Annex IV of Regulation (EC) No. 1907/2006 (REACH) sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACH as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties.
Substances included in Annex IV are exempted from registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage in which they are manufactured or imported (currently or in the future). Originally, Annex IV essentially reproduced the list of substances exempt from the obligation to report information under the repealed Existing Substances Regulation (Regulation (EEC) No. 793/93).
Article 138(4) mandated the Commission to carry out a review of Annex IV of REACH before 1 June 2008, with a view to proposing amendments, if appropriate. Recital 36 also required the review of Annex IV to take into account the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes.
The Commission agreed with the Member States and stakeholders a process for submission of proposals for amendments to Annex IV, criteria against which the proposals for amendment can be judged, documentation that should be provided and a timetable for completing this work. As part of the review, a study was commissioned to assess existing entries and proposals for amendments against those criteria.
As an outcome of the review, the Commission adopted the amendment of Annex IV (as well as Annex V) on 8 October 2008. Further details of the review process on these annexes are explained in a Commission Communication on Annexes I, IV and V and a related Staff Working Document as well as in the Final Report (Report, Appendix 1, Appendix 2, Appendix 3 from a contractor that was engaged by the Commission for the purposes of the review.
Annex IV of Regulation (EC) No. 1907/2006 (REACH) sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACH as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties.Substances included in Annex IV are exempted from registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage in which they are manufactured or imported (currently or in the future). Originally, Annex IV essentially reproduced the list of substances exempt from the obligation to report information under the repealed Existing Substances Regulation (Regulation (EEC) No. 793/93).Article 138(4) mandated the Commission to carry out a review of Annex IV of REACH before 1 June 2008, with a view to proposing amendments, if appropriate. Recital 36 also required the review of Annex IV to take into account the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes.The Commission agreed with the Member States and stakeholders a process for submission of proposals for amendments to Annex IV, criteria against which the proposals for amendment can be judged, documentation that should be provided and a timetable for completing this work. As part of the review, a study was commissioned to assess existing entries and proposals for amendments against those criteria.As an outcome of the review, the Commission adopted the amendment of Annex IV (as well as Annex V) on 8 October 2008. Further details of the review process on these annexes are explained in a Commission Communication on Annexes I, IV and V and a related Staff Working Document as well as in the Final Report (Report, Appendix 1, Appendix 2, Appendix 3 from a contractor that was engaged by the Commission for the purposes of the review.
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