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EU Updates REACH List of Hazardous Substances, Triggering Obligations on Economic Operators
23 July 2021
Earlier this month, the European Chemicals Agency (ECHA) announced that it has updated the EU’s Candidate List of Substances of Very High Concern (SVHCs). The List now contains 219 SVHCs. While the update does not (yet) ban any of the substances, economic operators including those hailing from Hong Kong should be aware of the substances newly added to the Candidate List. This is because of the various obligations – especially on articles producers – that are immediately triggered once a substance is added onto the List, as explained further below.
The 8 July announcement states that the list was updated after ECHA added eight new SVHCs to the Candidate List. This followed the SVHC identification process with the involvement of Member States’ representatives. Some of the newly added substances are used in consumer products such as cosmetics, scented articles, rubber and textiles. Others are used as solvents, flame retardants or to manufacture plastic products. Most have been added to the Candidate List because they are hazardous to human health as they are toxic for reproduction, carcinogenic, respiratory sensitisers or endocrine disruptors. The newly added substances are listed below:
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Substance name |
Examples of use or uses |
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2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers |
Cleaning agents, cosmetics, in scented articles, polishes and wax blends. |
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Orthoboric acid, sodium salt |
May be used as solvent and corrosion inhibitor. (The substance has not been registered under REACH). |
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2,2-bis(bromomethyl)propane1,3-diol (BMP); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA); 2,3-dibromo-1-propanol (2,3-DBPA) |
BMP: manufacture of polymer resins and in one component foam (OCPF) application. TBNPA: polymer production manufacture of plastics products, including compounding and conversion and as an intermediate. DBPA: registered as an intermediate. |
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Glutaral |
Biocides, leather tanning, x-ray film processing, cosmetics. |
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Medium-chain chlorinated paraffins (MCCP) (UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17) |
Flame retardants, plasticising additives in plastics, sealants, rubber and textiles. |
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Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP) |
Preparation of lubricant additive materials and of fuel system cleaners. |
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1,4-dioxane |
Solvent |
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4,4'-(1-methylpropylidene)bisphenol |
May be used in manufacture of phenolic and polycarbonate resin. (The substance has not been registered under REACH). |
Hong Kong sellers of, especially, articles, e.g., commonly used products such as toys, electronics and textile goods, may already be aware of the Candidate List, which is a list of substances that may have serious effects on human health or the environment. Substances on the Candidate List are also known as SVHCs, and are candidates for eventual inclusion in the Authorisation List (Annex XIV of the REACH Regulation). Once they are on the Authorisation List, companies will need to apply for authorisation to continue selling or using the substance in the EU after a so-called ‘sunset date’. SVHCs may also, in the future, be restricted by Annex XVII of the REACH Regulation, for use in goods (including consumer products) that are then sold to EU customers.
The main obligations that Hong Kong suppliers (of articles) should be aware of, and which are triggered once a substance is placed on the Candidate List, are the notification obligation and the provision-of-information obligations down the supply chain.
Inclusion on the Candidate List triggers notification and provision-of-information obligations under Articles 7.2 and 33 of the REACH Regulation, respectively. Under Article 7.2 of the REACH Regulation, the use of any chemical that is found on the Candidate List must be notified to ECHA by the EU producer or importer, whenever the SVHC concentration exceeds 0.1% weight by weight (w/w) of the article in question, in quantities totalling over one tonne per producer or importer per year. Only limited exemptions from this notification obligation apply. Importers and producers of articles containing a Candidate List substance have six months from the date of its inclusion in the list (8 July 2021) to notify ECHA.
Under Article 33 of the REACH Regulation, whenever an SVHC appears on the Candidate List, suppliers of articles containing it above a concentration of 0.1% (w/w) must also provide the downstream recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. Consumers also have the right to this information, but only on request. There are no tonnage thresholds or any exemptions whatsoever from this provision-of-information obligation. The obligation also applies immediately, upon the substance becoming an SVHC on the candidate list.
EU suppliers of substances on the Candidate List (supplied either on their own or in mixtures) have to provide their customers with a safety data sheet.
Since 5 January 2021, suppliers of articles on the EU market containing Candidate List substances in a concentration above 0.1% weight by weight must notify these articles to ECHA’s SCIP database. This duty comes from the Waste Framework Directive.
Please click on the following for the fully updated Candidate List, and for more information on the SCIP database.
- Chemicals
