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Dry goods sharing, the latest EU SDS update requirements analysis!
Release time:
2020-07-20 17:31
On 26 June 2020, the European Commission published an amendment to Annex II to REACH (COMMISSION REGULATION (EU) 2020/878). In combination with the requirements of the revised REACH regulation, the revised GHS of the United Nations and the new Annex VIII of CLP, the document revised the requirements for the preparation of the Chemical Safety Data Sheet (SDS) in Annex II of the REACH regulation and revised some contents and formats of the EU version of SDS. Applicable to all EU Member States.
Xin Anrun has analyzed and summarized this revision. This revision has absorbed the new requirements for SDS compilation in the 6th and 7th revisions of the United Nations GHS system (the United Nations GHS system is currently the 8th revision), and has considered the update requirements of other relevant laws and regulations. The main revision contents are as follows:
1. SDS Part 1-Product Identification
1.1, nano-form substances should be marked "nano-form"
Amendments to the REACH Regulation (COMMISSION REGULATION (EU) 2018/1881), with effect from 1 January 2020, amendments to Annexes I, III and VI to XII of the REACH Regulation will enter into force. According to regulations, due to the difference of particle size, shape, surface treatment, crystal type and surface area of the same nano-material, the subsequent hazard classification and data requirements may be different, and the information must be reflected in SDS.
1.2. If there is UFI in accordance with Annex VIII of GLP regulations, UFI shall be provided.
If a mixture is assigned a Formula Uniqueness Identification (UFI), and the product is not packaged or is a hazardous mixture product for industrial use, according to Part A of Annex VIII of the CLP Regulation, the UFI needs to be provided in section 1.1 of the SDS instead of displaying it on the label.
2. SDS Part 2-Hazard Classification
Added a description of whether the substance has endocrine disruptors, including the following two aspects:
2.1, increase the information of endocrine disrupting substances, the specific classification of pure substances is as follows;
① Whether the substance is included in the authorization list of Annex XIV of the REACH Regulation because it is an endocrine disruptor.
Whether the substance meets the criteria for determining endocrine disruptors identified by (EU)2017/2100 or (EU)2018/605.
2.2 for mixtures where the content of such substances is ≥ 0.1%, this shall be provided.
3. SDS Part 3-Composition Information
The third part is about the display of component information of substances or mixtures. There are many new contents in this revision, which are divided into two parts: pure substances and mixtures:
① Pure substance
Specific concentration limits (specific concentration limits), M-factors and acute toxicity estimates (ATE) for substances, if known, need to be shown in this section.
② Mixture
This revision updates some of the concentration limits for the composition of substances that should be reflected in mixtures exceeding the concentration limits,
The following table shows:
Component Hazard Category | Common Generic Cut-off values | |
New | Old | |
Respiratory Sensitization Class 1A | ≥0.01% | ≥0.1% |
Skin Sensitization Class 1A | ≥0.01% | ≥0.1% |
respiratory hazard | ≥1% | ≥10% |
The mixture contains endocrine disruptors (according to (EU)2017/2100 or (EU)2018/605) at a concentration of ≥ 0.1%.
4,SDS Part 9-Physical and Chemical Properties
Part 9 is about the physical and chemical properties of chemicals, according to the United Nations GHS regulations (seventh revised edition). The physical and chemical parameters have been revised and added as follows:
New | Old | |
physical and chemical properties | Physical state (physical state) | 外观（Appearance） |
Kinematic viscosity (Kinematic viscosity) | Viscosity (Viscosity) | |
Color (Colour) | -- | |
颗粒特征（Particle characteristics） | -- |
In addition, this revision adopts the data related to physical hazards and other safety characteristics in Table A4.3.9.2 and Table A4.3.9.3 of the United Nations GHS Regulation (Seventh Revision) SDS Preparation Guide (Annex 4).
5. SDS Part 11-Toxicological Information
This part shows the health hazard information of the whole product, including the detailed information of 10 hazards such as acute toxicity and skin corrosion/irritation in GHS classification. On the basis of the original, "endocrine disruptor information" is added to explain the secretion interference characteristics.
6. SDS Part 12-Ecological Information
Section 12 presents product environmental hazard information, including acute and chronic aquatic hazards, bioaccumulation potential, soil migration capacity, etc. The description of "information on endocrine disruptors" was added on the original basis.
There is no specific test data on ecotoxicity, biodegradability and bioaccumulation, and model prediction data can be considered.
Summary:
This EU revision of the tight content, keep up with the United Nations GHS system update pace. Through the above interpretation, I hope you can have a general understanding of the content of this time. If you have any questions in the later period, please feel free to contact us.
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