ChemRegs Newsletter – April 2019
12th ATP to CLP
The European Commission (EC) has published an amendment to the CLP Regulation via an ‘Adaptation to Technical Progress’ or ATP.
The CLP Regulation implements the internationally agreed ‘UN Globally Harmonized System of Classification and Labelling of Chemicals’ (GHS) in the EU.
The GHS itself is updated, revised and improved every two years as needs arise and the current version is the 7th revision of the GHS (GHS Rev 7), published in 2017.
GHS Rev 8 is due for publication in July 2019 (see our October 2018 Newsletter).
The 12th ATP to CLP, Commission Regulation (EU) 2019/521 of 27 March 2019, will amend Annexes I to VI of the CLP Regulation to align CLP to GHS Rev 6 and GHS Rev 7, as currently CLP is only aligned with the GHS Rev 5 (issued in 2013).
Note – The 13th ATP to CLP was published in May 2018 (see our October 2018 Newsletter) and the 14th ATP is in the process of adoption (see our December 2018 Newsletter). This is because the time required for drafting, discussing and agreeing the ATPs means that they are not always published and adopted in numerical order.
Some of the main changes introduced by the 12th ATP include:
Annex I – A new hazard class for desensitised explosives (Category 1-4) and a new hazard category, pyrophoric gases (within the hazard class flammable gases ). Adaptations to: the criteria for substances and mixtures which in contact with water emit flammable gases, the generic cut-off values; the general provisions to classify aerosol forms of mixtures; and the detail of the definitions and classification criteria as appropriate for the hazard classes explosives, flammable gases, flammable liquids, flammable solids, acute toxicity, skin corrosion/irritation, serious eye damage/eye irritation, respiratory and skin sensitisation, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity and aspiration hazard.
Annex II – The EUH Statement EUH 001 ‘Explosive when dry’ is deleted and many sections are renumbered.
Annex III – Hazard Statements H206, H207, H208 and H232 are added.
Annex IV – Corrected and revised Precautionary Statements.
Annex V – New hazard categories for flammable gases and a new hazard class desensitised explosives, have been added.
Annex VI: The new hazard categories for flammable gases and the new hazard class desensitised explosives, have been added in table 1.1.
The 12th ATP applies from 17 October 2020 to ensure that suppliers of substances and mixtures have time to adapt to the amended provisions, but these can voluntarily be applied earlier.
The amended provisions means that suppliers should take a systematic look at their products as they may need to re-classify substances and mixtures using the updated hazard criteria.
This may then affect any associated documentation such as Safety Data Sheets and product labels, which are required to be updated when new information becomes available that affects hazard classifications.
Other News
12 New substances to be added to REACH Authorisation List
The EC recently notified the World Trade Organization (WTO) its intention to add 12 new substances to the REACH authorisation list. Those substances will not be allowed to be placed on the market or used in the EU after a given date (“sunset date”), unless an authorisation is granted for their specific use, or the use is exempted from authorisation.
List of 12 Substances
| Name | CAS No | Concern |
| 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear | 68515-50-4 | Toxic for reproduction (category 1B) |
| Dihexyl phthalate | 84-75-3 | Toxic for reproduction (category 1B) |
| 2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3% of dihexyl phthalate | – | Toxic for reproduction (category 1B) |
| Trixylyl phosphate | 25155-23-1 | Toxic for reproduction (category 1B) |
| Sodium perborate; perboric acid, sodium salt | 10332-33-9 (monohydrate), 10486-00-7 (tetrahydrate) | Toxic for reproduction (category 1B) |
| Sodium peroxometaborate | 7632-04-4 | Toxic for reproduction (category 1B) |
| 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane or 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane | – | vPvB |
| 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) | 25973-55-1 | vPvB or PBT |
| 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) | 3864-99-1 | vPvB or PBT |
| 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) | 36437-37-3 | vPvB or PBT |
| 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) | 3846-71-7 | vPvB or PBT |
| diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) (ADCA) | 123-77-3 | Respiratory sensitiser (category 1) |
Proposed date of adoption: October 2019
Proposed date of entry into force: 20 days after publication in the Official Journal of the European Union.
ECHA releases new submission portal for poison centres
ECHA has released a new portal that allows companies to prepare and submit information on hazardous mixtures that can be used by poison centres.
Under the CLP Regulation, companies placing hazardous mixtures on the market have to provide information about these mixtures to the relevant national appointed bodies.
This information has to be provided in a harmonised format from 1 January 2020 for mixtures for consumer use, from 1 January 2021 for mixtures for professional use, and from 1 January 2024 for mixtures for industrial use.
The appointed bodies in Member States make this information available to poison centres so that they can provide rapid medical advice in the event of an emergency.
ECHA’s submission portal for poison centres is a secure, online way to centrally manage notifications – creating, submitting and following their status. It is based on the harmonised format which defines the information requirements set in the CLP Regulation.
The portal allows companies to notify several Member States in which they intend to place their products on the market with a single submission. This will reduce companies’ administrative burden and costs when submitting information on hazardous mixtures to appointed bodies in EU Member States and EEA countries. ECHA is not charging a fee for the use of the portal but some Member States may levy fees to cover their costs. Notifications submitted through the portal will be valid once the relevant Member State is ready to accept them.
Further improvements to the user interface and more functionalities will be implemented in future releases of the portal in July and November 2019.
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk