The EU Issued Amendments To The Annex To The REACH Code.

In 2010,

The revision of annex I is mainly consistent with the regulation No 1272/2008, such as:

In the 0.6 part of the chemical safety assessment process, it is specified that when exposure to No 1272/2008 (New CLP regulation) is annexed I or when PBT or vPvB substances are evaluated, exposure assessment and risk characteristics assessment should be carried out.

For the 1.0.1 part, the assessment of human health should be based on the classification of No 1272/2008 and accordingly.

For the 1.1.3 part, all non-human information used to assess a specific effect on human beings and determine the relationship between dosage (concentration) and reaction (influence) should be submitted in a brief manner.

If possible, one or more forms can be used to distinguish in vitro tests, in vivo tests and other information.

The relevant test results (such as ATE, LD50, NO (A) EL or LO (A) EL) and test conditions (such as duration of test, path, mode) and other relevant information should be submitted in internationally recognized measurement units.

For the part 1.3.1, according to the standards of No 1272/2008, the appropriate classification and markup have been described and judged. As long as they are used, special concentration thresholds obtained by regulation No 1272/2008 Clause 10 and directive 1999/45/EC clause 4 and clause 7 should be submitted, if they are not included in No 1272/2008, the third part of annex VI should be demonstrated.

Evaluation should always include a substance that is in accordance with the regulations. No 1272/2008 classifications of carcinogenicity into 1A or 1B, and the mutation is classified as 1A or 1B, and the reproductive toxicity is classified as 1A or 1B.

For part 1.3.2, if the information is not sufficient to determine whether the substance is classified as a specific harmful category or category, the Registrar shall specify and prove that the decision taken in the end is reasonable.

For the second sentence in part 1.4.1, for some dangerous classifications, especially teratogenicity and carcinogenicity, information may not be able to determine a threshold, so it is necessary to establish a DNEL.

The 2.1 part, the hazard assessment of physical and chemical substances, aims at determining its classification according to the regulation No 1272/2008.

The revision of annex XIII is mainly supplemented by the requirements for screening and assessment of P, vP, B, vB and T properties, as well as information requirements for screening and evaluation of P, vP, B, vB and T properties.