The EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation went into effect on June 1, impacting every company doing business in or exporting to Europe. As a result of the new legislation, all companies manufacturing, importing, distributing or using chemical substances (on their own, in mixtures or in articles) in Europe, are required to closely examine their chemical inventory for substances included in the regulation to ensure compliance.

REACH simplifies — but also complicates — the compliance work for companies manufacturing, importing or exporting into Europe. REACH is a European regulation, but as it regulates import of chemicals and articles into Europe, all companies doing business with Europe will be impacted.

Key components of REACH mandate the following:

• Registration of manufactured/imported chemical substances;
• Increased information and communication throughout the supply chain;
• Evaluation of some registered substances;
• Authorization for use of substances of very high concern;
• Restrictions: “Safety net”;
• The Chemicals Agency to efficiently manage the system.

The focus is on high-volume chemicals and on substances of very high concern.

Far reaching implications
The scope of REACH is vast, and there are several issues that could impact a company’s ability to gather the required data. Companies based outside of the EU may not be familiar with the regulation. For example, a paint manufacturer in the U.S. whose products are used in cars exported to Europe may find itself unexpectedly subjected to REACH. Such manufacturers may not know how to readily comply with the regulation. As such, importers will need to know the background of each substance used in their product, including European hazard classification and safety data sheets. Given the wide scope of the regulation, REACH is expected to have a huge impact on the supply chain.

Chemical manufacturers located in North America may also have a hard time complying with the new regulation. While U.S. regulatory bodies have in the past allowed manufacturers to claim “proprietary information” when completing forms, this is unacceptable under REACH. Manufacturers will now need to provide detailed information regarding the composition of all chemicals.

Another potential issue pertains to substance identification. REACH does not apply to mixtures, only substances, making it imperative that substances are properly identified. It is also important to determine if the substances are listed on EINECS (European Inventory of Existing Commercial Chemical Substances). Equivalent substances must also be identified so they can be grouped together under one substance under REACH.

How to prepare
Non-EU companies can prepare by establishing a good and reliable inventory of all chemicals (substances, mixtures and chemicals in articles) that are exported to EU. Each substance must be identified by CAS number, EINECS number, etc., and the amounts exported to EU must be known. All test data owned by the company must be identified, as it will likely need to be shared with other companies in the Scientific Information Exchange Forum (SIEF).

If the non-EU company uses mixtures for producing products that are exported to EU, the chemical composition of these mixtures must be known, as well as the producer of the substances. Eventually, the non-EU user who exports a product to the EU, and the producers of the constituent substances, will need to have agreement regarding which company will have responsibility for pre-registration and subsequent registration under REACH.

The European Substance Information System (ESIS) (http://ecb.jrc.it/esis/) provides information about which other companies manufacture or import substances today. This information can by used to start discussions with other companies related to data exchange.

Meeting registration and other requirements under REACH requires that a company have an EU subsidiary to do the work. Possible alternatives are to have the company’s EU customers register the substance(s), or appoint a representative. Outsourcing is also an option. In any case, the non-EU company has to play an active role during the pre-registration and especially during the registration of the substance(s). Depending on which solution the company chooses, request for information related to the pre-registration and the registration should be expected from the EU customers.

The REACH Implementation Projects (RIPs) can be downloaded from the home page of the European Chemicals Bureau (http://ecb.jrc.it/REACH).

SIDEBAR: Easing the burden

Working with an outsourced solution provider can help ease the burden of complying with REACH. An outsourced solution provider can offer the following:

• Training — to help identify responsibilities and establish an action plan.
• Portfolio analysis — by establishing an inventory with role (M/I or DU), tonnage, classification (current and EU/GHS) and registration requirements.
• Obtain raw material MSDSs and full composition of mixtures.
• Assist with substance identification.
• Identify possible registration, authorization and restriction requirements.
• SDS preparation.
• Assist during the registration process.