ChemRegs Newsletter – December 2019

REACH Committee agrees changes to EU SDS

The EU REACH Committee met last month in Brussels and unanimously gave a favourable opinion on the draft Commission Regulation amending Annex II to the REACH Regulation (EC) No 1907/2006.

Under the EU’s REACH regulation, hazardous chemicals manufactured in the EU or imported must be accompanied by a safety data sheet (SDS).

SDS contain information on properties and hazards, instructions for handling, disposal and transport, and first-aid, fire-fighting and exposure control measures.

Annex II of REACH gives the requirements for the compilation of SDS and describes what information should be included under each of the 16 headings of a SDS.

Annex II is based on the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The GHS (now on its 8th revised edition) is the basis of all the various classification, labelling and packaging of chemical regulations e.g. the EU CLP Regulations and also sets out the rules for the compilation of SDSs.

The current version of REACH Annex II only aligns the SDS with the 5th revised edition of GHS. The new regulation will amend REACH Annex II to update it and align it with the 6th and 7th revision of GHS and also with ‘poison centres’ notification requirements under CLP Annex VIII.

The proposed changes will apply from 1 January 2021 to reflect the need for operators to comply with CLP Annex VIII poison centre requirements from that date. This will allow the possibility that a unique formula identifier (UFI) be indicated only in SDSs regarding hazardous mixtures supplied for use at industrial sites. It will also require that the UFI be indicated in the SDS for certain mixtures that are not packaged.

Last minute adjustments to the new regulation state that CLP Annex VIII will determine in which cases a UFI shall or can appear on the safety data sheet, and from when. REACH Annex II will then indicate where it should be mentioned in the SDS.

Other amendments reflect changes from other REACH annexes to ensure safe use of nanoforms and specific SDS requirements for substances and mixtures with endocrine disrupting properties.

SDS will also be required to give, where available, specific concentration limits, multiplying factors and acute toxicity estimates for substances set in accordance with CLP.

It was decided that requiring operators who have already compiled safety data sheets to update them immediately in accordance with the provisions of the new Regulation would impose a disproportionate burden on them.

Therefore, it was decided that operators should rather be allowed to continue providing safety data sheets in accordance with the existing requirements of Annex II of REACH for a certain period. A transition period will apply, which runs from 1 January 2021 until 31 December 2022.

During this time, operators will be allowed to provide SDSs in accordance with the current REACH Annex II. However, the requirement to update with new relevant safety information or with an UFI will remain.

Once adopted by the Commission, the amendments will enter into force on the twentieth day after its publication in the EU’s Official Journal.

Other News

ADR name change

On 1 January 2021, the “European Agreement concerning the international carriage of dangerous goods by road (ADR)” will become the “Agreement concerning the international carriage of dangerous goods by road (ADR)”.

ADR was adopted by the UNECE in 1957 as a European agreement and has proved to be a successful example of the positive impact of international harmonization and cooperation on improving safety.

In addition to countries of the Pan-European region, Morocco, Tunisia and most recently Nigeria have now joined ADR, signalling increasing global demand for solutions for the safe transport of dangerous goods.  Other countries including Pakistan, Qatar, Jordan and Lebanon have expressed interest in joining. Some countries like Thailand are also integrating the ADR provisions, either fully or partially, in their national regulations.

Yet while ADR has been open to accession by all United Nations Member States since its entry into force in 1968, the “European” title of the agreement has proven to be a barrier to joining ADR for parliaments and legislative bodies in a number of countries.

For this reason, a protocol of amendment to remove the word “European” from the title of the ADR was adopted by a Conference of the Parties to the Agreement on Monday 13 May 2019.

By 30 November 2019, none of the 51 Contracting Parties had communicated an objection to the Secretary-General. Therefore, the amendment to the title of the ADR was deemed accepted and shall enter into force on 1 January 2021.

MERRY CHRISTMAS AND A VERY HAPPY NEW YEAR!!

We would like to wish you all a very Happy Christmas and a peaceful New Year.