There is a special transitional regime for substances which were already manufactured or placed on the market before REACH entered into force. Such substances are called phase-in substances.

Companies benefit from the transitional regime if they pre-registered their substances by 1 December 2008 (or in certain circumstances, made a later pre-registration before the relevant registration deadline).

Substances that fulfil at least one of the following criteria may be considered as phase-in substances in accordance with REACH:

  • Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS)
  • Substances that have been manufactured in the EU (including the countries that joined on 1 January 2007) but have not been placed on the EU market after 1 June 1992
  • Substances that qualify as "no-longer polymer''

For these substances, the REACH Regulation sets the following registration deadlines:

30 November 2010
Deadline for registering substances manufactured or imported at 1 000 tonnes or more a year; substances that are carcinogenic, mutagenic or toxic to reproduction above 1 tonne a year; and substances dangerous to aquatic organisms or the environment above 100 tonnes a year.

31 May 2013
Deadline for registering substances manufactured or imported at 100-1 000 tonnes a year.

31 May 2018
Deadline for registering substances manufactured or imported at 1-100 tonnes a year.

ll substances that do not fulfill any of the criteria for phase-in substances are considered as non-phase-in substances. Normally, non-phase-in substances have not been manufactured, placed on the market or used in the EU before 1 June 2008, (unless they were notified under the Dangerous Substances Directive (67/548/EEC)).

Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance before they can manufacture or import the substance.

All substances notified under the Dangerous Substances Directive (also called NONS) are considered to be registered under REACH and ECHA has assigned registration numbers to all the notifications. The owners of the notifications can claim the registration numbers from ECHA.

IUCLID (International Uniform Chemical Information Database) is a software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances. It is a key software application essential for chemical industry to comply with the REACH legislation. The IUCLID tool will assist chemical companies globally in fulfilling their obligation to submit data (such as REACH registration dossiers) to the European Chemical Agency.

Data that can be stored and maintained with IUCLID  include information about:

  • The party running IUCLID  (production sites, contact persons, etc.)
  • The chemical substances, namely their:
  • Composition
  • Reference information, like CAS number, IUPAC name and other identifiers
  • Classification and labeling
  • Physical/chemical properties
  • Toxicological properties
  • Eco-toxicological properties
  • Any report relevant to the substance (e.g. study result, assessment)

The OECD and the European Commission have agreed on a standard XML format, called OECD Harmonised Templates (OHTs), in which most of the aforementioned data are stored for easy data exchange. IUCLID 5 was, in 2007, and is still today the first application that has fully implemented this international reporting standard.
Numerous parties are involved in the IUCLID Project that is managed in a joint effort by OECD and ECHA, helped in their tasks by OECD Member Countries, the Business and Industry Advisory Committee (BIAC) of OECD as well as by the entire IUCLID users community.

REACH-IT is the central IT system that supports Industry, Member State competent authorities and the European Chemicals Agency to securely submit, process and manage data and dossiers. These three parties each have access to specific functions of REACH-IT which they can use to fulfill their requirements under the REACH and CLP regulations. REACH-IT also provides a secure communication channel between these three parties to help them coordinate the processing and evaluation of data and dossiers.

The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (EC) No. 1907/2006 demands that manufacturers or importers of most chemicals into the EU above 1 ton per year will need to register the chemicals with the European Chemical Agency (ECHA) – no matter whether the chemicals are part of a pure substance, preparation or article.

We can help you design the right registration strategy to achieve full compliance for the REACH registration process. RRC Group can assist you in assessing data requirements, evaluating data and preparing registration dossiers. For non-EU manufacturers RRC Group can also perform the role of an Only Representative; for importers or EU manufacturers, we can act as your Third-Party Representative.

Our roadmap to a successful REACH registration includes:

1. Inventory
Identification of substances, volume information, use mapping and collection of in-house data.

2. Inquiry
For phase-in substances that have not been preregistered and all non-phase-in substances an inquiry process at ECHA will be performed before placing the substances on the market for the first time.

3. Late pre-registration
If applicable a late pre-registration will be performed to benefit from an extended deadline for REACH registration in June 2018.

4. Data evaluation
Collection of existing data on the chemicals from Substance Information Exchange Fora (SIEF) and literature research.

5. Determination of data gaps
Evaluation of data gaps in the REACH registration dossier.

6. Completion of data requirements
If applicable “grouping of substances and read across” and “(quantitative) structure-activity relationship” [(Q)SAR} will be applied to fill data gaps.

7. Chemical safety assessment (CSA)/Chemical safety report (CSR)
A chemical safety assessment (CSA) needs to be completed for substances subject to REACH registration in quantities of ten tonnes or more per year. The CSA is the process that identifies the conditions under which the manufacturing and use of a substance is considered to be safe. The chemical safety report (CSR) documents the chemical safety assessment undertaken as part of the REACH registration process, and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios.

8. Preparation of a test proposal
For chemicals above 100 tonnes per year that have data gaps new tests might be necessary. Testing on vertebrate animals is the last resort for obtaining missing information on a substance and to be able to meet the information requirements of REACH. Proposals for testing need to be submitted to ECHA to check that reliable and adequate data will be produced and to prevent unnecessary animal testing.

9. Dossier preparation and submission
All data for REACH registration will be brought together in IUCLID, the registration dossier is created, and submitted to ECHA via REACH-IT.

10. Material Safety Data Sheet and CLP Labeling
A safety data sheet and CLP compliant labeling of the product contain the chemical is created.