/importers of substances 'in themselves' or in preparations.
	Safety data sheets must be provided to recipient of substance/ preparation when the substance has certain 'dangerous' characteristics. There is no quantity threshold.
	Effective date was June 1, 2007.
DOWNSTREAM USERS:
	Applies to commercial/industrial users (in the EU) of substances 'in themselves' or in preparations.
	Downstream users report to ECHA is required for any use of a 'dangerous' substance that is not identified by supplier's SDS (or is advised against). There is no quantity threshold.
	Chemical safety assessment is required when user's total quantity is 1 tonne or more and supplier's quantity is 10 tonnes or more.
	Effective date was June 1, 2008.
CLASSIFICATION and LABELING:
	Applies to manufacturers/producers/importers of substances 'in themselves', in preparations and in articles.
	Notification to ECHA is required for 'dangerous' substances of the substance's identity, hazard classification and hazard label. There is no quantity threshold; separate notification is not needed if registration is required.
	Effective date was December 1, 2010.
SUBSTANCES of VERY HIGH CONCERN:
	Applies to producers/importers of articles.
	Safe use information must be provided to recipient of article when SVHC is present. There is no quantity threshold.
	Notification to ECHA is required when quantity of SVHC is over 1 tonne and concentration in articles is above 0.1%. Separate notification is not needed if registration is required.
	Effective date was June 1, 2011. Notification is required six months after the SVHC is added to the Candidate List.
RESTRICTED SUBSTANCES:
	Applies to manufacturers/producers/importers of substances 'in themselves', in preparations and in articles.
	Use of a substance listed in Annex XVII must comply with the conditions specified in the annex. No report to ECHA is required.
	Effective date was June 1, 2009.
AUTHORIZATION:
	Applies to manufacturers/producers/importers of substances 'in themselves', in preparations and in articles.
	Each separate use of a substance listed in Annex XIV must be authorized by the European Commission (not ECHA). Authorizations usually include conditions of use and a specified review period.
	Effective date was June 1, 2008, but Annex XIV was empty until February 2011.

This summary of REACH is designed to provide you with an accurate, easy-to-understand overview of the topic. However:
ê	We have not attempted to cover the implementation issues that need to be addressed at your company or in your supply chain. For this type of assistance, please email or call us at 972-679-8996 to inquire about our services.
ê	This summary does not constitute legal advice. The actual standard in the original language should be reviewed and used for all business, legal, and product compliance purposes.

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