ChemRegs Newsletter – September 2019
EU Commission consults on proposed REACH SDS changes
The European Commission has started a consultation on an amendment to Annex II of Regulation (EC) No 1907/2006 (REACH) concerning safety data sheets (SDS).
The amendment is 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.
The REACH regulation implements the rules on safety data sheets arising from the internationally agreed UN GHS, which is updated, revised and improved every two years as needs arise. The current version is the eighth revision of the GHS (GHS Rev 8) published in 2019.
The rules for safety data sheets are laid down in Annex II to REACH and have been revised and updated since REACH came into force to reflect the changes made from the various GHS revisions. The current amendment to Annex II reflects the fifth revision of the GHS rules for safety data sheets.
The consultation is seeking views to adapt Annex II to the rules for safety data sheets of the sixth and seventh revision of the GHS.
Also, as of 1 January 2020, Commission Regulation (EU) 2018/18812 amending Annexes I, III and VI to XII of REACH comes into force. Regulation (EU) 2018/1881 introduces specific requirements for nanoforms (extremely small forms) of substances. As information related to those requirements is to be included in the safety data sheets, the Commission believes that Annex II to Regulation (EC) No 1907/2006 should be modified accordingly.
Further, Annex VIII to Regulation (EC) No 1272/2008, (CLP) on harmonised information relating to emergency health response (Poison Centres) will allow, inter alia, the possibility that the unique formula identifier (UFI) be indicated only in the safety data sheet as regards hazardous mixtures supplied for use at industrial sites i.e. not be put on the label. It will also require for certain mixtures which are not packaged that the unique formula identifier be indicated in the safety data sheet. As operators need to comply with the relevant obligations of Annex VIII to CLP as of 1 January 2021, for reasons of consistency, Annex II to REACH should reflect those changes as well.
The Commission Communication of 7 November 2018 ‘Towards a comprehensive European Union framework on endocrine disruptors’ indicates that the Commission is assessing how to improve the communication through the supply chain for endocrine disruptors under REACH in the context of the work on safety data sheets. A number of specific requirements for safety data sheets have been identified as relevant for substances and mixtures with endocrine disrupting properties and Annex II needs to be modified accordingly.
The proposed changes are scheduled to enter into force from 1 January 2020. However, safety data sheets provided to a recipient before 1 January 2020 may continue to be used until 31 December 2022.
The draft amendments and the consultation feedback form can be found at https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2018-5250193_en
The consultation is open from 12 September 2019 – 10 October 2019 (midnight Brussels time).
Other News
Significant Changes and Amendments to the IATA 61st Edition (2020)
IATA has published a list of the significant changes and amendments in the next edition of the Dangerous Goods Regulations for air transport due to come into force from 1 January 2020.
The 61st edition of the IATA Dangerous Goods Regulations incorporates all amendments made by the IATA Dangerous Goods Board and includes addenda issued by ICAO to the content of the 2019–2020 edition of the Technical Instructions.
The full list is available for download from here and includes:
2—Limitations
2.3—Dangerous Goods Carried by Passengers or Crew
Some restrictions have been amended.
2.6—Dangerous Goods in Excepted Quantities
2.6.7.1—A new paragraph has been added mandating that the excepted quantity mark must be applied on one face of the package.
4—Identification
4.2—List of Dangerous Goods
Various amendments have been made to the List of Dangerous Goods, including the addition of “environmentally hazardous substance” into Column D against UN 3077 and UN 3082 to identify that packages must bear the environmentally hazardous substance in addition to the Class 9—Miscellaneous hazard label;
5—Packing
5.0.2.11: This has been revised to clarify the exception from the calculation of the Q value where the dangerous goods have the same UN number, packing group and physical state, to include the same net quantity.
Packing Instructions
The single packagings tables have been revised to better identify composite packagings. The revised tables now clearly identify exactly which composite packagings are permitted.
Various packing instructions have been revised, including PI 650, PI 960, PI Y960 and PI 968 to PI 970.
7—Marking & Labelling
7.1.3.1—Has been revised to specify that the limited quantity mark, environmentally hazardous substances mark and lithium battery mark, when required, must be applied on one face of the package. Where the marks are applied by means of a label, the label must not be folded or applied such that it appears on different faces of the package.
7.2.4.5—A sentence has been added to the provisions for the “Keep Away From Heat” label to identify that the label should be affixed on the same surface of the package near the hazard label(s).
8—Documentation
8.1.6.9.2, Step 6—Consistent with the change to the format of information for composite packagings in the single packagings tables in the packing instructions, and additional example of the description of the type of packagings has been added for a composite packaging.
Appendix A—There are a number of changes and additions to the defined terms in the glossary.
Appendix D—Contact details for competent authorities have been updated.
Appendix E—Changes have been made to the list of UN Specification Packaging Suppliers (E.1) and the Package Testing Facilities (E.2).
Appendix F—The list of Sales Agents (F.2), IATA Accredited Training Schools (F.3—F.5) and IATA Authorised Training Centres (F.6) have been revised.
Appendix H—The guidance material on development and implementation of competency-based training for dangerous goods has been extensively revised. All the draft provisions for Subsection 1.5 have been moved to Appendix I—Impending Changes.
Appendix I—A new appendix has been added to provide the detail of the changes that will come into effect as of 1 January 2021 based on the adoption of the changes arising from the 21st revised edition of the UN Model Regulations as well as the changes that have been agreed to date by the ICAO Dangerous Goods Panel for inclusion into the 2021–2022 edition of the Technical Instructions. These changes include:
● The changes proposed to Subsection 1.5—Dangerous Goods Training to reflect the implementation of competency-based training for dangerous goods.
● Updates to the provisions for infectious substances to include general information on Category A medical wastes.
● Updates to the list of dangerous goods, which includes four new UN numbers, three for explosives, UN 0511 to UN 0513 and UN 3549 for Category A medical waste. UN 2216 Fish meal, stabilized has been revised from Forbidden/Forbidden to being permitted on both passenger aircraft and Cargo Aircraft Only.
● A number of new and modified special provisions.
● Change to the lithium battery handling mark to permit the mark to be a rectangle or square of 100 mm x 100 mm. The reduced size mark minimum dimensions will change to be 100 mm wide x 70 mm high.
● Changes to Section 10—Radioactive Materials to reflect the changes adopted by the International Atomic Energy Agency to SSR-6 (Rev. 1) 2018.
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