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Commission Review of REACH Annexes

The Commission has the possibility to review and amend Annexes of REACH in line with Article 131. Several reviews were specifically mandated by Article 138 or other provisions in REACH.

Reviews are currently ongoing of the following Annexes:

  • Annex VIII – Standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more
  • Annex IX – Standard information requirements for substances manufactured or imported in quantities of 100 tonnes or more
  • Annex X - Standard information requirements for substances manufactured or imported in quantities of 1,000 tonnes or more
So far, reviews have been made of the following Annexes:

Stakeholder consultation

The Commission engaged Member States and other stakeholders on the reviews, in most cases in a sub-group of the REACH Competent Authorities (CA), the Competent Authority Sub Group for the review of the Annexes of REACH (CASG (Annexes)).

Annex I

Annex I of Regulation (EC) No. 1907/2006 (REACH) sets out the details of how to carry out a Chemical Safety Assessment and document it in a Chemical Safety Report. The Annex has been supplemented by a technical guidance document on Information Requirements and Chemical Safety Assessment.

Article 138(4) mandated the Commission to carry out a review of Annex I of REACH by 1 June 2008, with a view to proposing amendments, if appropriate. As an outcome of the review, the Commission services have concluded that it is currently not appropriate to propose an amendment to the content of Annex I. The reasons for this conclusion are explained in a Commission Communication on Annexes I, IV and V. The Commission is however planning an amendment to bring Annex I into line with the CLP Regulation which was adopted in the meantime.

Annex II

Annex II of Regulation (EC) No. 1907/2006 (REACH) describes what information should be included under each of the 16 headings of Safety Data Sheets (SDS).

Safety Data Sheets are an important element of hazard communication and provide a mechanism for transmitting appropriate safety information on classified substances and mixtures, and certain non-classified substances and mixtures, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s).

The Commission is planning an amendment to bring Annex II into line with the CLP Regulation and with the guidance on the preparation of SDS as laid down in the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) of the United Nations.

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.

Annex XI

Annex XI sets out the general rules for adaptation of the standard testing regime (waiving) specified in the information Annexes. Part 3 of Annex XI deals with substance-tailored exposure-driven testing for sections 8.6 and 8.7 of Annex VIII, Annex IX and Annex X, where, on the basis of the exposure scenario(s) developed in the Chemical Safety Report, testing may be waived.

The Commission was given the task to adopt practical criteria defining what constitutes adequate justification for waiving tests. Recital 38 gives guidance that the criteria should be based on experience gained through RIPs.

In May 2008, ECHA published the technical guidance document on Information Requirements and Chemical Safety Assessment. On the basis of the experience reflected in this guidance document and after consultation of stakeholders, the Commission prepared an amendment of Annex XI, which was adopted on 16 February 2009.

Annex XIII

Annex XIII sets out the criteria for the identification of persistent, bioaccumulative and toxic (PBT) substances, and very persistent and very bioaccumulative (vPvB) substances; it does not apply to inorganic substances.

As mandated by Article 138(5), the Commission carried out a review of Annex XIII by 1 December 2008. Recital 76 requires the criteria in Annex XIII to be reviewed taking into account current and new experience in the identification of these substances and if appropriate to be amended with a view to ensuring a high level of protection of human health and the environment.

The experience reflected in the technical guidance document on Information Requirements and Chemical Safety Assessment, from the PBT working group under Regulation (EC) No 793/93 and Directive 67/548/EEC and from  the Regulation 850/2004 on Persistent Organic Pollutants has been taken into account in the review of Annex XIII. The conclusion of the review is that an adaptation of the criteria for the identification of PBT and vPvB substances is necessary. The Commission has consulted the REACH Competent Authorities and stakeholders. A Commission Regulation amending Annex XIII is expected later this year.  The Commission plans to publish a note explaining the details of the review process on this site after the adoption.

Annex XVII

Annex XVII sets out the list of restrictions of the manufacture, placing on the market and use of certain dangerous chemical substances, mixtures and articles. The Annex contains the restrictions of the marketing and use of dangerous substances adopted since 1976 in the framework of Directive 76/769/EEC. In accordance with REACH Art. 141, Title VIII and Annex XVII came into force on 1 June 2009.

In consultation with all interested parties, the Commission carried out a revision of Annex XVII, to harmonise the terminology, to adapt the provisions to the definitions under REACH and to delete obsolete provisions.

In addition, the revised version includes the most recently adopted restrictions under Directive 76/769/EEC on PFOS, arsenic, mercury in measuring devices, 2(2-methoxyethoxy)ethanol (DEGME), 2-(2-butoxyethoxy)ethanol (DEGBE), methylenediphenyl diisocyanate (MDI), cyclohexane and ammonium nitrate.

The revised Annex XVII was adopted on 22 June 2009 and published on 26 June 2009.