Regulatory Developments

Important Changes to Annex II to REACH Come into Force January 1, 2021

December 16, 2020 PRINT

As 2021 begins, new safety data sheet (SDS) requirements in the European Union (EU) will enter into force. Commission Regulation (EU) 2020/878 of June 18, 2020, amends Annex II to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). The requirements for SDS layout and content appear in REACH, while the hazard classification criteria and labeling requirements are derivative of Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). The changes to the regulation apply starting January 1, 2021, with certain provisions in Article 2 that note that noncompliant SDSs may continue until December 31, 2022.

Background

Annex II to REACH provides requirements for the compilation of the SDS for substances and mixtures. It includes the format, content, and section-by-section directions for the development of an SDS for the European Union (EU). Amendments to Annex II were necessary to align the specific requirements for nanoforms, endocrine disruptors, and unique formula identifiers (UFI) into the various sections and subsections of the SDS.

Highlights of the major changes include the following:

  • Addition of the UFI and nanoforms in Section 1;
  • Inclusion of endocrine disruptors in Sections 2, 11, and 12;
  • New considerations for the disclosure of ingredients in Section 3;
  • Clarifications on content and order of details presented in Section 9;
  • New subsections in Sections 11 and 12;
  • Clarifications on maritime transport in Section 14 for bulk cargoes; and
  • Specific provisions for authorizations and restrictions in Section 15.

A more detailed discussion on a few of the more significant changes follows.

Section 1 Changes

Subsection 1.1, Product identifier, is amended to include consideration for nanoforms and a place for the UFI in Other means of identification. The UFI is a code that will be required on the label of all hazardous mixtures. Importers and downstream users must provide specific product information, including the UFI, for the use of poison centres. ECHA’s Poison Centres website provides tools and support to help generate the UFI. The UFI and the other information provided on the product will be used primarily by poison centres in the event of an emergency. A UFI code is needed for each mixture, and if the mixture composition changes, a new UFI will need to be generated. The UFI must be included in Section 1.1 of the SDS. Annex VIII, Classification, Labelling and Packaging (CLP), requires that poison centre notification (PCN) be made prior to January 1, 2021. The Product identifier subsection also includes the addition of specific language related to nanoforms. ECHA defines nanoform or nanomaterial as “…chemical substances or materials with particle sizes between 1 to 100 nanometres in at least one dimension.” If the SDS includes one or more nanoform of a substance, it shall be noted using the word “nanoform” in Subsection 1.1.

Endocrine Disruptors

Subsection 2.3 includes Other hazards and notes the requirement for listing substances that have endocrine disrupting properties at concentrations equal to or greater than 0.1% by weight. The new Subsection 11.2, Information on other hazards, includes consideration for information on adverse health effects caused by endocrine disrupting properties for substances identified in Subsection 2.3; similarly, the new Subsection 12.6, Endocrine disrupting properties, addresses information on adverse effects to the environment caused by endocrine disruption. Both Sections 11 and 12 discuss obligations to provide summaries for the information provided from assessment criteria established by REACH and Commission Regulations (EU) 2017/2100 and (EU) 2018/605.

Section 9

Section 9 changes include more flexibility and clarification on content. Of note, all physical and chemical properties presented in Subsections 9.1 and 9.2 can be provided in any order and in any format deemed appropriate. Each SDS is still required to include the properties listed in Subsection 9.1, Information on basic physical and chemical properties, but the order and format are not relevant. Expanded clarification is provided for the properties noted to assist in proper communication. Consideration for Subsection 9.2, Other information, should be made, as it includes the addition of properties specific to physical hazard endpoints from Part 2 to Annex I of CLP.

New Subsections in Sections 11 and 12

Sections 11 and 12 include the addition of new subsections. As noted in the endocrine disruption discussion above, new Subsections 11.2, Information on other hazards, and 12.6, Endocrine disrupting properties, are included as mandatory. The inclusion of Subsection 12.6 as Endocrine disrupting properties means a renumbering for subsections, as Other adverse effects is now Subsection 12.7 and no longer 12.6.

Section 14

Section 14 changes include revisions to Subsection 14.7, Maritime transport in bulk according to IMO instruments. This subsection title has been revised from Transport in bulk according to Annex II of Marpol and the IBC Code to clarify the requirements of this subsection and to provide further guidance on the information to be presented. This includes specific details for liquid bulk cargoes, including ship type and pollution category. For solid bulk cargoes, shipping names, consideration for harm to the pollution category marine environment according to Annex V of The International Convention for the Prevention of Pollution from Ships (MARPOL), and whether the bulk cargo is hazardous according to the International Maritime Solid Bulk Cargoes (IMSBC) Code, the cargo group are to be added.

Section 15

Section 15, Regulatory information, changes incorporate, in the existing Subsection 15.1, Safety, health and environmental regulations/legislation specific for the substance or mixture, the inclusion of Union level details for substance-specific provisions related to either authorizations or restrictions. The conditions of any provisions of restrictions or authorizations must be added to the SDS in Subsection 15.1. There are currently 54 substances noted on the authorization list, and ECHA notes as of June 2020 that more than 932 downstream users have been covered by granted authorizations.

Commentary

The CLP and REACH regulations are complicated. Amendments to Annex II of REACH will require format changes to existing SDS templates. The inclusion and revision of subsections will make spotting noncompliant documents easy for enforcement. Entities placing products in the EU market must consider template changes and a host of significant substantive additions, including the incorporation of the UFI code, nanomaterials, endocrine disruptors, restricted substances, and authorized substances. These additions increase considerably the complexity chemical and other product manufacturers face when placing products in the EU market. Ingredients disclosed in Section 3 will require careful review as Subsection 3.2.2(b) compels disclosure of substances meeting specific criteria that are not classified in accordance with CLP. This now includes disclosure of endocrine disruptors or substances that have endocrine disrupting properties at concentration at or greater than 0.1% by weight. An overarching challenge many face in this framework relates to the increasingly difficult task of protecting confidential business information. U.S. approaches to trade secret provisions on the SDS are generous. There are limited circumstances that require ingredient disclosure on products for use in the United States, but it is increasingly apparent that for the exact same product for use in the EU, even if a product does not meet the classification criteria in the EU, there remain requirements for ingredient disclosure at low concentrations.


 
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