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Scheme to fulfil information requirements

   
 

Annexe VI of the REACH regulation describes a general scheme embodying four steps to be followed by the manufacturer or importer1 to fulfil the information requirements for registration:


fulfilling data requirements

Information gathering step

All existing data on the intrinsic properties of the substance to be registered should be gathered, irrespective of tonnage: human data, testing data (physico-chemical data, in vitro and in vivo data) and non-testing data (data obtained with predictive tools). Exposure data should also be collected to obtain insight into populations and compartments exposed, as well as the nature of the exposures, i.e. route, frequency and duration.

Such information may be obtained from a variety of sources such as in-house data of companies, from other manufacturers and importers (if there is an agreement on cooperation at this step) or, from databases or other sources in the literature. Acquiring results from non-testing methods would be especially important for substances for which testing data set is limited or non-existent.

The information gathered on physico-chemical and environmental fate properties, toxicity and ecotoxicity of the substance should be assessed for its reliability, relevance, and completeness2.


Consideration of information needs

The tonnage-triggered information requirements for REACH on physico-chemical, toxicological and ecotoxicological properties are described in column 1 of annexes VII to X. Specific rules for adaptation are provided in column 2 of these annexes, whereas general rules for adaptation of these standard requirements are provided in annexe XI. For substances manufactured or imported in quantities between 1 and 10 tonnes per year, information requirements on toxicological and ecotoxicological properties should only be provided for all “non-phase-in substances”3 and for “phase-in substances”4 meeting the hazard criteria specified in REACH annexe III.


Identification of information gaps

An assessment must be made of the adequacy of the available information for arriving at conclusions on hazard assessment, i.e.:

  • determine if the substance has to be classified, if yes define the classification and labelling.

For substances ≥10 tonnes per year,

  • determine if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB),
  • identify (a) dose descriptor(s) enabling the derivation of (a) concentration(s) of the substance below which adverse effects in the environmental sphere of concern are not expected to occur [PNEC(s), Predicted No-Effect Concentration(s)],
  • identify (a) dose descriptor(s) enabling the derivation of (a) level(s) of exposure to the substance above which a human group should not be exposed [DNEL(s)5, Derived No-Effect Level(s)].

If the available information is considered inadequate for at least one of the above objectives, further information is needed to fill data gaps on annexes VII to X.


Generation of new information or the proposing of testing strategies

When there is an information gap which cannot be filled by non-testing methods, potential registrants have to take action depending on the missing test/information:

  • when annexes VII and VIII apply, the registrant has to generate new information,
  • when annexes IX and X apply, the registrant has to prepare a testing proposal and submit this as part of the registration dossier to the European Chemicals Agency for its consideration.

Testing on vertebrate animals should always be the last resort.

It should be noted that REACH has several provisions to facilitate data sharing between registrants. Data collected through vertebrate animal testing must be shared (in exchange for payment).

General Decision Making Frameworks (GDMFs) have been developed in the Guidance on information requirements and chemical safety assessment. They elaborate on the procedures to be followed by the registrant in steps 1 to 4. The GDMFs are illustrated in the following schematic diagrams:


1. Non-EU manufacturers may appoint “Only Representatives” to fulfil the obligations of importers. Only Representatives are natural or legal persons established in the European Union and having sufficient background in the practical handling of substances and the information related to them. When an Only Representative is appointed, the non-EU manufacturer has the obligation to inform the importer(s) within the same supply chain of the appointment. Following such communication, the Only Representative takes up the role of the EU importers and fulfils their registration obligations.
2. Reliability: inherent quality of a test report or publication. Reliability of data is closely linked to the reliability of the test method used to generate the data. Relevance: the extent to which data and tests are appropriate for a particular hazard identification or risk characterisation.
3. Non-phase-in substances: substances that does not meet the definition of phase-in substances as given in the regulation.
4. A “phase-in substance” is a substance already manufactured or imported, under certain conditions, before the entry into force of REACH on 1 June 2007 (the article 3(20) of the REACH regulation gives the exact definition of a “phase-in substance”).
5. It may not always be possible to establish a quantitative DNEL via the identification of a concrete quantitative dose descriptor value. In these situations it may be possible nevertheless to define some quantitative or semi-quantitative dose descriptor or a qualitative approach that may also allow a conclusion that the use and handling of the substance may be regarded as adequately controlled.


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Prévention du risque chimique, France, 2007
This document is provided for information only and under no circumstances constitutes legal advice. The only authentic legal reference is the text of the REACH Regulation (Regulation (EC) n° 1907/2006).