1) What is the REACH regulation?

The EU has adopted a new EU regulatory framework for the Registration, Evaluation and Authorization of Chemicals (REACH). It is based on Regulation (EC) No 1907/2006 of the European Parliament and the Council of December 18, 2006, and on Directive 2006/121/EC of the European Parliament and the Council of December 18, 2006, which amended Council Directive 67/548/EEC. The two documents were published in the Official Journal on December 30, 2006.

The REACH framework assigns greater responsibility to the industry to manage the risks from chemicals and to provide safety information on substances. The aim is to better protect health and the environment through better and earlier identification of the properties of chemical substances. At the same time, the EU chemical industry should improve its capacity to innovate and imporve its ability to compete.

2) Which chemicals are subject to REACH?

Chemical substances that are manufactured and imported into the EU in quantities above 1 ton per year (about 30,000 chemicals) are subject to REACH. Substances refers to any chemical element and its compounds in a natural state or obtained by a manufacturing process, including any additive necessary to preserve stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

For a detailed definition please see : ECHA Guidance for Identification and Naming of Substances in REACH

3) Are there any chemicals that are exempted from REACH registration?

Yes, several chemical substances are exempted from the general obligation to register. They include substances with yearly volumes of less than 1 ton, pharmaceuticals, pesticides, biocides, and polymers. Additionally, all substances or groups of substances referred to in Annexes IV and V are exempted from registration. For a complete list of exceptions please see: REACH final text

4) What are “phase-in” substances and why are they important?

Substances that are already on the market in the EU are considered “phase-in” substances and will need to be pre-registered in order to remain in circulation while the REACH registration process is underway.

5) Which companies are subject to REACH (registration)?

Companies (distributors, importers and downstream users) that introduce at least 1 ton per year of a substance covered by REACH into the EU market (around 30,000 substances) are subject to REACH.

6) Are NON–EU companies required to register?

Yes, if they import substances, preparations or in some cases articles via their own EU-presence into Europe, but no (not directly), if they are exclusively U.S.-based.

Companies which are exclusively U.S.-based can use their EU-importers or for registration. U.S. based manufacturers may also appoint an EU-based representative for the purpose of registration, called the only representative. The only representative can be a subsidiary, a consultant, or any natural or legal person with experience in chemicals handling.

Extensive information will be required from the U.S.-based companies by the importer or the only representative for the registration. They may pass the cost of registration on to the U.S. manufacturer. 

7) How will the registration process work?

The EU-based manufacturer or importer of a chemical substance should submit his registration dossier for the chemical substance to the European Chemicals Agency - ECHA. The registration process includes information on the properties, uses, and safe handling of a particular substance. A fee is associated with registration. For detailed provisions on the fees please see: Fee Regulation.

A registration must be prepared in the form of a dossier in IUCLID 5. Before submitting the registration to ECHA, a registrant needs to sign-up in REACH-IT and create an account via the REACH portal. The registration submission must contain the dossier and must be accompanied by a completed submission form.

The Agency will assign a registration number and a registration date to each registration dossier received and will immediately communicate this information to the registrant. Within 3 weeks of the registration date, the Agency will perform an automated completeness check of the dossier to ascertain that all elements required for the registration are included. If the registration is incomplete, the Agency will inform the registrant within these 3 weeks from the registration date which further specific information is needed and will set a deadline for completion of the dossier. More information about the registration process can be found here

8) What is REACH “pre-registration”?

Substances that are already on the market can be pre-registered. As with full registration, the process will be electronic. Only pre-registered substances benefit from the phase-in periods and can continue to be sold before full registration is complete. The pre-registration window is small, beginning in June 1, 2008  and ending in December 1, 2008. More information about the pre-registration process can be found here

9) When can I register?

The obligation to register applies from 1 June 2008.

Chemicals that shall be marketed in the EU in quantities of more than 1 ton and do not meet the definition of “phase-in” substances are subject to a full registration, before the substance may be imported to Europe. More information about the registration process can be found here

Chemicals which meet the definition of “phase-in” substances and which were properly pre-registered benefit from extended registration deadlines. These extended deadlines depend on the tonnage band and the hazardous properties of the respective substance and are 30 November 2010, 31 May 2013 or 31 May 2018. The more hazardous the substance and the higher the tonnage band, the earlier the “phase-in” substance must be registered. More information on the registration deadlines for phase in substance may be found here.

10) What is an "Only Representative"?

U.S.-based manufacturers of chemical substances, preparations or articles may appoint an EU based entity to act as its only representative for the purposes of REACH registration.

The appointment of an only representative is useful in cases in which a U.S. manufacturer does not want to rely on its EU-importers for registration. It may provide the U.S. manufacturer with a higher degree of control over the registration process and reduce its administrative burdens related to REACH.

Upon appointment, the only representative assumes the obligations of an importer. The only representative incurs the duty to pre-register and to register the substances, preparations or articles, takes part in the obligatory data sharing process and - to a certain extent – takes part in the communication processes.

Several entities in the EU offer only representative services.

11) What is a "Third Party" Representative?

During the data sharing process, it may become necessary to disclose information to other stakeholders which the holder of the information considers confidential. To protect the interests of companies that wish to remain undisclosed, REACH allows for the appointment of a so called third party representative.

The third party representative acts as the agent of the manufacturer or importer vis-à-vis other market players. The identity of the company which appoints a third party representative is not disclosed to other market players. Unlike the only representative, the third party representative does not become a registrant. The companies appointing the third party representative retain full legal liability for the registration.

To ensure that the identity of the manufacturer or importer is not disclosed by the authority, the third party representative must be appointed upon registration or – where applicable – upon pre-registration.

Several entities in the EU offer third party representative services.

12) What is the "evaluation" element of REACH legislation?

REACH evaluation is the examination and appraisal of the registration dossiers. Beginning with the largest volume items, the Agency will examine, in more detail, registration dossiers for substances. As a result, registrants may have to provide additional information. Individual substances may, once evaluated, be restricted at the EU level, or they may be subject to authorization.

13) Can I participate in a joint registration?

Yes. Joint registration is necessary on the basis of the so-called “OSOR” principle (one substance – one registration). Here is how it works: a “lead company” will submit its registration dossier, which other companies can refer to, as members of a kind of registration consortium. This has the advantage of reducing the fee involved. Joint registrations, however, still require an individual dossier from each participating company. Data sharing is mandatory. It is always mandatory for animal testing, and it is mandatory on request from previous registrants for non-animal testing. Relevant compensation is also required.

The mandatory sharing of data and joint submission of information is limited to technical data and in particular, to information related to the intrinsic properties of substances. Such sharing will not involve exchanging information on market behavior, in particular as regards production, sales, or market share. More information about the registration process can be found here 

14) What is REACH "authorization"?

REACH authorization is specific to usage and is required for substances qualified as ”substances of very high concern”. It has a time limit. These substances include carcinogens and chemicals that are mutagenic and toxic for reproduction (CMRs); substances which are persistent, bioaccumulative, and toxic (PBTs and vPvBs); endocrine disruptors and substances “which give rise to an equivalent level of concern”. The authorization element of REACH is independent of registration and evaluation, and it applies without tonnage limits. Substances with a volume that is under the one ton-per-year limit may also be subject to authorization, even if they do not have to be registered.

Sixteen substances, including a number of phthalates, have been identified for the first 'Candidate List' of Substances of Very High Concern (SVHCs). The Public Consultation on these selected substances is open until 14 August 2008. Substances on the Candidate List will potentially require Authorization for the EU market.

15) How is the "authorization" granted?

Applicants must do an analysis of substitutes and prove adequate control of the risk of the substance, or prove that the socio-economic benefits of the substance outweigh the risks and no alternative substances or technologies are available.

16) How to register chemicals in finished products?

Substances incorporated in articles, such as chemicals in toys, textiles, or computers, have to be registered if they are present in the article in quantities of over 1 ton per year, and are “intended to be released during normal or foreseeable conditions of use”. (A classic example of  a substance intended to be released from a article is the perfume from scented toys.)

Notification of substances in articles apply in the case of articles containing substances on the “Candidate list”. If the article contains a substance of very high concern (SVHC), included in the “Candidate list” of substances for authorization, the substance has to be notified if it is present above 1 ton and above the concentration of 0.1%. More information about the registration process can be found here

17) How can I prepare for registration as a manufacturer or importer?

• Identify the EU legal entity or entities that is or are importing a substance. (If you have more than one, it might be worthwhile to consider using an “only representative” in Europe.)
• Determine the annual volume for each REACH substance entering the EU per legal entity.
• Collect basic available information on each substance (CAS number, EINECS or ELINCS, properties, C&L info, etc.).
• Assess future needs: Identify information gaps such as which info you have been told to provide in the registration dossier but do not have.
• Remember that the pre-registration phase ends on December 1, 2008. You, your importer or your only representative must pre-register on time if you want to benefit from the extended registration deadlines for “phase-in” substances. Companies will be automatically included in a Substance Information Exchange Fora (SIEF) when they pre-register in order to share animal data and potentially join a consortium to submit a joint registration.
• Identify customers by substance.

18) Links

http://echa.europa.eu/home_en.asp
http://reach.jrc.it
http://ecbwbiu5.jrc.it
http://www.buyusa.gov/europeanunion/reach.html
http://wko.at/reach
http://www.lebensministerium.at
http://www.reachhelpdesk.at

The U.S. Commercial Service Austria thanks HCAER Consulting for their assistance in gathering and analyzing the information about REACH that appears on this website. For more information about REACH and the impact it will have on your business in Austria, HCAER offers an initial consultation for clients of the U.S. Commercial Service free of charge. In order to take advantage of this offer, please contact Dr. Norbert Wiesinger directly at: HCAER Consulting, Rudolfsplatz 3/12, 1010 Vienna, Tel. 0043 650 440 1391, Fax. 0043 1 53 32 4910, Web: http://www.hcaer.eu, Email: office@N0SPAM.hcaer.eu