NEW DATA ON SAFETY DATA SHEETS in Regulation (EU) 2020/878 REACH

Regulation (EU) 2020/878 of the Commission, dated June 18, 2020, amending Annex II of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), which can be found at the following link: http://data.europa.eu/eli/reg/2020/878/oj

PDFs:

This Regulation is structured as follows:

Article 1: Annex II of Regulation (EC) No 1907/2006 is replaced by the text in the annex to this Regulation.
Article 2: Notwithstanding Article 3, safety data sheets that do not comply with the provisions of the annex to this Regulation may continue to be provided until December 31, 2022.
Article 3: This Regulation shall enter into force twenty days after its publication in the Official Journal of the European Union. It shall apply from January 1, 2021.

This Regulation has been structured as follows:

Article 1: Annex II of Regulation (EC) No 1907/2006 is replaced by the text in the annex to this Regulation.
Article 2: Notwithstanding Article 3, safety data sheets that do not comply with the provisions of the annex to this Regulation may continue to be provided until 31 December 2022.
Article 3: This Regulation shall enter into force twenty days after its publication in the Official Journal of the European Union. It shall apply from 1 January 2021.

The amendment that led to this Regulation is motivated by the following:

(1) Annex II of Regulation (EC) No 1907/2006 sets out requirements for the preparation of safety data sheets used to provide information on substances and chemical mixtures in the Union.

(2) Regulation (EU) 2018/1881 of the Commission, which amends Annexes I, III, and VI to XII of Regulation (EC) No 1907/2006, will become applicable as of 1 January 2020. This Regulation introduces specific requirements for nanoforms of substances. Since information on these requirements must be included in safety data sheets, it is appropriate to amend Annex II of Regulation (EC) No 1907/2006 accordingly.

(3) The Globally Harmonized System of Classification and Labelling of Chemicals (GHS), developed within the framework of the United Nations, establishes internationally harmonized criteria for the classification and labeling of substances and chemical mixtures, as well as standards for safety data sheets. The Union has confirmed its intention to incorporate the GHS criteria into Union law.

(4) The instruments provided for by the GHS to notify the hazards of substances and mixtures are labels and safety data sheets. The GHS provisions relating to safety data sheets are included in Regulation (EC) No 1907/2006. Therefore, the requirements relating to safety data sheets set out in Annex II of that Regulation must be adapted to the standards applicable to safety data sheets under the sixth and seventh revisions of the GHS.

(5) Annex VIII of Regulation (EC) No 1272/2008 of the European Parliament and of the Council will allow, among other things, the unique formula identifier to be indicated on the safety data sheet only for hazardous mixtures supplied for use in industrial installations. For certain non-packaged mixtures, it will also require the indication of the unique formula identifier on the safety data sheet. For reasons of coherence, Annex II of Regulation (EC) No 1907/2006 must reflect those changes and indicate where in the safety data sheet the unique formula identifier must appear.

(6) The Commission Communication of 7 November 2018, «Towards a comprehensive EU framework on endocrine disruptors,» indicates that the Commission is assessing how to improve communication along the supply chain concerning endocrine disruptors covered by Regulation (EC) No 1907/2006, in the context of work on safety data sheets. A series of specific requirements for safety data sheets relevant to substances and mixtures with endocrine-disrupting properties have been identified, so Annex II of this Regulation must be amended accordingly.

Additionally, Section 14 of Annex II of Commission Regulation (EU) 2020/878 of 18 June 2020 makes it mandatory to include transport information in safety data sheets within the EU as follows:

[Section 14: Transport Information] This section of the safety data sheet shall provide basic information on the classification for transport or shipment by road, rail, sea, inland waterways, or air of the substances or mixtures mentioned in section 1. When this information is not available or not relevant, it shall be indicated.

Where appropriate, information on transport classification shall be provided for each of the following international agreements transposing the United Nations Model Regulations for specific modes of transport: the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), the Regulations concerning the International Carriage of Dangerous Goods by Rail (RID), and the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN), all implemented by Directive 2008/68/EC of the European Parliament and of the Council, as well as the International Maritime Dangerous Goods (IMDG) Code for the transport of packaged goods, the relevant IMO Codes for the maritime transport of bulk cargoes, and the Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI).

[14.1. UN Number or ID Number] The UN number or ID number (i.e., the four-digit identification number of the substance, mixture, or article preceded by the letters «UN» or number «ID») listed in the United Nations Model Regulations, IMDG, ADR, RID, ADN, or ICAO TI shall be indicated. The «ID» code is only applicable to the transport of ID 8000 by air.

[14.2. United Nations Official Transport Name] The official transport name shall be provided as established in column 2, «Name and Description,» of Table A of Chapter 3.2 «List of Dangerous Goods» of the United Nations Model Regulations, ADR, RID, and Tables A and C of Chapter 3.2 of the ADN, to which the technical designation in brackets shall be added as required, unless it has been used as the product identifier in section 1.1. If the UN number and the official transport name remain unchanged across different modes of transport, it is not necessary to repeat this information. Regarding maritime transport, in addition to the official transport name of the United Nations, the technical name corresponding to the goods transported under the IMDG Code shall be indicated.

[14.3. Hazard Class(es) for Transport] The hazard class for transport (and subsidiary risks) assigned to substances or mixtures based on their predominant hazard in accordance with the United Nations Model Regulations shall be mentioned. As for land transport, the hazard class for transport (and subsidiary risks) assigned to substances or mixtures based on their predominant hazard in accordance with ADR, RID, and ADN shall be mentioned.

[14.4. Packing Group] Where applicable, the packing group number according to the United Nations Model Regulations, as required in the United Nations Model Regulations, ADR, RID, and ADN, shall be indicated. This number is assigned to certain substances based on their degree of hazard.

[14.5. Hazards to the Environment] It shall be indicated whether the substance or mixture poses a hazard to the environment according to the criteria of the United Nations Model Regulations (as reflected in ADR, RID, and ADN) and whether it constitutes a marine pollutant under the IMDG Code and emergency response procedures for ships carrying dangerous goods. When the substance or mixture is authorized or envisaged for transport on inland waterways in tanker ships, it shall be indicated whether it poses a hazard to the environment only when transported on such ships in accordance with the ADN.

[14.6. Specific Precautions for Users] All specific precautions that the user should or must take or be aware of in relation to transport or movement within and outside their facilities for all relevant modes of transport shall be indicated.

[14.7. Bulk Maritime Transport under IMO Instruments] This heading is only applicable when goods are transported in bulk in accordance with the following IMO instruments: Chapters VI or VII of the SOLAS Convention, Annexes II or V of the MARPOL Convention, the IBC Code, the IMSBC Code, the BCH Code, or their earlier versions, namely, the IGC Code or the GC Code. As for bulk liquid cargo, the product name (if different from that mentioned in section 1.1) shall be indicated as required by the shipping document and in accordance with the name used in the product name lists in Chapters 17 or 18 of the IBC Code or in the latest edition of IMO Marine Environment Protection Committee Circular (MEPC.2). The required ship type and pollution category, as well as the IMO hazard class, shall also be indicated in accordance with Annex I, point 3, Part B, point (a), of Directive 2002/59/EC of the European Parliament and of the Council. As for bulk solid cargoes, the bulk cargo transport category shall be indicated. It shall be indicated whether the cargo is considered harmful to the marine environment under Annex V of the MARPOL Convention, regardless of whether it is a dangerous material only in bulk according to the IMSBC Code, and as a cargo group to be considered according to that Code. As for bulk liquefied gas cargo, the product name and required ship type shall be indicated according to the IGC Code or its earlier versions, namely, the IGC Code or the GC Code.