REACH Pre-Registration Starts June 1—Impacts Both Equipment and Material Suppliers
REACH (“Registration, Evaluation and Authorisation of CHemicals”) is an ambitious chemical strategy—replacing or augmenting 40 existing EU laws and impacting multiple industries. REACH will require manufacturers and importers to register substances they wish to place on the market in the EU above volumes of 1 metric ton (MT) per year (per manufacturer or importer), with some exemptions.
For certain substances currently on the market, REACH takes a phased approach to the registration requirements. A so-called ‘pre-registration’ period is provided from June 1, 2008 through December 1, 2008. If you pre-register, you can delay formal registration for up to 11 years. If you do not pre-register, you lose this advantage, and will have to register without delay. Dangerous substances not pre-registered or registered may not be placed on the EU market.
As a first step for pre-registration, both equipment and chemical suppliers will need to know what substances they are manufacturing and/or importing into the EU, and the expected volumes. Equipment suppliers also need to determine if their products constitute ‘articles’ which contain chemical substances intended for release under normal use conditions.
Additional steps in the later registration and evaluation processes include gathering relevant data/information. These may include registrant identity, type of chemical hazard, use category, risk management scenarios for identified uses, exposure arising from use, and some form of chemical safety report. In many cases, downstream users (e.g., semiconductor device makers) are in the best position to collect such information.
In addition to registration, REACH contains criteria that are independent of the imported or manufactured tonnage. These include the format and translation of a safety data sheet (SDS), the observation of particular restrictions on certain substances, the need for specific authorization to import or manufacture certain substances, and a requirement to provide classification and labeling information to EU authorities for any dangerous chemical that has not otherwise been registered.
Only legal entities established within the European Union will be recognized for any registration, pre-registration or other REACH related authority communications. Therefore, companies based outside the EU must coordinate with their EU affiliates for REACH conformance, or consider establishing a person or company for this work, known as a REACH ‘Only Representative.’
Overall, REACH will impact the entire semiconductor manufacturing supply chain. And, non-compliance in one part of the industry will create havoc for everyone across the supply chain. To avoid such catastrophic business risks, SEMI is working with member companies and partners to support industry-wide compliance measures.
How is SEMI involved in REACH?
REACH activities at SEMI involve education, awareness raising, knowledge sharing and advocacy. Separate working groups for equipment suppliers and chemicals suppliers are leading these activities. The former group is for member companies that make semiconductor manufacturing equipment, while the latter addresses companies that make chemicals/materials for semiconductor device manufacturing. SEMI is also actively participating with our partners in the supply chain. If you would like to assist your company and the entire semiconductor industry in complying with REACH, please contact Sanjay Baliga, (Senior Manager in the EHS Division), at firstname.lastname@example.org.
The following sections focus on the pre-registration process. In the future, SEMI will provide additional information on other REACH compliance steps. Please check out the SEMI website (www.semi.org/ehs) for more information.
What Should You Do Before Pre-Registration?
To help you determine your obligations under REACH, consider visiting: http://reach.jrc.it/navigator_en.htm#1. To help you fulfill your REACH legislation requirements, consider downloading free software from the Europe Chemical Agency. IUCLID 5 is free software to help you create, manage, store, view, and export data on chemical substances: http://echa.europa.eu/reach/software/iuclid_en.html. IUCLID 5 will work with a new REACH on-line software tool (REACH-IT). REACH-IT software will allow you to submit chemical information soon, but information is available now at: http://echa.europa.eu/reach/software/reachit_en.html
What is Pre-Registration?
REACH requires manufacturers and importers to register substances placed on the market in the EU in quantities greater than 1 metric ton (MT) per year (per manufacturer or importer), with some exemptions. Pre-registration is allowed for certain so-called “phase in” substances. Pre-registration is not required, but it allows you to benefit from extended registration deadlines. The pre-registration process is also appropriate for manufacturers and importers of ‘articles’ containing a substance that is intended to be released. Manufacturers, Importers or Only Representatives established in the EU may submit information to ECHA to benefit from the extended registration deadlines.
What are the Benefits of Pre-Registration?
Pre-registration allows you to continue manufacturing or importing ‘phase-in’ substances until:
Substance Properties/Yearly Volume
Deadline for Registration of Phase-In Substances
CMR7 1 t/y
Other substances 1000 t/y
30 November 2010
Other substances 100 t/y
31 May 2013
Other substances 1 t/y
31 May 2018
What if You Manufacture or Import Substances Below 1 Ton per Year?
Manufacturers and Importers of phase-in substances or article producers and importers containing phase-in substances in quantities of less than 1 ton per year do not need to pre-register (because REACH registration is not required). However, they can register based on their intention to manufacture or import the substance in quantities of 1 ton or more in the future.
Who Can Pre-Register?
The people who can pre-register include:
- Manufacturers and Importers (established in the EU) of phase-in substances on their own or in preparations.
- Producers and Importers (established in the EU) of articles containing substances intended to be released under normal or reasonably foreseeable conditions of use.
- “Only-representatives” of non-EU Manufacturers, Producers or Importers. An “Only Representative” is someone appointed by a non-EU Manufacturer to fulfill the obligations of Importer.
How do You Pre-Register a Substance?
Pre-registration takes place when you electronically submit to ECHA (European CHemical Agency) the required information on a substance. This information includes:
- The official name of the substance specified.
- The name and address of the pre-registrant and the name of the contact person, and where appropriate, the name and address of a Third Party Representative.
- The envisaged deadline for registration and tonnage band.
- The name of other substances that are relevant for performing adaptations to the testing requirements.
- Optionally, you can decide if you want to act as a "facilitator" in the pre-SIEF discussions.
- Note that pre-registration does notinclude information on the composition of the substance.
You can pre-register by using one of these two methods:
- By direct encoding of the information on the REACH-IT website (On-line pre-registration)
- By submission of a 'bulk' pre-registration prepared separately on a specified computer file format required by ECHA and uploaded at the moment of the On-line pre-registration. A bulk pre-registration allows Pre-Registrants to submit one (or more) file(s) with the pre-registration information for multiple substances. The file has to follow published ECHA guidelines.
What is a SIEF?
REACH provides for the formation of SIEFs (“Substance Information Exchange Forums”) to:
- Facilitate data sharing for the purposes of Registration (to avoid the duplication of studies)
- Help classify and label substances where there is a difference in the classification and labeling of the substance between Potential Registrants.
SIEF participants include:
- “Potential Registrants” (Manufacturers and Importers; Producers and Importers; “Only Representatives” of non-EU Manufacturers)
- “Data Holders” (including Downstream Users and Third Parties).
A SIEF is not a legal entity, but a forum to share data and other information on a given substance. Participants in a SIEF can organize themselves however they want to in order to carry out their obligations under REACH—for example, to share data, especially those involving vertebrate animal testing. There are cost sharing criteria envisioned for some SIEF activities.
For More Information
The above article is not intended to be comprehensive. It summarizes some REACH information from a European Chemical Agency Guidance Document on Pre-Registration and Data Sharing: http://reach.jrc.it/docs/guidance_document/data_sharing_en.htm
For a lengthy REACH “Q&A”, visit the European Chemical Bureau’s REACH Q & A: http://ecb.jrc.it/documents/REACH/REACH_PROPOSAL/Questions_and_Answers_on_REACH.pdf.
In addition, visit the website at the European Chemicals Agency: http://echa.europa.eu/home_en.html