EU - REACH Exemptions
Commission Regulation (EC) No 987/2008 Annex VI & V Exemptions from the Obligation to Register in accordance with REACH article 2(7)a
REACH (Regulation (EC) No 1907/2006) established obligations for manufacturers, exporters and downstream users for registration and evaluation of substances.
Article 2(7)(a) of that Regulation provides that certain substances are exempted from obligations as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties.
Two Annexes (Annex IV and Annex V) comprise the list of exempted chemicals. Annex V also includes descriptions but not CAS number lists of a large number of types of byproducts. It also includes minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal, if not chemically modified and other naturally occurring substances if not chemically modified and not PBTs and not otherwise identified in the legislation as well as a number of biobased substances. See text for more.
http://echa.europa.eu/documents/10162/13655/reach_factsheet_on_communication_obligation_en.pdf
Annex IV
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Annex IV essentially reproduced the list of substances exempt from the obligation to report information under the repealed Existing Substances Regulation (Regulation (EEC) No. 793/93).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 V
Annex V of Regulation (EC) No. 1907/2006 (REACH) sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACH because registration is deemed inappropriate or unnecessary and their exemption does not prejudice the objectives of REACH.
Substances included in Annex V are exempted from registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage at which they are manufactured or imported (currently or in the future). Annex V is mainly based on the reporting rules for the EINECS Inventory and reflects the experience in the operation of the Directive 67/548/EEC on classification, packing and labelling of dangerous substances, as collected in the Manual of Decisions (MoD) to this Directive. In addition, Annex V contains a number of changes made during the legislative procedure for the adoption of REACH.
Article 138(4) mandated the Commission to carry out a review of Annex V of REACH before 1 June 2008, with a view to proposing amendments, if appropriate. Recital 36 also required the review of Annex V to take into account the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes.
The Commission undertook the review of Annex V, taking into account the comments received by Member States and stakeholders.
As an outcome of the review, the Commission adopted the amendments of Annex V (as well as Annex IV) 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. The Commission is also planning an amendment to bring Annex V into line with the CLP Regulation which was adopted in the meantime.
In addition, the Commission services have prepared draft guidance on the interpretation of Annex V. This draft guidance represents at the current stage the views of the Commission services only. It was handed over to the European Chemicals Agency for further development, in co-operation with Member States and relevant stakeholders and for subsequent insertion into the Guidance on registration. As the draft document might be helpful to stakeholders in relation to registration and pre-registration, it is made available here.
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:268:0014:0019:en:PDF