REACH Annex II, compilation of SDS
A new regulation regarding compilation of the SDS came into force. It modifies REACH (1907/2006) Annex II (guidance on compilation of Safety Data Sheet). The aim is to implementthe features of the CLP regulation 1272/2008 on classification and labelling.
Transition deadlines for the Safty Data Sheets:
| *Substances | put on the market before the 1st of december 2010 and not submitted to the relabeling and repackaging obligation as amended in article 61, paragraphe 4, of the regulation (CE) n° 1272/2008 |
The SDS shall not be substituted by a SDS complying with annex II of the regulation 453/2010 before the 1st of june 2012. |
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| **Mixtures | put on the market before the 1st june 2015 and not submitted to the relabeling and repackaging obligation as amended in article 61, paragraphe 4, of the regulation (CE) n° 1272/2008 |
The SDS shall not be substituted by a SDS complying with annex II of the regulation 453/2010 before the 1st of june 2017 |
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| ***Fiches de données de sécurité | for mixtures supplied to any recipient at least once before june 2015 |
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Overview of the changes:
Integration of subheading in the SDS Annex II (annexes I et II), part B defines the new structure of the Safety Data Sheet: Chapters 1-16 with their subsections (ex: 15.2 Chemical Safety Assessment), that should appear. (Exception in chapter 3: depending on the product nature, only the subsection 3.1 Substances or 3.2 Mixtures shall appear. The information provided in subsections depends also on the existence of an exposure scenario in annex of the SDS.(ex: chapters 7.3 et 8.2)
registration numberReference to the registration number in chapters 1 et 3: Substances: The whole registration number shall appear in chapter 1. End-users and distributors can truncate the last 4 digits under certain circumstances( see chapters 1.1. a) et b)). Mixtures: In addition to the above requirements, the registration numbers of the substances (ingredients) shall appear in chapter 3.
Uses advised againstReferences to the uses advised against in chapter 1 and 16 (see chapter 1.2)
Emergency telephone numberReferences to the emergency information services: If an official advisory body exists, its telephone number shall be given. If availability of such services is limited for any reasons, such as hours of operation, or if there are limits on specific types of information provided, this shall be clearly stated.(see chapter 1.4)
Classification Annexe II, version 1: classification of substances according to the CLP regulation and the dDSD for substances, or according to the DPD for mixtures Annexe II, version 2: classification of substances according to the CLP regulation Chapter 2: If the classification, including the hazard statements and R phrases, is not written out in full, reference shall be made to Section 16 where the full text of each classification, including each hazard statement and R phrase, shall be given. Chapter 16: If the classification, including the hazard statements and R phrases, is not written out in full, reference shall be made to Section 16 where the full text of each classification, including each hazard statement and R phrase, shall be given.
Labeling Reference to the complete labeling in chapter 2 instead of chapter 15 (see chapter 2.2)
PBT or vPvBInformation on whether the substance or mixture meets the criteria for PBT or vPvB in accordance with Annex XIII shall be provided. (see chapter 2.3)
ImpuritiesThe chemical identity of any impurity, stabilising additive, or individual constituent other than the main constituent, which is itself classified and which contributes to the classification of the substance shall be provided (see chapter 3)
To download the revised Annex II regulation 453/2010 published at the OJ the 07/09/2010.
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