Editor’s note: ISHN is pleased to introduce this new column authored by leading EHS authorities at ORC Worldwide. Their insights into emerging EHS issues will appear bimonthly.
The European Union’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) took effect June 1, 2008, replacing 40 laws governing industry’s use of chemicals within the European Union (EU). In this column we will focus on REACH’s most immediate requirements that are already affecting U.S. companies doing business in the EU.
Industry’s first REACH information requirements, commencing on June 1, are as follows:
Pre-registration for phase-in substancesThis consists of a simple declaration of the company’s identity and address, a point of contact, the chemical’s identity (e.g., name; CAS number; EINECS or ELINCS numbers*; and other identifiers), an expected registration deadline and tonnage band based on the amount manufactured or imported per year, and the identity of reference substances that may be used to model the chemical’s physical or biological effects.
Pre-registration is only available between June 1 and November 30, 2008, for phase-in substances under REACH. Pre-registration allows companies to delay for several years the deadline for submitting a detailed REACH dossier on the chemical’s hazards and use activities.
Inquiry on substance registration statusThis is the alternative notification under REACH for non-pre-registered substances and is required for any substances manufactured or imported at one tonne per calendar year or more. Under REACH inquiry requirements, sale and import of a substance must be suspended from June 1, 2008, until the inquiry process is completed and a registration dossier has been submitted.
Submission of either an inquiry or a pre-registration from each legal entity that manufactures or imports a particular chemical into the EU in quantities of one tonne or more per calendar year allows the European Chemicals Agency (ECHA) to organize potential registrants into Substance Information Exchange Forums (SIEFs). SIEFs will serve as information collection and dossier development committees, and will include representatives from potential registrants.
Early pre-registration or inquiry submission provides companies an opportunity to play a lead role in managing the pre-SIEF decision-making process that will formally identify the chemical, while meeting the pre-registration deadline of December 1, 2008, can avoid suspensions or bans on the chemical’s importation or manufacture
Critical aspects of industryâ€™s pre-registration under REACH
- Each existing legal entity in the EU must submit a separate pre-registration in order to use the delayed dossier deadlines. Due dates for submitting the dossier for a pre-registered substance are based on the average annual quantity of the chemical that a legal entity imported into the EU or manufactured during the past three calendar years:
- 1,000 tonnes per year or more require registration by November 30, 2010.
- 100 – 1,000 tonnes per year require registration by May 31, 2013, except substances very toxic to aquatic organisms (i.e., R50/53) that are due November 30, 2010.
- At or above 1 tonne per year requires registration by May 31, 2018, except carcinogenic, mutagenic, or reproductive toxics (CMRs) that are due November 30, 2010.
- Substances not eligible for pre-registration are identified in the EU’s EINECS database and include the substances considered already registered under Directive 67/548/EEC, as well as certain products covered by the Plant Protection Product Directive (98/8/EC) and the Biocidal Product Directive (98/8/EC).
- Companies located outside of the EU must appoint an EU-based “Only Representative” to submit pre-registration information on their behalf. The Only Representative must be proficient in the practical handling of substances and knowledgeable about information related to them. Non-EU manufacturers have an obligation to notify direct and non-direct customers, including importers, about the appointment, since the Only Representatives are required to maintain data on customers, customer’s uses, and importation quantities.
- Pre-registration incurs no fees or costs and need not be followed by a registration for the chemical. It can be a place-holder even if a company’s supplier is expected to take responsibility for the registration of that chemical. (Note: pre-registration information will be available to all potential registrants of the substance, although a potential registrant can appoint a “Third Party Representative” to protect its identity and association with a particular chemical.)
- Pre-registration can be submitted either through the REACH-IT Web site or by submitting a bulk data file to the ECHA. During pre-registration, companies can withdraw and resubmit their pre-registrations with revised information.
- During pre-registration, a company can indicate that it is willing to act as a “facilitator” in the pre-SIEF discussions that will determine the “sameness” of the substances identified by pre-registrants.
- The first pre-registration submitted for a chemical will cause the REACH-IT system to create a dedicated Web page, which will share contact information with other pre-registrants of that substance, and with pre-registrants of reference substances to be used in modeling the chemical’s physical or biological effects.
- Pre-registration is also available to first-time manufacturers and importers of a chemical for a limited time period bounded by six months from the date that a company’s manufacture or importation of the chemical first exceeds the one tonne threshold, and 12 months before the deadline that applies to the relevant tonnage band. Pre-registration of the 1,000 tonnes per year or more band is available until November 30, 2009; for 100 tonnes per year or more, it is available until May 31, 2012; and for chemicals at or above 1 tonne per year, pre-registration will be available until May 31, 2017.
- ECHA must publish a list of pre-registered substances by January 1, 2009. This list will identify the substance and the first expected registration deadline, along with the identities of reference substances that are expected to be used in modeling the chemical’s effects. Companies should review the list of pre-registered substances to assure that chemicals in their supply chains will continue to be available. For materials not listed, companies will be given the opportunity to list their need for the chemical at the ECHA Web site to identify new suppliers.
* EINECS: European INventory of Existing Commercial chemical Substances – contains approximately 100,200 substances.
ELINCS: European List of Notified Chemical Substances – contains approximately 4,380 substances.
ORC Worldwide is an international management and human resources consulting firm. Its occupational safety, health and environmental offices in Washington and Sacramento, Calif., consult on technical compliance and regulatory/policy issues. ORC’s Washington office is home to several meeting groups and networks for EHS executives, occupational health and safety physicians and lawyers, and environmental managers. ORC’s meeting groups and network members share best practices and benchmarking information during their meeting cycles and through informal surveys requested by members. ORC Worldwide can be contacted at (202) 293-2980; email@example.com; its Web site is www.orc-dc.com.