Last reviewed 1 December 2020
In this feature, Caroline Raine discusses the recent second amendment of Annex VIII of CLP (poison centres) which takes into account some of the workability issues.
Importers and downstream users placing hazardous mixtures on the market, and distributors who modify the label or packaging for hazardous mixtures, need to notify the ingredients in those mixtures classified as hazardous for physical effects and/or health effects. These notifications under Annex VIII of CLP are harmonised and are made directly to the European Chemicals Agency (ECHA) via their poison centre portal.
The regulation introduces new requirements for the submission of information relating to emergency health response and for the inclusion of a “unique formula identifier” (UFI) in the supplemental information provided on the label of a hazardous mixture. Importers and downstream users are required to start complying with the requirements in stages, according to a series of compliance dates depending on the use for which a mixture is placed on the market. Consumer and professional use from 1 Jan 2021 and industrial use mixtures 1 Jan 2024.
Second Amendment of Annex VIII of CLP
The second amendment to Annex VIII to CLP, concerning poison centres was published in the Official Journal on 13 November 2020 and entered into force on 14 November 2020. This amendment includes sector-specific and cross-sector solutions by addressing the concerns raised by industry on the administrative burden for companies while still meeting the information needs of poison centres.
The amendment addresses the challenges associated with:
Standard formulations for mixtures with raw material of natural origin
Unique Formula Identifier (UFI) for point of sale paints.
Components may be grouped in a submission in an interchangeable component group as long as they meet several conditions. The purpose of the interchangeable components is to allow companies to buy the same chemical from different suppliers. The criteria to be met is for all components in the interchangeable component group, they must meet the following conditions:
the technical function(s) for which the components are used in the mixture for which the submission is made is (are) identical,
the classification for health and physical hazards is identical (hazard class and category),
the toxicological properties, including at least the type of toxicological effect(s) and the target organ(s), are the same.
In addition, for all possible combinations of the resulting final mixture based on the components in the interchangeable component group, the hazards identification and additional information referred to in Section 2 of Part B are identical.
Where components are classified only for skin corrosion, skin irritation, eye damage, eye irritation, aspiration toxicity, or respiratory or skin sensitisation, or a combination thereof, they may be grouped in an interchangeable component group provided that the following conditions are met:
the classification for health and physical hazards (hazard class and category) is identical for all components
the pH, where applicable, of all components classified for skin corrosion, skin irritation, eye damage, or eye irritation is either acidic, neutral or alkaline
he interchangeable component group does not contain more than five components
for all possible combinations of the resulting final mixture based on the components grouped in the interchangeable component group, the hazards identification and additional information referred to in Section 2 of Part B are identical.
Standard formulations for mixtures with raw material of natural origin
As it is more important for components of natural origin to meet defined standards rather than chemical composition, it is difficult to know the exact composition of the mixture containing such components. In cases like this, standard formulas may be used to deviate from the default limits outlined in Annex VIII.
The new amendment gives us defined standard formulas, specifying mixture composition (components identity and concentrations).
Mixtures with a composition corresponding to a standard formula can be notified according to that formula and deviate from the default Annex VIII concentration limits.
There are 20 standard formulas for cement, 1 standard formula for gypsum and 2 standard formula for ready mix concrete.
For those fuels listed in the table below, the identity and concentration of the mixture’s components listed in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006 may be submitted. The identity and concentration of any other known component shall also be submitted.
Product description Automotive fuels — Unleaded petrol
Automotive fuels — Ethanol (E85) automotive fuel
Motor fuels — special petrol for powered implements
Liquefied Petroleum Gas used as fuel
Liquefied Natural Gas used as fuel
Automotive fuels — diesel engine fuels with/without biofuel
Paraffinic diesel fuels (eg GTL, BTL or HVO)
Automotive fuels — Paraffinic diesel fuel from synthesis or hydrotreatment
Liquid mineral fuels with the characteristics of domestic fuel oil
MK 1 diesel
Automotive fuels — Diesel fuel oil of environmental class 1 and 2 for high- speed diesel engines
Aviation turbine engine and piston engine fuels
Kerosene — Illuminating paraffin
Illuminating paraffin lampoil Type B and C
Heavy fuel oil
All grades of heavy fuel oil
Marine fuels, containing or not biodiesel
Fatty acid methyl esters (FAME) — Diesel B100
Fatty acid methyl esters (FAME) for use in diesel engines and heating applications
Point of sale — bespoke paints
Unique Formula Identifier (UFI) for point of sale paints, a new article has been introduced to the regulation;
“In the case of a bespoke paint for which no submission in accordance with Annex VIII has been made and no corresponding unique formula identifier has been created, the unique formula identifiers of all the mixtures contained in the bespoke paint in a concentration exceeding 0,1 % which themselves are subject to notification under Article 45 shall be included in the supplemental information on the label of the bespoke paint, located together and listed in descending order of the mixtures’ concentration in the bespoke paint, in accordance with the provisions of Section 5 of Part A of Annex VIII.
In a case falling within the first subparagraph, where the concentration of a mixture with a unique formula identifier in the bespoke paint exceeds 5%, the concentration of that mixture shall also be included in the supplemental information on the label of the bespoke paint next to its unique formula identifier, in accordance with Section 3.4 of Part B of Annex VIII.
For the purposes of this paragraph, ‘bespoke paint’ means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing.”
In summary the new requirements are:
No need to notify the final point of sale mixture.
UFI of base paint to be printed on can of final point of sale paint
UFI of tinters also to be provided on final point of sale paint (eg via sticker)
If concentration of hazardous tinters exceed threshold (5%), the percentage of the tinter has to be displayed besides the UFI.
The latest amendment to the regulation gives clarity on the workability issues.
Companies should ensure that they meet their legal obligations by notifying hazardous mixtures for health and physical effects to ECHA in a timely manner to meet their legal obligations.