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GB/T 41693-2022Identification guidelines for substances of very high concern (English PDF)

高关注化学物质评估判定导则

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

October 12, 2022

Implementation date

October 12, 2022

Scope

GB/T 41693-2022 is the English-translated version of 高关注化学物质评估判定导则.

GB/T 41693-2022 gives the guidelines for deciding whether a chemical substance is one of very high concern. It sets out the determination of CMR category 1 substances, of PBT substances, of vPvB substances and of substances of equal concern, and applies to the evaluation and determination of chemical substances of very high concern.

It defines SVHC as a substance presenting serious and irreversible hazards to people and the environment, and lists the groups covered, including substances such as endocrine disruptors for which there is scientific evidence of comparably serious effects.

It also defines carcinogenicity, mutagenicity and reproductive toxicity, and fixes a content of 80% or more for a substance carrying PBT or vPvB characteristics.

Clause 2 cites GB/T 24782 and GB 30000.24. It was issued on 12 October 2022 and has applied since 12 October 2022.

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Document preview — GB/T 41693-2022

National Standard of the People's Republic of China

ICS
13.300
Classification
A 80

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

1 Scope

This document specifies the determination of CMR category 1 substances, the determination of PBT substances, the determination of vPvB substances, and the determination of The determination of substances of equal concern.

This document is applicable to the evaluation and determination of chemical substances of very high concern.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 24782 Persistent, Bioaccumulative and Toxic Substances and Methods for Determination of Highly Persistent and Highly Bioaccumulative Substances

GB 30000.24 Chemical Classification and Labeling Specification Part 24: Reproductive Toxicity

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 SVHC

Chemical substances that present serious and irreversible hazards to humans and the environment.

Note: Include.

--- Substances with carcinogenicity, mutagenicity and reproductive toxicity (CMR category 1);

--- Substances with persistence, bioaccumulation and toxicity (PBT);

--- Substances with high persistence and high bioaccumulation (vPvB);

---Others have scientific evidence to prove that they can cause serious effects on humans or the environment, and are equally related to CMR substances, PBT substances or vPvB substances Substances such as endocrine disruptors.

3.2 Carcinogenic, mutagenic, toxic to reproduction; CMR

In adult males, mutations that may cause cancer or increase the incidence of cancer may result in mutations in human germ cells that can be passed on to offspring Substances with deleterious effects on (male) and female (female) sexual function and fertility and developmental toxicity to offspring.

3.3 Persistent, bioaccumulative and toxic substance; PBT

Substances that contain 80% or more of an ingredient with persistent, bioaccumulative and toxic characteristics.

3.4 Highly persistent and highly bioaccumulative substance; vPvB

Substances that contain ingredients with high persistence and high bioaccumulation characteristics in an amount of 80% or more.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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